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UNITED STATES
LIFE SCIENCES
2022
Funding and Regulatory Climate - Drug Discovery - Contract Services - Hubs and Academia - Artificial Intelligence
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Quebec
Fredericton
Timmins
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The East Coast Corridor:
MAINE
Dear Reader,
The Heart of Bangor
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Montreal
American Biopharma
Augusta
Welcome to the 2022 edition of the United States Life Sciences Industry Report.
CANADA Ottawa VERMONT
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Montpelier After two years of fighting Covid-19, the United States has offered a glimpse
NEW
HAMPSHIRE Portland of what the industry may look like in a post-pandemic world. Compared with
Kingston the investment frenzy that led to a peak in capital inflow into the industry in
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Concord early 2021, the financial climate has cooled considerably. The ensuing period
10
of dramatic correction has forced companies to work harder to prove their
Toronto worthiness of investors’ dollars. Within this context, it is increasingly small and
Albany BOSTON
mid-sized companies claiming ownership to the development pipeline and
Rochester M ASSACHUSETTS
NEW YORK commercialization of new drugs. Tireless advances have been made across
a variety of fields, such as gene editing and cell-based therapies, as well as
Buffalo Providence
Hartford in the introduction of novel drug delivery platforms and diagnostics tools.
nsing RHODE ISLAND
i These efforts culminated in 50 new drug approvals in 2021, in line with the
Detroit 0m CONNECTICUT
10
past five years of consistently strong output.
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200m
Erie
NEW YORK Of course, the magnitude of success does not rest squarely on the shoulders
Cleveland
P E N N S Y LVANIA Jersey City
TRENTON of only pharmaceutical and biopharmaceutical companies – contract service
GREATER providers are crucial to the health of the life sciences ecosystem. Responding
Pittsburgh Harrisburg PHILADELPHIA
to the heightened complexity of the field, the explosion of streamlined com-
OHIO NEW JERSEY panies with modern in-house manufacturing capabilities, and an industry-
Wilmington
Baltimore wide rallying cry for increased domestic production, CROs and CDMOs are
mi
Columbus Dover stepping up to create a more robust environment.
MARYLAND
300
Dayton Washington D.C. Annapolis DELAWARE
The following pages bring together insights from interviews conducted with
Cincinnati
WEST over 80 industry leaders whose experiences collectively span all areas of
VIRGINIA the sector. We would like to warmly thank these executives and researchers
Charleston whose thoughtful contributions were invaluable to the report as well as our
VIRGINIA association partners at BioNJ and Biocom California. We hope that you enjoy
Frankfort
Richmond
reading our 2022 edition of the United States Life Sciences Industry Report.
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Lexington Norfolk
40
Roanoke
N.C. Atlantic Ocean
DURHAM RESEARCH
TRIANGLE
CHAPEL HILL RALEIGH
Asheville N ORTH
Knoxville
i Charlotte C A R OLINA Alfonso Tejerina
0m
50 General Manager and Director,
Global Business Reports
Greenville (GBR)
SOUTH
Columbia
CAROLINA
Atlanta
Augusta
6 Introduction to USA Life Sciences 22 Introducing the Hubs 44 Interview with Aphios 60 Interviews with Lubrizol Life Science and 78 Interview with Ascendia Pharmaceuticals
45 Innovations Enhancing the Patient with Lonza 79 Interviews with AGC Biologics and with
8 The End of an Era? 26 The East Coast Experience 61 Keeping Up with Demands Forge Biologics
47 Interview with Karius and with Sight 64 Interview with AMPAC Fine Chemicals 80 Chemical Producers and Distributers
USA LI FE SCI ENCES 2 0 2 2 / C O N TE N TS
9 Interview with J.P.Morgan 28 Interview with BioNJ
10 Interview with Janssen Pharmaceuticals 29 Interview with MassBio Diagnostics 65 Interview with Cureline 82 Interview with Brenntag
11 Interview with EY 30 Interview with Pennsylvania 49 Interview with First Wave BioPharma 66 Interview with Murli Krishna Pharma 83 Interview with BASF Pharma Solutions
12 The Life Sciences Investment Climate Biotechnology Center 50 Interviews with Rani Therapeutics, 67 Interview with PsychoGenics
14 Interview with MPM Capital 31 The West Coast Nano Precision Medical and with Dyve 68 Industry Thoughts: Unique Offerings 84 Technology Services
15 Interview with Signet Healthcare Partners 33 Interview with QB3 Berkeley Biosciences 69 Interview with TCG Lifesciences
51 Industry Thoughts: Advancing 70 Interview with CordenPharma 86 Life Sciences Go Digital
Introduction to
16 Interview with EisnerAmper 34 Interview with Biocom California
17 Interviews with Xontogeny, Vertex Therapeutics 71 Interviews with Piramal Pharma Solutions, 88 Interview with AiCure
Ventures and with Edgewater Capital 36 Drug Discovery and Development Woodstock Sterile Solutions and with 91 Interview with RxS
Partners 52 Contract Manufacturing and
Chemicals 72
Contract Pharmacal Corp
A Post-Pandemic World
92
93
Interview with Markem-Imaje
Interviews with WhizAI and with Quartic.ai
USA Life Sciences
18 The Life Science Regulatory Climate 38 Therapeutic Fields on Fire
20 Interviews with PhRMA and with PBOA 40 Interview with Insmed 74 Interviews with Vetter Pharma GBR investigates the regulatory
21 Interviews with LaVoieHealthScience and 42 Interviews with Mammoth Biosciences 54 A Shifting Landscape International and with Nivagen 94 Concluding Thoughts and investment climates
with Buchanan Ingersoll & and with Arcturus Therapeutics 56 Interview with Cambrex Pharmaceuticals
currently impacting progress in
Rooney PC 43 Interviews with ConSynance 57 Interview with Syngene International 76 Interview with New Vision 96 Company Directory
the life sciences.
Therapeutics, AC Immune and with 58 Interview with Adare Pharma Solutions Pharmaceuticals
59 Interview with Aenova Group 77 Interview with Quotient Sciences
Evrys Bio
6-21
CANADA
Olympia WASHINGTON
NORTH MAINE
DAKOTA
Salem MINNESOTA
Helena MONTANA Bismarck Augusta
IDAHO Montpelier
OREGON
NEW
VERMONTHAMPSHIRE
Boise NEW YORK Concord
SOUTH
DAKOTA
Pierre
St. Paul
WISCONSIN MICHIGAN
Albany Boston Introducing the Hubs
WYOMING Lansing Hartford
Providence The concentration of strong
academic and research institutions,
Rhode Island
Connecticut
Madison
IOWA PENNSYLVANIA assertive organizations, and top
Carson City Cheyenne
NEBRASKA
Harrisburg Trenton pharma companies make certain
regions sparkle.
