UNITED STATES PHARMACEUTICALS AND BIOPHARMACEUTICALS 2021
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
UNITED STATES
PHARMACEUTICALS
AND BIOPHARMACEUTICALS
2021
Drug Discovery - Covid - Funding and Investments - Contract Services
Hubs and Academia - Accelerating Pipelines - Generics
Dear Reader,
Welcome to the 2021 edition of the United States Pharmaceutical and
Biopharmaceutical Industry Report.
Over the past year, the United States life sciences ecosystem faced
one of its greatest ever tests in responding to Covid-19. Fortunately,
thanks to years of research, development and risk taking, the industry
proved up to task, and proved its remarkable dynamism. Therapeutics
and vaccines were brought to market on timelines previously consid-
Compliance Solutions
ered to be impossible and, at least temporarily, public opinion of the
sector spiked as the industries’ valiant efforts were brought to light.
Beyond the headlines, companies continued to build on the progress
of the previous decades, despite the many challenges Covid presented
for clinical trials and supply chains. Undeterred, the industry obtained
Built from the Law
53 novel drug approvals, across indications ranging from precision
oncology to peanut allergy. With gene editing, cell-based therapies and
profoundly new ways of manipulating immune cells to target cancers,
today the industry has a far greater toolbox to treat disease than could
previously be imagined.
With many of the great uncertainties of the pandemic now behind us, it
is crucial for investors, pharmaceutical executives, manufacturers and
scientific researchers involved in the US pharma and biopharma indus-
try to remain unified and informed. The way in which groups across
For over 15 years, Porzio Life Sciences has been a true companion to industry, academia, government and the broader health-care system
have come together to fight this pandemic has been inspiring to many.
pharmaceutical and medical device companies. Our industry-leading products and
Continuing to partner in this way will be critical in successfully navi-
services clarify the compliance process for companies of all sizes, whether they gating public health challenges of the future.
operate in one state or 40 countries. With PLS solutions “built from the law,” your
The following pages offer widespread coverage of the state of the US
compliance team is empowered to take a proactive approach to risk management. pharmaceutical and biopharmaceutical industry, including big pharma
and its blockbuster drugs, emerging biotech and their innovative drug
pipelines, and the different service providers across the value chain,
from CDMOs and CROs to AI and big data platform companies. We
sincerely hope that you have a great conference, full of business and
networking opportunities at CPhI North America, and we hope you
enjoy reading our 2021 edition of the United States Pharma and Bio-
pharma Industry Report.
INDUSTRY-LEADING FLEXIBLE, CONFIGURABLE, END- THE NEXT GENERATION OF U.S.
REGULATORY GUIDANCE TO-END MANAGEMENT OF AND GLOBAL TRANSPARENCY
AT THE STATE, FEDERAL, HIGH-RISK ENGAGEMENTS. REPORTING, MONITORING
AND GLOBAL LEVEL. AND AUDITING.
Alfonso Tejerina
General Manager and Director
GBR
porziolifesciences.com | info@porziols.com
CONTENTS / UNITED STATES PHARMACEUTICALS AND BIOPHARMACEUTICALS 2021
Editorial Analysis
Introduction to US Life Sciences Life Sciences Investment Climate 57. Interviews with Poseida Therapeutics Contract Manufacturing and Generics 90. Generics
and with AVROBIO 93. Interview with Biophore GBR provides unique and first-
8. Industry rises to the occasion 34. Funding Environment 58. Interviews with Arena Pharmaceuticals 74. Contract Services 94. Interview with Nivagen Pharmaceuticals hand analysis into all aspects
10. Interview with Regeneron 37. Interview with J.P. Morgan and with Novan 74. Interview with Forge Biologics 95. Interview with Ascendia of the US pharmaceutical and
12. Interview with Hercules Capital 38. Interview with Signet Healthcare 59. Interview with Landos Biopharma 77. Interview with Aragen Life Sciences Pharmaceuticals biopharmaceutical industry
13. Interviews with Pharma and Biopharma Partners 60. Interview with Vedanta Biosciences 79. Interview with Contract Pharmacal Corp. 96. Interview with Zydus Cadila after months of research.
Outsourcing Association (PBOA) and 39. Interview with Ernst and Young LLP 61. Advancing Oncology 80. Interview with Quotient Sciences 97. Interview with Dr. Reddy’s Laboratories
with LaVoieHealthScience and with Burrage Capital 64. Interview with OncoSec Medical 98. Final Thoughts
14. Pricing 40. Venture Capital Incorporated
81. Interviews with Touchlight Genetics
and with Cascade Chemistry 100. Company Directory 8, 22, 34, 52, 74
16. Interview with Porzio Life Sciences LLC 42. Interview with Arch Venture Partners 65. Interviews with Constellation 82. CDMO M&A and Investment 102. Credits
17. Interview with ValGenesis 43. Interview with Vertex Ventures HC Pharmaceuticals and with InteRNA 84. Interview with Dipharma Francis UNITED STATES PHARMACEUTICALS
44. Interview with Xontogeny Technologies 85. Interview with New Vision AND BIOPHARMACEUTICALS 2021
Industry Explorations
Industry Hubs 45. Hub and Spoke 66. Interviews with Karyopharm Therapeutics Pharmaceuticals Global Business Reports
47. Interview with Xoma and with Foghorn Therapeutics 86. Interviews with Lonza Capsules and This research has been conducted by
22. Introducing the Hubs 48. Interview with PureTech Health 67. Commercializing Neuroscience Health Ingredients and Margarita Todorova and Jason Spizer
25. Interview with BioNJ 49. Interview with Roivant Sciences 69. Interview with Aphios with Piramal Global Pharma Edited by Mungo Smith
Graphic design by Gonzalo Da Cunha
26. Interview with MassBio 70. Interview with AC Immune 87. Interview with Adare Pharma Solutions
27. Interview with JLL Accelerating Pipelines 71. Interviews with PsychoGenics 88. Interviews with Clinigen Group A Global Business Reports Publication
For updated industry news from our
28. Originating Discovery and with Akili Interactive and with CordenPharma on-the-ground teams around the world,
please visit our website at gbreports.com,
30. Interview with Princeton University 52. Expanding Therapeutic Focus 89. Insights on Manufacturing subscribe to our newsletter by signing up
31. Interview with MIT Technology 55. Interview with AzurRx BioPharma and Distribution to our VIP list through our website,
or follow us on Twitter @GBReports and
Licensing Office 56. Interview with Insmed LinkedIn (gbreports)
Exclusive
Olympia Washington
Interviews
CANADA Leading industry figures share
North Maine their insights and exciting new
Salem
Helena
Dakota Minnesota developments with GBR.
