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Getting solutions to patients can be a long and complicated process. Working with the FDA is a key part of the sequence. Preparing for and understanding the FDA's needs is essential to smooth the way and shorten your time to approval.
Johnson & Johnson Innovation, JLABS is happy to be hosting Partha Roy PhD, Director, PAREXEL Consulting, to discuss the ins and outs of FDA meetings. Ron will pull from his vast experience which includes a decade plus run at the FDA to help guide us through these vital interactions. Topics will include:
Understanding the FDA's position; not just what it wants but why
What to agree on now and later; What does agreement mean?
The key to proceed
Understanding the dynamics within the FDA
Flexibility and norms and what they mean
Experts, Patients and Advocates at Meetings
Meeting minutes and follow up
Understanding the process will help you better prepare for your meetings and build confidence in and ability to adjust your own plan. Come prepared with your questions!
Presenter's Biography: Partha Roy | Director, PAREXEL Consulting Partha draws on over 17 years of drug development experience including 5 years of review experience at FDA with proven expertise in Clinical Pharmacology and Regulatory Sciences across multiple therapeutic areas encompassing both small molecules and biologics. Besides new drugs and novel biologics, Partha has specific review and development expertise in Inhalation and Nasal Products, Biosimilars, Complex Generics and OTC drug products. Over the last 5 years at PAREXEL, Partha has been providing strategic guidance on various clinical and regulatory aspects around 505(b)(2) and 505(j) pathways, BA/BE, dose selection, PK and PK/PD, biomarkers, clinical trial design, drug-drug interactions, special populations, pediatric plan and physician labeling. He utilizes his experience to negotiate drug development plans with review divisions at FDA and develop regulatory strategies with clients for a favorable outcome.
Have questions about The Art and Science of Productive FDA Meetings?
Contact JLABS @ TMC
When & Where
JLABS @ TMC
John P. McGovern Campus
2450 Holcombe Blvd, Suite J
Houston,
TX 77021
Thursday, May 3, 2018 from 10:30 AM to 1:00 PM (CDT)
Johnson & Johnson Innovation, JLABS (JLABS) is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-saving, life-enhancing health and wellness solutions to patients around the world. JLABS achieves this by providing the optimal environment for emerging companies to catalyze growth and optimize their research and development by opening them to vital industry connections, delivering entrepreneurial programs and providing a capital-efficient, flexible platform where they can transform the scientific discoveries of today into the breakthrough healthcare solutions of tomorrow. At JLABS we value great ideas and are passionate about removing obstacles to success to help innovators unleash the potential of their early scientific discoveries. JLABS is a no-strings-attached model, which means entrepreneurs are free to develop their science while holding on to their intellectual property. JLABS is open to entrepreneurs across a broad healthcare spectrum including pharmaceutical, medical device, consumer and digital health sectors. The JLABS flagship opened in 2012 in San Diego at Janssen's West Coast Research Center, and since then has grown to ten locations including the Bay Area, Boston & Lowell, MA, Houston, Toronto, Beerse (Belgium), New York City, and Shanghai, launching in 2019. For more information please visit jlabs.jnjinnovation.com.
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Getting solutions to patients can be a long and complicated process. Working with the FDA is a key part of the sequence. Preparing for and understanding the FDA's needs is essential to smooth the way and shorten your time to approval.
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