Salt Lake City Des Moines ILLINOIS
Sacramento NEVADA Columbus OHIO
Lincoln Indianapolis Dover
Delaware
22-35
Denver Springfield Annapolis
UTAH Topeka INDIANA Washington D.C.Maryland
VIRGINIA
COLORADO Charleston
WEST
KANSAS VIRGINIA
Richmond Atlantic Ocean
CALIFORNIA Jefferson Frankfort
City MISSOURI KENTUCKY
Raleigh
ARIZONA Santa Fe OKLAHOMA NORTH CAROLINA
Nashville
TENNESSEE
Little
Oklahoma Rock
Phoenix Columbia
USA LIFE SCIENCES 2022 NEW MEXICO City
Atlanta SOUTH
Industry Explorations ARKANSAS
United States CAROLINA
Global Business Reports
of America MISSISSIPPI GEORGIA
This research has been conducted by Pacific Ocean
International Boundary
Montgomery
State Boundary
LOUISIANA Jackson ALABAMA
Margarita Todorova, Kolby Kaller and StateNCapital
TEXAS
Elisa Iannacone
Drug Discovery and
Edited by Mungo Smith Tallahassee
Baton Rouge
Graphic design by Gonzalo Da Cunha Austin
Graphic layout and artworks by Özgür Ergüney
A Global Business Reports Publication FLORIDA
Development
MEXICO
For updated industry news from our on-the-
0 Breakneck advancements from cell
ground teams around the world,100
please 200
visit 300 Miles
our website at gbreports.com, subscribe to and gene therapy to innovative drug
our newsletter by signing up to our VIP list Gulf of Mexico delivery systems pave the way for the
through our website, or follow us on next generation of treatment.
Twitter @GBReports and
LinkedIn (gbreports)
36-51
INTRODUCTION TO
USA LIFE SCIENCES
“The industry’s response to Covid-19 was unprecedented - bringing a vaccine to
market in record time. Companies developed revolutionary therapies to curb the
severity of SARS infection, and new diagnostics continue to enter the market. It is an
enormous understatement to say the industry changed the world.”
– Joe Panetta,
President & CEO, GBR • Industry Explorations • USA LIFE SCIENCES 2022
Biocom California Image courtesy of Vedanta Biosciences
EDITORIAL Global Business Reports Industry Explorations INTERVIEW
↘↘
Introduction to Throughout the pandemic, we
USA Life Sciences have seen an unprecedented
level of collaboration across the
industry with broad and deep insights
on venture capital, partnerships and
funding for high-growth life sciences
private sector and among public companies.
The end of an era? and private sector actors toward
What is your assessment of the cur-
a common goal of combatting rent biotech investment landscape?
Covid-19. Biopharmaceutical Kathryn The biopharma and medtech deal
space has seen several ups—and a few
downs—since 2020. Despite market
McDonough
companies continue to work
The achievements of the life sciences including longstanding intellectual would look like if the industry came to- volatility in the first quarter of 2022,
industry over the past two years have property protections and voluntary gether to solve cancer in the same way around the clock to research, many of these changes point to op-
been nothing short of astounding. In technology transfers. Partnerships it came together around Covid-19, but portunities for life sciences companies
develop and produce safe and to build on their strengths and grow.
a previously unimaginably short time between industries and governments science is not simple and collaboration Co-Head of Healthcare for Middle
What does this mean for the rest
frame, the sector developed and pro- were also significant: The US govern- is even harder.” effective Covid-19 vaccines and Market Banking & Specialized of 2022? The pressure is on clinical
duced multiple Covid-19 vaccines that ment invested US$13 billion into the Nevertheless, the past two years
treatments to save lives. Industries programs as an already sensitive pub-
were effectively distributed to billions development of vaccines, and the FDA have created and strengthened bonds
J.P. MORGAN COMMERCIAL lic market leaves no room for missed
of people across the globe. Simultane- accelerated its regulatory review pro- between unlikely actors who may not
BANKING scientific milestones and valuation
ously, revolutionary therapies to curb cess without sacrificing quality to meet be so quick to forget what they can
catalysts.
the severity of infection and a host of the emergency. achieve when working together. While - Anne Pritchett, Also, licensing and private fund-
new diagnostics tools were introduced. Yet the driver of this collaboration collaboration may be challenging, this
Senior Vice President of Policy, raising will continue to support early-
Rather than celebrating a singular was a common enemy: the Covid-19 period has proven that life sciences stage science and company growth
entity – whether it be a pharma or virus. Individual motives took a back- companies are more than up to the Research and given the challenges in M&A exits
biotech company, a research institu- seat to an issue in which all stood to task. That is not a lesson that will likely Can you provide an update on how and IPOs.
tion, or even an administration – it is gain or lose collectively. With this in be so quickly unlearned. Membership, 2021 was from J.P. Morgan’s per-
instead a particular ethos that carried mind, a question naturally arises – spective, including any initiatives What trends do you see driving the
the day: the willingness to collaborate. once the pandemic is over, will every- The popularity of the life sciences
PhRMA the company took on in the life sci- sector forward?
A DNA map of the virus was distrib- body go home? Covid-19 presented a much-needed ences sector? Following multiple record years for
uted around the world to enable ef- Juliet Hart, CEO and founder of Hart facelift to the reputation of the life sci- ↖↖ 2021 was another banner year for licensing and venture funding, bio-
ficient collaboration in discovering & Chin, believes this will be the case. ences industry. Public opinion reached deal making in the life sciences sector. pharma deal making is off to a slower
vaccines. According to Anne Pritch- “Once this period is over, companies an all-time high, as people witnessed Biopharma therapeutics and discov- start in 2022. Most deal categories
ett of PhRMA, voluntary partnerships will no longer be unified by the same for the first time in recent history step up, who would? This level of al- ery platform companies led the way showed a decline, except for licensing
around the world led to over 370 col- goal, and competition will resume,” what it is like to live with a global un- truism from a public company allowed in licensing and venture attraction— in specific therapy areas, advanced
laborations for Covid-19 vaccine man- Hart predicts. “The experience has met medical need. As vaccines flew them, if only momentarily, to shift from while medtech activity remained well modalities and late-stage venture in-
ufacturing and 155 for therapeutics, made some people wonder what it through the development and regu- above its pre-pandemic levels. vestment.
