The 505(b)(2) Pathway: Getting to the Clinic Faster

Wednesday, April 20

6:30 pm IST | 9:00 a.m. EDT | 1:00 p.m. GMT

Use of the 505(b)(2) regulatory pathway has seen rapid growth as drug developers seek to avoid unnecessary duplication of research and get products to market faster. By making it possible to postpone or outright eliminate trial phases, the 505(b)(2) pathway offers a hybrid between the FDA’s traditional new drug application and its abbreviated new drug application processes — and the opportunity to significantly reduce development time and expense.

By taking advantage of existing safety and efficacy data, the 505(b)(2) pathway often enables sponsors to reduce the number of required studies. But it’s no magic bullet: Successful use of this option requires careful design and a thorough understanding of the underlying science. In this webinar, we describe the advantages of the 505(b)(2) pathway, look at common misconceptions, and offer practical advice on its application in the real world. Topics include:

Assessing your pre-IND. How do you know if your pre-IND meeting was successful? It was if you land on an approach that meets the FDA’s requirements, even if it’s not the one you initially had in mind.

The development plan. It won’t materialize without a hitch, because things happen, and a lot may change. Stay close to the FDA as the plan comes together to avoid costly missteps.

Simpler, shorter, less costly studies. Sponsors using the 505(b)(2) pathway often can forgo Phase 3 trials or postpone elements to the post-approval phase, when the product is already starting to generate revenue.

The importance of CMC. Take care of your chemistry, manufacturing, and controls. CMC issues trigger FDA refuse-to-file letters more than any other cause.

Speaker: Ken Phelps, Strategic Advisor, Premier Consulting

In 2003, Ken Phelps applied more than three decades of industry experience to found Camargo Pharmaceutical Services in Cincinnati with Dr. Ruth Stevens (chief scientific officer and executive vice president). It is no coincidence that 2003 was also the year the US FDA introduced guidelines governing the 505(b)(2) approval pathway. In the beginning, Camargo focused solely on being the industry’s 505(b)(2) development partner of choice.

Today, Camargo has become part of Premier Consulting, which has led the largest percentage of 505(b)(2) submissions of any team submitting to the FDA—Premier Consulting has led more than 1100 agency meetings and is the industry authority in 505(b)(2).

Before founding Camargo, Phelps’ diverse background in drug development had led to a number of executive-level assignments in the areas of quality control, project management and regulatory, clinical and medical affairs at Duramed Pharmaceuticals. Phelps also held a number of positions at Merrell-National Labs (which merged to become Merrell Dow and later evolved into Aventis), where he was responsible for global quality assurance, quality control, and processing technology, with an assignment based in Milan, Italy.

Today, as a thought leader in the shifting landscape of drug development and emergent pathways around the globe, Phelps addresses the financial challenges of pharmaceutical companies caused by the generics cliff and routinely presents on the topic at events worldwide. He has recently been invited to speak on the topic at DCAT and other international conferences and on how companies can realize the opportunities of 505(b)(2) and expanded marketability. Phelps is also a founding member of the 505(b)(2) Forum, an assembly of product developers and service providers interested in improving best practices across the 505(b)(2) development process. He publishes articles frequently and is a featured interviewee in publications, videos, and podcasts concerning new, repositioned, and differentiated product development around the globe.