AESARA Appoints Denise Sánchez as Vice President of Regulatory Counsel & Compliance Strategies
AESARA, a leading Value & Access agency, has announced the appointment of Denise Sánchez, JD, MS, MA, as Vice President, Regulatory Counsel & Compliance Strategies. Sánchez brings more than two decades of experience spanning regulatory policy, compliance, scientific strategy, and the practical application of regulatory requirements across the life sciences industry.
Her appointment adds significant regulatory and policy expertise to AESARA’s multidisciplinary capabilities, particularly at a time when pharmaceutical, biotechnology, and medical device companies face increasingly complex questions about evidence generation, communications, promotional practices, and regulatory compliance.
Sánchez has held senior regulatory roles within the U.S. Food and Drug Administration (FDA), serving twice as FDA Regulatory Counsel for Policy. Her first tenure was with the Center for Biologics Evaluation and Research (CBER), followed by a second role at the Center for Devices and Radiological Health (CDRH). Her experience on both sides of the regulatory equation gives her a distinctive perspective on how FDA policy is developed, interpreted, and ultimately applied by life sciences organizations.
Bringing FDA Policy Experience to Industry Challenges
Sánchez’s career has focused on the intersection of law, regulatory policy, science, and business. During her time at the FDA, she worked directly with regulatory policy and helped organizations understand how evolving requirements could affect product development, evidence generation, communications, and commercialization.
Her experience also extends beyond the agency environment. She has worked within emerging biotechnology companies, midsized organizations, and large global pharmaceutical companies, giving her direct insight into the operational realities that organizations encounter when implementing regulatory strategies.
Her industry experience includes positions and work involving companies such as Celgene, Optimer Pharmaceuticals, Ironwood Pharmaceuticals, and Allergan. Across these organizations, she has supported programs involving pharmaceuticals, biologics, and medical devices and has worked across a broad range of therapeutic and healthcare areas.
These areas include hematology, oncology, infectious disease, gastroenterology, immunology, women’s health, aesthetics, diagnostics, and regenerative medicine.
That breadth is expected to strengthen AESARA’s ability to advise clients on regulatory and compliance questions that extend across the product lifecycle, from early development and evidence planning through launch and commercialization.
A Perspective Built Across Multiple Sides of the Regulatory Process
According to AESARA Founder and Chief Executive Officer Sissi Pham, Sánchez’s ability to understand both regulatory policy and the realities of operating within a life sciences organization was a key reason for bringing her onto the team.
“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 Pham.
Pham emphasized that relatively few professionals have the opportunity to help develop FDA policy and subsequently apply that policy within commercial organizations.
“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,” Pham added.
Sánchez’s combination of legal, scientific, policy, and industry experience is particularly relevant to organizations that must balance regulatory requirements with the need to generate and communicate meaningful evidence.
Addressing the Challenge of Evidence and Regulatory Standards
One of the challenges facing pharmaceutical and healthcare companies is the need to translate broad regulatory standards into practical internal processes. Companies frequently need to determine whether evidence can be used in external communications, how information should be presented, and whether a proposed analysis meets applicable regulatory expectations.
In some areas, the underlying standards can be clear in principle but less straightforward in practical application.
For example, FDA’s 2018 guidance concerning communications consistent with FDA-required labeling states that data should be “scientifically appropriate and statistically sound.” However, the practical interpretation of those terms can create uncertainty for organizations seeking to use emerging evidence in compliant communications.
For companies, this uncertainty can lead to extensive internal review processes involving medical, legal, regulatory, health economics and outcomes research (HEOR), commercial, and other teams. While these reviews are designed to reduce compliance risk, they can also delay the use of evidence and potentially reduce its relevance to immediate business or patient needs.
AESARA has sought to address this challenge through the creation of the CFL-SASS consortium.
Building Consensus Around Real-World Evidence
The CFL-SASS consortium brought together 15 major pharmaceutical companies to develop an industry roadmap focused on the use of real-world evidence in promotion.
The initiative produced 17 consensus statements intended to help address questions surrounding the appropriate use of real-world evidence and provide greater clarity for organizations developing and communicating evidence.
The resulting report is expected to be released publicly, providing broader access to the consortium’s work and its recommendations.
Sánchez’s background is closely aligned with this type of effort because her career has involved not only interpreting regulatory expectations but also helping organizations determine how those expectations can be incorporated into real-world evidence strategies and business processes.
