The Emerging Biotech Leader

In this episode of "The Emerging Biotech Leader" podcast, host Ramin Frahood speaks with Helen Kargaryani, VP Global Head of Quality/Quality Services at SSI Strategy. With over 30 years of experience in the pharmaceutical and biotech industries, Helen shares her expertise on quality and risk management. 

Risk management in these industries is a critical process that helps companies identify, prioritize, and mitigate potential issues affecting their operations, compliance, and financial stability.  "Quality is the ultimate goal” Helen explains. “A Quality Management System maintains quality, while risk assessment helps us identify and mitigate risks to quality. Together, these three elements build a solid platform for compliance in the company." 

The approach varies between organizations based on their specific business, stakeholders, and patients served. 

Key Takeaways: 

Proactive risk management is essential for biotech and pharma companies:It helps avoid regulatory issues and financial losses, working in tandem with quality management systems (QMS) to ensure effective compliance. 

Risk management should be tailored and integrated: Strategies need to be customized to a company's size, resources, and specific needs. Importantly, risk management should be integrated into company-wide strategy and culture, not isolated to a single department. 

Common pitfalls in risk management can have severe consequences: Many companies fail by either not including risk management in strategic planning or not implementing it effectively. This can lead to regulatory non-compliance, financial losses, and potential product shortages affecting patients. 

Early implementation is crucial, especially for startups and small biotech firms: Even with limited resources, companies should start implementing risk management early on a small scale, ensuring their approach is scalable as they grow. 

This episode provides valuable insights into the critical role of quality and risk management in the biotech and pharmaceutical industries, based on Helen’s extensive professional experience and perspective. 

If you'd like to discuss how you might apply these learnings to your own context, contact us at letstalk@ssistrategy.com  

This episode offers critical insights on leveraging risk management as a strategic advantage in medical device development. In a conversation with Ramin Farhood, Bijan Elahi, with over 30 years of experience, provides a roadmap for integrating safety considerations into innovation pipelines, potentially accelerating time-to-market and enhancing competitive positioning. 

Key Strategic Takeaways: 

Early integration of risk management, starting at the concept stage, can significantly reduce costs and accelerate time-to-market. This approach can level the playing field between firms of different sizes and serve as a market differentiator. 

Bijan emphasizes the balance between innovation and safety, noting that firms demonstrating significant benefits, especially in underserved areas, may find more regulatory flexibility. 

Risk-based approaches are increasingly expected across all business operations. Implementing this holistically can improve efficiency and reduce vulnerabilities in supply chain and manufacturing processes. 

Strategic Implications: 

Prioritize early investment in risk management capabilities for long-term cost savings and faster market entry. Consider risk management expertise in key hires and partnership decisions. 

Use risk management insights to refine product pipeline strategy, focusing resources on projects with the highest likelihood of regulatory success and market acceptance. 

Foster a company-wide culture of safety and risk awareness. This aligns with regulatory expectations and can drive responsible innovation. 

Robust risk management practices can serve as a powerful narrative for investors, demonstrating foresight and responsible innovation. 

By integrating these insights, companies can potentially accelerate development timelines, enhance their competitive position, and build a reputation for responsible innovation that resonates with regulators, partners, and customers alike. 

Are you leading a biotech and would like to share your experience with our podcast audience? We'd love to hear from you! Please reach out to us. 

The latest Emerging Biotech Leader podcast tackles the important topic of patient-focused drug development, offering valuable insights for the biotech industry. Our host Kim Kushner engages in an insightful dialogue with Dr. Laurie Smaldone-Alsup, SVP Regulatory Science at SSI Strategy, who brings years of hands-on regulatory experience to the conversation.

Laurie’s career, spanning from pioneering HIV/AIDS treatments to her current work in rare diseases, underscores a powerful message: patients are not just beneficiaries of drug development, but essential partners in the process. She explains how early collaboration with patient advocacy groups can transform the development process, providing invaluable insights that shape everything from clinical trial design to regulatory strategies.

The discussion explores the delicate balance between scientific rigor and patient needs, particularly in the context of rare diseases. Laurie offers practical advice on educating regulators, developing meaningful endpoints, and building a solid foundation of disease understanding. Her approach challenges the notion that speed always equals progress, advocating instead for a thoughtful, patient-centric strategy that may initially seem slower but ultimately leads to more successful outcomes.

Another often overlooked challenge is getting boards and investors to support a patient-focused approach. Here Laurie shares strategies for convincing stakeholders of the long-term benefits, even when they're focused on short-term results.

This episode is more than just a discussion; it's a call to action for the biotech industry to reimagine drug development with patients at its core. For leaders and innovators in the field, it provides not just food for thought, but actionable strategies to enhance their approach to drug development and, ultimately, improve patients' lives.

If you'd like to discuss how you might apply these learnings to your own context, contact us now.

On this episode of Emerging Biotech Leader, Kim Kushner sits down with Edward M Kaye, M.D., CEO and director of Stoke Therapeutics, to talk about his work in rare disease drug development.

Throughout their conversation, Ed describes the challenges of first-in-class drug development. He explains the importance of understanding diseases thoroughly and the value of natural history studies. He also discusses making the case for long-term research to investors and the lack of established roadmaps.

What stands out is Ed's emphasis on putting patients at the center of the drug development process - not just as a tagline, but in practical, impactful ways. He talks about how Stoke includes patients in their work, from getting input on trial designs to keeping patient groups informed about company updates. This approach, Ed argues, not only benefits the patients but also de-risks development by ensuring the end product truly meets patient needs.

When it comes to success in biotech, Ed takes a broad view. He explains that while drug approval matters, the real aim is ensuring patients can access and use the treatments. This involves working with various healthcare systems and considering patient costs.

For biotech leaders tuning in, Ed offers some straight talk on building company culture and the sometimes lonely reality of the CEO role. It's a conversation that gets into the weeds of biotech leadership while never losing sight of the ultimate goal: creating meaningful therapies for patients who need them.

This conversation with Ed Kaye offers a practical look at the realities of biotech leadership and rare disease drug development. Whether you're new to the field or an experienced executive, Ed's insights provide valuable perspective on balancing scientific innovation, business challenges, and patient needs in the pursuit of new therapies.

Are you leading a biotech and would like to share your experience with our podcast audience? We'd love to hear from you! Please reach out to us.

Summary:

In this episode, host Kim Kushner is joined by Dr. Chantal van Gils, a leading expert in evidence and value strategy at SSI Strategy. Building on the previous podcast discussion with Christian Howell of Cognito, this episode delves into three key themes:1) differing evidentiary requirements for medical devices versus pharmaceuticals, 2) the critical importance of patient-focused drug development, and 3) strategies for getting buy-in to invest in real-world evidence generation.

Chantal explains the historical divide between the evidentiary burdens for drugs versus devices is narrowing as innovative companies push the boundaries. The role of real-world evidence is becoming increasingly vital - not just for post-market surveillance, but to help define the problem that needs solving and guide the entire clinical development journey.

Chantal emphasizes that RWE data is critical not just for regulatory approvals, but for convincing payers and patients of a product's value in the real world. She shares insights on how leading companies are building the business case and narrative around building real-world evidence as this strategic imperative.

Overall, this conversation offers a nuanced, forward-looking perspective on the evolving evidence standards shaping the biotech and medtech industries. Chantal's expert insights and the relatable style make this a must-listen episode for anyone seeking to understand the changing landscape and stay ahead of the curve.

If you'd like to discuss how you might apply these learnings to your own context, contact us now.

This episode features an interview with Christian Howell, Chief Commercial Officer at Cognito Therapeutics, a biotech company pioneering a neurotechnology approach to treat Alzheimer's disease. Christian draws on his diverse background spanning the military, medical device giant Medtronic, and now the biotech industry.

The conversation covers Cognito's evidence generation strategy to demonstrate the value of their non-invasive neural stimulation therapy. As Christian states, "It's critical to bring all the key players to the table early and be fully transparent about your data - that's how you build trust and alignment around value."

Key takeaways include:

With experience implementing value-based healthcare models at Medtronic, Christian also shares unique perspectives on driving innovation while developing novel therapies.

Learn from Christian’s approach spanning evidence generation, collaborative value demonstration, and creating an environment primed for breakthrough thinking.  Listen in and get inspired!

Are you leading a biotech and would like to share your experience with our podcast audience? We'd love to hear from you! Please reach out to us.

Episode Overview:

In this podcast interview, Ramin Farhood hosts Dr. Thomas Lönngren, an expert in drug regulation, approval, and market access. Thomas has an impressive career spanning over three decades, including a transformative tenure as the executive director of the European Medicines Agency (EMA). He currently serves as a strategic advisor, leveraging his experience to guide pharmaceutical companies and biotech through the complex landscape of regulatory approval and market access in the US and Europe.

A central piece of advice is the critical importance of early engagement with regulators, as he states, "Lesson number one, talk with the regulators first, and then you could start to build your regulatory strategy." This is especially important for novel modalities or complex products, allowing companies to shape their approach from the outset, understand the development path, and anticipate associated costs.

However, Thomas emphasizes that regulatory approval alone is insufficient for commercial success in today's landscape. Companies must also consider health technology assessment (HTA) and payer requirements, which can be more stringent than regulatory approval. Designing clinical trials with comparative data and incorporating real-world evidence from the start is essential to demonstrate meaningful value for patients and secure reimbursement.

Many biotech boards, particularly those dominated by US members, often overlook the global nature of the industry. Thomas advocates for boards to maintain a worldwide perspective, considering regulatory and access hurdles beyond just the US market. Failure to do so can result in costly delays and potential failure to commercialize a product successfully.

Looking ahead, he highlights emerging trends such as increased use of real-world data, remote monitoring of clinical trials, and joint HTA evaluations in Europe for oncology and advanced therapy products. Companies must stay informed of these developments and adapt their strategies accordingly.

Key takeaways:

Develop a regulatory strategy early, engaging with regulators for novel modalities.
Consider HTA and payer requirements from the outset, not just regulatory approval.
Design trials with comparative data and explore real-world evidence opportunities.
Boards must have a global perspective and understand requirements beyond the US.
Attract experienced biotech talent for leadership roles and functional experts.

If you’re facing similar challenges to those discussed in our podcasts, contact us now.

In this episode of the Emerging Biotech Leader podcast, hosts Kim Kushner and Ramin Farhood interview Keith Gottesdiener, President and CEO of Prime Medicine. They discuss Keith's unconventional career path, which spans roles as a physician, research scientist, drug development leader at Merck for over 16 years, and entrepreneurial biotech CEO at Rhythm Pharmaceuticals before joining Prime Medicine.

A key theme is Keith's approach of purposefully taking on new challenges outside his comfort zone at pivotal career junctures to expand his skills and experiences. He began as a practicing physician and research scientist, spending around eight years treating patients and conducting academic research. However, he found the slow pace of academia too limiting for his impatient, entrepreneurial mindset and what he wanted to achieve in life.

Keith talks about the transition to his first CEO role at Rhythm, where he had to quickly learn areas like fundraising, board management, and shaping the company culture despite his extensive pharma background. He emphasizes the criticality of building the right team with a collaborative, agile mindset suited for the biotech environment. Keith shares his philosophy that "People are really what makes a biotech great...you have the opportunity to form a culture that will allow biotech to succeed" and his methods for evaluating and recruiting talent aligned with the company's vision.

He contrasts the experiences of biotech company building versus his big pharma tenure at Merck, mentioning the need for flexibility and navigating funding challenges amidst the current constrained investment cycle while trying to rapidly scale Prime Medicine. The conversation also touches on Prime Medicine's new therapeutic approach via its proprietary technology, as well as Keith's perspectives on leadership and entrepreneurial mindsets.

Overall, the episode provides insights into the multifaceted skillset required to lead ambitious, transformative scientific endeavors as a biotech entrepreneur.

Are you leading a biotech and would like to share your experience with our podcast audience? We'd love to hear from you! Please reach out to us.

In this engaging episode of the Emerging Biotech Leader podcast, Kim Kushner, Ramin Farhood, and Jackie Levine discuss the key lessons learned from the previous conversation with Dr. Dan Bloomfield, CMO at Anthos Therapeutics. The trio focuses on the challenges biotech companies face when building organizations with evolving goals, the important role of leaders as connectors, and the magnitude of self-awareness and humility in effective leadership.

Jacqui emphasizes the significance of collaboration as well as introspection, stating, "It's about being self-aware and having a good understanding of what your strengths are and where there might be some gaps, whether it's in a particular expertise or a skill, and then being able to pull in the right people."

The hosts explore strategies for biotech companies to balance current needs with long-term objectives while maintaining organizational flexibility. They highlight the value of leaders who actively build connections across different departments, enabling them to become more strategic thinkers and partners.

The conversation sheds light on the key attributes of effective biotech leaders, emphasizing the importance of humility and the ability to trust and empower their teams to drive success in a rapidly evolving industry.

If you’re facing similar challenges to those discussed in our podcasts, contact us now. 

In this episode of the Emerging Biotech Leader podcast, hosts Kim Kushner and Ramin Farhad speak with Dr. Dan Bloomfield, Chief Medical Officer of Anthos Therapeutics. Dan generously shares insights from his diverse career that has spanned academia at Columbia University, over a decade at big pharma giant Merck across multiple leadership roles, and most recently entrepreneurial biotech startups.

A central theme that emerges in the discussion is the immense value Dan found in intentionally gaining cross-functional exposure early and often throughout his career. This allowed him to develop a well-rounded perspective and understand the critical interdependencies across an organization's many components. 

