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In what areas of pharma/biopharma are you most excited to see

increased adoption of artificial intelligence (AI) and machine


learning?
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Ed PHARMA'S
Roullard,ALMANAC
SVP of Marketing,
TV Operations, and IT, Actylis SIGN IN REGISTER

The potential use cases for AI applications in the pharma space are seemingly only limited by the creativity

of the industry. If news stories are correct, billions of dollars have already been invested within the industry

to bring AI to reality. We envision three different impacts.

The traditional industrial uses of AI — for supply chain visibility, supplier risk assessments, equipment

preventative maintenance, and even detailed production scheduling and so on — are the most likely to
mature first in the pharma space. As the industry levels up its digitalization, these application sets are the
most likely first entrants, with several key producers already building use cases in these areas. The
pandemic provided the impetus for this transition as all producers faced numerous supply chain issues and

shortages of excipients, APIs, and starter materials. It stands to reason that moving to AI-centered

platforms will bring the industry to new levels of productive efficiency, agility, and flexibility.

It is also easy to envision vast improvements in the business side of pharma organizations. For example, it
is very likely that predictive analytics will be part of the standard toolset used for market sizing. The vast

stores of demographic and population data, attitude studies, patient experiences, doctor conversion rates,
and so on can be leveraged to better estimate forecasts for a new drug. The irony of using AI to improve

the transactional intimacy with a potential end consumer should not be overlooked.

On the product development side, the rationale for AI is simple: it will dramatically advance drug

discovery and development. AI is exceptional at sorting and applying algorithms and rules to large

repositories of data (studies, chemical compounds and molecular structures, patient information, etc.); this
will create exceptional efficiencies in how the industry designs molecules. With several AI-developed

drugs already in the pipeline, it is hard not to see AI as a dramatic step change for the industry.

Marius Draeger, Senior Chemist, Alconox, Inc.

A wide-reaching and surprisingly subtle technology, such as AI, which is already affecting our lives to a

much larger degree than most of us are aware of, is hard to predict — especially in the areas of pharma and

biopharma. With the ever-increasing arsenal of documented chemical reactions, I believe a primary
function of AI will certainly be to sift through the literature to find ways of making as-of-now inaccessible

pharmaceuticals or to find new routes to make existing pharmaceuticals in more cost-effective ways.

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Current AI-based
PHARMA'S synthesis TV
ALMANAC planning tools leave a lot to be desired, and I am excited
SIGN INto seeREGISTER
how future
algorithms can make the overwhelming task of planning a multi-step synthesis more streamlined. While of

course much more limited in scope, in our own work at Alconox Inc., we are also looking to apply AI to
optimize detergent selection in order to improve service to our varied industry customers. Although AI is

quite powerful, it still requires human oversight. Thus, while we are excited for the possibilities AI offers,

we pride ourselves in our customer service and will always put you directly in touch with myself or one of
our other Alconox technical support experts.

Ben Josey, Ph.D., Field Application Scientist, Corning Life Sciences

The applications of AI in general are exciting and a bit terrifying. While the applications for AI in the
biopharma field are seemingly endless, I am most excited about the utilization of AI in the real-time

monitoring and analysis of clinical trial data in combination with advanced omics technologies, enabling

newer “dynamic” clinical trial designs; and connecting this analysis to everything from improving patient
recruitment, avoiding obstacles in the regulatory approval process, and even feeding back into guiding and

streamlining discovery efforts. This entire section of the field generates incomprehensible amounts of data
within relatively defined constructs; and this is exactly where AI and machine learning really excel —

processing, recording, and identifying trends in enormous data sets within closed systems.

Sebastien Latapie, Principal, Dynamk

It’s great to see increasing adoption of AI and machine learning (ML) tools throughout the life sciences.

One area where we believe there is a lot of promise is in the bioprocessing space. These tools are enabling

improvements in strain selection, process optimization, scale-up, and control strategies for commercial-
scale production. These can help drive improvements at many different stages and hopefully drive down

costs of manufacturing.

Additionally, AI and ML tools are well suited to make sense of increasingly large and complex data sets

with many applications in earlier stages of R&D. Today, target identification is rate-limited by what we can

measure and disease models. As improvements in measurement technologies and automation allow for
higher throughput and multiplexed approaches, AI and ML can help us gain insight from information that

is simply too complex for humans to process alone. Taken together, these will continue to accelerate the

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design–test–learn cycle andTV


PHARMA'S ALMANAC drive faster time to market for bioproducts. SIGN IN REGISTER

Martin Akerman, Ph.D., Chief Technology Officer and Co-Founder, Envisagenics

From early drug discovery to human trials, companies use AI/ML to deliver intelligent solutions to

decrease timelines and lower failure rates — improving patient outcomes more quickly.

AI/ML in target discovery is critical because it is the genesis of drug development. In this early 21st
century, there has been a significant increase in new drug modalities, such as immuno-oncology (e.g.,

CART-T, bispecifics) and RNA therapeutics (e.g., ASO, RNAi). We often see the same targets used for
multiple drugs and across many indications. Recycling old drug targets is problematic as they were not
developed in the context of new modalities. Therefore, we must find new optimized drug targets.

At Envisagenics, we use AI/ML to discover and develop immunotherapies and RNA therapeutics using

transcriptomics data. We analyze thousands of RNA-seq samples to identify druggable and tumor-specific
neoantigens for oncology and RNA splicing modulators for neurodegenerative diseases. We qualify target

specificity and safety during the discovery process. In conventional drug discovery, these attributes are

evaluated at a later stage — wasting time, resources, and money. Through AI/ML, we deliver novel
candidates for modern modalities in a fraction of the time, while de-risking drug assets earlier to increase

the probability of clinical success.

Muctarr Sesay, Chief Scientific Officer, GBI Bio

AI and machine learning play a critical role in the biopharma industry. The best use cases for these

technologies are drug discovery, drug manufacturing, diagnostic assistance, and optimizing medical

treatment processes. Over the years, biologics drug discovery in oncology, chronic, rare diseases, and
personalized medicine (such as theranostics) has become increasingly competitive and expensive, which

has driven pharmaceutical companies to look to AI as methods to reduce research and development costs
while avoiding costly errors.

