Chimeric antigen receptor (CAR) T cell therapies are an example of personalized medicine. Since 2017, the US Food and Drug Administration (FDA) has approved six CAR T cell therapy products. In the US, they are regulated in the same manner as biologics. Due to the complexity of these products, changes are often required. The FDA has issued draft guidance to manage these modifications titled “Manufacturing Changes and Comparability for Hu-man Cellular and Gene Therapy Products.”
This guidance provides the FDA’s perspective on managing manufacturing changes and assessing the potential impact those changes have on product quality.
US manufacturing facilities are continuing to develop innovative ways to produce and distribute personalized medicine. As this is an evolving class of drugs, there are opportunities to shape the industry. There are many opportunities for an Emerging Leader (EL) to help provide personalized lifesaving therapeutics to patients. EL is a community that consists of college students, recent graduates, and professionals who are transitioning into the pharmaceutical industry. As scientists and engineers, we work in areas such as process development, operations, research, project management, and facility design.
ISPE Communities of Practice (CoPs) offer platforms for industry professionals to discuss topics of interest. Advanced Therapy Medicinal Products, Bi-otechnology, and Pharma 4.0™ CoPs also provide a wealth of information on drug development, processes, and how to use analytics to present perfor-mance data.
Taking advantage of opportunities to advance your skills and increase your network will increase your visibility in your organization and the industry. Get involved with your local Chapter or Affiliate and participate in EL events.
Participation in ISPE Hackathons at your local level and at the Annual Meetings allows Emerging Leaders to interact with professionals from different regions while working on case studies. The ISPE Foundation provides professional development grants for conference and travel expenses to the 2024 ISPE Annual Meeting & Expo and the 2024 ISPE Europe Annual Conference. Women in Pharma® also sponsors a mentoring program to connect Emerging Leaders with seasoned pharma professionals and the Foundation partners with corporations to attract talent for internships. Emerging Leaders are encouraged to apply for both.
There are many advantages to joining Emerging Leaders:
- Professional development
- Access EL member-only resources
- Opportunities to establish and grow your network
- Exposure to thought leadership events
- Participation in Hackathons
- Career solutions to promote advancement
If you are not a member of ISPE, join today at ispe.org and:
- Actively participate in EL activities in your local Affiliate or Chapter
- Access Good Practice Guides and educational resources
- Join CoPs and connect with other industry professionals
- Add content, ask questions, and post your ideas on Engage
- Write a blog or article
- Talk with your manager and colleagues about presenting your project at a conference or local program
Learn more about Emerging Leaders
