Faculty – Stability Testing Summit

Joshua T. Ayers, Ph.D.
Stability Manager, ASTRAZENECA

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Dr. Ayers has been working in the pharmaceutical industry for more than 16 years. After finishing his Ph.D. at the University of Kentucky, he began his career working in analytical development developing methods and evaluating stability of Ph I and Ph II compounds. One move to Colorado later, Dr. Ayers focused more on generic drug substance stability programs. Currently, he is managing a stability program and quality control laboratory for AstraZeneca’s recently approved Lokelma product.

Tyson Chasse
Senior Director Analytical Sciences, CMC, AGIOS PHARMACEUTICALS

Anthony Chikere, Ph.D.

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Dr. Anthony Chikere is an experienced Scientist with over 17 years of experience in different areas of Biopharmaceutical production including: process development, process monitoring and control, process validation and quality assurance at leading pharmaceutical companies including Johnson & Johnson, BioMarin, Grifols and Bayer. Since 2017, he is responsible for managing the Continued Process Verification (CPV) program at Bayer Pharmaceuticals Berkeley, CA.

Heather Egland
Stability Coordination Manager, FRESENIUS KABI USA

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Heather Egland has a background in analytical chemistry, with almost 20 years’ experience in both medical device and pharmaceuticals. Beginning in raw material and finished product release testing, she moved to stability testing and HPLC method development for products in development. For the last 14 years, she has specialized in ICH stability requirements for NDA/ANDA submissions and regulatory commitments, with a focus on strategic thinking and continuous improvement.

Timothy Forsyth, Ph.D.

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Dr. Timothy Forsyth is an accomplished Chemist, with over 20 years of experience in different areas of drug discovery, drug development and statistical process control in academia and at leading pharmaceutical companies including Northwestern University, Dupont, Exelexis, Abaxis and Bayer. Since 2014, he is a Senior Scientist with the Manufacturing Sciences (MSAT) department at Bayer Pharmaceuticals, Berkeley CA in different roles, supporting manufacturing processes and multivariate process monitoring. He has authored ca. 25 peer reviewed Journals and 8 granted patents.

Chris Latoz
Manager Stability and Analytical Services, HOLLISTER INCORPORATED

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Christopher (Chris) V. Latoz is Manager, Stability and Analytical Services at Hollister Incorporated in Libertyville, IL. Chris has over 26 years’ experience in the medical device industry (Class I and II devices) working in R&D, Technical Services, and more recently, Stability. While at Hollister, Chris has led several process and capacity improvement projects, including the implementation of a LIMS (Laboratory Information Management System) for stability sample and data management; the construction of new walk-in stability storage chambers; and the implementation of a temperature and humidity monitoring system for stability chambers.

Peju Odunusi, Ph.D.
Group Leader, Stability, ABBOTT VASCULAR

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Dr. Peju Odunusi is an analytical R&D professional with over 25 years of experience in the pharmaceutical and medical device industries. She has extensive analytical expertise in all aspects of product development from inception to launch and has participated in numerous audits.

She has successfully established analytical and stability groups during her career and is very passionate about mentoring.

Amy St. Charles
Senior Principal Scientist/Group Leader of Biotherapeutics Stability, Reference Materials and Raw Materials, PFIZER

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Amy St. Charles is a Senior Principal Scientist at Pfizer, and a manager of the stability, reference materials and raw materials groups within the Biotherapeutics Analytical R&D organization. She received a BS in LBS Biochemistry from Michigan State University in 2000 and a MS in Quality Assurance and Regulatory Affairs from Temple University in 2006. Amy joined Pfizer in 2000 and has worked in both the commercial and the R&D space across a broad range of modalities including mAbs, ADCs, vaccines, and more recently, cell and gene therapy products.

Emily S. D. Trubee, M.S.

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Emily Trubee is a pharmaceutical professional with 15 years of experience in Quality Control, and Stability Testing and Management, with a focus on regulations-compliant stability programs for sterile injectables, solid oral dosage forms, and biological products. In her current role as Stability Manager at Adare Pharmaceuticals, she is responsible for managing the stability lifecycle of all products from pre-clinical through commercialization. Emily earned her Bachelor of Science degree in Chemistry from Wilmington College in Wilmington, OH and her Master of Science degree in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy

Chris Vitkun
Analytical Chemist/Stability Systems, A&Z PHARMACEUTICALS, INC.

Kayla Woodlief
Senior Manager, Biologics Stability and Analytics, BIOGEN INC.

Joseph Zelhof
Director, Global Stability, BRISTOL-MYERS SQUIBB

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Education: Masters of Science in Microbiology and Masters Business Administration from Seton Hall University

Work History: I spent the first 13 years of my career supporting QC testing in a microbiology laboratory, sterile and non sterile manufacturing, and industrial sterilization for Pfizer, Johnson and Johnson, and Schering Plough. For the last 13 years, I supported marketed product stability and premarket stability programs for Merck and Bristol Myers Squibb.

Certifications: Six Sigma Black Belt and Lean Practitioner.