AI has a great potential to transform drug discovery by accelerating the R&D timeline to make drugs more

affordable and improve the probability of U.S. FDA approval. AI and machine learning algorithms can
identify appropriate biomarkers and innovative molecules that may have failed in mid- to-late clinical trials

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populations or how the drug could be repurposed to enhance patient health in other diseases, particularly in

cancer and chronic diseases, which are leading causes of death in the United States.

In the process development and manufacturing of biologics sector, AI can provide various opportunities to
improve processes. This includes but is not limited to performing quality control testing of the drugs during
in-line manufacturing processes, as well as maintenance of batch-to-batch consistency, reducing material

waste, reducing production failure rate, and enabling faster production and more consistently meeting the
product critical quality attributes (CQAs). The development of predictive biomarkers for better screening
and diagnosing patients is continuing to be a key emerging area of AI application. Furthermore, machine

learning can help forecast and prevent over-demand and under-demand, as well as fix supply chain
challenges and failures during product manufacturing.

With increasing complexities of biologics drugs and manufacturing processes along with increasing

demand for efficiency and better product quality, modern manufacturing systems are endeavoring to confer

human knowledge to AI and machine learning. AI and machine learning tools becoming more accessible in
the coming years will facilitate faster and cheaper drug discoveries, manufacturing, and commercialization,

thereby becoming part of the natural process in the biopharma industry — not only for the large multi-
national companies but also mid-sized to small pharmaceutical companies and CDMOs.

Michael Kallelis, Chief Executive Officer, Mikart

The increased adoption of AI and machine learning holds significant promise in several areas of the
pharmaceutical and biopharmaceutical industry. An exciting contribution that AI can make is to offer

proven solutions to technical challenges and quality investigations. In drug discovery and development, AI
and machine learning can assist in identifying potential drug candidates, predicting their efficacy,

optimizing molecular structures, and reducing the time and cost of the drug discovery process. Today, we

all start from scratch when it comes to problem-solving. We rely on a small group of individuals that a
company employs to formulate solutions to given problems, whether these problems are in R&D,

manufacturing, or compliance. As a result, the approach to resolving an issue is predetermined due to the
experiences of the small group. Some in the group may have worked in the industry for many years, while

others may be early in their careers and have less experience to offer. The random competence of a group

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means that someALMANAC


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situation can repeat itself and become costly or impact patient safety. With AI, tapping into a vast pool of

industry-wide knowledge becomes possible. There would be no need to reinvent the wheel for a particular
OOS investigation or to determine if a process deviation is harmless or will result in an unacceptable

stability profile. We all become more competent faster, and product quality and patient safety will

significantly improve over the status quo — whether the industry will willingly share such experiences for
global use or whether companies will see such knowledge as proprietary to maintain a competitive edge.
Such ability improves the performance and image of our industry, which is committed to manufacturing
and administering safe drugs to a needy patient population. Proprietary knowledge is best kept at the drug

discovery and rational design level, not for compliance or process deviations.

Chris Wiedel, Chief Business Officer, Nu-Tek BioSciences

Using AI as a predictive method to produce critical raw materials would be very exciting. To be able to
take historical data from raw material production and link it to final drug output would be incredible.

Understanding the variation in production throughout an entire process should enable more efficient
production and ultimately cost savings. It should also enable us to identify the impact of a raw material like

ours on other processes further down the line. The AI could be able to use all the data to create a model
without bias or conflicting theories. The model could then help dictate operating parameters starting from

critical raw materials to finished drug production.

Shawn Cain, Senior Vice President of Development and Manufacturing, PCI Pharma
Services

Ultimately, AI is about increasing the cycles of innovation that improve the discovery, design, and delivery

of the therapies to patients.

The obvious use for AI within the pharma industry is upstream in the early-phase drug discovery and

screening process, where many drug candidates/molecules are evaluated to determine which candidates

would be selected for clinical testing. Currently, it is common to screen thousands of potential candidates to
get to a targeted product for a particular indication. Being able to compile all the data and feed them into an

AI engine should significantly reduce the number of candidates by utilizing the learning nature of AI and

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determining
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valuable in developing and executing predictive models. This type of data analysis would go well beyond

the tried-and-true design of experiments (DOE) approach and has the potential to significantly decrease
development timelines and costs.

However, we are most excited to explore the potential for AI in the downstream processing that a CDMO
like PCI Pharma Services engages. We see potential in feeding all the experimental data from formulation

and lyophilization cycle development into AI engines to again reduce the number of experiments and
process parameters by learning and projecting likely successful parameters to establish stable
manufacturing conditions. These tools could also be used in the more efficient running of our equipment,

from fill machines to lyophilizers. Once again, if we have data from each and every run compiling the
products information, viscosity, surface tension, density, charge, etc., along with the types of materials used

in their processing (e.g., tubing bags, fill needles) the hope is that we will materially decrease the
development lead time and save our clients and the healthcare system significant cost.

Another very practical application of AI is its ability to increase quality and mitigate risk. Inspection
systems, as an example, are an excellent use of AI principles, and we already see significant breakthroughs

in the advancement of inspection technologies. With the deployment and progression of AI solutions,
technologies can learn and become far more robust in their ability to view and interpret potential defects

and their relative severity. Furthermore, PCI has implemented cobot technologies for certain manufacturing

and packaging applications. Application of cobots certainly brings ergonomic and safety benefits, but these
learning robots can add significantly more value as smart solutions, as both inspection and control

mechanisms, and as affording real-time data capture for process analytical technologies (PAT). The
coupling of cobots and machine learning inspection systems opens tremendous value in optimizing

manufacturing and packaging operations.

Ihab Judeh, Ph.D., Marketing Director, Porton Advanced

AI and machine learning enable personalized treatment approaches by analyzing individual patient data,

including genetic information, medical records, and lifestyle factors. These technologies can identify
biomarkers, predict disease progression, and recommend tailored treatment plans, improving patient

outcomes and reducing trial and error in treatment selection. These technologies can analyze large data

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sets,PHARMA'S
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researchers narrow down the search space and identify potential therapeutic candidates more efficiently.It's

important to note that while AI and machine learning hold great potential in these areas, their adoption is
still ongoing, and there are challenges to address, including data privacy, regulatory considerations, and

ethical implications.

Jiwoong Park, Senior Specialist in Process Innovation, Samsung Biologics

When coupled with machine learning and predictive analytics, the AI transformation has the potential to
address some of the biggest challenges in the biopharma supply chain. Within the process innovation group
at Samsung Biologics, our responsibility is to continuously look for opportunities where we can optimize
the overall supply chain management process.

