2021 C-Suite Summit Program Book

OCTOBER 15, 2021

BECAUSE PATIENTS CAN’T WAIT®

www.BioNJ.org

2021 BioNJ BOARD OF TRUSTEES

OFFICERS Anthony S. Marucci, MBA
Founder, President, CEO & Director
William H. Lewis, JD, MBA, Chair Celldex Therapeutics, Inc.
Chair & CEO
Insmed Scott Megaffin
CEO
Christopher J. Schaber, Ph.D., Immediate Past Chair Adastra Pharmaceuticals Inc.
President & CEO
Soligenix, Inc. Jeffrey A. Nau, Ph.D., MMS
President & CEO
Debbie Hart, President & CEO Oyster Point Pharma, Inc.
President & CEO
BioNJ Andrew L. Pecora, M.D., FACP, CPE
CEO
Greg Oakes, MBA, Treasurer Outcomes Matter Innovations, LLC
President, North America
Vifor Pharma Stuart W. Peltz, Ph.D.
CEO
Michele Korfin, R.Ph., MBA, Secretary PTC Therapeutics, Inc.
Chief Operating Officer & Chief Commercial Officer
Gamida Cell Navneet Puri, Ph.D.
Founder, Chairman & CEO
BOARD MEMBERS Nevakar, Inc.

Sol J. Barer, Ph.D. Spiro Rombotis, MPH, MBA
Former Chairman & CEO, Celgene Corporation President & CEO
Chairman of the Board Cyclacel Pharmaceuticals, Inc.
Teva Pharmaceutical Industries
Marco Taglietti, M.D.
Angela Bechan President & CEO
Vice President, Head, Communications & SCYNEXIS
Corporate Social Responsibility North America
Sanofi ADVISORS

Tom Cavanaugh James Sapirstein, R.Ph., MBA
President Chairman, President & CEO
Janssen Immunology First Wave BioPharma

Mitzi Conners Academic Advisor
Executive Director & Head, Operations Reynold A. Panettieri, Jr., M.D.
MRL Business Development & Licensing Professor of Medicine, Robert Wood Johnson Medical
Merck & Co. School; Vice Chancellor, Clinical & Translational Science
Director, Rutgers Institute for Translational Medicine &
Amadou Diarra, Ph.D. Science; Emeritus Professor of Medicine, University of
Senior Vice President, Global Policy & Government Affairs Pennsylvania; Rutgers, The State University of New Jersey
Bristol Myers Squibb
Legal Advisor
Jayne C. Gershkowitz Steven M. Cohen, JD
Chief Patient Advocate Partner
Amicus Therapeutics, Inc. Morgan, Lewis & Bockius LLP

Christian Kopfli, Esq. State Government Official Advisor
CEO Kathleen Coviello
Chromocell Corporation Executive Vice President, Technology, Life Sciences &
Entrepreneurship
Emer Leahy, Ph.D. New Jersey Economic Development Authority (NJEDA)
President & CEO
PsychoGenics, Inc. Investor Advisor
George Heinrich, M.D.
Leigh Anne Leas Vice Chair & CEO
Vice President & Head, North America Public Policy New Jersey Health Foundation, Inc., & Foundation Venture
Novartis Services, Inc. Capital Group, LLC (FVCG)

Susan L. Levinson, Ph.D. Audit Advisors
CEO Teresa Leste
BioAegis Therapeutics, Inc. Principal, Life Sciences Strategy & Analytics
Deloitte
John Maki
President Brian Wilcomes
ConSynance Therapeutics, Inc. Strategy & Analytics Principal
Deloitte & Touche LLP

1

WELCOME

Transitioning to the ‘Next Normal’: Biopharma’s Role in
Addressing the COVID-19 Crisis and What’s Next

To all of today’s participants,

On behalf of the Board of Trustees of BioNJ, it is our honor to welcome you to our Ninth
Annual C-Suite Summit.

Each year, BioNJ’s C-Suite Summit brings together life sciences executives representing
a wide breadth of companies from early to late stage, public and private and revenue and
pre-revenue – as well as those who provide support along the way – for timely discussions
on the topics impacting C-Suite decision making in bringing new innovative treatments to
market. We are proud of the diverse group of participants we have with us today as each
and every one of you help to bolster New Jersey’s vibrant life sciences community and
bring new treatments and drugs to Patients around the world.

COVID-19 has brought unimaginable global disruption. Therefore, this year’s program is
dedicated to taking a look at the ‘Next Normal’. Our all-star roster of speakers will take a
deep dive into this past year’s successes and challenges, while discussing the next wave
of innovation across the value chain and sharing thoughts on how the industry might
deepen and scale its commitment to delivering a positive impact for society.

As always, we have many people to thank for their contributions in getting us to this
important day, including our Conference Partner McKinsey & Company, BioNJ’s
C-Suite Summit Volunteer Committee chaired by Dr. Arda Ural and Jan Campbell, our
distinguished speakers and our generous Sponsors. Their support, guidance and wisdom
have helped shape a compelling program. And, we thank each of them.

Thank you for being here and engaging in this critical conversation at this critical time.

