RAPS Names 2026 Fellows, Recognizing Leaders in Rare Disease and Regulatory Affairs
核心洞察
RAPS has named three regulatory affairs professionals as its 2026 Fellows, honoring sustained leadership contributions to the profession and their organizations.
Shekhar Natarajan of Dyne Therapeutics is recognized for nearly three decades of experience and advocacy in rare disease (搜索) drug development and regulatory policy.
Ola Oyinloye of Novo Nordisk and Mike Ryan, formerly of the FDA, are honored for advancing regulatory strategy across devices, combination products, and digital health.
Three regulatory affairs professionals have been recognized as the 2026 RAPS Fellows, an honor bestowed each year by the Regulatory Affairs Professionals Society for noteworthy and sustained leadership contributions to their organizations, to RAPS, and to the regulatory affairs profession.
RAPS Fellows hold the FRAPS designation and serve as important advisors and mentors for strategic collaboration, implementation of special initiatives, and international development across the regulatory community. Each new Fellow will be honored at RAPS Convergence 2026, taking place 15-17 September in Charlotte, North Carolina.
Shekhar Natarajan: Rare Disease Drug Development Leadership
Shekhar Natarajan is an experienced biotechnology leader with nearly three decades of industry experience across regulatory affairs and policy. He currently serves as vice president, international regulatory affairs and policy at Dyne Therapeutics, a biotechnology company developing therapies for people living with genetically driven neuromuscular diseases (搜索).
A recognized leader in rare disease (搜索) drug development, Natarajan is a strong advocate for addressing unmet medical needs in this field. He serves as chair of the Therapies Scientific Committee of the International Rare Diseases Research Consortium (IRDiRC) and is active in European regulatory and policy initiatives through the EU trade association EUCOPE and other regulatory bodies as an expert industry representative.
Ola Oyinloye: Regulatory Science and Digital Health Strategy
Ola Oyinloye, RAC-Devices, is a global regulatory affairs leader and advocate for advancing the regulatory profession, with expertise spanning medical devices, combination products, digital health technologies, and global regulatory strategy. She serves as regulatory science director at Novo Nordisk, where she integrates scientific and regulatory intelligence to inform enterprise decision-making.
Her work anticipates competitive pathways, approval timelines, and emerging regulatory, quality, and clinical trends, translating insights into strategic actions that strengthen pipeline development, accelerate innovation, and enhance long-term business competitiveness. She is an active contributor to EFPIA and BioPhorum, chair of the RAPS UK Local Networking Group, and a member of both the RAC-Devices Committee and the RAPS Regulatory Intelligence Europe Conference Planning Committee.
Mike Ryan: Modernizing FDA Regulatory Processes
Mike Ryan is an experienced regulatory leader who played a central role in modernizing regulatory processes as a regulatory advisor and senior leader at the US Food and Drug Administration (FDA). Over 21 years at the FDA, he worked across the full spectrum of premarket review, postmarket surveillance, and policy development in the Center for Devices and Radiological Health.
During his tenure at the FDA, Ryan served as a lead premarket reviewer and a total product life cycle manager, where he reviewed and oversaw hundreds of premarket submissions, developed dozens of regulations and guidance documents, and led continuous improvement and transformative initiatives in compliance and postmarket surveillance. He is now executive vice president, medical devices and combination products at Eliquent (搜索).
Rare Disease Regulatory Policy in Focus
The recognition of these Fellows coincides with growing momentum in rare disease (搜索) regulatory policy. Lisa Wright, director of regulatory policy at Novo Nordisk, notes that the rare disease space "has just become more accessible across the globe," with more regulators considering these diseases in ways they had not previously.
Wright, who leads a session at RAPS Convergence 2026 titled "Navigating the New US and EU Rare Disease (搜索) Regulatory Framework and Global Harmonization Efforts," highlights ongoing work to advance the patient voice in regulatory decision-making. "I would like to see regulators get more comfortable with patient experience data," she said, pointing to efforts by ICH, including new guidance E22 on patient preference information, as a potential driver of global progress.
Her session will explore the challenges and opportunities between the US FDA and EMA in the rare disease (搜索) space, including the different data sets utilized by each regulator, the future use of AI, and how to operationalize rare disease trials on a global scale. The panel brings together representatives from the FDA, EMA, the National Academies of Sciences, and a patient representative organization, including regulators involved in joint collaboration between those agencies and Health Canada.