Pharma Sessions

Kaskey's Hierarchy of Needs in Medical Affairs: Steering towards Successful Product Launches This episode of Pharma Sessions delves into the evolving role of Medical Affairs in pharmaceutical launches, emphasizing its transition from a supportive to a strategic partnership position. Stephen Dodge, SVP of Medical Affairs at Madrigal Pharmaceuticals has launched 25 products, and shares insights into the crucial involvement of Medical Affairs in launch strategies. The discussion translates the framework of Maslow's Hierarchy of Needs to Medical Affairs, particularly during product launches. Key areas discussed include understanding the foundational needs of Medical Affairs, such as organizational structure and the essential skills for personnel, as well as higher-level needs like engagement with key opinion leaders, evidence generation, and publication planning. The episode also touches on the importance of transitioning from planning to execution, ensuring effective communication and ongoing refinements to meet the ultimate goal of a successful product launch. 00:00 Welcome to Pharma Sessions: The Evolution of Medical Affairs 00:33 The Impact of AI on Medical Affairs: Insights from MAPS Annual Meeting 00:58 Exploring the Hierarchy of Needs in Medical Affairs 02:16 A Deep Dive into the Medical Affairs Professional's Journey 04:57 The Strategic Role of Medical Affairs in Pharmaceutical Launches 08:24 Building the Foundation: Organizational Structure and Team Dynamics 13:32 Elevating Medical Affairs: From Strategy to Execution 27:27 The Pinnacle of Medical Affairs: Achieving Self-Actualization in Launch Success 33:02 Reflecting on the Fulfillment and Complexity of Medical Product Launches The views expressed on this episode are our own and do not reflect those of our respective employers. Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

In this episode of Pharma Sessions, host Jonathan Kaskey speaks with Lars Dreesmann, the President and Site Head for Boehringer Ingelheim Fremont about how regulatory affairs can impact patient care. They explore the challenges and opportunities in the regulatory space, including the impact of technology and AI on regulatory affairs and the potential for collaboration between pharmaceutical companies. Lars shares his transition from academia to the pharmaceutical industry, the thrill of turning science into tangible products benefiting patients, and the strategic importance of regulatory processes. The conversation delves into how artificial intelligence could revolutionize data management and reporting in pharma manufacturing, and the complexities of producing biosimilars compared to original biologics. The podcast highlights the industry's collaborative spirit, shared goals to enhance drug manufacturing processes, and excitement for future scientific breakthroughs that could lead to curing currently incurable diseases. 00:00 Introduction to Smart Risk Taking 00:24 Welcome to Pharma Sessions 00:43 Guest Introduction: Lars Driessmann 01:20 Lars' Journey from Academia to Pharma Industry 03:01 The Role of Regulatory Processes in Pharma Manufacturing 17:08 The Impact of Technology on Regulatory Affairs 24:12 The Challenges and Opportunities in Biosimilars 34:26 The Future of Pharma Industry: A Look Ahead Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

This episode is sponsored by Acceleration Point. Pharma Sessions is hosted by Jonathan Kaskey In this episode Jonathan and Scott Thompson, the Co-CEO of Acceleration Point, discuss the impact of Artificial Intelligence (AI) on Medical Affairs. Examples of AI use in Medical Affairs include analytics, content creation, and productivity enhancements. Scott encourages experimentation with secure, customized AI tools to improve output. He outlines a case study where AI improved data quality and speed of information processing. Scott and Jonathan ultimately envision a world where AI technologies will help Medical Affairs expand its reach, improve communication, and increase its impact in the medical community. 00:18 Understanding the Role of AI in Med Affairs 00:46 Guest Introduction: Scott Thompson, Co-CEO of Acceleration Point 03:12 The Evolution of AI in Medical Affairs 04:46 The Impact of AI on Big Data and Medical Affairs 06:03 The Three Buckets of AI Application in Med Affairs 09:53 Overcoming Fear and Resistance to AI 13:12 The Future of AI in Medical Affairs 20:18 Case Study: Successful AI Implementation in a Global Med Affairs Team 30:18 Conclusion and Farewell Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

