RealPharma: Conversations with Pharma Pathfinders

Summary Ilisa Bernstein, a senior Vice President at the American Pharmacists Association, discusses the history and current landscape of drug importation policies with a focus on Florida's program. Safety concerns, supply chain issues, and intellectual property rights are key considerations. The impact on the Canadian drug supply and the transparency of imported drugs for consumers are also discussed. Manufacturer concerns regarding rebates and discounts, as well as potential oversupply and export restrictions, are highlighted. The conversation explores the complexities and concerns surrounding drug importation programs. It discusses the mechanisms that manufacturers may use to control drug importation, such as restricting volume or increasing prices. The potential impact on the drug supply in Canada and the need for policies to protect it are also examined. The logistical challenges at the border and the vulnerabilities in the drug supply chain are highlighted. The importance of maintaining patient confidence in drug quality and the risks associated with personal drug importation are discussed. The conversation concludes by considering alternative solutions to lower drug prices and the inspiration drawn from historical figures. Chapters 00:00 Introduction of Ilisa Bernstein 01:19 Background on Drug Importation 08:21 Safety Concerns 10:04 Supply Chain and Drug Source 14:58 Transparency and IP Issues 20:57 Consumer Transparency and NDC Numbers 21:10 Intellectual Property Concerns 22:59 Challenges and Points of Contention 25:12 Manufacturer Concerns: Rebates and Discounts 28:06 Oversupply and Export Restrictions 29:09 Mechanisms to Control Drug Importation 30:39 Policies to Protect Drug Supply in Canada 31:12 Logistical Challenges at the Border 33:07 Vulnerabilities in the Drug Supply Chain 35:03 Maintaining Patient Confidence in Drug Quality 36:31 Risks Before the Border 38:01 Complexities and Concerns for Community Pharmacists 41:31 The Future of Drug Importation Programs 44:00 The Motivation Behind Drug Importation Programs 46:01 Exploring Other Solutions to Lower Drug Prices 48:19 The Illegality of Personal Drug Importation 49:05 Balancing Cost Savings and Patient Safety 50:02 Inspiration from Historical Figures Resources: Ilisa Bernstein American Pharmacists Association The Partnership for Safe Medicines

Summary In this episode, Kristiaan Rawlings discusses the 2024-2025 Commercial Market Update and Salary Guide produced by EPM Scientific. The life sciences sector remains resilient due to aging populations, scientific advances, and robust investment. Hiring practices and compensation are influenced by these factors across the Americas, Europe, and APAC regions. The hiring focus has shifted from life-threatening diseases to more common health issues, such as dermatology and respiratory diseases. The most in-demand roles include marketing, commercial operations (salesforce effectiveness, commercial analytics, and training), and sales. Market access roles have seen less demand. Despite the availability of talent, salaries have remained high or even increased. In this conversation, Kristiaan Rawlings discusses the current trends in the life sciences job market, specifically in the commercial operations field. He explains the increase in demand for talent, the impact of title deflation, and the rise in salaries. He also highlights the regional differences in job opportunities, with a shift towards the East Coast of the United States. Additionally, he touches on the importance of executive presence and the return of in-person networking events. Overall, the conversation provides valuable insights into the evolving landscape of the life sciences job market. Chapters 00:00 High Demand for Marketing Roles 04:26 Focus on Core Areas with Existing Blockbuster Products 05:53 Sought-After Skills for Commercial Operations and Product Launches 13:54 Challenges with LinkedIn Applications and Fake Job Postings 24:25 Selective Market Based on Therapy Area and Experience 24:51 The Three Pillars of Focus: Salesforce Effectiveness, Commercial Analytics, and Training 25:21 High Demand for Talent in Incentive Compensation, Analytics, and Competitive Intelligence 26:17 Sales Roles in High Demand During Product Launches 26:46 Quiet Market in the Field of Market Access 27:14 Salaries Holding Strong or Increasing Despite High Supply of Talent 32:30 Geography Becoming Less of a Factor in Salary and Opportunity 41:08 High Demand for Medical Affairs and Health Economics 44:01 The Importance of Executive Presence and Networking for Career Success Resources Kristiaan Rawlings - LinkedIn 2024/2025 EPM Commercial Update and Salary Guide

