IND Submission for a 505(b)(2) Product

Duration: 60 Minutes
A 505(b)2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products. However, 505(b)(2) products require evidence from clinical trials conducted under an IND in support of the marketing approval application.
505 b 2 regulations
Instructor: Mukesh Kumar
Product ID: 500018
All sponsors of clinical trials in the US have to first file an Investigational New Drug (IND) application with the FDA containing extensive preclinical and clinical testing information in support of the proposed clinical trial. Since INDs for 505(b)(2) products rely heavily on the information available about the reference product, creating such an IND raises unique issues. This seminar will discuss the regulatory requirements and logistics for creating an IND application for 505(b)(2) products. This seminar contains a collection of practical tips from the trainer’s extensive IND submission experience.

Why Should you Attend:
Despite being around for more than 25 years, same as generic drugs, the 505(b)(2) products have only recently become more popular. The main reason is that due to several similarities with generic products, 505(b)(2) products offer some unique challenges. Just like NDAs for new drugs, 505(b)(2) products could require several clinical and non-clinical studies and could take a significant allocation of resources, albeit less than that for a brand new product but much higher than that for a generic drug. Like all drug development strategies, 505(b)(2) pathway requires careful consideration and planning taking into account all the potential issues to be addressed before embarking on development. Due to the similarities with traditional drug development, they offer a low risk market entry point by training the work force in the traditional development processes. However, as would be evident, there are unique challenges to developing such products – scientific, regulatory, logistical and financial – all of which could convert a potentially attractive project into a constant headache.

This seminar will discuss the practical strategies for clinical trial approval for such product. Key strategic considerations will be discussed using real-life case studies. Also discussed will be role of interactions with the FDA, global clinical trials, and projected trends for the near future.

Objectives of the Presentation:
The seminar aims to clarify the following key concepts:
  • The 505(B)(2) regulation and guidance from the FDA
  • Strategic considerations before embarking on a clinical trial for 505(b)(2) products
  • Key components of an IND application
  • FDA’s review process and ongoing consultation
  • Challenges to developing IND for 505(b)(2) products and possible solutions
  • Examples of successful strategies for developing such products
  • Searching for a 505(b)(2) project, future trends.
Who can Benefit:
  • Sponsors of INDs
  • Regulatory Affairs Professionals
  • Senior Management Executives (CEO, COO, CFO, etc)
  • Drug Discovery and Development Professionals (R&D and CMC)
  • Intellectual Property Experts
  • Clinical and Preclinical Laboratory Managers
  • Project Managers and Clinical Trial Specialists
  • Regulatory Compliance Associates and Managers
  • People investing in FDA-regulated product development projects.
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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