Podcast · Tech & Science

Medical Affairs Unscripted

by Lumanity Medical Affairs Consulting · English · Tech & Science

In Medical Affairs Unscripted we explore a range of topics related to the strategic role of Medical Affairs from the perspective of industry experts. Through these conversations with our guests we will share first hand experience to provide the listener with insights and knowledge about the evolving

New episodes: Monthly
Typical length: 43 min
Latest: 30 Sep 2026
Language: English

Latest episode

30 Sep 2026 · 39 min

Rethinking Global Medical Affairs: Co-Led Brand Strategy, Agile Teams & AI with Emad Siddiqui of Astellas

How can Medical Affairs teams move faster, align global brand strategy, and use artificial intelligence (AI) while keeping patients first? Emad Siddiqui, Senior Vice President, Head of Medical Affairs Global Brand Strategy at Astellas Pharma, joins host Peg Crowley-Nowick on Medical Affairs Unscripted. A surgeon by training, Emad describes his move from clinical practice into Medical Affairs and his belief in putting patients and science first. He explains the Astellas "Brand at the Center" model, where Medical Affairs and Commercial co-lead global brand teams and build the integrated global…

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Earlier episodes 29 most recent

S6 · E6 · 25 Aug 2026 · 43 min
One Size Does Not Fit All: Leading Medical Affairs Across a Diverse Portfolio
What happens when one Medical Affairs leader is responsible for oncology, neurology, immunology, fertility, HIV, and rare disease, all at the same time? The answer is not a bigger playbook. It is an entirely different way of thinking. Host Peg Crowley sits down with Lori Lebson, Senior Vice President of Global Medical Affairs at CalVista Pharmaceuticals, to dig into one of the most underestimated challenges in the field: leading Medical Affairs strategy across a truly diverse portfolio. Lori has lived this challenge from the inside. From large pharma to biotech, she brings a rare perspective…
S6 · E5 · 28 Jul 2026 · 48 min
Proactive vs. Reactive: How the SIUU Guidance is Reshaping Medical Affairs Strategy with Josh Bryson
The FDA finalized its guidance on Scientific Information on Unapproved Uses (SIUU) in January 2025, giving pharmaceutical and biotech companies a framework for proactive off-label communication with healthcare providers. Yet many medical affairs organizations are still navigating what it means in practice. In this episode, Peg Crowley-Nowick, PhD, MBA talks with Josh Bryson, PhD, Head of U.S. Medical Affairs and Evidence Generation at Argenx, about the real-world implications for medical affairs strategy. Josh and Peg examine what the FDA guidance permits, the data integrity and publication…
S6 · E4 · 15 May 2026 · 51 min
The Launch Starts Now: A CMO's Approach to Early Medical Affairs Strategy in Biotech with Nick Sarlis, MD, PhD, FACP
In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick speaks with Nick Sarlis, MD, PhD, FACP , Chief Medical Officer at Clara Biotech, about why successful biotech launches begin years before approval. Drawing on experience across six product launches and nine indications, Nick shares a practical CMO perspective on building medical affairs capabilities early, aligning scientific strategy across functions, and preparing organizations for launch success in today's biotech environment. Nick explains why "T-minus 30 months" is becoming the new standard for launch preparation and…
S6 · E3 · 10 Apr 2026 · 44 min
Medical Affairs as a Strategic Engine: De-Risking Biotech Development and Driving Commercial Success
What if the decisions that determine your drug's commercial success are already being made and medical affairs isn't in the room? In this episode of Medical Affairs Unscripted , Peg Crowley speaks with Nick Sen, SVP and Practice Lead at Lumanity Medical Affairs Consulting, about the evolving role of medical affairs as a strategic driver in biotech and pharmaceutical development. Drawing on experience across academia, commercial strategy, and market access, Nick explains why early medical engagement is no longer optional even for resource-constrained biotech companies. Instead, it is a…
S6 · E2 · 19 Feb 2026 · 47 min
Building the CMO Playbook: From Pre-IND to Launch in Early-Stage Biotech