Dan openly shares how when stepping into new roles interfacing with specialized teams like discovery and R&D, he'd be upfront with not knowing the intricacies of the things that are just common knowledge to senior scientists. While he understands the overarching goals, the finer operational details fall under the deep know-how of those teams. This humble approach shows an openness to learn from and leverage the subject matter experts around him. As Dan puts it, "I won't be able to tell you how to run an assay or select compounds, but I'll guide our overall direction."

Dan emphasizes the importance of actively seeking out opportunities to learn about different disciplines and roles. By expressing genuine curiosity about the expertise of others, he has been able to rapidly expand his own knowledge base. 

The conversation also covers insights Dan gained on the importance of proactively managing board and investor expectations through radical transparency about risks, timelines, required resources, and potential roadblocks at each stage. 

Dan also shares his perspectives on strategically building the optimal team makeup through a thoughtful combination of full-time hires and leveraging external consultants or contractors based on the inflection points on the horizon. This allows reserving capital while still accessing specialized expertise when needed.

Overall, this interview is packed with hard-won wisdom on leadership development, making the transition from bureaucratic big pharma to lean, innovative biotech environments, attracting top talent, and cultivating an entrepreneurial mindset. Dan's authentic sharing of experiences offers highly applicable lessons for biotech professionals in executive roles.

Dan’s key takeaways:

Are you leading a Biotech and would like to share your experience with our podcast audience? We ‘d love to hear from you!  Please reach out to us. 

In this episode of the Emerging Biotech Leader podcast, hosts Kim Kushner and Ramin Farhad are joined by Bob Honigberg to further discuss the considerable challenge of achieving bold missions in healthcare. Building on their discussion from Episode 28 where they interviewed Cleerly Health founder Dr. Jim Ninh, the episode provides useful perspectives for any mission-driven biotech seeking to prove game-changing healthcare concepts. What does it take to achieve major goals that could reshape patient outcomes worldwide?

Bob emphasized the most important hurdle companies face when pursuing daring healthcare mission. He noted that "Large, well-designed studies proving impact on outcomes as well as cost are needed for clinical adoption, regulatory approval, and reimbursement. This level of evidence takes significant investment." 

Bob's point highlights the challenge of gathering robust clinical data at meaningful scales. This perspective resonates throughout the conversation, as generating rigorous evidence through extensive studies is consistently referred to as the foundational requirement for proving solutions and achieving ambitious goals that could transform patient care.

Some key points were made about generating robust clinical evidence to support these missions:

In summary, Kim, Ramin and Bob made it clear that delivering on bold missions in healthcare requires tackling the difficult challenge of generating robust clinical evidence through extensive studies. While an audacious vision can motivate teams, that alone is not enough - proven impact must be demonstrated to realize the transformation.

Tune into the full conversation, where our team unpack this issue in greater depth and discuss creative ways that industry pioneers are overcoming these barriers.

"I believe that we can eradicate heart attacks from this world...If we can leverage these tools to accomplish those three goals, whether it's in coronary heart disease, valvular heart disease, myocardial disease, et cetera, et cetera, I think that's going to not be a slight improvement. I think it's going to be a game changer in terms of improving patient care and outcomes." ~ Jim Min, Founder and CEO at Cleerly

In healthcare, there is a constant need for innovation and improvement. One company making significant strides in this field is Cleerly Health, founded by Jim Minh. In a recent discussion, Jim and Ramin Farhood, a leading cardiologist, delved into building a research-based business organization and transitioning from prevention in the clinic to prevention at scale. They also explored the challenges of driving behavior change in the medical community to enable prevention. We will closely examine their insightful conversation and the groundbreaking work being done at Cleerly Health.

Building an Asset in Clinical Practice

Cleerly Health, founded in 2017, has emerged as a prominent player in the healthcare industry. With a focus on creating a standardized and personalized care pathway for coronary heart disease, the company leverages imaging and end-to-end artificial intelligence (AI) to achieve its goals. Cleerly Health aims to provide a comprehensive evaluation, education, treatment, and tracking system for patients with heart disease

Jim, a former cardiologist at Cornell Medical College and New York Presbyterian Hospital, has firsthand experience with the effectiveness of personalized medicine in cardiology. However, he realized the need to scale this approach and automate certain processes for more accurate insights. This realization led to the founding of Cleerly Health, with the goal of optimizing personalized medicine in cardiology using imaging technology and AI.

One of the critical challenges that Cleerly Health faced during its early stages was the feasibility of its approach. Developing algorithms, obtaining FDA clearance, and securing reimbursement from insurance payers were all significant hurdles. Despite these challenges, the founders remained determined to change the standard of care for heart disease prevention radically.

Cleerly Health focused on building a business that had a strong research foundation. This foundation was crucial for obtaining coverage and reimbursement from insurance providers. The company realized that in the healthcare industry, high-quality science is necessary to drive commercial growth.

Driving Behavior Change in the Medical Community

To achieve its ultimate goal of preventing heart disease and heart attacks, Cleerly Health adopted a disease-based approach to cardiovascular evaluation and treatment. This approach places emphasis on treating individuals with disease rather than waiting for symptomatic manifestations. Currently, the majority of heart attack patients do not exhibit symptoms before their events, underscoring the need for a shift in the current symptom-driven model.

The company is currently focused on treating the symptomatic population but is also pursuing a large-scale randomized control trial called the Transform study. This trial aims to study the efficacy of Cleerly Health's approach in the asymptomatic population. By expanding patient identification and treating individuals proactively, they hope to improve outcomes and reduce costs in the long run.

The Future of Cardiology and Digital Therapeutics

While Cleerly Health is making significant strides in the field of cardiology, it is not the only player focused on improving patient outcomes. Verily, a company that combines technology, science, and healthcare, is also working on developing technologies for earlier disease detection, interventions, and more personalized healthcare. Verily has developed advanced algorithms that analyze medical imaging data to predict the risk of cardiovascular disease.

Adopting digital therapeutics, such as software-based interventions, has also gained momentum. These interventions can improve patient outcomes, reduce healthcare costs, and increase access to care. However, challenges and barriers still need to be overcome for widespread adoption, including reimbursement and data privacy issues.

Cleerly Health is at the forefront of revolutionizing the field of cardiology. Through their innovative approach, leveraging imaging and artificial intelligence, they are working towards standardizing and personalizing care pathways for coronary heart disease. Their focus on comprehensive evaluation, standardized care, and personalized treatment highlights their commitment to improving patient outcomes and reducing healthcare costs.

As the future of cardiology unfolds, collaboration between companies like Cleerly Health and Verily, along with healthcare providers and regulators, will be crucial. The healthcare industry can strive toward a future where diseases like heart attacks can be eradicated by harnessing the power of advanced imaging and digital therapeutics.

Join us in our next episode as we continue exploring captivating topics in the dynamic world of biotech. 

Until then, keep pushing the boundaries of innovation and maximizing the value of your therapeutics.

We hope you enjoyed yet another informative Episode of the Emerging Biotech Leader. Please leave us a review or rate us on Apple or Spotify.

“I think outcomes for a lot of people means meeting milestones. So hitting that next clinical milestone, CMC milestone, et cetera, and that's, I think, one way of looking at it. Still, it's also about the culmination of outcomes and achieving something greater than bringing together one discipline and one win." ~ Adriana Valenciano, SVP, SSI Strategy

In this episode of the Emerging Biotech Leader podcast, hosts Kim Kushner and Adriana Valenciano discuss building an outcome-driven biotech company. The conversation focuses on three key themes: planning for globalization from the earliest stages of development, taking a multidisciplinary approach to defining milestones, and ensuring your team has the right skills at each growth stage.

Key Takeaways

Building an Outcomes-Driven Biotech

Achieving specific goals and milestones in biotech is crucial for organizations to thrive. This intentional results-oriented approach forms the foundational principle of being outcomes-driven. As Adriana explains, these outcomes go beyond clinical and CMC milestones; they encompass achieving regulatory buy-in, creating a straightforward patient-focused story, and ultimately moving the organization forward.

Planning for Global Success: A Multidimensional Approach

Regarding global success in the biotech industry, traditional paths may not always be the most efficient. While the default for many US-based companies is to run clinical trials in the US and seek FDA approval first, exploring other regions and countries as part of a global strategy can yield significant advantages.

Adriana highlights Canada's excellent centers and patient populations as a strategic platform for specific disease areas. Moreover, Europe may favor companies targeting pediatrics due to different regulatory requirements. Understanding the global regulatory landscape and what regulators prioritize in different regions is essential for successful international expansion.

A parallel development approach can also be advantageous, such as having a leader and a follower or running programs in parallel. In addition, economic benefits and reimbursement incentives in other parts of the world can support biotech organizations with limited funding. By considering these factors and taking a global approach, companies can accelerate their drug development process and increase efficiency.

Break Silos With A Multidisciplinary Approach

The biotech industry is composed of multifaceted challenges that demand a multidisciplinary approach. It is not enough for individual functions to address their own problems and milestones independently; cross-disciplinary collaboration is essential.

In smaller organizations, there is often a high level of connectivity and collaboration across disciplines. However, it is essential to remember that cross-discipline collaboration doesn't automatically account for organizational-wide planning. Influential leaders ensure that disciplines work together and collaborate seamlessly, allowing the team to build alternative strategies and adapt to new goals.

Adriana shares an example of a biotech company that had to reevaluate their strategy and bring the team together due to regulatory feedback. By involving different functions and data management, the team made necessary adjustments and successfully pivoted their approach. Motivation, collaboration, and good leadership were critical factors in adapting to new goals and adjusting plans.

The Power of Flexibility and Agility

Variables outside a biotech company's control, such as regulators, payers, feedback from the medical community, patients, and investors, can significantly impact outcomes and milestones. A balance between defining critical outcomes and key milestones while allowing flexibility and agility is crucial to navigating these uncertainties.

Adriana emphasizes that outcomes and milestones must be clear enough to rally the team and enable future iterations and adaptation. The ability to pivot and adjust strategy is paramount for success in the biotech industry, especially when considering complex regulatory landscapes, securing funding, and responding to changes in the market.

Looking Ahead for the Biotech Industry

Despite the challenges the biotech industry faces, there is cause for optimism. Improved funding opportunities, increased interest from investors, and alternative sources of capital have enhanced the landscape for emerging biotech companies. Moreover, the development of innovative therapies continues to address unmet medical needs, offering hope for improved patient outcomes.

As we conclude this episode, I thank our guest, Adriana Valenciano, for sharing valuable insights on building an outcomes-driven biotech. Defining intentional goals, embracing a multidisciplinary approach, and staying agile in response to change is essential for success.

Join us in our next episode as we continue exploring captivating topics in the dynamic world of biotech. 

Until then, keep pushing the boundaries of innovation and maximizing the value of your therapeutics.

We hope you enjoyed yet another informative Episode of the Emerging Biotech Leader. Please leave us a review or rate us on Apple or Spotify.

“Getting a drug to market is a change journey. The whole process is a change journey. And we pass through so many different stages and gates on the way there: we need to adapt almost regardless of circumstances, even if everything goes according to plan, we have to shift.” Johan Stromquist, President, NDA Group

As the quote above alludes, launching a biotech is never a linear journey. While there are tried and true processes and a documented multidisciplinary approach in bringing assets to market, adaptation to change is also required. 

And there’s no better trio equipped to discuss this vital topic–navigating change when planning and bringing innovations forward–than Kim Kushner, Doug Locke and Johan Stromquist. 

During this Episode, a first for Johan in the guest seat, you’ll hear a candid discussion on the various transformational stages organizations go through at major inflection points of growth, both funding and clinical. We hope you agree, this topic could not be more timely or relevant. Today’s market and landscape are forcing all sorts of change regardless of biotech companies being in the early stages of corporate build or, much further along in maturity. 

On that note, here are a few of the overarching themes to listen out for during this episode: 

Navigating people and resource sensitivities as a leaderHow to move past paralysis analysis when revising the former plan for a new one Scaffolding regulatory pieces as a framework for planning Assessing when to bring in council, partners and vendors as a stop gap and expert resource

True to form in each episode of The Emerging Biotech Leader, there is so much more covered including the types of people you need on your team (build vs operate talent), their key strengths and how to ensure you have both at the right time. With that foundation set, let's delve into some of the quotes and soundbites from Episode 26. 

On Building, Fixing and Meeting Change Head On 

Kim kicked off this topic and conversation by first inviting Doug to weigh in on how leaders are thinking about their design–where to start and where to build–across inflection points. 

Here’s what he’s been seeing in terms of the market and shifts. “I've been in about 15 meetings in the last three months where our corporate sponsors, usually the CEO, sometimes the CMO, or R+D regulatory head, they're up against some major change in the company. I mean, we all know what's going on in the marketplace right now with the cost of capital: interest rate, debtor and lender agreements are tough. Some movement there is precipitating a fresh look. At the timeline of the company relative to market facing goals and capital, you know the questions are, ‘Can we afford this program? Do we need to look at what we were going to deliver and are we going to change the timeline? Do we need to change the timeline because we don't have the bandwidth we thought we had?’ All of those issues are on the table. So a lot of different use cases of, ‘I have plenty of capital, but what we have is unworkable. I have limited capital and I have a goal that's too grand. And what do we do about that?’ This is the basis of the inflection point you're talking about.” 

Doug goes on to detail the amount of people, processes and systems impacted by these changes. Leaders have to think through funding, the talent on the team, the marketplace, their board, and their investors as well.

