The New Era ofLife Sciences 2024
Written by: Konstantin Tumanov & Ignacio Louzan
Project Directors: George Clarke & Lewis Hart

his report captures a historicalmoment for life sciences. What
were dreams or vague projections
until recently are now solidifying realities.
Highly personalized oncology therapies,
the possibility of early cancer detection
via a simple blood draw, AI's optimizationof drug discovery, unseen breakthroughs in
the formerly stagnating fields of neurology
or dermatology—inspiring illustrationsof each of these, and more, can be foundin this piece, the result of more than 100
conversations with industry leaders.

ROBERT CALIFF | COMMISSIONER OF THE
FOOD AND DRUG ADMINISTRATION (FDA)

But when dreams come true, new dreams
replace them. That is what drives science. As
the legendary biotechnologist and biotech
founder Robert Langer told us: 'What is truly
thrilling is the potential for discoveries thatare currently beyond our imagination. Just
as CRISPR emerged from basic research
to revolutionize genetics, future breakthroughs will likely come from areas we are
not even focused on today. It underscores
the importance of supporting fundamental,
curiosity-driven research.'

Should the FDA have a more flexible
approach when it comes to new lifesaving therapies?
Building on some of the lessons
learned during the pandemic such as
the benefits of enhanced communication and global regulatory collaboration, the FDA is committed to helping
facilitate the development and approval of safe and effective treatmentsfor patients with serious and rarediseases, especially when the productis the first available treatment.
READ THE FULL INTERVIEWIN THIS REPORT…
STÉPHANE BANCEL | CEO, MODERNADOUG LANGA | VP NORTH AMERICA, NOVO NORDISKOur research is continuously evolving to include a
broader range of diseases, including autoimmune
disorders and cardiovascular diseases,
highlighting mRNA's versatility.

Insulin icodec would represent the first and only
once-weekly basal insulin option for adults withdiabetes in the U.S.

PASCAL SORIOT | CEO, ASTRAZENECA

The personalized approach is already being
applied across 90 percent of our portfolio.

MARK VINEIS | COUNTRY PRESIDENT,NOVARTIS CANADA

There is a noticeable tension between the
nurturing of biotech innovation and thebureaucratic barriers to health care innovation.
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THE NEW ERA OF LIFE SCIENCES 2024

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A Turn of Tide
When work on this project started, in November 2023, it was palpablethat the industry had been through tough times. The sector was still
undergoing its post-pandemic slump—the depression in investment
and economic activity which followed the exuberance (some call it
irrational) of the COVID-19 years. Yes, we were assured that it wasa matter of time for it to be over, for funds, stationed behind thecorner, to be unbound again. But the slump had been ongoing for
longer than expected, and optimistic projections had to be taken witha grain of salt. Well, by the time our team attended the annual Biocom
California Conference in San Diego in late February 2024, the tides
had turned. By then, publicly traded biotechs were finally seeing an
upward trend in their stocks and representatives from major VCs andfinancial institutions, like Goldman Sachs, were reporting marked
increase in economic activity. 'Since January we have already seen
strong and meaningful deals being made,' confirmed Joseph Panetta,
the president & CEO of Biocom California. And indeed, M&As and
IPOs, being solid barometers for the health of the biotech sector,
have gone up recently. An example is the announced acquisition ofMorphoSys by Novartis for $2.9 billion. And unlike the furies fromthe pandemic times, speakers at the Conference insisted, optimism
is now based on hard science, like cell therapies, which are one of
the centerpieces of this report.

CONTENT BYINVESTMENT REPORTSWILLIAM HUMPHRIES |CEO, ALCAMICORPORATION

We focus on trust and quality, we understand thatevery role we play is critical. Trust differentiates us andwill likely become even more crucial as the legislation
perpetuates, and if it evolves.
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While in San Diego, we spoke with Avidity Biosciences, who had justreceived an oversubscribed $400 million financing, which, we weretold, came as a strong signal for the sector's recovery. The biotech
is developing a new class of RNA therapeutics called Antibody
Oligonucleotide Conjugates (AOCs) to treat muscle-related rarediseases, like myotonic dystrophy. 'The biotech sector is on thecusp of a recovery, fueled by continuous innovation and positive
developments across the industry,' Avidity's president & CEO, SarahBoyce shared. Importantly, she noted that investors are now much
more judicious: 'The challenges of the past few years, accentuated by
the COVID-19 pandemic, have led to a more discerning investment
landscape, yet the advances in targeting previously untreatablediseases signal an exciting era for biotech.' Avidity is not alone torejoice in the market renaissance—eight U.S. biotechs went public
in just the first few weeks of 2024.

THE NEW ERA OF LIFE SCIENCES 2024

The Many Facesof Oncology
This is more than timely as new cancer diagnoses in the U.S. are
expected to hit a record number—over 2 million—in 2024, according
to the American Cancer Society. Personalized immunotherapies arewhere expectations are highest. As an illustration, Moderna, whichbecame famous for its COVID-19 vaccine, is now working hard on
advancing its mRNA technology in oncology. 'Our personalized approach, particularly our progress in treating melanoma, has shownpromising results, with significant improvements in survival rates.
These therapies, developed in collaboration with Merck, leverage theimmune system's capabilities to better recognize and combat cancer
cells, illustrating the potential of mRNA technology in oncology,'
Moderna's CEO, Stéphane Bancel shared.
But what transpired from our numerous interviews is that the newsuperstars in oncology are cell and gene therapies. More than 1,000
such programs are currently in development and a good deal of them
are meant to address hard-to-treat cancers. As Thermo Fisher Scientific's president of Biosciences, Amy Butler, put it: 'Cell and genetherapies hold tremendous potential to be curative for diseases thatwere previously deemed untreatable, such as childhood leukemia
and breast cancer. These therapies offer a revolutionary approachby potentially eliminating the disease rather than merely managing
symptoms.' Smaller biotechs tend to be the main drivers of innovation in this area, but pharmaceutical giants have a pivotal role to play
too, especially due to their ability to channel considerable resources.
Sebastian Guth, the COO of Bayer Pharmaceuticals and presidentof Bayer US, corroborated: 'Bayer has actively participated in thisevolution by investing €3.5 billion in building our cell and gene therapy platform. We have made strategic acquisitions and partnerships,
such as Ask Bio for gene therapies and Blue Rock Therapeutics forcell therapies, to strengthen our position.'
One can consider chimeric antigen receptor (CAR) T-cell therapies
as the vanguard in oncology, particularly since the FDA has approved71

in 2023
new medicines approved by the FDA

DR. ZACHARY ROBERTS |EVP OF R&D AND
CHIEF MEDICALOFFICER, ALLOGENE
THERAPEUTICS
ALPHA3 will evaluate cema-cel as part of a 1L
consolidation regimen in LBCL patients who are most
likely to relapse. This is an incredibly innovative trial andone that just wasn't clinically possible until now.
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only six of them to date (the first approval was granted in 2017).
They are a type of immunotherapy that involves the administrationof genetically modified T-cells (the most powerful component of
the immune system), which allow for greater precision in targetingcancer cells. Recent breakthroughs in this space indicate that these
therapies may be a game-changer in oncology.
CAR Ts have demonstrated considerable success in treating deadly
blood cancers, often leading to long-term remissions. All six FDAapproved CAR T-cell therapies, developed by Novartis, Kite Pharma,
BMS and Janssen, target liquid tumors (blood and plasma). The
efficacy of these treatments can vary and certain issues, such as
cancer resistance and toxicity, persist. We spoke with a clinical-stage
biotech, CARGO Therapeutics, that tries to overcome cancer resistance and increase the efficiency of developed CAR T-cell programs.
'Current CD 19-targeted CAR T-cell therapies have set a transformative precedent in large B-cell lymphoma treatment, with about

DANIEL J. HICKLIN, PH.D. |PRESIDENT & CEO,WEREWOLF
THERAPEUTICS
Werewolf Therapeutics is developing a new generationof conditionally-activated immunotherapies, INDUKINE
molecules, that hold the promise of providing moretreatment options for patients with cancer.

Source: Nature

THE NEW ERA OF LIFE SCIENCES 2024

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THE NEW ERA OF LIFE SCIENCES 2024

are produced in advance, stored, and ready for rapid administration,
drastically reducing the time from patient eligibility to treatmentcommencement,' Roberts added.
CHRIS COZIC |EXECUTIVE VP &CHIEF PEOPLE OFFICER,GENMAB
Genmab is a scientific leader in antibody research,inspired by the power of the human immune system tofight diseases.