Summary In this episode, hosts Ian Wendt and Dr. Na-Ri Oh , and guest Kira Dineen discuss the intersection of genomics and healthcare. They explore the concept of personalized medicine and how advancements in genomics are revolutionizing healthcare. Kira shares her personal journey and the inspiration behind her DNA Today podcast. The conversation delves into the technology behind personalized medicine and the challenges of building comprehensive genetic databases. The ethical considerations of genomics, including access to information and the potential misuse of genetic data, are also explored. The episode concludes with a discussion on the need for ethical frameworks to keep pace with technological advancements in genomics. The conversation explores the controversial topic of gene editing, particularly the use of CRISPR technology. The hosts discuss the ethical considerations and the choice of genetic targets for editing. They also touch on the accessibility and long-term consequences of CRISPR. The conversation then shifts to the cost of treatment and the role of genetic testing in drug development. The potential of AI in genetic research is explored, as well as the future of personalized medicine. The episode concludes with a discussion on professional motivation and the importance of networking. Chapters 00:00 Introduction to Kira Dineen and the Intersection of Genomics and Healthcare 02:07 Genomics and Personalized Medicine 04:13 Kira Dineen's Personal Journey and the DNA Today Podcast 08:08 The Trend Towards Personalized Medicine in Biopharma 10:11 The Technology Behind Personalized Medicine 12:39 Building Databases and Overcoming Barriers 15:18 Ethical Considerations in Genomics 20:39 Ethics and the Use of Genetic Information 24:06 Ethics Keeping Pace with Technological Advances 25:44 Managing Ethical Considerations in Genetic Research 27:21 Controversial Gene Editing 28:18 Choosing Genetic Targets 29:10 Ethical Considerations 29:44 Accessibility of CRISPR 30:13 Long-Term Consequences of CRISPR 32:51 Healthcare Equity and Cost of Treatment 34:25 Cost of Genomic Sequencing 35:22 Genetic Testing and Drug Development 38:13 Role of Genetic Testing in Clinical Trials 42:20 AI in Genetic Research 46:34 Future of Personalized Medicine 49:56 Professional Motivation and Networking Resources: LInkedInTwitterDNAtoday.comBreath from Salt (DNA Today Episode #147Maury Povich interview on DNA TodayPatient Empowerment Program: A Rare Disease Podcast

Dive into the high-stakes world of Venture Capital in biopharma with Jim Trenkle! Have you ever wondered what it takes to turn groundbreaking scientific discoveries into life-saving treatments? What role do venture capitalists play in this thrilling journey from the lab to the clinic? This episode peels back the curtain on the biopharma venture capital scene, revealing the risks, rewards, and radical innovations driving the future of healthcare. Join hosts Dr. Na-Ri Oh and Ian Wendt as they explore with Jim the secrets of successful biopharma investments, the challenges of navigating the complex landscape of medical research funding, and the thrilling potential of the next big breakthroughs. Don't miss this conversation that could change the way you see medicine and innovation. In this episode, Jim Trenkle, a partner at Nova Holdings, shares insights on venture capital in the biopharma industry. He explains the different stages of investment, from seed rounds to IPOs, and the role of venture capitalists in providing capital and expertise. Jim discusses the current state of raising capital for biotech startups, including the impact of interest rates and market conditions. He also highlights the challenges and evaluation criteria in biotech VC, emphasizing the importance of a well-thought-out plan and addressing unmet needs. Jim Trenkle also discusses his own career path and the importance of finding work that has a deeper impact. He shares his journey from being a medicinal chemist to venture capital, highlighting the value of lifelong learning and broadening one's impact. Trenkle also discusses the challenges and skills required in venture capital, emphasizing the need for humility and the ability to make decisions that have a real impact. He reflects on the lessons learned from the Theranos scandal and the role of venture capitalists in evaluating companies. Trenkle explores the reasons behind company closures and failures in the biopharma industry and the potential for innovation and technological advances to shape the future of venture capital. He concludes with advice on career growth and the importance of following one's passion. Chapters 00:00 Introduction of Jim Trankel 01:01 Understanding Venture Capital in BioPharma 07:59 The Current State of Raising Capital for Biotech Startups 11:23 The Landscape of Biotech Funding 16:25 Challenges and Evaluation in Biotech VC 23:16 What Does Good Look Like and Pitfalls to Avoid 31:19 Jim Trankel's Career Path 31:59 Career Path and Impact 35:19 Challenges and Skills in Venture 37:05 Evaluating Companies and Capital Allocators 38:23 Lessons from Theranos 46:01 Company Closures and Failures 52:42 The Future of VC in Biopharma 58:32 Advice and Mentors Resources (LinkedIn)Novo Holdings 1. **2024 US Venture Capital Outlook | PitchBook**: Provides predictions for the US VC ecosystem in 2024, including insights on unicorn companies and valuation trends 2. **2024 Venture Capital Trends: Opportunities and Challenges - Founders Network**: Discusses the shift towards startups demonstrating strong fundamentals and a clear path to profitability 3. **2024 Outlook: Private Equity & Venture Capital - Cambridge Associates**: Highlights the expected increase in capital flows to private European turnaround and value strategies 4. **5 Trends to Watch: 2024 Venture Capital | Greenberg Traurig LLP**: Governance issues and IPO momentum are among the trends highlighted for VC in 2024 5. **Global Venture Capital Outlook: The Latest Trends | Bain & Company**: Covers a broad range of industries and the impact on venture capital funding 6. **4 Important Venture Capital Trends (2024-2026) | Exploding Topics**: Explores equity crowdfunding platforms like WeFunder and StartEngine, highlighting their growth and impact on the startup funding landscape 7. **Venture capital market to seek new floor in 2024 | EY - US**: Provides insights into the economic headwinds impacting investor...

