53rd Organic Process Research and Development

Dr. Cheng Yi Chen is a distinguished leader in chemical process development with over three decades of experience across at some of the most prominent names in the pharmaceutical industry, including Bristol Myers Squibb, Mirati Therapeutics, and Janssen Pharmaceutical Companies of Johnson & Johnson. In his current role as Chief Technology Officer at Asymchem Group, Dr. Chen oversees the development and manufacturing of all small molecule drug substance and drug products. His extensive expertise spans across R&D leadership, CMC strategy, GMP compliance, regulatory interactions, and global supply chain management, making him a pivotal figure in advancing pharmaceutical innovation from new molecular entities (NMEs) to commercialization.

Dr. Chen’s impact is further evidenced by his significant contributions to the commercial launch of multiple oncology drug substances, including the breakthrough drug adagrasib (MRTX849). His leadership in developing cost-effective and sustainable manufacturing processes for small molecules has resulted in successful filing of multiple INDs and NDAs, reinforcing his reputation as a leading authority in chemical process development. With a proven record of building high-performing teams, Dr. Chen has consistently driven innovation in drug development, contributing to the successful market entry of numerous pharmaceutical products.

Beyond his industry leadership, Dr. Chen is a prolific contributor to the scientific community. He has authored more than 120 publications and patents and delivered over 80 invited presentations at prestigious conferences worldwide. His ability to bridge the gap between scientific research and regulatory requirements has been instrumental in accelerating development timelines for life-saving therapies, further solidifying his influence on the advancement of modern medicine.

Dr. Chen holds a PhD from the Ohio State University, where he completed the first total synthesis of dl-Stenine under the guidance of Professor David J. Hart. His career achievements have been recognized with numerous awards, including the CEO Special Recognition Award at Mirati Therapeutics and the prestigious Edward J. Grabowski Award for Excellence in Process Research at Merck.

Sean Kelly is a Senior Scientist working in the Synthetic Molecule Process Chemistry group within Genentech Research and Early Development in South San Francisco for the last 10 years. An organic chemist by training, Sean has always been interested in the adoption of new synthetic technologies into processes and the interface of synthetic chemistry and chemical engineering. This includes past work in biocatalysis, aqueous micellar catalysis, and most recently the integration of Process Analytical Technologies and continuous flow chemistry into early stage development and manufacturing processes at Genentech.

Christina received her Ph.D. in Organic Chemistry from the University of Alberta, Canada with Prof. Jeffrey Stryker in 2000, focusing on mechanistic organometallic chemistry.  She then moved in search of warmer climes for post-doctoral research at Stanford University, California with Prof. Trost.

In 2003 she started her industrial career by joining DuPont’s Central Research & Development (CR&D) in Wilmington, Delaware, where she worked on designing novel thermomorphic catalysts for commercial applications.  Later, she shifted roles to become a process chemist with DuPont’s OLED business, developing cost-effective and robust chemical processes for electronic-grade small molecules and specialty polymers for the emerging solution OLED market.  In 2017 Christina joined DuPont’s new Emerging Technologies group to focus more on early R&D.  She has since been technical lead on such diverse projects as colorless polyimides, thermal interface materials and polyester medical adhesives.

Dr. Harshkumar Patel is a Principal Scientist working in Chemical Process Development (CPD) at the BMS New-Brunswick site in New Jersey. Harsh is originally from Mumbai, India where he pursued a bachelor’s in pharmacy and Master’s in Pharmaceutical chemistry. In 2012, he moved to the United States and attended University of Utah for doctoral studies in the laboratory of Prof. Matthew Sigman. His Ph.D. thesis focused on development of novel chemical transformations, specifically development of redox-relay enantioselective Heck reactions using Palladium catalysts. He is passionate about developing safe, economic, and sustainable processes to supply high quality active pharmaceutical ingredients (APIs) for the medicines being delivered to patients.

Zhihui Peng obtained his PhD degree in synthetic organic chemistry from the University of California at Irvine under the supervision of Prof. Keith Woerpel. Zhihui began his career at Merck Process Research in 2003, and joined Pfizer in Groton, CT in 2008. He is currently an Associate Research Fellow at Chemical & Research Development (CRD) organization of Pfizer, leading the commercial route and commercial process development to support Pfizer’s small molecule portfolio.