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40 percent of patients achieving long-term complete response,'
the company's CEO, Gina Chapman told us. Their goal at CARGO,
however, is to address the 60 percent of patients for whom these
therapies are not effective. 'Preliminary results are promising, showing a 53 percent complete response rate in this subgroup, which isremarkable considering these are patients with very limited options
and a median survival of less than six months prior to treatment,'
Chapman added. CARGO's lead candidate, firi-cel (CRG-022), iscurrently in Phase 2 trials.
CAR T-cell therapies can be autologous and allogeneic. In the case of
autologous (from Ancient Greek autós, 'self'), T-cells are taken fromthe patient being treated, they are genetically modified and reinserted
into their body. The aim is for the boosted T-cells to then destroy
the cancer. The other type, allogeneic (from állos, meaning 'other'),
involves a similar process, but cells are in that case provided by ahealthy donor for multiple patients. Autologous treatments are theonly ones currently available on the U.S. market. 'Allogeneic CAR T
products are developed using T-cells from healthy donors. These cells
are isolated in a manufacturing facility, engineered to express CARs
to recognize and destroy disease, and modified via gene editing tolimit autoimmune response when given to a patient,' explained Dr.
Zachary Roberts, EVP of R&D and chief Medical Officer of Allogene
Therapeutics. The company, whose lead program targeting B-cell malignancies is currently in Phase 2, claims to have overcome the issueof autoimmune reactions by additional gene editing. 'Our products

THE NEW ERA OF LIFE SCIENCES 2024

While we are still to see the first FDA green light in this space, theEuropean Commission granted the first approval globally for an
allogeneic T-cell immunotherapy back in 2022. The therapy, called
Tabelecleucel and targeting relapsed/refractory post-transplant
lymphoproliferative disorder (PTLD), was developed by California-based Atara Biotherapeutics. 'Our T-cell therapy has shownaround 50 percent response rate in treating relapsed/refractory
PTLD, leading to long-term survival in responders. This represents
significant progress in a deadly disease with no approved therapies,'
Atara's president & CEO, Pascal Touchon, added.
But while CAR T-cell treatments have made considerable strides intreating certain blood and plasma malignancies, the FDA has neverapproved them for treating solid tumors.' This has meant that more
traditional approaches like chemotherapies and surgeries continue
to be the primary options for solid tumors, which are also 90 percent
of all cancers. The great news is that another type of T-cell therapy
may be able to cut this Gordian knot. It was this January that the
FDA approved the first cellular therapy for a solid tumor—thedrug, called Amtagvi (lifileucel), is for metastatic melanoma andwas developed by California-based Iovance Biotherapeutics. 'This

ADRIAN RAWCLIFFE |CEO,
ADAPTIMMUNE
Adaptimmune aspires to be a leading, integrated commercial cell therapy company, transforming technology
into valuable therapies for patients, developing anddelivering innovative treatments for solid tumors andpotentially changing the landscape of cancer treatment.
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achievement opens a new frontier in oncology,' said Fred Vogt,
Iovance's interim CEO. In addition to melanoma, Iovance's treatment
has already shown promising results for non-small cell lung cancer.
But cell therapy and CAR Ts hold promises that go beyond oncology.
'One remarkable instance involves a patient who suffered from Myasthenia gravis for years and became immobilized in a wheelchair.
She received a single dose. Within months, she regained the ability
to walk—and she even surpassed her own husband's stamina on ahike recently,' shared Peter Maag, the CEO of Kyverna Therapeutics.
Maag is confident that his company is on the verge of revolutionizing
the treatment of autoimmune diseases. 'At a high level, autoimmune
diseases involve the immune system attacking itself. We extract T
cells from the patient, genetically re-engineer them, and re-inject
them. It reminds me of resetting a computer to get everything backto normal,' Maag said. Kyverna's lead candidate, KYV-101, is alreadyin Phase 2 for certain indications. Maag told us that part of its therapeutic allure stems from its prospective to offer a long-term remission for patients. Kyverna is not alone, as other biotechs, like Atara,also perceive the potential of cell therapies to fight autoimmunity.
Innovations in immunotherapy are not restricted to cell and gene therapies. Xilio Therapeutics, for example, is developing tumor-activatedimmunotherapies that allow for greater precision and, thereby, farless toxicity for healthy tissues. Systemic toxicity has been a principal
problem of modern immunotherapies. Oftentimes patients' tumors
are successfully shrinking, but the therapy has to be discontinued
due to overwhelming side effects. Xilio's president & CEO, Dr. René
Russo, shared: 'We have discovered that we can activate our firstmolecule, an anti-CTLA-4 monoclonal antibody, predominantly
within the tumor—showing 70 to 90 percent activity in the tumor
environment, while maintaining less than 15 percent activity in thecirculating blood.

DR. RENÉ RUSSO |PRESIDENT & CEO,XILIO THERAPEUTICS
Our geographic precision
medicines are tumor-selective
immunotherapies designed
to focus the immune system's tumor-destroying effectlocally in tumor tissue but not in healthy tissues. By
localizing activity to the tumor, we hope to overcome thetoxicities of prior generations of immunotherapies.
READ THE FULL INTERVIEWTHE BIOTECH HUBSDEBBIE HART | PRESIDENT & CEO, BIONJ

New Jersey continues to lead the way in biopharma
innovation, harnessing its rich pharmaceutical legacy
and ongoing support from both the private andpublic sectors. With a diverse and talented workforce
and an unparalleled density of FDA-registered manufacturing facilities, the state encapsulates the entire
drug development continuum – underscoring New
Jersey's pivotal and leading role in advancing healthcare breakthroughs.
JOSEPH PANETTA | PRESIDENT & CEO,BIOCOM CALIFORNIA

California's life science sector is a colossal $450
billion industry, employing 400,000 people.
KENDALLE BURLIN O'CONNELL |PRESIDENT & CEO, MASSBIO

Massachusetts' distinction in the life sciences industry is primarily due to its unmatched density andrichness of resources within a small area. Home toover 1,000 biotechs, 18 of the top 20 biopharmacompanies, investors, and academic institutions,
Massachusetts offers an unparalleled ecosystem.

E. ANDERS KOLB |PRESIDENT & CEO,THE LEUKEMIA &LYMPHOMA SOCIETY(LLS)

JANE DUNIGAN-SMITH | SVP & CSO,
BIOCROSSROADS

An unintended consequence of innovation in healthcare is the widening gap between those who can accesscomplex and costly therapies, and those who cannot.
True innovation must prioritize broad access to care andthis is a major focus for LLS.

Indiana is home to 2,700 establishments, including giants
like Eli Lilly and Company, and leaders in ag biosciencessuch as Corteva. Indiana also boasts significant achievements in medical device manufacturing, with Warsaw
recognized as the orthopedic capital of the world.

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'This targeted activity allows us to minimize side effects significantly, thereby enabling higher dosages and longer treatment
durations.' Xilio is also developing two cytokine programs withthe same objective, as cytokines have been known for their side
effects. 'We have been able to administer significantly higher doses
than previously possible, thanks to the tumor-selective activationof these molecules,' Russo told us, adding that these can now workin conjunction with cell therapies too.
Another company bent on solving the challenge of cytokine-based
therapies is Werewolf Therapeutics. 'Werewolf' is a metaphor forthe company's objective: 'They are designed to be delivered systemically and remain inactive throughout the patient's body, akinto a werewolf in daylight. However, upon entering the tumor microenvironment—comparable to the moonlight for a werewolf—ourdrugs are designed to transform into aggressive agents to stimulate
a powerful immune response and unleash an attack on cancer cells,'
Dan Hicklin, Founder & CEO of the biotech explained. 'Our solution
involves creating cytokine prodrugs, called INDUKINE molecules,
that remain inactive in circulation but activate upon reaching tumor tissue', Hicklin added. Werewolf is focused on treatments formelanoma, lung and kidney cancers.
After the many interviews we had in the oncology space, we concluded
that thinking of cancer as a single disease is outdated and erroneous.
Cancer has many forms and each of these may present differently in
different patients. This is the great attraction of personalized medicine in oncology. That also means that, if we are to be successful
in solving cancer(s), many different solutions will be needed—celland gene therapies, radiopharmaceuticals, mRNA, cytokines… The
list, most certainly, is yet to grow. And that is good news.