Her experience also includes direct engagement with Congress. She has served as an FDA technical expert on statutory amendments to the Federal Food, Drug, and Cosmetic Act, including provisions governing pre-approval information exchange.
This experience provides an additional layer of perspective on how statutory requirements, regulatory policy, scientific evidence, and business needs intersect.
Supporting Clients Earlier in Product Development
Sánchez said her approach is based on the importance of establishing regulatory strategy early rather than waiting until evidence has already been generated or a product is approaching commercialization.
“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.
She added that her professional experiences have demonstrated the value of building regulatory strategies collaboratively and early in the development process.
“My experiences have reinforced that the strongest regulatory strategies are built early and collaboratively,” Sánchez said. “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.”
The approach reflects an increasingly integrated view of regulatory strategy, in which compliance is considered alongside evidence generation, scientific objectives, patient needs, and commercial requirements.
Rather than treating regulatory review as a final checkpoint, Sánchez’s role is expected to help organizations incorporate regulatory considerations into decisions much earlier in the development and evidence-planning process.
Helping Reduce Delays in Evidence Review
For AESARA, the practical benefit of Sánchez’s appointment extends beyond helping clients navigate individual regulatory questions.
Pham pointed to the significant amount of time that can be required to move a single piece of HEOR or evidence-related material through an organization’s internal review process.
“What excites me most is what this makes possible for our clients,” said Pham.
“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,” she explained.
According to Pham, integrating regulatory considerations earlier in the development of evidence can help reduce these delays. Instead of creating materials first and determining later whether they meet the applicable evidence standard, teams can incorporate those requirements into the development process from the outset.
“With Denise, materials can reach the reviewing committee already built to the evidence standard, so approval takes weeks instead of quarters,” Pham said.
The potential impact, however, extends beyond accelerating the review of individual materials. AESARA sees Sánchez’s experience as an opportunity to strengthen the regulatory foundation of client strategies from the beginning.
Connecting Evidence, Regulation, and Business Objectives
The life sciences industry increasingly depends on evidence generated outside traditional clinical trials, including real-world evidence, health economics research, observational analyses, and other forms of data. As organizations seek to use these data in increasingly sophisticated ways, regulatory and compliance considerations become an important part of evidence strategy.
Sánchez’s experience across FDA policy, pharmaceutical and biotechnology companies, medical devices, and multiple therapeutic areas positions her to address these issues from several perspectives.
Her work across organizations of different sizes is also relevant to the varying needs of life sciences companies. Emerging biotechnology companies may require regulatory strategies that evolve alongside rapidly changing development programs, while larger pharmaceutical organizations may need to coordinate regulatory considerations across multiple functions and geographies.
By joining AESARA, Sánchez is expected to contribute to a model that brings regulatory counsel and compliance strategy closer to the broader evidence and value-access planning process.
Pham said that this broader perspective could influence decisions well before materials reach an internal review committee.
“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,” Pham said.
“Getting that right is worth more than any single approval we accelerate,” she added.
Strengthening AESARA’s Regulatory and Value & Access Capabilities
Sánchez’s appointment represents an expansion of AESARA’s regulatory counsel and compliance strategy capabilities, bringing together agency experience, legal expertise, scientific understanding, and industry application.
Her background across biologics, pharmaceuticals, medical devices, diagnostics, and regenerative medicine provides a broad foundation for supporting clients with diverse products and development programs. Her experience across therapeutic areas ranging from oncology and hematology to infectious disease, immunology, gastroenterology, women’s health, aesthetics, and other fields further complements the multidisciplinary nature of AESARA’s work.
At the same time, her experience working directly with FDA policy and legislative issues provides insight into the regulatory environment beyond individual product reviews.
As companies continue to generate larger and more complex bodies of evidence, the ability to understand regulatory expectations early and incorporate them into evidence strategies may become increasingly important. AESARA’s addition of Sánchez is intended to help clients navigate that environment while keeping scientific, patient, and business priorities aligned.
Through her new role as Vice President, Regulatory Counsel & Compliance Strategies, Sánchez will work with AESARA’s teams and clients to develop practical approaches to regulatory policy and compliance. Her experience on both sides of the regulatory process is expected to support companies seeking to move evidence from development into compliant, meaningful application more efficiently.
The appointment therefore strengthens AESARA’s broader mission of helping life sciences organizations connect evidence, regulatory strategy, value, access, and business objectives throughout the product lifecycle.
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.