“villain” to “hero” in the eyes of many.
latory processes, the public watched We have a team of relationship Big pharma is in-licensing earlier
At the same time, undercurrents of
with a keen interest, and in doing so, bankers and specialists dedicated to into discovery and technology plat-
a war on science came to a boiling
↘↘ learned about the groundbreaking point. Spectators and officials began
the life sciences and healthcare sec- forms. Large-cap biopharma has been
achievements being made in fields tors. Our focus continues to be on signing deals earlier in development
publicly arguing with scientific facts.
delivering the full strength of J.P. since the early 2000s. As high as 90%
The experience has made some people wonder what it would look such as mRNA technology. The lessons learned from this period
Morgan’s network, capabilities, and of deals happened in preclinical and
In the US, there has historically been are messy and contradictory, and it re-
like if the industry came together to solve cancer in the same way resources to help these companies earlier stages in 2019. Q1 2022 has
a pervading sentiment that pharma- mains to be seen whether in years to
thrive at every stage of growth. We seen much of the same following two
ceutical companies are overly profit- come the pandemic will have served
it came together around Covid-19, but science is not simple, and driven. The pandemic gave these com-
believe in the pivotal contributions years of Covid-related deal making
as a rallying point around the triumphs these entrepreneurs add to society, and a recent return to licensing dis-
collaboration is even harder. panies a platform to prove otherwise. of science, or a further solidification of shareholders and employees alike. covery programs.
AstraZeneca, for example, was not a dividing line between its advocates We provide tailored solutions in- Large-cap biopharma is doubling
even in the vaccine business before and disbelievers. cluding day-to-day credit, financing up on oncology and neurology across
- Juliet Hart, the start of the pandemic. That did not If 2020 was about reaction and 2021 and treasury services, as well as fi- all modalities. Tracking large-cap bio-
stop their executive leaders from mak- about action, 2022 will be a year of nancial solutions offered across other pharma’s deal activity among therapy
CEO & Founder, ing a decision to pour resources into picking up the pieces to create a stron- lines of business, including invest- areas and treatment modalities is top
developing a Covid-19 vaccine, aware ger, more unified force that is better ment banking, wealth management of mind to all business developers.
Hart & Chin that the global need had to be ad- equipped to confront large-scale pub- and more. Most of the top five within each cat-
dressed immediately. If leading phar- lic health crises that the future holds Through a new collaboration with egory saw increased upfront cash and
↖↖ ma and biotech companies did not in store. ■ Dealforma, we are able to provide the equity totals since 2019. ■
8 USA LIFE SCIENCES 2022 Industry Explorations Global Business Reports USA LIFE SCIENCES 2022 9
INTERVIEW Global Business Reports Industry Explorations INTERVIEW
↘↘ ↘↘
What are the most important initia- What role has digitization played for
tives that have been undertaken by In vaccines, we are progressing late- EY in the past year? Our primary objective is to
Janssen’s infectious diseases & vac- stage programs of break-through Our business has seen a positive uplift
pivot to areas that our clients
cines segment within the past year? vaccines against diseases where as we focused on digital initiatives to
We have been focused on multiple areas continue supporting our clients in the are focusing on, such as
in the vaccine space, including RSV, Co- vaccines are not currently available, life sciences sector. The pandemic has digitalization, ESG, and supply
vid-19, and antimicrobial resistance. such as RSV and multidrug resistant shed light on the importance of digiti-
We see an incredible opportunity in the bacterial infections, including ExPEC zation and AI, and EY’s Smart Review- chain management.
respiratory infection space, including er process has received significantly
and Staphylococcus aureus.
solutions for both Covid-19 and respira- more attention over the past months.
tory syncytial virus, or RSV, which affects
↖↖ This technology solution leverages AI ↖↖
over 64 million people worldwide per and ML algorithms to automate key
year, yet no vaccines or antiviral treat- activities in the promotional materials'
ments currently exist. For our Covid-19 review process. It allows for more ef-
vaccine, we implemented a develop-
ment plan that studied our vaccine in
diverse populations in Asia, Africa, Latin
Candice Long ficiency and reliability, ultimately miti-
gating the challenge of human error
and allowing better quality informa-
Arda Ural
America, the US and Europe. We also tion to enter the market faster, while
made a commitment to make up to 900 President – US Infectious Diseases & Vaccines reducing risks and cutting costs. The Partner & EY Americas Industry Markets Leader,
million vaccine doses available to the JANSSEN PHARMACEUTICALS solution accelerates the products of Health Sciences and Wellness
African Union and COVAX Facility, com- our biopharma clients to reach their EY US
bined, through 2022. patients faster.
Another area of focus for us is antimi- 2021 was a year defined by un-
crobial resistance, or AMR, which is one certainty, but EY experienced solid
of the top ten threats to global health In antimicrobial resistance, we are growth, and we have a positive out- of product and process quality in the Related to the topic of an aging pop-
to target it. This allows the individual’s
and is quickly becoming one of the lead- targeting multidrug resistant bacte- immune system to recognize the SARS- look for the future. Our primary objec- pharmaceutical manufacturing indus- ulation, what innovations are enter-
ing infectious disease-related causes of rial infections through a variety of ap- CoV-2 spike protein and be ready to tive is to pivot to areas that our clients try. Given the complexity of pharma- ing the market?
death worldwide. Our investigational proaches, including via CRISPR-Cas3 defend against it. are focusing on, such as digitalization, ceutical businesses, the supply chain Population age continues to feed what
extra-intestinal pathogenic E. Coli vac- engineered bacteriophage cocktails, ESG, and supply chain management. cannot afford one misstep, and conse- diseases pharmaceutical companies
cine candidate (ExPEC9V) is currently in aiming for first-in-class precision medi- Could you provide insight into Jans- quently the product and process qual- need to target, and oncology is by far
Phase 3 development for the prevention cine in the fight against AMR. sen’s recent agreement with Aspen With a change in government ad- ity have become even more important. the most common disease area of focus
of invasive ExPEC disease. In vaccines, we are progressing late- SA Operations and the impact you ministration, how has the regulatory for pharma. In addition to oncology,
Finally, we are working on developing stage programs of break-through vac- anticipate this having for Covid-19 landscape evolved? How has the Omicron wave altered cell and gene therapies are starting to
a functional cure for chronic hepatitis B cines against diseases where vaccines relief efforts in Africa? The life sciences industry is keeping its the IPO and special purpose acquisi- receive significant focus as a way to ad-
as well as focusing on steps that can be are not currently available, such as RSV The agreement enables the first Co- eye on H.R.5376, a legislation related to tion company (SPAC) landscape, and dress patient and population needs.
taken to mitigate the stigma associated and multidrug resistant bacterial infec- vid-19 vaccine to be manufactured and drug pricing that will require producers what is the trajectory we can expect
with the disease. We are investigating tions, including ExPEC. made available by an African company and pharma companies to behave dif- to see in 2022? Which of EY’s services are in most de-
multiple promising modalities, includ- for people living in Africa. Currently ferently. This regulation as part of the IPOs in 2021 were at an all-time high, mand within the life sciences sector?