Montana Bismarck Augusta
Idaho Montpelier
Oregon
10, 12, 42, 48, 60
New
Vermont Hampshire
Boise New York Concord
St. Paul
South Pierre Albany Boston
Dakota Wisconsin Michigan
Wyoming Lansing Providence
Hartford
United States
Rhode Island
Connecticut
Madison
of America Iowa
Pennsylvania
Carson City Cheyenne Harrisburg Trenton
International Boundary Nebraska
Salt Lake City Des Moines
State Boundary Sacramento Illinois
State Capital
Columbus Ohio
Nevada Lincoln Indianapolis Dover
Delaware
Denver Springfield Annapolis
Utah Topeka Indiana Washington D.C.Maryland
N Virginia
Colorado Charleston
West
Kansas Virginia
Richmond Atlantic Ocean
California Jefferson Frankfort
City Missouri
Industry
Kentucky
Raleigh
North Carolina
Thoughts
Arizona Santa Fe Oklahoma
Nashville
Tennessee
Little
Oklahoma Rock
Phoenix Columbia Excerpts of ideas shared with
New Mexico City
Atlanta
Arkansas
South
Carolina
GBR during interviews with
over 70 of the leading players
Mississippi Georgia in the US pharmaceutical and
Pacific Ocean Montgomery biopharmaceutical industry.
Louisiana Jackson Alabama
Texas 89, 98
Tallahassee
Baton Rouge
Austin
Florida
0 100 200 300 Miles
Gulf of Mexico
MEXICO
INTRODUCTION
TO US LIFE
SCIENCES
“A year ago, we were telling people externally we thought that
mRNA was going to become one of the biggest markets for
our DNA platform, but that it needed a clinical inflection point.
At that time nobody was producing at scale, but the effect of
Covid-19 was that these platforms were completely validated
by the efforts of BioNTech and Moderna.”
- Jonny Ohlson,
Executive Chairman,
Touchlight Genetics
GBR • Industry Explorations • UNITED STATES PHARMACEUTICALS AND BIOPHARMACEUTICALS 2021
Image courtesy of Vedanta Biosicences / Bearwalk Cinema
EDITORIAL Global Business Reports Industry Explorations
Intro to US In the US, the Trump administration
launched its vaccine taskforce named
"Operation Warp Speed," an expres-
erna’s Covid-19 vaccine was designed
in just 48 hours is astonishing. But they
are not the only ones with impressive
Life Sciences sion popularized by Star Trek.
Coincidentally, the most efficacious and
The past quarter-century has
seen tremendous progress
stories. 53 new drugs were approved by
the FDA in 2020 (the second most of any
trusted vaccines that are now being ad- in biomedical research, year), across indications ranging from
ministered across the US and the world precision oncology to peanut allergy,
INDUSTRY RISES TO are mRNA vaccines, which not long ago
leading to an increasing many using innovative technologies that
THE OCCASION were considered science fiction. Even understanding of cancer, hold the promise of uniquely impacting
as recently as one year ago, this techno- heart disease, diabetes and patient lives.
logy still received skepticism and lacked other devastating diseases.
validation.
Shortly after winning the Nobel Prize in Jonny Ohlson, executive chairman of
The nation has led the Reaping What We Sow
Chemistry, Jennifer Doudna comment- Touchlight Genetics, commented: “A world in such progress,
ed that over the course of the pandem- year ago we were telling people exter- due in significant part to It should not be understated that the
ic, she was reflecting on Thomas Kuhn’s nally we thought that mRNA was going reason the US life sciences ecosystem
wise investments by the
book “The Structure of Scientific Revo- to become one of the biggest markets was capable of responding in such rapid
lutions,” published in 1962. It made a for our DNA platform, but that it needed Federal Government in basic fashion is because of investments made
compelling case for “paradigm shifts,” a clinical inflection point. At that time, biomedical research. These decades earlier both by public institu-
in which the accumulation of challenges nobody was producing at scale, but the breakthroughs are beginning tions and private entities. Perhaps a sil-
to a supposed truth eventually over- effect of Covid-19 was that these plat- ver lining of the pandemic is the ampli-
to pay off in terms of new
turns the accepted understanding of it. forms were completely validated by the fied awareness by government officials
This seemed to explain the observation efforts of BioNTech and Moderna in therapies for and the public that the solutions in di-
that scientific ideas and practice often getting vaccines to market.” American patients. agnostic testing, drug treatments and
bumble along for a while but then ex- Messenger RNA is just one of several vaccines will come from industry as it
perience a rapid and substantial change new modalities that are enabling a translates basic science discoveries into
that disrupts the regular way of working. renaissance in biomedical progress. safe and effective products. In a press
Over the past year, Covid-19 has up- There are now tools for gene editing, - Christiana Bardon, conference this March, President Biden
ended lives around the world, leading cell therapy, microbiome, targeted pro- Portfolio Manager, declared: “Back in the ‘60s, we used to
to over 3 million deaths as of April 2021. tein degradation, both active site and Burrage Capital invest a little over 2% of our entire GDP
At its peak, the US witnessed multiple allosteric small molecules, and even in pure research and investment in sci-
days where its daily death rate reached digital therapies. All of these modalities ence. Today, it’s 0.7%. We’re going to
historical highs exceeding that of 9/11. are giving the R&D community a differ- change that.”
The sense of desperation that came out entiated toolkit to address distinctive More specifically, Biden has detailed
of this necessitated a rethinking of what conditions, which allows for tailoring his view that industries such as artificial
was previously considered possible. For and refining how we think about making intelligence, and biotech are central to
many years, the life science industry has new medicines. improve and disrupt the traditional drug sustaining America’s competitive posi-
had breakthrough ideas bubbling under The life sciences sector is now at a discovery and development process. tion in the world, therefore warranting
the surface, but accepted truths are dif- stage where the promises of cell and Collectively, these technologies make increased investments in medical re-
ficult to change. For example, people gene therapies are being delivered to up their VelociSuite platform, which search pertaining to insidious diseases
took it as a given that it takes years to patients; rare diseases, previously be- played a pivotal role in treating former such as cancer, Alzheimer’s and diabe-
develop a vaccine, that virtual medicine lieved to be incurable, are on the preci- President Trump when he was hospital- tes.
will never scale for doctors or patients, pice of real cures. Artificial intelligence ized due to Covid in October. Robert In addition to supportive funding to in-
and the regulatory system cannot adapt (AI) and machine-learning approaches Landry, CFO of Regeneron, outlined: stitutions such as the NIH, it is also es-
to innovation quickly enough to support are raising expectations that therapy “Thanks to three decades of investment sential that the FDA remains a priority.
