BARDA Innovation Initiatives in Medical Countermeasure Manufacturing
Keynote SeriesPharmaceutical Technology and BioPharm International are sponsoring a Keynote Series session on strategies and innovations to reduce drug shortages and improve availability of medicines on the INTERPHEX 2016 Exhibit Hall Innovation Stage. Admission is free to any attendee with an exhibit hall pass.
Wednesday, April 27
1:30–3:15 pm
Strategies and Innovations to Reduce Drug Shortages and Improve Availability of Medicines
Aging facilities and equipment, inadequate operator training, a lack of quality control, tighter regulatory enforcement, and business decisions to eliminate unprofitable product lines contribute to ongoing shortages vital drug products. In this session, industry thought leaders will identify triggers for drug shortages, methods to avoid production line shutdowns and update facilities, and innovative industry efforts to fulfill demand for needed therapies. A Q&A session will follow the presentations.
2-2:30 pm
BARDA Innovation Initiatives in Medical Countermeasure Manufacturing
This presentation will describe the Biomedical Advanced Research and Development Authority’s (BARDA) program initiatives in manufacturing technologies for medical countermeasure advanced development. Opportunities with the Centers for Innovation in Advanced Development & Manufacturing (CIADMs) and in Continuous Manufacturing will be discussed.
Speakers:
Michael Angelastro, Deputy Director for Manufacturing, Facilities and Engineering, Biomedical Advanced Research and Development Authority (BARDA)
Kimberly Sciarretta, PhD, Anti-Infectives (AI) Program, Division of CBRN Countermeasures, Biomedical Advanced Research and Development Authority (BARDA)
To register: http://www.interphex.com/pharmtech
Other presentations in this session:
1:30–2 pm
An Interdisciplinary Approach to Address Drug Shortages
2:30-3 pm
Continuous Manufacturing for Rapid Process Development
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
The Role of Forced Degradation in Method Development, Manufacturability, and CMC Strategy
April 28th 2025Forced degradation studies are critical in biologics development, particularly for monoclonal antibodies (mAbs). These studies simulate long-term environmental stressors to uncover degradation pathways and ensure the stability of critical quality attributes (CQAs), aiding in robust chemistry, manufacturing, and controls (CMC) strategies and regulatory compliance.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