In this episode, Peg Crowley-Nowick speaks with Joseph Elassal, MD, MBA, Chief Medical Officer of Ankyra Therapeutics, about the strategic, operational, and financial realities of leading clinical development from pre-IND through proof of concept and toward commercialization. Drawing on experience across large pharma, biotech partnerships, and early-phase oncology, Joe shares a practical roadmap for new and aspiring CMOs. They discuss how to prioritize essential capabilities, including clinical operations, regulatory strategy, biostatistics, and pharmacovigilance, while determining the right…
S6 · E1 · 3 Feb 2026 · 44 min
Medical Affairs Leadership: From Support Function to Strategic Lever
How Medical Affairs leaders can move their organizations from a supporting role to a strategic driver—through accountability, insight translation, and the smart use of AI. In this episode of Medical Affairs Unscripted , Peg Crowley-Nowick speaks with Greg Carpenter , Global Medical Strategy Leader in General Medicine at Sanofi , for a candid conversation on how Medical Affairs must evolve to remain relevant—and indispensable—in a rapidly changing industry. The discussion focuses on how Medical Affairs leaders can increase their strategic impact across pharma and biopharma organizations.…
S5 · E10 · 20 Nov 2025 · 51 min
It Doesn't Take Months: How an Expert CMO Builds a TPP That Drives Success - With Jeff Humphrey, MD
Medical Affairs Unscripted welcomes Dr. Jeff Humphrey—an experienced CMO with three decades across Bristol Myers Squibb, Pfizer, Bayer, Kyowa Kirin, and multiple biotechs—to discuss why the Target Product Profile (TPP) is the foundation of effective drug development. He shares a clear framework for "starting with the end in mind," from scientific fit and standards of care to regulatory precedent, investor expectations, and the smart use of AI. Humphrey also underscores the importance of working with patient-first KOLs and reminds listeners that poorly planned development can waste years of…
S5 · E9 · 29 Oct 2025 · 43 min
From First Patient Enrolled to First Script: Medical Affairs as the Throughline
Medical Affairs isn't a downstream function—it's the throughline connecting science, story, and strategy from development through commercialization. This episode features Howard Rutman, MD, MBA, Chief Medical Officer at Xalud Therapeutics and Peg Crowley-Nowick, PhD, MBA discussing the critical role of early Medical Affairs engagement. Key topics include how early Medical Affairs involvement speeds patient enrollment and data generation, qualities to seek in the first Medical Affairs hire, the value a lean team can bring to BioTech, and the importance of evidence plans that support physician…
S5 · E8 · 9 Oct 2025 · 36 min
Podcast Bytes - Bridging Science and Strategy: The Power of Medical-Commercial Collaboration
In this episode of Medical Affairs Unscripted, host Peg Crowley-Nowick talks with Shera Gruen, SVP of Strategy Consulting at Lumanity, about the power of collaboration between medical and commercial teams in pharma. Drawing on her 20 years of industry experience leading commercial teams, Shera shares lessons on aligning science with strategy, preparing for launch success, and managing uncertainty. From cross-functional teamwork to scenario planning and external partnerships, this conversation offers practical insights for anyone involved in bringing new therapies to market — and shows how…
S5 · E7 · 25 Jun 2025 · 51 min
The Intersection between New Product Planning and Medical Affairs with Cathy Symonds, PhD
In this episode of Medical Affairs unscripted , Peg Crowley-Nowick, PhD, MBA, Senior Advisor, Medical Affairs Consulting at Lumanity, and Cathy Symonds, PhD, Program Lead and Head of New Product Planning at Arbor Biotechnologies, engage in an insightful discussion about the evolving role of new product planning and its intersection with Medical Affairs. Peg and Cathy explore the strategic importance of new product planning in the lifecycle of medical products, emphasizing how early commercial strategy is essential for successful development and market entry. They discuss various frameworks…
S5 · E6 · 27 May 2025 · 45 min
Rare Insights: Navigating Medical Affairs in Rare Disease Launches with Eva Gallagher, PhD, CNMAP