There is currently an overall lack of agility in pharmaceutical supply chains; AI-based technologies could
provide complete visibility with predictive data and enable us to conduct much thorough but faster data

analyses, which could forecast potential issues at the early drug production stage and prevent production

delays or errors. This means we can predict hurdles and therefore properly allocate resources, which would
significantly reduce logistics costs and gaps in the pipeline.

Trond Erik Vee Aune, Ph.D., Chief Executive Officer and Co-Founder, Vectron
Biosolutions

One of the most challenging of the remaining questions in gene expression research is how gene sequence

information translates into protein function. The advent of structure prediction software, like AlphaFold,

has to a large extent solved the problem of predicting protein structure from gene sequence data, but we are
still far away from being able to predict protein function from gene sequence data or even from protein

structure. If computational methods like AI can improve the predictability of structure/function models, it
would not only reduce the need for experimental testing of the function of new proteins, but it would also

greatly facilitate rational design of proteins. In turn, this would vastly simplify drug discovery, allowing

biotech companies to perform in silico design of novel proteins for specific purposes to a much greater
extent than today rather than screening for natural proteins with the desired function.

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Ryan Thompson,
PHARMA'S Industry
ALMANAC TV 4.0 Senior Specialist, CRB SIGN IN REGISTER

I’m most excited about the improvements to the manufacturing processes. Biologics, and in particular

personalized medicines, are a challenge due to their high degree of variability. But given enough data,

advanced analytics will be able to provide incredible insights. Not just on the process control side, but

really in how the whole facility operates. By analyzing business data, lab data, process data, and people
data, the combination of predictive and generative AI tools will give our industry new ideas on how to
organize and operate our facilities.

Of course, drug discovery has been and will continue to be greatly impacted, and this is where the bulk of
capital is being allocated right now. This is exciting too, but I think one of today’s biggest challenges facing

biologics manufacturers is scale and cost of goods. AI and machine learning (ML) are much more powerful

than people in generating insights from large amounts of unstructured data. With manufacturers continuing
to build robust data platforms and building the infrastructure to begin making these insights, I think the

progress we will make in the near term will be more than impressive.

I am also very excited for the unknown. AI was always a pillar of Industry 4.0, but even five years ago I’m
not sure we could imagine the impact it is having today. If you ask me this question in another few years,

my answer may be completely different.

Raj Indupuri, Chief Executive Officer, eClinical Solutions

There are many opportunities for AI/ML across the entire clinical trials value chain, but in terms of

adoption what’s most exciting right now is seeing AI/ML applications that can help us scale and manage

some of the most challenging and time-consuming facets of managing the clinical data in trials. Everyone
across the industry is looking for cycle time improvements and efficiency gains. Clinical data is the

currency of life sciences, but, historically, manual methods have persisted within the data processes of
clinical development. As the volumes of data being collected from patients grew, it became unscalable to

manage those data without applying advanced approaches in data science like ML models or AI. Now we

are in a place where interest and intent in AI is being matched with heightened adoption of approaches that
are available today. Using AI models, we can automate data review to identify data quality issues and

augment the work of data reviewers so that they can identify some of the issues that would have taken
significant time otherwise. AI can detect outliers and data issues and quickly surface these as outputs that a

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dataPHARMA'S
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address these incredible numbers of individual data points. Applying AI to these clinical data use cases will

create efficiencies and decrease cycle times across clinical trials.

Jim Corson, Ph.D., Vice President of Life Sciences, Enthought

Most companies are striving to adopt AI and machine learning capabilities to accelerate their biopharma
discovery engines. Early adopters are identifying new potential targets for drug development and designing

new compounds using AI to augment research expertise and intuition in ways never seen before.

We’re already seeing with our customers how this technology is advancing the design of small molecule
compounds and therapeutics for neurological disorders. It will be very exciting to see even better

predictions of efficacy and potential side effects using real-world patient data. Neurological disorders are
extremely complex, and beginning to understand the root cause of these disorders by combining genomic
and proteomic data with our increasing understanding of brain physiology and microanatomy can allow

researchers to design more targeted therapeutics with increased efficacy and fewer side effects.

Amyotrophic lateral sclerosis, Huntington's disease, Alzheimer's disease, and Parkinson's disease are all
devastating disorders with no known cures. Current treatments can slow the progression and manage

symptoms of these diseases, but there is so much left to learn about the underlying causes and mechanisms.
AI and machine learning can integrate and analyze the vast amounts of data being generated about these

diseases giving us new insights to develop more advanced treatments and eventually cures.

Cristina Varner, Senior Vice President and National Life Science and Digital Health &
Telemedicine Practice Leader, Newfront

The potential applications of machine learning in pharma/biopharma are vast, and the technology is likely

to transform the industry in the years to come. Like many industries, the life sciences industry overall
needs to continue to evolve and improve efficiencies. Machine learning can help optimize clinical trials by

identifying patient populations that are most likely to respond to a particular therapy. AI algorithms can

help identify and screen patients who are suitable for clinical trials by analyzing large data sets and
electronic health records. The algorithms can match patients with specific eligibility criteria and engage

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themPHARMA'S
through online platforms,
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potentially be useful in streamlining the variability and complexity of clinical trial insurance. AI can

monitor patients remotely, eliminating time-consuming and costly regular hospital or site visits. AI has the
potential to improve the efficiency, accuracy, and safety of clinical trials by optimizing various processes

from recruitment to patient monitoring and data analysis.

Joseph Zabinski, Ph.D., Managing Director of AI & Personalized Medicine, OM1

I’m most excited to see AI and machine learning moving from buzzwords in healthcare to real-world
applications powering personalized medicine at scale.

Traditionally, even though we know patients’ medical records provide tremendous insight into how their

conditions evolve over time, much of that richness has been inaccessible. AI and machine learning have
allowed us to identify patterns within these real-world data at scale, associated with outcomes we care
about — presence of a rare disease, for example, or risk of rapid progression. With this information, we can

build a “digital fingerprint” for patients we’re focused on, and then use that fingerprint to compare patient

records in new data sources. This approach lets us bring another buzzword — personalized medicine — to
the forefront of clinical care. By applying AI calibrated using larger data sets to a single patient’s data,

clinicians can run digital assessment panels for multiple outcomes at once and help with point-of-care
decision-making around diagnoses, treatments, and even clinical trial participation, based on analytically

rigorous risk-benefit predictions. For life science companies, this personalization helps highlight patients

who could benefit most from available treatments and also spotlights areas of greatest unmet need for
future development.