lasting change. Over the past year, the discovery and development may not in our antibody discovery and develop- The FDA’s relationship with biotech has
US bio ecosystem turned this orthodoxy only be more innovative, but also more ment technologies, as well as our recent been a positive force for the industry, as
on its head, responding heroically, and time and cost effective. experience developing a multi-antibody they have shown that if there is a severe
faster than ever before in so many ways. cocktail for Ebola, our team was ready unmet medical need, they can work
The rapid pace at which industry moved to quickly mobilize when Covid-19 hit.” productively and collaboratively to get
was enabled by decades of research by Tech to the Rescue The team ultimately moved its inves- drugs out to patients as quickly as pos-
industry and academia, which formed tigational antibody cocktail against sible. Christiana Bardon, portfolio man-
the base for a mobilization never seen Regeneron is an exemplar of many of SARS-CoV-2 from lab to clinic in record ager at Burrage Capital, noted: “We
in the biological sciences. It rivaled the these trends, as they were able to rap- time. This process, which would normal- saw the FDA perform at “warp speed”
great efforts of the Manhattan Project idly produce a Covid antibody cocktail ly take years, was achieved in under six for Covid. But the truth is, they have
and the Apollo moon program. The Rus- leveraging their core capabilities for tar- months. been doing that same day job for years
sians even named their vaccine Sputnik, get discovery and validation enabled by The development of Regeneron’s an- with respect to cancer and other severe
evoking memories of the space race. a series of technologies that accelerate, tibody cocktail and the fact that Mod- unmet medical needs.”
8 U N I T E D S TAT E S P H A R M A C E U T I C A L S A N D B I O P H A R M A C E U T I C A L S 2 0 2 1 Industry Explorations Global Business Reports 9
INTERVIEW Global Business Reports Industry Explorations
Robert E. This was particularly true in the case of Amgen’s Blincyto,
which was approved in under three months for pediatric
With innovative thinking and Acute Lymphocytic Leukemia. “The FDA’s thinking is that
Landry efficient, parallel track use
of Regeneron’s proprietary
every day that they do not approve a drug like Blincyto
there is a child who may die of leukemia,” Bardon con-
cluded.'
VelociSuite technologies, the
team moved an investigational
Positive Sentiment Meets Strong Fundamentals
Executive Vice President, antibody cocktail against
Finance and Chief Financial Officer SARS-CoV-2 from lab to clinic in Given the widespread suffering from loss and lockdowns
REGENERON record time. leading to historically high unemployment, one might
have expected the business climate to suffer. It did to
some extent, as some clinical trials were disrupted and re-
mote sales posed major challenges, but things quickly re-
bounded as the year progressed. The life sciences indus-
try, in particular, had several tailwinds at its back; namely
Can you provide an overview of Re- miplimab) is achieving significant and specifically to block infectivity of a wave of positive sentiment from society and investors.
generon’s core brands? steady growth with recent FDA approv- SARS-CoV-2, the virus that causes Cov- As clinical trials for Covid treatments and vaccines hit
EYLEA (aflibercept) Injection continues als in two new indications, non-small id-19. The two potent, virus-neutralizing milestones, and people realized life would continue, the
to reach more patients in competitive cell lung cancer and basal cell carcino- antibodies that form the cocktail bind life sciences industry was praised for its innovation and
eye disease markets, with its efficacy, ma, in early 2021. Global net product non-competitively to the critical recep- bright future, driving stock market indices like the XBI to
safety and convenience setting a high sales for Libtayo were US$348 million in tor binding domain of the virus's spike all-time highs, outperforming nearly all other sectors.
bar for current and potential future en- 2020, representing 80% year-over-year protein, which diminishes the ability of In addition to positive sentiment, the fundamentals driv-
tries. We are confident in the durability growth. mutant viruses to escape treatment and ing the industry over the long term have not changed.
and continued growth of this important With 11 investigational therapeutics in protects against spike variants that have These fundamentals include aging demographics, in-
medicine for years to come. Annual EY- clinic for a wide range of cancers, includ- arisen in the human population, as de- credible innovation and the supportive regulatory envi-
LEA global net product sales reached ing eight bispecific antibodies, we con- tailed in Science. ronment. From that perspective, the industry is creating
nearly US$8 billion in 2020 (net product tinue to diversify our approach to oncol- many new drugs, which are going to go on to be ap-
sales outside the US recorded by our ogy and are positioned to lead the next How do Regeneron platform technol- proved and will be entering into a marketplace growing
collaborator Bayer), and US$4.9 billion wave of immuno-oncology innovation. ogies drive its efficient drug discov- in medical need. Even more exciting is the fact that we
in the US, still without a single price in- ery and development engine? still understand a fraction of human biology, thus there
crease since its launch in November What factors enabled Regeneron to Our core capabilities for target discovery is no shortage of potential for farfetched breakthroughs.
2011. play such an important role in deliver- and validation are enabled by a series of As Arda Ural, Americas industry markets leader-health
Looking to the rest of our growing port- ing Covid-19 antibody therapeutics to Regeneron-invented technologies that sciences and wellness at Ernst & Young, put it:
folio, more than 80% of our top-line market? accelerate, improve and disrupt the “Unlike 2008-2009, this is not a fiscal crisis; it is a pan-
growth in 2020 came from products and Thanks to three decades of investment traditional drug discovery and develop- demic, and there is a lot of liquidity in the overall system.”
revenues other than EYLEA. Dupixent in our antibody discovery and develop- ment process. Collectively, these Velo- According to EY’s figures, biopharma alone, excluding
(dupilumab) global net product sales ment technologies, as well as our recent ciSuite technologies represent some of private equity, possesses approximately US$1.5 trillion of
in 2020 (recorded by our collaborator experience developing a multi-antibody the most valuable biotechnologies ever liquidity to deploy. He continued: “Because of this un-
Sanofi) were more than US$4 billion, re- cocktail for Ebola, our team was ready to created, and aid our efforts to continu- derlying strength, valuations as evident by the S&P 500
flecting growth of 75% versus 2019. This quickly mobilize when Covid-19 hit. With ously accelerate the average timeline Biotech or MedTech indexes, did not suffer at all. Con-
‘pipeline in a product’ continues to reach innovative thinking and efficient, parallel from discovery to drug approval — ulti- sequently, IPOs and SPACs came back in a big way, and
more patients in need with an expanded track use of Regeneron’s proprietary Ve- mately allowing us to help more patients biotech IPOs are now at an all-time high.”
