The Art and Science of Productive FDA Meetings

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!

Speaker:
Partha Roy, PhD | Director, 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:
$15 | General Public
$20 | At the door

Location:
JLABS @ TMC
2450 Holcombe Blvd. Suite J
Houston, Texas 77021

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.