Webinar Announcement: Accelerating Drug Development via the FDA's 505(b)(2) Pathway
505(b)(2) New Drug Application (NDA) is one of the three drug approval pathways provided by the U.S. Food and Drug Administration (FDA). The 505(b)(2) submission pathway requires comprehensive research reports demonstrating safety and efficacy, but it also allows some of the information required for approval to be derived from relevant studies not conducted by the current applicant.
Compared with the traditional application pathway,This pathway enables sponsors to escape the competitive landscape of the generic drug market., eliminating the need for extensive preclinical studies and safety or efficacy testing during drug development, which will significantly reduce R&D costs and shorten the time to market.
In the upcoming broadcast of “Accelerating Clinical Trial Timelines: The 505(b)(2) Regulatory Pathway—Online WebinarChina, Ken Phelps, Global Regulatory Submission Expert,An In-Depth Analysis of the 505(b)(2) Fast Track for New Drug Review, aiming to help sponsors understand key considerations regarding the 505(b)(2) regulatory pathway and develop development strategies to efficiently accelerate research progress.
“Regulatory Pathways to Accelerate Clinical Trial Timelines”
“505(b)(2)” Live Online Course
Broadcast Start Time
October 28, 2021, 4:00 PM–5:00 PM
Seminar Agenda
● Part 01Key Points for Successfully Holding a Pre-IND Meeting
● Part 02Guidelines for Preclinical Research Activities
1. Tox Study Design
2. CMC
3. Supplier Selection
4. PK/Bridging Studies
5. Impact on Phase II/III Studies
● Part 03 Frequently Asked Questions About 505(b)(2)
● Part 04 Q&A Session
Scan the QR code to register and watch the online webinar for free.
Speaker Biography
Ken Phelps
Founder of Camargo
With over 30 years of industry experience, Ken Phelps co-founded Camargo Pharmaceutical Services with Dr. Ruth Stevens in Cincinnati, Ohio, in 2003. As a leading expert in global drug development and accelerated approval pathways, Phelps has proposed solutions to address the financial challenges posed by the complexities of the generic drug landscape. He is also a founding member of the 505(b)(2) Forum, an organization dedicated to enhancing practical execution throughout the 505(b)(2) development process.
Ming Pei
Head of Business Development, Greater China
Mr. Pei Ming is responsible for building the China team and managing business development in the Asia-Pacific region. With over 10 years of experience in pharmaceutical R&D, he has previously worked at globally renowned CROs and pharmaceutical companies, covering various aspects of operations, management, and business affairs.
For pharmaceutical and generic drug companies seeking to enhance their R&D competitiveness while avoiding the need to conduct extensive non-clinical studies as well as safety and efficacy testing during development, the advantages of the 505(b)(2) regulatory pathway are particularly pronounced. This submission pathway leverages prior approvals of existing drugs as references, thereby carrying relatively lower risk; it reduces redundant research, thus shortening the development timeline; and it may also confer market exclusivity for a period of three to seven years.
For sponsors lacking experience in the 505(b)(2) pathway, partnering with a CRO that possesses extensive expertise and seasoned knowledge is crucial. Pumeir Pharma can help them navigate the fiercely competitive drug development landscape with ease, facilitating the formulation of optimal R&D strategies and thereby accelerating clinical trial progress.
About Premier Research
Premier Research is a global clinical research organization (CRO) dedicated to helping biotechnology firms, pharmaceutical companies, and medical device innovators translate life-changing concepts and scientific breakthroughs into new diagnostic and therapeutic solutions. The company operates in 84 countries worldwide, employs 1,300 professionals, and boasts a robust network of international partnerships. Following its formal acquisition of the U.S.-based pharmaceutical services provider Camargo Pharmaceutical Services in 2021, Premier Research integrated Camargo’s extensive expertise in managing challenging drug development programs and navigating accelerated approval pathways. This strategic move has further enhanced the company’s knowledge coverage and professional capabilities in pharmaceutical services, enabling it to deliver comprehensive, end-to-end support across every stage of product development.