Preparing for expedited drug development requires a thorough understanding of the steps that comprise a successful first-in-human study. It’s essential to start with the end firmly in mind, identifying the target population and defining elements of the program long before you dose the first patient. This webinar will show you where to start and how to envision the end, describe the U.S. and European pathways for accelerating development and equip you to engage with regulators effectively.
The webinar will explore the target product profile — the drug development program summary that defines drug labeling concepts and commercial goals — and why the profile must include a development program plan that supports its objectives.
Register for this webinar to hear about:
- Understanding the multiple and essential interfaces with the Food and Drug Administration and European Medicines Agency
- The importance of having a pre-IND meeting with the FDA to minimize risk upfront, when mitigation efforts are most effective
- Avenues for expedited product review in the U.S. and Europe: what approaches are available, and how to use them to your best advantage
Speakers
Sameena Sharif, President, RPI, A Division of Premier Research
Sameena Sharif is a Pharma Executive with 22 years of experience as a leader in drug development, alliance, project and portfolio management. She has broad experience in management of projects at all stages of drug development – as early as target selection, to pre-IND through to NDA/MAA submissions and commercial planning. She has also led large cross functional teams in global alliances with Amgen, Otsuka, Genentech, Novartis, Onyx and AstraZeneca. Special interest in optimization of the drug development and alliance management process in small and midsize companies.
Message Presenter
Naomi Kautz, Senior Director, Regulatory Affairs, RPI, A Division of Premier Research
Naomi brings 20 years of multidisciplinary experience in biotechnology/pharmaceutical industry in Regulatory Affairs, Research and Development, and Policy after receiving her academic training in biochemistry. Her tenure in Regulatory Affairs has spanned early stage through late stage development and NDAs. Since 2009, her area of focus in Regulatory Affairs has been in the development of cell and gene therapy. In 2018, Naomi joined Regulatory Professionals, a regulatory consultancy firm that provides regulatory expertise to small and mid-sized biotechnology and pharmaceutical companies for both biologics and small molecule drug development programs. RPI is a division of Premier Research.
Message Presenter
Beatriz Criado, Associate Director, Regulatory Affairs, Premier Research
Beatriz is a senior professional with over 22 years of experience in the area of Regulatory Affairs in the pharmaceutical and biotech industry, progressively holding regulatory positions of increasing responsibility and leadership. Beatriz started her regulatory career at Norman and later on in Italfarmaco. Then she moved to Sanofi Pasteur MSD where she spent seven years as a Regulatory Affairs Manager. Her next job was at Exeltis where she was the Regulatory Affairs Manager of the corporate research center (Ladee Pharma Research Institute) based in Madrid. Prior to joining Premier Research, Beatriz worked at Biogen as an Associate Director in Regulatory Affairs.
Beatriz is well versed in bringing products from development to market and she has a solid background in biological and biotech-based products. She has broad experience in a wide variety of therapeutic areas, including immunology, neuroscience, women’s health, rare diseases and pediatric indications.
Message PresenterWho Should Attend?
- Contacts at Companies with Upcoming Phase I Trials
- CEO/COO of Biotechs
- Regulatory Executives
What You Will Learn
In this webinar, participants will learn about:
- Understanding the multiple and essential interfaces with the Food and Drug Administration and European Medicines Agency
- The importance of having a pre-IND meeting with the FDA to minimize risk upfront, when mitigation efforts are most effective
- Avenues for expedited product review in the U.S. and Europe: what approaches are available, and how to use them to your best advantage
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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