Mobile Manufacturing

Register Free: https://www.biopharminternational.com/bp_w/MM

Event Overview:

Mobile manufacturing is no longer a discussion for the future but happening now. With the advent of new technologies, distributed manufacturing and point of care manufacturing are becoming a thing of the present. This round table discussion solicits feedback from companies focusing on this space to allow for better access to care in the world.

Key Learning Objectives:

• The current regulatory restrictions holding back mobile manufacturing
• Technologies in this space that are allowing for this to become a reality
• How this space will evolve in the near future

Who Should Attend:

• Manufacturing and facilities
• Regulators and regulatory departments
• Quality
• Operations

Speakers

Dr. Kerry Love
CEO and President
Sunflower

Dr. Kerry Love is the CEO and president of Sunflower Therapeutics, a public benefit corporation focused on the development of innovative and efficient solutions for manufacturing proteins for use in biopharmaceuticals and vaccines. Kerry performed her doctoral studies at MIT in organic chemistry and then extended her research into biochemistry and microbiology at Harvard Medical School and the Whitehead Institute. She co-founded and directed R&D at Enumeral Biomedical using technologies she helped to develop at MIT for single-cell analysis in antibody discovery. She also served as the technical program manager for both the DARPA-sponsored InSCyT program, part of the Biologically-Derived Medicines on Demand Initiative, and the Gates Foundation-sponsored ULTRA program, part of the Grand Challenge for Innovations in Vaccine Manufacturing for Global Markets. She is an expert in yeast-based biomanufacturing and was the associate director of the AltHost Consortium, an MIT-led consortium of biopharmaceutical organizations for the advancement of alternative hosts in biomanufacturing. Kerry has authored more than 40 scientific papers and patents.

Luke Rogers
VP, Innovation
On Demand Pharma

Dr. Luke Rogers is the VP of innovation for On Demand Pharmaceuticals, working to commercialize their pharmacy-on-demand platform. He received his degree in medicinal chemistry from Trinity College in Dublin and completed his PhD research at Trinity College on the synthesis and biomedical applications of Tetrapyrroles. After a stint within the Merck manufacturing division, working on a large-scale GMP flow chemistry process steps, he transitioned to MIT to lead efforts on multiple iterations of the pharmacy-on-demand project within the Department of Chemical Engineering under Prof. Klavs Jensen. This work involved the development, optimization, and integration of miniaturized continuous manufacturing processes to produce APIs. After the successful demonstration of the manufacturing capabilities of such systems, he then transitioned to his current role, where he is helping lead CMC efforts towards several regulatory submissions of new manufacturing processes on the pharmacy-on-demand platforms. He is the recipient of the 2018 Pharmaceutical Discovery, Development, and Manufacturing Award for Excellence in “Integrated QbD Practice.”

Peter Makowenskyj
Director of Design Consulting
G-CON

Peter Makowenskyj has more than 16 years of experience in the pharmaceutical and biopharmaceutical industries. Peter held various roles within the industry, primarily around process solutions and engineering for drug substance facilities. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities. Peter joined G-CON Manufacturing in 2016, where he now consults with clients in the design of their cGMP facilities utilizing G-CON’s prefabricated autonomous cleanrooms by capitalizing on his process and regulatory know-how. Peter received his bachelor of science in chemical engineering and a minor in biomedical engineering from Cornell University. He received is M. Eng in chemical engineering from Cornell University. He is also very active within the PDA, where he currently sits on the PDA BioAB, and co-leads the Biopharmaceutical Manufacturing IG, and Mobile Manufacturing Task Force.

Kari Stoever
Chief External Relations Officer
On Demand Pharmaceuticals

Ms. Stoever is a results-oriented social entrepreneur with 20 years of global strategy, fundraising and leadership experience with medical research and treatment organizations. Previously, she served as the Director of Co-Investments at the Nike Foundation’s Girl Effect where she led a $210 million partnership between the President’s Emergency Plan for AIDS Relief (PEPFAR) and the Bill and Melinda Gates Foundation to reduce new HIV infections in adolescent girls and young women. Ms. Stoever also served on the board of the Georgetown Women’s Leadership Initiative and served on President Obama’s task force to design a platform for connecting programs working to promote entrepreneurship around the world. In 2010, she received the distinguished Stevie Award for Women in Business – Best Executive – Service Business up to 2,500 employees. Ms. Stoever holds a B.Sc. from George Washington University, a degree in nursing, and an Executive Masters in Leadership from the McDonough School of Business at Georgetown University.

Register Free: https://www.biopharminternational.com/bp_w/MM

​