ing combining antivirals with immuno- How does Janssen leverage innova- only about 12 percent of people in Af- Build Back Better Act will require our but factors causing uncertainty such EY continues to focus on addressing
modulators to transform how infectious tive technology for vaccine R&D? rica are fully vaccinated, well below the clients to double down on value-based as potentially increased interest rates, business challenges enabled by tech-
disease pathogens such as the hepatitis Our Covid-19 vaccine program leverag- WHO’s targets. contracting and outcomes-based pric- geopolitical tensions, inflation risks, nology-inspired solutions, and espe-
B virus (HBV) are managed by achieving es Janssen’s AdVac technology, which is ing. They will not only assign a price to and the possible emergence of new cially today, digitalization is extremely
high rates of functional cure. the same technology used to develop What is your prediction for the long- a pharmaceutical product but will also Covid-19 variants, may hinder eco- important to our clients. ESG has also
We developed a long-acting inject- and manufacture Janssen’s European term impacts that Covid-19 will have commit to an outcome for which they nomic recovery and play a role in the become a massive trend that is here to
able HIV treatment regimen in partner- Commission-approved Ebola vaccine on public perception of infectious can charge differently. financing environment in 2022. stay as investors and stakeholders want
ship with ViiV Healthcare to reduce the regimen and to construct both our RSV diseases and the importance of vac- There is attention on how the Fed- IPO candidates should remain flex- better ESG disclosures to help them un-
frequency of treatment. We are currently and HIV vaccine candidates. cines? eral Trade Commission (FTC) in the US ible with a plan B in place to meet derstand more about how a company
working to expand our partnership with Our AdVac technology is based on Covid-19 gave us a close look at our will regulate M&A activity. With a focus financing needs in case the IPO time- performs. Consumers also want to un-
ViiV Healthcare to explore our long-act- the development and production of ad- capacity for preparedness and rapid on protecting the public against anti- table is delayed. SPACs are currently in derstand the impact their choices are
ing rilpivirine and cabotegravir regimen enovirus vectors, or gene carriers. Ad- response when an infectious disease competitive behavior and unfair trade a more dire state than in 2021 due to having on the world, and employees
as both a monthly self-administered enovirus vectors are genetically altered outbreak becomes a pandemic. It illu- practices, the FTC can require a merg- the decreased availability of late-stage seek to know whether their company is
regimen and an ultra-long-acting regi- forms of an adenovirus that lack the minated the gaps in public understand- ing company to divest assets and rights assets and the window for IPOs start- driving greater equality, empowerment,
men, administered every three months DNA needed to replicate, so the vac- ing about the development and safety to refrain the new company from hav- ing to close. Companies need to start better working conditions and safer
or more. cine cannot cause a cold. In the case of of vaccines. We know vaccines can lead ing a monopoly position in the market. prioritizing their pipelines to put their and more sustainable communities. EY
For influenza, we believe that pre-ex- the Covid-19 vaccine, the immune sys- to higher quality, longer lives, but wide Additionally, the FDA has imple- next milestone in sight and avoid dilu- assists our clients in their ESG goals
posure prophylaxis has the potential to tem of someone who receives our vac- acceptance and uptake, in addition to mented a draft reporting program tion. I believe that companies without through nonfinancial reporting advisory
revolutionize the prevention of seasonal cine recognizes the Covid spike protein an adequate supply chain and access, so that certain key quality metrics a current late-stage asset will experi- and assurance, climate-related report-
respiratory viral infections in the most as foreign once it enters their cells, pro- need to occur for vaccines to be effec- are reported to the agency in an ef- ence choppy waters in this uncertain ing, sustainability and supply chain ad-
vulnerable populations. ducing antibodies and activating T cells tive for the global community. ■ fort to ensure continual improvement environment. visory, and outcomes measurement. ■
10 USA LIFE SCIENCES 2022 Industry Explorations Global Business Reports USA LIFE SCIENCES 2022 11
EDITORIAL Global Business Reports Industry Explorations EDITORIAL
More M&A activity? ↘↘
The Life Sciences What remains uncertain is the extent
to which the cooling down of the mar-
Tough times can scare off newer investors and entrepreneurs,
Investment Climate
ket will trigger increased M&A activity.
Some believe that large pharmaceuti- which is not all bad. These cycles help to screen out those investors
cal companies like Pfizer and Merck that
had been observing over-valuations and entrepreneurs who are not as committed to creating and
from the sidelines may find the current reaching a long-term goal.
climate more suitable for action.
A reckoning? EisnerAmper, one of the largest ac-
counting, tax and business advisory
firms in the US, helps life sciences com-
- Chris Garabedian,
panies going through IPO or second- Chairman and CEO,
ary offerings. John Pennett, partner-in-
charge of the national technology and Xontogeny
During the period of Covid-related anxiety in which the years. Over half of these were for preclinical or phase 1
life sciences group, revealed that the
industry received unprecedented media coverage, gov- companies.
company is increasingly busy with new
ernments pitched extensive resources into combatting the The frenzy has now ended, however, and the pendulum ↖↖
company formations, with four clients
spread of the virus. The ensuing ‘lockdowns’ meant that has swung far – arguably too far, according to some observ-
going public in Q4 of 2021 alone. While
people had more time at home, and more time therefore ers – in the other direction. In early 2022 the Financial Times
this is in many ways a testament to the For others, this shift may not hap- of activity will remain consistent despite
to spend on online trading platforms, and much atten- reported that 83% of recently listed US biotech and pharma perennial dynamism of the industry, it pen quite so definitively. James Gale, the market turbulence, as pharmaceu-
tion was drawn towards biotech. Zero interest rates also stocks were trading below their IPO price in what they called does not serve as a litmus test for the founding partner and managing di- tical companies are constantly on the
helped ensure that huge amounts of capital flowed into a “stock market bloodbath.” Yet there is a Wall Street adage current state of the life sciences finan- rector of Signet Healthcare Partners, hunt for new and innovative drugs to
high-risk technology. Furthermore, according to Pitch- that in a strong wind even turkeys can fly, meaning that in cial climate. commented: “As the capital market incorporate into their distribution pipe-
book data, venture capital firms invested record amounts a booming market it is nearly impossible to distinguish the According to Lori Hu, managing valuations fall back and exits via the lines after undertaking thorough due
of capital in the biotech industry over the past two years – winners from the losers. director of Vertex Ventures HC, the public markets become less viable or diligence. “M&A is like picking apples
US$12.6 billion in 2020 and US$16.1 billion in 2021. Overall, Christiana Bardon, co-managing partner of MPM’s BioIm- industry is currently experiencing a attractive, sellers may pause. At the – you only want to eat the apple when
IPOs pulled in almost three times more than in previous pact Capital and portfolio manager of BioImpact Equities temporary “hangover” effect and the same time, buyers may be affected by it is ripe. No one wants to eat an unripe
and Oncology Impact Funds, believes this period of dra- market will soon bounce back. “Expec- rising interest rates and the change in apple, even if its 50% off. Similarly, M&A
matic correction is currently close to the bottom, given that tations to finance for the long term are the market to dig in on lower pricing. occurs when companies meet their
Delivering many biotech companies are trading at cash balances. From
Bardon’s perspective, the extreme market corrections have
again receiving priority,” explained Hu.