Because Patients Can’t Wait®,

William H. Lewis, JD, MBA Arda Ural, MSc, MBA, Ph.D. Jan Campbell Debbie Hart
BioNJ Board Chair C-Suite Summit C-Suite Summit President & CEO
Chair & CEO Committee Co-Chair Committee Co-Chair BioNJ
Insmed Americas Industry Markets Senior Client Partner
Leader – Life Sciences & Korn Ferry International
Healthcare
Ernst & Young LLP 2

C-SUITE SUMMIT 2021 PROGRAM AGENDA

OCTOBER 15, 2021

Time Session

8:30 a.m. – 8:40 a.m. Welcome & Opening Remarks
William H. Lewis, JD, MBA, Board Chair, BioNJ &
Chair & CEO, Insmed
Debbie Hart, President & CEO, BioNJ

8:40 a.m. – 9:25 a.m. Keynote: An Imperative to Lead
Speaker:
Nicole Szlezak, M.D., Partner, McKinsey & Company

9:25 a.m. – 10:10 a.m. Panel: Striding into a “New Normal”
Panelists:
Elliott Levy, M.D., Head, Intrepid Alliance & Former Senior
Vice President, Global Development, Amgen
Brent Ragans, President, Ferring Pharmaceuticals, U.S.
Geralyn Ritter, Executive Vice President, External Affairs &
ESG, Organon

Moderated by:
Lucy Perez, Ph.D., Senior Partner, McKinsey & Company

10:10 a.m. – 10:40 a.m. Fireside Chat: A Rapidly Evolving Regulatory Landscape

Conversation With:
Peter Marks M.D., Ph.D., Director, Center for Biologics
Evaluation and Research, Food & Drug Administration

Interviewed by:
Jacqueline Berman, Partner, Morgan Lewis

10:40 a.m. – 10:45 a.m. Break

10:45 a.m. – 11:15 a.m. Fireside Chat: Digital Patient and HCP Engagement in a
Post-COVID World

Conversation With:
Tamara Elias, M.D., Vice President, Global Partnerships &
Innovation, MSD, Merck & Co.

Innes Meldrum, Senior Vice President, Chief Commercial
Officer, Otsuka

Moderated by:
Ben Hohn, Principal, Business Development, Pipeline & Launch
Strategy & Emerging Pharma; Lead, ZS Associates

3

C-SUITE SUMMIT 2021 PROGRAM AGENDA

OCTOBER 15, 2021

Time Session

11:15 a.m. – 12:00 p.m. Panel: Value Creation in the Industry

Panelists:
Steve Bryant, Ph.D., Vice President, Head, Global Business
Development, Genmab

Daniel Karp, Senior Vice President, Head, Business
Development, Organon

Elizabeth Naldi-Jacob, Vice President, Oncology & Head,
Corporate Development and Alliance Management
Merck & Co.

Moderated by:
Arda Ural, Ph.D., Americas Industry Market Leader – HS&W
Life Sciences & Healthcare, Ernst & Young LLP

12:00 p.m. – 12:05 p.m. Break

12:05 p.m. – 12:50 p.m. Panel: Rethinking Resilience – The Global Supply Chain

Panelists:
Gerry Collins, Vice President, Strategy & Services, Johnson &
Johnson Supply Chain

Fred Lowery, Senior Vice President, Thermo Fisher &
President, Customer Channels, Thermo Fisher Scientific

Stefan Roehr, Head, North America Supply Chain, Distribution
and Logistics, Sanofi

Moderated by:
Joseph Goldberg, Director, Strategy & Management
Consulting, National Life Sciences Industry Consulting Leader
RSM US LLP

12:50 p.m. – 1:20 p.m. Fireside Chat: Winning in the Digital Age
1:20 p.m. – 1:50 p.m.
Conversation With:
Nitin Seth, CEO, Incedo, Inc.

Interviewed by:
Emilio Ragosa, Partner, DLA Piper

Fireside Chat: Delivering Hope: Pfizer-BioNTech COVID-19
Vaccine Clinical Supply Chain Journey

Conversation With:
Michael Ku, PharmD, Vice President, Global Clinical Supply
Pfizer

Interviewed by:
Laks Pernenkil, Ph.D., Principal, Life Sciences
Deloitte Consulting LLP

1:50 p.m. – 2:00 p.m. Closing Remarks
Debbie Hart, President & CEO, BioNJ

4

Thank You to Our Conference Partner
Thank You to Our Sponsors

5

SPEAKERS

(in order of appearance)

Welcome & Opening Remarks

William H. Lewis, JD, MBA
BioNJ Board Chair &
Chair and CEO, Insmed

Mr. Lewis joined Insmed in 2012 as President and Chief Executive
Officer and as a member of the Board of Directors. He became
Chair of the Board of Directors in November 2018. Mr. Lewis is
the former Co-Founder, President and Chief Financial Officer of
Aegerion Pharmaceuticals and previously spent more than 10 years
working in investment banking in the U.S. and Europe. He also
previously worked for the U.S. government. Mr. Lewis serves as the
Chair of the Board of Trustees of BioNJ, the life sciences association for New Jersey. He is a
member of the Board of Trustees of Case Western Reserve University and also serves as a
member of the Board of the Helix Acquisition Corp.

