Navigating High-Potency API Risk in Small Molecule Development

Before a high-potency API's toxicology profile is even complete, someone has to decide how it gets handled, and that decision can carry real costs if it's wrong. In this video, experts in the field unpack the gap between early containment assumptions and the data that eventually catch up to them, as well as what sponsors and CDMOs can do to navigate it.

Register Free: https://www.pharmtech.com/pt_w/high-potency

Event Overview:

This conversation will explore a quietly consequential tension in small molecule drug development: containment and safety decisions for high-potency APIs often must be made before the toxicology data exist to justify them. Using interim Occupational Exposure Band classifications as a stand-in for a fully derived Occupational Exposure Limit, sponsors and CDMOs default to conservative handling assumptions that can later prove too cautious, too lenient, or simply costly to unwind once real data arrive. Drawing on perspectives from experts in this area, the conversation explores how that gap actually plays out in practice, what it costs when assumptions get revised mid-program, and what the industry could do to close the gap without compromising worker safety. The discussion aims to give formulation and CMC professionals a practical, candid look at a risk that affects roughly one-quarter of new pharmaceutical entities entering development today.

Key Learning Objectives:

• Understand the core mechanism creating the timing mismatch between when containment and handling decisions for a high-potency API have to be made and when the actual toxicology data needed to justify those decisions are available.
• Recognize the operational and financial consequences when assumptions get revised.
• Learn how cross-functional teams actually resolve the gap in real time.
• Gain a framework for evaluating CDMO partners on this specific risk.
• Identify where the gap is most acute and where the industry is innovating to close it.
• Anticipate how this area is likely to evolve over the next 3–5 years.

Who Should Attend:
This Drug Digest episode is best suited for professionals directly involved in small molecule formulation and development, especially:

• Formulation scientists and process development chemists who own or influence decisions about how a compound gets handled before its full toxicology profile exists.
• Industrial hygienists, occupational toxicologists, and EHS professionals who derive OEBs and OELs
• CDMO business development and operations leaders evaluating or selling HPAPI containment capability
• Quality and regulatory affairs professionals working in potent-compound programs
• Drug development executives and portfolio decision-makers who need to understand why HPAPI programs sometimes hit unexpected cost or schedule friction

Speakers:

Brian Haney PH.D
Senior Director of Global Technical Operations
Curia

Brian Haney, Ph.D., is Senior Director of Global Technical Operations at Curia, where he supports complex API development and manufacturing programs. A Ph.D. organic chemist with more than 15 years of experience in process research, API manufacturing, HPAPI manufacturing and DEA compliance, Brian brings deep technical expertise in the safe, scalable production of highly potent compounds. His work spans containment strategy, operator safety, cleaning and quality controls, and manufacturing approaches that help reduce risk from development through commercialization. Dr. Haney earned a B.S. in Chemistry from Allegheny College before completing his Ph.D. in Chemistry at the University of Pittsburgh.

Taylor Henderson
Environmental Health and Safety (EHS) Manager
Alcami

Taylor Henderson is an Environmental Health and Safety (EHS) Manager at Alcami, where she oversees the safety program for the company’s RTP campus. Her responsibilities include safe work permits, job hazard analyses, safety audits, employee training, and incident investigations.

Since joining Alcami as an intern five years ago, Taylor has advanced into her current leadership role and gained experience across three Alcami sites: Wilmington, St. Louis, and RTP. Her expertise spans laboratory safety and sterile fill-finish manufacturing. She also collaborates closely with consulting toxicologists on Occupational Exposure Banding to clearly communicate potential hazards and ensure appropriate controls are in place for each active pharmaceutical ingredient (API).

Taylor holds an Associate Safety Professional (ASP) certification, a Bachelor of Science in Marine Biology, and a Master of Science in Environmental Science from the University of North Carolina Wilmington

Mike McCoy
Toxicology and Industrial Hygiene
Sterling Pharma Solutions
Germantown, Wisconsin

Mike McCoy is the director of toxicology and industrial hygiene at Sterling Pharma Solutions, Germantown, Wisconsin. He is a Diplomate of the American Board of Toxicology with 18 years of professional experience in toxicology and industrial hygiene. His Bachelor of Science degree is in Medical Laboratory Technology (Clinical Laboratory Science) with a minor in chemistry from Marquette University in Milwaukee, Wisconsin. His Master of Science degree in Pharmacology and Toxicology is from the Medical College of Wisconsin in Milwaukee, Wisconsin. He is also a certified industrial hygienist. McCoy has numerous years of experience in occupational toxicology and industrial hygiene in the pharmaceutical industry and over 15 years of consulting experience across numerous industries, including pharmaceuticals and medical devices. He was also an adjunct lecturer at the Zilber College of Public Health at the University of Wisconsin-Milwaukee, where he taught graduate courses in environmental risk assessment and undergraduate courses in global environmental health. He has published numerous peer-reviewed manuscripts in toxicology and industrial hygiene and presented at global conferences.

Register Free: https://www.pharmtech.com/pt_w/high-potency