If you should find yourself at a similar crossroads, Doug, Kim and Johan discuss how to start navigating this and here’s a hint. As cliche as it may sound, you don’t have to navigate it alone. 

Johan shares, “I think that one of the greatest signs of leadership is the courage to ask for help. I think that is so important when you find yourself in these quite precarious leadership positions in biotech companies.”

In terms of the types of changes leaders are evaluating, Doug does go on to clarify. “Some are looking for a form of major intervention, maybe like a RIF or total change of go to market and others are seeking counsel. I.e ‘How can I make this happen?’”

As you’ve heard on the show before, it isn’t uncommon for early stage biotech founders and teams to have a lot to figure out. Kim sheds more light. “There's the concept that organizations in their earliest stages are trying to figure out, ‘Where do I build my initial programs? What country am I going to for my phase 2 because that seems to give me the greatest path forward from a regulatory perspective? And I need to figure out, ‘How am I going to get to market sooner than later somewhere?”

On the opposite side of that early stage planning and analysis, is the “fix stage” that Doug described when kicking this conversation off. 

Listen more for Kim’s distinction between the two, early stage vs fix stage companies, around 4:40. 

As a key contribution to this topic, Johan shared that regardless of stage, building a biotech and getting a drug to market is a change journey. 

“Even if everything goes according to plan, we have to shift. We have to adjust and we have to make changes because the people in the lab coats are not the people that are going to run our trials and the people who are running our trials are not the people who are going to sell our product, right? So there are these really important transformation points that every company that ultimately becomes successful just has to go through.”

The Role of Regulatory In Planning 

Another key piece of advice and insight from Johan pertained to regulatory. “At the end of the line, it's going to be that regulatory approval that ultimately provides the culmination of all of these years of success. I think from my point of view, and having 

had the great fortune and honor of working in the regulatory space for the last 20 years, I think is very important. And it starts with scaffolding. I would say this is required to start forming the foundation for a meaningful plan and a meaningful organization going forward.”

Johan's answer sparked a follow up from Doug, “If I could pick up on a piece of what Johan just said, the sliver of work, the regulatory, I mean, that reminds me of a conversation last week. It was with a new CEO in an established company. It's a rebuild of sorts, right? New CEO in a company that has been around a bit. This CEO came from a company that was well funded and much larger. So they had a broader team, had a viable clinical organization, had a strong regulatory partner that reported to them, yet in the new company, it's not there. It's that trusted voice, that hallway. You know, walking down the hallway and getting a point of view, if not a more rigorous structured milestone type activity, it’s not there.”

We’ll let you hear for yourselves the main reason Doug felt compelled to share this story–it lays the groundwork for the next set of challenges a leadership team now needs to evaluate: the people part–specifically the build skillset vs the operate skillset. 

Kim shared a poignant perspective on this as well. “It is often not an FTE or a full-time mindset of what you need to get from A to B, but you do need to bring in ...

“The reality is that the earlier one thinks about and invests in a safety process and a safety system, the more dividends that early thinking pays downstream.” Dr. Greg Fiore

Harvard-Trained Physician. McKinsey Consultant. Startup Advisor. These are just a few of the titles that describe our next guest, Dr. Greg Fiore.   

As one might imagine, with these titles comes a unique lens and broad array of experience within the world of pharmacovigilance (PV). 

Expanding upon the topic of PV and safety from Episode 24, “Cultivating A Culture of Safety” with Dr. Jason Campagna, Greg, the CEO of Exacis Biotherapeutics, joins Amit and Ramin to carry the conversation forward–providing best practices and wisdom from his 25+ year career. 

During this interview, all three cover topics that emerging biotech founders should have top of mind when it comes to pharmacovigilance including: 

When to think about safety.What role AI might play in safety within the next few years and, The skill sets and strengths that a safety/PV career cultivates and relies on. 

As a fun fact, did you know? The etymological roots for the word “pharmacovigilance” are: Pharmakon (Greek) = medicinal substance, and Vigilia (Latin) = to keep watch. (Source: Fornasier G, Francescon S, Leone R, Baldo P. An historical overview over Pharmacovigilance. Int J Clin Pharm. 2018 Aug;40(4):744-747. doi: 10.1007/s11096-018-0657-1. Epub 2018 Jun 15. PMID: 29948743; PMCID: PMC6132952.) 

Back when Greg and Ramin first started their careers, pharmacovigilance had very little to no budget, and Greg even joked that he had to look the word up in the 

dictionary. Times have changed. As of today, LinkedIn shows 3,000+ pharmacovigilance roles available in the United States alone. 

What you’ll hear during this conversation as well is that a key piece to a PV career entails building and maintaining subject matter expertise as it pertains to regulations around safety especially mandated by health authorities such as the FDA (Food and Drug Administration) in the United States or the EMA (European Medicines Agency) in Europe. 

Before you settle in to listen to the full episode, take a quick glimpse at these overarching highlights. 

On His Start In PV/Safety 

If Greg’s various titles piqued your interest, here’s how a few of them came to be plus a backstory on how he made his way to safety. 

“I was training in internal medicine and went into a pulmonary fellowship up in Boston at Brigham and Women's Hospital. And at the time, many of my colleagues had transitioned into non-traditional medical careers. This is going back 25 years and that was much less commonplace than it is today. So I started to explore what else was out there, you know, where else I could learn new skills. And I stumbled across McKinsey and Company and subsequently joined the company a couple of years into my fellowship in pulmonary. I never even completed the pulmonary fellowship. While I was at McKinsey, I learned quite a bit. As I started to look into my next step, the pharmaceutical industry made a lot of sense to me. And I ended up having a conversation–as many of us do–with a recruiter who really caught my attention around a very unique role at a large pharmaceutical company who had just acquired another pharmaceutical company.

And they had budgets in many of the different functions to complete the integration activities, but the pharmacovigilance department did not have such a budget at that time. I had to look up the word pharmacovigilance because I really didn't know what it was actually back then. The job really was a hybrid of a medical role, pharmacovigilance physician, but also really taking the lead on the integration activities so it sounded great. It was in a wonderful city. And I made the move into that company. Very shortly after I joined, the integration project got put on hold for a bit. And immediately, I had to dive very deeply into the pharmacovigilance activities and learn about the single case reports and periodic safety update reports. So that was my introduction.”

On The Best Time To Start Safety 

Much like Jason advised in Episode 24, Greg wholeheartedly agrees that the earlier a biotech can think about safety, the better. But the key question here is why? 

“I can see how some of the thinking around safety and pharmacovigilance and more around the operational side of that can sort of get swept up in the onboarding of CROs and thinking about clinical sites, enrollment, and some of the activities that would seem to be, you know, much more on the radar screen of the investors, let's say in the outside world. The reality though, is that the earlier one thinks about and invests in a safety process and a safety system, the more dividends that early thinking pays downstream.”

One specific example Greg shares on those dividends is using a centralized, single integrated database. 

“Having a single integrated database with a single set of processes allows for the coding and codification of the safety information to be done in a very uniform way across the entire product life cycle so that when we're performing analysis when we 

go back to search for certain things, we don't have to remember how we used to code things, how information was handled, etc., in a legacy clinical trial.”

Greg goes on to share that if you fail to start your safety planning early, that doesn’t mean there aren’t ‘tried and true ways’ to jump in really at any stage in the process–however, the earlier, the better. 

Amit wanted to know more from Greg on how safety systems evolve. Is PV always outsourced? Should it be internal? External? Are there other ways to craft a model? As a follow-up to this, Ramin wanted to also hear more about hiring early. 

“Really what we see, I would say, uniformly across the industry is that there's some capabilities in house and some capabilities that are handled by third party providers. And the third-party providers really span a spectrum of contribution.” Greg dives into much deeper detail on this around 8:46 of the interview. As a quick Cliffsnote: more inside, less outside, or more outside, less inside depends on a lot of factors.

“It's a little bit hard to say, ’there's a cookie cutter model’, but it's quite straightforward when we get in there, and we interview leadership and we understand what their investors are thinking.”

On The Role of AI in PV 

The inspiration for the next point of discussion came from Amit and what he’s been seeing at industry events. 

“I was at a couple of drug safety conferences earlier this year, and a very hot topic right now is AI and Chat-GPT and how we're going to use artificial intelligence in the PV space specifically on looking at and managing the safety profile of an asset. We'd love to hear your thoughts around that to see and really understand where you think this could potentially go.” 

Here’s what Greg shared. AI has been on the radar of safe...

“Safety doesn't live outside of you. It's not a yellow ribbon that you wear in hospitals that says, ‘it's patient safety week.’ It's not a sign in your office that says, ‘this is patient safety month.’ It's a consequence of how we approach our work on a day-to-day and hour to hour basis. And it's by definition, therefore, an emergent property of who we are and how we engage with our work.” Jason Campagna

With great innovation comes great responsibility especially as it pertains to developing new and emerging therapeutics, devices and treatments–which is why we’re covering a new topic here on the show today. We’re focusing oncultivating a culture of safety. 

In previous episodes of the Emerging Biotech Leader, we have talked about various types of responsibility. There’s the responsibility of managing the team. There’s the responsibility of navigating cross-functional stakeholder relationships. We’ve even touched on the responsibility of presenting to the board. 

That said, today’s podcast topic of safety is just as pertinent. By textbook definition, safety is the condition of being protected from or unlikely to cause danger, risk, or injury. 

To help us navigate this topic from the lens of the biotech sector, we have two new voices on the show: Amit Patel, Senior Vice President at SSI Strategy and Jason Campagna, Chief Medical Officer at Q32 Bio, Inc. 

Q32 Bio is a biotechnology companydeveloping therapeutics targeting powerful regulators of the innate and adaptive immune systems, with the goal of re-balancing the immune system in severe autoimmune and inflammatory diseases.

Our main co-host, Ramin Farhood, Sr. Vice President of Medical Affairs Practice at SSI, also lends his thoughts, voice and observations on this topic as well. 

Back to our featured guest. When it comes to safety, Jason Campagna’s expertise is extensive and vast. He's been a licensed physician leader who's practiced in academic, clinical medicine and private practice. He’s held roles in hospital administration and he’s worked and served on boards in industry as well. 

We’re thrilled to have Jason as a guest for many reasons including the opportunity to discuss how he prioritizes and strives to cultivate a culture of safety in any organization he leads. If the quote at the top of the page is any indication of his interview style, Jason holds no punches and offers insights that are clear, direct and compelling. On that note, here are a few key takeaways from this episode.

On The Importance of Safety In Biotech

Amit, Ramin and Jason all agree, building a culture of safety should be a top priority for both established, big pharma companies and smaller biotech startups as well. Afterall, patient safety is a universal concern, and even in the early stages of drug development, safety protocols should be firmly ingrained. 

From a business and planning standpoint, this means prioritizing safety from day one–focusing on the preclinical and phase one stages. Yet for brand new companies navigating this with limited expertise or covering an entirely new patient population, this may not be as cut and dry. In fact, Jason cautions that all companies should exercise prudence when it comes to prioritizing safety very early on. 

After some back and forth on this topic, Amit wanted more context. “It sounds like the output is patient safety but what are the inputs?”, he asked to help our listeners. 

Jason’s answer was very eye opening. 

“So, this is the eternal dilemma that we face. In the 1980s, there was a really interesting Yale psychologist named Scott Perrow. He wrote a book and  it's a widely influential book in the field of safety and risk called Normal Accidents. And he didn't mean “normal” in terms of description of frequency. He meant normal in description of how they unfold. In any major safety event that occurs, it's often the most banal and trivial things that lead to major safety events. It's something very minor. For example, the patient didn't exactly recall that they were supposed to stop their medication at this time. And when they called, the person who got them on the phone was a little rushed and they didn't quite hear the full sentence. And the next thing you know, these banal and trivial events all add up to go, boom, major consequence.”

Listen in for another key learning from Perrow and a story on the Gus Grissom capsule. 

As a pivotal takeaway, one of the inputs is to shift away from the view of “safety is a cost center”, to “it's an ongoing, priceless, life saving priority.” 

In terms of the economic arguments for investing in safety early and on a recurring basis, Jason does dive deeper into the topic around the 14:25 mark while Ramin also provides the invitation to move away from viewing safety as a “necessary evil.”

On  Strategy and Collaboration in Biotech Particularly with PV

All the discussion around unified alignment and ownership of safety in biotech opened up the door for Ramin to glean Jason’s thoughts on collaboration and partnership especially with PV. 

“I've seen in organizations, with my own experience, where PV and drug safety were really a strategic partner cross-functionally and being more proactive,” Ramin said. 

“They were not just sitting in the office and for a drug, you know, addressing events that happened and doing their investigations and the forms and the reporting as requested: they were actually being more proactive. They were trying to look for signals. And making sure that the product continues to sing in the market, because with those signals, there are certain actions you can take. You can focus on education. You can focus on papers, posters, manuscripts that you can have to make sure that the conditions are appropriately knowledgeable and have the education to make the right decisions. So Jason, what is your view about PV and safety as a strategic partner?”

Jason’s answer included a specific mentor, Clive. “I think Clive was the model for me on how safety and PV is, by definition, a strategic asset to a company. That being said, I think it's an anomaly, unfortunately. I think what you just outlined, teams that are consistently able to do that over long periods of time in a cross-functional manner, I think that's rare.”

For more on the importance of working cross-functionally in biotech, tune intoEpisode 13 of the Emerging Biotech Leader. 

To become a team that does collaborate with PV cross-functionally on a consistent basis, listen to Jason’s thoughts around HRO’s: high reliability organizations as well as how PV alignment can also help with sales. 