FDA indication for atopic dermatitis in lociSuite technologies, the team moved around the world, faster.
patients ages 6 to 11 and an FDA accep- an investigational antibody cocktail
tance of our supplemental application as against SARS-CoV-2 from lab to clinic in What drives Regeneron’s scientific Writing the next chapter
an add-on treatment for children aged record time. A process that would nor- agenda and how does it stay true to
6 to 11 years with uncontrolled moder- mally take years was achieved in under the company’s scientific roots? As we have witnessed with previous crises, Congress’s
ate-to-severe asthma, with even more six months. Regeneron was founded and has been positive view of pharma only lasts so long and eventually
room to grow as it meets its potential to led for over 30 years by physician-scien- politicians will go back to vilifying the industry for its high
transform the treatment of certain type How does Regeneron’s antibody tists – a rarity in the industry – and we ap- prices and profits. Furthermore, capital markets will not
2 inflammatory diseases. We also made cocktail work against new Covid-19 ply this science-focused mentality to our always be as easy as they are today with well paved exit
Dupixent treatment more convenient variants? work. We pursue therapeutic pathways ramps leading to mergers and IPOs. Nevertheless, the
with the FDA approval of a single-dose, REGEN-COV (casirivimab with im- based on our ability to see early prom- far-reaching changes that the Covid-19 crisis has brought
300 mg pre-filled syringe. devimab) is a cocktail of two monoclonal ise through genetic or deep biologic re- will outlast the pandemic and, in the long run, the US life
As the foundation of our oncology port- antibodies (also known as REGN10933 search. From there, we have found that sciences industry will positively alter the lives of many. ■
folio, our PD-1 inhibitor Libtayo (ce- and REGN10987) and was designed commercial success will follow. ■
10 U N I T E D S TAT E S P H A R M A C E U T I C A L S A N D B I O P H A R M A C E U T I C A L S 2 0 2 1 Industry Explorations Global Business Reports 11
INTERVIEW Global Business Reports Industry Explorations INTERVIEW
Scott Gil What are some of the key pieces of legislature that are driving the CDMO
business today?
We work with congressional offices to help give them an idea of what the CDMO
Bluestein We built up a deep network that
Roth sector is, and the role it plays not just in providing dosage forms for patients in
the US, but also the vast number of jobs it is responsible for in America. We got
enables us to be committed involved in drug shortage proposals with congress and FDA, which have not yet
President been moved into law but may be revisited soon. We also helped with the opioid
and dedicated to not just the omnibus the US Congress developed and passed. In particular, even before the
life sciences, but also the PHARMA & BIOPHARMA
pandemic, there were questions about the pharmaceutical supply chain and how
CEO & CIO OUTSOURCING ASSOCIATION (PBOA)
technology verticals. to secure it from a US-centric perspective. Once the pandemic hit, we had a lot
HERCULES CAPITAL more involvement with federal agencies, Congress, FDA and other bodies when it
became clear that CDMOs were going to be absolutely critical to manufacturing
vaccines and therapeutics that were going to help get the world through Covid.
Are we seeing the value of CDMOs expand in today’s market?
With some key exceptions, the CDMO sector is largely private equity owned. The
PE model is to hold companies for five to seven years and then either sell to an-
What were some of the key high- companies from the expansion stage by Covid-19, is the convergence of other PE firm or merge with another company. This model has held up for decades.
lights of 2020? of their lifecycle through to the es- the two sectors. Consequently, we What we have seen in recent years is an increase in valuations, partly because the
The momentum around innovation, tablished stage. Hercules can finance are doing more deals now across our notion that CDMOs represent a pharmaceutical investment that doesn’t carry the
coupled with years of sound strat- a company with a structured debt so- platform where we bring our techno- direct risk of R&D pipelines. You are getting some pharma benefits (steady de-
egy, enabled Hercules to have a ban- lution that ranges from US$10 million logy domain expertise and combine it mand and drug-driven growth), but without as much risk of collapse if a pipeline
ner year. We had record total and all the way up through US$200 million. with our life sciences team expertise. candidate fails. That said, you don’t get the upside of those drugs succeeding and
net investment income. Hercules also That gives us a significant competitive We are looking at a lot of healthcare blowing up in the market, but CDMOs are getting steady revenue growth. ■
ended the year with the strongest advantage in that we can find compa- tech companies along with traditional
balance sheet we have had. We were nies early in their evolution and help drug discovery and development bio-
able to complete several capital raises them finance themselves through mul- tech companies that are utilizing tech-
throughout the course of 2020, and we tiple value inflection points. nologies as they look to pipeline ex-
ended the year with nearly US$700 mil- pansion. We believe that having teams
lion of available liquidity. What are the principal advantages with expertise, not just in life sciences
On the investment and portfolio side,
we also had tremendous momentum
throughout 2020, and this accelerated
of venture debt?
Regardless of the quality of the com-
pany, there are going to be setbacks
but also in technology, gives us a sig-
nificant competitive advantage. Donna What are the key factors for companies trying to effectively communicate
with the general public?
Sophisticated investors and business development executives potentially looking
later into the year. For the third con-
secutive year, Hercules ended up com-
and successes. What is unique about
our team is that we understand this
What is the breakdown of Hercules’
asset mix? Are there certain areas
LaVoie to license in products have been the key audience, and most companies in the sec-
tor have been laser focused on how to communicate the scientific/technical part
mitting over a billion dollars of capital reality and, rather than look at these the company favors? of their stories to those types of people. With the pandemic, an unprecedented
to the venture technology and life sci- financings as singular events, which Our focus is on building a diversified, number of retail accounts were opened and we have seen greater interest because
ences industries. Despite a global pan- is what an equity raise or a standard non-correlated portfolio. We focus of enthusiasm over Covid vaccine development. As a result, the character and
demic, we had 22 IPO or M&A events capital raise is, we look at them as long about 50% of our asset base on the size of the audience biotech companies communicate to have changed markedly,
in 2020, which is a strong validation of term financing partnerships, where we technology vertical and about 50% of President & CEO and it is not something companies are accustomed to. Often biotech executives
our model. can support companies over a long pe- our focus on the life sciences vertical. LAVOIEHEALTHSCIENCE struggle with how to distill their message in a digestible manner. In a post-Covid
Our portfolio companies raised nearly riod of time. We are also significantly diversified world, this will no longer work.
