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:

• The importance of cross-sector partnerships and stakeholder engagement from day one

• Fostering a culture of innovation through mission-driven leadership

• Promoting employee accountability to take smart risks

• Learning quickly from failures versus avoiding them

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:

1. Develop a regulatory strategy early, engaging with regulators for novel modalities.

2. Consider HTA and payer requirements from the outset, not just regulatory approval.

3. Design trials with comparative data and explore real-world evidence opportunities.

4. Boards must have a global perspective and understand requirements beyond the US.

5. 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:

• Continually seek cross-functional opportunities to build a well-rounded skill set
• Maintain humility and openness to learn from subject matter experts
• Balance full-time hires with external consultants/contractors for flexibility

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:

• Large, well-designed clinical trials involving thousands of patients are needed to prove concepts, change practice, gain approvals and reimbursement.

• Downstream data is important to show how diagnostic or predictive tools impact treatment decisions and health outcomes. Real-world evidence of clinical utility is critical.

• Long-term studies may be required to demonstrate prevention of disease progression and cost savings over time. This level of evidence takes significant upfront investment.

• Standards of evidence will be high when trying to shift treatment paradigms or gain recommended screening status from influential bodies.

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.