“The M&A market has been relatively
We could thus see a protracted period
of lessened activity before we see the
proof of concepts and have de-risked
their assets such that the drug looks
sophisticated been largely appropriate. “Many of these corrections are ap-
propriate, because a lot of credit was given to companies
slow over the past year, as pharma ex- M&A markets start to build again.” promising to be successful in future clin-
formulations. that had exciting technologies or platforms but were still far
ecutives wait on the sidelines for the
valuation correction to play out, but I
The conviction that lower valuations
will lead to more M&A activity is not
ical trials,” said Bardon. “The question
that remains is which companies are ripe
from developing a real drug that would enter a clinical trial, believe that we will see M&A activities shared by all industry stakeholders. and ready for the picking.”
• Formulation receive regulatory approval, and ultimately help patients,” increase in this coming year.” MPM Capital’s Bardon believes the level Overall, the health of the life sci-
Development said Bardon. “Not all companies deserve to have their assets ences investment climate is expected
for Poorly taken forward. Having a more stringent funding environment
to return to the trajectory it had been
Soluble Drugs is not negative; it just means that companies must generate After setting record pace, biotech IPOs on pre-pandemic. “We are excited
• cGMP clinically meaningful data to deserve their valuations.”
Manufacture Chris Garabedian, chairman and CEO of the life sciences slump to start 2022 about the health and the growth of
the industry and the pace at which it
for Clinical
accelerator Xontogeny, views the market corrections from
Materials
a similar perspective. “After record years of private invest-
Number of biotech IPOs priced, by quarter has continued to evolve over the last
• CR, Parenteral ment, facilitating crossover rounds and taking companies 30
20 years,” commented Ryan Meany,
& Topical managing partner of Edgewater Capi-
through IPOs, people are realizing that our sector may need
Dosage Forms tal Partners. “The hallmark for us is its
to be more discerning in deciding which companies are wor-
thy and mature enough to bring to the public markets,” said malleability to consumer needs, which
O U R T E C H N O LO G I E S
Garabedian. “Tough times can scare off newer investors and 20 has manifested in important therapies
EmulSol entrepreneurs, which is not all bad. These cycles help to and broad adaptability to the business
screen out those investors and entrepreneurs who are not model and cycle.”
AmorSol The past two years have brought
as committed to creating and reaching a long-term goal.”
10 about unprecedented levels of inter-
NanoSol While it may appear that companies with good technology
are being indiscriminately punished just as they had been in- est and investment and reshaped the
discriminately rewarded earlier in the pandemic, the shift has way the broader world interacts with
732.640.0058 life sciences companies, particularly
been an important one in remembering the fundamentals 0
Robert.bloder@ascendiapharma.com Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 in biotech, and this bodes well for the
of the industry: no matter how sexy a particular company’s 2018 2019 2020 2021 2022
ascendiapharma.com technology or platform is, the end goal must remain to pro- financial support it will attract in the
vide products that help patients live healthier, longer lives. Source: BioPharma Dive years to come. ■
12 USA LIFE SCIENCES 2022 Industry Explorations Global Business Reports USA LIFE SCIENCES 2022 13
INTERVIEW Global Business Reports Industry Explorations INTERVIEW
↘↘ ↘↘
What is your assessment of the cur- What have been the key milestones
rent health of the life sciences invest- Having a more stringent funding for Signet over the past year, particu- We see a risk of rationing of
ment climate? larly with the company’s Fourth Fund
environment is not negative; it capital by biopharma companies
Since the peak of capital inflow into (Fund IV)?
the industry in February 2021, we have just means that companies must Signet has made several investments leading to a pullback in the
been in a period of dramatic correc- in Fund IV. We completed the invest-
generate clinically meaningful amount of funds being spent in
tion where the biotech indices have ment in Ascendia Pharmaceuticals in
fallen over 50%. I believe we are close data to deserve the valuations the first half of 2021. We participated R&D.
to the bottom of that correction period they are fundraising at. with Novo Holdings in acquiring Altas-
because many biotech companies are ciences, a fast-growing, well-run clinical
↖↖
trading at cash balances, meaning very ↖↖ research services organization. We also
little is being attributed to their tech- made a strategic investment into Juno
nology and programs. Pharmaceuticals, a Canadian marketer
Many of these corrections are appro- of complex generic injectables. Signet
Christiana Bardon James Gale
priate, because a lot of credit was given is hoping to leverage relationships with
to companies that had exciting tech- our portfolio companies and other enti-
nologies or platforms but were still far ties to find products for investment and
from developing a real drug that would to create partnership arrangements. In
enter a clinical trial, receive regulatory Co-Managing Partner, MPM’s BioImpact Capital and Portfolio early 2022, we acquired the consumer Founding Partner & Managing Director
approval, and ultimately help patients. Manager, BioImpact Equities and Oncology Impact Funds health contract manufacturing business SIGNET HEALTHCARE PARTNERS
When shifts like this happen, we must of Fagron, a Dutch personalized medi-
BIOIMPACT CAPITAL LLC, AN MPM COMPANY
remember the fundamentals of the in- cine pharmaceutical company. This ac-
dustry; despite how attractive a com- quisition was done not through Fund IV,
pany's technology or platform may be,
but rather through a special investment
the ultimate goal is to make progress
they want to buy companies who have and therefore what targets we should vehicle and fits in with Signet’s theme How have these trends impacted
towards bringing new drugs to patients. a reliable partner. At the start of 2020,
of investing in consumer health.
Additionally, not all companies de- met their proof of concept. address with our new developed drugs. Signet? they temporarily placed an export ban
serve to have their assets taken for- Additionally, we have developed many We build our investment models on 27 critical medications and in 2021,
To what extent has the turbulence genetic tools that have enabled whole To what extent do you see the gen-
ward. Having a more stringent fund- around particular investment situ- redirected Serum Institute to repriori-
impacted MPM Capital’s portfolio new classes of treatments, such as us- eral correction of market activity as
ing environment is not negative; it just ations, paying careful attention to tize the production of the AstraZen-
companies? ing living cells and living viruses to treat an opportunity for the industry?
means that companies must generate terminal values and exit multiples. eca vaccine for their domestic market.
