The Emerging Biotech Leader

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 pioneerin...

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 di...

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 deve...

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 t...

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...

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 Medicin...

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...

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...

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...

"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...

“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...

“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...

“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...

“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 C...

“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...

“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 a...

“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...

“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...

“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...

“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 m...

“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 drastica...

“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...

“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 Affair...

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 Crai...

“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 the why behind 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...