2022 Manufacturing Briefing Program Book

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.

Because Patients Canʼt Wait® www.BioNJ.org

AGENDA

8:00 a.m. – 8:30 a.m. Registration & Networking Breakfast
8:30 a.m. – 9:00 a.m.
9:00 a.m. – 9:30 a.m. We••• lcomHDTeaeeirkb&obCHiO.eaLpHriemtaonr,uitnP,nghPia.rRDnee,s.,imPdMhea.nrSDktc.s,&, PCCrEeEOsOid&,eBnFitoo, uNNnJedwer,JeBrioseCyeInntsrtiqitute of Technology (NJIT)
9:30 a.m. – 10:30 a.m.
Se••t tingLAatnuhdrerieeSatLaaGgneeon:unIena,drMiu, sMBtArEy,nTPgra,erPntnaderstrn,SeMhr,acMpKiincnKgseinMysae&nyuC&foamCctopumarinpnyganSytrategy of the Future
10:30 a.m. – 11:00 a.m.
11:00 a.m. – 11:30 a.m. The Road to Building an Agile Network: Lessons Learned from Pandemic, Post-Pandemic Cliff,
11:30 a.m. – 12:30 p.m. Supply Chain Instability
An industry perspective from key industry stakeholders on how they are incorporating lessons from
12:30 p.m. –1:00 p.m. recent events into manufacturing strategy.
1:00 p.m. – 1:30 p.m.
1:30 p.m. – 1:50 p.m. Pa••n elisDMtsai:kveidNOicwoelanz,zEox,eSceuntiivoer Director, Production Portfolio Management, Fisher Scientific
1:50 p.m. – 2:30 p.m. Merck & Co. Director, Engineering for Large Molecule Technical Operations,

Mo• derDataovri:d J. Kristjanson, PMP, Senior Director, Northeast Life Sciences Practice Leader,

CBRE Life Sciences

Networking Break

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

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.

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Biomolecular Engineering (NIIMBL)
• Orlando Serani, Program Architect, Advanced Therapies Supply Chain, Janssen
Pharmaceutical Companies of Johnson & Johnson

Mo• derJaotohrn: Tomtishen, Vice President, Operations, Cellares

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

Networking Lunch

Bio••N J Closing Remarks & Intro to Digital Capability Center America, McKinsey & Company
Sara Loewenthal, Manager, Digital Capability Centers North
Debbie Hart, President & CEO, BioNJ

Digital Capability Center New Jersey Event Tour (pre-registration required)
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.