MPM Capital portfolio companies were cancer or genetic illness. We are in the Signet’s thesis is that interest rates will
clinically meaningful data to deserve We assess the climate relative to his- More recently, India’s tilt towards Rus-
the beneficiaries of a great capital fun- midst of an incredible innovation era rise. Rising interest rates will have an
their valuations. I see corrections as a torical norms under different interest sia in the Ukraine-Russia war further
draising environment over the past two that is only accelerating. For example, effect in two parts. First, there is gener-
positive force in the industry, as it re- rate environments. Additionally, as raises questions about their alignment
years. Many of our portfolio companies last year we saw the first patient who ally a rotation in the investment market
minds us of basic principles such as we build an investment case, we are of interest with the US.
had the opportunity to raise private fi- was genome edited and cured of their away from high-tech growth and futuris-
capital efficiency. often risk adjusting management’s ro- We clearly need to secure drug sup-
MPM Capital is optimistic about the nancing, IPO and secondary financings hereditary genetic disease. tic earning streams towards companies
bust projections to consider downside ply in the US. That said, the market
future and sees the present as a great as public companies. That said, all our Several innovations abound regard- with revenues and earnings today. The
scenarios. This includes the prospect structure in the US, particularly for
buying time to be entering the market. companies have been affected by both ing RNA and DNA; mRNA enabled us decline in public share prices of biotech
companies over the past six months of a delay in the recovery of financing the purchase of generic medications
The long term fundamentals on the in- the upward and downward drafts, but to vaccine the world against Covid-19.
reflects that pivot towards value. Sec- for biotech companies. We see a risk which account for 80-85% of all pre-
dustry are healthy and intact. we hope they will go on to be success- Circular RNA is particularly exciting as
ond, if interest rates climb, the cost of of rationing of capital by biopharma scriptions, disincentivizes onshoring of
ful in their clinical trials. At the end of it enables us to not only deliver RNA
capital climbs. This has a converse ef- companies leading to a pullback in production. While branded pharmaceu-
Do you believe this market correc- the day, a successful outcome is how more broadly to the organs but also to
fect on multiples – meaning multiples the amount of funds being spent in tical companies would prefer to keep
tion will lead to an uptick in M&A you create value, and it is not subject produce proteins beyond for vaccina-
come down as the cost of capital rises. R&D. We are cautious with our port- production closer to the markets they
activity? to volatility. tion purposes.
If this happens, perceptions of valua- folio companies about rapid increases serve to mitigate potential supply chain
I do not believe that lower valuations
What advancements within the bio- Looking ahead, what themes will tion begin to shift on the buy and sell in personnel or capital expenditures in disruptions, the generic industry is still
lead to more M&A activity. M&A is
tech industry are you most excited MPM Capital hone its investment side. However, multiples often slowly capacity until we have better visibility highly dependent on India and China.
like picking apples – you only want to
eat the apple when it is ripe. No one about? around? decline, which induces a period of dis- about the future utilization of that ca-
wants to eat an unripe apple, even if its In the oncology space we are in the We are on our second oncology im- intermediation between buyers (who pacity. We thus have a wary eye about What key trends do you see driving
50% off. M&A occurs when companies middle of an incredible period of in- pact fund. While we have made great sense it has become a buyers’ market the impact of a slowdown in biotech growth for Signet over the next few
meet their proof of concepts and have novation, particularly regarding the progress regarding immunotherapy, and offer lower prices), and sellers (who financing on R&D spend and CDMO years?
de-risked their assets such that the genome sequencing revolution. This cell therapies, and our ability to cure still have a memory of higher valuations profitability. Signet’s investment strategy is guided
drug looks promising to be successful started in the early 2000s when we certain types of cancers, we cannot and hold their ground). It is then diffi- by determining which technologies will
in future clinical trials. From this per- sequenced the first human genome. yet cure all patients with those can- cult to bridge the gap between bid and How do you view the feasibility of be potential winners. We also track
spective, the M&A environment is ev- Two decades later, we now have ge- cers, nor can we cure all cancers. We ask unless people are becoming more reshoring efforts for American man- complimentary services that can create
ergreen, which is that pharmaceutical netic information about almost every still see a lot of exciting work to do in financially desperate to sell. We could ufacturing of pharmaceuticals? a more comprehensive offering to cus-
companies have an ongoing need for cancer patient as well as about various this space. Additionally, we are excit- thus see a protracted period of less- India’s actions recently have raised tomers. While Signet is a commercial
new and innovative drugs to fill their rare diseases. We can start to under- ed about the next frontiers in virology ened activity before we see the M&A questions about the security of drug stage growth equity fund, technology
commercial distribution pipelines and stand the genetic causes of diseases and neurology. ■ markets start to build again. supply from that country, traditionally guides our investment decisions.■
14 USA LIFE SCIENCES 2022 Industry Explorations Global Business Reports USA LIFE SCIENCES 2022 15
INTERVIEW Global Business Reports Industry Explorations INTERVIEW
↘↘
Can you give an overview of Eisner-
Amper’s activities and performance in The past 12 months have
the life sciences sector over the past been busy as we have seen
year?
The life sciences division is the leading a significant amount of new
industry vertical for our public company company formations, which
practice, more specifically for companies
that are going through IPO or second- require accounting, tax advisory
ary offerings. The past 12 months have and structuring support.
been busy as we have seen a significant
Chris Lori Ryan
amount of new company formations, ↖↖
which require accounting, tax advisory
and structuring support. We have also
Garabedian Hu Meany
seen many companies going through
significant M&A transactions and/or
preparing for IPOs. In Q4 of 2021 alone,
we had four clients go public, which was
John Pennett
extremely exciting. The largest growth Chairman and CEO Managing Director Managing Partner
Partner-in-Charge of the National Technology
engine for us is the capital markets, and XONTOGENY VERTEX VENTURES HC EDGEWATER CAPITAL PARTNERS
and Life Sciences Group
if they stay strong, it will be greatly ben-
eficial to our business moving forward. EISNERAMPER
EisnerAmper has added capabilities to
its portfolio, including grant accounting
How has the biotech sector been im- How does Vertex differentiate itself What excites you about the life sci-
capabilities in our South Florida office;
pacted over the past year and how did in the market? ences space?
