Strategy Design & Formulation Considerations for GLP Toxicology Studies

Life Sciences, Pharmaceutical, Preclinical,
  • October 05, 2017

A lack of planning for a new compound’s GLP toxicology study can severely trip up your IND. Upfront planning to design a successful toxicology study, identify problems and allow time for solutions can help avoid costly delays. Toxicology study design requires a customized strategy that is relevant to the intended clinical indication and route of administration and is acceptable to regulatory authorities. Formulation development plays an important role in assessing the in-vivo properties of a molecule during preclinical development, such as overcoming solubility issues and maximizing exposure.

Join our speakers for an open discussion of how to prepare for a GLP toxicology study. This seminar and discussion, led by Paracelsus toxicology consultant, Grace Furman, and Catalent formulation scientist, Meredith Perry, will evaluate critical areas in the drug development process to help ensure a successful toxicology study, including:

  • Key decision points in designing your GLP toxicology study
  • Scientific and regulatory requirements of a toxicology study
  • Why formulation development plays a crucial role in GLP toxicology studies
  • Formulation approaches and limitations for various animal species and routes of administration
Keywords:

Speakers

Grace M. Furman, PhD, DABT, CEO and President, Paracelsus, Inc.

Grace M. Furman, PhD, DABT, is CEO and President of Paracelsus, Inc., a consulting firm that specializes in toxicology services for the pharmaceutical industry. Her professional expertise relates to regulatory toxicology as applied to development of novel small molecule therapeutics.

Dr. Furman founded Paracelsus in 2006 after a successful tenure as a toxicologist and regulatory affairs professional in the pharmaceutical industry with companies such as Pfizer’s (previously Agouron Pharmaceuticals), DepoTech (now Pacira Pharmaceuticals, Inc.) for more than four years where she was instrumental in building the preclinical development group. She began her professional career in Cincinnati as a divisional toxicologist in Procter & Gamble’s Health Care Sector.

Dr. Furman received her Ph.D. in Biomedical Sciences with a specialization in toxicology from Northeastern University. She also holds a B.S. in toxicology and is a Diplomate of the American Board of Toxicology. Dr. Furman is an active member of the Society of Toxicology (SOT) and the American College of Toxicology (ACT) and has served on ACT’s Nominating Committee (2008) and on Council (2009-2011). Dr. Furman is also an active member of the Southern California Chapter of the Society of Toxicology and has held several Executive Council positions, include President, within this Regional Chapter.

Dr. Furman is chair emeritus of the San Diego Biotechnology Discussion Group and a founding member of San Diego’s Women in Biosciences. Additionally, Dr. Furman is an instructor for UCSD Extension, where her Toxicology in Drug Discovery and Development classroom and distance-learning courses are offered through the Drug Discovery and Development and AMDET Process Certificate Programs.

Stephie Lee, Associate Scientist, Catalent

Stephie Lee, M.S., is an Associate Scientist at Catalent in San Diego. She has a broad background in preclinical and clinical formulation, process development and GMP manufacturing of small molecule candidates, with a focus on early phase strategies for bioavailability enhancement of poorly soluble compounds. Stephie has managed more than 60 oral formulation programs, including spray dried dispersion, fluid bed processing, and micronization projects. Prior to joining Catalent, Stephie was a researcher in Dr. Richard Kaner’s laboratory at University of California, Los Angeles (UCLA), where she focused her research on the effects of various reaction conditions on the morphologies of nano conductive polymers such as polyaniline, polypyrrole and the fabrication of free-standing thin films of these materials. She received her Masters of Science in Chemistry and her Bachelor of Science in Biochemistry from UCLA.

Meredith Perry, Senior Scientist, Catalent

Meredith Perry is a Senior Scientist with Catalent (previously Pharmatek Laboratories) where she has worked since 2003. Meredith’s focus has been toxicology and clinical formulation development, including solutions, suspensions, capsules, and tablets, with immediate, delayed, or extended release characteristics. She has significant experience with analytical method development, including adaptation of HPLC methods to UPLC for improved separations and sensitivity.

During her tenure, Meredith has managed hundreds of oral and IV formulation and analytical development projects. She has coauthored the CMC section of FDA submission. Meredith is actively involved in the philanthropic community through her volunteer work with Pharmatek Foundation and Operation Amped. Meredith earned her B.S. in Chemistry and her B.A. in Economics from the University of California San Diego.

Who Should Attend?

  • CEO & Presidents
  • Director / VP Preclinical Development, Drug Development, CMC, Manufacturing, Analytical Development, Formulations or Formulation Development
  • Director / VP Quality Assurance and Regulatory
  • Technical Section Managers
  • Principal Analytical Chemists
  • Team Leaders
  • Formulation Development Scientists
  • Consultants for Drug Development, CMC, QA

Xtalks Partners

Catalent

Catalent is the #1 industry partner for advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise and the broadest portfolio of advanced technologies to bring more customer products to market faster, enhance product performance and ensure reliable clinical and commercial product supply. Our team of over 10,000 people, located at over 30 sites on five continents, produces +70 billion doses of +7,000 products for more than 1,000 customers from 87 of the top 100 global pharmaceutical marketers, to 24 of 25 biological marketers, to 21 of 25 leading consumer health marketers, to thousands of small innovators globally. Our passion is to help unlock the full potential of your product.

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