Medical Affairs Unscripted

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 having an impact on the valuation of new drugs.

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 ensure that you get the most value from the team, both from a US and a Global perspective. As they conclude, they explore what kinds of skills are required of a well-prepared Field Medical team and how to ensure they are properly prepared.

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 are coming to the industry.

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 collection and learning about the patient experience through social media and how these insights can be leveraged for patient-focused drug development. Finally, Damian and Peg explore sentiment analysis and how it can be measured and used in social media.  With all of the advancements being made in the digital landscape, staying at the forefront of social media listening can be a powerful tool for Medical Affairs teams.

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 for teams at different stages of the product lifecycle.

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 efficient training can greatly increase employee retention as well as help an organization speak with a unified voice. Medical Affairs professionals who value a curious mindset and believe in encouraging growth within their teams will find valuable insights from these industry experts.

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 organization and how they chose to work in a consulting role rather than in a more typical role as a Medical Science Liaison (MSL) or Medical Information Specialist. They wrap up by describing the different types of consulting work they find most fulfilling and how they “stay curious” and grow their careers.

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 with the commercial side of the organization while building a Medical Affairs team and Dr. Yee describes how each team member should be a “triple threat” in the areas of scientific excellence, business acumen, and emotional intelligence. He provides first-hand experience and advice on all of these topics, and we believe that CMOs will find a wealth of Medical Affairs knowledge in this podcast.

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 topic on future episodes.

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 Global and US Medical Affairs, building a team with the right person matched to the right role, and ensuring communication across the team. Dr. Peg Crowley-Nowick as Head of Medical Affairs at Lumanity has worked with many teams to support leadership development. She adds her perspective and experience while facilitating this podcast.3

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 objective of this podcast is to stimulate discussion about measurements and value in a more effective way.

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 - How training can vary significantly across different regions - How to measure the value of field based medical teams both internally and externally

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 of the new product offerings and capabilities of the expanded team. They reflect on how smoothly and seamlessly the integration has been and discuss some of Dr. Crowley Nowick’s goals for the organization going forward.

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 their central mission.

With the pharmaceutical industry becoming more and more heavily competitive, knowing how to conduct an insightful and multidimensional assessment of your Medical Science Liaison (MSL) team to identify gaps and hire the right MSLs to not only accelerate a corporate competitive advantage, but also to cultivate the natural diversity of a proper team for internal peer-to-peer development and external stakeholder rapport is more critical than ever.  

With an extensive and influential career in Medical Affairs (MA) at Sanofi Pasteur spanning more than two decades starting in the field and now the current Senior Director of the Field Medical Team in the Vaccines therapeutic unit at Sanofi Pasteur, Christina Tankersley, PharmD has mastered the know-how of building, training, and maturing a diverse, multidisciplinary MSL team. She joins Dr. Peg Crowley-Nowick, Founder and President of Zipher Medical Affairs on this inaugural podcast of the second season of Zipher Medical Affairs Unscripted to share her invaluable experience on how to intentionally identify key diversities needed in constructing a balanced and symbiotic MSL team, and how to overcome the challenges of unifying team members across the now common virtual office settings. Dr. Crowley-Nowick also draws on Dr. Tankersley’s vast experience and innate propensity for coaching and mentoring to discuss the possible pitfalls of the industry’s current trend in condensing the onboarding experience for MSLs and potentially driving MSLs into the field prematurely and asks her to expound on her innovative approach for onboarding. Lastly, Dr. Tankersley characterizes the fundamental cornerstone of an MSL development plan and fostering actions to support that vision.

Leading Medical Affairs (MA) organizations have begun to strategically redefine their team’s requisite executional capabilities to enhance and tailor frontline engagement initiatives, to improve the impact of knowledge development (insights and evidence generation), and to further solidify their position as a vital leader rather than a support function within the biopharmaceutical industry. These executional capabilities ultimately accelerate the time to market, creating a competitive advantage as well as (and most importantly) maximizes the number of patients reached with life-saving treatments.

