Our CMC Consultants
At Drug Discovery Alliances, our team of expert consultants brings decades of experience across the pharmaceutical, biotechnology, and clinical research industries. While we maintain the anonymity of our consultants to protect confidentiality, their collective expertise ensures that our clients receive best-in-class guidance and strategic support at every stage of the drug development process.
Consultant #1
Consultant 1 is the Founder and President of their own Consulting LLC, specializing in advancing drug discovery projects through strategic consulting. With over 30 years of experience in medicinal chemistry and pharmaceutical R&D, they have held leadership roles at Tetra Therapeutics, Pfizer, Icagen, and GSK. Thier expertise spans drug discovery strategy, lead optimization, formulation development, CRO management, and intellectual property evaluation. They have contributed to the development of key therapeutics, including relutrigine (PRAX-562) and Prax-20. Their extensive industry experience enables them to guide clients in optimizing their R&D efforts from discovery to commercialization.
Consultant #2
Consultant 2 is a seasoned pharmaceutical development leader with over 30 years of experience in CMC (Chemistry, Manufacturing, and Controls), formulation development, and clinical manufacturing. Currently leading CMC teams at Bristol Myers Squibb, they have held senior leadership roles at Celgene, Actinium Pharmaceuticals, NPS Pharmaceuticals, and Schering-Plough. With expertise spanning drug product development, process optimization, technology transfers, and regulatory strategy, they have been instrumental in bringing innovative therapies to market. Additionally, as a former adjunct professor at Stevens Institute of Technology, they have contributed to the advancement of pharmaceutical manufacturing education.
Consultant #3
Consultant 3 is a pharmaceutical development expert with over 25 years of experience in analytical development, formulation, and quality systems. They have played a key role in supporting the development of novel therapeutics, contributing to multiple approved NDAs and MAAs. Their expertise spans method development, validation, stability programs, and reference standard management across various dosage forms, including parenteral, inhalable, and oral solid and liquid products.
Having worked with companies such as Marinus Pharmaceuticals, Asklepion Pharmaceuticals, ViroPharma (now Takeda), Cephalon (now Teva), and Magellan Laboratories (now Catalent), they have extensive experience in small-molecule drug development. They are a strong advocate for the principles of ICH Q14, ensuring analytical methods are designed for selectivity, stability, and regulatory compliance. A frequent speaker at industry conferences, they bring deep knowledge in stability programs, reference standards, and analytical method development to support global clinical and commercial drug programs.
Consulatant #4
Consultant 4 has a background in Organic Chemistry with a focus on Medicinal Chemistry and a minor in Food Science. With extensive experience in the pharmaceutical, biotechnology, and tobacco industries, they hold 74 U.S. patents and have spent over 27 years in drug discovery and pharmaceutical development. Their expertise includes API scale-up, process development, GMP manufacturing, regulatory documentation (INDs, NDAs), and managing contract outsourcing for APIs and formulations.
They have over 16 years of experience supervising and mentoring scientists in medicinal chemistry, analytical chemistry, and chemical process development.
Additionally, they have served for more than 19 years on an Institutional Review Board (IRB) at Atrium Health Wake Forest Baptist Medical Center.
As a consultant to the pharmaceutical industry, they provide strategic guidance on API synthesis, CMC issues, scale-up manufacturing, and regulatory submissions. Their work in the tobacco industry spans over 13 years, with contributions to new tobacco materials, synthetic nicotine, and electronic nicotine delivery systems (ENDS), earning 10 tobacco-related patents. They have also played a key role in tobacco-related clinical studies, PMTA regulatory submissions, and FDA documentation. With eight publications and 25 conference presentations, they bring a wealth of knowledge to drug and product development.
Consultant #5
Consultant 5 is a highly experienced organic chemist with over 40 years in the field. After earning a BS in Chemistry from the State University of New York at Buffalo, they completed a PhD in Organic Synthesis at the University of Pennsylvania, followed by an NIH Postdoctoral Fellowship at the University of California, Irvine.
They began their career as a Process Chemist at Merck, where they worked in Process Research for nearly a decade. In 1996, they founded a world-leading process research company, serving as President and CEO until 2023. Now working as an independent consultant, they specialize in solving complex organic chemistry challenges and providing strategic guidance for IND-enabling work, helping move development candidates from discovery to Phase I clinical trials.
Consultant #6
Consultant 6 is a seasoned leader in chemistry and innovation, with a career spanning over two decades. Combining scientific expertise with strategic business acumen, they have a proven track record of leading and managing large, diverse teams. Most recently, they served as Senior Vice President of Small Molecule Discovery at Osmo, where they advanced olfactory science by leveraging AI and machine learning to develop new fragrance ingredients aimed at enhancing human sensory experiences, health, and well-being. Their work at Osmo included synthetic chemistry, perfumery, and laboratory operations, leading to the successful development of multiple new ingredients for fine fragrances and cosmetics.
Prior to Osmo, they held leadership roles at Firmenich (formerly Senomyx), including Vice President of Chemistry and Natural Products. Their contributions led to the discovery of new natural flavor ingredients such as sweeteners, sweet enhancers, bitter blockers, and cooling agents, many of which are now commercially available in foods, beverages, and pharmaceutical applications. They also played a key role in strategic collaborations, including a long-term partnership with PepsiCo supporting natural products research.
Their career also includes leadership roles at TransTech Pharma, Biocept Incorporated, and Ontogen Corporation, where they advanced drug discovery platforms and helped develop novel APIs that have successfully completed Phase II clinical trials. With numerous patents and scientific publications, their expertise spans organic synthesis, taste modulation, and GPCR-targeted research.
They hold a Ph.D. in Chemistry from the University of California, San Diego, where their research focused on the total synthesis of complex natural products. With a strong leadership background and deep technical knowledge, they are recognized for their impact at the intersection of chemistry, synthetic biology, innovation, and human sensory experience.