Join us on a deep dive into the world of Health Economics and Outcomes Research (HEOR) with the remarkable Iris Tam, PharmD, a luminary in value-based evidence generation within the biopharma industry. In this episode, our hosts Ian and Na-Ri explore with Iris the critical role of HEOR in transforming today's pharmaceutical landscape, from drug development to global marketing strategies and beyond. Unpacking the complexities of HEOR, they delve into its definition, significance, and the evolving importance of this field in aligning drug development with payer expectations and patient outcomes. Iris shares invaluable insights on the key elements that payers scrutinize in HEOR studies, and the strategic considerations essential for successful global product launches. Ethical considerations in HEOR research also take center stage, highlighting the responsibility of ensuring integrity and patient-centricity in evidence generation. For professionals eager to make their mark in HEOR or advance their careers, Iris offers sage advice, emphasizing the need for robust data, the value of learning from post-mortems, and the art of using failures to forge successful future strategies. This episode is not just an exploration of HEOR's impact on healthcare but a guide to understanding the challenges of demonstrating product value and the crucial role of user adoption. Whether you're a seasoned professional or new to the field, Iris's journey and insights offer inspiration and guidance for navigating the complexities of HEOR in the biopharma industry. Chapters Resources: Iris Tam Coeus Consulting Group ISPOR HEOR Resources ISPOR Top 10 HEOR Trends

Dive into the world of fertility with Shelley Bailey, the visionary founder and CEO of Famlee Fertility, on our latest episode. Discover Shelley's personal journey that led to the creation of Famlee, a company revolutionizing the fertility landscape with its home-based testing and clinical treatments aimed at empowering women to understand and enhance their fertility. In this enlightening conversation, Shelley unravels the role of Famlee in supporting women through their fertility treatment journey, debunking common myths and misconceptions that surround fertility. Learn about the holistic approach and tailored treatment plans Famlee offers, designed to balance hormones and improve fertility from the comfort of home. Tune in to gain valuable insights into overcoming fertility challenges, the importance of personalized care, and the future of fertility treatments. Whether you're navigating your own fertility journey or simply interested in the innovations transforming women's health, this episode promises to enlighten, inspire, and empower. Chapters: 00:00 Introduction to Shelley Bailey and Famlee Fertility 04:02 Shelley's Personal Journey and Inspiration for Starting Famlee 09:47 The Role of Famlee in the Fertility Treatment Journey 14:38 Positioning Famlee in the Healthcare Landscape 17:10 Common Myths and Misconceptions about Female and Male Fertility 23:39 The Journey with Famlee: Holistic Approach and Treatment Plan 32:47 Challenges Faced as a Founder in the Fertility Sector 42:15 Future Plans and Expansion for Famlee 43:49 Mentors and Inspiration in Shelley's Entrepreneurial Journey Resources: Famlee Fertility Shelley Bailey https://opa.hhs.gov/adolescent-health/reproductive-health/understanding-fertility-basics https://resolve.org/what-are-my-options/understanding-infertility/ https://www.mayoclinic.org/healthy-lifestyle/getting-pregnant/in-depth/fertility/art-20047584 https://us.fertility.com/female-fertility https://www.yourfertility.org.au https://resolve.org/what-are-my-options/infertility-101/