In recent years, AI and machine learning tools have made this kind of personalization possible. We’re now
getting past the hype and seeing broader real-world adoption of these tools. As their use grows, I’m excited

to see stronger cases built for AI-powered clinical decision support to get the right treatment to the right

patient at the right time.

Anand Parikh, Co-Founder and Chief Executive Officer, Faeth Therapeutics

I think AI and machine learning will greatly accelerate biomarker and drug target discovery and lead to

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morePHARMA'S
personalized medicines.
ALMANAC TVThis has long been a goal of AI in the biotech industry,
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fallen short — but as AI innovations continue at this breakneck pace, boosting its predictive capabilities

with each new cycle, AI-driven biomarker discovery and drug development will reach new heights never
before achieved.

At Faeth, we use machine learning to match cancer patients with the best precision nutrition treatment. Our
MetabOS™ platform combines machine learning and functional genomics to uncover the precise nutrient

vulnerabilities for a tumor based on genotype and organ of origin. We sequence a patient’s tumor biopsy
and run the genetic information through the MetabOS™ platform, which identifies the specific nutrients
the tumor relies on to survive and resist treatments. We then enroll patients in the trial best fit for that

metabolic trait. In the future, we expect to tailor these interventions based on individual RNA sequencing
data, advancing towards truly personalized medicine. We’ve generated thousands of potential strategies for

nutrient restriction in cancer treatment, illustrating the power of machine learning in uncovering new
therapeutic avenues. We envision AI and machine learning not only illuminating current scientific

understanding but also sparking new insights in cancer diagnostics and therapeutics. We can go beyond
broad treatment groups based on one or two genetic signals to nutrient control tailored to individual genetic

signatures.

Lynn Allen, Senior Vice President of Business Development, MedPharm

Artificial Intelligence allows drug development companies to screen a high volume of compounds to assess

structure–activity relationships (SAR) for disease indications. It can help shorten and decrease the cost of
drug discovery through several pathways. With vast amounts of data, models can predict what might be the

most clinically successful candidate.

Once the AI hypothesis is identified, it must be tested. For most drug development companies, that means

animal models. MedPharm offers one additional step before the cost, time, and lack of translation of animal

testing as we continue to optimize human ex vivo models that assess the hypotheses from AI models, which
can improve the compounds’ development risk profile before animal or human testing.

In one business case, MedPharm partnered with a company that specializes in AI modeling. The company
identified a drug candidate using AI that could target atopic dermatitis. Once the mechanism of action is

predicted, MedPharm employs its ex vivo models to test specific inflammatory pathways. In this case,

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MedPharm was ALMANAC


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assessing the drug candidate’s pharmacological effects
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IN an ex vivo human
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skin model for atopic dermatitis by evaluating multiple inflammatory pathways, which will need to be

confirmed in animal and human clinical studies.

More drugs that are identified by AI or machine learning and further verified by ex vivo models should lead
to better drug discovery at a faster rate. For diseases with unmet needs or therapeutic treatments, this could
significantly accelerate drug development to increase the chances of success.

Josh Ludwig, Global Director – Commercial Operations, ScaleReady

When it comes to cell and gene therapy manufacturing, we need to inject AI into areas that can streamline
data input, output, and interpretation. Human error is inevitable given the mass quantities and complexities

of data generated as part of every manufacturing process. Inserting algorithms that can simplify the process
would be extremely beneficial in shortening timelines and increasing therapy accessibility for patients.

However, with only six T cell drugs approved for treating diseases, I believe our industry is still some time

away from utilizing the power of AI to meaningfully reduce manufacturing complexity. Machine learning

is most effective when working with well-structured data, but this space remains highly siloed and far from
standardized. We are at a crossroads as we begin to integrate automation, but early efforts have increased

complexity rather than reducing it. That not only bakes in complexity that perpetuates longer timelines,
cash burn, and lack of scalability, but it limits applications for AI tools.

The marriage of cutting-edge AI with cutting-edge cell and gene therapies seems like a natural fit, and the

potential benefits of integration are thrilling. But we also know the downside to doing too much too fast;
after all, this is a field that created cures for deadly diseases but is still struggling to make enough of them.

In order to reach a place where AI can truly change the paradigm, we must continue to focus on
simplification.

Larry D. Rushing, Director, Enterprise Data Sciences & Analytics, Catalent

Technologies such as AI and ML are increasingly being used in biopharmaceutical process development,

where multiple parameters can be analyzed automatically during manufacturing stages to ensure product
quality remains within specification. Process efficiency can be increased, reducing cost and accelerating

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timelines.
PHARMA'S ALMANAC TV SIGN IN REGISTER

The advantages of using AI and ML are in the detection and extraction of information from patterns in
complex data sets, and they have opened the door to innovative startups with capabilities to identify new

drug targets.

There is the potential for AI and ML to assist in identifying which drug candidates will work safely in
humans, not only to guide candidate selection, but with the advent of the FDA Modernization Act, which

authorizes the use of computer models as an alternative to animal testing in some circumstances. This can
again save time and money in the clinical development of new drugs.

Outside of direct impact on drug development, there are other advantages that AI and ML potentially
possess. With the ability to analyze real-time data, AI can monitor global health to improve disease

surveillance, to alert authorities to potential new outbreaks and facilitate an earlier response. By analyzing
data from global news, online search activity, discussion sites, and public health databases, AI can detect

patterns that highlight the emergence of a new disease or the wider spread of an existing one, giving public

health officials a new tool to fight future pandemics.

Karen Madden, Chief Technology Officer, the Life Science business of Merck KGaA,
Darmstadt, Germany

Whether we are empowering researchers in the lab to find the next scientific breakthrough or supporting
our customers in the manufacturing and testing of novel therapies and diagnostics, AI is at the forefront of

nearly every digital initiative now underway in our Life Science business.

As millions of people are waiting on the promise of new drugs and therapies to come to market, one of the
most exciting fields where AI and machine learning systems are utilized is to accelerate and reduce cost of

drug discovery.

According to Bekryl, a market research firm, AI has the potential to offer more than U.S. $70 billion in

savings for the drug discovery process by 2028.

