Pete Taft, Founder of PharmApprove™, to Once Again Co-Chair FDA Advisory Committee Conference
To Share Lead with sanofi-aventis’s Kevin Malobisky.
Princeton, NJ, March 24, 2011 --(PR.com)-- Pete Taft, Founder and CEO of Princeton-based drug development communications firm PharmApprove™, has been asked repeat his role as co-chair of the Forum on Effective Preparation for FDA Advisory Committees.
The conference, organized by the Center For Business Intelligence (CBI), brings together diverse industry and regulatory affairs perspectives to discuss the current regulatory climate, examine trends in Advisory Committee proceedings, and share best practices for preparing to deliver sound arguments for approval of a drug, biologic, or device at these public hearings. The conference will be held on March 29-30 in Washington, DC.
“From both the Agency and the Advisory Committees perspective, the environment has become increasingly conservative for new drug approvals. The recent hearings on oncology and obesity treatments, for example, may cause sponsors to change their approach to AC hearing preparation,” says Taft, whose 12-year-old firm helped establish the field of Advisory Committee preparation.
Taft will serve as co-chair, along with Kevin P. Malobisky, Associate Vice President for Global Regulatory Affairs at sanofi-aventis.
Highlights of the conference include a discussion on the role of FDA Advisory Committee meetings, a series of presentations on best practices for successful and effective AC preparation, and Pete Taft’s keynote presentation on how Advisory Committee members approach their work, based on personal interviews with past members.
Other distinguished presenters include Michael Ortwerth, Director of Advisory Committee Oversight, FDA; Gary Appio, United States Safety and Risk Director, Novartis; and Geoffrey Levitt, Associate General Counsel, Worldwide Regulatory and Policy Law, Pfizer Inc.
About PharmApprove™
PharmApprove™ is a strategic communications consulting firm that helps pharmaceutical development teams prepare and deliver their product’s key messages at critical, high-profile regulatory events in both the United States and Europe.
PharmApprove™ works in partnership with development teams to make a clear and compelling case for approval in several public forums. Over the last decade, PharmApprove™ teams have helped to create and deliver over 60 drug, biologic and device development communications programs across 18 therapeutic areas both in the US and overseas, including more than 45 Advisory Committee preparation projects.
Currently, PharmApprove™ teams are helping to prepare four drug and device teams for upcoming Advisory Committee hearings, providing services including strategy development, medical writing, presentation coaching, slide creation, and project management.
PharmApprove™ is a division of Taft and Partners, a marketing and corporate communications firm also located in Princeton, NJ.
About Pete Taft
Pete Taft is the CEO of Taft and Partners, a communications consultancy. Pete founded the PharmApprove™ division in 1999 when pharmaceutical clients began asking him to assist in preparing global teams for critical regulatory presentations in both the US and Europe. Since then, Pete has been involved in over 60 PharmApprove™ Advisory Committee Preparation projects, providing strategic oversight and individual and group coaching services. In addition, he has conducted dozens of “lessons learned” sessions, videoconferences, workshops, seminars, and individual coaching sessions within the industry. Pete began his career covering crime, politics and law for both magazines and newspapers, winning several awards for his work. He later served as a communications executive in both the public and private sectors, advising leaders in business and government on strategic communications, public speaking, and media relations.
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The conference, organized by the Center For Business Intelligence (CBI), brings together diverse industry and regulatory affairs perspectives to discuss the current regulatory climate, examine trends in Advisory Committee proceedings, and share best practices for preparing to deliver sound arguments for approval of a drug, biologic, or device at these public hearings. The conference will be held on March 29-30 in Washington, DC.
“From both the Agency and the Advisory Committees perspective, the environment has become increasingly conservative for new drug approvals. The recent hearings on oncology and obesity treatments, for example, may cause sponsors to change their approach to AC hearing preparation,” says Taft, whose 12-year-old firm helped establish the field of Advisory Committee preparation.
Taft will serve as co-chair, along with Kevin P. Malobisky, Associate Vice President for Global Regulatory Affairs at sanofi-aventis.
Highlights of the conference include a discussion on the role of FDA Advisory Committee meetings, a series of presentations on best practices for successful and effective AC preparation, and Pete Taft’s keynote presentation on how Advisory Committee members approach their work, based on personal interviews with past members.
Other distinguished presenters include Michael Ortwerth, Director of Advisory Committee Oversight, FDA; Gary Appio, United States Safety and Risk Director, Novartis; and Geoffrey Levitt, Associate General Counsel, Worldwide Regulatory and Policy Law, Pfizer Inc.
About PharmApprove™
PharmApprove™ is a strategic communications consulting firm that helps pharmaceutical development teams prepare and deliver their product’s key messages at critical, high-profile regulatory events in both the United States and Europe.
PharmApprove™ works in partnership with development teams to make a clear and compelling case for approval in several public forums. Over the last decade, PharmApprove™ teams have helped to create and deliver over 60 drug, biologic and device development communications programs across 18 therapeutic areas both in the US and overseas, including more than 45 Advisory Committee preparation projects.
Currently, PharmApprove™ teams are helping to prepare four drug and device teams for upcoming Advisory Committee hearings, providing services including strategy development, medical writing, presentation coaching, slide creation, and project management.
PharmApprove™ is a division of Taft and Partners, a marketing and corporate communications firm also located in Princeton, NJ.
About Pete Taft
Pete Taft is the CEO of Taft and Partners, a communications consultancy. Pete founded the PharmApprove™ division in 1999 when pharmaceutical clients began asking him to assist in preparing global teams for critical regulatory presentations in both the US and Europe. Since then, Pete has been involved in over 60 PharmApprove™ Advisory Committee Preparation projects, providing strategic oversight and individual and group coaching services. In addition, he has conducted dozens of “lessons learned” sessions, videoconferences, workshops, seminars, and individual coaching sessions within the industry. Pete began his career covering crime, politics and law for both magazines and newspapers, winning several awards for his work. He later served as a communications executive in both the public and private sectors, advising leaders in business and government on strategic communications, public speaking, and media relations.
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Contact
Taft and Partners
Katherine Zimoulis
609-683-0700
www.taftandpartners.com
Katherine Zimoulis
609-683-0700
www.taftandpartners.com
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