Debbie Hart
President & CEO
BioNJ

Ms. Hart worked alongside New Jersey’s biotechnology industry
leaders to establish BioNJ in 1994. Recently, she was named by
Governor Murphy to the NJ Commission on Science, Innovation
and Technology; as Co-Chair of the New Jersey Commission on
Higher Education Strategic Plan Working Group on Research,
Innovation and Talent; and the NJ Commission on Higher
Education and Business Partnership. Additionally, Ms. Hart served
as Chair of the NJ Biotechnology Task Force. She was named
one of the world’s 100 Most Influential People in Biotechnology by Scientific American
Worldview and most recently as a PharmaVOICE 2021 Red Jacket Honoree, a hall of fame
award recognizing inspiring leaders of today and tomorrow.

Keynote: An Imperative to Lead

Nicole Szlezak, M.D.
Partner
McKinsey & Company

Ms. Szlezak is a Partner in McKinsey’s Zurich office and a leader
in McKinsey’s Pharmaceuticals and Medicals practice. She
also co-leads McKinsey’s Global Regulatory Service Line and
Regulatory Industry Roundtable. The focus of Ms. Szlezak’s work
is on R&D strategy, organization design and ESG. Ms. Szlezak’s
previous roles include Chief Scientific Officer, Prize4Life, a non-
profit organization to accelerate breakthroughs in Lou Gehrig’s
Disease (ALS); Researcher, Harvard Center for International Development; and a Clinical
Researcher, University of Tübingen focusing on malaria and schistosomiasis.

6

SPEAKERS

(in order of appearance)

Panel: Striding into a “New Normal”

Elliott Levy, M.D.
Head, Intrepid Alliance; Former Senior Vice President,
Global Development, Amgen

Dr. Levy has worked in the pharmaceutical industry since 1997,
the last seven at Amgen, where he led clinical development.
Over the course of his career, he has played a major role in
the development of 21 approved medicines, including the
first modern immunotherapy for cancer (Yervoy), the first
oncolytic virus for cancer (Imlygic), the first new cornerstone
transplant therapy in 25 years (Nulojix) and the first specific preventative therapy for
migraine (Aimovig). In addition to delivering medicines to market, as a leader of large,
diverse organizations, Dr. Levy has managed significant process and organizational
transformation efforts and trained many people who progressed to major leadership
roles in the industry.

Brent Ragans
President
Ferring Pharmaceuticals, U.S.

Mr. Ragan’s vision for serving patients is grounded in Ferring’s
70-year commitment to science, research and the relentless
pursuit of therapies that help people build families, stay healthy
and fight disease. Becoming President in June 2020, Mr. Ragan
focused Ferring U.S. in the therapy areas where it makes the
greatest positive differences for patients. Previously as U.S.
Chief Commercial Officer, he led commercial strategy and operations as the company
introduced new products and doubled its sales. Mr. Ragan has extensive experience in the
pharmaceutical industry, including leading multiple units and teams in both prescription
pharmaceuticals and consumer OTC. Before joining Ferring in 2012, he built and led
several multibillion dollar brands for Sanofi.

Geralyn Ritter
Executive Vice President, External Affairs & ESG
Organon

Ms. Ritter is focused on upholding Organon’s vision and
representing its values in the world by guiding and shaping how
the company interacts with key stakeholders and the environment.
She joined Organon from Merck & Co., where she spent 12 years,
most recently serving as Corporate Secretary leading shareholder
engagement, governance and ESG. Previously, she served as
Head of Global Public Policy and Corporate Responsibility, where she was the President
of the Merck Foundation and led the creation of Merck for Mothers, a global initiative to
end maternal mortality. A survivor of a traumatic injury, Ms. Ritter is a passionate advocate,
frequent speaker and an author on resilience and trauma recovery.

7

SPEAKERS

(in order of appearance)

Moderated by: Lucy Perez, Ph.D.
Senior Partner
McKinsey & Company

A former cancer researcher, Dr. Perez brings a strong technical
background to her work with organizations across the life sciences
sector. Since joining McKinsey, she has partnered with CEOs and
top teams at leading organizations across North America, Europe
and Asia. Dr. Perez leads McKinsey’s evidence generation work
within the Pharmaceuticals & Medical Products Practice, helping
clients generate and apply research insights, clinical data and
real-world evidence to maximize patient benefit, demonstrate product value and catalyze
innovation. In addition to her client service, Dr. Perez co-leads McKinsey’s North America
Hispanic Latino Network, a platform for consultants and Hispanic and Latino leaders to
connect and build community as well as advance their professional development.

Fireside Chat: A Rapidly Evolving Regulatory Landscape

Peter Marks M.D., Ph.D.
Director, Center for Biologics Evaluation and Research
Food & Drug Administration (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.

