505(b)(2) Regulatory Planning: Designing Streamlined Programs to Create Value for Patients and Sponsors

Life Sciences, Clinical Trials, Drug Discovery & Development, Patient Safety,
  • Wednesday, September 29, 2021

The 505(b)(2) pathway allows sponsors to develop new drugs by leveraging data from a diverse range of sources and establishing a bridge to data from a previously approved drug. When successful, the 505(b)(2) pathway enables sponsors to realize significant time and cost savings, often while carrying lower risk and preserving exclusivity benefits.

Sponsors can use the 505(b)(2) pathway to develop drugs with new indications, dosage forms or strengths, formulations, dosing regimens, routes of administration, or even active ingredients. In many cases, these changes create new, differentiated products that patients or healthcare providers prefer over previous versions, leading to both improved experiences for patients and tremendous commercial value for sponsors.

Register for this webinar to discover early planning best practices for building and executing a successful, streamlined 505(b)(2) development program and to hear a case study demonstrating how a product developed through this pathway can dramatically improve the patient journey.


Cathy Gatza, Camargo

Cathy Gatza, PhD, VP of Regulatory and Strategy, Camargo

Dr. Gatza is responsible for leading multidisciplinary teams in developing overall drug development program strategies and for reviewing and preparing regulatory documentation, including pre-IND meeting packages, INDs, NDAs, and other applications for submission to regulatory agencies. Her work also includes leading interactions with the FDA.

Prior to joining Camargo, she was a postdoctoral fellow at Duke University Medical Center, where she studied the role of the type III TGF-beta receptor in breast and colon cancer. Dr. Gatza received a B.Sc. in Biology from Virginia Tech and a Ph.D. in Cell and Molecular Biology from Baylor College of Medicine in Houston, Texas. She has received several NIH awards, has presented her work at multiple national conferences, and has authored 15 peer-reviewed publications.

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Andrea Miller,Camargo

Andrea Miller, Manager of Life Science Solutions, Camargo

Andrea is responsible for securing new clients to further Camargo’s growth strategy. She develops relationships with qualified prospect companies to identify needs, design and propose effective solutions, and win new business opportunities for Camargo. She has over 20 years of experience in the pharmaceutical industry including sales, marketing, operations and regulatory consulting, with over 10 years of experience in the women’s health care sector. She is the Director of the non-profit Winning With ALS, which she started with her late husband and which provides support for children living with a parent who has been diagnosed with ALS.

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Who Should Attend?

Senior professionals from pharma and biotech companies involved in:

  • Clinical Trials
  • Clinical Operations
  • Drug Development
  • Regulatory Affairs

What You Will Learn

In this webinar, participants will learn the answers to the following questions:

  • What is the 505(b)(2) regulatory pathway?
  • What are the benefits and regulatory implications of the 505(b)(2) pathway?
  • How can a sponsor prepare and plan for a 505(b)(2) development program?
  • How can the 505(b)(2) pathway be leveraged to improve the patient journey?

Xtalks Partner


Founded in 2003, Camargo Pharmaceutical Services is a leading global strategy, regulatory and commercial partner for emerging biopharma companies. Camargo specializes in rare and complex development programs where no playbook exists, with integrated solutions to reach milestones with speed and capital efficiency.

Camargo has experience in complex development programs and accelerated approval pathways that leverage our core expertise in areas such as oncology, pediatrics, rare disease, and 505(b)(2). Camargo is proud to support clients in more than 35 countries around the world. Visit camargopharma.com.

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