Life is different at a biotech. But is that a good thing? Like so much in life, the answer is, "it depends." On this episode I speak with Orlando Granado-Balaez about his journey from being a nurse to transitioning into medical affairs and ultimately thriving in smaller pharmaceutical companies. He shares his experiences in different roles within medical affairs, including being the first MSL in a company and the challenges and rewards that come with building out a team. Orlando also provides advice for individuals considering a transition from larger companies to start-up environments in medical affairs, emphasizing understanding the role, asking right questions, and maintaining a learning mindset. 00:00 Introduction to the Podcast 00:25 The Journey from Big Pharma to Biotech 01:21 Personal Career Path and Transition into Medical Affairs 02:49 The Appeal of Startups and the Concept of Pivoting 03:30 Experience in Small Pharma and the Transition from Big Companies 05:09 Building a Medical Affairs Team from Scratch 06:02 The Challenges and Rewards of Leadership in a Startup 07:57 The Hiring Process and Building a Team 09:59 The Importance of Fit and Transparency in Hiring 11:07 The Role of Consultation and Networking in Career Transition 26:04 The Future of Medical Affairs and Final Thoughts Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

The Science of Sleep: Exploring its Role in Performance and Well-being for Medical Affairs In this episode of Pharma Sessions, Jonathan Kaskey is joined by Dr. Alison Kole, a sleep expert, to discuss the importance of sleep and its impact on personal and professional health. They discuss the dangers of insufficient and poor-quality sleep, including poor cognitive and creative function. On the other hand, they stress the benefits of prioritizing good quality sleep for enhanced productivity, improved mood and better physical health. The episode also covers practical advice on achieving good sleep, including creating regular bedtime and wake time habits, being mindful of light exposure before bedtime, yielding to drowsiness when it occurs, and managing jet lag. The podcast concludes with the implications of new sleep research technology and the potential downside of relying too heavily on consumer wearables for sleep information. 00:00 Introduction to the Importance of Sleep 00:19 Welcome to Pharma Sessions Podcast 01:00 Exploring the World of Sleep with Dr. Allison Kole 01:46 Dr. Allison Kole's Journey into Sleep Research 04:23 The Impact of Sleep Deprivation 04:39 The Role of Sleep in Medical Affairs 06:28 The Importance of Adequate Sleep 07:47 The Dangers of Sleep Deprivation 08:24 The Effects of Sleep Deprivation on Work Performance 16:46 The Impact of Alcohol on Sleep 21:44 Tips for Better Sleep Management 23:10 The Importance of Regular Wake Time 23:27 Creating a Pre-Bedtime Routine 23:48 Understanding Your Sleep Pattern 24:23 Creating a Relaxing Environment Before Bed 24:52 Personal Bedtime Routine and Reflection 26:26 The Role of Reading in Sleep 27:49 Sleep Tips for Travelers 28:08 Understanding Jet Lag 33:39 Creating a Work-Life Balance for Better Sleep 40:44 The Future of Sleep Research and Technology Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

In this compelling episode of Pharma Sessions, host Jonathan Kaskey engages in an insightful discussion with esteemed guest Jose Borbolla-Escoboza. Delving into the intricacies of global launch excellence, Jose, a seasoned oncologist, shares his wealth of experience in pharmaceuticals, particularly in Mexico, the UK, and the US. Together, they explore the multifaceted process of global launch preparation and the crucial role of global in facilitating tools for local country launches. Jose's expertise shines through as he emphasizes proactive communication and the pivotal role of Medical Affairs in navigating regulatory timelines and managing access programs. The episode offers a comprehensive understanding of the challenges, strategies, and skill sets involved in launching medical products in diverse global markets. It's an illuminating conversation that delves into the complexities of achieving global drug access while recognizing the need for strategic adaptation at the local level. Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