Dr. Jerome Adams, the 20th US Surgeon General, discusses various topics related to public health, including Operation Warp Speed, diversity in clinical trials, improving healthcare access and outcomes, addressing health inequities, collaborative approaches in healthcare, challenges with pricing models, the importance of prevention and health literacy, and lessons learned from COVID-19. In this conversation, Dr. Jerome Adams discusses the impact of political pandering on public health messaging and the erosion of trust in the CDC. He emphasizes the need for proper funding and communication in the CDC to effectively respond to public health crises. Dr. Adams also highlights the importance of practical information and listening to the public, as well as supporting public health workers. He suggests protecting the independence of CDC directors and Surgeon Generals to instill trust in the organization. The conversation also touches on the reputation of the pharma industry and the paradox of trust and distrust in public health organizations. Dr. Adams concludes by sharing his guiding principles of caring and finding common ground. Takeaways Chapters 00:00 Introduction to Dr. Jerome Adams 02:18 Discussion on Operation Warp Speed 05:34 Importance of Diversity in Clinical Trials 09:52 Improving Healthcare Access and Outcomes 18:03 Addressing Health Inequities 23:35 Collaborative Approach in Healthcare 25:30 Challenges with Pricing Models 30:21 Importance of Prevention and Health Literacy 35:06 Lessons Learned from COVID-19 45:57 The Impact of Political Pandering 46:53 The Perception of Political Leanings 47:40 The Erosion of Trust in the CDC 49:27 The Need for Proper Funding and Communication in the CDC 51:51 The Importance of Practical Information and Listening to the Public 53:25 The Importance of Supporting Public Health Workers 54:16 Protecting the Independence of CDC Directors and Surgeon Generals 55:47 The Reputation of the Pharma Industry 58:12 The Paradox of Trust and Distrust in Public Health Organizations 01:04:07 Guiding Principles: Caring and Finding Common Ground Resources: Dr. Jerome Adams (LinkedIn) Dr. Jerome Adams (Twitter/X) Dr. Jerome Adams (Purdue University) Crisis and Chaos: Lessons from the Front Lines of the War Against Covid-19 Operation Warp Speed Resources: GAO ReportGAO Congressional ReportOWS Distribution Strategy

Trying to understand how pharma can effectively partner with patient advocates to support better patient outcomes? In this episode, Coy Stout discusses his journey in patient advocacy and the intersection of patient advocacy, policy, and social work in the pharma industry. He shares personal stories that motivated him to get involved in the field and highlights the importance of patient-centricity in biotech companies. Coy also discusses the role of technology in patient advocacy and the challenges and controversies surrounding patient advocacy in diseases like ALS and Alzheimer's. He emphasizes the need for transparency, collaboration, and patient input in decision-making processes, especially when it comes to drug pricing and access. In this episode, Coy Stout shares his insights on patient advocacy and the importance of patient-centered care. He discusses the challenges faced by patients and the need for more diverse representation in healthcare and pharma. Coy also highlights the transformative medicine happening now and the opportunity to bring real-world expertise into the industry. He envisions a future where patients and their caregivers are actively involved in guiding research and commercialization efforts. Overall, Coy emphasizes the importance of creating space for patients and their communities to contribute to innovation in healthcare. Chapters: 00:00 Introduction 01:32 Motivation for Patient Advocacy 04:38 Early Relationships Between Advocacy Groups and Pharma 07:08 Patient-Centricity in Biotech Companies 09:42 Gold Standard of Patient Advocacy 10:51 Intersection of Patient Advocacy and DEI Initiatives 12:45 Engaging Employees in Advocacy 17:34 Role of Technology in Patient Advocacy 20:50 Controversies and Challenges in Patient Advocacy 31:07 Patient Advocacy in ALS and Alzheimer's Disease 38:00 Balancing Patient Advocacy and Drug Pricing 54:53 Closing Remarks Links: Patient Advocate Foundation (PAF) offers various patient-friendly resources to empower individuals in leading their healthcare journey. These resources include publications, tip sheets, webinars, and interactive materials2. The American Medical Association (AMA) is dedicated to advocating for patients’ access to quality healthcare. Physicians actively work to address health disparities and fight for patients’ rights through legislative efforts and legal support. National Patient Advocate Foundation (NPAF): The NPAF provides additional resources to support patients in their healthcare experiences.

