The biopharmaceutical industry produces medicines that treat and prevent some of the most prevalent and debilitating diseases that affect human health. These medicines are derived from biological sources using highly complex manufacturing processes.
Innovative technologies, many originating in academic labs, can be applied to improve the safety, quality, cost, efficiency, and speed of biopharmaceutical manufacturing. However, bridging the gap from benchtop proof of concept to scale-up for clinical and commercial manufacturing remains a challenge to implementing innovative processes.
The Bio Manufacturing Partnering Forum (held in conjunction with AUTM’s 2019 Western Region Meeting) will explore how academia and industry can collaborate to validate and scale innovative manufacturing technologies to improve the production of biological therapeutics. Critical issues such as how to speed innovation, how to develop standards that enable more efficient and rapid manufacturing capabilities, and how to educate and train a world-leading biopharmaceutical manufacturing workforce will be examined.
*Tentative schedule, program subject to change
Thursday, September 19
|8:30 - 8:45 a.m.
|8:45 – 10 a.m.
The Evolving and Emerging Challenges of Biopharmaceutical Technical Operations and Manufacturing: a Perfect Storm
The featured speaker, Dr. Patrick Y. Yang, will address the evolving and emerging challenges of biopharmaceutical technical operations and manufacturing. A super star in the bio manufacturing ecosystem, Dr. Yang will offer a forward thinking session on insights into the new generation of bio manufacturing with actionable insights for tech transfer offices. This is a cant-miss discussion.
|10 – 10:30 a.m.
|10:30 a.m. – Noon
||Innovation in Bio-manufacturing: Leveraging Technology Transfer to Advance the Manufacturing of New Therapeutics"
Gregory Theyel, PhD, Director, Biomedical Manufacturing Network
Bio-manufacturers are uniquely aware of the challenges faced during the development and manufacturing of biologics, and they have the responsibility to make better, faster, cheaper, and higher quality therapeutics for serving patients. Academia plays a key role in conducting fundamental research and pioneering new technologies; suppliers develop and commercialize new technologies; and regulators ensure that new advancements conform to existing guidelines or develop new guidelines in collaboration with industry. This session will probe how to leverage technology transfer between bio-manufacturers, academia, suppliers, and regulators to advance the manufacturing of new therapeutics
|Noon – 1:30 p.m.
|1:30 – 3 p.m.
||Bio Manufacturing Showcase and Facilitated Networking
John Balchunas, NIIMBL
Gregory Theyel, Biomedical Manufacturing Network
Chris Yochim, NIIMBL
|3 – 3:30 p.m.
|3:30 – 5 p.m.
||Emerging Needs in Bio Manufacturing Education and Workforce Development
John Balchunas, NIIMBL
Jason Davis, Rensselaer Polytechnic Institute (RPI)
Jenny Ligon, National Center for Therapeutics Manufacturing
Snehal Patel, Juno Therapeutics
The community of education, training, and workforce development professionals are keenly-focused on "emerging” technologies such as gene therapy, cell-based therapies, gene editing, and regenerative medicine. Caught up in the race to commercialization, industry and academia are developing new processes, new job classifications, and disruptive technologies that could change the manufacturing paradigm altogether. This session will explore how broad communication, collaboration, and partnership is critical to ensuring tomorrow’s workforce is ready to drive this next wave of technology innovation and adoption.
|5 – 7:30 p.m.
Socializing face-to-face with colleagues and industry pros has never been easier. Bring business cards!