In this episode of "Pharma Sessions," host Jonathan Kaskey delves into the crucial topic of why negotiation skills are essential in the field of medical affairs. Joining him, Megan Vignos, Head of Scientific and Value Communications for US Medical at Biogen. Together, they explore the importance of negotiation in medical affairs, and how a scientific mindset can aid in building effectiveness. Megan emphasizes the significance of maintaining a positive relationship with compliance officers, avoiding an adversarial approach, and employing the experimental method to foster curiosity and better comprehend compliance decisions. Drawing from her own experience as a medical science liaison and subsequent roles as an associate medical director and medical director, Megan shares personal anecdotes that highlight the increasing need for negotiation skills at each level of one's career. She offers valuable insights on negotiating with partners, understanding and aligning priorities, and exploring alternative bargaining options beyond financial aspects. Throughout their discussion, Jonathan and Megan tackle the topic of negotiation in various contexts, from negotiating with habitually late attendees during meetings to negotiating job offers and career progression. They address common fears and misconceptions about negotiation, emphasizing that being a strong negotiator can demonstrate value and effectiveness, both in job offers and when collaborating with cross-functional partners. Tune in to this enlightening episode of "Pharma Sessions," where Jonathan and Megan unveil the vital role negotiation skills play in medical affairs, offering practical strategies and insights to help navigate the world of negotiation in the healthcare industry. Don't miss the chance to enhance your negotiation expertise and achieve better outcomes in your professional endeavors. Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

In this episode of Pharma Sessions, host Jonathan Kaskey interviews Dr. Huma Qamar, Head of Clinical Development and Medical Affairs at Ocugen, Inc. With her extensive background in clinical research and medicine, Dr. Qamar has been a pioneer in merging these two fields. Throughout this episode, she shares her invaluable insights on gene therapy, specifically focusing on inherited retinal diseases. Here are the top five things you'll learn: 1. The importance of patient-centered outcomes research and the different phases of clinical trials. 2. The challenges and advancements in developing gene therapies for unmet medical needs. 3. How to navigate the regulatory landscape of gene therapy and the role of the FDA in this process. 4. The significance of patient-reported outcomes and how they impact clinical development and medical affairs. 5. The future of gene therapy, including its potential to revolutionize healthcare and improve patients' quality of life. Subscribe to the PharmaSessions substack for exclusive content and show updates: www.pharmasessions.substack.com Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

Join host Jonathan Kaskey in this thought-provoking episode of Pharma Sessions as he invites special guest Denise Bronner, Director of Clinical Trial Diversity and Inclusion at Janssen, to delve into critical issues facing the pharmaceutical industry. Together, they explore the challenges of data sharing, the underrepresentation of non-white individuals in clinical trials, and the need for more inclusive physician training. Top 5 learnings from the episode: Tune in to this eye-opening episode of Pharma Sessions and be part of the movement to advance health equity, bridge the gaps in clinical trials and physician training, and ensure that all patients receive the care they deserve. Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

In this episode, host Jonathan Kaskey invites Patrina Pellet to discuss effective time management strategies for medical professionals. From calendar audits to time blocking, Pellet shares valuable insights on how to optimize your daily schedule, prioritize your tasks and avoid feeling burnt out. Discover the power of color-coding and task tracking to manage your workload efficiently and achieve your goals. Tune in now to master the art of time management and increase your productivity with Pharma Sessions. Episode guide: - Importance of controlling time and being strategic, especially in medical affairs - Speaker highlights four strategies for effective time management: calendar audit, aligning priorities, time blocking, and changing one’s identity - Importance of utilizing buffer time and catch-up time in time blocks to anticipate and address unexpected events - Benefits of time blocking entire day according to goal categories and using color-coded categories to track progress - Speaker shares personal struggles with managing time and workload, emphasizing the need for patience and practice to develop new habits - Recommendations for creating color-coded “buckets” in calendar to organize different tasks and responsibilities - Suggestions for maximizing effectiveness of time blocking by assigning specific tasks and combining events and tasks in Google Tasks and Google Calendar - Importance of preparation and prioritizing top priorities to avoid decision fatigue and distraction Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

We are excited to bring you the latest episode of our podcast series where we tackled the vital role of medical information in the healthcare industry. Tim Fish is the Sr. Director of Medical Information, Knowledge Management, Med/Promo Review, Scientific Training & Development at Alkermes. Tim has been in the medical information role for 15 years and shared valuable insights on the importance of receiving and responding to inquiries, reviewing content, and researching answers in medical information. During the episode, we delved deeper into each of the four R's of medical information and how it can reveal challenges in patient care delivery systems. We also highlighted the collaborative nature of Medinfo with other parts of medical affairs and how it can provide tailored content for different materials and responses. We also discussed the potential of using generative authoring or GPT for medical information and the benefits of outsourcing tasks to vendors. The episode emphasized that the real value is in insights and trends, not just basic productivity numbers. In light of the COVID-19 pandemic, we also talked about how video chat options for medical inquiries are becoming more common, and self-service options for medical inquiries are also becoming more popular. Lastly, we discussed the importance of monitoring medical information and how companies track internal business interests or initiatives, scientific concepts, and areas of special interest. The episode emphasized the importance of proactive monitoring to preemptively gather information on new data and its potential impact. Thank you for tuning in to our podcast series. We hope that this episode has provided you valuable insights about the role of medical information in the healthcare industry. Make sure to stay tuned for our next episode! Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