Interviewed by: Jacqueline Berman
Partner
Morgan Lewis

Ms. Berman advises companies on U.S. Food and Drug
Administration (FDA) regulatory, compliance and enforcement
issues, as well as clinical trials and FDA-regulated product
development programs. She also counsels clients on the safety,
labeling and reporting requirements for consumer products
under the laws enforced by the U.S. Consumer Product Safety
Commission (CPSC), the Federal Trade Commission (FTC) and related state enforcement
agencies. Ms. Berman’s clients include pharmaceutical, device, biologic, dietary
supplement and food/food additive manufacturers. She is a frequent speaker and author
on topics including clinical trials, good manufacturing processes (cGMPs) and other FDA
regulatory issues affecting the pharmaceutical and biologics industries. Ms. Berman was
recognized as U.S. Rising Star – Regulatory by the LMG Life Sciences 2021 Americas Awards.

8

SPEAKERS

(in order of appearance)

Fireside Chat: Digital Patient and HCP Engagement in a
Post-COVID World

Tamara Elias, M.D.
Vice President, Global Partnerships & Innovation, MSD
Merck & Co.

Dr. Elias has been avidly involved with health care for over 20
years across a wide spectrum of diverse experiences, beginning
with medical school, extending into surgical residency, followed
by health care strategic consulting, private equity investing,
corporate strategy and business development, product
innovation and P&L, inclusive of board member positions.
Currently, in her role at Merck, Dr. Elias leads global “non-product” (“around the pill”)
commercial partnerships for Human Health with start-ups and established players across
the value chain. Her team’s work includes external monitoring of key health care trends,
scouting of relevant partners, execution of win-win contracts and deal structures and
partnering with markets to share best practices and scale based on local successes.

Innes Meldrum
Senior Vice President & Chief Commercial Officer
Otsuka

Mr. Meldrum is responsible for the commercial success of
the North American business which includes Neuroscience,
Nephrology and Digital products. He was drawn to Otsuka by the
allure of working for a truly different organization. Mr. Meldrum
embraces Otsuka’s unique culture as a catalyst for growth that
empowers people to pursue their passions in creative ways,
while encouraging innovative thinking that makes a tangible difference in the lives of
patients and their families. In his role, he oversees Commercial Strategy and Commercial
Operations, including market access, training and development, sales and marketing
operations, as well as business insights and strategy.

Moderated by: Ben Hohn
Principal, Business Development, Pipeline & Launch Strategy &
Emerging Pharma; Lead
ZS Associates
Mr. Hohn is an East Coast Region Principal who focuses on
business development, pipeline strategy and launch for biotech
and pharmaceutical clients. He is part of ZS’s Global Emerging
Pharma vertical that serves more than 120 Emerging Pharma
clients annually and leads ZS’s Emerging Pharma Team in the
Eastern United States. Additionally, Mr. Hohn is a leader in
ZS’s BD, Pipeline and Launch Strategy Practice. He has 25 years of experience helping
biopharma clients with the strategic choices and challenges that intersect and cross the
boundaries of commercial and product development. Mr. Hohn’s project teams regularly
work across top global markets, including U.S., EU, Japan, China as well as ROW.

9

SPEAKERS

(in order of appearance)

Panel: Value Creation in the Industry

Steve Bryant, Ph.D.
Vice President, Head, Global Business Development
Genmab

Dr. Bryant is fast approaching his 20 year tenure milestone at
Genmab, where he currently serves as Vice President, Head of
Global Business Development. He is a member of Genmab’s
Global Leadership Team and has also served as Alliance Manager
for the joint steering committee for several of Genmab’s key
collaborations, including with Roche and Janssen. His deal sheet spans the complete
gamut of BD&L, including in-and out-licensing, options, research, co-development
and co-commercialization. His creative approach to deal making is well recognized and
appreciated. He is well known in the biotech partnering community and has worked hard
to build lasting relationships with other professionals in the industry, following the maxim
that deals are first and foremost done between people that know and trust each other.

Daniel Karp
Senior Vice President, Head, Business Development
Organon

Mr. Karp leads global mergers & acquisitions, licensing,
collaborations, alliance management and integration at Organon.
Previously, he served as Executive Vice President, Corporate
Development at Biogen. Prior to joining Biogen, Mr. Karp held
a number of positions of increasing responsibility at Pfizer Inc,
including Vice President, Head of Business Development for
Worldwide Research & Development, and Vice President, Head of Business Development
for Pfizer Vaccines, Oncology and Consumer Healthcare. Mr. Karp has broad experience
across a wide range of transaction structures, therapeutic areas, technologies and stages
of development. He has led, developed and built high performing organizations that have
executed dozens of transactions totaling over $72 billion in upfront payments.

Elizabeth Naldi-Jacob
Vice President, Oncology & Head, Corporate Development and
Alliance Management
Merck & Co.

Ms. Naldi-Jacob has been with Merck & Co. for six years in
various roles within the Business Development Organization. She
is currently a Vice President in Corporate Development as the
Head of Oncology. In this role, Ms. Naldi-Jacob leads acquisitions
and late-stage partnerships in oncology as well as alliance
management and companion diagnostics. She has executed
several large strategic partnerships for Merck in oncology with
AstraZeneca, Eisai Co. and Seagen Inc. In addition, Ms. Naldi-Jacob has a led a number
of acquisitions in oncology, including Peloton, VelosBio and Arqule. Prior to joining
Merck, Ms. Naldi-Jacob was at Pfizer for five years in business development with her last
role being Head of Business Development Evaluation.

