BioNJ Manufacturing Briefing 2022

Name: BioNJ Manufacturing Briefing 2022
Start: 2022-09-09T08:00:00-05:00
End: 2022-09-09T14:30:00-05:00

September 9 @ 8:00 am - 2:30 pm

Manufacturing Strategy of the Future –
Adaptation, Acceleration & Agility
With Insights from McKinsey & Company

Friday, September 9, 2022 | 8:00 a.m.-2:30 p.m.
NJIT Campus Center Atrium, First Floor
150 Bleeker Street, Newark, NJ 07102*

Biopharma manufacturing has been evolving rapidly and even more so since COVID-19. Join us for BioNJ’s Manufacturing Briefing on September 9 where you’ll hear from and engage with industry thought leaders on important topics, including:

Industry Trends Shaping Manufacturing Strategy of the Future
Lessons Learned from Pandemic, Post-Pandemic Cliff, Supply Chain Instability
Incorporating Innovation into Manufacturing Strategy of the Future
A Strategy to Accelerate Manufacturing Performance and Productivity of Tomorrow

Attendees are also invited to take a “Digital Capability Center” Tour. Be sure to forward this email to colleagues and customers who could also benefit from these topical discussions and perspectives! Registration is $95 for BioNJ Members and $175 for Future Members.

BioNJ Manufacturing Briefing 2022

Agenda
8:00 a.m. – 8:30 a.m.	Registration & Networking Breakfast
8:30 a.m. – 9:00 a.m.	Welcome & Opening Remarks Debbie Hart, President & CEO, *BioNJ* Haro Hartounian, Ph.D., CEO & Founder, *BioCentriq* Simon Nynens, CEO, *New Jersey Innovation Institute (NJII)*
9:00 a.m. – 9:30 a.m.	Setting the Stage: Industry Trends Shaping Manufacturing Strategy of the Future Andrea Gennari, MEng, Partner, *McKinsey & Company* Laurie Lanoue, MBA, Partner, *McKinsey & Company*
9:30 a.m. – 10:30 a.m.	The Road to Building an Agile Network: Lessons Learned from Pandemic, Post-Pandemic Cliff, Supply Chain Instability An industry perspective from key industry stakeholders on how they are incorporating lessons from recent events into manufacturing strategy. Panelists: Mike Nicolazzo, Sr. Director, Production Portfolio Management, Fisher Scientific David Owen, Executive Director, Engineering for Large Molecule Technical Operations, *Merck & Co.* Moderator: David J. Kristjanson, PMP, Senior Director, Northeast Life Sciences Practice Leader, *CBRE Life Sciences*
10:30 a.m. – 11:00 a.m.	Networking Break
11:00 a.m. – 11:30 a.m.	Case Study: Incorporating Innovation into Manufacturing Strategy of the Future This case study will discuss some examples of incorporating innovation into the CMC development process and bringing manufacturing into the future. John Knighton, Ph.D., MBA, Vice President, Cell & Gene Therapy API, Janssen R&D, *Janssen Pharmaceutical Companies of* Johnson & Johnson
11:30 a.m. – 12:30 p.m.	Panel: A Strategy to Accelerate Manufacturing Performance and Productivity of Tomorrow A discussion on what is on the horizon, including potential game-changers and enablers, such as the use of digital, technology enablement, process yield improvements and talent. Panelists: Alex Klarer, Director of Cell Therapy & Process Development, *BioCentriq* Orlando Serani, Program Architect, Advanced Therapies Supply Chain, *Janssen Pharmaceutical Companies of Johnson & Johnson* Moderator: John Tomtishen, Vice President, Operations, *Cellares*
12:30 p.m. – 1:00 p.m.	Keynote: Manufacturing Matters Back by popular demand, Dr. Marks will highlight the importance of quality manufacturing for biologics, the need for manufacturing capacity both for products in development and for future surge capacity in the event of emergency and provide guidance and resources for manufacturers. Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research (CBER), FDA
1:00 p.m. – 1:30 p.m.	Networking Lunch
1:30 p.m. – 1:50 p.m.	Closing Remarks
1:50 p.m. – 2:30 p.m.	Digital Capability Center New Jersey Event Tour (optional) The Digital Capability Center New Jersey is a state-of-the-art learning facility which concentrates on the impact of digital enablement across cell & gene therapy related operations. It provides an immersive learning experience that simulates the journey to operational excellence — including observations of a simulated manufacturing process in its before-and-after state, digital use cases and plenaries on lean principles and enabling mindsets. Attendees will tour the facility and experience a selection of the digital use cases. Given the space availability at the center, the tour will be limited to the first 30 people to sign up. A registration form will be sent closer to the meeting date.

Event location:	General Attendee Parking:
NJIT Campus Center Atrium, First Floor 150 Bleeker Street Newark, NJ 07102	NJIT Parking Deck 154 Summit Street Newark, NJ 07103
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Contact Cheri Hennessy at CHennessy@BioNJ.org to learn about Sponsorship opportunities. Call (609) 890-3185 with any questions.

*All registrants must be up-to-date on COVID-19 vaccinations as defined by the CDC in order to attend BioNJ’s Manufacturing Briefing. If the community level of COVID-19 remains low or medium, masks will not be required to be worn, but anyone is welcome to wear a mask based on personal preference. However, if transmission is at a high level, everyone will be required to wear a mask except when eating or drinking. BioNJ will update these protocols, as appropriate, subject to any new CDC guidance or requirements by the venue, in compliance with local/state/federal guidance and we will announce any policy changes in advance of event.