In the latest episode of Medical Affairs unscripted, Peg Crowley-Nowick, PhD and Senior Advisor, Medical Affairs Consulting at Lumanity, engages in a compelling conversation with Eva Gallagher, PhD, CNMAP, VP, Head of Medical Affairs at Agios Pharmaceuticals. They explore the strategic role of Medical Affairs in the rare disease space, discussing best practices for building effective teams, engaging diverse stakeholders, and leveraging digital tools for education. Eva's journey and success in the field offer a blueprint for how Medical Affairs can drive impactful change and enhance patient…
S5 · E5 · 18 Apr 2025 · 31 min
Podcast Bytes - From Tweets to Trends: Leveraging Social Media for Medical Affairs Insights with Jamie Doggett
In this episode of Medical Affairs unscripted , Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity , discusses the critical role of social media listening in healthcare with Jamie Doggett, Associate Director of Social Media Insights and Analytics at Lumanity. They explore the insights obtained from Jamie's whitepaper, Transforming Scientific Conversations: Adapting to a New Era of Healthcare Social Media . Jamie highlights how unprompted online conversations among healthcare professionals and patients can reveal critical insights for pharmaceutical companies.…
S5 · E4 · 27 Mar 2025 · 45 min
Realizing Value through Effective Medical Affairs Operations with Keith Poole
Join Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, in this episode of Medical Affairs Unscripted as she engages with Keith Poole, Executive Director and Head of Medical Excellence & Impact Enhancement at Merck KGaA, Darmstadt, Germany. They delve into the critical role of Medical Operations in fostering a high-performance culture within organizations. The discussion covers the strategic collaboration between medical operations teams and Medical Directors, focusing on advisory board meetings, strategy, budgeting, and analysis and communication of…
S5 · E3 · 6 Mar 2025 · 44 min
Creating Synergies by Integrating Across Medical Affairs with Caroline Ojaimi, PhD
In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, speaks with Caroline Ojaimi, PhD, Head of Global Scientific Communications, Congresses, and External Engagement at Takeda Oncology. Dr. Ojaimi shares her passion for Medical Affairs and provides insights into strategically redesigning organizational structures to enhance agility, efficiency, and cross-functional collaboration. Their discussion covers the importance of dedicated congress leadership, the role of external engagement in shaping scientific…
S5 · E2 · 24 Feb 2025 · 25 min
Podcast Bytes - Use of GenAI in Medical Publications with Tim Becker, PharmD, RPh
In this Medical Affairs unscripted Podcast Byte , Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, discusses the recently released insights report: Expert Perspectives on the Use of Generative AI in Medical Publication with her colleague, Tim Becker, PharmD, RPh, EVP, Creative Scientific Solutions at Lumanity. Their discussion sheds light on the safe and proper use of Generative AI in medical publications, addressing key concerns such as hallucinations, data privacy, and the need for transparency and accountability. They also explore the future impact of…
S5 · E1 · 31 Jan 2025 · 42 min
Establishing Strategic Connections to Accelerate Clinical Trials with Smitha Sivaraman, PhD, MBA
In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, engages in an enlightening discussion with Smitha Sivaraman, PhD, MBA, Vice President of Medical Affairs at Verastem Oncology. Their discussion highlights the growing trend of integrating Medical Affairs into the Clinical Development process, and how this integration can streamline development when executed properly. Dr. Sivaraman shares her insights on the expectations for Medical Affairs teams working alongside clinical development, the ideal timing for their…
S4 · E7 · 27 Nov 2024 · 47 min
Insights for Building a Rockstar MSL Team with Cathy Andorfer, PhD
In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, welcomes Cathy Andorfer, PhD, the national Director of Field Medical for Tourmaline Bio, and author of "The Art of Excellence: Build a Rockstar Career as a Medical Science Liaison and Beyond." Their conversation explores the vital role of medical affairs, emphasizing the importance of strategic vision, continuous learning, and effective communication within the team. Cathy shares her experiences and insights on leadership, stressing the necessity of repetition and…
S4 · E6 · 23 Jul 2024 · 39 min