Dr. Khalil Ramadi, an assistant professor at New York University Abu Dhabi, discusses the field of bioengineering and his work in neuromodulation and ingestible electronics. He explains that bioengineering encompasses tinkering with biology and physiology, and its focus has shifted from building hardware tools for the clinic to devices that can be implanted in the body. Dr. Ramadi's interest in neuromodulation stems from the need to improve brain technologies and find non-invasive ways to target specific areas of the body. He also explores the potential applications of neuromodulation in areas such as obesity, eating disorders, and diabetes. The challenges in bioengineering include regulatory issues, access to innovations, and the scalability of devices. In this conversation, Khalil Ramadi discusses the field of bioengineering and its potential impact on healthcare. He shares insights on the future of bioengineering education, emphasizing the need for innovation and commercialization. Khalil also predicts advancements in personalized care and the potential for new technologies to diagnose and treat diseases. He highlights the importance of finding inspiration and overcoming challenges in the field. Lastly, he introduces Project Prana Foundation, a nonprofit organization focused on developing technologies for decentralized care. Chapters 00:00 Introduction to Dr. Khalil Ramadi 03:47 Defining Bioengineering 06:33 Dr. Ramadi's Journey into Bioengineering 10:30 The Role of a Bioengineer 11:56 Focus on Neuromodulation and Ingestible Electronics 16:41 The Gut-Brain Connection 17:26 Applications of Neuromodulation 20:38 Neuralink and the Future of Bioengineering 25:05 Neuromodulation and GLP-1 Agonists 29:27 Challenges in Bioengineering 33:33 The Future of Pharma and Bioengineering 36:18 Ensuring Access to Bioengineering Innovations 40:20 The FLASH Pill and Appetite Stimulation 47:02 The Future of Bioengineering Education 51:10 Predictions for the Next 10 Years 55:00 Finding Inspiration and Overcoming Challenges 58:31 Project Prana Foundation Resources Dr. Khalil Ramadi: https://www.linkedin.com/in/khalil-ramadi/ Ramadi Lab: RamadiLab.com Ingestible electronics: Science Robotics paper for gastric stimulation: https://www.science.org/doi/10.1126/scirobotics.ade9676 Project Prana: https://www.projectprana.org/isave Nano Robots Shrink Bladder Cancer: https://www.irbbarcelona.org/en/news/scientific/nanorobots-shrink-bladder-tumours-90 Light Powered Yeast: https://www.science.org/content/article/scientists-engineer-first-light-powered-yeast DNA Detection Advances: https://scitechdaily.com/rapid-disease-diagnosis-bioengineering-breakthrough-boosts-dna-detection-sensitivity-by-100x/

