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21st Biopharma Recap, Nirmatrelvir Development Story

October 1, 2023


1. Recap of The 21st San Diego Biopharma Conference



The 21st San Diego BioPharma Conference, the flagship event of the SoCal Association for Biomedical and Pharmaceutical Advancements (SABPA) since its inception in 2002, recently took place in San Diego, a beautiful coastal city in California and a biotech hub where top-tier biotechs and biopharmas call home. The BioPharma conference, focusing on identifying growing opportunities for start-ups and biopharma, exemplified impressive resilience demonstrated by the SoCal biomedical and pharmaceutical community under the current economic environment. “During the economic downturn, the entire industry, including biotech or biopharma, is facing a strong headwind for sustaining and growing business. We are providing a forum for an in-depth discussion for companies seeking development opportunities and strategies,” said Hua Gong, Ph.D., President of SABPA. “We are taking this opportunity to recognize the outstanding scientists and community members who have made tremendous contributions to the SoCal life science industry, especially those who are working tirelessly during the COVID pandemic.” 



SABPA is a San Diego-based grassroots organization founded by biotechnology and pharmaceutical professionals and scholars in 2002, with over 3500 members across the globe. Ming Guo, Ph.D., and Chair of the SABPA Entrepreneur Committee announced that SABPA recently changed its official name to SoCal Association for Biomedical and Pharmaceutical Advancements to better serve the SoCal biotechnology and pharmaceutical community. The BioPharma conference, similar to other SABPA events, is also organized by SABPA volunteers. The SABPA EVP of the San Diego Chapter, Yi Liu, PhD, CEO of Kumquat Biosciences gave the opening remark during the conference. Yinghong Gao, Venture Partner and VP of BD of Viva Biotech, and Shuangwei Li, Ph.D., the director of Calibr chaired the morning and afternoon sessions. 



During this event, high-caliber industry leaders shared their personal journeys and insights with the SoCal life science community. Laura Shawver, Ph.D., CEO of Capstan Therapeutics, who has served as a CEO and board member for multiple start-up companies in the past 30 years, offered her unique insights and lessons valuable to scientists at all stages of their careers. Allison Luo, MD, Chief Medical Officer of Prometheus Biosciences, during her presentation “Having Everything Ready When the East Wind Comes,” shared her journey from the clinical development of Humira at Abbott, to her experience of serving as CMO for multiple companies tackling gastrointestinal diseases, to the recent successful acquisition of Prometheus Biosciences, the largest acquisition in history at the phase 2 stage as measured by purchase price. 


Other industry leaders also provided their solutions to address biotech’s needs for growth in today’s environment. Luisa Salter-Cid, Ph.D., CSO of Pioneering Medicines introduced Pioneering Medicine’s strategy to conceive new medicines by leveraging Flagship Pioneering’s vast portfolio of technology platforms and proprietary innovation processes. Chun-Lin Chen, Ph.D., the founder and CEO of Medicilon provided examples of how Medicilon, a leading Chinese CRO, has empowered global clients to clear IND submissions and enabled drug development.



San Diego is also blessed with its world-renowned research institutions and scholars. Professor Jeffery Kelly of the Scripps Research Institute elucidated how to ameliorate neurodegenerative disease from a fundamental scientific point of view. Professor Tony Hunter reviewed several decades of development of protein kinases, an important class of enzymes responsible for cancer development and regulation.



Cultivating the next-generation entrepreneurs is at the core of building the SoCal biotechnology ecosystem. Richard Glynne, Ph.D., CSO of Inception Therapeutics outlined their bold visions to incubate the early-stage biotech companies addressing the pressing unmet medical needs. Richard showcased multiple Inception portfolio companies ranging from chemoproteomics, to targeted protein degradation, to developing the First-in-Class small molecule treating neurodegenerative diseases. An in-depth panel discussion focused on biotech building and scaling under the current macro environment, and Jim Krenn, JD, Partner of Morrison & Foerster chaired the session. The panel discussion provided many practical solutions and valuable guidance to the challenges biotech founders may be facing during the early stages of founding a biotech. The panelists include Niall A. O’Donnell, Ph.D., Managing Director of RiverVest, Hunter Reed, MBA, Principal of Alexandria Venture Investments, Tari Suprapto, Ph.D., Director for Search and Evaluation of Novo Nordisk, Jonathan Wang, Ph.D., Chairman and CEO of Inmagine Biopharmaceuticals. The conference was concluded with a networking reception exclusively sponsored by Viva Biotech, and the venue was kindly sponsored by Morrison and Foerster.