ALEC FORD |CEO, KARIUS
Every year in the U.S., over2 million patients with cancer
are admitted to hospitals due
to infections. Current diagnostics for infections often fallshort resulting in poor outcomes. Our mission is to improve
diagnostics and reduce the nearly 1000 deaths a day due toinfection among immunocompromised patients.
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2023

2024

Biotech IPOs reached pre-pandemic levels during Q1 of 2024.
That is more than three times what was raised from biotech
IPOs in Q1 2023.
Source: BioPharma DiveTHE ONCOLOGY VANGUARDSEBASTIAN GUTH | PRESIDENT, BAYER US

The advancement in cell and gene therapies ispivotal. We have seen a significant increase in FDA
approvals in this area. Bayer has actively participated in this evolution by investing $3.75 billion inbuilding our cell and gene therapy platform.
MARKUS WARMUTH|
CEO, MONTE ROSA THERAPEUTICS

Monte Rosa's therapeutic candidates, designed asorally bioavailable drugs, offer a novel approachto cancer treatment by targeting specific genomic
aberrations or oncogene over-expressions. Thismethod stands out for its convenience and potential for higher market penetration compared to
injectable therapies.
EMMANUEL ABATE | PRESIDENT, GENOME MEDICINE,
AND HEAD OF SUSTAINABILITY, CYTIVAThe history of biologics is mostly about moderating disease, but cell and gene therapies can be
curative and that's why they generate so much
excitement.
MATTHEW B. KLEIN, M.D. | CEO, PTC THERAPEUTICS

Our gene therapy for the rare disease AADC deficiency has allowed children who were previously
unable to spontaneously move to begin to lift theirheads, crawl, and walk, transforming their lives.
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Uncovering Cancer
Tackling deadly diseases like cancer via advanced therapeutics
is only one side of the coin; the other is early detection. Luckily,
breakthroughs in diagnostics are also proliferating.
Every health system and, naturally, every individual would be greatly
relieved if a universal early detection cancer test were discovered.
We spoke with a company that claims to have made significant
progress in that direction. GRAIL has developed a multi-cancer,
early detection blood test called Galleri that 'can identify over 50
types of cancers, focusing particularly on highly lethal cancers thatlack existing screening modalities in population health, such as
pancreatic, esophageal, and liver cancers,' GRAIL's CMO, Jeffrey
Venstrom told us, emphasizing that nearly 70 percent of cancer
deaths are caused by cancers without recommended screening.
The Galleri test identifies genomic features and abnormal DNA
fragments in one's blood, employing advanced techniques to also
provide information about a tumor's location. But, with about 40
percent of positive predictive value for the moment, the test is still
not to be used in isolation and at the expense of traditional screening. 'Over the next few years, our primary goal is to secure broad
adoption and FDA approval through our ongoing clinical trials andour breakthrough designation status,' Venstrom added. GRAIL has
also initiated a collaboration with CMS (Centers for Medicare andMedicaid Services) to conduct a real-world implementation study,
called the REACH, targeting the Medicare population.

STEVE SCHAEFER |PRESIDENT,KYOWA KIRINNORTH AMERICA
Focusing on the rare disease space enables us totarget investments into meeting patients' needs
with precision and empathy, often touching lives in
profound ways. Our work to bring these innovations
to patients extends beyond scientific achievement;
it is about the real-world impact we hope to have on
individuals and their families.
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cancer itself,' said Alec Ford, the CEO of Karius—a company thatprovides rapid and accurate diagnosis of infections, notably focusing
on oncology patients. Cancer patients are exceptionally vulnerable
to infections, Ford explains, adding that traditional approaches toinfectious diagnosis are slow and cumbersome, threatening many ofthese patients' lives. 'By analyzing a small blood sample, within just
24 hours we can identify microbial DNA from over 1,000 pathogens,including bacteria, fungi, parasites, and viruses,' Ford highlighted
the benefits of the Karius test. At any rate, the examples of GRAIL,
Personalis and Karius demonstrate that, in oncology-related diagnosis
too, multiple lines of action are required.

Others, like Personalis, are targeting patients who have already hadcancer. 'Our focus is on individuals with a high risk of recurrence,
where the value and impact of early detection justify the cost. As technology costs decrease, expanding to broader early detection becomes
more feasible,' reasoned Christopher Hall, the CEO of Personalis.
The Bay Area biotech's technology is centered on the identificationof Minimal Residual Disease (MRD) and utilizes whole-genome
analysis to create a unique tumor profile for each patient.
As we find out, however, treating patients with cancer is not just about
cancer. 'Over half of all cancer deaths are due to infections, not the

DR. DAVID O'NEILL |PRESIDENT, FACIT

FACIT is changing the research economics dynamic – byusing seed capital to not only support IP discoveries
and entrepreneurs, but also to encourage startups togrow roots in Ontario and promote a self-sustaining
innovation ecosystem.
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The Hidden Catalysts
in Medical Innovation

The driving force behindmy three-decade-longcommitment to life sciencesis the profound impact wemake on patients' lives andpublic health.

PAUL MCKENZIE | CEO, CSLREAD THE FULL INTERVIEW

Beyond scientific conundra, a major concern associated with most ofthese novel therapies is their accessibility. This is an issue inherent
to personalized medicine. While much more precise, potent andsparing for the patient, it involves significantly more resources. As
in the case of autologous cell therapies, an entire team of scientists
may be engaged to work on the modification of the cells of a single
patient. In fact, a record was recently broken with the price of Orchard
Therapeutics' (a subsidiary of Kyowa Kirin) Lenmeldy gene therapy
drug set at $4.25 million. 'The pricing really reflects the profound
impact hematopoietic stem cell gene therapies can have—helping
transform a fatal, devastating disease into something that may be
addressed with a one-time treatment. It also recognizes the significant investment required to bring such innovative, personalized
treatments to market for an ultra-rare disease,' Kyowa Kirin North
America's president, Steve Schaefer explained. Whereas these arecertainly valid points, the question of accessibility remains to be solved.

in certain cases. Service providers, like Contract Development andManufacturing Organizations (CDMOs), can have a key role to playhere. Cellares' CEO & Co-Founder, Fabian Gerlinghaus, emphasized
the degree of the scalability problem: 'About 20 percent of patientsare dying on the waitlist even though they are eligible for approved
cell therapies because the industry is unable to meet patient demand.' Cellares has developed a manufacturing platform, called
Cell Shuttle, which, Gerlinghaus claims, successfully integrates
and automates the entire cell therapy manufacturing process into
one place. 'It encapsulates the functionality of approximately 100
benchtop instruments in a single, compact machine,' Gerlinghaussaid, adding that this 'reduces labor and space requirements by 90
percent. The other key difference is that the Cell Shuttle can process
16 cell therapy processes simultaneously.' Gerlinghaus anticipatesthat the Cell Shuttle will be able to meet worldwide demand for celltherapies in the future.

As mentioned, specifically in the CAR T-cells space, costs can betempered via the allogeneic card, which allows for the productionof multiple doses from a single manufacturing run. Yet, solutions do
exist for autologous therapies, which can have important advantages

Cellares is an example of how contract service providers can playa critical role in supporting the work of biopharma companies. Another such illustration comes from Nucleus RadioPharma, a CDMO
operating in the space of radiopharmaceuticals. Highly promising,such therapies rely on low-energy isotopes that integrate cancer-targeting molecules. Radiopharmaceuticals can allow for precise tumor
treatment while minimizing damage to surrounding tissues. 'The
potential in this field is significant, especially for conditions likeneuroendocrine tumors and prostate cancer, where targeted radiotherapy could have a transformative impact,' Théodore Leondaridis,
the Global Oncology Head of Pierre Fabre Group shared with us.
The company is considering its entry into this space, as the sector is
attracting more and more attention, as exemplified by recent news
about AstraZeneca's pending $2.4 billion acquisition of Fusion Pharmaceuticals, known for developing next generation radioconjugates.
But for all their prospects, radiopharmaceuticals have an Achilles'
heel—manufacturing and logistics. Nucleus RadioPharma's CEO,Charles Conroy, told us that the industry is particularly challenging'due to the short half-life of isotopes, which complicates logistics
similar to shipping ice without refrigeration.' To address this, theCDMO is establishing multiple production sites across the U.S. 'We
are strategically situating our facilities near major medical centers

We have significantly expanded our R&D capabilities, including doubling the footprintof our flagship Innovation
Center in Bridgewater, NJ.
In this highly collaborativeenvironment, we work closelywith customers to develop
customized solutions.

