An estimated 350 million people around the world live with major depressive disorder (MDD) and more than 700,000 die due to suicide every year. While existing treatments such as medications and psychotherapy can make a difference, there remains a critical need for more effective drugs that offer sustained relief and prevent relapses.
North America dominates the antidepressant drug market, and most developers first target approval in the US before seeking approval in other regions. However, the regulatory pathways are not harmonized, and a draft guideline released by the European Medicines Agency (EMA) may complicate plans for globalization.
In this webinar, the expert speaker will cover the current guidance on MDD trials and explore strategies for navigating differences in regulatory requirements to efficiently bring drugs to market in both the US and the EU.
Register for this webinar today to gain insights into how to bring drugs for depression to market in the US and EU.
Speakers
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.
Message Presenter
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.
Message PresenterWho Should Attend?
This webinar will benefit managers and above at biotech and specialty pharma companies with job functions including, but not limited, to:
- Clinical operations
- Medical affairs
- Project management
- Regulatory affairs
What You Will Learn
The attendees will learn about:
- The pathway to approval in the US vs EU
- The potential impact of the draft EMA guidance on development planning and regulatory strategy
- The key considerations for designing and operationalizing a maintenance study in MDD
- The proactive planning required for targeting the global market
Xtalks Partner
Premier Research
Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com.
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