Clay T Cramer

Nonclinical Pharma Solutions was founded in 2019. Clay has over 30 years of drug development experience with small molecules and biologics in diverse therapeutic areas, including anti-infectives, cancer, cardiovascular disease, vaccines, and transplant rejection. Since founding of NcPS LLC, Clay has prepared numerous risk assessment reports on formulation ingredients and impurities using existing data. He conducts excipient evaluations and justifications for proposed limits. He has supported the ADME/toxicology sections for the development of novel therapeutics for a number of therapeutic indications. Clay is experienced at designing, implementing, managing, and executing nonclinical programs form pre-IND through approval. He has regulatory experience (pre-IND briefing documents, and CTA documents), and US FDA (CTD Sections 1.9 (pediatric plan), 1.12 (environmental analysis), 2.2 (CTD introduction), 2.4 (nonclinical overview) and 2.6 (nonclinical written and tabulated summaries) of NDA registrations. In addition, Clay has experience supporting equivalent nonclinical sections of successful EMA CTAs and MAA reviews (EU and Switzerland). He has experience in product labeling with both the US FDA (Package Insert) and European EMA (Summary of Product Characteristics) regions. Clay has participated in FDA teleconferences, WRO and face-to-face pre-IND meetings, end-of-phase 2 meetings, and EMA scientific advice meetings (BfArM, MHRA (prior to Brexit), MEB). While at prior employers, he served on various project teams and initiatives, frequently performing due diligences for partnering/in-licensing. Clay led a small molecule and macromolecule discovery efforts for CV therapies at prior positions and has published ~30 publications and over 100 internal documents.

Director of Nonclinical Development at Esperion Therapeutics, a biotechnology company pursuing the development of small and macromolecule therapies for the treatment of cardiovascular disease. Project leader of nonclinical development for lead compound. Utilize extensive experience supporting discovery and nonclinical pharmaceutical development. Extensive experience in investigative and safety toxicology. Disease indication areas include cardiovascular/lipid diseases, diabetes, and obesity research.

Researcher responsible for leading a multidisciplinary team to identify early stage macromolecule leads candidates for treatment of dyslipidemia and other risk factors associated with cardiovascular disease.

Research Scientist in Investigative Toxicology; World Wide Drug Safety. As part of the Investigative Toxicology group I supported issue resolution in toxicology and drug development. Supported group goal to facilitate the efficient selection of lead compounds and development of candidate compounds.