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to expedite the transfer of isotopes and drugs into patient studies
and eventual commercial use,' Conroy said. But while infrastructuralissues persist, Conroy is optimistic that the large investments that thesector is attracting will solve these. 'Contract service providers havebecome increasingly relevant as innovators, as well.' 'The shift fromsmall molecules to large molecules and biologics marks a significant
evolution in health care. This transition necessitates specialized
expertise in areas like cell and gene therapy, where CDMOs excel,'observed William Humphries, the CEO of Alcami Corporation. To
respond to this new reality, global service providers are expanding
and/or profiling their activities. 'We have broadened our service
scope by acquiring CELLforCURE from Novartis, a state-of-the-art
cell and gene therapy manufacturing unit. This acquisition allows us
to offer a more comprehensive range of CDMO activities, extending
our expertise from small molecules to cell and gene therapy,' theCEO of the French-based SEQENS, Pierre Luzeau, told us.
Crucially, more than meeting new demands, service providers arealso proactive innovators. A telling illustration comes from Codexis,
which offers engineered enzymes to its various clients. One of its
platforms, ECO Synthesis, is designed to address the scalability andsustainability challenges that have characterized the RNA synthesis
space. Particularly the latter is a topic that has received little media
attention but, as we are told, conventional RNA synthesis is heavily
reliant on environmentally detrimental solvents. 'ECO Synthesis
operates in water, dramatically reducing the carbon footprint andeliminating the need for large-scale, expensive containment facilities.
This innovation not only promises a more sustainable approach but
also significantly reduces capital investment requirements, enabling
the production of siRNA at scales previously deemed unfeasible,' theCEO of Codexis, Stephen Dilly noted.

KEVIN ALI |CEO, ORGANON

Achieving a women's health moonshot is within ourcollective reach. I'm energized by the positive trends
I see across scientific discovery, focused government
attention and private sector that are turning this future
into our present.
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THE ADVENT OF SERVICE PROVIDERSJAMES FOSTER | PRESIDENT & CEO,CHARLES RIVER LABORATORIESCell and gene therapy represents the mostdynamic growth area within our portfolio,
signaling a significant shift in our business focus.
MICHAEL MCMULLEN |PRESIDENT & CEO, AGILENT TECHNOLOGIESOur technology allows for live cell analysis, enabling
researchers to observe the metabolic health of cells
in real time. This capability is crucial for evaluating
potential therapeutic treatments' effects.
CARL HANSEN, PH.D. |FOUNDER AND CEO, ABCELLERAIn May 2023, AbCellera announced a $512
million co-investment with the governmentsof Canada and British Columbia to build newcapabilities and infrastructure to develop
innovative antibody-based medicines.

TREVOR P. CASTOR |PRESIDENT & CEO,APHIOSCORPORATION
Zindol highlights our platform's capacity to offer natural,
effective treatments with fewer side effects, addressing
significant needs in areas like hyperemesis in pregnancy
and post-operative care and versatility for improving
quality of life.
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AUDREY GREENBERG | CHIEF BUSINESS OFFICER,
SK PHARMTECO

Platform technology, distributed manufacturing,
automation, and AI will revolutionize therapy production and distribution.
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THE NEW ERA OF LIFE SCIENCES 2024

The Forefront of Tech
You probably remember how until recently, medical data management
was a manual chore, with each patient's details recorded on paper.
But the digital revolution has transformed this process. However,
now medical data is not just digitized; it is also centralized in thecloud—something resembling an immense, invisible filing cabinet.
The magic unfolds when AI intervenes in this vast pool of centralized
data. With lightning speed, AI identifies patterns and connections
that would take humans much longer to uncover. As Mandar Paralkar,
Global VP and Head of Life Sciences, SAP, told us, this makes AI'increasingly used in drug discovery, quality control, and regulatory
submissions, enhancing outcomes by managing both structured andunstructured data'. According to McKinsey & Company, AI application
boosts the efficiency of initial manual assessments of drug targets
by over 30%. Furthermore, AI-enhanced compound screening insilico has not only tripled the performance of chemical compound
activity models but also slashed the time needed to pinpoint newleads by more than fourfold—which means no less than drugs being
discovered at four times the pace. Insmed, an innovator in the fieldof rare disease therapies, is one of the examples of a biotech starting
to leverage these tools.
As CEO Will Lewis told us: 'The company's collaboration with
Google Cloud aims to integrate AI in drug discovery, development,commercialization, and internal operations to enhance efficiency
and innovation.' In his view, 'AI's potential to accelerate understanding and optimize processes without replacing the human element
signifies a pivotal moment in the industry.' Similarly, the CEO ofLabcorp, one of the largest laboratory service providers in the world,
told us that AI plays a transformative role in both customer-facing
and operational aspects of the company's work. 'For example, we
employ neural networking to enhance patient check-in processes
at our service centers, improving accuracy and efficiency in patient
identification and insurance verification. This not only speeds up
the process but also allows our staff to focus more on patient care,'Adam Schechter highlights. However, AI's power comes with a corresponding responsibility; Dr. Diem Nguyen, CEO of global healthcompany SIGA, warned us that 'The dual nature of AI and biotechnology present significant benefits and risks. While these technologies
have led to many advancements in virus sequencing and treatment
development, they can also pose a threat if used malevolently.'

TOM LANGAN |PRESIDENT AND
CHIEF COMMERCIAL
OFFICER, VERADIGM
Unique to Veradigm is our ability to engage providers
directly via the Veradigm Network. Our experienceand knowledge in catering to providers, life science,and health plan customers also contribute to ourcompetitive edge.
READ THE FULL INTERVIEWTHE NEXT FRONTIERMARK HERBERT | VP OF BIOPHARMA BUSINESSDEVELOPMENT, VARDA SPACE INDUSTRIESThe unique conditions of low Earth orbit offer acompelling value proposition for the pharmaceuticalindustry. Varda's operational costs for space-based
manufacturing are justified by the significant benefits that can be achieved, such as the developmentof novel drug formulations and the potential tounlock discoveries that are not possible on Earth.
JOHN VELLINGER |PRESIDENT, REDWIRE IN-SPACE INDUSTRIES

We specialize in developing research equipment
and facilities for space to discover new opportunities that can improve human health on Earth.
Microgravity, which cannot be simulated on Earth,offers a unique environment for life science andphysical science processes.
SEEMA VERMA | EVP AND GM,
ORACLE HEALTH AND LIFE SCIENCES

Oracle is innovating by integrating vast amountsof data from our electronic health records, which
are one of the largest in the world, and clinical
trial management systems.
JOHN CROWLEY | PRESIDENT & CEO,BIOTECHNOLOGY INNOVATION ORGANIZATION (BIO)

Advancing biotechnology is crucial for many reasons. My leadership at BIO emphasizes biotechnology's significance in ensuring preparedness against
pandemics, enhancing public health, and bolstering
the strength of our nation and allies.
READ THE FULL INTERVIEWS

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AI & Drug Discovery
A biotech specialized in the treatment of cancer, Genmab, has begun
to utilize AI across several of their operations, as revealed by theircreation of an AI incubator to foster innovation, generating over 140
concepts in various areas. While currently focused on simpler tasks,
Chris Cozic, Executive Vice president & chief People Officer, told
us that the future application of AI in their operations is poised for
grander challenges. Specifically, Genmab believes that AI will playa 'significant role in predictive analysis and protein design,' which
involves using AI to firstly understand and secondly manipulate
protein structures. Proteins play a central role in drugs as they often
serve as targets that the drugs bind to, modifying biological processes to treat diseases. Consequently, this means that with AI we canpredict how proteins interact with other molecules—which enables
researchers to virtually design proteins with specific therapeutic
properties. This capability has the potential to be a game-changing
advance compared to previous drug discovery methods, which reliedheavily on trial and error and extensive laboratory experiments,
making the process slower and less efficient.
AstraZeneca's CEO, Pascal Soriot, further illustrated the rapid
application of AI into their drug discovery efforts: 'Our AI-enabled
platforms are using generative models to identify potential drug
molecules twice as fast as traditional processes and help us prioritize those that will be most effective. We are also using generative
AI and machine learning in antibody discovery, cutting the time toidentify target antibody leads from three months to just three days.'
Service providers, like PerkinElmer, have also been quick to integrate
AI in their offerings. 'Our OneSource services offering exemplifies
how AI can optimize operations within biopharma R&D labs. By
relieving scientists from the burdens of instrument complexity andmaintenance, we enable them to focus on their primary objective: drug
development. AI aids in predicting lab utilization rates, maintenancerequirements, energy consumption, and other operational aspects,

THE NEW ERA OF LIFE SCIENCES 2024

DEBASHIS GHOSH |PRESIDENT, BUSINESSGROUP, TATACONSULTANCYSERVICESGenAI is paving the way for a health care system thatis responsive, affordable, and personalized. This aligns
perfectly with emerging trends in precision medicine,promising a future where complex diseases are treatedeffectively and economically.
READ THE FULL INTERVIEW

3.5B

8B

2023

2030

Over recent years, total investment in AI-mediated drug discovery
is $3.5 billion by 2023 – expected to reach $8 billion by 2030.
Source: Fortune Business Insight

