PharmApprove Panel at BIO Addresses Success in Drug Development Beyond Regulatory Approval

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PharmApprove President Dr. Laurie Smaldone to Moderate Panel of Experts on Market Access and “Thinking Like a Payer” at the BIO International Conference in Philadelphia, PA

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"We want to help biotech companies anticipate what payers are going to want to know, and make sure those considerations are included in the development plan from day one." - Dr. Laurie Smaldone, PharmApprove President and CSO.

PharmApprove – the leading strategic, regulatory and scientific communication consultancy to the pharmaceutical and biotechnology industries – will be presenting an interactive discussion on market access during the 2015 BIO International Convention in Philadelphia, PA. PharmApprove’s session, titled “Approval ≠ Commercial Success: Start Thinking Like a Payer,” will take place on June 16th at 10:15 am.

Dr. Laurie Smaldone, PharmApprove President and CSO, will moderate the group, which includes Steffen Thirstrup, PhD, Director of NDA Group’s Regulatory Advisory Board and former Head of Division at the Danish Health and Medicines Authority (former Danish Medicines Agency) and Coos de Graaf, PharmApprove Vice President, European Operations and former EVP and Head of Global Development at Solvay Pharmaceuticals.

According to Dr. Smaldone: “With this panel, we want to ensure that companies don’t waste their development dollars on products that will ultimately have no standing in the marketplace. Regulatory approval is a huge success benchmark, but it’s just as important to make sure that approved medications are positioned for optimal reimbursement. That’s why we want to help biotech companies anticipate what payers are going to want to know, and make sure those considerations are included in the development plan from day one.”

Prior to joining PharmApprove, Dr. Smaldone was Senior Vice President of Global Regulatory Science at Bristol-Myers Squibb, and also served as CEO of an early-stage inflammation company. She received her MD at Yale University, where she completed her residency in Internal Medicine and fellowship in Medical Oncology. Panelists Thirstrup, who is also an adjunct professor in pharmacotherapy, and de Graaf also have extensive experience with both clinical development and payer negotiations.

“The question of how to anticipate payer concerns is applicable to large and small biotech companies, all over the world” said de Graaf. “Any company’s survival is contingent on being commercially successful. And if you’re not inviting all of the necessary voices to the table early, you might wind up overlooking considerations that not only support approval but valuation until it’s too late.”

PharmApprove’s panel will begin with an overview, before moving into an interactive discussion involving several real-life case studies that showcase some of the pitfalls that can occur when payer concerns aren’t addressed early enough. Audience participation is encouraged throughout. Participants will leave with a clear understanding of the differences between designing programs for regulatory approval and for commercial success – and how to achieve both.

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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