Dr. Leyna Mulholland

Global Regulatory Affairs


Dr. Leyna Mulholland is a global pharmaceutical professional with extensive drug development experience includingglobal clinical research, regulatory affairs, and project management. Proven international registration experiences in IND/CTA/CTN with track records of more than 20 successful marketing applications of NDAs/MAAs in US/EU, respectively. She has substantial experience in biologic products as well as small molecules and companion diagnostics (CDx) development. She had been part of international joint ventures and successful launches of products worldwide. She can provide her effective communication skills gained across internal and external stakeholders to the projects she is working on. She combines excellent global regulatory strategic experience with solid scientific expertise, also in effective development of benefit and risk management plans and target product process determination.


Her specific fields of expertise are related to:

  • Therapeutic areas of excellence in oncology, CNS, and metabolic disease with Life Cycle management in mind
  • Knowledge in US and international regulatory requirements, including ICH and GXP regulations
  • Extensive agency interaction expereince;  participated in more than 30 successful regulatory meetings on drug development, CMC quality challenges, successful filing strategy, and launch of biological products with US FDA, EMA, Japanese PMDA, and Korean FDA
  • Broad experiences in R&D to support regional/global requirements in the areas of drug development, non-clinical, and clinical development for successful registration
  • Due Diligence studies and International joint ventures:  Established over 30 in- and out-licensing and technology transfer projects.


Dr. Mulholland worked in three Big Pharma, i.e.Eli Lilly, Merck, and Hoffman-La Roche for almost 20 years.  She was involved with the set up of strategic drug development plans, quality drug development and CMC issues, and successful filing plans and strategy.  She had participated in the preparations of NDA and MAA/BLA and reviewed a number of documents to ensure the delivery of high quality dossier to regulatory agencies. With her leadership and guidance, she has a track record of more than 20 drug (biologics) applications and approvals during her appointment. As part of successful filing of BLA/MAA, she participated in successful inspections of Herceptin by PMDA in Europe, Actemra EMA inspection in Japan, and Perjeta inspection by USFDA.


As a consultant, Dr. Mulholland guided teams for IND filing, lifting of clinical hold, dealing with CMC and manufacturing issues by through negotiations with US FDA.


During her tenure in Big Biopharma, Dr. Mulholland was involved in development products portfolio review, prioritization of development, and Drug Safety Committee to maximize the company’s portfolio and life cycle management not only in the USA but also worldwide. Participated in discussions on portfolio periodization to win the stiff external competitions. As a global member of projects, she had participated in a number of project meetings, discussions and negotiations with regulatory agencies including the European Medicines Agency (EMA), USFDA, PMDA and other Asian Health Authorities including China FDA for successful development options, high quality delivery of drug products, and successful application submissions.  


Academically Dr. Mulholland was in cancer research and instructor at University of Michigan Medical School and Indiana University School of Public Health, providing graduate level advance courses to graduate students for 7 years.  She obtained her BS in Pharmaceutical Science from Hoshi University, Tokyo Japan; BS in Biochemical Toxicology and PhD in Genetic Toxicology from the University of Michigan, Ann Arbor, Michigan. Dr. Mulholland served as an instructor at EUCRAF for 3 years and she was an invited faculty at the Regulatory Affairs education program at Peking University in China, where more than 100 professionals obtained certifications in regulatory affairs.   She served as a Chairman of Regulatory Affairs SIAC in DIA for 2 years representing US regulatory affairs and in 2006 she received the DIA’s Program Award for leading active Regulatory Affairs SIAC and workshops worldwide.  She was a dynamic speaker and instructor at various DIA workshops and Clinical training at Risk Assessment and Management. During her career at Merck, she lead a company-wide training in proactive risk assessment and management to ensure streamlined drug development. 


Services:

  • Global Regulatory Affairs
  • Japan and US Agent for Biopharma Excellence