In this episode (EP20) of BioTalk Unzipped, host Gregory Austin and co-host Dr. Chad Briscoe interview Dr. Jim Shen, the Executive Director and Head of Regulated Bioanalysis Operations at BMS. They discuss topics such as the advancements in cancer therapies, the integration of AI and mechanistic modeling in drug development, and the complexities of regulatory submissions. Dr. Shen shares his journey into bioanalysis and his passion for mass spectrometry.

Chapters

01:15 - Introduction, Background, and Passion for The American Cancer Society

03:46 - Advancements in Cancer Therapies, Opdualag

08:03 - From Small Molecule to Large to Hybrid

12:52 - NEW NEWS! - Halda Raises $126M for a New Targeted Cancer Therapy

18:30 - Dr. Shen’s Journey from Computers to Chemistry into Bioanalysis

27:00 - The Integration of AI and Mechanistic Modeling in Drug Development

34:30 - Navigating the Complexities of Regulatory Submissions

Takeaways

• Advancements in cancer therapies, such as immunotherapy and antibody drug conjugates, have revolutionized the treatment landscape and improved patient outcomes.

• The integration of AI and mechanistic modeling in drug development shows promise but is still in its infancy. More research and collaboration between software and hardware engineers are needed to fully realize its potential.

• Navigating the complexities of regulatory submissions requires adherence to international guidelines and validation of analytical methods to ensure accuracy and precision.

• Dr. Shen's journey into bioanalysis highlights the importance of pursuing your interests and finding enjoyment in your work, even if it may not align with your initial plans.

Sound Bites

• "Advancements in cancer therapies have revolutionized the treatment landscape."

• "Antibody drug conjugates are one of the most exciting and interesting types of molecules."

• "The integration of AI and mechanistic modeling in drug development shows promise but is still in its infancy."

New News Story:

• Startup Halda raises $126M to advance new type of targeted cancer therapy

• https://www.biopharmadive.com/news/halda-series-b-riptac-prostate-cancer/723933/

How to reach us:

American Cancer Society

https://www.cancer.org/

Dr. Jim Shen

• https://www.linkedin.com/in/jimxshen/

• Bristol Myers Squibb - https://www.bms.com/

Dr. Chad Briscoe

• https://www.linkedin.com/in/chadbriscoe/

• Celerion - https://www.celerion.com/

Gregory Austin

• https://www.linkedin.com/in/gregoryaustin1/

• ECI - https://eci-rx.com /

Images

ADC Mechanism of Action

https://www.researchgate.net/figure/Antibody-drug-conjugate-ADC-structure-and-mechanistic-schematic-Inset-in-upper-right_fig1_364183953

https://www.researchgate.net/figure/General-structure-of-antibody-drug-conjugate_fig1_355319441

Keywords

Bioanalysis, Cancer, Oncology, Research, Drug Development, Compliance, Regulatory Compliance, AI, ADC, Antibody Drug Conjugates, immunotherapy, Pharmaceutical, Biotechnology, Podcast, Science, Pharmaceutical Science