Biotech—it's complicated. A successful product launch requires grit, determination, and clear direction. But let’s be real, the path to launch isn’t a straight one. There are curves, hard turns, and dead ends. Here’s the good news, you don’t have to navigate the complexities alone. Welcome to The Emerging Biotech Leader, where we help biotech leaders maximize the value of their therapeutics from clinical development to product launch.
…
continue reading
Biotech Product Launch Podcasts
…
continue reading
Joanna Kaniewska from T Shaped uncovers career planning strategies for STEM professionals, helping you grow and shape a career that aligns with your goals and passion. Discover what accomplished scientists, engineers, and innovators have done to reach their current positions and learn about their paths to leadership. Through success stories and challenges faced, see how passion can be channeled into fulfilling careers. It features exclusive interviews, invaluable career planning tips, and ke ...
…
continue reading
Are you working in healthcare market research or competitive intelligence or market intelligence? Do you often face information overload, from the pharma news portals, clinical trial registries, regulatory agencies, financial reports, investor releases, pharma summits, investment news, and financial summits etc.? It is hard to keep a track of all the forces (external and internal) that affects a product’s development and performance in the healthcare/ pharmaceutical market. We at RAS Life Sc ...
…
continue reading
Welcome to the podcast where the genuine stories of guests take center stage, offering insights into the people behind the science, their journeys, and aspirations. Uncovering the Trials and Errors. I'm Kasia Kuzmicz-Kowalska, a recent PhD graduate, driven by a passion for both science and storytelling. Join me and my guests on a journey Beyond Academia. Expect a candid exchange of experiences, invaluable advice and a deep dive into the advantages and challenges of various career paths. Allo ...
…
continue reading

1
Adapting Biotech Leadership Across Development and Therapies
25:29
25:29
Play later
Play later
Lists
Like
Liked
25:29Biotech leaders are asked to do a lot; move fast, manage limited resources, and guide teams through very different stages of development. In this episode of The Emerging Biotech Leader, host Kim Kushner talks with Dr. Benit Maru, Senior Vice President at SSI Strategy, about what it really looks like to lead in that environment. They cover: The cont…
…
continue reading

1
The CMO’s Role in Building a Scalable Biotech Strategy
46:28
46:28
Play later
Play later
Lists
Like
Liked
46:28In this episode of The Emerging Biotech Leader, Kim Kushner speaks with Dr. Michael Goldstein, ophthalmologist and multi-time Chief Medical Officer, about the realities of biotech leadership across modalities and development stages. Dr. Goldstein reflects on lessons learned from leading clinical programs in small molecules, biologics, gene therapie…
…
continue reading

1
Designing Patient-Centric Trials That Work
16:35
16:35
Play later
Play later
Lists
Like
Liked
16:35What does it take to bring patient-focused values into the real decisions that shape drug development, especially when you're moving fast, working lean, and under pressure to deliver? In this episode, host Kim Kushner speaks with Victoria Oswald, Vice President at SSI Strategy, about how biotech teams can start small but think deliberately when emb…
…
continue reading

1
Build the Company You Say You Are: How culture shapes real-world execution
31:37
31:37
Play later
Play later
Lists
Like
Liked
31:37In this episode, Kim speaks with Jill Milne, Ph.D., CEO of Astria Therapeutics, about what it really takes to build a biotech company around patient needs, not just in mission statements, but in everyday decisions. Drawing on her 25+ years in pharma and biotech, Jill shares how Astria is redefining what it means to be patient-first, why culture is …
…
continue reading

1
From Vision to Viability: The Decisions That Define a Biotech
23:26
23:26
Play later
Play later
Lists
Like
Liked
23:26What 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 t…
…
continue reading

1
Five Fundamentals for Building a Biotech That Lasts
36:23
36:23
Play later
Play later
Lists
Like
Liked
36:23In 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-eye…
…
continue reading
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…
…
continue reading

1
Expanding the CMO Role: The Value of Difference
35:01
35:01
Play later
Play later
Lists
Like
Liked
35:01In 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…
…
continue reading

1
Enabling Successful Sites, Episode 5: Strategies for improving communication between sites, sponsors and CROs
22:38
22:38
Play later
Play later
Lists
Like
Liked
22:38Investigative sites have shared that one of their top frustrations with the clinical trial process is with the poor communication flow and overall lack of responsiveness from sponsors and CROs. In this episode of ‘Enabling Successful Sites’, Karen McIntyre, Vice President, Global Site Alliances sits down with Jakub Jedrzejewski, Global Project Mana…
…
continue reading