This episode is the second in Pharma Sessions' series of conversations about clinical trial diversity. The first episode was with a former pharma executive turned clinical trial consultant. In this episode we share a different, more community oriented perspective. Renarda Jones is a clinical trial professional with over 20 years’ experience in clinical research., mainly in Cancer and Alzheimer’s disease research. Starting as a research assistant, working her way up to study coordinator and clinical research associate, Renarda had the opportunity to work with underrepresented and underserved communities, specifically the black community. Personally witnessing inequalities regarding clinical trials prompted Renarda to start Diverse Research Now in 2020. Diverse Research Now is working at a community level to ensure that underrepresented and underserved communities get access to highly-qualified medical professionals and frequent medical care, which is one of the benefits to enrolling in a clinical trial. It is their mission to: Episode Summary: - Introduction to the need for more discussions about clinical trials in communities - Renarda Jones’ background, experience, and role in Diverse Research Now - The importance of seeing representation in health discussions - The need for a safe and private space for asking and receiving information - The history of health inequities in clinical trials and the establishment of Diverse Research - Patient recruitment and its effects on clinical trial diversity - The Biden administration and legislation for improved diversity - Importance of inclusivity in good science - Negative experiences of underserved communities with healthcare - The speaker’s personal experience with medical trial decision-making - Need for improved outreach and education on clinical trials - Importance of knowing the basics and when to get involved in clinical trials - Addressing the lack of consideration of clinical trials as a treatment option in communities of color. Follow me on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Follow Renarda on LinkedIn: https://www.linkedin.com/in/renardajones/ Find Diverse Research now here: https://www.diverseresearchnow.com/ Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

In Today’s episode Tom Caravela and I explore the question–what does a perfect MSL organization to support a product launch look like? I’ve knonw Tom for years, and asked him to share his unique perspective on field medical organizations. In addition to being a certified speaker, trainer and coach as well as a podcaster, Tom is the founder of an Executive Search Firm called The Carolan Group. They’re known for their niche expertise for specializing in the recruitment and placement of highly scientific professionals called Medical Science Liaisons. Tom is also the host of the popular medical affairs podcast, MSL Talk, which now has over 250,000 listeners in over 80 countries. We talk about: Links: Join PharmaSessions for free on Substack for exclusive content: pharmasession.substack.com Follow me on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Tom Caravela: https://www.linkedin.com/in/tomcaravelamslrecruiter/ https://www.carolangroup.com/ Follow MSL Talk on: Instagram: https://www.instagram.com/msl_talk_podcast/ MSL Talk is a podcast that features helpful information for current Medical Science Liaisons, Medical Affairs leaders, job seekers looking to break into the pharmaceutical industry in their first MSL role as well as anyone interested in hearing good industry conversation and medical affairs discussions. #msl #medicalaffairs #medicalscienceliaison #MSLTalk #pharmaceutical Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

Steve Royle is an innovative pharmaceutical professional with experience in both the commercial and medical affairs sides of the industry. After starting in sales and marketing, Steve moved to the agency side of global medical communications and medical education. He went on to found Swipe Health and Rumi. Recently, Steve has used his expertise to create mymedicalafairs.com, a Netflix-style database of medical affairs events and topics. Through mymedicalaffairs.com, we crowdsourced the topics for today's conversation. The discussion included: - Medical Affairs: Shift in Responsibilities - Exchange of Ideas and Information Sharing - Opportunities for Progress in the Short to Medium Term - MSL Upskilling and Micro-Learning - Digital Platforms for Training - Tracking Engagement and Identifying Sticky Points - Omnichannel Emphasis - The Importance of Active Listening - Tracking HCPs' Digital Behavior and Insights - A Unified Strategy that Combines Digital and In-Person Efforts - Health Misinformation on the Internet - Future of MSLs - Focus on Communication and Commercial Aptitude ✉️ pharmasessions.substack.com to follow along! Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