10

SPEAKERS

(in order of appearance)

Moderated by: Arda Ural, Ph.D.
Americas Industry Market Leader – HS&W Life Sciences & Healthcare
Ernst & Young LLP

Dr. Ural is the Americas Health Sciences and Wellness Industry
Markets Leader. In this role, he is in service to EY’s life sciences
and health care professionals in North and South America,
helping them to solve EY’s clients’ most pressing issues at the
C-Suite level, building a sector community and upholding the
principles of One EY. Dr. Ural has been the U.S. Sector Leader for
EY’s Life Sciences Transactions Advisory Services, Strategy & Operations Practice and
the Market Segment Leader for East Region Transactions Advisory. He has a proven track
record in pharma, biotech and med tech industry with almost 30 years of experience in
general management, corporate strategy, marketing, new product development and
M&A, including acquisitions, spins, divestitures and mergers.

Panel: Rethinking Resilience – The Global Supply Chain

Gerry Collins
Vice President, Strategy & Services
Johnson & Johnson Supply Chain

Mr. Collins works with Janssen’s business segment strategy teams
to drive Johnson & Johnson Supply Chain transformation. This
includes leading Enterprise Strategy Development, Enterprise
Planning & Performance Management process, as well as
Enterprise Portfolio Management. Services include acquisition
and divesture, supply chain systems solution and supply chain
service design. Prior to taking his role in 2016, Mr. Collins led the end-to-end integration
of Janssen’s Parenteral Product Portfolio. In 2010 he was appointed as Platform Leader
for Janssen’s Biologics Global Manufacturing network; in 2009 he served as the General
Manager for Janssen Biologics and Janssen Pharmaceutical; and in 2008 Mr. Collins was part
of the Odyssey team which integrated all the Johnson & Johnson Active Pharmaceutical
Manufacturing sites to create one global supply chain organization.

Fred Lowery
Senior Vice President, Thermo Fisher & President, Customer Channels,
Thermo Fisher Scientific

Mr. Lowery is an accomplished and dynamic corporate leader with
a proven track record leading teams to drive profitable growth. He
has developed strong operating teams, launched innovative new
products, acquired businesses and successfully led organizations
for over 25 years while working for several Fortune 500 companies.
In his current role, Mr. Lowery has oversight of Fisher Scientific, the
company’s industry-leading distribution business for laboratory
supplies used in academic and government research, biopharma, health care and industrial
markets. He is also the executive sponsor of Thermo Fisher Scientific’s Just Project initiative.
As part of this project, Thermo Fisher has donated $25M in equipment and solutions to
enable COVID-19 testing at historically Black colleges and universities across the U.S.

11

SPEAKERS

(in order of appearance)

Stefan Roehr
Head, North America Supply Chain, Distribution and Logistics
Sanofi

Mr. Roehr has spent his entire 36-year career with Sanofi, the
first 18 years in Finance in the U.S. in various departments and
functions and the subsequent 18 years in Supply Chain. He
started as Head of Global Inventory Management in Germany
and then moved to Head of Global Performance Indicator
Management in France. Mr. Roehr was Head of Supply Chain
in Venezuela followed by assignments in Panama and Brazil. In 2016, he assumed the
position of Head of Global Supply Chain Management for North America. He and his
team are accountable for the customer service and integrated business planning for
various business units in the region as well as having responsibility for the distribution
and warehousing of more than USD $13 Billion (in revenue).

Moderated by: Joseph Goldberg
Director, Strategy & Management Consulting, National Life
Sciences Industry Consulting Leader
RSM US LLP

Mr. Goldberg has deep experience working with medical device,
life sciences services and biopharma companies where he
services clients by managing and leading strategic projects that
deliver results and create value for the organization. Mr. Goldberg
focuses on leading back office transformation initiatives around
event-driven transactions; target operating model design and execution; business
process design, automation and implementation; enterprise application architecture
design and implementation; organizational design and execution; and complex program
and project management.

Fireside Chat: Winning in the Digital Age

Nitin Seth
CEO
Incedo, Inc.

Mr. Seth is an accomplished industry leader with a unique
combination of experiences – an entrepreneur, a management
consultant and a senior executive. As the Chief Executive Officer
at Incedo, he is responsible for definition and execution of
Incedo’s strategy, creating and implementing the company’s
vision and mission and shaping a unique and effective
organization culture. Mr. Seth is currently leading an organization-wide transformation
to realize the company’s goal of becoming a world-class technology solutions firm
that delivers exceptional client value, has distinctive capabilities and is an aspirational
workplace for the best of minds. Prior to Incedo, Mr. Seth was the Chief Operating Officer
of Flipkart, where he was responsible for customer and supply chain operations, strategy
to execution capabilities and corporate functions for the company.