To identify potential target molecules to treat diseases, researchers traditionally carry out large screens of
molecular libraries with numerous rounds of tests to a promising compound.

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ThePHARMA'S
sheer size ofALMANAC
the libraries
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SIGN REGISTERimpossible
for individual researchers to review everything themselves — and that’s where AI and machine learning

can help.

The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the
United States and Canada, with its deep scientific expertise, helps researchers with efficient technology
platforms that drive faster development of better therapies to patients. Our teams have developed software

that combines AI, machine learning, and computer-aided drug-design methods, which is a valuable toolkit
for our customers in discovery stages.

Good examples are AIDDISON™ drug discovery software and Synthia™ Retrosynthesis Software —
which combined can offer scientists intelligent, improved, faster, and novel approaches to drug discovery
while considering sustainability in the design. This increases the success rate of lead candidates in drug

discovery and development.

While AIDDISON™ drug discovery software can generate new molecules tailored to needs, explore the

vast chemical space, and refine the search with machine learning pharmacokinetic models and 3D docking
tools; Synthia™ Retrosynthesis Software allows for the identification of safer, most cost-effective, higher-

yield routes to chemical targets out of tens of thousands of potential approaches.

By marrying generative AI to chemical synthesis, we can let the computer focus on the more prosaic, time-

consuming tasks, freeing up the scientist to conduct the experiments that require a human touch.

Serafim Batzoglou, Ph.D., Chief Data Officer, Seer

In the not-so-distant future, AI and machine learning will be used across biology and medicine to make

powerful predictions: who will get sick, what the trajectory of their disease will look like, and what
medicine they are most likely to benefit from. This leap in our understanding of disease onset, progression,

and treatment will happen thanks to the integration of AI and machine learning using multi-omic data —

using the holistic context of genomics, transcriptomics, metabolomics, and proteomics to understand
biology and human health like never before. In the past few months, generative AI tools have improved at

a breakneck pace to make highly accurate predictions using contextual clues. This same power can be
applied in biology, using different data points across nucleic acids and proteins to fill in gaps in our

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understanding
PHARMA'SofALMANAC
the connection
TV between genotype and phenotype, between what’s
SIGN happening
IN inside our
REGISTER

bodies at the molecular level and how that manifests as health … or disease. Thanks to an influx of

biological data, particularly from genetic sequencing, it’s now feasible to apply the predictive power of AI
and machine learning to biology. We’ll need data across populations, however, to realize the true strength

of these tools: from thousands of patients, at different time points in progression of a disease, such as

cancer, to how those patients respond when receiving different drugs. AI can help to identify specific
biological signatures that correlate with disease risk, and match patients with the drug that has the greatest
chance of helping them.

Dalip Sethi, Ph.D., Director of Scientific Affairs, Terumo BCT

AI and machine learning is already beginning to greatly enhance the capabilities of the entire industry. The

first area is drug discovery, where AI is being deployed to predict protein folding and interaction modeling.

As first-generation molecules discovered with the help of various machine learning techniques make their
way through the development process, it will be amazing to see their impact both on patients and the

industry, and I expect the role of these advanced technologies in the drug development process will
explode.

Another space ripe for AI adoption is cell therapy manufacturing, where a prediction algorithm to improve
cell culture would be immensely useful. Cell culture is a tedious and complex step in cell therapy

production, and each subtype within the diverse set of cell therapy applications utilizes cell culture under a

unique set of conditions. Available data sets can be used to train machine learning models, and as more and
more culture experiments feed the models, the better predictions would become. The ability to predict cell

culture parameters based on such analytical capabilities would be an exciting advance.

Lothar Finster, Vice President Growth and Digital Marketing EMEA,


LABVANTAGE Solutions, Europe ltd.

LabVantage Solutions is excited to see increased adoption of AI and machine learning in the

pharma/biopharma industry. One promising area is drug discovery and development, where AI can analyze
vast amounts of data to identify potential drug targets and predict the efficacy and safety of new

compounds. This accelerates the process and increases success rates.

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Another area is clinical


PHARMA'S ALMANAC trials
TVand patient recruitment. AI and semantic search technologies
SIGN IN can efficiently
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sift through data to identify suitable participants, leading to faster recruitment and improved trial outcomes.

AI also enhances pharmacovigilance and drug safety monitoring by analyzing real-world data to detect

patterns indicating safety concerns or adverse reactions. This proactive approach improves patient safety
and regulatory compliance.

Manufacturing and quality control processes can benefit enormously from AI-powered analytics. Real-time

monitoring and analysis of production data can detect anomalies, predict failures, optimize processes, and
ensure adherence to quality standards, leading to increased efficiency and improved product quality.

AI and machine learning are already making an impact in the pharma/biopharma industry and have huge
potential for greater contributions in the future. These tools can revolutionize drug discovery, enhance

clinical trials, improve drug safety monitoring, and optimize manufacturing processes. LabVantage’s
mission is to leverage synergies from our AI and semantic search capabilities to enable pharma and

biopharma companies to harness these technologies and drive innovation in their respective fields.

Susan Wood, Ph.D., Chief Executive Officer, VIDA

We’ve already seen the impact of these technologies in respiratory trials, where AI-enabled, imaging-based

digital biomarkers are delivering highly precise measures of lung physiology to better understand the
impact of a therapy, its mechanism of action, and the characteristics of responders. With these insights,

sponsors can make faster go/no-go decisions, increase the power of a study, and more tightly define

inclusion criteria — all accelerate the timeline of a therapy. We are at a point where we can produce up to
15,000 individual metrics per imaging study across over 50 validated imaging biomarkers.

AI can be applied beyond the analysis of an image. We are increasingly using AI/ML in new ways to
optimize data quality and optimize clinical trial imaging. I’ll share three examples.
1. Our digital biomarker solution employs AI in quality control, looking for scan quality issues, such as
excess patient motion.
2. Our digital biobank — a vast repository of highly curated imaging data — can be used to simulate a
control arm by selecting “digital twins” of the subject inclusion criteria in the trial. Not only does this
significantly reduce the number of subjects needed for a trial, but it also means a larger percentage of
trial participants can receive the therapy versus a placebo.
3. We also use intelligence for trial site recruitment, matching high-performance trial sites with new trial

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opportunities that are likely


PHARMA'S ALMANAC TV to be a strong fit. SIGN IN REGISTER

We will continue to see increased adoption of AI to streamline the clinical trial process — from recruitment
to analysis — so promising therapies can reach patients sooner. Imaging data are highly structured and a

great source of data for AI inclusion.

