Regardless of the pharmaceutical development company, therapeutic area or regulatory pathway taken to get a drug onto the market, at some point there is a need to validate the business and scientific/regulatory case in a “proof-of-concept” clinical trial. If the development program supporting a proof-of-concept trial is done well, then it is up to the drug to demonstrate an acceptable risk-benefit profile.

In this audio conference, our speaker examines the framework necessary to maximize the chance of a successful proof-of-concept trial for a new chemical entity (the hardest case). The session also includes a discussion and case histories of the supporting nonclinical safety program, pharmacokinetic and pharmacodynamic evaluations, maximum tolerated dose issues, study design and endpoints in the context of a regulated industry.

This audio conference covers:

• Drug development questions that need to be addressed before a proof-of-concept trial is conducted
• Which factors influence dose selection and dosing regimen for a proof-of-concept clinical trial
• How to minimize the time to get to the proof-of-concept clinical trial
• How much time and money is necessary to get to the proof-of-concept stage
• The major risks in conducting a proof-of-concept clinical trial that can be mitigated with smarter drug development approaches

About the speaker:

Scott Oglesby, PhD, has 20 years of experience in the creation, planning and management of over 50 U.S. and international development programs in multiple therapeutic areas ranging from pre-IND to the marketing application stages. He has significant technical expertise in the clinical, preclinical, and chemistry, manufacturing and controls aspects of development, as well as regulatory requirements and expectations across numerous therapeutic areas. This expertise spans senior management tenures in contract research organizations, start-ups and international pharmaceutical companies.

In addition, Dr. Oglesby’s experience encompasses both small molecules and biologics, and covers all major routes of administration. He has logged over 30 meetings across 12 different FDA divisions and other regulatory agencies, including the FDA’s Office of Orphan Products Development. Dr. Oglesby received his PhD in neurobiology from UNC Chapel Hill.

Who should attend?

• Regulatory Affairs
• Clinical Managers
• Research & Development
• Training/Learning & Development

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.