1
Is there room for new COAs in neuroscience?
28:32
28:32
Play later
Play later
Lists
Like
Liked
28:32As we strive to improve health outcomes for patients with neurological conditions, the development of new clinical outcomes assessments (COAs) is crucial. Advancements in COAs are at a tipping point, significantly impacting the future of clinical trials and patient care. Our clinical development and regulatory experts discuss the importance of deve…
…
continue reading

1
Enabling Successful Sites: Episode 4, Part Two: Leveraging AI to improve patient recruitment and retention
8:17
8:17
Play later
Play later
Lists
Like
Liked
8:17AI is becoming increasingly prevalent in the healthcare industry and clinical research. For clinical trial recruitment, AI can be extremely helpful in finding potential patient volunteers as well improving overall retention rates. In part two of this ‘Enabling Successful Sites’ podcast episode on improving patient recruitment and retention, Karen M…
…
continue reading

1
Enabling Successful Sites: Episode 4, Part One: Partnering with sites to improve patient recruitment and retention
26:56
26:56
Play later
Play later
Lists
Like
Liked
26:56Patient recruitment continues to be a major cost driver and top challenge in clinical research. More than half of sites have to pay recruitment expenses out of their own funds, as sponsor budgets won’t cover some of necessary education and recruitment practices that sites must perform in order to meet enrollment goals and stay in business. This ‘En…
…
continue reading
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 fr…
…
continue reading

1
Leveraging people, processes and technology to deliver for biotech
21:35
21:35
Play later
Play later
Lists
Like
Liked
21:35Small and emerging biotech companies have varied challenges compared to mid-large size pharma companies, with paths that aren’t always as straightforward as taking a compound through clinical development to launch. Our biotech clients drive towards these key inflection points from proof of concept to compound development, to capital raises based on…
…
continue reading
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 af…
…
continue reading

1
Right Time, Right Team: How to Optimize Medical Leadership
32:22
32:22
Play later
Play later
Lists
Like
Liked
32:22Have 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 clin…
…
continue reading

1
The New Board Game: Strategic Moves in Biotech
16:43
16:43
Play later
Play later
Lists
Like
Liked
16:43The 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 conve…
…
continue reading

1
Supercharging Biotechs: The Power of Strategic Board Engagement
35:24
35:24
Play later
Play later
Lists
Like
Liked
35:24How 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 a…
…
continue reading

1
Navigating market access in neuroscience: Challenges and strategies
26:22
26:22
Play later
Play later
Lists
Like
Liked
26:22Dr. Andreas Lysandropoulos, Senior Vice President and Global Therapeutic Head of Neurosciences, and Wyatt Gotbetter, Senior Vice President, Worldwide Access Consulting, join Bev Hope, Parexel’s Marketing Strategy Director, in a podcast discussion of how sponsors can build a value proposition and market access strategy for novel neurological and psy…
…
continue reading

1
How Smart Risk Management Safeguards Your Biotech Venture
25:50
25:50
Play later
Play later
Lists
Like
Liked
25:50In 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 crit…
…
continue reading

1
De-risking Drug Development | Episode 5: Expand the use and value of your product over time
34:38
34:38
Play later
Play later
Lists
Like
Liked
34:38De-risking Drug Development is a five-part podcast series that explores the business-critical decisions that take place at each stage of the drug development process. We know that novel therapies often don’t meet their revenue expectations, but through informed decision-making, you can minimize risk and maximize the probability of commercial succes…
…
continue reading

1
De-risking Drug Development | Episode 4: Implement market launch strategy, pre-approval
33:53
33:53
Play later
Play later
Lists
Like
Liked
33:53De-risking Drug Development is a five-part podcast series that explores the business-critical decisions that take place at each stage of the drug development process. We know that novel therapies often don’t meet their revenue expectations, but through informed decision-making, you can minimize risk and maximize the probability of commercial succes…
…
continue reading

1
Where Risk Meets Opportunity: Strategies for MedTech Success
44:57
44:57
Play later
Play later
Lists
Like
Liked
44:57This 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 com…
…
continue reading

1
Patients as Partners: A Winning Strategy for Drug Development - Laurie Smaldone-Alsup: 37
24:25
24:25
Play later
Play later
Lists
Like
Liked
24:25The 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 conv…
…
continue reading

