FDA 505(b)(2) Applications Seminar
Regis Technologies invites you for a seminar on FDA 505(b)(2) applications. Two guest speakers from PAREXEL Consulting, Dr. Aloka Srinivasan and Dr. Partha Roy, will deliver the two part seminar. Read their abstracts below for more details. A light breakfast will be served.
Join us for coffee and chemistry on Friday, March 4th, 8-9:30AM.
Coffee served at 8:00am; presentation begins at 8:30am; Q&A at 9:30am.
Regulatory Pathway Considerations for 505(b)(2) Applications at FDA
Aloka Srinivasan, Ph.D., Principal Consultant, PAREXEL Consulting
This presentation will highlight the following:
- Regulatory Pathway – Where does a 505(b)(2) fit?
- Objectives of 505(b)(2) applications
- Critical questions related 505(b)(2) submissions
- The thin line between 505(b)(2) and 505(j)
Aloka Srinivasan, Ph.D.
Aloka Srinivasan, Ph.D., is currently a Principal Consultant at PAREXEL International. Aloka has over 10 years of experience in FDA and other government agencies, performing scientific research and evaluating the chemistry, manufacturing, and control (CMC) sections of applications. Aloka is experienced in assessment of ANDAs, INDs, NDAs, with a focus on 505(b)(2) applications, , and DMFs for diverse therapeutic classes of drugs. Prior to joining PAREXEL, Aloka was a Team Leader in Office of Generic Drugs, FDA and instrumental in establishing the groundwork for a Drug Substance (related to Type II DMFs) Review Division at CDER. Aloka actively participated, Question based Review (QbR) and Quality by Design (QbD) initiative in CDER/FDA. She is also the primary author of a Question Based Review for Type II DMFs, currently part of the CDER mapp 5015.10. As a team leader in Office of Generic Drugs, Aloka specialized in review of drugs of diverse therapeutic classes including topical antibiotics, anti-diabetics, anti-epileptic, iron carbohydrate and other complex generics. At PAREXEL, Aloka has worked on numerous NDAs including 505(b)(2) applications, starting from the pre-IND meetings to approval. Aloka has authored several articles and presented the office initiative related to QbD and DMFs on behalf of FDA as well as PAREXEL. Aloka received many awards including Center Director’s Special Citation 2011, CDER/FDA for leadership in implementing and developing the innovative DMF Review System.
All 505(b)(2)s are not created equal.
Partha Roy, Ph.D., Director, PAREXEL Consulting
This presentation will highlight the following:
- Key distinguishing features across 505 applications: b1, b2 and j
- Definition of a 505(b)(2) Application
- Objectives of 505(b)(2) Pathway
- Type of Information to Reference
- 505(b)(2) Q&A and recent examples/case studies
Partha Roy, Ph.D.
Dr. Roy has over 15 years of pharmaceutical R&D experience both in industry and US FDA with proven expertise in Clinical Pharmacology and Regulatory Sciences across multiple therapeutic areas encompassing both small molecules and biologics. Dr. Roy provides strategic guidance on various clinical and regulatory aspects of drug development. His primary areas of expertise include Biosimilars and Biologics, Oral Inhalation and Nasal drug products, Over-The-Counter medications, Pediatric drug development and Formulation development and. As a FDA reviewer/team leader, Dr. Roy had extensive review experience dealing with issues around 505(b)(2) pathway, BA/BE, dose selection, PK and PK/PD, biomarkers, clinical trial design, drug-drug interactions, special populations, pediatric plan and physician labeling.
Dr. Roy utilizes his experience to negotiate drug development plans with review divisions at FDA and develop regulatory strategies with clients for a favorable outcome. He is currently helping multiple clients mapping out regulatory strategies for drug candidates ranging from pre-IND to NDA stages, each one facing significant development challenges. Dr. Roy also frequently leads and coordinates FDA submissions (PIND, IND, NDA, post-marketing) for clients. Dr. Roy holds a PhD in Biochemical Toxicology from the College of Public Health, University of South Florida, and has completed a postdoctoral training in Drug Metabolism and Pharmacokinetics at Boston University. Dr. Roy is a frequent speaker at national and international meetings and has authored several peer-reviewed articles.