For more on-site photos, please click here.




2. Nirmatrelvir Development Story: From Milligrams to Metric Tons in 18 months


When: Tuesday, October 24, 2023 6:00 PM

Where: Online

Please click here for Free registration!


About the Speaker:

Nga obtained her B.S. in Chemistry from Purdue University and her M.S. in Organic Chemistry from the University of California, Irvine. She joined Pfizer Process Chemistry in Dec. 1998. Over her career as a process chemist in Groton, she has worked across the spectrum of process chemistry from early clinical development (discovery interface) to commercial route development. She has worked developing processes on many Pfizer commercial compounds including Ibrance, Steglatro, Daurismo, Cibinqo, and most recently Pfizer’s COVID-19 vaccine and oral therapy. Nga has been awarded the ACS Technical Achievements in Organic Chemistry Award as well as the Heroes of Chemistry Awards as part of the Palbociclib and Nirmatrelvir teams and Team Innovation Awards as part of the Palbociclib and lipids teams.


About the lecture:

Nirmatrelvir (PF-07321332, 1) is a selective, orally bioavailable inhibitor of SARS-CoV-2 2 M. Development of an efficient synthesis of this molecule was critical for the rapid advancement of the compound from first synthesis to successful emergency use authorization in just 17 months. This paper provides an overview of the development of the commercial synthesis, with a focus on the supply chains for the three starting materials, which leveraged key synthetic studies from earlier protease research programs and/or commercial products.






3. Process chemistry in the development of KRAS drugs


When: Tuesday, November 7, 2023 6:00 PM

Where: Novartis Institutes for BioMedical Research (10675 John Jay Hopkins Drive San Diego, CA 92121)


Please click here for Free registration!


About the Talk

This talk will cover the latest developments in the field of KRAS G12C inhibitors. The first Xiaohu Deng, Ph.D., will present on “Scaleup Efforts on the Production of the First-generation, Atropisomeric Covalent KRAS G12C Inhibitors ARS-1620 and ARS-2102”. The second speaker, Chengyi Chen, Ph.D., will talk about “Adagrasib (MRTX849) Commercial Route”. Finally, speaker, Haiming Zhang, Ph.D., will discuss the “Development of an Atroposelective Process of KRAS G12C Inhibitor GDC-6036”.


About the Speakers

Dr. Xiaohu Deng -Former Head of CMC at Wellspring Biosciences more info.

Dr. Cheng Yi Chen - VP of Chemistry Process R&D at Mirati more info.

Dr. Haiming Zhang - Distinguished Scientist and Director at Genentech more info.



4:00-5:00 pm Networking and light dinner

5:00-5:10 pm General introduction and quick overview of ACS SD & SABPA

5:10-5:15 pm Welcome speech by NIBR San Diego (Venue provider)

5:15-5:30 pm Overview of Medicilon

5:30-6:00 pm Xiaohu Deng, Ph.D., “Scaleup Efforts on the Production of the First-generation, Atropisomeric Covalent KRAS G12C Inhibitors ARS-1620 and ARS-2102”

6:00-6:30 pm Cheng Yi Chen, Ph.D., “Adagrasib (MRTX849) Commercial Route”

6:30-7:00 pm Haiming Zhang, Ph.D., “Development of an Atroposelective Process of KRAS G12C Inhibitor GDC-6036”

7:00-7:55 pm Q&A

7:55-8:00 pm Closing remarks


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