1
Rare Diseases, Real Lives: Bridging Patient Needs and Drug Development - Dr. Edward M. Kaye : 36
26:42
26:42
Play later
Play later
Lists
Like
Liked
26:42On 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 an…
…
continue reading

1
Podcast: Accelerated approvals – what’s next, confirmatory trials, access, and pricing
12:51
12:51
Play later
Play later
Lists
Like
Liked
12:51Focusing on cell and gene therapies, this podcast discusses the use of accelerated approvals for fast tracking promising novel medicines through clinical development to registration.By PAREXEL
…
continue reading

1
Real-World Evidence and Putting Patients at the Center of Drug Development - Dr. Chantal van Gils : 35
22:46
22:46
Play later
Play later
Lists
Like
Liked
22:46Summary: 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) th…
…
continue reading

1
De-risking Drug Development | Episode 3: Plan how to get to market quickly, post proof-of-concept
39:29
39:29
Play later
Play later
Lists
Like
Liked
39:29De-risking Drug Development is a five-part podcast series that explores the business-critical decisions that take place at each stage of the drug development process. We know that novel therapies often don’t meet their revenue expectations, but through informed decision-making, you can minimize risk and maximize the probability of commercial succes…
…
continue reading

1
Daring to Fail Forward: The Mindset Catalyzing Healthcare Breakthroughs - Christian Howell : 34
39:30
39:30
Play later
Play later
Lists
Like
Liked
39:30This 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 Cogni…
…
continue reading

1
Enabling Successful Sites Ep. 2: Empowering Sites to be More Inclusive Through Cultural Sensitivity Training
27:09
27:09
Play later
Play later
Lists
Like
Liked
27:09The second episode of our ‘Enabling Successful Sites’ series features a discussion between Karen McIntyre (VP, Global Site Alliances), Xoli Belgrave (Sr. Director, Head of Clinical Trial Diversity and Inclusion), Jamie Langley (Executive Director, Parexel Academy) and Dr. Lovie Negrin, CEO and Founder of Randomize now on how we can empower and leve…
…
continue reading

1
Enabling Successful Sites Ep. 3: Taking the complexity out of oncology trials
26:40
26:40
Play later
Play later
Lists
Like
Liked
26:40Oncology clinical trials present unique challenges for investigative sites, including complex trial designs, challenging eligibility criteria, and invasive procedures. In addition, the oversaturation of trials leads to competition for patients and experienced sites. The third episode of Enabling Successful Sites features a discussion between Karen …
…
continue reading

1
Avoiding Common Pitfalls in the Biotech Development Process - Dr. Thomas Lönngren : 33
31:13
31:13
Play later
Play later
Lists
Like
Liked
31:13Episode 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, …
…
continue reading

1
De-risking Drug Development | Episode 2: Focus on safety and efficacy and prove quickly that your product works
38:13
38:13
Play later
Play later
Lists
Like
Liked
38:13De-risking Drug Development is a five-part podcast series that explores the business-critical decisions that take place at each stage of the drug development process. We know that novel therapies often don’t meet their revenue expectations, but through informed decision-making, you can minimize risk and maximize the probability of commercial succes…
…
continue reading

1
Redefining Roles: From Medical Practice to Biotech Ventures - Keith Gottesdiener : 32
42:56
42:56
Play later
Play later
Lists
Like
Liked
42:56In 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 R…
…
continue reading

1
Ep020 - Ryan Cubero: Navigating the Ups and Downs of Career Transitions
1:27:24
1:27:24
Play later
Play later
Lists
Like
Liked
1:27:24What does a data scientist do? How does the work environment in a start-up contrast with that in academia? What challenges await those who switch scientific disciplines? How to stay involved with the scientific community beyond academia? The typical academic path involves numerous transitions—changing projects, labs, and institutes. Mobility is not…
…
continue reading

1
Balancing Current Needs and Long-Term Goals in Biotech : 31
23:16
23:16
Play later
Play later
Lists
Like
Liked
23:16In 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 ro…
…
continue reading

1
De-risking Drug Development | Episode 1: How to drive value in pre-clinical development
23:37
23:37
Play later
Play later
Lists
Like
Liked
23:37By PAREXEL
…
continue reading

1
Growing Early Biotech Startups Through Connection - Dan Bloomfield : 30
38:54
38:54
Play later
Play later
Lists
Like
Liked
38:54In 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…
…
continue reading

