The Art and Science of Productive FDA Meetings

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06/02/2018 11:30 06/02/2018 14:00 America/Los_Angeles The Art and Science of Productive FDA Meetings Johnson & Johnson Innovation, JLABS , 329 Oyster Point Blvd , South San Francisco , CA JLABS Bay Area false DD/MM/YYYY
February
6
Event

The Art and Science of Productive FDA Meetings

Johnson & Johnson Innovation, JLABS , 329 Oyster Point Blvd , South San Francisco , CA

February 06, 2018 from 11:30 AM to 14:00 PM (PDT)

$10 - $35


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 Ron Farkas, MD PhD, Vice President, Technical, 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!

Speaker:
Ron Farkas | Vice President, Technical , PAREXEL Consulting read bio»

Agenda:
10:30 AM | Registration & Networking
11:00 AM | Presentation
11:40 AM | Q&A
12:00 PM | Networking Lunch
1:00 PM | Program Close


Fees:
$25 | General Public
$10 | Student/Academic
$35 | At the door

Location:
JLABS @ SSF
329 Oyster Point Blvd - 3rd Floor
South San Francisco, CA

Presenter's Biography:
John Bates Ron Farkas | Vice President, Technical, PAREXEL Consulting
Dr. Ronald Farkas is a senior regulatory professional with over 15 years of experience in all phases of drug development from preclinical development through marketing application, advisory committee meetings, labeling negotiations, and the post-approval period. Dr. Farkas has in-depth cross-disciplinary expertise in clinical safety and efficacy, clinical pharmacology and pharmacogenomics, preclinical development, statistical analysis, and biomarker/surrogate endpoint development and utilization.

Dr. Farkas uses his extensive scientific, drug development and regulatory experience to assist clients in negotiating with regulatory authorities across the entire product life cycle to achieve their company objectives.

Prior to joining PAREXEL, Dr. Farkas was a Cross-Disciplinary Team Leader at FDA in CDER's Division of Neurology Products, with prior assignments to the Office of New Drugs Guidance and Policy Team and the CDRH Office of Device Evaluation. Prior to joining the FDA, Dr. Farkas was an assistant professor and attending surgeon at the Johns Hopkins University Wilmer Ophthalmic Institute.

Dr. Farkas completed residency training in ophthalmology at the Harvard University School of Medicine Massachusetts Eye and Ear Infirmary, subsequent to earning dual MD and PhD degrees in neuroanatomy and neuropharmacology from the University of Illinois at Chicago School of Medicine.
Connect with Ron:   Connect on LinkedIn


JLABS Bay Area

About Johnson & Johnson Innovation, JLABS 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 healthtech sectors. The JLABS flagship opened in 2012 in San Diego at Janssen's West Coast Research Center, and since then has grown to ten global locations including the Bay Area, Boston & Lowell, MA, Houston, Toronto, Beerse (Belgium), with New York City, opening in June 2018, and Shanghai in 2019. For more information please visit www.jlabs.jnjinnovation.com or follow @JLABS. About Johnson & Johnson Innovation Johnson & Johnson Innovation LLC focuses on accelerating all stages of innovation worldwide and forming collaborations between entrepreneurs and Johnson & Johnson's global healthcare businesses. Johnson & Johnson Innovation provides scientists, entrepreneurs and emerging companies with one-stop access to science and technology experts who can facilitate collaborations across the pharmaceutical, medical device and consumer companies of Johnson & Johnson. Under the Johnson & Johnson Innovation umbrella of businesses, we connect with innovators through our regional Innovation Centers, Johnson & Johnson Innovation | JLABS, Johnson & Johnson Innovation - JJDC, Inc. and our Business Development teams to create customized deals and novel collaborations that speed development of innovations to solve unmet needs in patients. For more information please visit www.jnjinnovation.com or follow @JNJInnovation.

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