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thereby enhancing efficiency and productivity,' Dirk Bontridder,
PerkinElmer's CEO said.
The Solution to Equity in Clinical Trials?
To address the limitations inherent in the traditional management ofclinical trials, decentralized trials and AI promise an opportunity fortransformation, as exhibited by our conversations with innovatorsin the field. Seema Verma, EVP and GM at Oracle Health and Life
Sciences, told us that the current state of trial management is 'remarkably manual,' characterized by 'extensive paper documentationand labor-intensive data entry processes.' This approach heightens
the risk of errors and hinders efficiency of trials, with a considerable
amount of time spent on data handling. Julie Ross, president andCEO at Advanced Clinical, asserts that 'the next significant challenges
in clinical trials revolve around leveraging AI and business process
automation. As we move towards decentralized trials, the focus is
on making trials more accessible to patients in diverse locations.'
Decentralization in clinical trials not only enhances the efficiency
and scalability of data management but also fosters greater diversity
among participants, as it breaks down geographical and logisticalbarriers, enabling a more representative cross-section of the population to contribute to and benefit from research. This is not aminor point. Looking at the diversity statistics of clinical trials: 'inall the medications approved by the FDA in 2020, the clinical trial
participants were: 75 percent White, 11 percent Hispanic, 8 percent
Black African American, 6 percent Asian. Only 30 percent of theparticipants were over 65 years of age and more than half of thepatients were located in the US' (Teva Pharma). Consequently, if
clinical trials with integrated AI could reduce the number of participants needed in placebo arms (referring to a group of participants
who receive a placebo instead of the active treatment) and utilize
data-driven approaches to streamline trials, these percentages could
become increasingly balanced.

AI APPLICATIONS

DR. DIEM NGUYEN | CEO, SIGA TECHNOLOGIESThe dual nature of AI and biotechnology present
significant benefits and risks. While thesetechnologies have led to many advancements invirus sequencing and treatment development,
they can also pose a threat if used malevolently.

PRIYA ABANI | PRESIDENT & CEO, ALIVECOR

AliveCor has incorporated a network of forwardlooking cardiologists into our platform to facilitate
tele-appointments between these specialists andour users. This service began modestly with only
a handful of appointments each month but has
seen significant growth into the triple digits.

JOSEPH DEVIVO | PRESIDENT & CEO,BUTTERFLY NETWORK

Telemedicine is integral to our vision of healthcare's future, where patients can perform scansat home with professional oversight from afar.
Our clinical studies have shown promising results
in self-scanning by patients under telemedical
guidance, moving us closer to a world where
health care is more accessible and immediate.

JASON GOREVIC | FORMER CEO,TELADOC HEALTH

The growth in our mental health business reflects
the pent-up demand in this sector. Our platform
addresses challenges like navigating the healthcare system and the stigma associated withseeking mental health care.

ANTHONY COSTELLO |CEO,MEDIDATAMICHAEL STOMBERG | CEO, PROPHARMA

No amount of technology can replace trust in the clinical
trials process. We need to bridge the gap between the vast
amount of data patients create in a lifetime and the tiny fraction of those data used in clinical trials today. This can only
be done with the right combination of technology and trust.

It is crucial to underscore that while AI opens up
unprecedented possibilities, it does not replace
the need for human expertise. The real value
lies in combining AI's capabilities with the deep
domain knowledge of our professionals to ensure
the highest quality outcomes.

READ THE FULL INTERVIEWTHE NEW ERA OF LIFE SCIENCES 2024

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THE NEW ERA OF LIFE SCIENCES 2024

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This new format of decentralized clinical trials is being implemented by Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry. CEO,
Anthony Costello, told us that 'patients now participate actively
from their locations, contributing data through mobile phones andwearables, significantly changing the landscape of data collection andincreasing the authenticity and applicability of clinical trial data inreal-world settings.' Additionally, Costello explained that 'recently
we have focused on harnessing AI to leverage data from the 33,000
trials we have conducted, which aids in optimizing trial designs andoperational efficiency.'
Verily, Alphabet's health technology branch, is also dedicated to making
clinical research easier for its biopharma clients. Verily Viewpoint,
part of the company's suite for enhancing clinical research, includes
services aimed at optimizing clinical trials through technology. 'This
encompasses patient recruitment, consent processes, and clinical trial
management. Viewpoint, also includes Workbench, which connects
data providers and researchers on a collaborative health care data
platform for analysis and insights and, exemplifies Verily's innovative
approach to clinical research, enabling more efficient, data-driven
studies,' Verily's Chairman and CEO Stephen Gillett told us.
The Bones of Innovation
As we witness the exponential advances made through software,
hardware advancement seen in robotics, glucose monitoring andother medical devices craft the bones of the life sciences. Globus
Medical, originally focused on spine health, has expanded its influence into orthopedics and trauma care. With the advent of robotic
technology, surgical procedures have undergone a transformation,'revolutionizing the field by providing surgeons with high precision
tools for tasks like pedicle screw placement, allowing them to focus
more on patient care rather than the technical aspects of surgery.'QUENTIN BLACKFORD |PRESIDENT & CEO,IRHYTHMTECHNOLOGIESIn the next five years, I envision iRhythm playing a pivotal
role in detecting, predicting, and preventing disease on a
global scale. While our initial focus was on cardiac health,our future includes expanding into adjacent markets likesleep disorders, hypertension, and heart failure.
READ THE FULL INTERVIEWDan Scavilla, CEO of Globus Medical, told us. Similarly, Zimmer
Biomet is making strides in the integration of robotics to the fieldof extremities care. The company's ROSA Shoulder system is theworld's first robotic-assisted surgery system for shoulder replacement, according to the company's CEO. Their hardware devices are
not only advancing per se, but also by connecting to the cloud andleveraging the power of interconnectivity. As president & CEO, Ivan
Tornos, told us, 'Virtually all products in our portfolio either collectdata or feed data to the rest of the interconnected ecosystem of care.
With partnerships with Apple and Microsoft.'
A company that was founded with the very idea of applying AI to
medical devices, and as early as 2006, is iRhythm Technologies. Its
objective is to provide a more effective alternative to the traditional
Holter monitor, which is a wired portable electrocardiogram (ECG)
that records the electrical activity of the heart for up to 48 hours.
IRhythm's device, called Zio, is a patch ECG monitoring device
designed to be worn continuously for up to 14 days. 'We know thatmany cardiac arrhythmias are missed with the Holter monitor due
to the limited time in which they are worn by patients. Our device
outperforms the conventional Holter monitor in effectiveness andconvenience, backed by substantial clinical data—helping physicians reach a definitive diagnosis and decrease time to treatment,'iRhythm's president & CEO, Quentin Blackford, told us. The data
Blackford refers to is analyzed by iRhythm's FDA-cleared AI algorithm, compared against a database of various arrhythmia readings,
validated by trained cardiac technicians and presented to physicians
as an actionable report.
Another illustration of the integration of hardware and softwarecomes from one of the leaders in thrombectomy devices, Penumbra.
The company has developed tools which, with computer assistance,
can remove blood clots much more seamlessly. As Penumbra's
Co-Founder & CEO, Adam Elsesser, explained, the traditional, manualapproach often involved significant blood loss as well as the risks
coming from the intervention of a human hand. 'Lightning Flash andLightning Bolt 7 represent significant innovations in thrombectomy
by improving the efficiency and safety of blood clot removal. These

