Faculty – Stability Testing Summit

Joshua T. Ayers, Ph.D.
Former 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, Ph.D.
Senior Director Analytical Sciences, CMC, AGIOS PHARMACEUTICALS

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Dr. Tyson Chasse is the Senior Director of the Analytical Sciences group within CMC at Agios Pharmaceuticals. After receiving his Ph.D. at North Carolina State University, he has worked 15 years in the pharmaceutical industry focused on analytical R&D, stability and release of drug substance and drug product from DC selection through commercial products. He has spent the last 5 years establishing analytical development and stability strategies to support accelerated drug development in the Oncology and RGD space within a dynamic global regulatory landscape.

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.

John O’Neill

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John has a degree in Pharmaceutical Sciences from Columbia University and a Masters in Health Systems Management from Union University.  His career has taken him from Registered Pharmacist to …

  • Liquids and Semi-solids Formulator at Sterling Winthrop
  • QC Manager at Sanofi-Aventis
  • Medical Device Quality Steward at Boston Scientific
  • Independent Consultant
  • Principal Stability Specialist for Biologics at Genentech
  • Associate Director for Stability at both Gilead and Regeneron

John is a past chair of the Stability Working Group of the International Pharmaceutical Federation and is a member of the Product Quality Research Institute Stability Working Group.  For the past 31 years, John has been the Facilitator of the Pharmaceutical Stability Discussion Group, which has made him privy to just about everything that can go right or wrong with the Stability function.  As president of John ONeill Enterprises LLC, he is currently launching stabilityhub.com, a stability information website.

Jeremy Pariseau
Stability Scientist, SANOFI

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Jeremy Pariseau is a Stability Scientist at Sanofi in Waltham, MA. He has previous experience as a Stability Scientist at Biogen and Bioverativ as well as an extensive Quality Control background.  Jeremy’s stability experience ranges from progressing an early phase clinical biologic to an IND to commercialization and lifecycle management of multi-strength lyophilized injectables used to treat Hemophilia A and B.  Jeremy has a Bachelor’s of Science in Biological Sciences from the University of Massachusetts, Lowell and a Professional Science Master’s degree in Pharmaceutical Biotechnology from Northeastern University.  In addition to his ongoing work with clinical and commercial biologics for Hemophilia, Jeremy has most recently been working on a late-stage clinical mAb targeting the complement pathway to treat Cold Agglutinin Disease, in preparation for filing a BLA.

Kamran Simani

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I have over 30 years of experience in pharmaceutical field with focus on Quality and Stability. I received my bachelor’s degree in Medical Technology and completed my master’s in Microbiology from Indiana State University. Started career at Massachusetts Biologic Laboratories managing release and stability testing of plasma derivatives and bacterial vaccines (17 years). Subsequently, joined Biogen and led a team of scientists to manage stability of clinical biologic and small molecule products (11 years). Later, I moved to Shire and led developmental and clinical stability programs (3 years) for biologics. Finally, I joined Alnylam in July 2019 as the Director of Stability overseeing developmental and clinical stability programs for the oligonucleotide portfolio.

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.

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

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Kayla Woodlief is currently the Senior Manager of Biologics Stability & Analytics at Biogen. In this role, she manages a team responsible for clinical and commercial stability programs, trending, specification establishment and CPV for commercial programs. Kayla has over 15 years of industry experience with the past 10 years focused on Stability program management. In her free time, Kayla enjoys reading, travel and baking.
Kayla holds a B.S. in chemistry from Arkansas State University.