One additional perspective Jason shares especially as it pertains to strategy and collaboration is preparing for the worst…even in the absence of it. “In a...

“It's not always smooth sailing or a straight line path. So being able to address those different inflection points, being able to resource accordingly, flex in, flex out, and really focus on ‘what are the most important priorities?’ Make sure you're addressing those, the ‘must haves’ versus the ‘nice to haves.’” Jacqui Levine, Vice President, SSI Strategy 

Preparing for a biotech launch now or at some point in the future? Then you’ll want to bookmark Episode 23 of the Emerging Biotech Leader, which serves as a mini masterclass on how to think about launching as well as what's to follow post-launch. 

SSI’s Adriana Valenciano, Senior Vice President, is host again alongside Ramin and a new voice to the podcast, Jacqui Levine, Vice President of SSI Strategy. Based on their collective experience, Adriana, Ramin, and Jacqui provide ways to prepare for all stages of launching and how to understand everything that’s required. 

As a preview of what’s to come in this discussion, our trio cover:

Share this episode with colleagues and peers–and without further ado, let’s get you into the recap. 

On Biotech vs Big Pharma Launches: What’s Different? What’s Similar? 

To kick things off, Adriana, Ramin, and Jacqui discussed the distinctions between launching in biotech vs Big Pharma as well as what was similar.  

On the latter, Ramin did share that while Big Pharma comparatively has bigger budgets, increased headcount, and brand recognition, the skill of prudence and monitoring one’s P&L with attention and discretion is always table stakes regardless of the launch company’s size. “You will have more resources in Big Pharma, but they aren’t unlimited.”

Given their smaller budgets, biotechs do have to plan for different ways of resourcing while also understanding the constraints they’re facing. This is why Jacqui’s quote about the reality of “rough waters” and accepting that things won’t always be smooth sailing is important to remember. 

She adds, “You really need to take a risk-based approach; you can't do everything all at once. So thinking strategically, planning through the life-cycle of what would be needed as well as being able to account for some of the ups and downs, is key.”

Speaking from several launches and a transition from Big Pharma to biotech himself, Ramin also shared more advice.  

“In bringing a new product to market and bringing a new product to patients, there's a lot of excitement internally, cross-functionally, within medical affairs, within clinical, within commercial. So that's really a piece that I enjoy in launching a product. I mean, it is very multi-dimensional. It's not just one focus, and it's definitely not a straight line. I think one thing that I noticed in the smaller biotech companies with regards to the resources, you really have to be hyper-focused on your execution plan, and you have to sequence them.” 

Ramin shares some additional context around the need to be agile and what launching sequentially has to do with the required skill of communication.  Make sure to take notes on this topic because he provides a simple yet clarifying framework with questions for you and your team to answer as part of your launch communication plan. 

For those who may share a similar professional background to Ramin, having worked in Big Pharma and then pivoted to biotech, he emphasized how essential it is to bring those rigorous planning and collaboration skills to your new, albeit smaller, org. Adriana refers to this as “hyper coordination.” 

“You know, we see this often with clients where they're used to operating with individualized functions that are very productive, but when you get them all together, it can be very challenging to keep them coordinated and aligned to the end goal and the end game, which is that launch. And so, it's really about creating many more communication channels and pathways so that you're facilitating a very symbiotic team with clear objectives and plans.”

On Prioritizing Stakeholders and Skills for Launch 

The communication theme created a really natural segue for the next topic, which was prioritizing and involving stakeholders. 

Jacqui shared that who to focus on depends on a few key things. “Is it a rare disease? Is it going more mass market? What are the nuances of it? Because stakeholders are going to be different depending on the scenario. But, you know, regardless, making sure that the patient is at the forefront of why we're all doing this–that is critically important.”

Ramin echoed Jacqui’s answer and added: “I think that the two main groups you want to focus on are these: one is the patient advocacy groups and the patients. And the other one is definitely your KOLs.”

Listen in to hear Ramin’s “words to the wise” about avoiding a shotgun approach and how to be a facilitator between these two groups. You can also pick up more tips on being patient first in Episode 18 of The Emerging Biotech Leader. 

From a skillset perspective, Jacqui shared how important it is to truly and honestly acknowledge what you and your team can do internally versus where you might want to leverage partners. 

And before they moved on to the next topic, which was thinking strategically and also taking action, Adriana said it best when she shared, “Launch planning can be so iterative.”Jacqui then elaborated further. “I think there's a number of different things that are really important. One is to be able to think strategically, but also to be able to translate that into execution.” 

As you execute your launch, one thing you may not anticipate–but can think about ahead of time–is how you’ll manage through setbacks and keep your teams engaged. Be prepared for a variety of scenarios.   

Ramin emphasized some final suggestions: you’ve got to be a broad thinker and be receptive to communication reflected towards you. Articulate your points and keep an open mind when people have feedback, especially as you prep to meet and present with the board. 

On What Can Put Your Launch at Risk

Planning a launch keeps you focused on the here and now. But how well are you set up for your post-launch efforts? Adrian, Ramin, and Jacqui strongly advise that you think about your post-marketing world, i.e., do you have the infrastructure, compliance, and other pieces required? You can’t just be what they describe as “product ready”--you must be “organization ready,” aka company ready, too. 

Adriana articulated this best, given what she has seen in the field, with Ramin helping her complete the thought. “If you're not ready from many different lenses: P.V., medical affairs, and obviously commercial payers, etc., take note,” which is when Ramin chimed in with–”I think sometimes we confuse launch date and approval date.” 

He then added, “Approval date is when t...

“You're actually able to make a difference, not just at your local level or your regional level, but much more on a global level. You know, you may be one of the lucky few that is able to get involved in guideline development and those guidelines are then applicable across the world.’” Benit Maru, Senior Vice President, SSI Strategy

“Should I stay or should I go?” You might recognize those words as lyrics from The Clash; however, they also pertain to the decision to stay in academia or join the world of pharma and biotech. What happens when one leaves the sector and role they’ve known to carve out an entirely new career and skills in another? 

This is precisely what Adam Schwartz, Ramin Farhood and Benit Maru discuss in this episode of the Emerging Biotech Leader—a follow up to Episode 21 featuring Victoria Niklas, Chief Medical Officer at Oak Hill Bio. 

All three members of the SSI team further examine the balancing act needed to transition from academia to industry, once again, acknowledging the misconceptions and impacts of 'selling out.' 

In case you are new to our show, Ramin Farhood is Sr. Vice President of Medical Affairs Practice at SSI and a regular staple and host of the Emerging Biotech Leader. Adam Schawrtz is President of SSI Strategy, guest hosting in Kim Kushner’s absence and Benit Maru is the European Lead and Medical SVP for SSI also serving as a Chief Medical Officer for SSI clients. Today, he’s our special guest expanding upon his 25 years in academia plus 7 more of his career recently spent in industry.

Formal introductions aside, let's dig in to a few of the key concepts covered in this episode. 

Those include: 

Embracing the Transition: From Academia to Biotech 

Much like Victoria Niklas and other podcast guests who have transitioned from academia or bedside medicine to work in pharma and biotech, Benit, too, received his fair share of caution, stigma and discouragement. 

“I was warned, you know, if you leave, you're never going to be able to come back.”

As a byproduct, Adam and Benit hope this ongoing discussion reminds everyone that diverse experiences are the catalyst for long lasting change. When academics or practicing physicians bring their specific experience to industry, by way of career transition, it actually improves innovation which subsequently improves patient outcomes. Ramin weighed in on this as well. 

“I’ve actually seen that individuals are really successful when they make the transition coming from academia and having been a research scientist. When coming into pharma, they become that voice. They almost bridge the industry and academia together in a very powerful and beneficial way for the patient.”

Keeping on this theme of patient impact, Adam probed to get more understanding from Benit on how to silence any guilt or self-doubt. Listen to the episode for his answer. 

A big part in moving forward, that was available to Benit via hindsight, was how rewarding it was to experience an opportunity to expand beyond adult medicine to treatments in the pediatric sector. 

Benit also went on to share: “It is a challenge to think I'm letting patients down by no longer treating them one to one. But, you know, in hindsight, you're not letting them down because you're going up a notch and you're actually able to make a difference, not just at your local level or your regional level, but much more on a global level. You may be one of the lucky few that is able to get involved in guideline development and those guidelines are then applicable across the world.”  

As a piece of transparency, he does disclose that missing patients is normal as you move into your new sector. Try to stay focused on the bigger cause. 

Effective Communication for CMOs: Navigating Stakeholders and Challenges

Effective communication is another topic that finds its way into each Emerging Biotech leader episode. Timing, knowing your audience and delivery of communications in biotech are essential. 

In her interview, Victoria Nikklas spoke to this need for ‘guarded optimism.’ In agreement, Benit also shares that those who have worked bedside before understand this really well. 

“You kind of have to be really careful about what you say to a patient, that to me is a parallel where you think, ‘Okay, this is good. But I just need to be careful’ and that is kind of that ‘guarded optimism’ piece that Victoria mentioned.”  

Adam expanded upon guarded optimism from his perspective, too. 

“I feel like in medicine in general, and especially when you're talking about developing new therapies, you have to be optimistic. Otherwise, you wouldn't be thinking of these ideas. You wouldn't be taking the steps to even try to get there if you weren't optimistic about the idea. But at the same time, we have to be realistic, and we have to be understanding of what the limitations are. Make sure that you're grounded in some reality, right? And waiting and taking the appropriate steps to test the science and prove things out before you're sort of just running.”

This sparked the topic of CMOs needing to speak across multiple stakeholders, especially balancing science and business conversations. 

Benit provided a few insights into how this was a struggle initially at the beginning of his career. “You know, how granular do you need to be? Too scientific? Not scientific enough? I think that's one of the challenges of communication–knowing the audience and how to communicate.”

As a CMO, communication is one area where you can’t shy away from asking for help, which spurred another myth Benit wants to debunk–that asking for help “looks bad.” To further make the case for transferable skills and relevant experiences from academia to industry, Benit shared, “Somebody that's actually got quite a good tenure in medicine and academia, they're comfortable in asking for help when needed.” 

To provide further encouragement, Adam reminds our listeners: “You need to be able to rely on a team around you because no CMO is going to be great at everything that is part of their responsibilities.”

What causes this false belief? The misconception and pressures of “needing to know all the answers.” Adam, Ramin and Benit dive deeper into managing this form of imposter syndrome further. Keep your ears opened for that topic. 

On Fostering Growth and Adaptability in the Biotech Industry

The topic of communication inspired yet another theme: confidence. Only in this case, having the confidence to reach out to others–peers, your network, your team, whomever can help close knowledge and skills gaps. 

It's one thing to acknowledge you need and w...

“I will always have deep empathy for patients and want to do the best that I can, but I feel very satisfied that I'm driving development of OHB 607, which has the potential to change the trajectory. So, I don't have to sit and remind myself why I'm doing that–there are patients on the other end.” Victoria Niklas

How can you break into biotech from academia without guilt, fear, or self-doubt? After listening to our guest, Victoria Niklas, in Episode 23 of the Emerging Biotech Leader, you may just have the answer to that question. Victoria is the Chief Medical Officer at Oak Hill Bio. As you’ll soon learn, she has been in pharma and biotech just shy of 10 years–7 to be exact. Prior to this time, Victoria was an academic neonatologist and translational scientist beginning at UCLA, rising through the ranks at the University of Virginia in Charlottesville, Children's Hospital of Los Angeles, and finally returning to UCLA before taking her first industry role with Prolacta Bioscience as their first Chief Medical and Scientific Officer. 

In addition to our new guest and a new topic–we have a new guest host: SSI President Adam Schwartz, who is joined by Ramin. 

True to form, both get Victoria to open up and share more on the uncertainty and upside in pursuing a new path, especially in making the transition from academia to pharma to biotech. 

As a preview of what’s to come, Victoria shares more on:

No matter your career crossroads–big Pharma to biotech, academia to biotech, bedside medicine to biotech, we know you’ll find this interview invaluable.  

From One Sector To The Other - In Pursuit of Impact

While it’s still evolving some seven years in, Victoria’s pharma career includes a background in research spanning various roles, including time at Takeda. “My experience in research helped me develop a strong foundation and understanding of the scientific and medical aspects of drug development, which has been invaluable in my current role at Oak Hill Bio.”

Her first stepping stone into this world from academia came by way of a professional connection–just as she felt a nudge to pursue a new path. “I began to feel as if I wanted a bigger stage with which to have an impact, you know, particularly in the care of extremely premature newborns where drug development in that area doesn't rival that of other areas. In thinking about how to do that, I was very fortunate. I was approached by the CEO at Prolacta Bioscience, who said, ‘You know, we'd love to have you come and join us as our first chief medical and scientific officer.’ So I took that opportunity and never looked back.”

From Prolacta, she was then recruited to go work at Takeda to lead a drug pipeline focused on extremely premature newborns. Then, the work at Takeda led to Oak Hill Bio–a byproduct of them choosing to out-license that program. This next role, however, did require a different approach–she didn’t just apply and interview. Listen for specifics on how this all came together during the podcast. 

On The Transferable Skills Required To Make A Move 

As we’ve discussed in previous episodes of The Emerging Biotech Leader, transferable skills go a long way when making a career pivot. 

Chris Morabito covers this topic inEpisode 15 of The Emerging Biotech Leader. 

The key skills that helped Victoria transition from academia to biotech included multitasking, leadership, and guarded optimism. Most likely a new term for you, here’s how she defined that for Adam and Ramin: “So I think it’s being optimistic, but, you know, not necessarily guarded–but just realistically optimistic, always.” 

