RealPharma: Conversations with Pharma Pathfinders

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 00:00 Introduction of Iris Tam 02:08 Definition and Significance of HEOR 04:07 Evolution and Increasing Role of HEOR 07:49 Components of HEOR: Health Economics and Outcomes Research 10:26 Impact of HEOR on Drug Development and Marketing Strategies 25:46 Key Elements for Payers in HUR Studies 38:47 Considerations for HUR in Global Launches 41:35 Ethical Considerations in HUR Research 46:41 Skills and Experiences for Success in HUR 51:49 The importance of user adoption 52:01 Learning from post mortems 53:01 Using failures to inform future strategies 53:55 The challenge of proving product benefits 54:23 Closing thoughts and advice 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, CEO and Founder of Famlee **Understanding Fertility: The Basics** - HHS Office of Population Affairs: Explore fundamental aspects of fertility, including menstrual cycle and fertility awareness. https://opa.hhs.gov/adolescent-health/reproductive-health/understanding-fertility-basics **RESOLVE: The National Infertility Association**: Offers detailed information on the female reproductive system and resources for managing infertility stress and relationships. Support groups and professional help are also available. https://resolve.org/what-are-my-options/understanding-infertility/ **Female Fertility: Why Lifestyle Choices Count - Mayo Clinic**: Provides insights into how lifestyle choices impact fertility and offers practical tips for maintaining a healthy lifestyle to improve fertility. https://www.mayoclinic.org/healthy-lifestyle/getting-pregnant/in-depth/fertility/art-20047584 **Fertility.com**: Contains comprehensive information about female fertility facts, age, and the reproductive system, including the menstrual cycle and the male’s role in conception. https://us.fertility.com/female-fertility **Your Fertility**: Offers a range of fact sheets on topics like the effects of caffeine, alcohol, and smoking on reproductive outcomes, understanding ovulation, and the role of exercise in improving fertility. https://www.yourfertility.org.au **Infertility 101 from RESOLVE**: Provides an overview of infertility basics, along with support options, including online communities and advocacy information. 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 Operation Warp Speed was a significant achievement in public health, demonstrating the collaboration between the public and private sectors to develop and distribute COVID-19 vaccines. Diversity in clinical trials is crucial to ensure that medications and treatments are effective for all populations. Improving healthcare access and outcomes requires a holistic approach that addresses social determinants of health and promotes health equity. Collaboration between different stakeholders, including the government, private industry, and the community, is essential to drive positive change in healthcare. Pricing models in the pharmaceutical industry need to be reevaluated to ensure the affordability and accessibility of medications for all individuals. Political pandering can have a detrimental impact on public health messaging and erode trust in public health organizations. Proper funding and communication are essential for the CDC to respond to public health crises effectively. Practical information and listening to the public are crucial in public health communication. Supporting and retaining public health workers is vital for a strong public health infrastructure. Protecting the independence of CDC directors and Surgeon Generals can help build trust in the organization. The pharma industry needs to address issues of inequity and community engagement to improve public perception. There is a paradox of trust and distrust in public health organizations, which requires addressing underlying issues. Caring and finding common ground are important guiding principles in public health work. 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 Report GAO Congressional Report OWS 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. Chapters00:00 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 ResourcesDr. 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. Chapters00:00 - 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 ResourcesKristiaan Rawlings LinkedIn EPM Scientific Biopharma Layoff Tracker 2023 BioSpace: 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. Chapters00:00 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 ResourcesDr. Arthur Caplan Succumbing to AI with a whimper, not a bang Working Group on Compassionate Use and Preapproval Access (CUPA) Vaccine Working Group on Ethics and Policy Working Group on Pediatric Gene Therapy & Medical Ethics Transplant Ethics and Policy If you donate DNA, what should scientists give in return? A ‘pathbreaking’ new model Treating 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 answered Regaining Trust in Public Health and Biomedical Science following Covid: The Role of Scientists Protect newborn screening programs Why 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.