Generative AI Unleashed: Revolutionizing Innovation and Efficiency in Medical Affairs with Jane Carroll, MS, BSN
In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, welcomes Jane Carroll, MS, BSN, Vice President of Global Strategy and Operations at Moderna. They discuss the evolving role of medical affairs and the impact of generative AI, specifically ChatGPT, on the field. Jane shares her experiences leveraging AI as a copilot to enhance efficiency and innovation in medical affairs. They delve into the potential of AI to speed up publication processes and reduce biases, ultimately impacting patient care positively. The…
S4 · E5 · 28 May 2024 · 9 min
Podcast Bytes - The Digital Transformation of Medical Affairs with Dan Hennessy, PhD
Medical Affairs is going through a digital transformation. What this means, what it will look like, and what value it will bring to pharmaceutical and biotech companies is still unknown. In this third episode of our short form podcast series, we discuss this topic with Dan Hennessy, PhD . As the Vice President of Medical Affairs at Merus N.V., he has a wealth of Medical Affairs experience and insights . T his conversation brings us further along in trying to understand the changes that are coming to the industry, and more specifically how it may affect clinical trial enrollment and engagement.
S4 · E4 · 30 Apr 2024 · 46 min
The Value of Medical Affairs – Strategic Thinking and Continuity from Clinical Development to Commercialization and Beyond With Jodi Smith, PhD
In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, and Jodi Smith, PhD, the Global Medical Strategy Lead in Thoracic Oncology at Pfizer, discuss the value of Medical Affairs. While they agree that there's a cost associated with bringing Medical Affairs into the early development of a drug, they see a clear and measurable benefit, from accelerated enrollment to having a solid foundation for commercialization. Through their many years in different roles within Medical Affairs, they know that to achieve these…
S4 · E3 · 8 Mar 2024 · 42 min
Excellence in Leadership – International Women's Day Special With Aree Cheshire, PhD, and Amber Gilbert, MBA
Curiosity, empathy, authenticity, strength. Good leaders express many key characteristics and come in all shapes and sizes. In this special International Women's Day episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, Aree Cheshire, PhD, VP of Client Strategy in UK Communications at Lumanity, and Amber Gilbert, MBA, Global Practice Lead for Value, Access & Outcomes at Lumanity, meet to discuss excellence in leadership. During their conversation they touch on whether good leadership qualities are innate or learned, how to…
S4 · E2 · 29 Feb 2024 · 34 min
The Patient Impact in Drug Development and Value Demonstration with Len Lichtenfeld, MD, MACP
Now, more than ever, the patient voice is being heard by the pharmaceutical industry. In this episode, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, and Len Lichtenfeld, MD, MACP meet to discuss the ways patients are providing advisement in drug development and valuation. After hearing about Len's extensive experience, they delve into the new regulatory changes coming to pharma and biotech that will require the patient experience to be taken into consideration during the drug development process. They conclude by discussing how the patient experience is…
S4 · E1 · 1 Feb 2024 · 37 min
The Role of the MSL in Clinical Trial Enrollment with Dan Hennessy PhD
Having a clinical trial that is properly supported and engaged is no easy feat, but accomplishing this can greatly improve the success of your asset. In this episode, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, and Dan Hennessy PhD, Vice President of Medical Affairs at Merus N.V., meet for a second time to discuss MSL and stakeholder engagement. They delve more specifically into the key role that Medical Affairs plays in accelerating and improving clinical trial enrollment and highlight how to use MSLs and a Field Medical team in different ways to…
S3 · E11 · 16 Nov 2023 · 10 min
Podcast Bytes - The Digital Transformation of Medical Affairs with Christian Dimaano, PhD, MPH