Dr. Tamas Suto is passionately dedicated to improving the lives of patients and public health as evidenced by his decades in not only direct patient care, but also in industry spanning the commercialization process from identification of a drug candidate through the end of the lifecycle of a compound. His extensive experience in large pharma as a global executive in MA leadership at Sanofi, Amgen, and Roche/Genentech prior to his current position as SVP., & Head of Global MA Oncology at Merck KGaA, Darmstadt, Germany underpins his well-founded and impressive vision of the critical capabilities of the MA team. Dr. Peg Crowley-Nowick, Founder and President of Zipher Medical Affairs, guides Dr. Suto in this podcast in sharing the paramount yet foundational competencies for impactful individual contributions in each of the four key elements of the MA team pursuits: insights, evidence generation, stakeholder engagement, and medical leadership. 

Our host Peg Crowley-Nowick, PhD, MBA, Founder & President of Zipher Medical Affairs and Muriel Siadak, PAC, Senior Medical Director at Seagen Inc., spotlight the ever-increasing value and impact of insights on product strategy, positioning, and tactics. As Medical Affairs (MA) teams are now more than ever asking deeper, multifaceted questions to gain insights about the drivers of patient and healthcare professional decisions, Ms. Siadak, shares her vast experience in MA to help us explore the importance of ensuring that insights are appropriately gathered, disseminated to and discussed with internal stakeholders, and leveraged cross functionally.

Contact Zipher at www.ziphermed.com/contact to learn how to develop a program within your organization.  

Drs. Crowley-Nowick and Keir set the stage for a successful launch as they consider the key components of a MA Team and their contributions on the road to launch and beyond, from the formation and training of the Medical Science Liaison Team (MSLs) to the early inclusion of Medical Information, to developing best practices for Scientific Communications while also engaging with Patient Advocacy groups as part of the planning process. They also address the importance of a robust Data Generation program with the Medical Director at the helm gaining insights and trends from these data which allows the organization to pivot as necessary.

In this eighth episode of Zipher’s Medical Affairs Unscripted, our host Peg Crowley-Nowick, PhD, MBA, Founder & President of Zipher Medical Affairs met with Chris Keir, MD, MS. Dr. Keir’s extensive experience and understanding of the dynamic nature of the peri- and post-launch environment has lead to successful outcomes.  He was instrumental in leading the launch of the first globally, commercialized CART-T cell therapy, tisagenlecleucel-T, for Novartis.  Most recently, he built a medical affairs organization for Array BioPharma, Inc., and led the US launch of binimetinib and encorafenib in combination for advanced BRAF-mutated, unresectable, or metastatic melanoma.  During the acquisition of Array BioPharma by Pfizer, Dr. Keir was responsible for the medical transition while also preparing for a second launch for encorafenib in combination with cexutimab in BRAF-mutated colorectal cancer. Dr. Keir has recently shifted into the diagnostic space as the V.P., of MA at GRAIL, Inc., and is leading the launch of their new technology for early cancer detection.

Starting from the clinical trials and ending with meeting the regulatory demands across various countries, bringing a product to market successfully has become increasingly difficult. Therefore, it is critical that an overall launch strategy is established and executed. Developing an integrated and comprehensive launch roadmap is the first step in preparing for launch. Delivering the Medical Affairs program on time, on target, and on budget is essential for success. A solid program management function and systems ensures that progress is monitored, measured, and communicated and adjustments to the course based on internal and external insights are clearly visible to the entire organization.

In this seventh episode of Medical Affairs Unscripted, our host Peg Crowley-Nowick, PhD, MBA, Founder & President of Zipher Medical Affairs had the opportunity to meet with John Walsh, MD who is not only leading the Medical Affairs organization as Senior Vice President at Ardelyx, Inc., but is also a practicing clinician in the areas of Family Medicine, Urgent Care, Telemedicine, and Pre-Hospital Emergency Medicine. Because of Dr. Walsh’s unique position as a physician in industry and practicing clinical medicine, he provides valuable insights on what drives a successful launch. Additionally, he discusses how to prepare for and manage the operations of an effective launch. He and Dr. Crowley-Nowick discuss the use of visualization and tracking tools to easily measure progress, ensure organizational alignment, meet desired communication cadence for management and teams, and ensure tactics are driven by overarching priorities.