Camille Pope is the Chief Medical Lead at Acclinate, helping pharmaceutical companies and healthcare organizations access and engage communities of color so research is more inclusive. She'd previously worked for several large pharmaceutical companies in both field medical and medical affairs leadership roles. We discuss the importance of diversity in clinical trials, the new FDA guidance, the impacts that a lack of trial diversity can have when presenting information to patients and providers, and why medical affairs has the skillset to make change. Don’t miss an episode and subscribe to the newsletter: ✉️ pharmasessions.substack.com What You’ll Learn: 05:50:00 How to assess the primary endpoint of clinical trials. 06:54:00 The demographics of patients in clinical trials. 11:34:00 How can we think differently about who we are engaging in clinical trials? 16:32:00 Clinical Trial Diversity Workstream. 21:50:00 How to measure patient representation in clinical trials 24:50:00 How to ask about clinical trial options? 27:11:00 Prioritization and budgets Resources: Jonathan Kaskey 👤 LinkedIn: www.linkedin.com/in/jonkaskey 🔗 Website: www.pharmasessions.substack.com ✉️ Email: pharmasessions@substack.com 🐤 Twitter: @PharmaSessions 🎥 YouTube: @PharmaSessions Camille Pope 👤 LinkedIn: https://www.linkedin.com/in/camille-pope/ Spotify: https://open.spotify.com/episode/2CqK5Apvgnm6B2EGTI8sHN?si=1a45fe814913417f Apple: https://podcasts.apple.com/us/podcast/increasing-clinical-trial-diversity-with-camille-pope/id1641549065?i=1000605399386 Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

Chris Caudle is a LinkedIn specialist for execs working in the healthcare and life sciences sectors. He helps clients to develop their personal brand, increase their visibility, leadership and reach bigger audiences using LinkedIn as their launchpad. In this episode Chris talks about how to use social media, specifically LinkedIn. He discusses the benefits of having a strong online brand and how to make it stand out. Chris and Jon talk give examples about using social not only for personal branding, but to actually do the work of medical affairs. And stay tuned for the end for a full profile breakdown of someone doing an outstanding job on LinkedIn. Don’t miss an episode and subscribe to the newsletter: ✉️ pharmasessions.substack.com Key Takeaways: What You’ll Learn: 00:03:00 Grow your online presence with LinkedIn. 00:09:00 Increase visibility to influence stakeholders. 00:15:17 Humanize your organization. 00:17:16 Build a mission-based profile. 00:24:51 Collaborate to build authority. 00:25:30 Opportunities for connection. Resources: Jonathan Kaskey 👤 LinkedIn: www.linkedin.com/in/jonkaskey 🔗 Website: www.pharmasessions.substack.com ✉️ Email: pharmasessions@substack.com Christopher Caudle 👤 LinkedIn: www.linkedin.com/in/christopherbcaudle 🔗 Website: www.makebusinesssocial.com ✉️ Email: chris@makebusinesssocial.com ✉️Substack | 📱Tiktok | ▶️ YouTube | 🐦 Twitter | 🎥 Instagram 🔗 Website: https://pharmasessions.buzzsprout.com/ Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

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Evan Reddick recently joined an exciting emerging biotech with a major phase 3 trial win, and preparing to launch a first-in-class oral medication for breast cancer, serving as the AVP and Head of Global Medical Affairs Strategy. Evan previously had a number of field and leadership roles at a large pharma. A highlight was the very first topic discussed, the framework of “Standing in Success”, and what that means for leaders. But we covered so much, I'm really excited to hear what you have to say! Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

Riad Dirani is the VP of Global HEOR at Teva Pharmaceuticals. We talk about: The views expressed here are mine and Riad's, and don’t reflect those of our employers. Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com

Amber Spierer is the VP of Patient Affairs at EQRx, formally head of US Patient Engagement at Novartis. We talk about: The views expressed here are mine and Amber’s, and don’t reflect those of our employers. Pharma Sessions is hosted by Jonathan Kaskey Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/ Or join the Pharma Sessions Substack: www.pharmasessions.substack.com