Sivan Bercovici, Chief Technology Officer, Karius

Recent advancements in artificial intelligence are fundamentally reshaping the landscape of opportunities
across all major industry sectors and aspects of life. This surge of significant breakthroughs, which further
accelerated in recent months, continues to provide notable benefits in areas like healthcare, biotechnology,
education, and agriculture, to mention a few. The advent of the fine-tuned skill-as-a-service framework

provides innovative tools capable of harnessing significant bodies of knowledge while delivering on-

demand expertise. The cascade of knowledge synthesis and problem solving now requires fewer search
(and research) cycles, as we shift our focus from serially retrieving answers to requesting machines to

deliver an outcome.

Advancements in these technologies are consistently providing superior outcomes across a broad array of
tasks. We now have more adaptable automation capabilities at our fingertips, which can seamlessly adjust

to new assignments, as we are further removing barriers around querying and programming. The tectonic
shift from formal language imperative programming toward natural language declarative programming

means that we can describe a desired outcome through natural language, rather than instruct the computer

how to go about a task in a step-by-step fashion. We're embracing innovative team dynamics through
substantial human–machine collaborations, designed to engage in intricate and lengthy processes. These

cooperative efforts span a spectrum of activities, from the less uncertain realm of software development to
the highly uncertain pursuit of scientific discovery.

As a result, we should expect more out of our investments in drug discovery, the delivery of care, and the

overall prevention of disease.

Talat Imran, Chief Executive Officer, Rani Therapeutics

At heart and by training, I’m a computer scientist, so I’m a strong proponent of the progress we’re seeing

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in applying
PHARMA'SAI and machineTV
ALMANAC learning to this field. One of the most interesting areas
SIGN where
IN AI could play a
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part in the future is for clinical decision making. We have lots of great tools available, but as heuristics get

more complicated, it can be difficult to decide what the ideal clinical protocol to follow is. AI will be able
to tease these decisions and pathways out.

The biopharma space is not like other areas, where you have a plethora of aggregate material to train these
models. In this case, we are limited by what we know and what we've already done preclinically and

clinically. One thing that would be really interesting as an application of AI is for drug–drug combinations.
Combinatorics is something that humans struggle with, since it’s most often not a straightforward cause-
and-effect when it comes to combining complex molecules. There are a number of companies applying AI

to pure drug discovery, but I think that AI’s ability to rapidly evaluate combinations of molecules could
lead to situations where 1+1 = 3, from an efficacy perspective.

Naveen Kumar, Chief Commercial Officer, Rune Labs

I’m excited to see AI and machine learning used more in predictive analytics. Especially in our work with

Parkinson’s patients, combining high-quality symptom data and AI can enable accurate predictions across a
slew of problems currently plaguing the field. For example, AI models could help predict when a patient

might need a specific therapy, based on their detailed symptom data. Plus, predictive models can help
match people with Parkinson’s to a particular clinical trial that is most likely to address the underlying

cause of their symptoms. Especially as the neurodegenerative disease progresses and a patient begins to see

less of a benefit from their medication, matching people with Parkinson’s to clinical trials for disease-
modifying therapeutics can help give renewed hope. Another way AI can help is distinguishing between

the two major types of motor symptoms a person with Parkinson’s experiences: tremors (involuntary
muscle movements that are rhythmic) and dyskinesia (involuntary muscle movements that are irregular). A

lot of patients themselves are unable to distinguish between tremors and dyskinesia, but treatments for the

two distinct symptoms are on either end of the spectrum. It’s key that we improve patient and clinician
ability to detect and predict dyskinetic episodes, and AI can help bridge this gap.

Maurice Exner, Chief Science Officer, Sherlock Biosciences

AI in biopharma is most often associated with therapeutics development, where it is routinely used for

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everything fromALMANAC
PHARMA'S discovery to
TVclinical trials. But these algorithms are breaking SIGN
through
IN in diagnostics
REGISTER as

well, with a growing list of potential applications.

One is accelerating molecular diagnostics development — a historically slow, laborious process that

requires researchers to manually test hundreds of different combinations of sequences and primers to find
the right pairing to most accurately and sensitively identify the disease. In particular, finding the right
disease-specific target sequence is a challenge because it has to be both unique enough to avoid false

positives and unlikely to mutate so there are few false negatives. In the new world of CRISPR-based
diagnostics, we also need to add in guide RNAs, adding complexity to a process that was already akin to
shooting in the dark and hoping for a hit.

Today, we’re using machine learning to predict and recommend combinations that are most likely to be
effective, depending on the specific disease. Wet lab testing confirms the prediction, and data is fed back

into the platform to improve the algorithms’ predictive capabilities.

Perhaps the most exciting opportunities for AI enhancements are the ones we don’t yet know about. It’s

one of the main reasons why we integrate AI teams into every aspect of the company at Sherlock.

Jonathan Brennan-Badal, Chief Executive Officer, Opentrons

I’m most excited to see increased adoption of AI, and specifically large language models (LLMs), to make
automation more accessible to life science labs around the world. Right now, there are robotic technologies

available to automate a variety of lab protocols, but these systems are either very limited “one-trick robots”

or powerful platforms that are inaccessible to anyone who isn’t a programming expert. With LLMs,
however, we can begin to bring down that barrier so automation is accessible for everyone. We’ve

demonstrated how this works with our own Opentrons robots: ChatGPT is capable of creating working
Python code for an automated experiment, such as performing a serial dilution or setting up a PCR

reaction, and this protocol will run successfully on our robots. For legacy robotics, creating a workable

protocol like this often takes a great deal of time and extensive automation expertise. LLMs make it
possible to design experiments in natural language, without needing to know how to code. But we’ve only

just scratched the surface of what LLMs can achieve in the world of lab automation. My dream is a robot in
every lab, easily programmable by any scientist with AI, that can execute reliable and reproducible

experiments to push the pace of life science discovery even faster.