www.BioNJ.org

SPEAKERS

Chathuranga “Chat” DeSilva, Ph.D., Senior Director, Business Development, BioCentriq
Dr. DeSilva completed his Ph.D. in Chemical Engineering from Columbia University, specializing in polymer-based drug
delivery systems. He later co-founded a start-up company to commercialize work in this area. Dr. DeSilva has over eight years
of experience in research & development and has published several peer-reviewed journal articles on his work in specialty
polymers. Prior to joining BioCentriq, Dr. DeSilva worked in chemical distribution at Brenntag North America and Consulted
for Academic Venture Exchange. In his current role, he leads the Business Development function for BioCentriq.
Andrea Gennari, MEng, Partner, McKinsey & Company
Mr. Gennari is a Partner in McKinsey’s London office where he leads the McKinsey Biopharma Operations Service Line driving
projects in multiple geographies spanning across Manufacturing, Quality, Compliance and Network strategy. He is the leading
organizer of Biopharma Operations Roundtables, where industry leaders from established and emerging biopharma discuss
trends and opportunities in the biologics industry. Mr. Gennari is also co-leader of the Cell & Gene Therapy Digital Capability
Center in collaboration with NJII.
David Gardner, Executive Director, Master Data & Digital Strategy, Bristol Myers Squibb
Mr. Gardner serves as Executive Director, Master Data & Digital Strategy at BMS. In this role, he works with partners across
Global Product Development and Supply to establish future-looking ways of working to drive performance; including digital
technology applications, process performance as well as data management and governance techniques. Prior to BMS, Mr.
Gardner held similar roles within the biopharmaceutical industry and worked with companies to drive efficiencies in process,
technology and data from different functional perspectives — including manufacturing and its enabling partners.
Debbie Hart, President & CEO, BioNJ
Ms. Hart worked alongside New Jersey’s biopharmaceutical industry leaders to establish BioNJ in 1994. Under Ms. Hart’s
leadership, BioNJ has become the trusted voice of the life sciences industry in New Jersey. Ms. Hart was named one of the
world’s 100 Most Influential People in Biotechnology by Scientific American Worldview; a PharmaVOICE 2021 Red Jacket
Honoree and to PharmaVOICE‘s 100 Most Inspiring People list with repeat appearances on ROI-NJ’s Influencers Power
List; ROI-NJ’s Healthcare Influencers: ROI-NJ’s Women in Business List; to the NJBIZ Healthcare Power 50, to the NJBIZ
Manufacturing 50, one of New Jersey’s top CEOs by COMMERCE Magazine and for the tenth time in 2022 to the NJBIZ
Power 100.
Haro Hartounian, Ph.D., CEO & Founder, BioCentriq
Dr. Hartounian engineered the launch of BioCentriq, a revenue generating Cell and Gene Therapy Contract Development
and Manufacturing Organization and led the creation of NJIT’s new Professional Master’s Degree Program in Cell and
Gene Therapy Sciences. Dr. Hartounian provided strong leadership to drive an aggressive growth and profitability
strategy for BioCentriq’s business and provided the necessary direction and dynamic leadership for R&D, manufacturing,
business development, regulatory and compliance and operations. Dr. Hartounian has nearly 30 years of experience in the
biotechnology industry working for large and mid-size biopharmaceutical companies.
John Knighton, Ph.D., MBA, Vice President, Cell & Gene Therapy API, Janssen R&D, Janssen
Pharmaceutical Companies of Johnson & Johnson
With over 30 years of biopharmaceutical experience, Dr. Knighton has held a number of roles within the biopharmaceutical
field. Currently, he is Vice President of Cell & Gene Therapy API Process Development at Janssen’s Pharmaceutical R&D,
which is part of the Johnson & Johnson Family of Companies. Dr. Knighton leads a diverse and dedicated team of scientists
and engineers in biopharmaceutical cell and gene process development, GMP clinical production, global technology transfer
and technical commercial product support. Dr. Knighton started his career at GlaxoSmithKline in biopharmaceutical research
and development.
David J. Kristjanson, PMP, Vice President, Life Science Advisory, CBRE Life Sciences
Mr. Kristjanson has 25 years of commercial real estate experience with a focus on life sciences. His projects range from
greenfield to renovations of R&D laboratories, vivarium, GMP manufacturing, vaccine development, aseptic clean rooms
and multiple science buildings throughout the United States. Mr. Kristjanson has vast knowledge of the lifecycle of pharma
and biotech projects, including business case creation, programming, URS/URB/BOD, design development, procurement,
construction, IQ/OQ/PQ validation and commercialization. He advises clients through his deep expertise gained overseeing
two million square feet of life sciences projects. Mr. Kristjanson currently leads the project management life sciences practice
for CBRE throughout the Northeast region.
Laurie Lanoue, MBA, Partner, McKinsey & Company
Since she joined the firm in 2011, Ms. Lanoue has done a wide range of projects in operation and manufacturing
excellence for the medical devices, aerospace, pharmaceutical and advance industries. Her recent work experience
includes leading several major transformation programs in operation and manufacturing, developing and implementing
manufacturing excellence principles, supporting the Global Operation Excellence SVP in designing a new Lean and
Operation Excellence program and leading a workforce and shift restructuring effort at a major manufacturing organization.

SPEAKERS

Teik C. Lim, Ph.D., MSc, President, New Jersey Institute of Technology (NJIT)
Dr. Teik C. Lim is the 9th President of New Jersey Institute of Technology and also holds the title of Distinguished
Professor of Mechanical Engineering. Prior to joining NJIT on July 1, 2022, Dr. Lim led the University of Texas at Arlington
as interim President from 2020-2022 and was Provost and Vice President for Academic Affairs at UTA from 2017-2020.
Dr. Lim’s career has spanned from the private sector to university administration.Dr. Lim is internationally recognized as a
leading scholar in the field of structural vibrations and acoustics as well as modeling and simulation technology.

Sara Loewenthal, Manager, Digital Capability Centers North America, McKinsey & Company
Ms. Loewenthal is the Manager for McKinsey’s North America Digital Capability Centers. In this role, she oversees all
operations at the locations in New Jersey and Atlanta. Previously, she was an Engagement Manager in McKinsey’s Operations
Practice, where she helped clients to strengthen their manufacturing and supply chain capabilities through operational
excellence and digital transformations. Prior to her time at McKinsey, Ms. Loewenthal worked in various manufacturing, supply
chain, and sales and marketing roles for Georgia Pacific.

Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research (CBER), FDA
Dr. Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and
completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in
Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development.
Dr. Marks joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

Mike Nicolazzo, Senior Director, Production Portfolio Management, Fisher Scientific
Mr. Nicolazzo has held various commercial and portfolio management roles with enhanced responsibilities throughout
his 17-year tenure with Thermo Fisher Scientific. Over the years, he has remained dedicated to creating a better
environment for Thermo Fisher Scientific’s end users. In his current role as Senior Director of the Production Portfolio,
Mr. Nicolazzo is focusing Thermo’s team and suppliers to build the best portfolio for our production customers.

David Owen, Executive Director, Engineering for Large Molecule Technical Operations, Merck & Co.
Mr. Owen has been in the biopharmaceutical industry for 25 years – all at Merck. He spent approximately 10 years doing
design-build work in Vaccine Process Engineering before joining Vaccine Operations. Since joining Vaccine Operations,
Mr. Owen has held a variety of roles in Operations and Technical Operations. He has served as Live Virus Vaccines Technical
Lead and most recently Polysaccharide Vaccines Technical Lead. Mr. Owen is currently the Executive Director of Technical
Operations at Merck’s West Point plant site. The Technical Operations business is responsible for the process, the process
equipment, the process automation, deviation management investigations, change management and MES.
Gene Schaefer, MSc, ScD, Senior Fellow, National Institute for Innovation in Manufacturing Biomolecular
Engineering (NIIMBL)
Dr. Schaefer has over 35 years of experience in the biopharmaceutical field ranging from early-stage process development
to commercial product support for protein therapeutics. Prior to joining NIIMBL, Dr. Schaefer was Senior Director, API Large
Molecule Pharmaceutical Development & Manufacturing Sciences at Johnson & Johnson. He also led the Protein Therapeu-
tics Development group at Bristol Myers Squibb with additional industry experience with Schering-Plough and Genzyme. As
a Senior Fellow, Dr. Schaefer is involved in leading the N-mAb case study as well as playing an important role in the Process
Intensification Program and the Regulatory Considerations Committee.
Orlando Serani, Program Architect, Advanced Therapies Supply Chain, Janssen Pharmaceutical Companies
of Johnson & Johnson
Mr. Serani has led the program strategy for the Chimeric Antigen Receptor T-Cells therapeutic area since May 2018. This
includes digital strategies, supply chain network design and supply chain capability development for this therapy platform,
currently targeted as a last line of defense for multiple myeloma. Prior, Mr. Serani was Vice President, Information Technology,
Customer and Logistics Services – the logistics and customer services organization which serves all Johnson & Johnson
businesses globally. He also led the technology organization of the Consumer Medical Devices supply chain, including
diabetes, contact lenses and vision surgery products and services. Mr. Serani began his career with the
Johnson & Johnson Consumer business in Italy in 1988.
John Tomtishen, Vice President, Operations, Cellares
Mr. Tomtishen has more than 10 years of experience in cell and gene therapies, biologics and vaccines, with diverse roles
in Business Operations, CMC/Technical Operations, Supply Chain, Engineering/Facilities and Operational Excellence. Prior
to Cellares, Mr. Tomtishen served as the Site Managing Director at Legend Biotech’s corporate headquarters. At Legend,
Mr. Tomtishen had an integral role in the clinical development and BLA filing of Carvykti™ (ciltacabtagene autoleucel) in
collaboration with Janssen Pharmaceuticals. He also worked for Novartis Pharmaceuticals within Cell and Gene Technical
Development & Manufacturing where he played an integral role in the filing and approval of the first CAR T-cell BLA,
Kymriah™ (tisagenlecleucel).

THANK YOU TO OUR SPONSORS

Ascendia Pharmaceuticals is a specialty pharmaceutical CDMO that provides custom sterile- and non-sterile-enabling formulations
and manufacturing, along with analytical methods for new chemical entities, biologics, and 505(B)(2) products, as well as OTCs,
nutraceuticals, and animal health. Our technologies include nano-emulsions, amorphous solid dispersions, oral controlled release,
self-emulsifying drug delivery systems (SEDDs) and production of nano-particles. Following formulation selection and optimization,
Ascendia can transition a development program quickly to cGMP manufacture of first-in-man clinical materials. Ascendia’s
manufacturing capabilities include dosage forms for oral, topical or parenteral administration. Ascendia offers its manufacturing
services to pharmaceutical and biopharmaceutical companies who seek a CDMO partner for their formulation as it transfers from a
pre-clinical phase to early clinical development.

