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By Jeff Hemenway

Hemenway-finalAny scientist in the area of formulation selection for research and toxicology studies can tell you how challenging this area of pharmaceutical development can be. Formulation selection plays a critical role in preclinical research and toxicology studies, and can significantly affect the outcomes for new chemical entities (NCEs). The preclinical formulation scientist is often faced with many unique challenges that are specific to research, efficacy, and toxicology studies that are not present in other areas of drug product development. There is a great deal of flexibility in excipient selection and formulation strategy for single dose pharmacokinetics (PK) or acute PK/pharmacodynamics (PD) studies, where more aggressive formulation strategies can be used. However, for oral bioavailability studies, the use of aggressive formulation approaches to achieve biopharmaceutical performance may provide unrealistic expectations for what can be achieved with formulations suitable for toxicology and for clinical formulations.

Formulation selection for toxicology studies is one of the most challenging aspects of early stage development. Toxicology formulations must balance maximizing exposure with tolerability of the formulation vehicles in different species. Toxicology formulations must often accommodate extremely high doses using limited dose volumes while avoiding adverse effects from the vehicle. Most well-established pharmaceutical companies have their own internal expertise in this area, often including a database of excipient levels and combinations that are recommended for use in research and toxicology studies. However, this important and often controversial subject is not well covered in the literature and is seldom shared in public forums resulting in many misconceptions and little harmonization across the industry.

In an effort to bring together experts in these areas to share their experience and discuss the very latest developments, the Formulation Design and Development section is proud to present the 2015 Annual Meeting and Exposition FDD Open Forum: Great Expectations: Ensuring Research and Toxicology Formulations Translate from Discovery to Development from 7:00 pm–9:30 pm on Wednesday, October 28. The session will be moderated by Nicole Buist, Ph.D., chair, Excipients focus group and principal scientist, Merck & Co. Inc., and Mehran Yazdanian, Ph.D., chair, Drug Candidate Selection focus Group and senior director, Teva Pharmaceuticals.

Invited Speakers and Presentation Titles:

  • Robert Strickley, Ph.D., Principal Scientist, Gilead Sciences Inc. “Strategies for Defining Toxicology Formulations: Maximizing Exposure While Avoiding Adverse Vehicle Effects”
  • Shayne Gad, Ph.D., Toxicology Consultant, Gad Consulting Services. “Case Studies in Toxicology Formulation Selection and Effects on the Outcomes for NCEs”
  • Christopher Towler, Ph.D., Fellow, Novartis. “Creative formulation approaches in the very early space of Drug Discovery: What’s moving the needle in exposure these days?”
Jeffrey N. Hemenway, Ph.D., is a senior scientist at Gilead Sciences Inc. He has 10 years of industrial experience in formulation and process development and is currently the AAPS Formulation Design and Development section vice chair.