Dr. Kumar Gadamasetti

CEO, Certum Bio

San Francisco Bay Area, CA

Presents:

“The Pharma & BioPharma Industry:

Drug Discovery, Development & Launching

and Career Opportunities”

Friday, May 1, at 12:20 PM

Abbott Hall Room 138

Abstract: The pharmaceutical and biopharmaceutical industries have seen rapid advancements in the past five decades, dating back to the beginnings of discovering aspirin, the serendipitous finding of penicillin, to lately the synthetic biology leading to CAR-T cell biology, CRISPR gene editing technology, and ADCs to help alleviate the pain and suffering of humankind. The drug discovery, development, and manufacturing take a village, including academic researchers who make seminal scientific discoveries, entrepreneurs who start the pharmaceutical and biotechnology companies based on these discoveries. Multinational companies rightfully take advantage of the bandwidth of resources combined with the financial capacity to take the NDE/BDC via IND filing, from first in human (FIH) through clinical trials to launch the drug to market under the regulatory and ethical framework and eventually bringing the drug to the patients.

Despite all the advancements, the cost of developing the small molecule and the biologic drugs alike is still prohibitively high, and the timelines are excruciatingly long. The talk centers around the “The Journey of Drug Development Life Cycle” by the author. Topics will cover small molecule cancer drug, PaclitaxelTM and enhancing the longevity via reinventing and repurposing. Also, will be addressed the challenges in developing and marketing ADCs (MylotargTM) to treat various cancers, exploring synthetic biology, DNA mutations, chemistry, and health disorders like Sickle Cell Disease and treatment (CasgevyTM), and touch up on the big picture of AI-DL in discovery and development of monoclonal antibodies (mAbs). Overall, the projects and programs discussed will also address and relate to reinventing oneself and finding ways to explore pathways to career opportunities at various phases of development.

Bio: Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. Currently he is the CEO of Certum Bio in the San Francisco Bay area, active in consulting with pharmaceutical and biotech companies. Over the past 35 years his focus has been in the areas of the R&D of drug substance (API) as well as drug product (formulations), manufacturing and outsourcing the small molecules as well as biologics. He has a joint appointment as the Member of the Board of Advisors with Berkeley Postdoctoral Entrepreneurial Program (BPEP; https://bpep.berkeley.edu/) at UC Berkeley. Kumar is active in fundraising and believes in the cohesiveness between the biopharma/pharma companies and the CROs/CDMOs. The major therapeutic areas he engaged in include Cancer, CV, CNS and infectious & rare diseases. He worked in fortune 500 companies [Bristol-Myers Squibb Co, NJ-USA (Scientific Investigator) and Amgen, CA-USA (Group Head)], as well as mid-size and startups/CROs [Discovery Partners International Inc. (Sr. Director). CA; X-Mine, Brisbane, CA (Chief Operating Officer); Delphian Pharma, San Francisco, CA (President & CEO) and Certum LLC, San Francisco Bay Area, CA (CEO)]. He has been actively involved on both sides of the business in managing CDMOs and CROs. Of the several programs he worked at the Pharmaceutical and Biotech companies, three culminated in making to the market, addressing the needs in alleviating the pain and suffering of patients [PaclitaxelTM – Bristol-Myers Squibb; SensiparTM – Amgen and DuexisTM - Horizon Therapeutics]. As the Founder and Chairman, he spearheaded the ACS ProSpectives international conferences on, ‘Process Chemistry in the Pharmaceutical Industry’, and as the chair, speaker and the moderator at numerous national and international conferences on API Process Chemistry, Drug Discovery & Development and Clinical Studies. He has been a visiting professor at Catholic U., Louvain, Belgium and U. Pittsburgh, Pittsburgh, PA and visiting speaker at Humboldt U. in Berlin, Germany. In addition to several peer reviewed publications and patents he published two volumes on, ‘Process Chemistry in the Pharmaceutical Industry’ and most recently (Springer-Nature publishers, Dec 2024) the third volume entitled, ‘Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry - Using Chemistry and Bioengineering to Enhance the Performance of Biologics’, jointly with the bio-process leaders at Pfizer Inc. Kumar’s current interests broadly include drug discovery & development – 1. Protein conjugates (ADCs and other) in cancer therapeutics 2. New paradigms and repurposing drugs in the drug development of Huntington’s Disease and fibromyalgia 3. AI-ML in drug discovery & clinical studies. 4. API process R&D, drug formulations & manufacturing and 5. Teaching and conducting workshops at academic institutions and Pharma/Biotech Industry. He earned his Ph.D. from the University of Vermont (Advisor: Prof. Martin Kuehne) and was a post-doctoral fellow at the University of Virginia.

CONTACT:

Dr. Kumar Gadamasetti, Ph.D.

San Francisco Bay Area, CA

kumar@certumUS.com

Books by Dr. Kumar Gadamaseh (authored and edited) used for teaching and conducing workshops at the universities and the pharmaceutical and biotech industries in the USA and around the world.