BioCentriq is a New Jersey based cell and gene therapy contract development manufacturing organization (CDMO) with new
state of the art facilities which are fully operational and registered with the FDA. Our goal is to advance the manufacturing of cell
and gene therapies to make them more accessible to patients. Our process development and MSAT (Manufacturing Science and
Technology) teams specialize in helping small and mid-size biotech optimize and scale their cell and gene therapies for clinical
manufacturing. Get to know BioCentriq and experience the innovative, open, and collaborative approach we bring to every project. ​

CAI is passionate about helping biotech and pharma companies bring their novel, life-enhancing therapies to patients.
In any phase of the product lifecycle, we build an integrated roadmap to guide you toward manufacturing readiness.
Then, with our industry expertise, we can assist with manufacturing scale-up, tech transfer, quality system implementation, quality
control, regulatory affairs, and site operations. CAI has over 25 years of experience and is an employee-owned company with an
impeccable reputation for exceeding expectations on every client engagement. For more information, please contact Matt Oravetz
at 203-209-5439.

CBRE Group, Inc. (NYSE: CBG), a Fortune 500 and S&P 500 company headquartered in Los Angles, is the world’s largest commercial
real estate services firm in terms of 2018 revenue. The CBRE Life Sciences Group is dedicated to providing the life sciences industry
with the highest level of real estate services and project management available. The New Jersey based professionals in this group
deliver unique expertise and focus to meet specific needs for the biotech, pharmaceutical, medical device and related industries
Deeply rooted in the New Jersey life science sector and backed by CBRE’s robust resources, strengths and integrated service
delivery platform, our advisors offer solutions that address virtually all real estate related needs for owners and occupiers.

CRB is an architecture, engineering, consulting and construction company dedicated to the success of our clients in creating prod-
ucts that nurture bodies and save lives. We work with you to develop and bring your products to market quickly and in a cost-effec-
tive manner through comprehensive services that span project and facility lifecycles. Our mission is to provide best-in-class solutions
that drive success and positive change for our clients, our people, and our communities. Our mission applies to what we do and
how we do it. Recognizing our impact and influence in the communities we serve, we pursue corporate social responsibility through
the lenses of people, community and planet.

THANK YOU TO OUR SPONSORS

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $40 billion and approximately
100,000 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. For more information, please contact Kristin Roosevelt at
[email protected], or 610-453-0370.

Integrated Project Management Company, Inc. (IPM) is a business consulting firm focused on planning and implementing
critical initiatives across multiple industries, including life sciences, healthcare, consumer products and industrial products. Since its
inception in 1988, IPM has served more than 500 clients and completed more than 5,000 projects. Headquartered in Chicago, IPM
has regional offices in Boston, St. Louis, Los Angeles, San Francisco, Minneapolis and Parsippany. IPM was a recipient of the 2018
Malcolm Baldrige National Quality Award. To learn more about IPM and its services, visit www.ipmcinc.com or call 630-789-8600.

Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of nucleic acids and small
molecules with its lipid nanocrystal (LNC) platform technology. The company is developing its own internal portfolio of products as
well as partnering with leading pharmaceutical companies to develop novel formulations that capitalize on the unique characteristics
of the LNC platform.

McKinsey & Company is a global management consulting firm that is a trusted advisor and counselor to many of the world’s most
influential businesses and institutions. McKinsey’s Life Sciences practice helps biopharma clients across the industry outperform and
innovate across the entire value chain.

MMR Consulting USA Inc. is an experienced and dedicated engineering team delivering robust solutions to the biopharmaceutical
industry nationwide. We provide Engineering, Automation Services, Commissioning, Qualification and Validation (CQV), Capital
Project Management, Construction Project Management & Project Controls, Computer Systems Validation (CSV) and Compliance.
For more information, please go to www.MMRengineering.com.

Myra EB Systems is a cloud based software platform tailored to fit the needs of pharmaceutical drug substances and drug prod-
ucts, data management and supply chain management. Our platform excels in 3 key areas: Accessibility, Visualization, Ease of Use.
We are reducing the number of manual procedures necessary for data management as well as increasing the accessibility of data to
allow for better and more informed process decisions. We have successfully increased the CMC delivery rate by 82%. Our subscription
based model is easy to implement as proven by our current partners, including big pharma and companies across the biotech industry.