12.3B

65.6B

2023

2032

Health care Robots Market Size:estimated growth at a CAGR of 18.4 percent
Source: Acumen Research and Consulting
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computer-assisted vacuum thrombectomy technologies are built
on the concept of mechanical clot removal, which is becoming
preferable to drug-based methods due to the latter's risk of bleeding
and the necessity for careful monitoring. Our approach, focusing on
aspiration, aims to maximize safety, speed, and simplicity and avoid
damage to the delicate structure of the blood vessels,' Elsesser said.
Both Lightning Flash and Lightning Bolt 7 employ sophisticatedalgorithms to recognize the difference between blood clot and blood
flow, making lives of both surgeons and patients easier.
Prytime Medical Devices is also bringing innovative tools to the aidof surgeons with the aim of minimizing blood loss. Its focus is severeinternal bleeding that is often the result of car crashes or war-related
traumas. The Texas-based company's CEO, David Spencer, shared:'The challenge with internal bleeding, especially in the case of severe
trauma, is that traditional exploratory surgery to locate and address
the source of bleeding has a high mortality rate.' To address that,
Prytime has developed a tool called REBOA which involves inserting
a balloon catheter into the aorta through a small incision in the leg,
effectively blocking blood flow to control hemorrhage and maintain
vital blood supply to the heart, lungs, and brain. 'This approach significantly reduces the invasiveness of the procedure and increases
the chances of survival by preventing further blood loss,' Spencer told
us. The REBOA technology is notably used in Ukraine. 'The inabilityof the Ukrainian military to evacuate casualties quickly due to drone
threats has made our technology crucial for providing soldiers with achance to survive by 'turning down the faucet' on hemorrhage, thus
buying time for medical intervention,' Spencer shared, noting thesimilar urgent necessity in civilian car crash cases.
Genes and Proteins
Next Generation Sequencing (NGS), having revolutionized thestudy of the human genome, may be a familiar term by this point.
We spoke with a Japanese start-up, Mitate Zepto Technica, which,through the use of semiconductor technology, claims to be able to
make DNA analysis up to a hundred times cheaper. 'Traditionally,
analyzing DNA sequencing data necessitated outsourcing or the useof supercomputers, a process that could take weeks and was prohibitively expensive,' Keisuke Harashima, Mitate Zepto Technica's
CEO shared. Still in prototype phase, the company aims to launch its
technology in early 2025. Simultaneously, proteomics, the study ofproteins, has not received the same amount of attention as genomes.
Proteins are coded by genes. There are 20,000 genes in the humangenome, and these create over 1 million proteins that comprise thehuman proteome. Our understanding of the proteome is pivotal, since
this could allow for a deeper understanding of biological processes,

ADAM ELSESSER |CO-FOUNDER & CEO,PENUMBRA

Our goal is to significantly expand access to CAVT so patients [with blood clots] are able to get more advanced
treatment quickly, potentially resulting in better care.
READ THE FULL INTERVIEW

leading to insights into the mechanisms of diseases, such as Alzheimer's, whose progression can be traced via proteomic signatures.
Omid Farokhzad, a pioneer in the field and a Founder of Seer, told
us: 'Seer was founded to address the key challenges faced in thefield of proteomics, with the aim to elevate our understanding andtechnological capabilities up to par with those of genomics.' He is
certain that advancements in proteomics like the Proteograph are
yet to reveal many previously unknown biological insights. Referringto the company's analytical device, the Seer Proteograph, Farokhzad
added: 'Since the introduction of our product, the tools at the readyfor scientists to analyze the proteome have significantly advanced.
We have moved from being able to analyze a few hundred proteinsin a handful of complex samples, such as plasma, to detecting up to
10,000 proteins in plasma and conducting studies with thousands ofsamples.' Seer has already announced important partnerships withcompanies like Thermo Fisher and SpaceX.

DAVID SPENCER |PRESIDENT & CEO,PRYTIME MEDICALDEVICES
Prolonged REBOA buys physicians time, meeting alarge unmet military and civilian need in advanced
hemorrhage control. Physicians in Ukraine are using
pREBOA-PRO️ to transport their soldiers to safety, while
U.S. physicians are documenting 4X more time to treat
their hypotensive patients.
READ THE FULL INTERVIEWTHE NEW ERA OF LIFE SCIENCES 2024

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Alzheimer's:
Approaching a Cure

KEISUKE HARASHIMA |FOUNDER & CEO,MITATE ZEPTOTECHNICA
Our innovative device completes genome analysis in justfive minutes at a fraction of traditional costs. This techno–
logy not only speeds up DNA calculations but is also set tosignificantly lower operational expenses, making genomic
medicine more accessible and cost-effective globally.
READ THE FULL INTERVIEW

Enhancing Diabetes Management
According to the World Health Organization, approximately 422
million people suffer from diabetes, of which Americans represent
37.3 million. The prevalence of diabetes is rising steadily, disrupting
the lives of those diagnosed by demanding both management andmonitoring, according to the Centers for Disease Control. Yet, thistask has become much simpler through innovation in monitoring
systems. A glucose monitor features a sensor that goes easily inserted
beneath the skin, where it can measure glucose levels in the fluid
around cells. The sensor then generates an electrical current basedon the glucose concentration, and the monitor then translates thiscurrent into a readable glucose value.
Before the development of glucose monitors, people with diabetes
primarily relied on urine glucose tests to manage their condition.
As Timothy T. Goodnow, president & CEO at Senseonics, explains,'CGM (Continuos Glucose Monitoring) represents a leap forward indiabetes management, providing continuous glucose readings thatoffers the user a dynamic view of their glucose levels in real time.
This technology moves beyond traditional finger-stick tests, offering glucose data every five minutes'. Goodnow further highlighted
the future direction, stating that 'innovations will aim to further
reduce the management burden on people with diabetes by eliminating external components and integrating directly with personal
devices for seamless glucose monitoring.' Similarly, the presidentof Ascensia, Rob Schumm, emphasized the role of software integration, 'The company's cloud-based solutions and partnerships aim toprovide a more cohesive and user-friendly experience, allowing forreal-time data sharing with health care providers and caregivers,
thus improving disease management.' Once again we stumble upon
the recurring trope interconnectivity, enabling predictive analytics
and real-time data sharing, and rendering diabetes management far
simpler for millions.
This pace of innovation keeps on increasing; AI is speeding up drug
discovery, and cloud-based systems provide an interconnectivity ofelements that were previously impossible to connect. And then thereis the hardware—robots that bring precision to surgeries that wereonce fraught with greater risks. These advancements represent big
leaps—maybe too big for us to fully understand just yet—towards
a future where health care is radically faster and more integrated
than ever before.

Prevalence and Economic Impact
Alzheimer's slow impairment of memory and cognitive functions
continues to divide the wider scientific community, given the disease's
complex nature, involving a mix of lifestyle, genetic, and environmental
factors. Seven million Americans grapple with Alzheimer's, according
to the Alzheimer's Association. In view of an aging population andextended life spans, the figure is projected to double by 2050. The
financial toll is equally impactful, as Alzheimer's care is expected tocost $360 billion in 2024 according to the Alzheimer's Association,rising to nearly $1 trillion by 2050​​.
However, investors are also up to the challenge. There has been anotable shift in investment focus towards neurological disorders inrecent years. Previously, the sector was known for the hesitancy it
caused in investors, who had spent billions in research on diseases
like Alzheimer's that brought little progress. But recent breakthroughs
have changed this, transforming the sector into one of the mostpromising and attractive investment areas.

REGENERATIVE MEDICINEROBERT LANGER | INSTITUTE PROFESSOR, MIT

Tissue engineering and regenerative medicine,which I have worked on extensively, offer
ways to create human-compatible tissues andorgans. While the prospect of using animalorgans, such as pig hearts, presents an intriguing solution to the organ shortage crisis, I do
not believe it will replace other approaches.
Instead, these technologies will likely coexist.
ABDULKADER RAHMO | PRESIDENT & CSO,SMSBIOTECH

Unlike conventional stem cell therapies, which
typically involve the differentiation of stem cells
into specific cell types, SMS cells stimulate the
body's endogenous cells to regenerate tissue.
This approach ensures the regenerated tissue
is fully compatible with the host, avoiding
potential immunological issues associated withforeign cells
LAURA NIKLASON | PRESIDENT & CEO,HUMACYTE GLOBAL

Our therapeutic product, the Human Acellular
Vessel (HAV), uses human cells to create replacement tissues. This technology leverages abioreactor process that mimics the human body's
environment, enabling us to grow engineered
arteries that can treat various vascular diseases.

