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 role of Medical Affairs.
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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 ...
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 v...
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 of...
Peg Crowley-Nowick and Cathy Symonds discuss the strategic significance of New Product Planning (NPP) as an early commercial strategy, emphasizing the creation of Target Product Profiles (TPP) to guide product development. They delve into critical collaborations between NPP, Medical Affairs, and other functions, stressing the importance of gathering comprehensive insights and developing strategic narratives. The conversation also covers essential skills for NPP professionals and best practices for navigating complex regulatory and commercial landscapes to achieve patient outcomes and commercial success.
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 th...
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 he...
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,...
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...
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 pri...
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 expectatio...
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. ...
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 u...
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. This conversation brings us further along in trying to understand the changes that are coming t...
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 t...
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. Dur...
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 consideratio...
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 ...
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. This conversation brings us further along in trying to understand the changes that a...
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 impac...
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 ...
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 de...
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. This conversation brings us further along in trying to understand the changes that are coming to the industry.
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 or...
Whether your drug is in an early development phase or in the lifecycle management phase, it is important to know when and how to invest in Medical Affairs. In their discussion this month, Peg and John Yee, MD, MPH and former CMO at Sobi, focus on the value of and the critical need to invest in Medical Affairs. They see Medical Affairs as the "bridge" across all functions and that it sits at the intersection of medicine, science, and business. They highlight the need to communicate and engage wit...
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. Over the remainder of 2023, we'll be releasing additional short form podcasts, podcast bytes, where we discuss this topic with our guests. Janet Loesberg, PharmD, SVP of Global Medical Affairs at Blueprint Medicine, is our first guest and we greatly appreciate her insights. We look forward to delving into this t...
Are you leading or building a Medical Affairs organization? This month Peg had a great conversation with Janet Loesberg where they discussed leadership and the barriers to success in Medical Affairs. Janet Loesberg, PharmD, Senior Vice-President of Global Medical Affairs at Blueprint Medicine, and a biotech board member, brings many years of experience, holding a variety of leadership positions in the pharmaceutical industry. She delivers great advice and perspectives focused on leading in Globa...
Defining metrics and KPIs for demonstration of value is a significant challenge for leaders in Medical Affairs. During this episode of Medical Affairs unscripted, Dr. Crowley-Nowick speaks with Dr. Randy Krauss, Head of Metrics, Analytics, & Performance in Global Clinical Operations at Merck. They discuss the key ideas, lessons learned, and recommendations that have come from Dr. Krauss's work in clinical operations and how those ideas can be translated into the Medical Affairs space. The ob...
During the latest episode of our Medical Affairs unscripted podcast, Dr. Crowley-Nowick speaks with Dr. Robin Winter-Sperry, Former Global Field Based Medical Lead at Ipsen Biopharmaceuticals. The conversation covers: - What Field Based Medical entails and the roles of Medical Science Liaisons and Field Medical Directors across the globe - What skills are required of field based medical teams today and what the future holds - The unique requirements of those managing a field based medical team -...
During this episode of Medical Affairs unscripted, the roles are reversed and Dr. Crowley-Nowick speaks with guest interviewer Dennis Crowley (of The Entrepreneur's Story podcast) about Zipher continuing its journey in Medical Affairs as a part of Lumanity. They discuss Zipher's history, the acquisition, the integration, and how Zipher, now Lumanity, fits into the larger company structure. Dr. Crowley-Nowick explains how being a part of Lumanity is beneficial to our clients while including some ...
During this episode of Medical Affairs unscripted, Dr. Crowley-Nowick continues the conversation with Holly Schachner, MD, SVP, Clinical Development at North Sea Therapeutics, discussing how the landscape has changed since they last spoke, two and a half years ago, as the pandemic was just unfolding. They also discuss how Medical Affairs continues to play an integral role in bridging across functions, bringing key stakeholders to the table, so that getting needed therapies to patients remains th...
