ComplianceOnline

Practical Strategies to a successful 505(b)(2) product

Instructor: Mukesh Kumar
Product ID: 701801
  • Duration: 60 Min

recorded version

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Training CD

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Read Frequently Asked Questions

In this 505(b)(2) related webinar, know the complete details, key strategies, regulatory considerations, and marketing strategies for developing 505(b)(2) products.

Why Should You Attend:

A 505(b)(2) products is an improved or altered version or a new use application for a previously FDA-approved drug. Every year FDA approves about twice the number of 505(b)(2) applications compared to traditional 505(b)(1) applications. It is projected that due to increased challenges in creating new products, 505(b)(2) products might comprise more than 70% of all FDA approvals over the next 10 years. This pathway is particularly attractive to manufacturers transitioning from generic drugs to innovator products.

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 505(b)(2)webinar will discuss the practical strategies for drug development via 505(b)(2) regulatory pathway. Key strategic considerations will be discussed using real-life case studies. Also discussed will be role of interactions with the FDA, global clinical trials, market access, reimbursement issues and projected trends for the near future. Lastly, the 505(b)(2) pathway will be compared to that for biosimilars.

Areas Covered in the Seminar:

  • The 505(B)(2) regulation and guidance from the FDA.
  • Strategic considerations before embarking on a 505(b)(2) development project.
  • Intellectual property issues with such products.
  • Key development steps for such products.
  • FDA’s review process and ongoing consultation.
  • Challenges to developing 505(b)(2) product and possible solutions.
  • Examples of successful strategies for developing such products.
  • Searching for a 505(b)(2) project, future trends.
  • 505(b)(2) and biosimilars.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

  • Regulatory affairs professionals
  • Senior management executives (CEO, COO, CFO, etc)
  • Drug discovery and development professionals (R&D and CMC)
  • Intellectual property experts
  • Project Managers and Clinical trial specialists
  • Regulatory Compliance Associates and Managers
  • People investing in FDA-regulated product development projects

Instructor Profile:

Dr. Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India.

He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

Topic Back Ground:

505(b)2) products are typically improved or altered versions or a new use application for previously FDA-approved drugs. 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.

It involves making significant changes to an existing FDA approved product, called reference product, to create a new product with its own indication, formulation, population, and/ or other differences that need to be supported with clinical studies. A major advantage of this pathway is that it allows a sponsor to rely, at least in part, on the FDA’s findings of safety and/or effectiveness for a previously approved drug, thereby reducing the number of clinical trials required for approval. The biggest incentive to develop 505(b)(2) products is 3 years of market exclusivity available to the approved product.

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 are subject to full user fee under the Prescription Drug User Fee Act (PDUFA), 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. These issues include intellectual property concerns, supporting information available either from reference products or literature, the logistics of conducting clinical trials with generic-like products, market competition for approved products and business considerations for international product launch. Every year FDA approves approximately twice the number of 505(b)(2) applications than the traditional 505(b)(1) applications. It is projected that due to increased challenges in creating new products, 505(b)(2) products might comprise more than 70% of all FDA approvals over the next 10 years. This pathway is particularly attractive to manufacturers transitioning from generic drugs to innovator products. 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.

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