US$7 billion of equity capital. These Venture or structured debt from Her- within each of those two core verticals,
results are a testament to the overall cules is significantly less dilutive than so we have exposure to drug discov- How does LaVoieHealthScience assist in implementing a strategy?
strength, not just of the ecosystem, but a straight equity raise. Our team is ery and development, therapeutics, You cannot run your communications for investors’ sake only. What you need to
of the companies that we are so fortu- not looking to manage or direct op- healthcare tech, healthcare services do is build a foundation of key messaging and positioning aligned with key audi-
nate to partner with. erations, we are not looking for board and medical device companies. Our ences. That may be pharmaceutical partners, government authorities, health care
seats or control, we look to establish largest sector concentration within life providers, and all of that communication and relationship building creates value
What makes Hercules’ financing ap- financing partnerships where we rely sciences continues to be drug discov- for the company.
proach unique in the industry? on the existing management team to ery and development, because it cre-
We are arguably the only player that continue to make the right decisions. ates the best diversified risk profile Often failure or ambiguous data is something companies must deal with.
has been in this market consistently for from a funding perspective. Secondly What is the best way to handle these situations?
the last 16 plus years that has achieved Given Hercules’ domain expertise in this tends to be where the largest The number of times that we get the call after data readout and a client says, “It
scale. We built up a deep network both technology and life sciences, market opportunities exist. The last was a homerun. We hit all the endpoints p value of x, and we are off to the races,”
that enables us to be committed and are you seeing a trend toward con- consideration is that this is where we is very rare. Most of the time clients call to say, "We did not meet the primary end-
dedicated to not just the life sciences, vergence of the two areas? think we can make the most difference point, but we have seen activity at this dose level in this subset of patients.” The
but also the technology verticals. We What we have seen over the course of because it is where our capital can be challenge with that is public markets ask merely: Is endpoint achieved? yes or no,
also have the unique ability to finance the last 12 plus months, exacerbated most useful. ■ and what is the p value? That is how stocks trade. ■
12 U N I T E D S TAT E S P H A R M A C E U T I C A L S A N D B I O P H A R M A C E U T I C A L S 2 0 2 1 Industry Explorations Global Business Reports U N I T E D S TAT E S P H A R M A C E U T I C A L S A N D B I O P H A R M A C E U T I C A L S 2 0 2 1 13
EDITORIAL Global Business Reports Industry Explorations EDITORIAL
Pricing Pharma is a popular target, because
out-of-pocket costs to individuals are
high relative to the rest of the world. US
paying the same, they will leave (ie deny
their citizens access).
The reason the US biotech landscape
ures. For instance, pancreatic cancer is a
devastating diagnosis for which we need
breakthrough drugs; but because the
tailers, PBMs and other intermediaries. It
is not sexy, but a major solution to lower-
ing US drug costs is in improving these
consumers spend roughly three times as is so fertile and well funded is because historical probability of success is much In our Boston study we intermediation costs. We should ask why
A QUANTUM OF INCENTIVE FOR A much on drugs as their European coun- there is that willingness to pay. Michael lower than in other areas of oncology (per
showed that patients were parties who have not invested in inno-
QUANTUM OF INNOVATION terparts, and 90% more as a share of in- Kauffman, who co-founded Karyopharm BIO, a drug for pancreatic cancer enter- vation nor taken development risks are
come according to a report from Univer- Therapeutics along with his wife, Sharon ing Phase 1 trials has only a 1.1% chance spending 37% less time in taking a big portion of the price that the
sity of Southern California. Calculations Shacham, remarked: “The fact of the of approval), investors would need to the clinic, and their disease consumer pays.”
Although the heroic actions of the bio- suggest that the US market accounts for matter is that it is great that the US reim- know that a drug that shows needle- progressed for 30% less time. Improvements in this area would also
pharmaceutical industry granted it a 64 to 78 % of worldwide pharmaceutical burses drug prices at the levels they do moving efficacy would be reimbursed at make manufacturing within the US more
temporary reprieve from intense scrutiny
That means less doctors’
profits. These profits drive the cycle of because without that engine we would a higher price than the average cancer competitive. From Nivagen Pharmaceuti-
on pricing, it is sure to return as influen- drug innovation that ultimately benefits not have such a robust biotechnology drug. visits, less clinic time and cals’ CEO Jay Shukla’s perspective: “The
tial leaders on both ends of the political patients around the globe. and pharmaceutical industry. We cannot less progression. Different issue we have is that the consumer does
spectrum in the US find it politically ad- This is frustrating to many, but the so- do the kind of work we want to do if we countries put very different not see the savings because there are so
vantageous to capitalize on people’s lution is not to lower US revenues. RA do not get sufficient return on the suc- Increasing Transparency many middlemen – the wholesaler, PBM,
general low regard for the industry. Capital’s Peter Kolchinsky has done work cessful investments to continue to work.”
values on that and insurance company – each getting a
We often hear the phrase “sky-rocketing elucidating the fact that this would alter The fear around imposing price controls Calls for price controls come on the back percentage. That is what is inflating the
drug prices” in the media and from poli- net present value (NPV) calculations, po- as proposed in HR 3 is that it will stymie of already increased scrutiny over price - Michael Kauffman, price, and that is putting pressure on
cy makers, but the data shows this is not tentially turning them negative, and in innovation. The Department of Health transparency. Porzio Life Sciences LLC, manufacturers to operate in lower cost
Co-Founder and Former CEO,
the case. In fact, work done by the Drug that case, innovation would cease. There- and Human Services has calculated that a provider of compliance software for jurisdictions. If there were a way to either
Channels Institute reveals net drug price fore, it is important to get other countries legalizing importation would shave only transparency reporting, has unique in-
Karyopharm reduce the middleman's exposure, sell
increases have been on the decline and to pay more. Until then, EU countries are 1% to 2% off the nation’s collective phar- sight into this push from state and nation- Therapeutics direct-to-consumer, or direct-to-pharma-
in single digits for the last six years. This like bad roommates, merely pitching in. maceutical bill, but the bill could result al governments around the world. John cy, then the cost of manufacturing would
includes innovative as well as generic Since every bit of revenue helps, you do in investors being less willing to pursue Patrick Oroho, the company’s executive not be a significant factor.”
drugs, despite the outliers we see from not want to turn them out (ie refuse to drug development for diseases in areas vice president and chief strategy officer,
time to time. sell them drug), but if you insist on them where there have been many historic fail- observed that states have become in-
creasingly strict in requiring transparency Social Contract
around prices, such that they want to see Distribution inefficiencies
if a pharma company increased its price One of the key proposals being ad-
more than a certain percentage in a given One of the key problems with the sys- vanced by RA Capital’s Peter Kolchinsky
year. Today this trend continues to grow tem is that affordability is a function of is the idea of a social contract between
stronger, as individual states in the US are out-of-pocket costs imposed by payers patients and the biopharma industry. At
requiring companies to show them how and premiums are impacted by net drug its core, the proposal is about accept-
they arrived at a price for their new prod- prices. The manufacturer of a drug estab- ing that prices will be initially high on
uct. The government thinks that if they lishes the drug’s list (gross) price, which branded drugs in order to pay for inno-
force companies to be transparent, then is called the Wholesale Acquisition Cost vation. But in return for paying a high
they will be more reluctant to engage in (WAC). A drug’s net price equals its list price up front for drugs, companies via
significant price increases. price minus rebates as well as such other government legislation, will agree to al-
Because of these more stringent dynam- reductions as distribution fees, product low genericization without undue delay.
