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Dr. Dandekar, the director of toxicology at Xenometrics, LLC, in Stilwell, Kan., will present, “Drug Development Strategies, from Discovery to the Clinic” on Thursday, Jan. 30, in room 1005 at the Durham Research Center.
The talk will begin at noon, and a complimentary lunch will be provided. Space is limited, so lunch and seating will be available on a first-come, first-served basis.
Dr. Dandekar has more than 15 years of experience in academic, agrochemical and pharmaceutical research and development. He earned his zoology doctorate from the Maharaja Sayajirao University of Baroda, India.
Dr. Dandekar is expected to discuss several key points of drug research and development, including:
- What are investigational new drugs (INDs) and new drug applications (NDAs)?
- Small molecule drugs vs. large molecule or biologic drugs.
- Six-step plan for lead candidate selection.
- Types of IND-enabling nonclinical studies.
- Routes of administration.
- Primary causes of drug candidate failure in clinical trials.
- De-risking strategy: Cardiovascular and CNS screening.
- Duration of toxicity studies required to support Phase I and II clinical trials.
- IND-enabling nonclinical study timelines, cost and planning.
Xenometrics, L.L.C., is a contract research organization providing study services to the biotechnology, pharmaceutical, companion animal health, and industrial- and agro-chemical industries. Xenometrics’ study services include PK/ADME, general toxicology, safety pharmacology, and development and reproductive toxicology studies.