A final transferable skill she mentioned is thriving and surviving on very little sleep. We hope you appreciate her honesty there. 

On Disregarding Stigmas and Preconceived Notions

Adam was curious to uncover how Victoria overcame questions and skepticism about her new pursuits. 

“Victoria, you mentioned some of your colleagues in academia sort of “warning you” as you were thinking about taking that step into pharma. And it's obviously something that many medical professionals and scientists go through when they're in academia, and then they're thinking about whether or not it's a good step for them. What are some of the things that colleagues of yours were warning you about? And were they true?”

Victoria did shed light on the misconceptions about "selling out" or abandoning patients, emphasizing how many in her same shoes venture into the industry driven by a genuine desire to make a difference and keep the patient at the heart of drug development. She covers more specifics of the “sell out” and skepticism on her motives and commitment–be sure to listen for those details. 

As a solution to break this stigma down, Victoria highlights the importance of increasing education and understanding within the medical community–to bridge the gap between academia and pharma.

For those currently in medical school, contemplating which path to take, or even making the leap from another sector to biotech, Victoria shares more about why this should change, even starting at the academic level. 

“There's no class in medical school where you go to learn the pharmaceutical drug development process. So, it is a gap. But appreciation for what the pharmaceutical industry and biotech are doing to expand drug development, I think that sentiment people completely understand and get. So much of it, I think, is just not being aware of the nuances of it. Number one. Number two the expense of it. And number three, how long it takes, especially to have a robust process to prove efficacy with an appropriate safety profile.”

On Managing Out Licensing–What Was Required To Make This Happen? 

If you’re a loyal listener of this show, you know that Ramin has a remarkable way of asking questions that provide teachable moments for the biotech community. This was the basis for his inquiry around the licensing agreement between Takeda and Oak Hill–and how Victoria played a part in moving that forward. 

“What was your negotiating strategy? What regulatory aspects did you have to consider in that whole process? Basically, how did you make that happen?” 

We won’t make you wait to get Victoria’s answer. Here’s what she said.

“One was shoring up the team because I think given the nature of the population and the incredible connections that people on our team at Takeda had developed, you know, we had to take the view that it's not over. Ok? This doesn't mean these patients will never receive this drug in the longer term. So, shoring everybody up and keeping people laser-focused on that. 

“And the second thing was helping develop the message. From Takeda's perspective, I was sitting there as the representative, as the on...

“There are clear distinctions, as we've talked about, between device and pharma from a medical affairs perspective. I think they each require this special touch and strategic medical affairs plan, but I think what we're also converging on is that they’re almost more similar than we think.’” Leah Damesek, Vice President of Medical Affairs, SSI Strategy. 

Disruption. It’s a word that many associate with dramatic or abrupt change. But in order to disrupt something in biotech, particularly shifting a standard of care from one type of treatment to a new protocol using a medical device, there has to be collective, cohesive, methodical buy-in. In Episode 19 of the Emerging Biotech Leader, our interview with Shon Chakrabarti of Inari Medical echoed how disrupting a care pathway has many moving parts. 

Now, in Episode 20, Kim Kushner, Ramin Farhood, and a new voice from the SSI team, Leah Damesek, Vice President of Medical Affairs Strategy, continue exploring what it takes to bring disruptive devices to market. Listen in to observe a few overarching themes that emerge and guide the conversation.

The trio keep no secrets–the medical device industry is more advanced, compared to pharma, when it comes to strategically utilizing real-world evidence. And as you’ll hear, this is brought up not to poke holes but to provoke thought and understanding for anyone looking to shift from one sector or the other. 

Throughout this episode, Kim, Ramin, and Leah also discern additional differences and similarities between device and pharma. What’s vital to both–no matter which side of the industry you find yourself on–is that the main goal never deviates from this credo: do right by the patients. 

On that note, enjoy these highlights, and as always, we encourage you to listen to the full episode, too. 

On Bringing The Medical Community Along 

Right at the top of the interview, Kim asked Leah about the challenges with conversations–from a medical affairs lens–when meeting with the physician community. 

Many of these physicians have been treating their patients in a specific way for decades. To that point, Leah shared, “Bringing the medical community along to make a change in their practice that has been so instilled in them for so many years and through so many different variations of guidelines is a really big change. Something that I think about a lot as we're working with our clients is helping all sides of the care continuum and the caregiver team move with the industry change. So, it's not just about bringing new physicians and new specialties on board, but also what's in it for the existing specialists that are treating these patients?”

What else does driving disruption and adoption entail? 

Leah highlights the importance of helping physicians feel like valued participants on the cutting edge of care for new devices or drugs, as opposed to pushing them to the sidelines. Ramin agreed and added this reminder from Episode 19: “It's really, really important early on that you have the customers (doctors)  involved and that they get the right training to feel comfortable using the device and they feel comfortable that they can also make the patient feel comfortable with what they're doing.” 

As they navigate a new normal, Doctors must understand device use, who it’s best for, what updates and advancements are coming, post-approval, and more considerations for full adoption. Building on that, Kim points out that a new ecosystem gets created when a treatment pathway is disrupted by a new device or drug. 

“It's more than just training the physician who's going to be the user, but it's also training the physician who now has to be a referer, and historically was the person to treat that patient. If we can't actually get the patient to the appropriate, in this circumstance, Interventionalists, where, you know, they've been typically treated in their home cardiology office, that's a really different care pathway for a patient.”

Working In Harmony: More Than A Pipe Dream

With disruption overhauling the “old way of doing things,” how do you mitigate friction to ensure the current physician, new physician, and patient are all aligned?

Ramin describes this unit as a “triangle.” While the talk track and training for both physicians is mostly procedural and straightforward, driving patient confidence and adoption is where there is more variability. 

“Maybe you've been on a particular drug for many years, and now maybe it's not working right? Or maybe the side effect profile is not good anymore. So, you have to have that conversation with the patient so that they feel comfortable to be referred and have some type of procedure. Even if it’s not a full-blown operation, it still becomes really scary for them.”

As a best practice, Ramin shares a few things to remember. Nurses need to be included in this training/adoption loop as they spend a significant amount of time with patients as well. 

Also, enabling and training both physician groups–former and newer–with aligned messaging is vital. And this all has to be done in harmony, which really falls on the founding team to ensure and plan for from day 1. 

On Setting Up A Center of Excellence 

While Kim was hearing these points come up, she requested a few tangible examples of what success looks like when Centers of Excellence are executed flawlessly. “In particular, I'd love to hear what you've seen be successful in setting up those models and what some of the barriers to success have been for industry.”

Leah jumped right in to answer with a success example first: the early adopter approach. 

“The successful factor was the early adopter model. What I've seen in setting up that Center of Excellence is that no one wants to feel like they're not on the cutting edge of research. I'm actually thinking about this in a gene therapy context, going from potentially a surgical intervention to moving towards a one-time treatment that 

would no longer need potentially any intervention from a surgeon. And so thinking about what, ‘What's in it for the surgeons?’ How can you be an early adopter? How do you want to think about how you're giving a certain device to a patient now, and you're moving towards a different type of surgery, right? That's one way to think about it.”

As for barriers, Leah points out that those can arise from low data volume or if a treatment, even though minimally invasive, is no...

“My primary advice is to get comfortable with discomfort right away and open your mind to how your particular skill set can benefit patients on this tremendously big scale.’” Shon Chakrabarti MD MPH, Vice President, and General Manager Chronic Venous Therapies, Inari Medical. 

Episode 19 of the Emerging Biotech Leader commemorates a milestone. This interview features one of our first guests with a background in medical devices. 

Unlike previous episodes, our guest also works outside of rare disease and targets a wider population of patients with unmet needs. And now for the big reveal on who this guest is: Shon Chakrabarti MD MPH, Vice President, and General Manager Chronic Venous Therapies, Inari Medical. Shon is an Interventional Cardiologist by training, bringing his education, experience, and expertise to Inari–they design tools to treat both Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT), focusing on the critical vessels of venous disease. 

Kim hosts this episode solo which gives her and Shon ample time to cover a lot of ground, particularly: 

Whether you work in medical devices yourself or are considering a change from clinical practice to industry, this episode will help you understand how to think about a career pivot, what it takes to bring a medical device to market, and why it’s so critical to “listen to the evidence and the effects that your medical device has in the real world.”

We cover a few highlights here, but of course, the full interview contains so much more. Listen along and let us know, do you read these recaps before or after each episode? We’re open to gathering some data of our own. 

Nothing Changes if Nothing Changes: From Practice to Product 

Treating patients one-on-one and providing bedside care seems like the complete opposite of working in the medical device space, but Shon threads his two roles, that of Physician and Physician Leader now in industry, together under the theme of change. 

In fact, Inari isn’t the first medical device company Shon has worked for. While the devices may be different, and the disease states may be different, the idea in this sector of biotech is to help patients fully address their issues through advancements and innovations that demonstrate improved efficacy. 

On this topic, Kim wanted to know Shon’s POV from the clinician side, specifically going against the “status quo” of current treatment modalities and what shift is required to, as she put it, “think about trying a new technology in a patient, whether it's a person in a study or speaking to other physicians about why they should adopt something that that is new?”

Shon cites three things that will help change occur. 

Shon also shares that physicians do start to see the unmet need early on in various ways. “In your day-to-day practice, and in the cath lab and in the O.R., it's intuitive. You know when you're using something that hasn't been updated in 30 years where patient outcomes have been the same, and it isn't keeping up with other disease states.”

Listen in for more details and context as to how Shon has observed his three bullet points transforming physician adoption and patient outcomes in the cardiovascular field. 

On Medical Affairs for Med Device 

The role and significance of Medical Affairs continues to be an important theme for biotechs, and it’s especially important for medical devices. As Kim touched on with Shon, “You're in the position where you're not just speaking about the modality and the science and educating on why this therapy is better than this one, but you're also hands-on training on the device itself.”

Listen to episode 13:“Making A Mark In Medical Affairs” 

Given Shon’s expertise in this and navigating the patient-physician-payer matrix, Kim was curious to hear more. “You're educating different segments in the medical community as well as the different sub-specialties that have trained in different ways over these decades, I would love your thoughts on all of this from a medical affairs perspective.”

Shon’s answer was perfect for the entire biotech industry: “One thing about medical affairs leaders–a good medical affairs leader is critical to the success of a device or pharma company. So there's a really important role there. It's not something that you dabble in or dip your toe in the water on. It's something you dive into.” 

Once again, this is where Shon’s prior experience treating patients comes into play. 

“There's a certain perspective you get from taking direct care of patients. It's hard to describe, but it sort of involves this deep empathy and understanding of needs from a patient perspective. It also involves familiarity with health care delivery and the nuances of that and patient journeys, and to almost compare, it's like seeing a language you can functionally survive in an environment where you don't speak the language, but there's a lot lost in terms of context, and I think it's very much similar. So my experiences impact things like design considerations, they impact go to market strategies, they impact clinical research plans. There is really nothing that isn't touched by having been on that side of patient care.”

Learning On The Job: The Real-World Residency 

After a significant amount of time in med school and providing patient care, Kim was curious, where else did Shon learn GTM, product development, and even marketing for med devices? 

He shared that he’s learned on the job. Here’s why that's been an advantage. Compared to peers who went a more traditional path for biotech, i.e. business school, Shon hasn’t just worked on one case study or one aspect of biotech. The same learner's mindset and drive that got him through rigorous med school training at Harvard is still alive and well.

“I feel like I'm almost in another training program, another residency here in these early years. I learn every day! And the interactions of interfacing with upstream marketing or reporting on strategy or interfacing with the business development team and M&A team about other technologies that are out there–I love it. I think it's a ton of fun probably because it's all new learning for me. So I think I chose to join companies that were not necessarily in the startup phase but a little more mature in terms of the teams they've developed. And that was probably good luck. But it resulted in an environment where I could safely insert myself into projects and learn from really great leaders around me: commercial leaders, marketing leaders, business and strategy leaders.”

The main takeaway here is to follow that calli...

“A lot of the work is in asking ‘how do we distill this down into the simplest, most digestible narrative that feels obvious when you hear it back?’” Kim Kushner, Chief Business Officer, SSI Strategy. 

Episode 18 of the Emerging Biotech Leader welcomes a new voice to the show: Kate Goldstein, Senior Vice President of SSI. Fresh off the heels of Episode 17, Kate, Kim, and Ramin continue to unpack more value from Luminopia’s founding story and subsequent growth. 

If you haven’t had a chance to listen to that yet,here’s the link. 

One of the most powerful components of a biotech is its value story. But getting clear on that isn’t always easy. In this new era of biotechs and clinical development, the value story and narrative isn’t just for investors: it's for other stakeholders like physicians and patients, too. As stakeholders get involved earlier in the process to increase patient-centricity, they want to understand the value as well. In fact, it's almost table stakes.  

This begs the question, how do you approach this when bringing a novel modality to market? How does an unmet need influence the value story? How were Scott and his team able to get theirs so clear? What does patient centricity have to do with product market fit? These are a few clues as to what you’ll be hearing during this episode. 

Listen along to pick up more highlights, approaches, and thoughts. 

Uncovering The Obvious Is Not That Obvious

Kim kicked off the interview with a question for Kate first. How was Luminopia able to be so clear with its value story compared to other biotechs with traditional modalities? 

Kate quickly weighed in: the story resonated with more than one audience. “I think one of the ways that we're really going to get truly novel modalities to market for the first time is by telling the story that the entire stakeholder community, you know, the regulators, payers, the patients, the physicians can all buy into and all get behind when there's something new.”

