Two tours at FDA and two decades inside industry across pharmaceuticals, biologics, and devices—a perspective clients rarely find at partner agencies, let alone in one person
CHAPEL HILL, N.C. & LONDON & ZUG, Switzerland–(BUSINESS WIRE)–#AESARA–AESARA, a leading Value & Access agency, today announced that Denise Sánchez, JD, MS, MA, has joined the company as Vice President, Regulatory Counsel & Compliance Strategies. She served twice as FDA Regulatory Counsel for Policy—first at the Center for Biologics Evaluation and Research and later at the Center for Devices and Radiological Health—and brings more than 20 years of experience at the intersection of regulatory policy, compliance, science, and real-world business application.
“When we first worked with Denise more than a decade ago, she was the lawyer in the room—and she was also the one asking how we could find a compliant way to get the research out and still meet the business need. I have wanted her on this team ever since,” said Sissi Pham, Founder and Chief Executive Officer of AESARA. “Very few people have helped write FDA policy and then had to live with it inside a company. That is exactly the perspective our clients need right now.”
Her industry work has spanned pharmaceuticals, biologics, and medical devices, and therapeutic areas including hematology, oncology, infectious disease, gastroenterology, immunology, women’s health, aesthetics, diagnostics, and regenerative medicine. Having worked inside emerging biotechnology companies, midsized organizations, and large global pharmaceutical companies—among them Celgene, Optimer Pharmaceuticals, Ironwood Pharmaceuticals, and Allergan—she brings a practical understanding of how regulatory strategy must evolve with the science, the product’s stage of development, and the needs of the organization. She has also worked directly with Congress as an FDA technical expert on statutory amendments to the Federal Food, Drug, and Cosmetic Act, including the provisions governing pre-approval information exchange.
That range matters in a field where the standards are frequently set without being defined. FDA’s 2018 guidance on communications consistent with FDA-required labeling requires that data be “scientifically appropriate and statistically sound” but does not say what that means, leaving companies to interpret the standard on their own at the cost of months of internal review. AESARA convened the CFL-SASS consortium to close that gap, developing an industry roadmap with 15 major pharmaceutical companies that delivers 17 consensus statements on the use of real-world evidence in promotion. The report will be released publicly.
“What I bring to AESARA is a perspective informed by having worked on both sides of the regulatory equation and across many different areas of the life sciences industry,” said Sánchez. “My experiences have reinforced that the strongest regulatory strategies are built early and collaboratively. My goal is to work alongside our clients and AESARA’s cross-functional team to think beyond what the rules permit and toward how thoughtful regulatory policy judgment and application can help advance our clients’ scientific, patient, and business objectives.”
“What excites me most is what this makes possible for our clients,” Pham continued. “An HEOR team can spend six months to a year moving a single piece through internal review, and by the time it clears, the business need it was built for has passed. With Denise, materials can reach the reviewing committee already built to the evidence standard, so approval takes weeks instead of quarters. And that is the smaller half of it. She makes us better at the beginning—when a client is deciding what evidence to build, what regulators will expect of it, and how the plan has to change as the product moves from development to launch. Getting that right is worth more than any single approval we accelerate.”
About AESARA
AESARA is a Value & Access agency working to be the agency of choice for value-evidence solutions and forward-looking access strategies. Founded in 2016 by CEO Sissi Pham and now in its 10th year, AESARA supports biotech and biopharmaceutical companies from development through global market expansion: designing clinical trial and real-world evidence strategies, preparing teams for FDA, EMA, PMDA, and other regulatory and stakeholder engagements, and planning pricing, market entry, and launch. The company is woman- and minority-owned and ISO 27001 certified, with professionals across the U.S., Canada, and Europe and local expertise covering the top 10 pharmaceutical markets worldwide. Its people come from inside the industry they serve—as AESARA puts it, “We’ve walked in your shoes and share your value and purpose.” The AESARA Foundation, established alongside the company to express its founding vision, supports initiatives that strengthen communities and advance sustainable social impact.
Contacts
Media Contact:
Ruslan Horblyuk
CSCO
AESARA
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