managed services, which allow virtual ginning, it is hard to get there as there lic marketplace. There has been pres- Xontogeny’s activities evolve? Vertex is a global investment fund with We are excited about life sciences
companies to have a managed services is a significant volume of companies sure on biotech stock, and some of the The past year saw significant pull-back in offices in the US, China, Singapore, In- because of the development oppor-
computer solution; and outsourced ac- with interesting ideas, and investors are recent vintage biotech IPOs are trading public valuations. The XBI had one of its
dia and Israel. Vertex is a female-led tunities for small to middle market
counting capabilities in San Francisco going to the sources they feel are most well below their IPO price. This is not a worst years on record in 2021, which con-
fund, and we strive to increase diver- enterprises outside the control of big
through acquiring Keating Consulting likely to succeed. great sign for the industry as a whole, tinued into 2022. After record years of
sity. We are driven by early stage sci- pharma. This is due to the increased
Group, which provides outsourced fi- but there is still cautious optimism for private investment, facilitating crossover
rounds and taking companies through ence and are pragmatists in the way we development of personalized medi-
nancing and accounting services to ven- What advice would you give first time what the markets are going to look like
IPOs, people are realizing that our sector deploy capital to most effectively drive cine, particularly with the advent of
ture-backed companies. We continue to entrepreneurs? for at least the first part of 2022.
may need to be more discerning in decid- companies to success. gene therapies.
increase our geographical footprint. Finding a strong partner to help supple-
ing which companies are worthy and ma- We are also observing a shift away
We aim to become more visible and ment skill sets is extremely important. If there was one thing you could from one-size-fits-all drugs, which cre-
ture enough to bring to the public markets. What have been the recent high-
reach all the life sciences communities in For example, if it is a scientific founder, change in the Tax Act that would help We set out with an early private equity ates more opportunities for CDMOs
the areas where we operate. We support finding a partner with business devel- people across the board, what would lights?
model that would work in any macro-mar- and CROs—spurring the development
universities and their entrepreneurial opment expertise can be critical. At a it be? Over the past year we invested in So-
ket environment. We developed our thesis of mid to small biopharma companies
programs, and regularly speak at vari- very early stage, companies do not nec- An expansion of the R&D credit, which around investing in lead products that fo- noma Biotherapeutics, which uses a
that match our portfolio. Finally, the
ous events, accelerators and incubators, essarily have the funds to bring such a will help innovative companies attract cus on specific value creation. Treg therapy platform to treat auto-
speed of recent innovation in the life
encouraging entrepreneurship. person on board, but we have seen cre- more capital to allow them to determine immune diseases; Allay Therapeutics,
sciences has been profound, as exem-
ative deals where the company is able to if their science is worthwhile. Can you highlight some upcoming in- which delivers durable pain relief in an
plified by the Covid-19 vaccine rollout,
How many entrepreneurs have you seen share some equity, most often a future vestments Xontogeny is excited about? effort to reduce the opioid usage in the
We are continuing to incubate companies which bodes well from a growth stand-
successfully form companies and IPOs? equity arrangement and maybe a prom- Which services have been in most de- US; and Indapta Therapeutics, which
at Xontogeny and anticipate announcing point.
Across the technology and life sciences ise of employment when the company mand and driving growth for Eisner- has developed a natural killer (NK) cell
several new seed investments in this up-
community, we have seen many en- is funded. There are also public and Amper? therapy platform to increase access to Could you speak to the consolidation
coming year. We are very excited when
trepreneurs become successful. They private incubator groups that help early- Support for IPOs and SPACs—whether these companies receive their Series A cell therapies for cancer patients. trend in the CDMO industry and the
mostly gain their experience in larger stage companies complete their man- they be tax, auditing or consulting cli- funding, often through the Perceptive attractiveness of CDMOs from a pri-
organizations, and from there start agement teams and skill sets by using an ents—has been in significant demand. Xontogeny Venture (PXV) fund, created What is Vertex’s vision for 2022 and vate equity standpoint?
their own companies from the experi- outsource model. EisnerAmper has seen substantial through a strategic relationship between beyond? While we have only invested in hybrid
ence and lessons learned. From a pub- growth in its tax services division, with Xontogeny and Perceptive Advisors. Be- We want to develop products that can CDMOs in the past, they are attractive
lic company perspective, credibility is What can we expect to see in the M&A demand coming especially from clients tween our funding mechanisms for Seed deliver a step-change benefit for pa- to private equity in the sense that they
and Series A investments, we have a full tients. The market will always have ups
critical, and we are seeing this even and IPO landscape moving forward? that have an international aspect to their combine traditional manufacturing
portfolio of over 20 companies.
more so in the venture capital commu- The IPO markets have certainly tight- businesses. We are also supporting com- and downs, but we remain optimistic with cutting edge technology.
nity. At the early stage of investment, if ened with a bit of a slowdown in the pro- panies regarding ownership and the tax about funding new science and innova- We are bullish on CDMOs because of
How do you see Xontogeny evolving?
you are not able to secure a significant cess. There is still a substantial amount ramifications surrounding shares and We want to create the next generation of tion. We are always excited to invest in several domestic trends, including a
venture capital round it will be very dif- of money to be spent, some deals are stock options, especially as companies biotech leaders not only through financial and partner with new companies work- general onshoring effort that is being
ficult to do so at a later stage. If you do still getting done, and a lot of compa- are growing and thinking about what an investment, but also through exposing them ing towards making a difference for pa- driven largely by quality control con-
not have the inside track from the be- nies are in the queue to go into the pub- exit might look like. ■ to the decades of experience of our team. ■ tients worldwide. ■ cerns from pharma. ■
16 USA LIFE SCIENCES 2022 Industry Explorations Global Business Reports USA LIFE SCIENCES 2022 17
EDITORIAL Global Business Reports Industry Explorations EDITORIAL
Image courtesy of Mammoth Biosciences.
The Life Sciences James Sapirstein, chairman, presi-
dent and CEO of First Wave BioPhar-
CDMO division of Lubrizol Life Sci-
ence, which, for this reason, sticks to
Regulatory Climate
ma, believes that what the general technologies he views as scalable and
public typically fails to understand cost-effective.