12

SPEAKERS

(in order of appearance)

Interviewed by: Emilio Ragosa
Partner
DLA Piper

Mr. Ragosa counsels clients on securities offerings, mergers and
acquisitions and venture capital transactions. He also advises on
corporate transactions ranging from seed financings, venture
financings and private placements to public offerings. Mr. Ragosa’s
clients include private and public companies, as well as venture
capital firms and underwriters. His experience makes him uniquely
capable of advising clients from formation through capital raising until a sale or IPO. Within
the technology industry, Mr. Ragosa has experience with digital media, financial services
technology, e-commerce and health care IT. Within the life sciences sector, his experience
includes biotechnology, medical devices and specialty pharmaceuticals.

Fireside Chat: Delivering Hope: Pfizer-BioNTech COVID-19
Vaccine Clinical Supply Chain Journey

Michael Ku, PharmD
Vice President, Global Clinical Supply
Pfizer

Dr. Ku has over 25 years of biopharmaceutical experience and
currently provides strategic leadership for clinical supply chain
functions in support of Pfizer’s clinical trials in over 70 countries. In
2020 he led the Pfizer-BioNTech COVID-19 vaccine clinical supply
chain teams to the successful Emergency Use Authorization of the
world’s first mRNA COVID-19 vaccine. Having a deep appreciation
for talent development and motivated by helping colleagues thrive, Dr. Ku shares his
leadership skills with a focus on diversity, equity and inclusion by serving as Pfizer’s
Executive Leader of the Global Asian Alliance Enterprise Colleague Resource Group. He
also serves as an Executive Sponsor for the Pfizer Pharmacy Association and founded the
Pfizer/MCPHS Biopharmaceutical Fellowship Program.

Interviewed by: Laks Pernenkil, Ph.D.
Principal, Life Sciences
Deloitte Consulting, LLP

Dr. Pernenkil has over 15 years of consulting and technical
operations experience in pharmaceutical, biologics and medical
device sectors. At Deloitte, his experience includes smart / digital
manufacturing and plant floor operations, plant engineering,
facilities management, material sourcing, distribution, performance
improvement, operational excellence and market entry operations
strategy. Dr. Pernenkil is the Global and U.S. leader for Smart Factory, Digital Manufacturing
& Industry 4.0 offering in life sciences. He has prior experience from Novartis, Alkermes and
Amgen in various technical operations and operations strategy roles.

13

SPONSORS

Conference Partner

McKinsey & Company is a global management consulting firm that seeks to help clients
realize their most important goals. In life sciences, McKinsey provides specialized
capabilities that focus on the needs of small- and mid-cap companies in clinical and early
commercialization stages. These include TA and clinical strategy, medical, regulatory,
market access and digital and analytics capabilities.

CEO Sponsors

As populations age and chronic diseases become commonplace, health care will take
an ever larger share of GDP. Scientific progress, augmented intelligence and a more
empowered patient are driving changes in the delivery of health care to a personalized
experience that demands health outcomes as the core metric. This is causing a power
shift among traditional stakeholder groups, with new entrants (often not driven by profit)
disrupting incumbents. Innovation, productivity and access to patients remain the industry’s
biggest challenges. These trends challenge the capital strategy of every link in the life
sciences value chain, from R&D and product supply to product launch and patient-centric
operating models. Our Global Life Sciences Sector brings together a worldwide network
of 23,000 sector-focused professionals to anticipate trends, identify their implications and
help our clients create competitive advantage. We can help you navigate your way forward
and achieve sustainable success in the new health-outcomes-driven ecosystem.

Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to
identifying, developing and marketing innovative products in the fields of reproductive
health, urology, gastroenterology, endocrinology and osteoarthritis.

Incedo, a Digital Transformation consulting, analytics and technology services company,
works with leading life sciences and health care companies to deliver transformative and
innovative solutions leveraging Data, AI and Cloud across clinical and commercial value
chains. We help clients win in the digital age!

14

SPONSORS

President Sponsors

Biotechnology Innovation Organization (BIO) is the world’s largest association representing
member companies of all sizes, state biotechnology groups, academic and research
institutions and related organizations across the United States and in 30+ countries.
BIO members research and develop innovative health care, agricultural, industrial and
environmental biotechnology products. BIO also produces the BIO International Convention,
the world’s largest gathering of the biotechnology industry, along with industry-leading
investor and partnering meetings held around the world.

Innovation starts with insight and seeing challenges in a new way. Amid today’s
uncertainty, stakeholders are looking for new ways to transform health care and reshape
its future. Our global life sciences and health care practice helps clients transform
uncertainty into possibility and change into lasting progress. Comprehensive consulting,
financial advisory, risk management, audit and tax, along with software products and
platforms, deliver value at every step – from insight to strategy to action. The industry-
wide experience and cross-discipline capabilities of our professionals are aligned to help
companies see what’s in front of them and what’s ahead.
Learn more: www2.deloitte.com/us/lifesciences

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more
than $30 billion and approximately 80,000 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.