Kate and Ramin agreed that most biotech founders have the semblances of a story–as Kate described it, “The bones are there. But the full story still needs to be flushed out.” 

As an add-on to this, Kim shared that the value story does often get flushed out by Medical Affairs or even HEOR, but that doesn’t have to be the only way to craft it. She also distinguished that the value story and the founding story are not the same.

“Scott and his team have done a fantastic job at simplifying this down into a really digestible soundbite, if you will, for why this–Luminopia–matters, why people should pay attention, and telling the story of the product market fit that has gotten them where they are today, which is really based on this unmet medical need or this patient-centric view. That is a goal for a lot of organizations. But the value story is rarely in the founding story of where the organization came from.”

If you’d like another real-world example of a biotech value story done right, listen to what Kate shares about Zolgensma, which in her words, also helped “catapult gene therapy as a whole.” 

Incorporating The Voice of The Patient Sooner Than Later

As an add-on to that example, Ramin brought up another point that’s becoming more and more common. The story of the patients is now front and center. Traditionally in biotech, companies work backward. Product approval was the first goal. Then came connecting with thought leaders and the pathways for reimbursement. This was some 20-40 years ago. But now, the primary goal is what Scott and Luminopia demonstrate: start with the patient first. 

Ramin added why this new approach is vital for biotech founders to embrace. 

“The agencies are very interested in this, and they engage with the patients. They engage with patient advocacy groups to have a better understanding of their perspective. What do they think? What is their voice? And it's not unheard of that the agencies reach out to them and have a conversation with them and get their input.”

Across the board, Kim, Ramin, and Kate all agreed that it's paramount to think about what patients will experience and go through. Some biotechs even have a CPO: Chief Patient Officer. 

This quote from Ramin drove this point home. “It makes a huge difference if you start thinking about that early on, even as early as your pre-preclinical studies, the animal studies. Maybe your entire focus is not on the patient yet, but at least you want to start thinking about ‘if things will work out, what would be the meaning and impact for the patients?’”

Putting themselves in the patient seat, a powerful exercise took place. Each was challenged to recall mid-interview the last “delightful” experience they personally had in healthcare. Their answers and the stats they shared about clinical trial costs and dropout rates will surprise you. Listen in for those details. 

Other Ways To Learn What “Good” Looks Like 

If the value story is so critical and yet equally as challenging to clarify–where else can biotech founders look to pick up ideas? Kim says there’s a lot to be learned from Europe. 

“Value in Europe is not just ‘dollar for dollar value,’ but if you're showing similar outcomes, which ones are going to have a better outcome for the patient? Which ones do patients prefer?”  

Bringing this full circle, Luminopia also provides ideas as well. They were creative in their story due to the lack of innovation and being one of the first FDA-approved virtual reality modalities. 

The word “creative” inspired Kate to share another paradigm shift she has witnessed firsthand. “We're now in a position to start implementing really core patient impact initiatives early on in the development cycle, and that really shows how the industry has shifted over the last decade or so.” 

Adding to why Luminiopia’s value story was so different stemmed from their diverse industry backgrounds. Ramin pointed out how their unique, non-traditional backgrounds, aka non-medical, actually thwarted them from the default habit of talking about “bringing another pharmaceutical to market” and instead served as a catalyst for them to be inherently patient-centric. 

Kate pointed out that this theme of innovation and embracing new ways to achieve better outcomes has been a core theme of the podcast. 

“What we seem to get to every time, no matter the discipline or the modality, is that there needs to be a sense of creativity and a lack of feeling hindered by whatever the precedent before you was.”

Those words serve as a rallying cry to help emerging biotech founders from all professional backgrounds–research, pharma, and tech–

think about various aspects of biotech management that are outdated and ripe for change. 

To close out the show, Kim posed this question to Ramin and Kate, but we’ll share it with you, too: “What...

“I won't say that we had this all planned out because when I started, it was just a crazy idea that we were excited about, but it ended up working out really well where we're trying to create a new class of medicine with digital therapeutics or with prescription digital therapeutics.” Scott Xiao, Co-Founder and CEO, Luminopia.

What’s possible when you think about leveraging technology to drastically improve a condition that hasn’t seen innovation or adaptation to the standard of care in 30-40 years?

If your name is Scott Xiao, the answer is launching a biotech company called Luminopia where children between the ages of 4-7 years old can now overcome suppression in their visual cortex without having to wear an eye patch or utilize atrophy drops. Through virtual reality, Luminopia treats amblyopia, commonly known as lazy eye–the leading cause of vision loss in young adults. One and a half years ago, Luminopia received FDA approval and now has their sights set on serving patients outside of the U.S. 

In Episode 17 of the Emerging Biotech Leader podcast, Kim, Ramin and Scott discuss how a small and mighty team of 5-6 people made it through to commercialization while addressing an unmet need and creating a new class of medicine. 

On The Team’s Mantra Going Into This

Scott started off as an undergraduate at Harvard with no prior experience in biotech. By all accounts, he has now made it past several critical inflection points and Luminopia’s impact is multiplying. Scott and his team have secured partnerships with the leading pediatric Ophthalmologists, media companies such as Sesame Street and notable investors. 

But how did all of this come to be? Scott had a close friend who experienced amblyopia and through this friend, learned that the standard of care for amblyopia is an eye patch.

“One of our mantras going into this whole endeavor was ‘we can't take technology and go out looking for a problem to tackle.’ You're never going to be successful with that approach. So it was more about, ‘hey, we realize that there's an unmet need in this very prevalent condition.’ We realized that technology, specifically VR, can actually have an impact. Let's go out there and build something to make a better treatment.”

Scott and his team knew they were onto something big when they took their initial prototype to Dr. David Hunter, the chief of Ophthalmology at Boston Children's Hospital. “He was kind enough to take the meeting and spent a whole hour with us. And he was the one that really said, ‘Look, you're on to something.’”

By then, Scott felt confident that his technology could enable a new modality and treatment that wasn’t previously possible. As Kim puts it: this also wasn’t a matter of taking baby steps, or making a small improvement for the condition. “This was a leapfrog effect. How did you deduce that you were ready to take this on?” 

On Building A Biotech: Which Way Should You Operate 

Scott is the first to admit, although this was a “simple decision”--it hasn’t been a straight path. While the benefits of Luminopia’s technology were clear given their targeted, immersive manner, there were clinical trials to be had, FDA approval to be obtained and challenges to overcome. 

“Although we are a small but mighty team, we had the support and guidance and worked with people who had done this before.” 

One of the key areas Scott sought guidance on was Regulatory. 

Listen to the episode for Scott’s quick story on meeting the Head of Luminopia’s clinical team and how he, (Scott), crash coursed his way through learning the ins and outs of a feasibility analysis. 

As you’ve heard from other guests on the podcast, Scott had many stakeholders to consider: patients, parents and the pediatric Ophthalmologists for starters. 

“We knew instinctively that in order for this technology to have an impact on patients, we needed the physicians to be intimately involved in that process because the pediatric Ophthalmologists and the Optometrists are the ones that drive practice and drive management of the condition.”

To inform and help other listeners of the show planning for their own Clinical trial milestone, Ramin asked Scott to elaborate. How did he and his team obtain 23 sites and robust clinical trial data? Once again, Scott shared more on navigating a regulated space and what type of evidence was required. Be sure to listen for the answer.

As a quick easter egg: it was “easier” for the Luminopia team to run Clinical trials given the unmet need. There was also upside due to a virality quotient, also known as word of mouth, given how small the community of pediatric Opthamologists is–approximately 1200 practitioners give or take. They all wanted to bring Luminopia to their patients and referred doctors across a mix of locations throughout the U.S. 

On Maintaining Hyper Efficiency

One of the key questions Scott and his team had to decide up front was which way to operate: lean, agile and moving at the speed of light like a tech company? Or, adhering to more of the thoroughness and linear approach of a healthcare company? 

Luminopia did a blend of both, skewing more towards the Pharma mold of working in a step like progression but also while evaluating which areas of their business they could do differently. 

“We knew that we needed to go through the same level of rigor when it came to clinical development as a traditional biopharma company, but because of the space we're in, because our technology works, (the fact that it's safe and doesn't have any serious adverse effects), we could be a lot more efficient with how we ran the trial.” 

In running his company with this blended approach, the advantages for the Luminopia team, or any biotech for that matter are, in Scott’s own words, “we can figure out what's working well, what we need to tweak and then scale as we go.” 

And scale they will! Listen to to hear where Luminopia is focusing next, both in patient population as well as geography and treatments, with traumatic brain injury and stroke treatment at the forefront. 

Final Thoughts on GTM for Biotech 

As things started to wind down, Scott answered another question on operations and execution, this time from Ramin and specific to go-to-market. “Why do you think go-to-market in digital health is challenging in pharma/pharmaceutical?”

Scott’s honest answer was this: the culture and DNA of both could not be more different. Healthcare is complex. You have to tailor the GTM to the space that you’re in and the product that you have.

“It's also challenging because the Venn diagram, the overlap between people that have deep health care experience and people that have true consumer tech or enterprise tech experience, that overlap is not very big either. Right? So what types of people are you actually hiring and who can provide the right mix of perspectives for you to tackle these challenges?”

Hiring and assessing your team’s strengths are a big piece of the puzzle on the path towards commercialization. To keep your company efficient, growing and on the right trajectory, Scott encourages what we’ve often heard echoe...

“You may not have the resources as a CMO, especially with smaller biotech companies, but you have to be resourceful.” Ramin Farhood, Senior Vice President, SSI Strategy 

Every guest on the Emerging Biotech Leader builds on the insights from our previous contributors while also adding their own unique best practices, analogies and experience. 

In that spirit, for Episode 16, we’re grateful to have Hootan Khatami, Senior Vice President of Medical at SSI driving the conversation forward on CMOs, (Chief Medical Officers), by sharing his reality on what the CMO role is and what it entails.

One of Hootan’s key lines is that being a CMO is like walking a tightrope in a pair of high heels. But here’s why knowing that now is encouraging vs discouraging: you’ll be better prepared to handle the role and truly understand the stakes and requirements that come along with it. This is a role of utmost importance to a biotech since it serves as the face of the company. 

Kim, Ramin and Hootan unpack the competing priorities CMOs have while pairing this knowledge with real-world “how-to’s” on preparing and setting yourself up for success in this role. 

Our hosts and guest also discuss: 

This episode is a quick listen with no shortage of helpful discussion. Read and follow along for a few key takeaways. 

On Filling The Gaps 

As we heard in Episode 15 of the Emerging Biotech Leader, CMOs interface across so many contacts: the board, KOLs, patient advocacy groups as well as their CEO. Adding to that, the CMO also oversees study design and the science behind a therapeutic or treatment. 

“The toughest role of the CMO is to fill the gaps as one person,” Hootan shared. “There is a lot of complexity and it can be a lonely road if you don’t have a real thought partner to help you narrow down the options, solve puzzles and help you execute.”

This is where Ramin encourages CMOs to find their leverage. 

“You may not have the resources but you have to be resourceful. You can tap into previous CMOs at other companies who you are networking with or, align with friends that know somebody who’s been working with investors that you want to reach out to, helping you understand where they're coming from and what their perspective is.”

As a new CMO, stay optimistic that constraints will uncover new ways for you to do more with less. And your newfound resourcefulness will become an in-demand skill regardless of future funding and headcount by helping you build an agile approach to problem-solving. 

Why An Open Mind is Key 

Ramin, Kim and Hootan acknowledge that it's impossible for a CMO or any new biotech leader to have the exact answer for every question and challenge. Why? Regulatory alone is changing at a fast pace, not to mention the unique situations brought on by current funding pendulums, rapid digital advancements and the economy. 

To help CMOs round out their expertise with the wisdom of others, Hootan suggests creating a sounding board.

“You always have the option to get close to and gain advice from advocacy groups, and other organizations that can help you out. There are also consultant firms out there who have “been there, done that” and have worked with many different clients who can provide good advice as well. I think overall, you kind of have to keep an open mind and be open to getting advice, knowing and feeling comfortable with what you know and understanding that there's a lot that you don't know.” 

With reassurance, Ramin reminds us all: “There’s a lot you don’t know but the answer is out there.”

On that topic, Hootan raises visibility around the fact CMOs will hear a lot of noise. 

“A key challenge in the role is cutting through the noise. There is a lot of information coming at you, the question becomes ‘what do I do with it?’ Really boiling it down is the toughest. It's the biggest joy and the toughest thing anyone has to do.”

Here’s how Hootan advises that you prioritize: be selective on where you put your energy and focus. There’s the scientific knowledge responsibility of the CMO then the other task of boiling down the data. “It’s normal to say, ‘this is what I know, this is what I don’t know.’ Break things into smaller pieces of the puzzle.” 

As Kim hears each of these characteristics and traits, she brings up the topic of learning agility and grit. 

“Be willing, on the grit side, to do the work! It's doing the work of learning, it's doing the work of translating it. It's doing the work of connecting all of these critical pieces within the business internally, as well as bridging to the external community, whether it's the board, investors, KOLs patients, but also bridging to your commercial colleagues and bridging to your other R&D colleagues, the CSO marketing and other functions internally.”

In response, Hootan weighs in that EQ is another critical skill. Active listening and self-awareness will help you take in the information that you receive, then analyze what you will do with that information and better explain yourself. 

“Use active listening to narrow the questions on what is clear and what is gray.” 

