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Executive Interview
Prior to the Phase IV conference, Q1 was able to sit down with Nayan Nanavati, the Vice President of the Peri-Approval Clinical Excellence group within PAREXEL to discuss the driving factors impacting post-marketing research today. His insightful comments and straightforward approach to partnering with the industry makes it clear why PAREXEL is a leader in the peri-approval research market. As Mr. Nanavati commented during the interview:
"In late phase clinical research we must represent ourselves as an ambassador of [our client], representing the pharmaceutical company with enthusiasm and pride. We strive to become an extension of the company as opposed to a contractor working in isolation."
For a full copy of the executive interview with Mr. Nayan Nanavati; click here.
Phase IV Clinical Trials Conference
July 23-24, 2006
Philadelphia, PA
Event Overview:
At the recent Phase IV Clinical Trials conference that took place July 24-25 in Philadelphia, attendees really found what they were looking for. Feedback focused around a quality conference agenda highlighting the importance of a comprehensive approach to post-marketing surveillance, resulting in the faster completion of trials while maintaining regulatory compliance.
Topics Addressed Included:
Evolution of Late Phase Clinical Trials: Current Opportunities, Challenges and the Future
Nayan Nanavati
VP, Peri-Approval Clinical Research
PAREXEL
Feedback from Mr. Nanavati's session indicated that the content was not only interesting and engaging, but also very relevant to topics that the audience wished to hear about. Attendees noted that his session was an excellent way to start off the conference, raising a variety of thought provoking topics which were discussed throughout the program. As one attendee noted, "Nayan Nanavati was excellent; he asked and answered relevant questions and thought-provoking considerations. Very intelligent and great communicator of translating requirements into practice."
Panel Discussion: Impact of Regulatory Guidelines on Post-Marketing Research
The panel discussion, including John Flaherty of Shire, Erhan Berber of Novartis, led by Nayan Nanavati of PAREXEL was a valuable session for attendees as a catalyst for discussions throughout the remainder of the day and cocktail party as executives shared best practices in maintaining regulatory compliance in an evolving regulatory landscape.
Pharmacovigilance and Risk Management in the Conduct of Post-Marketing Research
Neila Smith, MD
Head of Pharmacovigilance
Astellas Pharma
With drug safety and risk management a top priority within every pharmaceutical company, it was not a surprise that Dr. Smith's session was one of the most highly rated sessions, with attendees indicating that her review of current safety trends were extremely valuable. Her presentation style also received high marks for her ability to cover a great deal of material in a short time, but with excellent depth.
Other Sessions During the Conference Included:
Designing Phase IV Clinical Studies Based on Specific Objectives
Dennis Decktor
Senior Director, Medical Affairs
Centocor
Exploring the Impact of Retrospective Studies on Post-Marketing Research
MaryAnn Clark
Advanced Bionics, Reimbursement & Outcomes Research
Boston Scientific
Balancing Scientific & Commercialization Objectives in the Conduct of Post-Marketing Research Studies
Erhan Berber
Director, Medical Affairs
Novartis Pharmaceuticals
Impact of Regulations and Guidelines on Post-Marketing Research
Christopher-Paul Milne
Assistant Director
Tufts Center for the Study of Drug Development
Evaluation of Tools and Technologies Available to Streamline Post-Marketing Trials
Stanley Kachnowski
Health Information & Policy Management
Columbia University
AND MANY MORE!!
If you attended this conference but did not receive the updated presentations, please email: Info@Q1Productions.com