READ THE FULL INTERVIEWS

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Innovative Treatment Approaches
Japanese giant Eisai, has recently been in the spotlight thanks to thelaunch of LEQEMBI, designed to target and clear the infamous amyloid
beta plaques, known for their strong association with Alzheimer's disease and contribution to neurodegeneration and cognitive decline. Paul
Hawthorne, Executive VP and chief Business Officer, told us about thesignificant benefits of their new treatment, stating that 'we estimate thatover 10 years cumulatively, the gradual adoption of LEQEMBI treatment
at this pricing approach could give back about 60 percent of the potential
positive social impact of several tens of billion dollars to the U.S. society.'
These savings would come from the treatment's positive effects, such as
improving health outcomes and reducing health care costs. Martin Tolar,
president & CEO at Alzheon also highlighted advancements in treatment
options with their drug ALZ-801, noting, 'We have completed enrollment forthe pivotal APOLLOE4 Phase 3 clinical trial of our novel oral medication,
ALZ-801/valiltramiprosate, which as our data have shown, avoids certain
adverse effects, such as brain edema and microhemorrhage, that have been
seen with other treatments'​​. This promising drug candidate might be out
in the market very soon, as Tolar told us that they 'expect to complete
the pivotal Phase 3 trial this year and aim for regulatory approval shortly
thereafter. If all goes according to plan, ALZ-801 could be available in the
U.S. by 2025.' Another notable example in the field is that of Sinaptica
Therapeutics, which specializes in personalized neuromodulation, a novel
approach to Alzheimer's treatment. Ken Mariash, CEO, explained their
therapy, which has completed a Phase 2 trial, to us: 'Our patented new
Alzheimer's treatment is based on precision non-invasive brain stimulation, using high-powered magnetic fields to induce electrical currents inthe brain. The study demonstrated an 82 percent slowing of Alzheimer's
progression on the primary endpoint, using a painless treatment with
virtually no side effects'. These new approaches considerably minimize
adverse effects, slowing the progression of Alzheimer's and offering patients better coexistence with the disease. Though the ultimate cure for
Alzheimer's remains hypothetical, these new developments offer hopefor patients that so desperately need it.
An Answer to the Mental Health Crisis?
The mental health crisis seems to be an epidemic, with 'one in eight people
worldwide suffering from a mental disorder,' according to the World HealthOrganization—a figure exacerbated by the COVID-19 pandemic. As CEO
of atai, Florian Brand, told us, mental health issues 'include a range ofconditions such as depression, addiction, and anxiety.'
Amidst this unprecedented epidemic, you might have noticed a resurgenceof interest in psychedelic treatments, particularly psilocybin, for conditions
such as treatment-resistant depression. A historic study by Johns Hopkins
in 2006 has revitalized the field: It was the 'first research since the 1970s toadminister a classic psychedelic (psilocybin) to drug-naïve participants.' The
study revealed that 'psilocybin led to profound experiences that 67 percent
of participants rated as among the top five most meaningful experiencesof their lifetime.' Additionally, 'the single psilocybin session led to positivechanges in moods, attitudes, and behavior for 14 months (and possibly
longer), with 64 percent indicating the experience increased well-beingor life-satisfaction.' The research also 'established the safety of high dose
psilocybin administration,' showcasing its potential for profound therapeutic
impact. (Hopkins). In response to these promising developments, companies

THE NEW ERA OF LIFE SCIENCES 2024

KEN MARIASH |CEO, SINAPTICA
This Phase 2 trial showed 80 percent+ slowing of
Alzheimer's progression on gold standard cognitive andfunctional endpoints using non-invasive neuromodulation, leading to Sinaptica's founding. I've never encountered placebo–controlled efficacy data as strong.
READ THE FULL INTERVIEW

LONG-AWAITED BREAKTHROUGHSJESSICA BALLINGER | PRESIDENT & CEO,LYNDRA THERAPEUTICS

Lyndra's approach fundamentally changes thetreatment paradigm for schizophrenia and bipolar disorder. Traditional treatments require frequent visits to health care facilities for injections.
Lyndra's oral dosage form, deliverable at home,
simplifies the treatment regimen to just once aweek, enhancing patient adherence.
MARTIN TOLAR | FOUNDER, PRESIDENT & CEO,ALZHEON

The challenge in identification and development of
new treatments has been immense, especially considering the long-standing reluctance of investors
to fund research in this area. However, our team's
relentless focus on understanding of the disease
process has led to significant breakthroughs
OMID FAROKHZAD | CHAIR, CEO & FOUNDER, SEER

The Proteograph's applications extend into various areas of health research. Collaborations
with institutions like Mass General Hospital
have enabled studies that trace the progression of Alzheimer's disease through proteomic
signatures, identifying proteins previously
unrecognized in the context of the disease.
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such as atai Life Sciences and Otsuka are exploring the therapeutic potentialof psilocybin, which, as Brand told us, 'works by inducing a neuroplasticity
burst, which forms new neural connections in the brain and supports thegrowth and survival of neurons.' The latest studies are demonstrating 'arobust evidence base for the potential efficacy of psychedelics in treating
mental health conditions, with promising response and remission rates
for even the most stubborn cases such as treatment-resistant depression.'
Furthermore, in relation to psychedelics, Japanese big pharma company
Otsuka has recently acquired psychedelic biotech Mindset Pharma for
Mindset Pharma for $59.1 million dollars. This move is particularly meaningful as it depicts a radical attitude shift from the big players on the field,
seeing potential in an area that was previously considered unfruitful anddangerous. Bearing in mind that no psychedelics—with the exception of
esketamine—have seen FDA approval yet, a move from big pharma into
the field, with its expertise and experience, might provide the final pushneeded for these new treatments to arrive in the market. Tarek Rabah,
CEO at Otsuka NA, claims that Otsuka is 'dedicated to advancing sciencein mental health care, exploring new treatment mechanisms, including thepotential of psychedelics to help treat psychiatric conditions and neurologicaldisorders with high unmet needs.' Caution is still advised by the medical
community, and drugs of the sort remain a taboo—exemplified by the factthat a person possessing at least 25 milligrams of psychedelic mushrooms oranother hallucinogen can face a possible sentence of up to 15 years in prison.
Despite the challenges and societal taboos associated with these substances, the significant investments by leading pharmaceutical companies
and the promising results from recent studies underscore a potentiallytransformative era in mental health therapy. This wave of innovation
could well provide crucial breakthroughs for those suffering from someof the most challenging mental health conditions, potentially reshaping
our approach to mental wellness in the decades to come.

Sabirnetug is at the forefrontof next generation AD thera–
pies, showing selectivity fortoxic a-beta oligomers in our
Ph 1 trial. With ALTITUDE-AD,
our Ph 2 trial, we're one step
closer to providing patientswith a differentiated treatment option.

DANIEL O'CONNELL |CEO, ACUMEN
READ THE FULL INTERVIEWSkin Deep: Advancements
in Dermatology
The skin is the largest organ of the human body, serving as a protective
barrier between us and the world. Yet, in this curious society of ours, theskin came to represent much more than its strict biological functions. As
noted by Frank Watanabe, president & CEO at Arcutis Biotherapeutics,'The skin, being a 'calling card' to the world, plays a crucial role in oursocial interactions and self-esteem.' The regulation and upkeep of important biological functions and the quest for aesthetics coexist in this area,
rendering dermatology a very particular field. The market dynamics areequally compelling. According to Almirall's Chairman and CEO Carlos
Gallardo, 'There is a wave of innovation in dermatology due to a deeper
understanding of disease biology and the introduction of biologics'.
A notable example of innovation in the field is that of Dermavant's
VTAMA cream, the first non-steroid cream on the market, which targets
the underlying mechanisms of plaque psoriasis—a chronic autoimmune
condition characterized by raised, red patches covered with a silvery
white buildup of dead skin cells. This cream, acting as an aryl hydrocarbon receptor (AhR) agonist, fosters skin homeostasis by downregulating
inflammatory mediators, without any of the negative side-effects that
often come alongside classic steroidal creams. Todd Zavodnick, CEO of
Dermavant Sciences, notes the significant adoption of VTAMA, with 'justunder 14,000 unique prescribers and over 300,000 units sold within thefirst 20 months. Frank Watanabe, President at Arcutis Biotherapeutics
also participates in the fight against psoriasis: 'Our lead product, ZORYVE(roflumilast) cream, is suitable for chronic use, and is specifically approvedby the FDA for sensitive skin areas.' These newer treatments promise toaddress the severity of the symptoms that affect patients' quality of life.

Source: Research and Markets

The global dermatology market will reach a valuation of $48bn by2027, and has been growing at double digit figures year on year
THE NEW ERA OF LIFE SCIENCES 2024

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At Dermavant, we want toestablish VTAMA cream as thefoundational therapy for plaquepsoriasis in adults and potentially, atopic dermatitis, if approvedby the FDA. Our goal is totransition the field from conventional treatments to innovative,
effective, and safe treatment
options, essentially moving fromthe 'cassette to digital music' era
in dermatological treatments.

Balancing Natureand Science
TODD ZAVODNICK |CEO,DERMAVANTSCIENCESREAD THE FULL INTERVIEW

Anti-aging solutions have also become a prominent trend across thelifesciences, spanning from supplements and nutrition to dermatology.
Allergan Aesthetics is pushing the trend further, with 'products that
contribute to this broader movement by focusing on local tissue aging,offering treatments that restore tissue function or create a more youthfulappearance at the site of treatment.' Darin J. Messina, Ph.D., Senior Vice
president, Aesthetics R&D, told us more about the science behind theirapproach: 'Focusing on stem cells, biomaterials, and growth factors, we aim
to restore tissue function through regenerative cues, enabling our body's
stem cells to rebuild damaged tissues. This approach is pivotal in bothaesthetic and therapeutic applications, showcasing our commitment toinnovation in regenerative medicine.' Through the use of these regenerative use of stem cells and biomaterials, Messina claims that their ultimate
mission 'is to empower confidence by evolving consumer perceptions
from vanity towards quality of life and youthful aging.