about the high price tags associated Some drug manufacturers have found
with the industry is that US companies alternative ways to bring their prod-
have a narrow window to monetize ucts to market to lower costs. When
their product under patent before re- Medicure Inc. went to introduce its
Clearing up confusion strictions are lifted and generic com- cardiovascular drug Zypitamag to the
panies enter the marketplace with market, the company found it challeng-
about quality metrics alternative formulations. The money ing to attain insurance coverage given
gained during this initial period is the low pricing of generics. Not want-
crucial for gaining capital for new de- ing to increase the price of the drug in
velopments. “Although I believe that accordance with the desires of PBMs,
In 2015, the FDA produced an original draft of an initiative complexity of pharmaceutical businesses – with focus now medicines they need… We support we should do whatever we can to pro- Medicure Inc. decided instead to sell
to create a more objective system of measuring, evaluat- shifting to biologics, antibodies, and cell and gene thera- policies to address market distortions vide access to drugs for patients that directly to people who are uninsured
ing, and monitoring both the product and process lifecycle pies—the supply chain cannot afford one misstep, and con- such as 340B reforms and policies like need medications, patenting is very or underinsured through a partnership
within pharmaceutical manufacturing. Seven years and a sequently the product and process quality have become the West Virginia law that requires the important,” explained Sapirstein. “If a with North Carolina-based pharmacy
few revisions later, confusion remains over exactly how com- even more important.” rebates and discounts that insurance company cannot protect its rights and Marley Drug. “Through our partnership
panies should incorporate the FDA Quality Metrics report Rather than simply discard the initiative, the administra- companies and middlemen receive have the ability to make some kind of with Marley Drug, we sell Zypitamag for
to measure quality management. The most basic problem tion should continue to collaborate meaningfully with those are shared directly with patients at the money on what it’s developing, there just US$1/day and are generating more
deals with the obfuscation of the metrics themselves. it affects most directly. The current minimum standard to pharmacy.” will never be innovation.” revenue than if we had insured the
“When it comes to quality metrics there remains no ensure a manufacturer’s products are of safe and sufficient For Pritchett, such reforms are clear This is a top concern not only for product through a PBM,” commented
consensus on definitions – for example what constitutes a quality is through compliance with CGMP requirements. ways to address issues like the high pharma companies but also for cer- Albert Friesen, the company’s CEO and
'batch'?" posited Gil Roth, president of the Pharma & Bio- Yet CGMP compliance by itself does little to demonstrate out-of-pocket costs patients see due to tain CDMOs that deal with complex chairman of the board. “In truth, most
pharma Outsourcing Association (PBOA), a non-profit that whether that company is actively striving to improve its the increasing use of deductibles and manufacturing processes such as pharmaceuticals are inexpensive to
works to enhance the regulatory and legislative business sustainable compliance. Quality metrics can help evaluate coinsurance. Yet according to Jason technologies related to drug device make, and it is the insurance that signifi-
interests of CDMOs. “My standard joke for this is that until supply chain robustness by demonstrating opportunities to Parish, co-leader of the life sciences in- combination or complex nanopar- cantly drives up costs.”
we all spell ‘harmonization’ the same way, we are not go- improve manufacturing practices. As such, decision makers dustry group at Buchanan Ingersoll & ticles. While these types of technolo- With no clear-cut solution, the prob-
ing to make a lot of progress. We need to have a common at contract manufacturing companies would be wise to of- Rooney PC, the consequences of state- gies pave the way for future innovative lem of drug pricing continues to fester
language.” fer their feedback within the FDA’s designated timeframe to level involvement do not mirror these therapeutics that may ultimately help unproductively. The elusive challenge
The result of this confusion is that even companies that ensure their voices are taken into account concerning future legislators’ intentions: “The result is a patients, their sophistication impacts is to find a compromise that allows for
want to comply have difficulty understanding how to. Fur- renditions of the initiative. complicated patchwork of regulation the cost of manufacture and thus the an innovative research, development,
thermore, the report’s industry-wide implementation may around the country, and one of the cost of goods. “I am concerned the and manufacturing climate while ensur-
actually cause more harm than good in terms of operations. Drug pricing remains contentious perverse side effects of this is that cre- current regulatory environment will ing patients can afford the medications
For CMOs and CDMOs that make an expansive range of The issue of drug pricing in the US has always been messy, ating transparency in the system has make innovation more challenging as they need. Looking beyond the cost of
products, one small slip-up may not be representative of and the failure to address the issue at the federal level has led to higher prices. The problem of it will become increasingly difficult to innovation, legislators should also pay
overall operations. For facilities that handle only one prod- further complicated matters. As a result, state governments not having federal legislation in place justify the costs of certain products,” attention to the earnings made by inter-
uct, any problems could ruin the entire operation’s reputa- are attempting to independently regulate their jurisdictions. is far bigger than anyone recognizes admitted Robert Lee, president of the mediaries downstream. ■
tion. Roth sees a reputational problem at play: “The FDA has Over the past year, roughly 500 drug pricing bills were in- and has gotten worse throughout the
been pushing to create a rating system for all sites, so payers troduced by state legislators with the aim of forcing drug pandemic.”
can pressure license holders into revealing their manufacture price transparency, capping price increases for state payers, In addition to leading to purportedly
↘↘
site ratings. This involves public shaming and splits the goal and regulating PBMs. For example, West Virginia recently higher prices, many worry that the cur-
of what Quality Management Maturity Metrics are supposed passed a law mandating that rebates and discounts current- rent regulatory environment is threat- Through our partnership with Marley Drug, we sell Zypitamag for just
to do: incentivizing quality vs. identifying potential quality ly offered by biopharmaceutical companies to insurers and ening the very ethos of the life sci-
problems that could lead to shortages. These are issues for other intermediaries will be shared with patients. In 2020, ences industry – its cult of innovation.
US$1/day and are generating more revenue than if we had insured the
the whole value chain, not just CMOs.” the state’s legislature had passed a bill requiring pharma- Speaking of the current policy environ- product through a PBM. In truth, most pharmaceuticals are inexpensive
To their credit, the FDA acknowledges that reception of ceutical drug manufacturers and companies offering health ment under the Biden administration,
its Quality Metrics could be more positive and has request- benefit plans to submit pricing information to be posted on Donna LaVoie, president and CEO of to make, and it is the insurance that significantly drives up costs.
ed feedback from industry stakeholders. In March 2022, the state transparency website. LaVoieHealthScience, acknowledged
the administration established a docket to solicit com- Anne Pritchett, senior vice president of policy, research that no real progress has been made on
ments on changes to the reporting program and will ac- and membership at PhRMA, a trade group that lobbies on the problem: “The regulation of drug - Albert Friesen,
cept recommendations until June 7, 2022. Despite its com- behalf of pharmaceutical companies, believes such reforms pricing remains an ongoing issue, with
plications, the Quality Metrics Reporting program remains can be beneficial. Speaking on behalf of her organization many drugs treating rare diseases re- CEO & Chairman of the Board,
imperative, especially with the heightened sophistication about its patient-centered agenda, Pritchett said: “There is tailing at prohibitive prices. The trade- Medicure Inc
of manufacturing. no doubt that the system needs to work better for patients, off of innovation and drug pricing is a
Arda Ural, partner and EY Americas industry markets lead- and many common-sense reforms are available to policy- tricky topic and not one that has been
er health sciences and wellness, acknowledged: “Given the makers who support helping patients access and afford the resolved.” ↖↖
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