ics biopharma companies increasingly returns, chargeback discounts to hospi- After a patent expires, society will enjoy
want to diversify their sources of revenue tals, price reductions from the 340B Drug the benefits of the cheap, effective ge-
and they want to do it earlier than they Pricing Program, and other purchase dis- neric versions for the rest of time. Similar
did before. “In the past, most companies counts. Negotiated and statutory rebates to a home mortgage, what society pays
always went for approval in the US, and to third-party payers, however, are the during a period of exclusivity leads to it
then launched their product first in the largest and most significant components collectively owning a forever upgraded
US. Only once it was up and successful of gross-to-net price differences. standard of care and longer lives. It is es-
in the US after a number of years would Consequently, brand-name manufactur- sential, however, that during the period
you seek approvals elsewhere around the ers earn substantially less revenue than in which society is paying high prices for
world, because the US provided your best drug list prices imply, due to the gross-to- the branded drug that insurers make ap-
opportunity to recoup all the money you net difference between a manufacturer’s propriate care affordable for all patients.
put into R&D. Now, with controls around list and net prices. Under this proposal a middle ground is
price increases and requirements for To address this issue of therapeutics established where the innovative ecosys-
price reductions or price controls, you are distribution, Signet Healthcare Partners tem would be minimally disrupted, and
starting to see parallel approvals. Com- CEO James Gale suggests: “We should society’s burden of paying high prices for
panies launching their first drug are seek- consider the allocation of the final con- that innovation would not proceed be-
ing approval in the US, and also seeking sumer price to the various parties in the yond the duration of patents. If success-
approval in various countries elsewhere supply chain. There is enormous waste in ful, it could go a long way in ratcheting
in the world,” explained Oroho. the money being paid to distributors, re- down the rhetoric on price controls. ■
14 U N I T E D S TAT E S P H A R M A C E U T I C A L S A N D B I O P H A R M A C E U T I C A L S 2 0 2 1 Industry Explorations Global Business Reports U N I T E D S TAT E S P H A R M A C E U T I C A L S A N D B I O P H A R M A C E U T I C A L S 2 0 2 1 15
INTERVIEW Global Business Reports Industry Explorations INTERVIEW
John Siva ValGenesis makes the end-to-
This April, we launched our end validation lifecycle process
Patrick new global system, Porzio Samy 100% digital, reducing validation
cycle time by over 50% and thus,
GST 5.0. It combines the US
Oroho State, federal, local, and the
rest of the world into one
helping life science companies
release their products to market
Executive Vice President and comprehensive system. CEO & Chief Product Strategist more quickly.
Chief Strategy Officer VALGENESIS
PORZIO LIFE SCIENCES LLC
What are the key problems ValGenesis is solving for custom- One year later, the department implemented an additional Val-
ers? Genesis module to manage change control as a closed-loop
What is the fundamental problem Porzio product. At this stage, they have to put in nies wanted to have a global view of all Validation is a key lifecycle process for the life science industry process with validation. Through this upgrade, users could cre-
Life Sciences’ helps clients solve? their transparency and aggregate spend their interactions with healthcare practitio- before releasing systems for production, commencing with sys- ate their process flows and descriptions to capture the required
Once a company is getting close to com- process, but also what we call their HCP ners, because they are considered high- tem assessment, authoring requirements and risk assessment, justification for changes made within a validated system. Within
mercializing its product in the US, they engagement process. Because, if you risk interactions. authoring test cases, creating trace matrices, executing test the next twelve months, the ValGenesis solution was extended
must get state licenses in order to distrib- were to just pay a physician to prescribe This April, we launched our new global cases, implementing change management, performing periodic to a global biologics’ development division for validation docu-
ute their product across the country. It can your product, that is a violation of the anti- system, Porzio GST 5.0. It combines the reviews, and ending with the retirement process. In life science ments required in a state-of-the-art manufacturing process for
take anywhere from nine to 15 months kickback statute. US State, federal, local, and the rest of the companies, validation is predominantly a paper-based, manual new products and a supply center in Europe.
to get all those in place. Early on, when There are however, safe harbors and carve world into one comprehensive system. process compared to other processes that are automated and ValGenesis today streamlines the validation process for more
a company is two years from their first outs that allow you to hire healthcare This software enables you to do reporting digitized, whether they be laboratory information management, than 3,000 users across five global company sites. Real-time ac-
product approval, they have an idea as to practitioners who have a right to prescribe all over the world. You can see how many quality management, or enterprise resource planning. Validation cess to validation documents and data enables various stake-
when they are going to submit their new your product, and pay them for their ser- HCPs you are engaged with, total dollars is complicated, messy and error-prone when managed manually holders to achieve compliance collaboratively and efficiently.
drug application and when they plan on vice. There must be a documented need spent, total number of transactions. You as a paper-based process, leaving islands of data in different
launching. At that time, they also have a for the specific service, a fair market value can drill down into individual countries formats, and resulting in huge compliance risks. What are your observations in terms of the pace of cloud
semblance of an idea about what their fee and a contract specifying the services and have a heat map or bar graphs and ValGenesis manages each of the validation lifecycle stages as adoption amongst life science companies?
distribution model is going to look like, so and fees to be paid. Companies must you can look who you are spending the a module and connects the dots that flow data from system as- Life science companies have always been more conservative
they are already reaching out to the ma- monitor and report what service the HCP most money with, be it through clinical tri- sessment and author requirements right up to the retirement when it comes to the adoption of cloud technologies. These
jor distributors, and one thing those dis- is providing and how much they are be- als, consulting work or promotional work. stage. ValGenesis makes the end-to-end validation lifecycle pro- companies with fears about data privacy, data and IP protec-
tributors will tell them is that they can only ing paid for such services. This legislation We track the laws, regulations, and pend- cess 100% digital, reducing validation cycle time by over 50% tion were in the habit of purchasing a commercially available
take their product if it is properly licensed passed under the Affordable Care Act, ing legislation for clients and then we ar- and thus, helping life science companies release their products software system, installing it in their internal servers, and man-
across the country. Often, the distributors and it is called the Physician Payments chive all that information so that we are to market more quickly. aging it in compliance with a corporate IT strategy and a set of
will tell the company to come to Porzio Sunshine Act. It is also referred to as the able to show that it has been properly standard operating procedures. Aside from the development of
Life Sciences to have their supply chain CMS Open Payments program. done, all along. Are there Case Studies of how clients have integrated Val- the software package, everything else is owned, managed, and
and distribution model analyzed, and Government agencies, investigators and Genesis software into their workflow? maintained by the internal IT staff of the company. This results in
to determine whether they are a virtual prosecutors are mining the data that is Are there any new policies that you see A U.S. site for global biotechnology manufacturing and prod- high overhead costs to the company. The expense and capital
manufacturer or traditional manufacturer. reported to uncover inappropriate pay- on the horizon that might impact com- uct supply operations had its validation documents and change burden of the on-premise model in many companies takes a
Then they will determine what States they ments that can violate the anti-kickback pliance? control requests associated with several key products being ap- back seat to the inherently slow pace of deploying functionality
need to be licensed in, and what type of li- statute. As a result, companies are very One of the things happening both at the proved by stakeholders across company sites in the US and Eu- to the business.
