Sunday, April 16, 2023

12-2 pm

Notre Dame of Maryland – Doyle Hall

Parking is available near the building – Directions can be found from the NDM website

Lecture by Dr. Matthew A. Zajac

Current Position: US Head of Chemistry Development (CMC)

GlaxoSmithKline, Upper Providence, PA

Title of the topic:

“Adventures in the Small Molecule

Pharmaceutical Industry Illustrations

of Chemistry Careers in Big Pharma”

It is rare occurrence throughout history to have a large group of highly trained and educated scientists working on a common goal. We are in the era where this reality exists in multiple industries but is especially apparent within large pharmaceutical companies. Chemistry careers in the pharmaceutical industry run the gamut of disciplines within the drug development paradigm. The majority of big pharma companies have sizable computational, analytical, biochemical, formulation, organic, and inorganic/organometallic cohorts which affect drug development in a phase-appropriate manner. They all play a key role in different aspects of drug development and, more importantly, synergistically amplify the rigor and scientific depth of the program teams that develop the drugs. The development of a pharmaceutical drug usually starts with a new insight into a disease state or new genetically validated information that could translate to clinical efficacy. Biochemists then work to identify a target protein in association with the disease state. With that protein in hand, the biochemistry team begins the search for a molecular starting point which could affect the target protein leading to a positive outcome on the disease. At this stage in the process, millions of compounds are screened quickly and assessed for activity against the protein. From this exercise, organic chemists select lead molecules and then further modify them, in a hand-crafted fashion with the help of computational chemists, to obtain molecules that meet safety, efficacy, and pharmacokinetic standards. The chosen molecule is the active pharmaceutical ingredient (API). Organic and organometallic chemists scale up the potential pharmaceutical and this API material is used in toxicology studies to generate the relevant safety data. The drug product form (tablet, injectable, etc.) is developed by formulation chemists for the specific API and disease state. The nascent drug will be progressed through clinical trials where analytical chemists ensure quality by testing the API/drug product at every stage. Once proven effective in these clinical studies, the data will be assessed by the regulatory agencies for approval. Making it to market is a huge success since it is the patientimpact that keeps the chemist’s jobs fulfilling and worthwhile. An enormous team of highly trained chemists is required across disciplines to bring a drug to market.

Dr. Matthew A. Zajac’s Bio:

Matt Zajac graduated with his BS in Chemistry from Stevenson University in 1998. During his
undergraduate research under the direction of Professor Sara Narayan, he completed the total synthesis of caffeine and was part of an NIH project team generating inhibitors of HIV reverse transcriptase. Matt then joined the labs of Professor Ed Vedejs at The University of Michigan. During his tenure at Michigan, he received the Pharmacia Research Fellowship and completed the macrocyclic core of Diazonamide A. Upon completion of his Ph.D. in 2003, Matt was awarded the Virginia Cochary Research fellowship of the American Cancer Society and began his postdoctoral research in the labs of Andy Myers at Harvard University. His work at Harvard included probing functionalized nitrones as a potential therapeutic moiety. Upon finalizing his studies in 2005, Matt joined GlaxoSmithKline as a chemical development scientist in the process chemistry department. Between 2010-2015, he took multiple secondments across the organization which allowed him to learn a variety of aspects related to drug development outside of his formal training. He then returned to his home department as Director of Chemistry and was later promoted to head of US Process Chemistry. In Matt’s current role, his department has accountability to develop drug substance manufacturing routes that are both economically effective and environmentally
friendly.