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Bridget Seay,ALMANAC
PHARMA'S Executive
TV Director of Customer Experience & Commercial
SIGN IN Consulting,
REGISTER

epocrates

There are a couple of interesting ways I’m excited to see AI increasingly applied in our industry. One

promising route on the R&D side is utilizing AI and machine learning (ML) to make the drug development
process more efficient. Leveraging AI/ML will significantly reduce development costs, make medication

more affordable, and allow for quicker delivery of therapeutics to the market, providing faster relief to
those in need.

From a marketing standpoint, AI/ML provides a massive opportunity to fine-tune pharma messaging to
better align to the physician and patient journeys. Rather than parsing through all available data manually,
AI can more quickly review and analyze that data, whether it’s data from a physician-used tool or data

from a patient-worn device, so that marketers can adjust their messaging strategies appropriately for the

specific audience they’re trying to reach. Ultimately, optimizing messaging through AI ensures that
pharmaceutical companies are using their marketing dollars more effectively and that the right information

is reaching the right physicians and patients at the right time.

David Radspinner, Ph.D., Chief Executive Officer, VintaBio

The range of analytical technologies deployed in biopharma is constantly growing. I see tremendous

opportunities to apply AI algorithms to raw data or metadata from these different platforms, especially
where they are evaluating the same molecule, process, or system. Since many of the deployed technologies

have some level of information that is confounded with other technologies, in addition to the unique

attributes targeted by those methods, this will allow us to leverage a variety of data sources together that
are today siloed.

I would also like to see AI applied to biological systems modeling, especially animal modeling. Preclinical
testing today is both expensive and time-consuming, adding years onto the drug development process, and

is often coupled with complex ethical considerations.

Mark Mintz, Chief Information Officer, Charles River Laboratories

As an industry that is rapidly evolving and increasingly moving toward animal-free alternatives, we see

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opportunities
PHARMA'S across the drug
ALMANAC TVdiscovery and development process to utilize AI SIGN
and machine
IN learning (ML)
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to ensure a sustainable future where responsible animal use and patient safety remain top priority. For

Charles River, our Global Technology team is integrated throughout our businesses, exploring alternative
digital solutions that will allow for the responsible use of animals, including the opportunity to reduce

animal usage. This integration requires close partnership with the industry, working together to ensure

programs are designed with a 3Rs (reduction, replacement, and refinement) mindset. One example is
already in use in early discovery — Logica, an integrated, iterative AI-driven process that delivers
advanceable small molecule leads and candidates. By integrating leading AI and data generation, platforms
like Logica can help advance and de-risk candidates, which should lead to reduced attrition in clinical

studies.

Mahesh Karande, President and Chief Executive Officer, Omega Therapeutics

We’re experiencing a revolution across multiple fronts in the industry. The rise of mRNA therapeutics
promises a new class of programmable medicines that code for proteins capable of fundamentally changing

cellular physiology to treat or cure diseases. But being able to design and engineer proteins and get them to
perform specific functions is incredibly challenging. In the past, engineering a single protein was a

monumental feat requiring an arduous trial-and-error process, but now with the computational power of AI
and machine learning (ML) and creating bespoke algorithms, we can accomplish in weeks to months what

previously took years. Additionally, each iteration and new data generated accelerates the process and

improves the likelihood of success. The compression of development timelines coupled with improved
chances of success will ultimately translate to safer, more effective therapeutics.

While expediting and improving our ability to engineer therapeutics, AI and ML are revolutionizing our
ability to mine and interpret vast quantities of genetic code and information. Although the human genome

was mapped more than 20 years ago, our understanding of the nature and organization of DNA is still

growing. AI and ML have enabled predictive frameworks to program medicines with prospectively
determined outcomes in terms of levels of control of gene expression and cellular programming to treat or

even cure diseases. Through computationally guided programmable mRNA medicines designed to behave
exactly as we intend, we could potentially address almost any disease.

Carsten Rudolph, PharmD., Chief Executive Officer, Ethris

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We are extremely
PHARMA'S enthusiastic
ALMANAC TV about the increasing implementation of AI in the fieldINof drug
SIGN discovery,
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particularly in the advancement of mRNA vaccines and therapeutics. While mRNA technologies have

emerged as an innovative and effective approach for treating challenging conditions, certain challenges still
exist, such as stability, tissue-targeted delivery, and manufacturing. We believe that there are four

significant areas where AI can enhance mRNA technology and assist in designing the next generation of

mRNA therapeutics, thus improving efficacy and reducing immunogenicity.

First, AI can assist in optimizing the untranslated regions (UTRs), which can significantly enhance mRNA
performance. Secondly, AI can aid in optimizing codons by analyzing transcriptome and proteome data,
enabling the identification of codon combinations that yield high protein expression while requiring

minimal mRNA levels, thereby increasing potency. Third, AI can contribute to the discovery and
optimization of lipid nanoparticles (LNPs) to facilitate efficient and targeted delivery of therapeutic

payloads while minimizing systemic spill-over and potential side effects. Lastly, AI can play a role in smart
antigen design, predicting future virus mutations and enabling proactive measures against frequent

adaptations; this renders continuous vaccine development for new variants, such as COVID, unnecessary.

We have initiated two collaborations that leverage AI to develop next-generation mRNA candidates and

are actively exploring additional opportunities. One collaboration, funded by CEPI, is our partnership with
DioSynvax, with the goal of developing mutation-agnostic, broadly active beta-coronavirus vaccines to

prevent future pandemics. Additionally, we have teamed up with the prestigious Helmholtz Institute in

Munich to optimize UTRs, aiming to significantly improve translation efficiency.

Akihiro Ko, Chief Executive Officer, Elixirgen Therapeutics

One of the biggest topics that comes up in this space is how we can use AI to better understand data. There
are a lot of data generated across the life sciences industry every day. But one of the fundamental issues

with these large data sets is trying to analyze them in such a way that we can parse out what is valuable and

what is noise. AI and machine learning are important tools that can help us clean up data and reanalyze it
for use across different applications.

So, what does that mean on a day-to-day basis? AI has the potential to help us in everything from drug
discovery and clinical trial development to marketing and manufacturing. Because of the wealth of

knowledge that AI can pull from, it can help us make more strategic decisions as well as automate tasks.

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For PHARMA'S
example, AIALMANAC
has the potential
TV to help us discover new molecules, design better
SIGNtrials,
IN and identify
REGISTER

quality control issues in manufacturing. It can even help us understand how to best “talk” with HCPs and

patients when it comes to commercialization.