THANK YOU TO OUR SPONSORS

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mis-
sion is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid man-
ufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing
U.S. competitiveness in this industry. NIIMBL is funded through a cooperative agreement with the National Institute of Standards
and Technology (NIST) in the U.S. Department of Commerce with significant additional support from its members.the health and
welfare of its participants.

The New Jersey Innovation Institute (NJII), an NJIT corporation, was founded in 2014 and helps turn ideas into workable solutions
across four divisions: healthcare, entrepreneurship, defense and homeland security and professional and corporate education.
NJII combines the vast resources of NJIT, strong and far-reaching industry and government relationships, and proven methods for
building industry centric ecosystems to help drive innovation and deliver solutions that make a direct impact on the economy and
the health and welfare of its participants.

New Jersey Manufacturing Extension Program (NJMEP) is a private, not-for-profit organization that improves the profitability and
competitiveness of New Jersey manufacturers. Backed by the National Institute of Standards and Technology (NIST), NJMEP enables
organizations to enhance their productivity and efficiencies, reduce costs, and improve employee performance. For more than 20
years, NJMEP has used its extensive network of connections and proven track record of success to help manufacturers adapt to the
latest innovative technologies and best practices to realize more than $4.16 billion in value.

PendoTECH offers technology for manufacturing & process development of biopharmaceuticals with a focus on unique single use
in-line sensing technologies designed specifically for the biotechnology Industry. Along with the sensors are complementary product
lines of software and hardware products that collect data from the sensors for analysis. Sensors include: Pressure, Temperature, UV
Absorbance, Flow and Conductivity. These products assist users in meeting the FDA’s initiative in the area of PAT (process analytical
technology) for QbD (Quality by Design) for manufacture of their products. Software / hardware expansion options are available to
create a complete process control system for all unit operations in a biotech process. These options facilitate the integration the
sensors and other devices such as pumps, scales, detectors and many more for both critical lab operations and for GMP production.

RCM Life Sciences is a division of RCM Technologies — a premier provider of business and technology solutions in the areas of
healthcare, life sciences and engineering. The Life Sciences division specializes in Regulatory Compliance with focus on Risk Based
Validation solutions offered through technology, consulting and managed services for pharmaceutical, biotech and medical device
industries. We are proud of our reputation as thought leaders and partner with the most innovative companies within the regulated
space. Our global team of experts bring extensive hands-on industry experience in risk assessments, compliance audits, validation
and CAPA processes to ensure safety, product quality and customer satisfaction.

THANK YOU TO OUR COMMITTEE

Jim Furey, PendoTECH, Co-Chair
John Paul Tomtishen III, Cellares, Co-Chair
Stuti Agarwal, McKinsey & Company
James Bruno, MBA, Ph.D., Chemical & Pharmaceutical Solutions
Gerardo Callegari, Ph.D., Rutgers, The State University of New Jersey
Michael R. Epstein, CRESA Global, Inc.
Dennis Flynn, Javan Engineering
Andrea Gennari, McKinsey & Company
Haro Hartounian, Ph.D., New Jersey Institute of Innovation (NJII)
Doug Hausner, Ph.D., Thermo Fisher Scientific
Hana Ioannidis, Ph.D., BioCentriq
Rashida A. Karmali, JD, Ph.D, MBA, CLP, Tactical Therapeutics, Inc.
Katie Kelleher, MBA, McKinsey & Company
David Kristjanson, PMP, CBRE Life Sciences
Amy Lamperti, BioCentriq
Shahid Manzur, EY Parthenon
Fernando Muzzio, Ph.D., Rutgers, The State University of New Jersey
Kristin Roosevelt, Thermo Fisher Scientific
John Shea, Merck & Co.
Ravendra Singh, Ph.D., Rutgers, The State University of New Jersey
Vincent Smeraglia, JD, Rutgers, The State University of New Jersey
Derron Stark, EY Parthenon
Angelo Stracquatanio, Apprentice.io
Jim Streemke, Hovione, LLC
Tom Sullivan, CBRE Life Sciences
Wayne P. Weiner, Pharmatech Solutions, LLC
Thomas R. Wescott, MMR Consulting
Keith Westby, IVERIC Bio, Inc.