PharmApprove is staffed by a team of experienced professionals from a wide range of backgrounds who are assigned to projects as needed to meet project goals. A PharmApprove principal takes the project lead position and serves as the day-to-day contact with the client team. Our staff includes:
Pete Taft, President and Managing Partner
Pete is Managing Partner and CEO of Taft and Partners, a communications consultancy. Pete founded PharmApprove in 1999 when pharmaceutical clients began asking him to prepare global teams for critical regulatory presentations in both the US and Europe. Since then, Mr. Taft has been intimately involved with every one of our 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.
Martha Arnold, Principal
PharmApprove Principal Martha Arnold possesses over 25 years’ experience in facilitating marketing and regulatory communications for pharmaceutical firms, and has been project lead on over 20 projects at PharmApprove, with particularly deep experience in Oncology and Cardiology. She has worked with Pete and the team to continuously update and refine our process, and is the architect of our current approach. Martha has also led PharmApprove Lessons Learned projects. Previously, she consulted to Kyowa Pharmaceutical, serving as a “virtual marketing” department advising on commercial, marketing and regulatory strategy on istradefylline, a novel agent for Parkinson’s Disease. As Senior Vice President at Anesta Corp, she led the approval team for the novel opioid analgesic Actiq. This approval required negotiation of a groundbreaking risk management program, in many ways a precursor to today’s REMS. Ms. Arnold started her career at Johnson & Johnson, where she successfully managed a broad range of products and worked extensively in the marketing-regulatory interface of several Rx to OTC switches, including Pepcid, Imodium, and Nicotrol. Martha received a BA from the University of Virginia and an MBA from the University of Chicago School of Business.
Elaine Klein, Principal
PharmApprove Principal Elaine Klein has over 20 years’ experience managing pharmaceutical and consumer products in all stages of development and commercialization. At Pharmapprove, she has led multiple Advisory Committee projects over the past three years in Anti-infective, GI, Oncology and Pulmonary therapeutic categories. Prior to joining PharmApprove, Ms. Klein spent six years at Bristol-Myers Squibb, where she served as Vice President of Global Marketing for Plavix, and Vice President of Pravachol Lifecycle Management. In these roles, she worked closely with clinical, regulatory and medical affairs staff in planning and executing FDA submissions and Advisory Committee meetings. Ms. Klein began her career at Johnson & Johnson, where she held a variety of brand management assignments for OTC pharmaceuticals in therapeutic areas including GI, Analgesics, Allergy, Smoking Cessation and Nutritionals. Elaine earned her MBA from Harvard University after a BS from the University of Pennsylvania.
Lisa Peluso, Project Associate
Lisa Peluso provides project management and overall coordination of client, company and vendor services for Advisory Committee preparation projects. Prior to joining the firm, Ms. Peluso was Executive Assistant to the President of Kyowa Pharmaceutical, where she served as the principal liaison between the Tokyo, UK and US offices, handling correspondence and VIP visits. She has broad experience supporting multi-functional drug development teams across several therapeutic categories. Fluent in Japanese, Ms. Peluso lived in Tokyo for 12 years, serving in an executive assistant and marketing coordinator capacity for the Tokyo managing partner of the world’s largest law firm.
Delores Graham, Medical Writer
Delores Graham, a clinical research scientist with education in pathology and toxicology, has over 15 years’ experience in regulatory and manuscript writing for pharmaceutical, medical device, and diagnostic companies in a wide range of therapeutic areas. As a project team member, Ms Graham has participated in negotiations during many FDA meetings. As Manager of Regulatory Affairs at DAKO Corporation, Ms Graham presented the manufacturers’ position at an FDA Advisory Meeting assessing regulations for monoclonal antibodies. Recently, she has worked with six companies to produce briefing documents for FDA Advisory Committee meetings.
Maryanne Visconti Gottfried, Medical Writer
Maryanne Gottfried has over 20 years of industry experience and, as a medical writer, has been involved in all forms of regulatory submission writing. In addition to the preparation of several briefing documents, Ms. Gottfried has participated in nine NDAs/BLAs in several therapeutic areas for clients in the pharmaceutical and biotech industries. In addition to her writing, she has held positions in all aspects of clinical development including data management, monitoring, project management and clinical quality assurance.
Sarah Moesher, Slide Specialist
Experienced in the field of graphic design with special emphasis in presentation development, Ms. Moesher spent over 20 years supporting corporate executives in the aerospace industry. Ms. Moesher has spent the last eight years supporting pharmaceutical clients in the development of comprehensive, science-based slides for regulatory presentations to both US FDA’s Advisory Committee and European EMEA. Additional responsibilities include final slide preparation for investors’ and analysts’ meetings, podium presentations at international medical conventions, and Board of Directors meetings.
John Ellis, Presentation Coach
A graduate of Yale Business School and former New York actor, John Ellis helps presenters, moderators and bullpen members present and answer questions with relaxed confidence. John has been interviewed on nationally televised news programs (60 Minutes, 20/20), and employs a hands-on coaching style that elicits almost immediate positive change in his clients; he is particularly skilled with accents and challenging voice patterns.
Linda Davis Pizzico, AV Director & Presentation Coach
A former network television producer, Ms. Pizzico helps PharmApprove train its presenters, moderators and bullpen members to answer tough questions in pressure situations. Ms. Pizzico also provides PharmApprove with audio and video production services during mock panels and Advisory Committee meetings.
Rebecca Taylor, Public Relations
Formerly senior director of communications at Bristol-Myers Squibb, Rebecca Taylor manages all media relations and media training for both Taft and Partners and PharmApprove. Ms. Taylor began her career as a daily newspaper reporter in New Jersey and Pennsylvania, later joining the New Jersey governor’s office and eventually rising to the top position of communications director and press secretary. In her ten years at BMS, Ms. Taylor was instrumental in managing all aspects of the company’s corporate communications, including media relations, speechwriting, crisis communications, and issues management.