Morgan Lewis is a cross-border, full-service law firm that handles a broad range of matters
for clients in the life sciences sector – from innovation and emerging-business issues
through research, development and regulatory approval; marketing and distribution;
product reimbursement; fraud, abuse, product liability and intellectual property litigation;
licensing and collaborations, mergers, acquisitions and other corporate transactions; and
outsourcing. Our comprehensive cross-practice life sciences team is made up of more
than 250 global partners and counsel, including more than 60 professionals with advanced
scientific degrees. No matter the location, we have the capability to advise life sciences
companies on the wide array of transactional and regulatory matters they face throughout
the world.

15

SPONSORS

President Sponsors (continued)

RSM’s purpose is to deliver the power of being understood to our clients, colleagues
and communities through world-class audit, tax and consulting services focused on
middle market businesses. The clients we serve are the engine of global commerce and
economic growth, and we are focused on developing leading professionals and services
to meet their evolving needs in today’s ever-changing business environment. RSM US
LLP is the U.S. member of RSM International, a global network of independent audit, tax
and consulting firms with 48,000 people across 120 countries. For more information, visit
rsmus.com, like us on Facebook, follow us on Twitter and/or connect with us on LinkedIn.

ZS is a professional services firm that works side by side with companies to help develop
and deliver products that drive customer value and company results. ZS is a leading
life sciences consulting firm globally for the biotech and pharmaceutical industry. We
leverage deep industry, practice and issue-area expertise, leading-edge analytics,
technology and strategic advisory to create solutions that work in the real world. With
more than 35 years of experience and 10,000 plus ZSers in 29 offices worldwide, we are
passionately committed to helping our client companies and their customers thrive.

Executive Sponsors

DLA Piper’s life sciences team is comprised of lawyers who have legal, scientific and
medical knowledge who understand the complexity of the business and regulatory
environments in which our clients operate. Many of our lawyers are medical doctors or
have advanced degrees in such fields as biostatistics, molecular and cellular biology,
microbiology, chemistry, biochemistry and chemical engineering. We have spent time in
labs, doctors’ offices and board rooms just like our clients. This experience allows us to
provide a unique combination of technical, business and legal acumen to our approach in
helping life sciences companies succeed in this dynamic market.

Organon is a global health care company formed through a spinoff from Merck, known as
MSD outside of the United States and Canada, to focus on improving the health of women
throughout their lives. Led by the reproductive health portfolio coupled with an expanding
biosimilars business and stable franchise of established medicines, Organon’s products
produce strong cash flows that will support investments in future growth opportunities
in women’s health, including business development. In addition, Organon is pursuing
opportunities to collaborate with biopharmaceutical innovators looking to commercialize
their products by leveraging its scale and presence in fast growing international markets.

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SPONSORS

Board Sponsors

Amicus is a global, patient-dedicated biotechnology company focused on discovering,
developing and delivering high-quality medicines for people living with rare metabolic
diseases. Amicus is the Latin word for friend. This name signifies our collaborative
approach to developing medicines by incorporating the patient perspective every step of
the way. By championing mission-dedication, innovation, performance and integrity, we
are united by our passion for making a difference and committed to pushing ideas as far
and as fast as possible.

Apprentice.io delivers the life sciences industry’s only intelligent software platform built
to help teams scale faster – from COVID to cancer. From small/large molecule to cell
and gene therapy, Apprentice’s cloud-based system leverages artificial intelligence,
augmented reality and Pharma 4.0 principles to increase an organization’s speed
to market. Run your entire batch campaign and leverage your data for continuous
process improvement while taking your existing procedures and making them smart.
Optimize your entire supply chain, performing predictive consumable and raw material
management, smart equipment tracking and preventive maintenance scheduling. Elevate
your teams’ potential using language-independent, global collaboration tools in or out of
the lab and suite to increase speed to resolution and decrease travel.

At Faegre Drinker, we foster an environment of creativity, innovation and mutual respect.
Our recognition as a Mansfield Certified Plus firm demonstrates that we hold ourselves
accountable for progress on building a diverse workforce, diverse leadership teams and
diverse pipelines to leadership. Faegre Drinker is a firm designed for clients, providing
exceptional counseling, transactional, litigation and regulatory services to organizations
in the health and life sciences industry ranging from emerging companies to multinational
organizations. With more than 1,300 attorneys, consultants and professionals in 21
locations across the United States, United Kingdom and China, Faegre Drinker is one of
the nation’s top 50 law firms. For more information, visit www.faegredrinker.com.

A biopharmaceutical company focused on developing innovative, inhaled
pharmaceuticals for the site-specific treatment of serious lung diseases, such as
pulmonary infections in cystic fibrosis patients and cancers affecting the lung. The
company is committed to significantly improving the quality of life and health care of
patients suffering from these life-threatening diseases.

17

SPONSORS

Board Sponsors (continued)

PwC’s Pharmaceuticals and Life Sciences industry group is a passionate community of
solvers coming together to help build trust in society and solve important problems.
We are a diverse team who are dedicated to serving the life sciences sector and are
committed to delivering effective solutions to the complex business challenges facing
pharmaceuticals and life sciences companies. Our breadth and scale enables us to
serve category leaders of all types and sizes, including: proprietary and generic drug
manufacturers, wholesalers and distributors, specialty drug makers, medical device
suppliers, biotechnology companies, pharmacy benefit managers, contract research
organizations and industry associations.

