Speaker Profile

John A. McLane

Vice-President of Clinical and Regulatory Affairs, Clinquest Inc.

Dr. McLane has over 25 years of progressive experience in all phases of global development with both large and small pharmaceutical companies. His knowledge basis has lead full development projects with over 50 clinical and medical device programs and to successful INDs, IDEs, NDAs and EMEA/CTA applications. Key strengths include the early development of clinical and regulatory strategies, risk management and identification, and negotiating with regulatory officials.

Additional development activities include developing business rationale, teams, programs, and strategies for early clinical and combination product candidates in metabolic diseases, respiratory and oncology areas. He has also successfully completed in- and out-licensing reviews and negotiations including those for orphan indications and in vitro diagnostics. He possesses particular expertise in the initial formation and development of new start-ups and early clinical companies and has provided major contributions to business plans and presentations to venture capitalists for significant fund-raising.

Dr. McLane has been leading recent regulatory and clinical services for clients in the various therapeutic areas at Clinquest.

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Maintaining Compliance of Clinical Sites with Regards to the FDA Draft Guidance on (Risk-Based Approach to Monitoring)

Monitoring of clinical sites is a critical part of the Good Clinical Practices. With the advent of electronic data capture (EDC processes and more recently the FDA guidance, Oversight of Clinical Investigations-a Risk-based Approach to Monitoring some changes in the way we monitor sites and the data collection are taking place.

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