This episode discusses the biopharmaceutical job market and the impact of the COVID-19 pandemic. It explores the state of the job market, including layoffs and hiring trends in the industry. The conversation also delves into the role of recruiters in the life sciences industry and provides insights into their day-to-day activities. Additionally, it offers advice for candidates on how to approach working with recruiters and highlights the importance of building long-term relationships. The episode concludes with a discussion on the impact of technology on job applications. In this conversation, Kristiaan discusses the current hot areas in the industry, including GLP-1s, dermatology, neurology, ophthalmology, and respiratory. He also talks about the trend of title deflation and how candidates should focus on the responsibilities and long-term opportunities rather than just the title. Kristiaan provides insights into compensation trends, including base salaries, bonuses, and long-term incentives. He also addresses the topic of work onsite vs. remote and how companies are expecting employees to be onsite two to three times a week. Finally, he shares advice on charting your path and being willing to do what others won't to achieve your goals. Chapters 00:00 - Introduction to the Biopharmaceutical Job Market 02:05 - State of the Job Market and Layoffs in the Biopharmaceutical Industry 03:31 - The Impact of the Great Resignation on the Pharmaceutical Industry 06:07 - The Influence of Disease Areas on Hiring Trends 08:30 - The Commercial Space in the Biopharmaceutical Industry 12:55 - A Day in the Life of a Life Sciences Recruiter 19:33 - Different Approaches and Business Models of Recruiters 24:51 - How Candidates Should Approach Working with Recruiters 27:49 - Building Long-Term Relationships with Recruiters 32:00 - Success Stories of Candidates Who Overcame Challenges 37:13 - The Impact of Technology on Job Applications 43:48 - Hot Areas in the Industry 48:23 - Title Deflation 57:26 - Compensation Trends 01:02:33 - Work Onsite vs. Remote 01:09:01 - Charting Your Path Resources Kristiaan Rawlings LinkedInEPM ScientificBiopharma Layoff Tracker 2023BioSpace: How to Prepare for Your Biopharma Job Search

Dr. Arthur Caplan, a distinguished bioethicist, discusses various topics related to bioethics. He highlights the importance of bioethics in areas such as organ transplantation, genetic testing, artificial intelligence, and personalized medicine. Dr. Caplan emphasizes the need for informed consent in research ethics and the importance of providing research participants with the results of studies. He also addresses the ethical considerations in organ transplantation, including the allocation of scarce resources and the role of living donors. Additionally, he discusses the ethical implications of expensive treatments and the allocation of limited resources in healthcare. The conversation explores the disparity in healthcare attention given to rare diseases compared to chronic conditions. It highlights the need for organized advocacy and lobbying for conditions that lack representation. The discussion also delves into the balance between investing in genetic therapies for rare diseases and preventive measures for chronic conditions. The ethical considerations of gene editing using CRISPR technology are examined, including the need for monitoring and surveillance of adverse effects. The potential for societal inequalities in access to gene editing is discussed, raising concerns about eugenics and the widening gap between those who can afford the technology and those who cannot. Chapters 00:00 Introduction to Dr. Arthur Caplan 01:35 The Importance of Bioethics in Various Areas 09:25 Informed Consent in Research Ethics 17:29 Balancing Scientific Progress and Ethical Considerations in Human Subject Research 33:41 Ethical Considerations in Organ Transplantation 47:22 Healthcare Resource Utilization and Pricing 48:25 Disparity in Healthcare Attention 51:18 Balancing Rare Diseases and Chronic Conditions 53:36 Genetics vs. Environmental Intervention 58:26 CRISPR and Bioethical Concerns 01:05:13 Societal Inequalities in Access to Gene Editing 01:06:03 Inspiration from Ben Franklin Resources Dr. Arthur CaplanSuccumbing to AI with a whimper, not a bangWorking Group on Compassionate Use and Preapproval Access (CUPA)Vaccine Working Group on Ethics and PolicyWorking Group on Pediatric Gene Therapy & Medical EthicsTransplant Ethics and Policy If you donate DNA, what should scientists give in return? A ‘pathbreaking’ new modelTreating the dead; how far ought medicine go to obtain transplantable organs?Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?Research involving the recently deceased: ethics questions that must be answeredRegaining Trust in Public Health and Biomedical Science following Covid: The Role of ScientistsProtect newborn screening programsWhy the Gene Was (Mis)Placed at the Center of American Health Policy

Coming January 2024! RealPharma Podcast is your gateway to the world of biopharmaceuticals and healthcare. Your hosts are two industry veterans who engage in in-depth conversations with pharma pathfinders/leaders who are shaping the future of medicine. Hear the stories behind the news that challenge traditional viewpoints and offer fresh perspectives that will make you rethink what you know about the healthcare industry.