Vice President Sponsors

Centri Business Consulting is dedicated to providing high quality finance and accounting
consulting services to its clients by being reliable and responsive to their needs. Centri
provides companies with the expertise they need to meet their strategic accounting
and reporting demands. Centri’s seasoned team will guide you through the financial
reporting and compliance challenges of the life sciences industry. We offer customized
life sciences accounting services designed to meet the demands of your company as
they emerge and evolve. From going public to expanding your product portfolio and
everything in between, we can help you anticipate and overcome any obstacle.

A Top 40 Firm, Friedman LLP has been serving the accounting, tax and business
consulting needs of public and private companies for almost one century. Our Life
Sciences Services Group works with pharmaceutical, biotechnology and medical device
companies, as well as other related businesses, at every stage of their lifecycle. We
understand the high price paid to be a success in the industry, particularly as the world
still faces COVID-19. Our agility in adapting demonstrates the importance of partnering
with an accounting firm that enables private and public life sciences companies, and bio-
entrepreneurs, to be innovative while remaining assured that their complex and evolving
accounting, financial reporting and tax needs are met.

At Insperity, it’s not just HR outsourcing, it’s HR that makes a difference.™ Our
comprehensive, scalable HR solutions offer an optimal blend of service and technology
to facilitate growth by streamlining processes related to payroll, benefits, talent
management and HR compliance. We provide the tools to help you lighten your
administrative load, maximize productivity and manage risks – so you can focus on
growth. Because that’s what it means to have a true HR partner.

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SPONSORS

Vice President Sponsors (continued)

Focused on labor and employment law since 1958, Jackson Lewis P.C.’s 950+ attorneys
located in major cities nationwide consistently identify and respond to new ways
workplace law intersects business. We help employers develop proactive strategies,
strong policies and business-oriented solutions to cultivate high-functioning workforces
that are engaged, stable and diverse, and share our clients’ goals to emphasize inclusivity
and respect for the contribution of every employee.

Merck is a global research-driven pharmaceutical company that discovers, develops,
manufactures and markets vaccines and medicines to address unmet medical needs. The
company devotes extensive efforts to increase access to medicines through far-reaching
programs that not only donate Merck medicines but help deliver them to the people who
need them.

MEMBERSHIP

BioNJ is New Jersey’s life sciences trade association. Our nearly 400 Members represent
the full life sciences ecosystem, from research-based innovation companies, academia and
Patient advocacy groups to economic development organizations and service providers.
As a BioNJ Member, your entire Team can take advantage of the many opportunities and
benefits that are available through Membership.
BioNJ...

Acts as a conduit for idea sharing, learning, collaboration and mentorship
through its many networking and educational programs
Provides an extended marketing arm, offering a platform to showcase your
science, services and organization to a broad network
Advocates in both Trenton and Washington D.C. to ensure that government
fosters medical innovation and Patient access
Works with policymakers to secure incentives and programs that allow
New Jersey’s innovation ecosystem to flourish
Provides deep savings through our Purchasing Consortium so Member
companies can preserve their working capital
Offers numerous business-building tools, such as BioNJ’s Talent and Career Portal

For more information on BioNJ Membership, please contact
Kim Minton at [email protected] or call 609-890-3185.

19

Sincere Thanks to Our
BioNJ C-Suite Summit Committee Members

Marc Beaver, BioBridges
Brion Brandes, Incedo

Marshall Calman, LeaderStrong
Jan Campbell, MBA, Korn Ferry International

Mitzi Conners, Merck & Co.
Manya Deehr, JD, Consultant

Stephanie Hassler, Pfizer
Emma Kemble, McKinsey & Company
Adam Knepp, Ph.D., McKinsey & Company
Jack Levitt, MBA, EMTM, LeaderStrong

Marci Newnham, BioBridges
Vaishali Patadia, Ph.D., MBA, MPH, Sanofi

John Pennett, EisnerAmper LLP
Ravi Raghunathan, CohnReznick LLP
Kristin Roosevelt, Thermo Fisher Scientific

Tony Torrington, EY
Raul Trillo, M.D., MBA, Nevakar
Arda Ural, MSc, MBA, Ph.D., Ernst & Young LLP

Alain Van Loo, Assetive
Brian Wilcomes, Deloitte & Touche LLP

Joe Wolfe, RSM US LLP

Debbie Hart BioNJ Team Dana Sacco
Samantha Bamberger Peggy Schell
Debbie Mennito John Slotman
Randi Bromberg Kim Minton Kristin Stettner
Donna Gibbons Ann Wieczkowski
Denise Machado Katina Pearl-Blando
Dawn Piccioni
Cheri Potts

Whitehorse Executive Center • 1255 Whitehorse-Mercerville Road
Building B, Suite 514 • Trenton, NJ 08619

Phone 609-890-3185 • [email protected] • www.BioNJ.org