Measuring the impact of the Medical Affairs (MA) organization is not as straightforward as it is for other functions (e.g., increase in revenue or market share for Commercial) and remains a challenge for most pharmaceutical companies today. There have historically been no simple metrics to evaluate the influence of MA, so our host Peg Crowley-Nowick, PhD, MBA, Founder & President of Zipher Medical Affairs met with Meg Heim, RN, MBA, previously Vice President, Global Head of Scientific Engagement Strategy, Operations and Program Management at Sanofi and currently President at Heim Global Consulting, to discuss a methodology she developed and employed to truly measure the effectiveness of the Medical Affairs (MA) organization.

After briefly touching on Meg’s experience in advocacy and policy and its importance in advancing MA, Dr. Crowley-Nowick asks Meg to explain what MA has to do to demonstrate impact. The conversation focused on how to measure impact over time and ensure that this resonates throughout an organization. Additionally, Meg addresses the importance of working with vendor partners to fill in gaps in expertise and to provide support services that can prove to be incredibly valuable for insights, decision making, and refining strategy (e.g., data on key opinion leaders). 

Medical Affairs (MA) continues to shed its historic role as a support function and establish itself as a critical pillar alongside Commercial and Research & Development (R&D). However, shifting from independently, operating functional areas to strategic, cross-functional, business-wide partnerships remains a challenge for MA.

Zhen Su, MD, MBA, the current Senior Vice President and Global Head of the Oncology Franchise for Merck KGaA, Darmstadt, Germany offers novel approaches for modernizing perspectives at an individual level regarding the role of MA, by fostering an appreciation and internal mindset of MA as a strategic, partner, while still maintaining the ever-important compliance boundaries.

Dr. Su has over 20 years of experience in academic and pharmaceutical medicine across Clinical Development, MA, Commercial and Business Development consequently allowing him to provide personal insights regarding the value and impact of improving cross collaboration and synchronizing focus across the business.  

Host Peg Crowley-Nowick, Ph.D., MBA, Founder & President of Zipher Medical Affairs invites Dr. Su to also share his thoughts on navigating product launches during the COVID-19 era and beyond. Drs. Crowley and Su close the podcast with a discussion about how to ensure that teams work together in this new virtual environment.

In this Internal Edition of the Zipher Medical Affairs Unscripted podcast series, Dr. Peg Crowley-Nowick, Founder & President of Zipher Medical Affairs is joined by Zipher’s own Julie Cahill, M.D., Vice President of Consulting and Medical Director Services to continue the conversation from Episode 4: Data Generation • The Intersection Between Medical Affairs and Clinical Development by expanding further on the need to identify data gaps and how organizations can work together to consider the full scope of research that can be used to fill those gaps.

Dr. Cahill, an industry expert and a board-certified general surgeon, shares how Medical Affairs, though often overlooked in early data generation planning initiatives, can actually be a strategic partner in building a cross-functional data generation program. Our host and expert guest discuss the importance of early consideration of potential data gaps, what data/evidence generation means to different companies, and when Medical Affairs should start planning for data generation. They also take us on a detailed tour on how to coordinate the collective and complementary perspectives of each of the functional areas to create a prioritized and persisting, but pliable data generation program. Dr. Crowley-Nowick also asks Dr. Cahill to provide an overview of the advantages and disadvantages of using technology to conduct these planning workshops in our unprecedented times of the COVID-19 pandemic.

Lastly, because of the ever-evolving organizational priorities and landscape of clinical care, the frequency in which a data generation program should be reviewed and refined is discussed as well as the value of developing a communication plan to ensure consistency in external messaging.

As the Medical Affairs Unscripted podcast series continues to distinguish Medical Affairs as one of the major pillars of biopharmaceutical organizations, Dr. Peg Crowley-Nowick, Founder & President of Zipher Medical Affairs hosts Dr. Adam Schayowitz, an industry veteran and current Vice President and Medicine Team Lead at Pfizer, to discuss the intersection between Medical Affairs (medical) and Clinical Development (development) with regards to data generation as medical continues its evolution as the third pillar in industry.

