Drug Dealin

SUMMARYIn this episode, Shivu and Kenny discuss how you as a caregiver or patient can use public resources like 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.CHAPTERS00:00 Introduction to Clinical Trials03:04 The Importance of Patient Involvement06:13 Navigating Clinical Trials: A Practical Guide09:06 Using AI to Enhance Patient Care11:53 Drafting Effective Communication with Doctors14:27 Empowering Patients Through Knowledge17:46 Finding the Right Treatment Options20:30 The Role of Research in Patient Advocacy23:03 Conclusion and Future Directions34:38 OutroQuestions? Email us at: ⁠⁠mailto:[email protected]⁠⁠Follow ⁠Shivu on X⁠(@bigpharmasharma): https://x.com/BigPharmaSharmaSign up for Shivu's newsletter: https://www.bigpharmasharma.com/⁠ ⁠Follow ⁠Kenny⁠ on Linkedin: 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.

SummaryIn 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. Chapters00:00 Introduction and Overview of Predictions04:37 Grading 2025 Predictions10:35 Shivu's 2025 Predictions and Grades16:53 2026 Predictions: Emerging Trends22:50 Regulatory Landscape and the FDA's Role30:46 Predictability in Drug Approval Processes30:51 The Metabolic Space and GLP-1s33:08 Big Pharma's Entry into Obesity and Diabetes34:56 The Risk of Commoditization in Drug Markets37:06 Differentiation in the GLP-1 Market39:40 The Rise of Psychedelics in Psychiatry47:21 Pharm-to-Table Model in Pharma54:06 Empowering Patients through Direct AccessQuestions? Email us at: ⁠⁠[email protected]⁠⁠Follow ⁠Shivu on X⁠: @bigpharmasharmaSign up for Shivu's newsletter: Big Pharma Sharma⁠ ⁠Follow ⁠Kenny⁠ on LinkedinThe 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."

SUMMARYIn 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.CHAPTERS00:00 Introduction to M&A in Biopharma03:35 Understanding Contingent Value Rights (CVRs)06:47 Recent M&A Deals and Trends13:17 Impact of Patent Cliffs on M&A Activity17:43 The Portfolio Approach to Drug Development22:00 Current Trends in Deal Volume and CVR Usage28:58 Valuation Trends in Late-Stage Companies32:51 The Buyer-Seller Dynamic in Pharma Deals38:27 Evaluating CVRs and Acquirer Capabilities42:31 GenMab’s Strategic Acquisition and Market Positioning48:11 The Rise of the Biotech Middle Class55:49 The Aggressive Landscape of Pharma Hiring56:56 Innovation in RNA Interventions57:53 The Metsera Bidding War Begins01:00:11 Pfizer’s Acquisition Strategy Unfolds01:03:48 Regulatory Implications and Government Influence01:07:41 The Future of Metabolic Disease Treatments01:10:27 Interloper Behavior in Pharma Acquisitions01:15:35 The Role of Government Relationships in Pharma01:19:05 Concluding Thoughts on M&A Trends01:22:14 OUTRODOWNLOADS:M&A and CVR analysis available hereCONTACT US: Questions? Emal us at: ⁠⁠[email protected]⁠⁠ Follow ⁠Shivu on X⁠Sign up for Shivu's newsletter: Big Pharma Sharma⁠ ⁠Follow ⁠Kenny⁠DISCLAIMER: 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.

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 Scope02:53 Timeline of Instability at the FDA14:00 Impact of Instability on Drug Development19:54 Case Study: RepliMune's Regulatory Journey34:00 Navigating FDA Interactions and Accelerated Approvals58:03 The Role of a Healthy FDA: History and Function01:12:40 Organizational Culture and Stability in Regulatory Agencies01:15:24 Navigating Institutional Changes at the FDA01:18:45 The Importance of Consistency in Health Guidelines01:22:27 Transparency and Data Disclosure in Drug Approvals01:25:18 The Case for an Independent FDA01:29:53 Lessons from the Federal Reserve's Independence01:35:11 Engendering Trust in Health Institutions01:41:49 Final ThoughtsCONTACT US:Questions?: ⁠⁠[email protected]⁠⁠Follow us on X Follow Shivu on XSubscribe to Shivu's newsletter, Big Pharma Sharma ⁠⁠Follow Kenny

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 checkoutLearn more about slingshot at: www.slingshotinsights.comContact Joe McCann:Email: [email protected]: @JMac_SIContact us:Questions?: ⁠[email protected]⁠Follow us on X: ⁠⁠https://x.com/DrugDealinPod⁠⁠Follow Shivu : ⁠⁠https://linktr.ee/shivusharma⁠⁠Subscribe to Shivu's newsletter: ⁠https://www.bigpharmasharma.com/⁠Follow Kenny: ⁠⁠https://www.linkedin.com/in/kennylalwani/⁠Chapters00:00 Recap of Insights from Joe's Conversation03:05 Introduction to Expert Calls and Their Importance11:10 Joe McCann's Background and Journey18:52 Understanding the Value of Expert Calls26:46 Differentiating Between Academic and Community Physicians32:33 Risk Profiles and Decision-Making in Medicine32:49 Managing Patient Care and Treatment Options34:45 Navigating Expert Calls and Communication Strategies37:22 Understanding Bias in Medical Opinions41:34 Identifying Red Flags in Expert Interactions45:30 Differentiating Client Needs: Investors vs. Industry47:41 The Importance of Follow-Up Calls50:42 Patient Engagement and Empowerment57:09 Utilizing Guidelines and Resources for Better Care01:00:44 The Importance of Proactive Healthcare01:05:15 Navigating Clinical Trials and Patient Advocacy01:08:48 Understanding Quality of Life in Treatment Decisions01:09:55 Surgery Insights: Complications and Surgeon Selection01:19:01 Entrepreneurship in Healthcare: Joe's Journey01:25:20 Recap of Insights from Joe's Conversation01:27:58 Building Confidence in Patient-Doctor Interactions01:30:41 The Importance of Communication and Understanding01:33:35 Navigating the Healthcare System Effectively01:35:59 The Role of KOLs vs Community Physicians01:38:37 The Impact of AI in Healthcare01:41:18 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:Shivu's recent substack post discussing GLP-1s for CNS disease: https://www.bigpharmasharma.com/p/what-2025-holds-for-glp-1s-in-brainGLP-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?: [email protected] us on X: ⁠https://x.com/DrugDealinPod⁠Follow Shivu : ⁠https://linktr.ee/shivusharma⁠Subscribe 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.Chapters00:00 Introduction to GLP-1s02:52 The Evolution of Oral GLP-1s06:26 Challenges in Patient Adherence10:34 Exploring CNS Impacts of GLP-1s14:44 Mechanisms of Action in CNS Diseases19:13 Potential in Addiction Treatment24:23 Future Directions and Research Opportunities30:20 Exploring the Mechanisms of New Medications35:16 Long-term Use and Dosing Challenges39:57 Promising Data in Addiction Treatment43:56 The Future of CNS and Metabolic Dysfunction Treatments50:44 The Path Forward in Drug Development54:50 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?: [email protected] Follow us on X: https://x.com/DrugDealinPodConnect with Shivu: https://linktr.ee/shivusharmaCheck 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 Biotech05:46 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.Have feedback for us? Feel free to leave a comment or send us an email at [email protected]: 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.

Kenny and Shivu each cook up three predictions for Biopharma in 2025NOTE: This episode was recorded on January 10th, 2025Have feedback for us? Leave a comment or email us at [email protected]: 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.