PharmApprove is staffed by a team of experienced professionals with diverse backgrounds who are selected and assigned to meet the specific needs of each project. Each PharmApprove project is led by a Principal-level team member, who drives the project both strategically and executionally, serving as the day-to-day contact with the client team. Our Principals come to PharmApprove with deep experience as leaders of cross functional teams. Their knowledge of the development process and of team dynamics developed over many years in industry is applied to the specific situation of each project to help meet each team where they are, and take them to where they need to be to achieve success. The PharmApprove team includes a number of other support professionals who manage the strategy, messaging, communication, production and logistics aspects of each project.
Pete Taft 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, Pete 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.
Laurie Smaldone, MD
President Laurie Smaldone has over 25 years of global leadership experience in the pharmaceutical and biotechnology industries with deep experience in drug development, regulatory strategy and approval processes across all major therapeutic areas. Dr. Smaldone served in clinical and regulatory roles of increasing seniority and scope at Bristol Myers Squibb, including former Senior Vice President of Global Regulatory Science and Vice President of Corporate Strategy and Business Risk Management. During this time she led multiple teams in both US FDA and European EMA proceedings, including preparations for numerous key FDA meetings, Advisory Committee hearings and EU Scientific Advice and Oral Explanations. In addition, she has overseen the development and commercialization of drugs for cardiovascular, metabolics, immunology, oncology, HIV/AIDS, neuroscience, dermatology, inflammatory and immune-based diseases. Laurie has worked in large and small organizations, is an excellent communicator, and brings broad R&D, commercialization, business development, and team development experience to the PharmApprove team. She received her MD at Yale University, where she completed her residency in Internal Medicine and fellowship in Medical Oncology.
Principal Martha Arnold possesses over 25 years’ experience in facilitating marketing and regulatory communications for pharmaceutical firms, and has been project lead on over 30 projects at PharmApprove across a broad variety of therapeutic categories. She has extensive experience in cross functional, development team activities, working closely with clinical, regulatory and scientific experts to move candidates through all stages of the product lifecycle. 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. 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 an MBA from the University of Chicago School of Business and a BA from the University of Virginia.
Principal Elaine Klein joined PharmApprove in 2008 and has led Advisory Committee projects for drugs and devices in a number of therapeutic areas, including oncology, cardiovascular, anti-infective, gastrointestinal, and pulmonary. Prior to PharmApprove, Elaine spent 20 years as an executive with major healthcare companies, heading marketing for multi-billion dollar pharmaceutical businesses and leading key product development teams. At Bristol-Myers Squibb, her positions included Vice President, Global Marketing for Plavix, BMS’ largest business, and Vice President, Pravachol Global Marketing. In these roles she was responsible for global brand strategy, communications and product development, and worked closely with clinical and regulatory colleagues to develop and launch several new indications. In her role as Commercial Lead, Cardiovascular Development at BMS, Elaine was involved in early clinical development of apixaban. Elaine began her career at Johnson & Johnson, where she held marketing and management positions of increasing responsibility for OTC pharmaceutical and nutritional products including Tylenol, Motrin and Imodium. She earned an MBA from Harvard Business School and a BS from the University of Pennsylvania.
Douglas Hay, PhD
PharmApprove Principal Doug Hay has over 25 years’ experience in regulatory affairs and pharmaceutical development, including global regulatory leadership as Vice President, Global Regulatory Science at Bristol-Myers Squibb and The Medicines Company, and Senior Vice President, Regulatory Affairs at Shire Pharmaceuticals. Doug has led regulatory and development teams in multiple therapeutic areas, including the full breadth of cardiovascular disease, cholesterol reduction, diabetes, renal disease, gastrointestinal, autoimmune disease, anti-infectives, dermatology, antivirals, antifungals, pain, neurology, and oncology. Doug has been responsible for numerous meetings with global health authorities, including product defenses before the EMEA’s CHMP and FDA Advisory Committees. Experience with the Cardiovascular and Renal Drug Advisory Committee includes Capoten for Left Ventricular Disfunction, Caopten for Diabetic Nephropathy, and Plavix. Doug recieved his PhD in Zoology (Physiology) from Northern Arizona University.