censes are needed. That is one of the first concerned that they are engaging the federal and state levels is price transpar- rope. The department was facing many challenges commonly The cloud business model changes the game significantly. True
areas we solve. HCPs appropriately and that they are fol- ency. States are requiring transparency associated with paper-based validation. The work eventually got multi-tenant cloud computing-based systems can deliver signifi-
Once that is done, we start to get ready lowing all the rules. around prices such that they want to see done, but with more manual effort, duplication, and time than cant value by sharing infrastructure and software across several
for interactions with healthcare practitio- At Porzio, we have been doing State re- if you increased your price more than necessary, given the technologies available. customers. Pre-pandemic, some leading life science companies
ners. When the companies are starting to porting for life science companies in the a certain percentage in a given year or The company sought a digital validation solution that could de- had started their digital transformation pursuing cloud-enabled
plan how to sell and market their product. US since 2005. Then, in 2014 we began more than a given percentage over the liver similar ROI improvements that it had come to expect from capabilities with clinical trials and data science. But the current
They must make decisions about whether with the nationwide reporting under the last three years. Now, on top of that, there other enterprise systems such as ERP, DMS, LIMS, and MES. It pandemic has now created an inflection point in digital adop-
to target physicians or advanced practice federal Open Payments program, and in are individual states in the US that are needed a forward-looking approach that would eventually lead tion and technology-led business transformation.
registered nurses, physician assistants, 2015 we started doing reporting around requiring companies to show them how to 100% electronic validation lifecycle management.
and other types of healthcare practitio- the world. At that time, we had two dif- they arrived at a price for their new prod- ValGenesis was configured to meet more than 95% of the com- What role has ValGenesis played for clients working remote-
ners. This is important because, if you ferent systems; Porzio Aggregate Spend uct. The companies must file a disclosure, pany’s requirements out-of-the-box and was implemented, vali- ly during the pandemic?
have the right to prescribe a product in ID, that handled the US, and Porzio GST as the product is launched. The govern- dated, and put into production in 12 weeks. ValGenesis offered Technology has advanced to provide new platforms to manage
a particular state, the government is very that handled the rest of the world. As time ment thinks that if they force companies the ability to migrate from paper toward 100% electronic valida- manufacturing and validation processes remotely. With the help
interested in the type of financial interac- went on, and more and more enforcement to be transparent, then they will be more tion. The project-level implementation was deemed a success of the ValGenesis platform, our clients can now manage the vali-
tions taking place between you and some- on anti-kickback and Foreign Corrupt reluctant to engage in significant price in- based on efficiency improvements, eliminating non-value-add- dation process remotely or with limited onsite resources, with-
body who has the right to prescribe your Practices Act started taking hold, compa- creases. ■ ed activities, and enabling consistency. out any disruption to their supply chain. ■
16 U N I T E D S TAT E S P H A R M A C E U T I C A L S A N D B I O P H A R M A C E U T I C A L S 2 0 2 1 Industry Explorations Global Business Reports U N I T E D S TAT E S P H A R M A C E U T I C A L S A N D B I O P H A R M A C E U T I C A L S 2 0 2 1 17
INDUSTRY
HUBS
”The outbreak of Covid-19 challenged us to rapidly innovate
and continuously iterate to address the pandemic and its
far-reaching impacts, and Massachusetts led the way in
developing tests, therapies, and vaccines that have helped
combat the virus”
- Kendalle O’Connell,
President and COO,
MassBio
GBR • Industry Explorations • UNITED STATES PHARMACEUTICALS AND BIOPHARMACEUTICALS 2021
Image courtesy of CordenPharmaFA C T S H E E T Global Business Reports Industry Explorations FA C T S H E E T
Massachusetts Source: MassBio
New Jersey Source: Choose New Jersey
Quest Diagnostics
50+ biotech companies,
Catalent
2 million+ s.f. in lab space, Allergan
UMass-Lowell and 11 other colleges
50+ biotech companies, WPI,
Quintiles Stryker Orthopaedics
UMass-Worcester, and 16 Ferring BD
other colleges
GlaxoSmithKline Bayer Healthcare
NORTHEAST AbbVie
Daiichi Sankyo Parexel
250+ biotech companies, Frontage Laboratories
the top 4 NIH-funded hospitals Cambrex Corporation
BOSTON in the U.S., and 48 colleges Pfizer
Pfizer Novartis GlaxoSmithKline
CAMBRIDGE
Valeant Biotrial
WORCESTER CORE NIH funding US$3.711 billion, Zoetis
35.2 million square feet, Celgene Merck
(according to CBRE) Janssen Daiichi Sankyo
Amneal
Eli Lilly
WEST 128/SUBURBS Roche PTC Therapeutics
Catalent Pfizer
Allergan
SOUTHCOAST Novo Nordisk
Bristol-Myers Squibb Dr. Reddy’s Laboratories
Johnson & Johnson Sandoz
Covance
The immediate western suburbs Parexel
Bristol-Myers Squibb Otsuka
include 75+ biotech companies, Aurobindo
15 colleges, Janssen PPD
Home of UMass-Amherst and 3 million s.f. of lab space
21 other colleges.
Area known as
The Knowledge Corridor Strong med device and biopharma
PHARMACEUTICAL
manufacturing capacity, with numerous AND BIOTECH CLUSTERS
land sites in BioReady communities
and 10 colleges
#1
REGION
#2 REGION
for NIH Funding for NIH Funding
20 U N I T E D S TAT E S P H A R M A C E U T I C A L S A N D B I O P H A R M A C E U T I C A L S 2 0 2 1 Industry Explorations Global Business Reports U N I T E D S TAT E S P H A R M A C E U T I C A L S A N D B I O P H A R M A C E U T I C A L S 2 0 2 1 21EDITORIAL Global Business Reports Industry Explorations EDITORIAL
Introducing veloped around Cambridge, 18 of the top 20 big pharma
companies have a presence in Massachusetts. Kendalle
O’Connell, MassBio’s president and COO, pointed out: “We
27,000 life sciences graduates each year and the world’s
highest concentration of scientists and engineers per square
mile – and our vigorous ecosystem, fostered by Government
The Hubs are seeing unprecedented levels of collaboration between
biotech companies and large biopharma organizations,
support, world-renowned research universities, leadership
in the area of cell and gene therapy and advantageous lo-
which MassBio is dedicated to facilitating. One of the first cation, life sciences companies continue to be attracted to
Covid-19 vaccines was borne out of a partnership, and we New Jersey.”