1
Ep019 - Peggy Sotiropoulou: Mythbusting Biotech Industry: Insights from a CSO
56:14
56:14
Play later
Play later
Lists
Like
Liked
56:14What does a CSO of a biotech company do on a day-to-day basis? How much truth lies behind the common stereotypes about working in the biotech industry? What can make you stand out as a candidate for a biotech industry job? Step into the dynamic world of biotech with our latest episode as we debunk common myths and uncover the realities of working i…
…
continue reading

1
Enabling Successful Sites, Episode 1: Solving Site Feasibility and Start-Up Challenges
16:40
16:40
Play later
Play later
Lists
Like
Liked
16:40The site feasibility and initiation process can be a frustrating one for investigative sites due to lengthy questionnaires, duplication in data requests, and unrealistic recruitment targets and start-up timelines. In the first episode of our Enabling Successful Sites podcast Parexel's Karen McIntyre, VP of Global Site Alliances and Marta Leon, VP o…
…
continue reading

1
Rare Endpoints: Delivering on Unmet Patient Needs
11:19
11:19
Play later
Play later
Lists
Like
Liked
11:19The latest episode of Preparing for a Cell and Gene Future features a discussion between Jamie Pierson (Program Lead within Parexel’s Cell and Gene Center of Excellence) and Kim MacDonnell (Associate Director for Rare Diseases). They consider uses of surrogate markers as endpoints in rare disease development and look ahead to positive directions es…
…
continue reading

1
Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 3
13:22
13:22
Play later
Play later
Lists
Like
Liked
13:22In this third episode on advancing precision oncology, we continue discussing the role of expanding patient access to biomarkers and evolving testing capabilities. Our precision oncology experts delve into the challenges and opportunities that lie ahead in the rapidly changing landscape. They explore advancements in data, machine learning, and test…
…
continue reading

1
Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 2
13:27
13:27
Play later
Play later
Lists
Like
Liked
13:27In this second episode on advancing precision oncology through patient access to biomarkers and testing, the discussion focuses on the benefits of integrating multi-omic data in precision oncology and how it can enhance treatment selection. Our experts discuss the importance of looking beyond genomics and considering other omics, such as immunomics…
…
continue reading

1
Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 1
20:51
20:51
Play later
Play later
Lists
Like
Liked
20:51In this first episode, join our clinical development and market access experts who discuss the role of biomarker research, discovery, and patient access in advancing precision oncology to date. Biomarkers have been central to improving patient outcomes and guiding treatment guidelines in lung, breast, and blood cancers. With that backdrop, our expe…
…
continue reading

1
Ep018 - Ashley Ruba: How to launch a fulfilling non-academic career?
1:08:32
1:08:32
Play later
Play later
Lists
Like
Liked
1:08:32What does a Human Factors Engineer do? What can lead to a decision to exit academia, and what can drive someone to share their transition publicly? What are the do's & don'ts of job hunting? Our guest is Ashley Ruba - an American researcher, currently working as a Human Factors Engineer at Arthrex. Ashley is also a founder of After Academia, a coac…
…
continue reading

1
Ep017 - Rose De Guzman: Making science more accessible through Product Management and Mentoring
53:47
53:47
Play later
Play later
Lists
Like
Liked
53:47What does the position of Product Manager entail? What makes someone who has a good chance of becoming a PI leave academia? How to deal with imposter syndrome during big career transitions? Our guest is Rose De Guzman - a Filipino-American scientist, currently working as a Product Manager at Evident Scientific. Rose is a passionate advocate for mak…
…
continue reading
The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials. In today’s episode, Fierce Pharma’s Angus Liu talks with Parexel regu…
…
continue reading

1
Episode 016 - Prequel with Kasia Kuzmicz-Kowalska
15:26
15:26
Play later
Play later
Lists
Like
Liked
15:26Why was Science on Trial [and Error] on a long break? What is coming in the new season? In this special Prequel episode, Kasia Kuzmicz-Kowalska opens up in a candid self-interview, addressing the reasons behind the extended break of the show. She reflects on her personal journey, navigating the challenges of completing her PhD while prioritizing he…
…
continue reading
In this new introduction get to know the host of Science on Trial [and Error], Kasia Kuzmicz-Kowalska, and find out more about the podcast. What's the idea behind the podcast? What can you expect from the new season that looks Beyond Academia? Our new lineup spans a broad spectrum of scientific careers, ensuring there's something for everyone. Allo…
…
continue reading