Trevor Rainey received his B.Sc. degree in Chemistry from the University of Texas at Austin; he then continued at UT, completing his Ph.D. degree whilst working under the supervision of Prof. Philip D. Magnus in the field of natural product total synthesis. Following graduation, Trevor moved to Princeton University where he worked as a post-doctoral fellow in the laboratory of Prof. Sir David W.C. MacMillan in the area of asymmetric organocatalysis. Trevor relocated to Montana in 2008 where he assumed a position as Assistant Professor at Montana State University before then leaving academia and accepting a position at Gilead Sciences in 2016. Over the past 9 years spent at Gilead, Trevor has had the opportunity to work on and lead numerous development programs.

In 1981, Dr. Sanghvi received his Ph.D. in organic chemistry from National Chemical Laboratory (Pune, India), where he worked on the synthesis of natural products.  From 1982 – 1985, his post-doctoral research on the synthesis of modified nucleosides was carried out at University of London with Professor C.B. Reese. In 1986, he joined the Nucleic Acids Research Institute at ICN Pharmaceuticals, California. At ICN, he was involved in the design, synthesis and screening of novel nucleosides and nucleotides as antiviral and antitumor agents. From 1989 – 2003, he worked at Ionis Pharmaceuticals, California. The focus of his research at Ionis has been on the discovery, development and manufacture of oligonucleotide-based therapeutics, DNA and RNA modifications in combinatorial and diagnostic research.

Dr. Sanghvi has authored/co-authored over 220 scientific publications in leading journals, including several book chapters and has co-inventorship of more than 40 patents. Throughout his professional history, he has attended and made numerous presentations at local and international scientific meetings and have successfully organized several symposiums. He is an editor of two books entitled Carbohydrate Modifications in Antisense Research and Palladium-Catalyzed Modification of Nucleosides, Nucleotides and Oligonucleotides. He is also a member of editorial board for Current Protocols in Nucleic Acid Chemistry, a Wiley publication.

In May 2003, he founded Rasayan Inc., a company focused on the consulting, outsourcing services and supply of products related to nucleic acid field.  Rasayan is engaged in the strategic planning, securing raw materials for manufacture of oligonucleotide-based drugs on large-scale, experimental design, optimization of synthesis and purification protocols on lab scale to kilo scale, including process chemistry. Dr. Sanghvi is also a founding member of Sapala Organics, a CRO/CMO located in Hyderabad, India. Currently, he serves as President of Sapala business in North America looking after sales and marketing for the company. His specific interests include design, synthesis, chemistry and biochemistry of novel carbohydrates, nucleosides, nucleotides, and oligonucleotides for their application in therapeutics, combinatorial chemistry, and medical diagnostic research.

Jonathan Reeves received a B.S. in chemistry from Hope College in Holland, MI in 1997. He then obtained his Ph.D. in 2002 from the University of Pittsburgh under the guidance of Professor Peter Wipf. After two years as an NIH postdoctoral fellow at Indiana University with Professor David R. Williams he joined the Chemical Development department at Boehringer Ingelheim Pharmaceuticals in Ridgefield, CT in 2004, where he is currently a Distinguished Research Fellow.

Dr. Rutherford earned her PhD in physical organic chemistry with Prof David Collum at Cornell University.    and was an NIH postdoctoral fellow with Prof Stephen Buchwald at the Massachusetts Institute of Technology.      She joined Pfizer in the Chemical Technologies group in Process R&D in Groton, CT, where her work focused on catalysis, automation, flow technologies, and developing and implementing new technologies for the process chemistry environment.      She moved on to a tenure-track position teaching organic chemistry at Lafayette College in Easton, PA, and then to a role as a Product Development Chemist at Restek, a chromatography consumables manufacturer in Bellefonte, PA.   In April 2023, she is joined Takasago International Corporation as a Technical Marketing Chemist.

Steven Weissman is Cognition Therapeutics’ vice president and head of CMC. In this role, he is responsible for the process development and manufacturing oversight for lead candidate, CT1812. Before joining Cognition, Dr. Weissman was the director of chemical development at Lexicon Pharmaceuticals, where he was responsible for clinical supply and eventual global commercial manufacturing of telotristat etiprate. Previously, during his 18-year tenure at Merck in manufacturing and process chemistry roles, he contributed to developing scalable routes to over 30 clinical candidates and to the commercial manufacturing synthesis of approved HIV therapies, Isentress and Crixivan.

Dr. Weissman has co-authored 32 peer-reviewed research articles and is an inventor on 13 U.S. patents. In addition, he was a member of the editorial advisory board for the ACS journal, Organic Process Research & Development. He earned a B.A. in chemistry from the University of Vermont, a Ph.D. in chemistry from Tufts University and conducted his post-doctoral training with Nobel laureate, Herbert C. Brown, at Purdue University.