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A trend is emerging across the life sciences: that of 'returning tonature'. CEO Rob Fried of longevity supplement developer, ChromaDex, describes this period as 'marked by a contradiction where,
alongside health advancements, lifestyle factors such as consumptionof ultra-processed foods counteract potential gains in health.' In viewof this challenge, the dietary supplement industry has become oneof beacons of this trend, promising customers an enhanced well-being through the consumption of natural compounds. However, thesupplements industry operates largely without the typical oversightof pharmaceuticals, as the FDA does not require these products
to undergo pre-market approval. This means that the efficacy andsafety of supplements do not have to be validated through objective
and standardized scientific trials—even though some companies do
engage in stringent analysis of their products—before they reachconsumers. When bearing in mind that according to the Council
for Responsible Nutrition, 74 percent of U.S adults take dietary
supplements, 55 percent qualifying as regular users, the fact that
quality varies significantly, and products often do not deliver theadvertised benefits becomes very problematic. In this somewhat
chaotic context, some companies stand out by committing to scientific rigor and natural ingredients. Several supplements companies
are trying to use natural methods to tackle one of the biggest modern
challenges—overconsumption and obesity. Some of the most alarming
figures stem from this area. Worldwide, more than 1 billion people are

THE NEW ERA OF LIFE SCIENCES 2024

obese—650 million adults, 340 million adolescents and 39 million
children, according to WHO. The U.S. adult obesity rate stands at 42.4
percent, according to the National Institutes of Health. Furthermore,
worldwide adult obesity has more than doubled since 1990, andadolescent obesity has quadrupled, according to the World Healthorganization. Calocurb's Founder and CEO, Sarah Kennedy, told usthat 'navigating the modern world, filled with endless temptations,especially unhealthy food choices contributing to rising obesity andmental distress levels, presents a considerable challenge.' The New
Zealand-based company's research into evolutionary biology has
led to the discovery of a specific hop extract that curbs appetite bytargeting bitter taste receptors. As noted by Kennedy, 'Publishedclinical trials have shown a hunger reduction of 30 percent, craving
reduction of 40 percent and average calorie intake reduction of 18
percent after one hour.'
Nature's Sunshine Products, with its reach across 40 countries and a
product portfolio of over 600 items, is another example in the spaceof the nature-centric approach. As Terrence Moorehead, CEO, told
us, 'recognizing the diminished nutritional value in modern dietsand lifestyle factors contributing to poor health, we emphasize theimportance of gut health as foundational to overall well-being.'
Moorehead is mindful of the market it operates in, as he told us that'the primary challenge for Nature's Sunshine is differentiating itself
in a market saturated with companies that prioritize marketing overgenuine nutritional value.'
Supplement company LifeVantage focuses on the activation of the
body's natural processes: 'Modern lifestyles have diverged significantly
from our bodies' original programming, creating a 'perfect storm'
for not only increased oxidative stress, but a decline in function,
leading to numerous health issues. Our activation approach seeks tocounteract this by reactivating our body's natural processes, rather
than merely supplementing or putting a bandaid on the real issue,'
Steve Fife, president & CEO, told us. Fife emphasized the science
underlying their products: 'Our original focus on the NRF2 pathway,

Our success in addressing
significant challenges in rarediseases not only showcases
our commitment to making
a difference in patients' lives
but also sets the stage for
future breakthroughs.

MATTHEW B. KLEIN M.D. | CEO,PTC THERAPEUTICS
READ THE FULL INTERVIEWTHE NEW ERA OF LIFE SCIENCES 2024

The gut influences various bodily
systems through the gut-brain
axis, gut-skin axis, and its interaction with the liver and kidneys
in drug metabolism. It is a nexus
point for understanding and treating a multitude of health issues.

BEN SCRUGGS | CHAIRMAN AND CEO,ALTIS BIOSYSTEMSREAD THE FULL INTERVIEW

a critical area for managing oxidative stress, set us apart from thevery beginning by enhancing the body's response to stress beyond
what traditional supplementation offers.'
A story exemplifying the passion this sector can arouse in individuals and entrepreneurs is that of Rob Fried, CEO of ChromaDex.
Fried transitioned from successfully producing several Hollywood
blockbusters to the supplements space thanks to a vision of metabolic health and anti-aging playing a central role in the society of
the future; Fried did not see this as a trend, 'but as a reflection of adeeper, philosophical inquiry into the nature of life, death, and thehuman condition.'
The company's operations are heavily centered on the science ofNAD, a coenzyme critical to cellular repair and metabolic functions,which 'declines as we age, contributing to the aging process.' Fried
told us: 'My fascination with NAD and its potential in slowing aging
is rooted in its foundational role in cellular health and energy metabolism. ChromaDex's focus on NAD, particularly through its productnicotinamide riboside, aims to combat age-related decline in NADlevels, thereby addressing aging at a cellular level.' In simpler terms,
NAD tackles aging by addressing it 'at a cellular level.' According toFried, the feedback of users of their product span 'from miraculous
health recoveries in infants to improvements in cognitive functions inadults.' However, its widespread use faces some challenges, including'the dietary supplement industry's history of mixed messages andunverified claims, which has led to a general skepticism among consumers.' ChromaDex intends to distinguish themselves from thesecompanies through a 'commitment to rigorous scientific research,
regulatory compliance, and safety, setting us apart in an industry rifewith misinformation and questionable practices.'
Whereas the dietary supplement industry is criticized for its reliability,
companies such as the ones we have featured show a productive commitment to merging nature with science providing solid benefits. Theirwork bridges the ever increasing gap between our ancient biologicalneeds and modern lifestyle demands, setting a new standard for what
consumers can and should expect from trustworthy supplements.

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To be continued …
This report, woven from discussions with over a hundred pioneers
in the field, not only highlights the current innovations in personalized medicine, early detection technologies, and AI-enhanced drug
development, but also invites us to dream anew. The commitment
to fundamental, curiosity-driven research is not just a cornerstone,
but a catapult into future discoveries that may yet again surpass
our imaginations. At the end of our interview, Christopher Molloy,
Chancellor Emeritus at Rutgers University, spoke to the importanceof keeping true to this path, and we believe that in his message lies
the kernel of the scientific spirit: 'It is crucial to adhere to rigorous
scientific principles, communicate advancements clearly, and confront
disinformation. As we explore new frontiers, like artificial intelligence,
ensuring these technologies are developed responsibly and remain
under control is vital. Ultimately, maintaining a commitment totruth and ethical conduct in science will help society understandand address its challenges effectively,'
Working on the second edition of The New Era of Life Sciences hasbrought us the additional gratification that a fine work's serial nature
may entail—we have been delighted to have new and fascinating
voices join in, while observing the very real progress that most of
our past year's interviewees have made towards their respective
objectives. With this in mind, and given the undisputable nobilityof life sciences' overarching task—saving human lives—we are morethan looking forward to next year's edition when, hopefully, more
dreams will have become reality.

Despite common misconceptions, the aesthetic field isdeeply rooted in science, notmerely vanity. We prioritize
technologies that address unmet needs within the aesthetic
space, ensuring our offerings
stand out for their safety andeffectiveness.

DARIN J. MESSINA PH.D. |SENIOR VP, AESTHETICS R&D,
ALLERGAN AESTHETICS / ABBVIEREAD THE FULL INTERVIEW

177.5B2023

The global dietary supplements market size was estimated at
approximately $177.50 billion in 2023
Source: Grand View Research

INVESTMENTS AND RESULTS
PHIL MURPHY | GOVERNOR OF NEW JERSEY

Last year, companies with a footprint in New
Jersey accounted for more than 50 percent of
all novel drug approvals.
PETE SALZMANN | CEO, IMMUNOVANT

Immunovant has attracted significant attention
and investment from the market, highlighted by a$200 million investment from Roivant Sciences inAugust of 2021 and a $450 million capital raise in
October of 2023.
ARND KALDOWSKI | CEO, SONOVA GROUP

We have been pioneers in introducing rechargeability and full connectivity with Android and Apple devices in hearing aids. We are exploring the integration of AI and deep neural networks for enhanced
denoising capabilities directly in the hearing aids.
This would significantly improve the user's ability todiscern speech from background noise.
ROBERT BLUM | PRESIDENT & CEO, CYTOKINETICS

Aficamten demonstrated significant improvementsin patients with obstructive hypertrophic cardiomyopathy across all endpoints in a Phase 3 clinical
trial, including measures of exercise capacity, qualityof life and safety. These results represent a pivotal
moment for patients and our company.
READ THE FULL INTERVIEWS

THE NEW ERA OF LIFE SCIENCES 2024

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