#409 ‒ Inside modern drug development: the science, economics, and regulatory hurdles behind bringing new medicines to patients | Lloyd Klickstein, M.D., Ph.D.

In short

This podcast episode features Dr. Lloyd Klickstein, a seasoned drug developer, discussing the intricate process of discovering and developing new medicines. He contrasts incremental drug improvements with tackling unmet medical needs, using sarcopenia and the drug Bimagrumab as a case study. The conversation covers the science and economics behind drug development, different drug modalities (small molecules, biologics, gene therapy), the challenges of clinical trials and regulatory approval, and the strategic use of intellectual property. Dr. Klickstein emphasizes the importance of addressing complex diseases and the significant value this brings to society, despite the inherent risks and costs involved.

Key takeaways

• Drug discovery is a complex, lengthy, and costly process involving multiple stages from identifying unmet needs to regulatory approval and commercialization.
• The pharmaceutical industry often favors incremental drug improvements over tackling high-risk, complex diseases due to existing infrastructure and financial incentives.
• Translational medicine aims to bridge the gap between scientific discovery and clinical application, but faces significant hurdles in navigating regulatory pathways and market adoption.
• The development of new therapies, particularly for conditions like sarcopenia, offers immense value to society by addressing significant unmet medical needs.
• Understanding the science, economics, and strategic considerations behind drug development is crucial for appreciating the challenges and triumphs in bringing new medicines to patients.

Chapters

1. 00:00

   Introduction and Mission

   Host Peter Attia introduces the podcast's mission: to translate longevity science into accessible information, focusing on providing the best health and wellness content without relying on paid ads, supported by members.

2. 01:10

   Guest Introduction: Dr. Lloyd Klickstein

   Dr. Lloyd Klickstein is introduced as a physician, scientist, rheumatologist, and drug developer with over two decades of experience in discovering and developing new medicines.

3. 02:15

   Dr. Klickstein's Background: Physician-Scientist Path

   Dr. Klickstein explains his transition from an initial plan for medical school to pursuing an MD-PhD after discovering a passion and aptitude for scientific research during his undergraduate years at Brigham and Women's Hospital.

4. 04:10

   Transition to Industry and Translational Medicine

   After a career in academic medicine, Dr. Klickstein moved into the pharmaceutical industry, joining Novartis Institutes, where he helped pioneer translational medicine and led the new indication discovery unit.

5. 07:00

   The Black Box of Drug Discovery

   Peter highlights the 'black box' nature of drug discovery for the public and introduces the discussion on how new medicines are created, why the process is long and costly, and how scientists prioritize research areas.

6. 10:00

   Incremental vs. Quantum Steps in Drug Development

   Dr. Klickstein differentiates between incremental drug improvements (e.g., oral instead of injectable) and quantum leaps, noting the industry's bias towards lower-risk, incremental advancements due to infrastructure and funding.

7. 15:30

   The Challenge of Unmet Medical Needs

   Developing drugs for complex, less-defined conditions (like sarcopenia) is harder, requiring more extensive regulatory pathways and stakeholder education compared to improving existing treatments.

8. 20:00

   Case Study: Sarcopenia and Bimagrumab

   The discussion delves into sarcopenia, a condition of muscle loss and weakness, and the development of Bimagrumab as a potential therapy, highlighting the high mortality rate associated with frailty and nursing home placement.

9. 30:00

   Drug Modalities: Small Molecules vs. Biologics

   Dr. Klickstein explains the distinctions between small molecule drugs, biologics, gene therapies, and other platforms, noting the different development and regulatory considerations for each.

10. 35:00

    Intellectual Property and Patent Strategy

    The conversation touches on patent law, trade secrets, and how companies strategically protect their innovations, often through multiple patents covering different aspects of a drug's development and use.

11. 45:00

    The Process of Clinical Trials and Regulatory Approval

    The complexities of navigating clinical trials, FDA approval processes, and commercialization are discussed, emphasizing the long and arduous journey from discovery to patient access.

12. 50:00

    Future of Obesity and Muscle Preservation Therapies

    The discussion looks ahead to the next generation of therapies for metabolic disease, focusing on obesity and muscle preservation, and their potential to reshape treatment paradigms.

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