REMOTE WORK COMPELS NEW believe that new ways of connecting early-stage companies On the manufacturing front, President Biden’s preference for
PERSPECTIVES ON CLUSTER with established biopharma organizations will accelerate sci- prioritizing manufacturing in America also stands to benefit
ence and improve patient lives.” New Jersey, as it is home to approximately 139 biomanu-
Similarly, in New Jersey, of the over 800 different programs facturing facilities. Already, and late in 2020, Governor Phil
addressing Covid, 70 are being developed by companies Murphy signed the Economic Recovery Act of 2020, which
based in the Garden State. The first FDA-approved saliva includes an incentives package of new and revised programs
We all know the cliched stories of friends who have moved America’s biopharma industry is dominated by clusters; criti- test was developed early on by Rutgers University, and Pfiz- to support innovation industries, such as biopharma.
away to pursue their dreams: actors head to Hollywood, cal masses in one or a few places of unusual competitive suc- er, which has a large presence in New Jersey, delivered the John Huang, CEO of TheWell Bioscience, a biomedical
bankers to New York City, and winemakers to the vineyards cess in particular fields. This teaches us that, paradoxically, first vaccine – with additional vaccines coming from legend- technology company that helps scientists build a robust 3D
of Sonoma. The life sciences version of this is to head for the enduring competitive advantages in a global economy ary New Jersey companies including J&J, Sanofi and GSK. microenvironment that can closely mimic the natural extra-
Cambridge, the Bay area or back where it all began with JNJ lie increasingly in local things, like knowledge, relationships, There were also scores of smaller companies, such as Onco- cellular matrix for multiple 3D cell models such as organoids,
in 1866 in New Jersey. In theory, more open global markets, motivation, that distant rivals cannot match. By being in close Sec working on a vaccine, with Soligenix, Insmed and BioAe- tumor spheroids and cell co-culture, believes New Jersey to
faster transportation and virtual communication should di- proximity, it promotes both competition and cooperation. gis all working on their own contributions to addressing the be an ideal location for a company such as his: “New Jer-
minish the role of location in competition. Afterall, the in- These clusters in New Jersey, Boston and the Bay area, com- coronavirus and many others like them. Additionally, 40% of sey provides a unique opportunity to establish an excellent
dustry just had one of its most productive years ever despite bine a unique blend of biomedical science, venture capital, all new FDA approvals in 2020 came from companies with a industrial network. Geographically, New Jersey is ideal, as
large portions of staff operating remotely. But if location entrepreneurial talent, risk-taking culture, and geographic footprint in New Jersey. it connects to many biotech hubs and resources. We have
matters less, why, then, is it true that the odds of finding density. Other regions have some or all of these elements, BioNJ founding president and CEO, Debbie Hart, comment- made great connections in the area, and the driving distance
a world-class biotech company in Boston are much higher but not in the same magnitude or with the same momentum. ed: “Known for our strong presence of big Pharma, including to clients is reasonable. New Jersey has a great talent pool
than in most any other place? Post-Pandemic, however, it could be the case that the gap 8 out of top 10 R&D companies, incredible talent pool – with to take advantage of with many great universities in the area.
is narrowing. An egalitarian trend toward greater dispersion
of life science business activity has gained momentum as re-
mote work has taken hold. This prompted some to seek out
areas with lower cost of living, ostensibly higher quality of
life and lower taxes. James Sapirstein, president and CEO
of Florida-based AzurRx BioPharma, expressed his view on
this trend, noting: “AzurRx is a small company, and we never
New Jersey’s Life Sciences Industry and
felt it had to reside in the most expensive area in the coun-
try. In the biopharmaceutical industry, the feeling has always
been that companies need to operate in the “biotechnol-
ogy hubs” in and around Boston or San Francisco, because
that is where the talent is, as well as university partnerships
and venture capitalists.” He continued: “VCs like to have
Making a Difference Together
the management teams running their portfolio companies
located in the same cities as their own offices. Private equity The discovery and development of new therapies and cures by New Jersey life sciences companies allow Patients to live longer,
does not feel that way, and certainly retail investors do not healthier, more productive lives – benefiting the health care system, the economy and society as a whole. And Because Patients
feel that way. Therefore, I think VCs will back off of the tra- Can’t Wait®, BioNJ’s mission is to bolster the medical innovation coming from New Jersey’s life sciences ecosystem.
ditional model now that they see companies that are highly
functional working remotely.” New Jersey: A Life Sciences Powerhouse
As a result, Sapirstein believes that companies will start • Nearly 3,300 life sciences establishments – home to 13 of the top 20 global biopharma companies
gravitating towards tax-free geographies, such as Florida
• #2 state with large and specialized employment in drugs and pharmaceuticals
and Texas. While anecdotes of people fleeing big cities for
sunnier skies are pervasive, biopharma is not an industry that • 139 FDA-registered biopharma manufacturing facilities (leading the nation!)
can be easily moved from one place to another. In fact, it • More than 30% of all cell and gene therapies in development
can be argued that the pandemic validated the importance • Over 40% of all FDA drug approvals in 2020 came from a company with a footprint in NJ
of being in these clusters. According to MassBio, Massa- • Home to the first FDA approved COVID-19 vaccine and saliva test!
chusetts led the way in developing tests, therapies and vac-
cines that have helped combat Covid-19. More than 95 life
sciences companies with a presence in Massachusetts have Thank you to New Jersey’s life sciences industry for providing new hope for Patients around the world. Because Patients Can’t Wait®
been involved in this effort, many of which are the small and For more information on BioNJ, New Jersey’s life sciences trade association, please visit www.BioNJ.org.
emerging biotech companies that make up the backbone
of the cluster. Because of the robust startup community de-
22 U N I T E D S TAT E S P H A R M A C E U T I C A L S A N D B I O P H A R M A C E U T I C A L S 2 0 2 1 Industry Explorations Global Business Reports U N I T E D S TAT E S P H A R M A C E U T I C A L S A N D B I O P H A R M A C E U T I C A L S 2 0 2 1 23You can also read