Dr. Crowley-Nowick draws on Dr. Schayowitz’s expertise which crosses both medical and development to get his insight on the potential impact medical can have on development programs, in particular supporting the data generation program. He answers questions regarding cross-functional strategies for data generation, such as what and how medical contributes, when the development team should be engaging with medical, where medical can help accelerate development programs, and more. The host and expert guest discuss the advantages of using this broader team to identify, prioritize, and address data gaps.

Also, Dr. Schayowitz shares his recommendations on how Medical Affairs intersects with Clinical Development in the planning and execution of a data generation strategy and its implementation throughout the lifecycle of an asset.

Lastly, the podcast closes with Dr. Schayowitz’s experience in his shift from medical to development and the value of having medical aligned with both the development and commercial organizations with regards to data generation.

For more information visit www.ziphermed.com or email us at info@ziphermed.com. 

Zipher’s Medical Affairs unscripted features Randi Goeckeler, an industry expert with over 25 years of experience and most recently the Executive Director of Global Stakeholder Relations at Allergan, who discusses how to build an integrated, strategic stakeholder relations program to accelerate availability of treatments for patients and ultimately help them have better outcomes.

Host Peg Crowley-Nowick, Ph.D., MBA, Founder & President of Zipher Medical Affairs invites Randi to share her insights on the challenges that organizations are facing regarding stakeholder relations and how to ensure that engagements are innovative, intentional, interconnected, and impactful. As presented in her Stakeholder Relations Strategic Engagement Roadmap, Randi addresses the differences between transactional versus strategic engagements, and she also describes the required elements for designing a strategic framework for stakeholder relations, while maintaining compliance. Additionally, Dr. Crowley-Nowick asks Randi to share her experiences on how to fuse the focus of regional and global teams. The podcast closes with novel ways that Medical Affairs organizations can use digital media during the current COVID-19 disruption to accomplish objectives that were once carried out at face-to-face venues.

During this episode of Medical Affairs unscripted, Dr. Crowley-Nowick has a conversation with Holly Schachner, MD, former CMO of Specialty Medicine at Allergan to examine the business objective of Medical Affairs (MA) organizations and how MA can move closer to being identified as a strategic pillar within the life sciences industry alongside the Research & Development and Commercial organizations.

Dr. Schachner, who has nearly 20 years of experience in the pharmaceutical industry after her work as a clinician and researcher, provides key insights for MA professionals on how to use their position and experience from industry and clinic to help drive internal strategies in alignment with external needs; the needs of the patient. She offers valuable guidance on how the MA organization plays an important role from early in the development of a molecule through to launch and beyond, and how MA is the link that can maintain consistency of the ‘why’ behind the cross-functional activities being conducted. Ultimately, Dr. Schachner shares her thoughts on the roadblocks to MA becoming the 3rd strategic pillar within life sciences organizations and how to overcome these challenges.   

For more information visit www.ziphermed.com or email us at info@ziphermed.com. 

Peg Crowley, Ph.D., MBA, Founder & President of Zipher Medical Affairs meets with Dan Hennessy, Ph.D., MBA, Vice President of Strategic Excellence at EMD Serono to discuss a fresh look at the complexity of the matrix of stakeholders who play a critical role in the patient care cycle, including the layers of individuals in the clinics and hospitals, in healthcare economy, and in advocacy societies.

Drs. Crowley and Hennessy, who combined have about 35 years of experience in industry, address the importance of maintaining scientific exchange between the stakeholders and Medical Affairs organizations during a pandemic, which has created an unanticipated interruption to former methods of engaging with stakeholders. They offer an overview of the challenges with the current channels of communication as well as suggestions on how to maintain previously established relationships and how to navigate the development of new engagements in our current landscape of communication. They also discuss the key risks of not engaging with stakeholders, and not building and maintaining those relationships effectively. Lastly, they examine the future of communication with stakeholders in the short-term and long-term and how to adapt with this constantly changing environment during a pandemic.

For more information visit www.ziphermed.com or email us at info@ziphermed.com.