Ramin specifies as well, “You have to make sure that your voice is heard and your perspective is there for discussion, whether it's with internal folks or externally.”

Continued Thoughts On Organizational Structure 

As a piggyback on Episode 15, Kim is curious about Hootan’s thoughts on organizational structure. From his POV, here’s what works and doesn’t work for the CMO reporting relationship. We hope you love his answer as much as we did.

”There’s no such thing as optimal. There's different paths for different organizations, for different reasons and different stages. Instead of quicksand, it’s slow sand. It’s hard to predict what’s going to change when. What is ideal is a modular or evolving support structure with key points that are constant.”

To hear more from Kim, Hootan, and Ramin on the one piece of advice CMOs should know before jumping in and a few other helpful tips, listen to the full episode. 

Missed Episode 15, Navigating The CMO Role with CMO Chris Morabito? 

Hit this linkto access the replay.

“The expansions of your expertise and your external network are two key fundamental things that one should be focusing on as you think about developing your career towards a CMO pathway.” Dr. Christopher Morabito, Astria Therapeutics. 

Welcome to this week’s Emerging Biotech Leader recap. In our previous Episodes, we touched on the topic of careers and what to know about the role of Medical Affairs. In doing so, we uncovered two key trends relevant to career progression within that function: working collaboratively/cross-functionally and utilizing your network. 

As it turns out, these two themes are also the basis for a thriving career as a Chief Medical Officer (CMO), a position that has continued to see increased demand. If you’ve been examining what’s next for you as a clinician, or you’re new to the CMO role, this episode will review what it takes to be a CMO, how you can make the transition from clinical practice to being a CMO, and—true to our show’s description–the pitfalls you should avoid along the way.  

Kim and Ramin are joined by Dr. Christopher Morabito, Chief Medical Officer of Astria Therapeutics. Chris’s background provides the perfect foundation to truly understand what CMO involvement is like, be it across Big Pharma or in an emerging biotech. As is often the case on our show, when we bring these industry perspectives together, you’ll hear that CMO responsibilities and functions will vary depending on the size, scope, and stage of a biotech company. 

In this episode, Kim, Ramin, and Chris also dig into: 

-Understanding reporting relationships 

-The kinds of functions that Chief Medical Officers are focused on

-How the CMO role is really designed to bring physician leadership to help larger populations of patients gain access to treatments 

Listen along and enjoy the actionable takeaways that our hosts and Chris provide. 

On What Inspired His Own CMO Path + Pursuit 

Chris was junior faculty in neonatology at UCSF, before becoming the Chief of Neonatology at Lehigh Valley Health Network, where he worked for about 5 and a half years. Here’s how he went from these two roles to working at Merck. 

“I practiced neonatology. During my fellowship training, I spent a lot of time at the bench looking at cardiovascular development, which was very fulfilling. However, I realized quickly that it takes a lot of grant writing time to be successful, and I didn't have that kind of patience. 

“So, I decided to focus on clinical practice instead, and I went off to lead a group of neonatologists in a neonatology facility in Pennsylvania. And I did that for a number of years. 

“During that time, I had some amazing, fulfilling events and activities in my professional life and my personal life. Everything was great. But something was missing, and it took me a few years to figure out what that was. It turned out, I believe, now, in retrospect, that it was this desire to do more for larger populations of patients.”

Once that lightbulb went off, Chris got further clarity on “doing something more for the community, broadly defined,” so he started to look at roles on the industry side. He was VP of Medical first for a few years for a medical communications and strategy company, then went on to work for Merck as clinical monitor (clinical research physician) working on early and late stage development of cardiovascular disease. 

Chris is one to practice what he teaches, it took him 12 years and a few diff hats to land a CMO title. Prior to that, he also held the positions of Sanofi and Takeda as a global program lead, head of Portfolio Strategy, head of R&D Integration after a major acquisition, then Head, Research and Development, Plasma Derived Therapies reinforcing the value of working cross-functionally.

What To Know About The Clinician To CMO Transition

As clear cut as Chris’s pivot story from the hospital to industry to CMO sounds to us all, Kim did surface that there can be a stigma around making a transition from working 1-on-1 with patients to moving into Big Pharma and biotech, aka “the dark side.” 

Chris and Ramin agreed that a preconceived notion does exist; however, Chris believes that this perspective is unfair. What is fair to say, from Chris’s observations, is that the transition isn’t always easy. As part of the cross-functional work required to become a CMO, you undergo a total shift in leadership style, contribution, and identity. In clinical practice, doctors call the shots, but those are not the dynamics of being a CMO. 

In his own words: “You have to prepare for it. There is a shift where you are no longer the lead, sharing the orders. You do become a team player where your weight is equal.” 

CMO: One Acronym, Many Meanings 

There are CMOs for biotechs. And then, there are CMOs for IPOs. Ramin wanted to understand just how vast and varied a CMO’s roles and responsibilities can be. 

What Chris offered in response was a level-set to define what a CMO does regardless of company size: “The CMO is the role that's responsible for linking the target profile of a drug, or drugs, to the medical community with medical community defined as health care providers (those who treat patients) and patients and their caregivers combined.”

Listen for specifics on how the CMO is truly a “link” and steward of the clinical strategy. Chris also elaborates further on the distinction between working at a Big Pharma company vs. working at a biotech with a thought-provoking question from Kim on the mindset shift that’s required.  

The CMO Role is External Facing: How To Leverage That For Networking and More

In the here and now as well as the future, the CMO role will continue to be externally facing. Prompted by Ramin’s inquiry on what to share with aspiring CMOs, Chris reflects on just how important having a network is. 

“As you go through your career, as hard as it is, maintain relationships. They don't have to be people that you talk with on a regular basis, but you should at least know them, connect on LinkedIn with them, call them, text them every once in a while, maintain a personal relationship….develop a virtual Rolodex so that when you do need somebody who has special specialty expertise in pediatric investigational plans for a rare disease, you could pick up the phone literally and call that person and say, ‘Listen, can we tap into your expertise for this? Or who do you know that we could tap into for this expertise?’”

Kim also points out that this “network effect” isn’t just specific to CMOs. CEOs, Medical Affairs, whomever it may be, “there’s a very common theme that you can't really do it yourself.”

Listen toEpisode 11, Leading and Succeeding, What it Takes To Build A Biotech. 

Also, just because the CMO role is externally facing doesn’t mean introverts should shy away from it. Chris himself identifies as an introvert, which totally surprised Kim….but may provide reassurance if you can relate. 

Much like learning to be more of a team player, Chris provides encouragement that you can also learn how to lea...

In Medical Affairs, timing is everything.

If we had to summarize this next Episode of the Emerging Biotech Leader in one sentence, it would be “a deeper dive on both the impact and importance of Medical Affairs,” inspired by our interview with Rachel Couchenour in Episode 13. But that single sentence alone wouldn’t convey the robust takeaways and mindset shift that this episode provides.

Max Craig, Vice President at SSI Strategy, joins hosts Ramin and Kim for a detailed discussion, one where all 3 strategically remind biotech leaders of pitfalls to avoid and how to think and plan for Medical Affairs appropriately. 

One specific example that you will hear from Max: think about Medical Affairs metrics before it’s too late.

 As a preview of what’s to come in Episode 14, here’s more on what Max, Kim, and Ramin explored:

We could keep going, but we don’t want to give this entire episode away in a recap. 

On that note, we’ll let you read it and then hit that play button! 

Expanding on Episode 13: The 4 Levels of Leadership 

One of the key themes of Episode 13 was working cross-functionally, specifically across all stakeholders. As a follow-up in Episode 14, this topic was broached once more. For Ramin, who has previously held roles in Medical Affairs, the best way to work across the entire enterprise is to first level-set, then expand your focus, and lastly, stay focused on the long-term vision: the patients and HCPs. 

“It's hard enough to collaborate within your own function. How do you then collaborate outside that? And also, when it’s not your expertise necessarily? There’s a delicate balance. I think the first thing that I have done, and I've seen successful people doing actually much better than I have done, is to start thinking about across the enterprise and not just solely focus on your own function.” 

While this may not be a natural tendency when your biotech is experiencing urgency and needs to make every dollar and milestone count, thinking across the entire enterprise can be learned. This is where the 4 Levels of leadership come into play. 

First, Max observes that some of the best Medical Affairs talent understand working cross-functionally is an art of give-get. “Show up to your meetings with a purpose and be prepared to listen.”

Max also says it helps to think of your career and skills in Medical Affairs through a leadership lens, the 4 levels of leadership. There's individual contribution. Then there's being a “leader of leaders,” then an enterprise leader, and finally, an external leader. 

With these in mind, you can circle back to Ramin’s advice and stretch your thinking beyond your silo.   

Taking Time: Behavior Change Doesn’t Happen Overnight 

What does patience have to do with patients? Besides our play on words, a primary role in Medical Affairs, especially in rare disease, is involvement with patient groups, communities, and parents or caregivers. 

Yet the value from those efforts isn’t available on day one of forming the team. Results are a long-term game, and the specific results Medical Affairs drives occur from a sequence of events versus one stand-alone initiative or action. 

Kim shares this POV: “One of the biggest challenges with the value of Medical Affairs is that medical efforts take time. You can't move behavior change in the medical community overnight. It doesn't take one interaction to completely change sentiments. We're talking about deeply ingrained understandings and behaviors that we have to shift mindsets and industries and behaviors related to. And that takes time. And most organizations are impatient, especially in biotech, where we don't have the time and money to do it.”

This is where the idea of looking at Medical Affairs by way of opportunity cost becomes important. 

How do you measure opportunity cost? Kim shared a few examples. 

Again, these results become tangible in hindsight. And the data backing them up doesn’t lie. Max shares, “A lot of work has been done, and we have case studies saying the difference in uptake with different levels of market preparation by global 

medical affairs. Those uptake curves are so much longer when you haven't had medical affairs out there beating the drum.”

Wise Words on Starting Medical Affairs Early

As we near the end of our recap, we’ll touch on the topic of timing–a key theme in this episode and Medical Affairs planning overall. 

To help biotech leaders evaluate their thinking specific to timing and when to start Medical Affairs, Kim turned to Ramin. 

Here’s what he shared: “Ideally, we want to start sooner and sooner, but you also have to keep in mind that sometimes the resources are not there. We also have to wait until the data release before we can activate MSLs, or we have to wait for X, Y, Z to happen, right? Especially for a smaller biotech company. I don't think there's anything wrong with that. You just have to sequence it, right? However, what you're going to see as the trend going forward is getting medical affairs involved, just like what you said, Kim, early on. The earlier, the better, right? Even in the pre-clinical development, the studies and getting started getting those insights.”

Max added that you really have to understand the patient communities you are going into. 

“We would like two years as kind of the bare minimum for, you know, when you should bring medical affairs on for kind of your bigger value maximization. But you really have to understand the patient community that you're going into, the HCP communities that you're going into, and those really need to drive how and when Medical Affairs needs to be built up and how it should be structured.”

Kim, Ramin...

“I've found that it's usually not the ‘what’ or the ‘how’ that will get me where I need to go with a Senior leader. It's the why. They want to understand thewhybehind it.” Rachel Couchenour, VP, Global Medical Affairs, Travere Therapeutics. 

Working cross-functionally. Some would call it a skill. Others would say it’s a talent. For our guest on Episode 13 of the Emerging Biotech Leader, it’s her natural way of being. During her 20+ year career, Rachel Couchenour has held the titles of Assistant Professor, Medical Therapeutic Liaison, Sr Director of Medical Affairs, and now, Vice President of Global Medical Affairs at Travere Therapeutics.   

Using Rachel’s experience as a focal point, this episode explores the value of working cross-functionally in emerging biotechs, especially concerning a career in Medical Affairs. Kim and Ramin ask all the right questions, especially uncovering how an investment in Medical Affairs should never be brushed off or perceived as a “nice to have.” 

Our guest and hosts help emerging Biotech leaders truly understand the impact and significance of Medical Affairs on patients and practitioners. Conversely, they also help Medical Affairs reinforce their value across stakeholders, internal validation, and launches.

These are just a few key points touched on during Episode 13. Read below for more! And as always, we thank you for tuning in and being here. 

A Day In The Life of Medical Affairs 

To say the Medical Affairs organization has many moving parts is putting it mildly. 

On any given day, Rachel and her team are responsible for all of the activities and strategies within the Medical Affairs organization at Travere. Functions within her purview include education, scientific communications, evidence generation, medical information, and all the other capabilities that the Medical Affairs organization needs.

On the importance of these areas, Kim reminds us of the end result; that we’re all patients, and as patients, we benefit greatly from the work of the Medical Affairs team. Elaborating further on this, Kim shared: 

“I lean in a lot to the idea that if I were bringing my parent to a physician, I would like to assume that the physician knows the best possible treatment on the market available for whatever they have to diagnose my family with...And they know how to get it, and they have the entire path in front of them. And the only way they can do that is if Medical Affairs are showing up and doing their job. It's the only function that exists solely to make sure that the baseline assumption as a patient or as a caregiver holds true.” 

Rachel shared this advice for Medical Affairs peers in other organizations who want to keep sight of their impact. 

“I want to start by saying that we, as Medical Affairs professionals, should never underestimate the value of our work in a successful launch. If we think of ourselves as a critical partner, that helps you get in the right mindset because I think mindset is a really big aspect of this.” 

If you’re in Medical Affairs and want a tip for keeping your mindset in check, listen out for Rachel’s sticky note story. 

