What does it really take to launch a biotech company that lasts? In this episode, host Kim Kushner sits down with Dr. Marcia de Souza Lima , a physician-executive whose journey spans clinical care, global pharma, investment, and startup leadership. Together, they explore the earliest days of company formation—where every decision, from team design to product development, can shape the long-term path of the organization. The conversation begins with a familiar framework—the “Five P’s” of early bi...
Jun 26, 2025•23 min•Ep. 48
In this episode of The Emerging Biotech Leader , host Kim Kushner speaks with Al Beardsley, CEO of Cirius Therapeutics, about the foundational principles that guide sustainable biotech company building. A seasoned operator with experience across early discovery and late-stage development, Al introduces his “Five P’s” framework—a practical, clear-eyed guide for leaders responsible for turning science into durable enterprise value. The discussion covers: Product – How to ensure scientific innovati...
Jun 13, 2025•36 min•Ep. 47
In this episode, Chief Business Officer Kim Kushner talks with Dr. Carrie Brownstein, SVP Medical at SSI Strategy, about how to think through the fit between a biotech leader and their company’s stage of development. Carrie shares lessons from her own path from large pharma to biotech and how different kinds of experience shape what a CMO can offer at different points in a company’s growth. They talk about building the right kind of support team, knowing your own limits, and making space for oth...
May 30, 2025•16 min•Ep. 46
In this episode of The Emerging Biotech Leader , Chief Business Officer Kim Kushner and Dr. Carrie Brownstein, SVP Medical at SSI Strategy are joined by Dr. Chrystal Louis, Chief Medical Officer at TScan Therapeutics, to discuss how different professional experiences shape leadership approaches in the biotechnology sector. Dr. Louis brings extensive experience across clinical development and medical affairs, with a career spanning pediatric oncology, industry leadership roles, and the buildout o...
May 15, 2025•35 min•Ep. 45
As biotech innovation accelerates across therapeutic areas organizations face complex strategic decisions about their future. In this episode of The Emerging Biotech Leader, former EMA Director Dr. Thomas Lönngren offers insights into the market dynamics and organizational requirements that will define success in 2025. Several key themes emerged from our discussion that will shape the industry's trajectory in the coming year. A Fight for Funding The funding environment remains challenging, with ...
Dec 18, 2024•37 min•Ep. 44
When does a biotech need a Chief Medical Officer? "If you're asking, you probably needed one yesterday," suggests Dr. Benit Maru in this straight-talking episode of Emerging Biotech Leader. The SSI Strategy medical lead breaks from convention, arguing that early-stage organizations - particularly those in rare disease or novel modalities - can't afford to postpone medical leadership. His analysis cuts through traditional timing metrics to focus on strategic impact and organizational readiness. B...
Dec 03, 2024•25 min•Ep. 43
Have you ever wondered what makes a great biotech CMO? In this episode of the Emerging Biotech Leader , Dr. Steven Zelenkofske shares the practical, hard-earned insights he’s gained from his five CMO positions and multiple board roles, offering straightforward advice on how CMOs can step in early, build strong executive relationships, and drive clinical programs to successful outcomes. This episode is your behind-the-scenes look at the evolving role of biotech’s top medical leaders. Steven strik...
Nov 18, 2024•32 min•Ep. 42
The relationship between biotech leadership and their boards is evolving, particularly as private equity takes a larger role in the industry. In this episode of the Emerging Biotech Leader, Nick Amigone from Amulet Capital Partners offers a unique perspective on building effective board relationships from the private equity vantage point. The conversation explores three distinct board structures that shape company governance: Public Company Boards: Diverse shareholders acting as fiduciary repres...
Nov 04, 2024•17 min•Ep. 41
How can biotech CEOs and their boards foster strong, trusting relationships that drive effective decision-making and long-term success? In this episode of Emerging Biotech Leader , host Kim Kushner explores this critical question together with Don de Bethizy. Don is a seasoned life sciences executive with over 30 years of experience, having served as a founder and CEO as well as board member and advisor. The episode highlights key strategies for building trust, setting clear objectives, and mana...
Oct 22, 2024•35 min•Ep. 40
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....
Oct 07, 2024•26 min•Ep. 39
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...
Sep 24, 2024•45 min•Ep. 38
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...
Aug 29, 2024•24 min•Ep. 37
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. Wh...
Aug 16, 2024•27 min•Ep. 36
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 e...
Jul 29, 2024•23 min•Ep. 35
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 br...
Jul 10, 2024•40 min•Ep. 34
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 ...
Jun 26, 2024•31 min•Ep. 33
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...
Jun 12, 2024•43 min•Ep. 32
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 collabora...
May 29, 2024•23 min•Ep. 31
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 gainin...
May 15, 2024•39 min•Ep. 30
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 pati...
Mar 01, 2024•26 min•Ep. 29
"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 ...
Feb 14, 2024•38 min•Ep. 28
“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...
Jan 29, 2024•23 min•Ep. 27
“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 marke...
Dec 12, 2023•28 min•Ep. 26
“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 fr...
Nov 29, 2023•28 min•Ep. 25
“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...
Nov 07, 2023•43 min•Ep. 24
“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, wh...
Oct 23, 2023•27 min•Ep. 23
“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 ...
Sep 26, 2023•33 min•Ep. 22
“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...
Sep 11, 2023•39 min•Ep. 21
“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...
Jul 24, 2023•23 min•Ep. 20
“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 diseas...
Jul 13, 2023•33 min•Ep. 19
