Ep. 6: Should the FDA Be Independent?

Ep. 9: Using AI to Find Novel Treatment Options

SUMMARY In this episode, Shivu and Kenny discuss how you as a caregiver or patient can use public resources like clinicaltrials.gov [http://clinicaltrials.gov] and Large Language Models (LLMs) like ChatGPT to discover the latest treatment options for a particular disease and empower yourself to have a more productive conversation with your doctor. Kenny and Shivu discuss an example of this situation from an episode of Apple TV's "Shrinking", starring Harrison Ford. In the episode they go through a demo of how they would find new treatment options for Ford's character, a patient suffering from Parkinson's Disease who has exhausted all available treatment options. CHAPTERS 00:00 Introduction to Clinical Trials 03:04 The Importance of Patient Involvement 06:13 Navigating Clinical Trials: A Practical Guide 09:06 Using AI to Enhance Patient Care 11:53 Drafting Effective Communication with Doctors 14:27 Empowering Patients Through Knowledge 17:46 Finding the Right Treatment Options 20:30 The Role of Research in Patient Advocacy 23:03 Conclusion and Future Directions 34:38 Outro Questions? Email us at: ⁠⁠mailto:drugdealinpod@gmail.com⁠⁠ [drugdealinpod@gmail.com⁠⁠] Follow ⁠Shivu on X⁠(@bigpharmasharma): https://x.com/BigPharmaSharma [https://x.com/BigPharmaSharma] Sign up for Shivu's newsletter: https://www.bigpharmasharma.com/⁠ [https://www.bigpharmasharma.com/⁠] ⁠ Follow ⁠Kenny⁠ on Linkedin:  [https://www.youtube.com/redirect?event=video_description&redir_token=QUFFLUhqbFRpZFJubWFFTDZmZ3pjMkxFbHd3SDVUcldVd3xBQ3Jtc0tuOVZHVkh5N0xhdVotYnRMRUdiUHZJNl9ia2ZVM29wUW1JUE5tbmZRWXMwMUxmUFB0Mlh2Sm1JcjJ4dU56TUxGbjF4X2M4c2tnMlEyNTMtT1NTMWtUamFCVnVKV0ZkR1RiRkpYalkzb1dpeWZ4azNuWQ&q=https%3A%2F%2Fwww.linkedin.com%2Fin%2Fkennylalwani&v=BWLdXCsWrdQ]https://www.linkedin.com/in/kennylalwani/ [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.

Ep. 8: 2026 Predictions

Summary In this episode, Shivu and Kenny review their predictions for 2025 and make new predictions for 2026. They discuss trends in mergers and acquisitions, market performance, the impact of AI in drug development, and the rise of digital advertising in the pharmaceutical industry. They also explore the evolving landscape of biotech companies, regulatory changes from the FDA, and the growing interest in metabolic diseases and psychedelics. Finally, they introduce the 'pharm to table' model in pharma, emphasizing direct-to-patient commercial channels and how these increase patient agency. Chapters 00:00 Introduction and Overview of Predictions 04:37 Grading 2025 Predictions 10:35 Shivu's 2025 Predictions and Grades 16:53 2026 Predictions: Emerging Trends 22:50 Regulatory Landscape and the FDA's Role 30:46 Predictability in Drug Approval Processes 30:51 The Metabolic Space and GLP-1s 33:08 Big Pharma's Entry into Obesity and Diabetes 34:56 The Risk of Commoditization in Drug Markets 37:06 Differentiation in the GLP-1 Market 39:40 The Rise of Psychedelics in Psychiatry 47:21 Pharm-to-Table Model in Pharma 54:06 Empowering Patients through Direct Access Questions? Email us at: ⁠⁠drugdealinpod@gmail.com [drugdealinpod@gmail.com]⁠⁠ Follow ⁠Shivu on X⁠: @bigpharmasharma [https://x.com/BigPharmaSharma] Sign up for Shivu's newsletter: Big Pharma Sharma [https://www.bigpharmasharma.com/]⁠ ⁠ Follow ⁠Kenny⁠ on Linkedin [https://www.linkedin.com/in/kennylalwani] The Disclaimer: "Legal wants us to remind you that while we’re very confident behind these mics, we are not medical professionals. These opinions are for educational and informational purposes only. Please do not swap your doctor’s guidance for our banter—that’s a bad trade. Consult an actual healthcare provider for any real medical conditions. Stay safe, stay informed, and keep the lawsuits to a minimum."