Lastly, as we navigate through these exciting times, it’s important to remember two things. (1) Asking the
AI software the right questions is an essential part of getting the results that you’re looking for. (2) AI is a
powerful tool that we can use to do our work better, but we need to use it responsibly, always keeping the

patient at the center of what we do.

Yochi Slonim, Co-Founder and Chief Executive Officer, Anima Biotech

AI / machine learning is a technology with the potential to transform drug discovery and development. The

first AI-discovered drugs are already in the clinic, with small biotechs and big pharma working on
hundreds of projects in this area. When applied to drug discovery, AI may be used to solve several key
problems. The first is the identification of novel targets, which may be achieved through the use of

language models, such as ChatGPT, which can analyze and understand vast amounts of biological

information related to proteins and pathways. Another significant application is designing drugs against
known hard targets or designing novel antibodies. Many companies in the AI drug discovery space are

working in this direction. A completely novel application of AI is elucidating the mechanism of action of
drugs. For example, drugs that are discovered using phenotypic screening methods have a significant

advantage, as they work "out of the box" in the live biology of a disease model; however, understanding

their mechanism of action has always been very challenging.

Adam Savitz, M.D., Ph.D., Chief Medical Officer, Alto Neuroscience

In the past decade, revolutionary breakthroughs in therapeutic areas, including oncology and gene therapy,

have been enabled by precision medicine. Although tailoring treatments to a person’s unique biology has
proved beneficial and life-saving, mental health has failed to innovate in this way. Psychiatric medications

are prescribed on a trial-and-error basis. Finally, the field of psychiatry is harnessing big data and machine

learning approaches to develop digital tools, diagnostics, and therapeutics that show potential to reveal and
treat subpopulations of patients across CNS disease states. The identification of AI-derived brain

biomarkers and development of corresponding therapeutics is enabling a precision psychiatry approach.

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UntilPHARMA'S
now, psychiatric
ALMANAC diagnoses
TV have been based on clinical symptoms, without biological
SIGN IN biomarker tests
REGISTER

that guide diagnosis, prognosis, or treatment selection. By combining artificial intelligence with data from

behavioral tests, brain function measures including electroencephalography activity, and activity trackers,
we look to find ways to optimize treatments for patients that benefit them because of their targeted nature.

Consequently, by moving away from the scatter shot approach that pervades clinical practice today, the

lives of those experiencing mental health conditions will dramatically improve.

Chris McClain, Senior Vice President of Sales and Business Development, Be The
Match BioTherapies®

AI and machine learning should be valuable throughout the drug development life cycle and then beyond
into clinical applications. The process of treating diseases is fundamentally a process of utilizing existing

knowledge and then incrementally building on it. You see it in the literature, an ongoing building of the

knowledge base. Machine learning and AI are ways of building on the knowledge base but at speeds
previously unthinkable. It will transform the way we characterize diseases, develop drugs, and implement

them as cures.

Lindsey Clarke, Ph.D., Vice President of Commercial, MicrofluidX

I’m excited to see the impact that AI/ML could have in unlocking the full potential of cell and gene
therapies. Cell and gene therapies are complex living medicines that have demonstrated considerable

efficacy across many areas of unmet need — from serious genetic disorders to oncology and autoimmunity,
these innovative new treatments are showing considerable benefit. However, their widespread usage is

already being limited by the difficulty and cost of making them. One major challenge associated with the

delivery of cell and gene therapies is the significant variability in the biological starting materials used in
each batch’s manufacture, something that is further compounded in autologous approaches with the use of

patient-derived materials that may have disease and prior treatment effects. Today, manufacturing
approaches are standardized, and this variability is not effectively controlled for.

As the next generation of manufacturing technologies are developed, with greater digital capabilities and

the ability to monitor manufacturing in real time becomes a reality, I can envisage AI/ML approaches that
could effectively predict the most optimal growth conditions in response to the biological variability of the

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starting materialALMANAC
PHARMA'S and then adapt
TV during manufacturing to the way that cells areSIGN
growing,
IN providing
REGISTERmore
robust, effective, and optimal manufacturing solutions.

Richard Perry, Ph.D., Head of Data, Sterling Pharma Solutions

The pharmaceutical industry is rapidly adopting AI and machine learning (ML), and examples of
applications include drug discovery, route optimization, predictive maintenance, supply chain management,
and demand forecasting.

One area of particular interest to Sterling is chemical process modelling. This can involve running
thousands of virtual experiments to select the most promising ones to run physically in the lab. This saves
time and money and allows for a more thorough search of the manufacturing recipe space.

Once at full-scale manufacture, process models can be used to inform further optimization. These models

are particularly useful when trained on real data observed throughout scale-up. As process models improve,
we will be able to control the scale-up and manufacturing process much more effectively. This will lead to

more repeatable batches with higher yields and lower impurities.

The AI theme for 2023 is almost certainly going to be the advances made in large language models
(LLMs). While the future impact of these models is much debated, and nothing of great significance has

been applied to chemistry yet, it is only a matter of time. As LLM models become more accessible to
smaller niche players in the software industry, I expect there to be a revolution in search interfaces for

private domain specific company data, such as the artifacts created by experimental scale-up chemists. The

building blocks for such applications are there, they are just waiting for someone to put them together.

Read Part 2: Q2. How is an increased focus on patient-centric


concerns influencing the way that you work?

Tags: Innovation | Roundtable | Catalent | Alconox Inc | MilliporeSigma | Samsung Biologics | Artificial Intelligence |
Charles River Laboratories | Machine Learning | PCI Pharma Services | Dynamk Capital | Sterling Pharma Solutions |
Corning Life Sciences | eClinical Solutions | CRB | Be the Match BioTherapies | Alto Neuroscience | Karius |
Envisagenics | Vectron Biosolutions | Omega Therapeutics | epocrates | Anima Biotech | Mikart |

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Porton Advanced Solutions | Nu-Tek BioSciences | Actylis | Faeth Therapeutics | GBI | OM1 | Elixirgen Therapeutics |
PHARMA'S ALMANAC TV SIGN IN REGISTER
MedPharm | LabVantage Solutions | Terumo Blood and Cell Technologies | Q32023 | Newfront | Rani Therapeutics |
Rune Labs | Enthought | ScaleReady | Seer | VIDA | Opentrons | VintaBio | Ethris | Microfluidx |
Sherlock Biosciences

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