Daniela Drago

About Daniela Drago

The path from scientific breakthrough to patient bedside can feel daunting. Complex regulations, evolving standards, and the urgency to deliver can be overwhelming. But what if you had a partner who walked this path countless times and helped chart it for others?That\'s where I can come in. For 25+ years, I have dedicated my career to cutting through regulatory complexities, ensuring that life-changing innovations reach the patients who need them – faster. My experience is diverse: I have been in the trenches within pharmaceutical/biotech companies, driven research in academic institutions, and provided strategic counsel in consulting organizations. These perspectives allow me to anticipate hurdles and identify opportunities others might miss.CAREER HIGHLIGHTS Contributed to the approval of many new life science products from major regulatory bodies totaling billions in addressable market value. Developed and executed regulatory strategies for small molecules, biologics, gene & cell therapies, and combination products in rare and common disease areas, including oncology, ophthalmology, and neurology. Led several regulatory agency interactions, including meetings with FDA (CDER, CBER, and CDRH), EMA, MHRA, TGA, BfArM, Anvisa, SwissMedic, and Health Canada. Prepared or evaluated 100+ global regulatory applications, including orphan drug, fast track, breakthrough, and RMAT designations, INDs, CTAs, NDAs, BLAs, MAAs, and post-marketing supplements/variations. Served as an expert witness in pharmaceutical and biotech litigations. Testified at depositions and trial, and submitted expert reports in complex disputes. Authored 50+ publications and delivered 100+ presentations at international conferences, universities, and governmental agencies. Received multiple honors and awards, including induction in the Alpha Eta Honor Society for the Health Professions, the TOPRA Award for Regulatory Excellence, the RAPS Community Leadership Award, and the US President’s Volunteer Service Award. Recognized as a Fellow by the Regulatory Affairs Professional Society (FRAPS) and The Organisation for Professionals in Regulatory Affairs (FTOPRA).INTERESTS OUTSIDE WORK I enjoy traveling, ethnic food, and playing tennis. I was born on the Mediterranean coast and learned how to swim before I could walk, but my winter enthusiast and ski-loving husband and son take me to the slopes more often than to the beach. Want to discuss working together? Send me a message here on LinkedIn.

Experience

1. Board Member

   Regulatory Affairs Professionals Society (RAPS)

   Jan 2023 — Present

   I serve on the board of directors for the Regulatory Affairs Professionals Society (RAPS). In this role, I help guide RAPS\' strategic direction and policy-making to ensure it remains a trusted resource for advancing regulatory excellence. As a board member, I am committed to upholding the organization’s legal and fiduciary responsibilities, fostering its long-term sustainability, and enabling strategic decisions that benefit the global regulatory community.

Education

• EPFL

  Postdoc

  2002 — 2003

• ETH Zürich

  Ph.D., Chemistry

  1998 — 2002

• Università degli Studi di Messina

  BS/MS, Chemistry

  1992 — 1997

Skills

• Pharmaceutical Industry
• Regulatory Affairs
• R&D
• Cross-Functional Team Leadership
• Pharmaceutics
• Lifesciences
• Management
• Pharmacovigilance
• Organic Chemistry
• Drug Development
• Clinical Development
• Gmp
• Regulatory Submissions
• Biotechnology
• Clinical Trials
• Technology Transfer
• Fda
• Validation
• Sop
• Life Sciences