Ep.7: Biotech M&A Insights: CVRs, Patent Cliffs & The Pfizer-Novo Bidding War

SUMMARY In this deep dive into biopharma M&A trends, Shivu and Kenny analyze 10 years of acquisition data from major pharma players, revealing rising deal volumes and the increasing prevalence of Contingent Value Rights (CVRs) as risk mitigation tools. The hosts dissect the unprecedented Pfizer-Novo bidding war over Metsera, examining how this “interloper” situation reflects broader industry dynamics around patent cliffs and portfolio diversification strategies. The episode provides insider perspectives on why investors never seem satisfied with “enough” M&A activity and how companies balance internal R&D with external acquisitions in their portfolio approach. CHAPTERS 00:00 Introduction to M&A in Biopharma 03:35 Understanding Contingent Value Rights (CVRs) 06:47 Recent M&A Deals and Trends 13:17 Impact of Patent Cliffs on M&A Activity 17:43 The Portfolio Approach to Drug Development 22:00 Current Trends in Deal Volume and CVR Usage 28:58 Valuation Trends in Late-Stage Companies 32:51 The Buyer-Seller Dynamic in Pharma Deals 38:27 Evaluating CVRs and Acquirer Capabilities 42:31 GenMab’s Strategic Acquisition and Market Positioning 48:11 The Rise of the Biotech Middle Class 55:49 The Aggressive Landscape of Pharma Hiring 56:56 Innovation in RNA Interventions 57:53 The Metsera Bidding War Begins 01:00:11 Pfizer’s Acquisition Strategy Unfolds 01:03:48 Regulatory Implications and Government Influence 01:07:41 The Future of Metabolic Disease Treatments 01:10:27 Interloper Behavior in Pharma Acquisitions 01:15:35 The Role of Government Relationships in Pharma 01:19:05 Concluding Thoughts on M&A Trends 01:22:14 OUTRO DOWNLOADS: * M&A and CVR analysis available here [https://www.bigpharmasharma.com/api/v1/file/8e1f259d-f231-4ffc-978a-7ff7d071e088.pdf] CONTACT US: * Questions? Emal us at: ⁠⁠drugdealinpod@gmail.com [drugdealinpod@gmail.com]⁠⁠ * Follow ⁠Shivu on X [https://x.com/BigPharmaSharma]⁠ * Sign up for Shivu's newsletter: Big Pharma Sharma [www.bigpharmasharma.com/subscribe]⁠ ⁠ * Follow ⁠Kenny⁠ [https://www.linkedin.com/in/kennylalwani?miniProfileUrn=urn%3Ali%3Afs_miniProfile%3AACoAAAYyJFcBgv5P_VjMtPhTGKUTqDvOYVgrFiQ&lipi=urn%3Ali%3Apage%3Ad_flagship3_search_srp_all%3BqmJhXnB%2FQwyZ0SHtDPJtZg%3D%3D] 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.

Ep. 6: Should the FDA Be Independent?

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 [https://x.com/DrugDealinPod⁠⁠⁠] * Follow Shivu on X [ ⁠⁠⁠https://x.com/BigPharmaSharma] * Subscribe to Shivu's newsletter, Big Pharma Sharma [https://www.bigpharmasharma.com/subscribe] ⁠⁠ * Follow Kenny [https://www.linkedin.com/in/kennylalwani]

Ep. 5: How to Talk to Doctors | Feat. Joe McCann, Co-Founder/CEO of Slingshot Insights

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 [drugdealinpod@gmail.com] * Follow us on X: ⁠⁠https://x.com/DrugDealinPod⁠⁠ [⁠https://x.com/DrugDealinPod⁠] * Follow Shivu : ⁠⁠https://linktr.ee/shivusharma⁠ [⁠https://linktr.ee/shivusharma]⁠ * Subscribe to Shivu's newsletter: ⁠https://www.bigpharmasharma.com/⁠ [https://www.bigpharmasharma.com/] * Follow Kenny: ⁠⁠https://www.linkedin.com/in/kennylalwani/⁠ [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