Medical Affairs is going through a digital transformation. What this means, what it will look like, and what value it will bring to pharmaceutical and biotech companies is still unknown. In this third episode of our short form podcast series, we discuss this topic with Christian Dimaano, PhD, MPH . As the VP, Head of Medical Affairs at Kinnate Biopharma, he has a wealth of Medical Affairs experience and insights . T his conversation brings us further along in trying to understand the changes that are coming to the industry .
S3 · E11 · 27 Oct 2023 · 38 min
Untapped Potential of Social Media Listening in Medical Affairs with Damian Eade
Social media listening is an area with great untapped potential in the pharmaceutical industry. In this episode, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, and Damian Eade, Managing Director, Social Analytics, Insight at Lumanity, discuss how a Medical Affairs team approaches social media listening differently than a commercial team. They review the differences between traditional key opinion leaders and digital thought leaders as well as discuss the impact these "digital influencers" have in the social media landscape. They talk through insight…
S3 · E10 · 28 Sep 2023 · 42 min
Building US, EU, & Asia PAC Field Medical Teams during Early Development with Christian Dimaano, PhD, MPH
A thoughtfully and carefully built Medical Affairs team, and in particular, a Field Medical team can enhance study enrollment and serve as a foundation for future commercialization. In this episode, Peg and Christian Dimaano, PhD, MPH, VP, Head of Medical Affairs at Kinnate Biopharma, discuss the differences between building a Medical Affairs team in the US compared to building teams in the EU or Asia PAC, and the ideal timing for bringing field medical onboard. They review the pros and cons of outsourcing a field team versus building internally and highlight the different skill sets needed…
S3 · E9 · 31 Aug 2023 · 48 min
Learning and Development to Propel an Organization Forward with Adeola Davis, PHD, MPA, and Mary Winkles, PharmD
An effective learning and development program can be transformative for a Medical Affairs organization. In this discussion, Peg, Adeola Davis, PHD, MPA, Director of Learning Development at Arcadia Pharmaceuticals, and Mary Winkles, PharmD, Global Director, Medical Affairs Training and Capability at Vertex Pharmaceuticals, break down what it takes to build a successful learning and development program and how to measure its success. They highlight when organizations should build a learning and development program and how to think about scalability. Additionally, they discuss how effective and…
S3 · E8 · 28 Jul 2023 · 17 min
Podcast Bytes - The Digital Transformation of Medical Affairs with John Yee, MD, MPH
Medical Affairs is going through a digital transformation. What this means, what it will look like, and what value it will bring to pharmaceutical and biotech companies is still unknown. In this second episode of our short form podcast series, we discuss this topic with Dr. John Yee. As the former CMO at Sobi, Dr. Yee has a wealth of Medical Affairs experience and insights . T his conversation brings us further along in trying to understand the changes that are coming to the industry .
S3 · E7 · 27 Jun 2023 · 41 min
Why PharmDs are a good fit for Medical Affairs with Lumanity Medical Affairs Consulting PharmDs
In this special episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD interviews three of Lumanity Medical Affairs Consulting PharmDs, Stephanie Wong, George Shyu, and Chris Maclafferty. They discuss the different paths they took from earning their degree to joining the pharmaceutical industry as well as the additional training and knowledge they felt were required to be successful in Medical Affairs. They breakdown the skills and expertise that PharmDs can bring to a Medical Affairs organization and how they chose to work in a consulting role rather than in a more typical role as a…

About Medical Affairs Unscripted

Medical Affairs Unscripted is a English tech & science podcast from Lumanity Medical Affairs Consulting. Melo plays each episode straight from the publisher's own feed — no ads added, no account needed — and remembers where you stopped, in this browser only.

Publisher: Lumanity Medical Affairs Consulting
Language: English
Category: Tech & Science
New episodes: Monthly
Typical length: 43 min
Latest episode: 30 Sep 2026
Feed: RSS — paste into any podcast app
Apple Podcasts: podcasts.apple.com/podcast/id1514654024

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