Drug Dealin – Details, episodes & analysis

Kenny and Shivu each cook up three predictions for Biopharma in 2025

NOTE: This episode was recorded on January 10th, 2025

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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.

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.

Have feedback for us? Feel free to leave a comment or send us an email at DrugDealinPod@gmail.com

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.

What is Drug Dealin' going to be about? How are the Drug Dealin' hosts and should you listen to us? What type of content can you expect from this show?

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.

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.

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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/

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.

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

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:

• Shivu's recent substack post discussing GLP-1s for CNS disease: https://www.bigpharmasharma.com/p/what-2025-holds-for-glp-1s-in-brain
• GLP-1 Growth Graph: Zheng, Z., Zong, Y., Ma, Y. et al. Glucagon-like peptide-1 receptor: mechanisms and advances in therapy. Sig Transduct Target Ther 9, 234 (2024).

Contact us:

• Questions?: drugdealinpod@gmail.com
• Follow us on X: ⁠https://x.com/DrugDealinPod⁠
• Follow Shivu : ⁠https://linktr.ee/shivusharma⁠
• Subscribe to Shivu's newsletter: https://www.bigpharmasharma.com/

• Follow Kenny: ⁠https://www.linkedin.com/in/kennylalwani/⁠

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

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:

• DD Pod listeners who sign up for a "Starter" membership at Sling Shot Insights can get their first month FREE by entering the promo code: drugdealinpod25 at checkout
• Learn more about slingshot at: www.slingshotinsights.com

Contact Joe McCann:

• Email: Joe@slingshotInsights.com
• X: @JMac_SI

Contact us:

• Questions?: ⁠drugdealinpod@gmail.com⁠
• Follow us on X: ⁠⁠https://x.com/DrugDealinPod⁠⁠
• Follow Shivu : ⁠⁠https://linktr.ee/shivusharma⁠⁠
• Subscribe to Shivu's newsletter: ⁠https://www.bigpharmasharma.com/⁠

• Follow Kenny: ⁠⁠https://www.linkedin.com/in/kennylalwani/⁠

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 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

CONTACT US:

• Questions?: ⁠⁠drugdealinpod@gmail.com⁠⁠
• Follow us on X
• Follow Shivu on X
• Subscribe to Shivu's newsletter, Big Pharma Sharma ⁠⁠
• Follow Kenny