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BioNJ’s Manufacturing Briefing
November 12, 2020 @ 8:45 am - 1:30 pm
Reimagining the Future of BioManufacturing, Cell and Gene Therapy and the Industry’s Response to Operation Warp Speed and COVID-19
– With Insights from McKinsey & Company –
Biopharma manufacturing has been evolving rapidly and even more since COVID-19 set the world asunder. The pandemic combined with the promise of Cell & Gene Therapy and Biopharma 4.0 have opened up a host of opportunities and challenges for manufacturing. This program features industry thought leaders who will review where we are, what lies ahead and what it will take to get there.
Take a look at the agenda…
8:45 a.m. – 9:00 a.m. | Welcome and Opening Remarks
• Debbie Hart, President & CEO, BioNJ
• Angelo Stracquantanio, M.S., CEO & Co-Founder, Apprentice.io
9:00 a.m. – 9:30 a.m. | Setting the Stage: Reimagining the Future of Biopharma Manufacturing
An overview to set the stage for the session to follow inclusive of reimagining manufacturing in the ‘new normal’ post-COVID19 (including changes in demand, emergence of new technologies such as mRNA, etc.), the Future of CGT Manufacturing – scaling up, commercializing & planning for new horizons in development, as well as how Industry 4.0 will play a role in these transformations.
• Andrea Gennari, MBA, Partner, McKinsey & Company
9:30 a.m. – 10:15 a.m. | Case Study: Manufacturing Response to Operation Warp Speed and the Call to COVID-19
Operation Warp Speed (OWS) has changed everything and will help to ensure that COVID-19 vaccines, once approved, will be available to the masses. This session features BARDA on the OWS program and a case study by Sanofi Pasteur on the industry’s response (e.g. vaccine production and therapeutic approaches) and how they are changing their operations to answer the call.
• Mireli Fino, Site Head, Protein Sciences, Sanofi Pasteur (9:30 a.m. – 10:00 a.m.)
• Thomas Warf, Expert Consultant, BARDA – Biomedical Advanced Research and Development Authority, US Department of Health and Human Services (10:00 a.m. – 10:15 a.m.)
10:15 a.m. – 11:00 a.m. | Panel: The Future of Cell & Gene Therapy Manufacturing
Panelists will provide a high level overview on how their companies are thinking about the future of CGT Manufacturing including new manufacturing technologies, new ways of working, and new process developments.
• Jason Cameron, Senior Vice President, Technical Operations, Amicus Therapeutics
• Joseph Tarnowski, Ph.D, Senior Vice President, Cell and Gene Therapy Platform, Medicinal Science and Technology R&D, GlaxoSmithKline
• John Tomtishen, Director of Manufacturing, CMC Technical Operations, Legend Biotech
• Beth Webb, Commercial GM, Cell & Gene Therapy, Cytiva (formerly GE Healthcare Life Sciences)
Moderated by: Haro Hartounian, Ph.D, Senior Vice President & General Manager, BioCentriq™
11:00 a.m. – 11:05 a.m. | Break
11:05 a.m. – 11:50 a.m. | Industry 4.0 Overview & How It Will Transform Biopharma Manufacturing
This session features a review of Industry 4.0 featuring a review of the impact of COVID-19 on the future state, as well as a Case Study relating to how a biopharma manufacturing company is using digital, analytics and/or automation to transform its operations to optimize the biopharma manufacturing process itself, and the way they work.
• Katie Kelleher, MBA, Associate Partner, McKinsey & Company
• Eugene Schaefer, MS, Sc.D, Senior Director, BioTherapeutics Development, Janssen R&D
11:50 a.m. – 12:50 p.m. | Reflections on Current & Future Horizons
Keynote by Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation & Research (CBER), FDA
And once again…Back by popular demand, Dr. Marks will provide the view from the FDA.
12:50 p.m. – 12:55 p.m. | Closing Remarks and Transition to Real World Examples
12:55 p.m. – 1:30 p.m. | CAI — Allogenic CAR-T Manufacturing Facility
This session will feature a case study on constructing a 105,000 sq. ft. GMP biopharmaceutical facility to manufacture a novel Allogenic CAR-T therapy, from greenfield to commercial product.
• Joseph Micsko, Director of Operations, Bay Area, CAI
12:55 p.m. – 1:30 p.m. | Virtual Tour of BioCentriq™ – Take a Tour of the First Cell & Gene Therapy Processing & Clinical Manufacturing Center in Newark, NJ
Take a virtual tour of the latest cell and gene therapy manufacturing center to open its doors in Northern New Jersey. Located on the campus of NJIT, BioCentriq™ is a state-of-the-art Cell and Gene Therapy Development and Manufacturing Center and Center of Excellence owned by the New Jersey Innovation Institute (NJII). It is equipped with two GMP suites for cell & gene therapy clinical production and a cell & gene therapy process development pilot plant. You’ll see the new facility and learn more about the unique approach the team takes with its clients to help them move from bench to scale while also developing the workforce of the future.
Registration is $75 for BioNJ Members and $100 for Future Members.
Contact Kim Minton at KMinton@BioNJ.org to learn about sponsorship and Membership opportunities. Call (609) 890-3185 with any questions.
Thank You to Our Sponsors
Apprentice.io is an intelligent manufacturing execution system built to help the life sciences scale faster – from COVID to cancer. From small and large molecule to cell and gene therapy, Apprentice’s flexible system leverages the power of artificial intelligence, augmented reality and Pharma 4.0 to increase your speed to market. Learn more at apprentice.io.
Attaineo is a leading talent acquisition & consulting firm with offices across North America. We have extensive experience recruiting within the pharmaceutical and biotechnology space, including cell & gene therapy. Service offerings include contingency, retained and project recruitment services. Our leadership team has over 40 years of combined experience recruiting within the life science space. Learn more at www.attaineo.com.
Avantor, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. We set science in motion to create a better world. Learn more at avantorsciences.com.
CAI solves manufacturing, facility and regulatory challenges in any phase — from clinical trials through scale up to commercial manufacturing. Applying our integrated qualification and regulatory expertise reduces time to market and produces superior performance and quality. CAI has over 20 years of experience and is 100% employee owned. Learn more at www.cagents.com.
DLA Piper is a global law firm with over 4,000 lawyers in over 40 countries. The firm has ranked #1 in M&A global deal volume in Mergermarket for nine consecutive years and is the #1 most active law firm in healthcare devices and #3 in pharma and biotech by PitchBook 2018. Learn more at www.dlapiper.com.
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $23 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Learn more at www.thermofisher.com.
PendoTECH offers low-cost, single use in-line sensors for pressure, temperature, conductivity, UV absorbance & flow (that are also robust enough for re-use!). They have complementary monitors/transmitters and are targeted towards biotech process development & manufacturing. Advanced systems are also available for automation & data collection. Learn more at www.pendotech.com.