Marianne Andreach joined PharmApprove after nearly 30 years in the pharmaceutical and biotech industry, with experience in preclinical research, sales, marketing, medical education, product planning, medical affairs, business development and development team leadership. During her career, Marianne has led multi-disciplinary, cross-functional teams in product development, commercialization and business development, working closely with internal and external clinical, scientific, safety, regulatory and manufacturing experts. A particular focus has been identification, development and utilization of KOLs in multiple therapeutic areas. Previously she was with The Medicines Company, Esperion Therapeutics and Parke-Davis, where she was a team member for the global launch of Lipitor. Marianne began her career at E.R. Squibb, later Bristol-Myers Squibb, as a bench scientist and was later part of the US launch team for Pravachol. She received a BA from the College of the Holy Cross.
General Manager Cathleen McNulty is responsible for day-to-day operations and oversees PharmApprove’s contracting, billing and staffing functions. She works in conjunction with our Principals to track progress on deliverables and manage project budgets. Prior to joining PharmApprove, Cathleen spent over 20 years in the financial services industry in various marketing, operations and compliance positions. She earned a BS from Bucknell University and an MBA from Rutgers University.
Associate Director of Client Services, Lisa Peluso provides overall coordination of client, company and vendor services for Advisory Committee preparation projects. She has worked on over 20 drug and device projects across several therapeutic categories. Lisa also provides communications training to executives in pharma and other industries. Prior to joining the firm, Ms. Peluso worked at Kyowa Pharmaceutical, where she supported both commercial and clinical teams and served as the principal liaison between the Tokyo, UK and US offices.
Senior Project Associate Lisa Starke has coordinated more than 15 PharmApprove projects in the past 12 years, managing FDA, EMEA and CMC meetings with clinical/marketing teams in a wide variety of therapeutic area. She has over 20 years’ experience in advisory committee preparation, health education programming and research. In her earlier career, Ms. Starke served as a communications and adult learning specialist at the American Heart Association and the March of Dimes Foundation, advising business, scientific and medical professionals on strategic communications initiatives and developing and conducting continuing medical education programming. Lisa earned a BS from NY University and an M.S. in Adult Education and Training from Rutgers University.
Project Associate Sarah Elmer provides project management and overall coordination of client, company and vendor services. Ms. Elmer has an extensive background in the coordination and execution of meeting & event logistics for pharmaceutical and media companies.
A graduate of Yale Business School and former New York stage actor, John Ellis coaches presenters, moderators and bullpen members to present and answer questions with 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 those with whom he works. He is particularly skilled at training presenters to deliver material compellingly, working with them on voice, body language, and overall expression while at the podium or bullpen microphone.
Eric Nitzberg is a communication coach, trainer and facilitator who partners with leaders and organizations to help them prepare for the most pivotal moments in the lives of their organizations. He has particularly strong expertise in helping technically-oriented professionals develop greater skill in “the people side” of communication. Prior to joining PharmApprove, Eric worked as a professional public speaker and executive. He has delivered hundreds of presentations to small and large audiences, and has spent thousands of hours crafting high-impact messages.
As a communication coach, Seth Rigoletti has worked with politicians, engineers, scientists, executives and authors to teach them how to have greater presence, communicate in a clear fashion and deliver a more impactful message. The focus of his work is on authenticity and resonance, helping clients to be more persuasive in their communication, feel more genuine while doing it and reach more people with their message.
Experienced in the field of graphic design with special emphasis in presentation development, Sarah Moesher spent over 20 years supporting corporate executives in the aerospace industry. Sarah has spent the last eight years supporting clients in the development of comprehensive, science-based slides for regulatory presentations to FDA Advisory Committees and the European Medicines Agency. She also has experience in slide preparation for investor and analyst meetings, podium presentations at international medical conventions, and Board of Director’s meetings.
A seasoned communications professional with over 10 years experience in developing and delivering presentations for the pharmaceutical industry, Jodi Volker has provided on-site slide production, slide retrieval and logistics support for over a dozen Advisory Committee preparation projects, and is committed to outstanding customer service on every level.
Ann Overton has close to 15 years in the presentation industry, including nearly a decade in the regulatory sector helping teams prepare for FDA Advisory Committees. She is an expert in creating and formatting complex medical slides and has an excellent eye for layout and design. Ann helps establish the highest possible standards for all presentations and is skilled in content management and version control. She works effectively and efficiently in high-stress, tight-deadline environments.