PharmApprove to Reveal Tips for Effectively Communicating With the FDA in Order to Avoid Costly Course-Corrections

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PharmApprove President Dr. Laurie Smaldone to Moderate Panel of Regulatory Experts at the BIO International Conference in San Diego, CA

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“Ultimately, we expect the audience to learn how to bring new medicines to market more quickly, economically, and safely. That’s good news for patients and everyone involved.” - Dr. Laurie Smaldone, PharmApprove President & CSO

PharmApprove – the leading strategic, regulatory and scientific communication consultancy to the pharmaceutical and biotechnology industries – announces plans for an interactive session on FDA communications at the 2014 BIO International Convention in San Diego. Dr. Laurie Smaldone, PharmApprove President and CSO, will moderate a panel of experts on Wednesday, June 25 at 3:00 PM. The session is designed to prevent the kinds of communication mis-steps that can lead to expensive backtracking. It is titled: “Are You Really Hearing What the FDA is Saying? Lessons Learned in Regulatory Communications.”

Dr. Smaldone has 25 years of leadership experience in drug development, regulatory strategy, and regulatory approvals across all major therapeutic areas and product technologies. “Frequently, drug developers will design their clinical studies without a complete understanding of what the FDA is looking for,” according to Dr. Smaldone. “Then they have to go back and undertake costly and time-consuming additional studies or appeals. That’s why we are convening a panel with deep industry and Agency experience, who can offer their strategic insights on the agency’s expectations.”

Joining Dr. Smaldone are three well-known authorities in product development and FDA communications:

  •     Dr. Eric Brass, Professor of Medicine, David Geffen School of Medicine at UCLA and Director, Harbor-UCLA Center for Clinical Pharmacology
  •     Dr. Marianne Mann, Consultant and former Deputy Director, FDA Division of Pulmonary and Allergy Drug Products
  •     Dr. David Essayan, Executive Vice President, ONCORD, Inc. and former Supervisory Medical Officer, FDA.

The four experts will share common pitfalls in communication with the FDA and tips for successful interactions. For example, sponsors often approach their FDA meeting with the assumption that the Agency had not read the briefing booklet or carefully considered their position. Dr. Mann notes that this is not the case:

“The most productive meetings with the FDA are when sponsors explore the reasons for differing opinions in order to find a mutually agreeable path forward. Understanding the FDA’s position fully is the best initial step towards successfully negotiating a path forward. By first listening to the FDA and understanding their point of view, a more open dialogue will follow, and sponsors will have a chance to present alternative opinions and views.”

Attendees will actively participate through real-time electronic polling on a series of regulatory case studies, choosing which of several communications options would lead to regulatory success. The panelists will then discuss the options and provide their optimal answer. The audience will also have ample opportunity for asking questions and posing alternative answers.

The goal of the session is to point out some frequent mistakes that are made on the development path, and leave participants better prepared for the future. “Ultimately, we expect the audience to learn how to bring new medicines to market more quickly, economically, and safely,” Dr. Smaldone explained. “That’s good news for patients and everyone involved.”

About PharmApprove: PharmApprove is the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries. The firm offers both strategic and tactical support to companies facing high-profile, high stakes events and engagements anywhere along the road to approval and commercialization, helping them win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. Learn more at

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Rachel Darwin
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