Going Global: Bringing Drugs for Depression to Market in the US and EU

Adam Simmons, Vice President, Program Strategy, Neuroscience, Premier Research

As Executive Director, Clinical Program Strategy, Adam Simmons is responsible for providing strategic planning, coordination, knowledge and expertise in neuropharmacology for clinical research projects and/or standalone consultative services. Adam has over 20 years of experience in drug and device research working for pharmaceutical companies and academic medical centers with over 30 publications across neuroscience indications and research methodologies. He also supported scientific communication and media appearances in support for the launch of LYBALVI®, a program for which he served as Alkermes’ Clinical Lead and presented data at major scientific congresses. Additionally, Adam has overseen clinical trials conducted in over 25 countries across North and South America, Europe and Asia Pacific.

Adam holds a Master’s in Public Health in Epidemiology from Emory University and a Bachelor’s degree in Health and Society from the University of Rochester. Currently, Adam sits on the steering committee for the STARR Coalition, a non-profit patient advocacy organization that connects people living with mental illness to clinical research. He has also been involved as a speaker or in support of patient advocacy activities with organizations including the National Alliance of Mental Illness, the Depression and Bipolar Support Alliance, the National Council for Mental Wellbeing and others.

Federica Martini, PhD, Associate Director, Regulatory Affairs, Premier Consulting

Federica Martini, Associate Director, Regulatory Affairs, Premier Consulting, is a regulatory professional with 10+ years of experience in the pharmaceutical and biotech industries. She has supported pre-approval biologics for allergy, oncology, neurology, ophthalmology, dermatology, pediatric and rare disease indications, and brings extensive knowledge in cell and gene therapies.

Federica has a strong background in developing EU regulatory strategies, leading cross-functional teams in health authority interactions, and in supporting regulatory applications, including document development to support applications such as Scientific Advice, PRIME, Clinical trial Applications (CTA), Orphan Drug Designations (ODD), Pediatric Investigation Plans (PIP), and Development Safety Updated Reports (DSUR). Federica also supports regulatory activities with the FDA, including participating in FDA meetings, Investigational New Drug (IND) applications and amendments, initial Pediatric Study Plans, ODD, and more.

Federica holds a Bachelor of Veterinary Medicine from the University of Camerino in Italy, a Master of Medicine in Research and Development from the University Autonoma of Madrid, and a Ph.D. in Veterinary Pharmacology and Toxicology from the University Complutense of Madrid in Spain.