SUMMARY: In this episode, Shivu and Kenny discuss the recent developments surrounding Replimune and its interactions with the FDA. They explore the implications of leadership changes at the FDA, the importance of patient advocacy, and the challenges faced by small biotech companies in navigating the regulatory landscape. The conversation highlights the critical role of stability in drug approvals and the potential impact on patient care, particularly in oncology. They discuss the complexities of the FDA's role in drug development, the importance of confirmatory studies, and the impact of leadership changes on regulatory processes. They also talk about the historical evolution of the FDA, its commitment to patient safety, and the challenges it faces in maintaining consistency and transparency. The conversation culminates in a thought-provoking discussion on the potential benefits of an independent FDA, akin to the Federal Reserve, to enhance trust and efficacy in drug approvals.
DISCLAIMER: The views and opinions expressed in this podcast are for informational and educational purposes only. They are not intended as medical advice and should not be used as a substitute for professional medical judgment or guidance. Always consult a qualified healthcare provider with any questions you may have regarding a medical condition or treatment.
CHAPTERS:
00:00 The FDA's Independence and Scope
02:53 Timeline of Instability at the FDA
14:00 Impact of Instability on Drug Development
19:54 Case Study: RepliMune's Regulatory Journey
34:00 Navigating FDA Interactions and Accelerated Approvals
58:03 The Role of a Healthy FDA: History and Function
01:12:40 Organizational Culture and Stability in Regulatory Agencies
01:15:24 Navigating Institutional Changes at the FDA
01:18:45 The Importance of Consistency in Health Guidelines
01:22:27 Transparency and Data Disclosure in Drug Approvals
01:25:18 The Case for an Independent FDA
01:29:53 Lessons from the Federal Reserve's Independence
01:35:11 Engendering Trust in Health Institutions
01:41:49 Final Thoughts
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Summary:
In this episode we chat with Joe McCann, CEO of Slingshot Insights. Joe estimates he has done somewhere between 5-10K calls interviewing physicians. In today's episode we tap into his insights on how to get more out of your conversations with doctors. Joe opens up his expert playbook on how to prepare and conduct calls with doctors. We also discuss how these tips/tricks can be applied by the everyday person to get more out of your interactions with healthcare practitioners and ensure you are getting the best care possible.
Disclaimer: The views and opinions expressed in this podcast are for informational and educational purposes only. They are not intended as medical advice and should not be used as a substitute for professional medical judgment or guidance. Always consult a qualified healthcare provider with any questions you may have regarding a medical condition or treatment.
PROMO CODE:
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Chapters
00:00 Recap of Insights from Joe's Conversation
03:05 Introduction to Expert Calls and Their Importance
11:10 Joe McCann's Background and Journey
18:52 Understanding the Value of Expert Calls
26:46 Differentiating Between Academic and Community Physicians
32:33 Risk Profiles and Decision-Making in Medicine
32:49 Managing Patient Care and Treatment Options
34:45 Navigating Expert Calls and Communication Strategies
37:22 Understanding Bias in Medical Opinions
41:34 Identifying Red Flags in Expert Interactions
45:30 Differentiating Client Needs: Investors vs. Industry
47:41 The Importance of Follow-Up Calls
50:42 Patient Engagement and Empowerment
57:09 Utilizing Guidelines and Resources for Better Care
01:00:44 The Importance of Proactive Healthcare
01:05:15 Navigating Clinical Trials and Patient Advocacy
01:08:48 Understanding Quality of Life in Treatment Decisions
01:09:55 Surgery Insights: Complications and Surgeon Selection
01:19:01 Entrepreneurship in Healthcare: Joe's Journey
01:25:20 Recap of Insights from Joe's Conversation
01:27:58 Building Confidence in Patient-Doctor Interactions
01:30:41 The Importance of Communication and Understanding
01:33:35 Navigating the Healthcare System Effectively
01:35:59 The Role of KOLs vs Community Physicians
01:38:37 The Impact of AI in Healthcare
01:41:18 Outro
Summary: In this episode, Shivu and Kenny delve into the evolving landscape of GLP-1 drugs, particularly focusing on the recent advancements in oral formulations and their potential applications beyond diabetes and obesity, including CNS diseases and addiction. They discuss the challenges of adherence, the mechanisms of action, and the economic implications of these therapies, while also highlighting the importance of early intervention in treatment. The conversation emphasizes the promising future of GLP-1s in various therapeutic areas and the ongoing research that will shape their role in healthcare.
References:
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Disclaimer: The views and opinions expressed in this podcast are for informational and educational purposes only. They are not intended as medical advice and should not be used as a substitute for professional medical judgment or guidance. Always consult a qualified healthcare provider with any questions you may have regarding a medical condition or treatment.
Chapters
00:00 Introduction to GLP-1s
02:52 The Evolution of Oral GLP-1s
06:26 Challenges in Patient Adherence
10:34 Exploring CNS Impacts of GLP-1s
14:44 Mechanisms of Action in CNS Diseases
19:13 Potential in Addiction Treatment
24:23 Future Directions and Research Opportunities
30:20 Exploring the Mechanisms of New Medications
35:16 Long-term Use and Dosing Challenges
39:57 Promising Data in Addiction Treatment
43:56 The Future of CNS and Metabolic Dysfunction Treatments
50:44 The Path Forward in Drug Development
54:50 Outro
A conversation with biotech leader, Sujal Shah, former CEO of CymaBay Therapeutics about his company's story arc, leadership, resilience, and building a biotech company in the face of adversity.
Questions?: drugdealinpod@gmail.com
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Connect with Shivu: https://linktr.ee/shivusharma
Check out Big Pharma Sharma: https://bigpharmasharma.substack.com/
Connect with Kenny: https://www.linkedin.com/in/kennylalwani/
00:00 Introduction to Biotech Leadership
03:00 Sujal Shah's Journey in Biotech
05:46 Leadership Philosophy and Team Dynamics
09:13 Navigating Challenges at CymaBay
11:48 The Development of seladelpar
15:07 Strategic Decisions in Drug Development
17:58 Clinical Trials and Regulatory Interactions
20:50 The NASH Study and Its Implications
47:10 Navigating Drug Development Challenges
49:07 The Patient-Centric Approach in Drug Development
51:56 Facing Clinical Setbacks and Organizational Resilience
53:36 Unexpected Findings and Immediate Reactions
01:00:27 The Emotional Toll of Drug Development
01:05:08 Rebuilding Purpose and Finding Answers
01:19:52 Patient Advocacy and Support During Crisis
01:23:30 Uncovering the Truth: The Role of Independent Panels 01:33:59 Independent Review and Safety Assurance
01:36:50 Leadership Challenges and Stakeholder Management 01:40:12 Resilience in Adversity
01:43:51 Turning Point: Stock Recovery and Investor Relations 01:47:07 Skepticism and Ongoing Challenges
01:55:00 Data Presentation and Competitive Landscape
02:01:11 Building a Robust Evidence Package
02:04:53 Reflections on Leadership and Future Aspirations
In this episode, we unpack, examine, and debunk the public perception that drug companies intentionally do not pursue curative therapies, because it is financially less beneficial to them. We speak from our own experience working on curative therapies in Oncology and HCV, discuss how difficult it is to develop cures, the implications of curing a disease for drug companies, and how the industry can do a better job fostering trust with patients.
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Kenny and Shivu each cook up three predictions for Biopharma in 2025
NOTE: This episode was recording on January 10th, 2025
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