On Medical Affairs and Stakeholder Alignment 

With a deeper understanding of how much Medical Affairs handles and contributes, Ramin started to examine Medical Affairs' role in a biotech launch further. 

“Obviously, everything is aligned with the overall brand strategy and enterprise strategy, but Medical Affairs are the ones that are on the ground driving it. How do you use stakeholder management to make sure that you have a strong launch readiness strategy?” 

Once again, Rachel tied back the reliance on cross-functionality. Using her background and career as an example, she emphasizes how cross-functional collaboration and experience translate into a better understanding of what your stakeholders need and how you can be of value. Of particular importance was this clear advice:  once you understand what's important to them, you will speak their language better. 

“You know, they may not always speak our language of Medical Affairs, and it may take more than one engagement cross-functionally for them to fully see the value of why we may need to do a Symposia at a Congress–that maybe we hadn't planned to do. They may believe that the MSLs can do all the education that's needed. So sometimes, when you explain that you can reach thousands of individuals versus hundreds, that's what’s critical to them. It helps to speak their language versus the Medical Affairs lingo.”

One final reminder from Rachel on the role of Medical Affairs in a launch: 

“Medical Affairs is the one department that should be and is the leading edge out there to prepare the market, to understand the disease the way that we see it, and also to understand the treatment landscape.”

On What The Future Holds For Medical Affairs 

Rachel offers this insight if a career in Medical Affairs is your end goal. 

“I often encourage people to look laterally because sometimes to go up in an organization, you need to move laterally to have shared experiences with people that you want to partner with. An example I'll give was still technically within Medical Affairs. It was a small startup company. I was the first of one of two Medical Affairs hires at that organization. They didn't need as much work from a traditional Medical Affairs person. We weren't doing a lot of medical education. We were doing a lot of scientific communications. We didn't need to publish data, but they needed support in their clinical department. I learned so much in clinical from the clinical operations and the clinical development team at that organization. And I think that also served me really well in Medical Affairs.”

What other skills can serve you well, especially as the demand for Medical Affairs becomes greater and greater with each new biotech launching? Excellent communication skills. Both verbal and across digital mediums, too. 

“To get to that omnichannel type of educational approach, we're going to need people with a digital skill set. Patients are becoming more empowered, and they need to have the information. And I think it's incumbent upon us in the same way that we feel that accountability with KOLs and ATPs, we should also feel that same thing for the patient and caregiver community.”

Now that you’ve read our recap, we’d love to hear: has this changed your understanding of Medical Affairs' role in biotech? We’ll be back with more interviews for you soon! 

“The good news and the bad news are the same news.” Rik Reppe, VP Digital, Acquis Consulting Group  

We are excited to announce a new service, Digital-Led Biotech Strategy, in partnership with Acquis Cortico-X. Through this service, our clients will get access to medical, business, and digital experts to maximize theraputic value through a digital-led approach to solving challenges for biotech companies.

Our mission with each episode of the Emerging Biotech leader is to provide actionable insights and strategic thinking from experts across all facets of biotechnology. And this BONUS EPISODE, with SSI CEO Doug Locke at the host helm again, delivers on that promise. 

As we’ve often heard in previous episodes, building and growing a biotech provides no shortage of competing priorities. There’s fundraising, manufacturing, conducting trials, developing a clinical strategy, preparing for CMC readiness, building out a Medical Affairs team, leading the team, and so much more. 

Listen to Episode 6 of the Emerging Biotech Leader onTeam Agilityhere. 

Utilizing and capitalizing on digital innovation is also an important priority for biotechs in this modern era. And our two esteemed guests, Rishi Thurkal and Rik Reppe of Acquis Cortico-X, are experts on that. At Acquis, Rishi is Head of Life Science Digital Transformation, and Rik is Vice President of Digital Innovation. 

If you’ve found yourself flustered by rapid changes across the digital landscape, or you’re currently evaluating how to iterate on your existing digital approach, we invite you to hit play, listen, and read along for highlights. 

Doug, Rishi, and Rik take the seemingly daunting world of digital and bring it down to a manageable level with frameworks and guidance to help you and your team capitalize on its power and promise, regardless of your entity’s size. 

On The Digital “It” Factor  

What sets a biotech up for success in digital? Some might assume bigger budgets, more tools, and a larger team. But Rik says that’s a myth. 

“A lot of companies are kind of like, ‘Well, we don't have resources, we don't have the technology base to work from. And you're right, you don't have those things. That's the bad news.The good news is that you don't have those things. Digital is a game about speed and agility.

It's really hard, not impossible, but it’s hard for a massive entity to be fast and agile.It is comparatively easier for a smaller entity. And so, we can find ways where you do not need to be concerned with the question of: ‘Can I compete?’ You have a competitive advantage due to your size, and you can realize greater gains at a faster rate than those larger companies.” 

Once you embrace how to level the playing field is for biotechs in digital, the next line of thinking is around what to prioritize and how to make decisions around digital. 

This is where Rik and Doug share more on the upside in digital, given its federated or decentralized framework. Rik specifically says that you don't want decisions around digital up top in the centralized, hierarchical command and control structure. That said, listen to his advice around guardrails and establishing protocols around collaboration vs. control. 

Adding to the conversation, Rishi emphasizes that you need to make sure your digital strategy is aligned with the company strategy.

“What biotechs need to get, and that's what we try to do, is enable a cohesive strategy to reduce organizational burden and create this seamless intersection of the holistic set of digital solutions being aligned to their therapeutic goals.”

Navigating Change Management With Competing Digital Priorities 

What tends to happen to biotechs evaluating their digital innovation? Doug provides this real-world example: the clinical team identifies their specific need for one solution. Medical Affairs casts their eye on their own specific portal. CMC is underfunded, and they need something huge. Everyone has a hand in the pie, so who gets the biggest slice? 

To help leaders identify what to do in this type of scenario, Doug turned to Rishi and Rik for their POV on aligning competing priorities. Rishi advises a clear, tactical approach. In addition to having the right team to support digital, it’s imperative to complete a strategic assessment. 

“When you do a strategic assessment, do it with a team that has medical expertise, the business expertise, as well as digital expertise to best evaluate the business objectives and goals and thereby, through that evaluation, identify gaps. More importantly, this team also identifies the opportunities that are out there in order to invest in digital capabilities.”

Rishi provides much further food for thought on the strategic assessment process, be prepared to grab a pen and paper or in digital fashion, your laptop or phone to take notes! 

Doug, ever the expert host he is, then guides the conversation towards the reality that decisions and determinations are not often as seamless as presented: board and stakeholder buy-in must be achieved first.

On Ensuring Longevity When Investing In Digital 

Perhaps you’re a biotech leader excited about digital, but your biggest concern, especially having a therapeutic background is, how long is its shelf-life? Doug asks this very question of Rik. 

In his own words, “How do we ensure that the solution–for the six months we're working on–follows a thesis that's appropriate for the company?” Adding context to this: Doug specified investing in something today that may be able to last for two years. 

Enter the role of the steering committee. Rik elaborates on this further, particularly how consultants can help build them out. In a nutshell: before you get ready for digital and the assessment mentioned above, get clear on what you need as a business. Define the outcomes and with those inputs in mind, a trusted partner, such as Acquis, can uncover the right tools, allocate a determined investment and help you create a living government, most likely in the form of a steering committee. 

“These aren't big cumbersome, hard things. These are steering committees that meet on a weekly basis and are reporting directly back to the leadership of the company to make sure that we stay on point and that discipline A hasn’t drifted, meeting with predictable cadence and frequency.” 

On What Makes A Digital Innovation Project Successful 

As we wind down our recap, we’ll share Rik’s thoughts on what makes a digital innovation project in biotech successful. His answer is nothing short of eye-opening. 

“I’ve done digital in a million places, right? We've got folks in our joint team who have done Medical Affairs science, life sciences in a bunch of places. There is an inherent tension between those two.Instead of running from that tension, we want to run at that tension because it takes both.”

In layman's terms: opposite strengths, when anchored by the business outcomes, are more likely to solve the digital gap from angles ...

“The best leaders that I've seen are the ones that realize that it’s always “go, go, go,” and they need to move fast. But they still consciously take time to think, to pause a little bit and have a more of a multi-dimensional view of what's happening, as opposed to always being at a fast pace, moving forward and getting things done.” Ramin Farhood, Emerging Biotech Leader Host+Vice President Of Medical Affairs Practice, SSI Strategy

We’re back again with Episode 12 of the Emerging Biotech Leader. Ramin and Kim have returned. And Doug is still on air joining them for a frequently discussed topic that can be a little ambiguous to put into practice: authentic leadership. As you’ll hear from our hosts, the more you do it, the more natural it becomes. 

For Biotech CEOs who are just getting started or even those who are now midcourse, it’s not uncommon to ask, “What does authentic leadership really mean? How do you emulate it?” 

With 1,000’s of decisions and multiple layers of responsibility on any given day, how can Biotech CEOs, or any CEO for that matter, show up and guide their team without always having the answers or next steps, perfectly defined? 

These topics are what this episode covers and then some. Read along, listen along, and prepare to be transformed by these powerful takeaways. 

What It Means To Lead With Authenticity—And Why It Matters

Part of the ambiguity in being an authentic leader stems from not fully understanding how it's defined or embodied. As a starting point, here’s how the dictionary defines authenticity: of undisputed origin; genuine. Synonyms include real, true, honest-to-goodness, and valid—while the dictionary defines the opposite of authentic as fake or spurious. 

This theme of authenticity reemerged when we met with Ilan Gadot of Solid Biosciences during Episode 11. Reflecting back on that interview, Doug, Ramin, and Kim agree that Ilan embodied authentic leadership to a T. How did he do this? Through his willingness to be honest in different settings, admitting what he didn’t know, and truly getting to know people and making them feel good, supported, and safe. 

In case you missed it,access Episode 11 here. 

Doug explains an example of what this looks like in action: 

“Being authentic is when what was said publicly, privately, and also at the strategic mandate level all align. There is consistency in messaging and communication from the boardroom, to team meetings with ten people, and then also in the 1:1s and that traceability is from the executive layer. What is said in the toughest of settings is followed by what's done when you're trying to motivate a few people, then a team orientation and a meeting with someone individually…when that chain of custody is aligned and the people that are part of it can say, ‘That was authentic, and that was authentic’…I think they'll run through walls when they encounter, ‘Hey, this is making sense to me. This is what I need to do.’”

Authentic leadership requires a guard-down, open approach. Your team, investors, and even advisors can sense when you are abiding by the ‘fake it until you make it’ mentality and trying to get by on charisma as opposed to honestly admitting 

knowledge gaps or pausing to gather more information from advisors, or other parties, before a decision can be made.

Reread our highlight quote at the top of this recap with this in mind. 

While it may feel contradictory to admit that you don’t have a precise answer for everything and are still figuring it out, authentic leadership creates an environment of aligned learning and growth towards solutions, outcomes and building a path forward in uncharted territory, a given for any biotech whether specializing in new and innovative medical devices, gene therapies, digital biomarkers and more.

As a bonus, authenticity begets authenticity. Ramin emphasizes: “(authenticity) will also allow others around you to feel comfortable that if they don't know something, they don't have to make it up. They don't have to pretend.”

If You Don’t Have All The Answers, Who Does? The Importance of Advisors

What does authenticity have to do with advisors? Everything! From being able to laser in on where the knowledge and execution gaps are, to establishing rapport and trust with those advisors, to achieving business breakthroughs: authenticity is the founding principle.

You’ll hear Doug, Kim, and Ramin emphasize that it’s one thing to have advisors and it’s another thing to utilize them. People often know who to go to, but true success with advisors requires a guard-down approach and clear alignment around when to connect. Connecting frequently ensures that meetings are consistent and trust is established over time—as opposed to one-off or, as Doug describes it, “episodically and maybe somewhat haphazardly” meeting.

“If we had our druthers, we would help organizations kind of bubble up that, you know, honest assessment of what's going wrong or right between two inflection points in the company and make the best of that advisory array and use it consistently so that the rapport and the interdependencies are worked out.”

Authenticity, paired with a defined plan, facilitates execution and intimacy between all parties and the ability to measure results and course correct, all with the advisor's experience and best practices as part of the path forward. As is often encouraged in every episode: the best biotech leaders are proactive, not reactive. If you haven’t done so already, connect with your advisors and build that plan to meet moving forward. 

The Best Advisors May Not Always Be In Biotech

Having been an advisor for several biotechs in her role at SSI, Kim offers advice to further anchor the idea of genuine self-appraisal and honesty around missing competencies. She encourages leaders to identify knowledge gaps and find advisors outside the life sciences sector. Take technology for example: 

“I think there are macro leadership challenges where there's actual, additional benefit from having somebody as a sounding board, or a group of people as a sounding board, who are not in the throws of biotech day to day, but might be in an adjacent industry or something related that are facing similar challenges because it changes your objective point of view on how you manage team dynamics in X, Y and Z situation, whether it's somebody in tech who's, you know, given where we are today dealing with massive layoffs. Biotech has dealt with similar things in the last 6 to 12 months.”

Kim brings this point home with the following thought:  “I think we get a little stuck sometimes on, you know, ‘these are the four people that really are my people,’ and we don't lean in enough to those who can provide the different points of view to really evolve our thinking to the next level.”

If you’re committed to changing your leadership style and approach, it’s encouraged to change up your sounding board, too. 

After listening to this episode and reading this recap, let us know: how will you put authentic leadership into practice this year? 

We’ll be back again with a new episode soon. Be sure to subscribe to our show, so you never miss out on the latest thought leaders, advice,...