Christopher Cole

J.D. Mowery, President, Bora Pharmaceuticals

In an interview regarding the presentation “Beyond Traditional Markets: The Strategic Importance of Emerging Pharma Trends and CDMO Innovation” at CPHI Europe 2025, held Oct 28-30 in Frankfurt, Germany, panelist J.D. Mowery, president, Bora Pharmaceuticals, offers insights into critical trends shaping the biopharmaceutical industry, drawing on his 25 years in the sector. The discussion focused on evolving supply chains, regulatory needs, macroeconomic forces, and the accelerating integration, but also the operational hurdles, of artificial intelligence (AI), the necessity of establishing global standards for sustainability, and the need to increase trust in outsourcing partnerships.

PharmTech: How is the sector reimagining supply chains to protect against rising tariffs, geopolitical shocks, and global disruptions?

J.D. Mowery: When considering the CDMO sector, the biopharma industry, and geopolitical concerns like tariffs, we are seeing a pivot toward localized supply chains. Many organizations are looking to execute clinical trials and conduct as much work as possible within the region where they operate.

At Bora, we have the advantage of executing this strategy on a global scale across our different regions. For instance, our sites in Mississauga and Maple Grove have commonality, allowing us to serve the APAC region there or conduct a tech transfer to handle services within the US region. These pressures—similar to how people reacted to COVID and constraints on crossing borders—are expected to remain in place for at least the next three to five years.

What role should regulatory harmonization play in ensuring timely access to critical medicines during cross-border disruptions?

Regulatory support is crucial during constraints like tariffs or border shipping issues. As an industry, we already understand the value of reciprocity among different regulatory agencies and the importance of having common standards so that treatments and therapies are treated equally within a given country.

The more regulatory bodies work together to achieve common standards and recognize one another's work, the greater the benefits. This cooperation results in cost savings for countries, cuts down on factors like greenhouse emissions (by reducing travel), and ensures that local regulators, especially where language barriers exist, are better equipped to perform proper facility assessments. Reciprocity was always important, but current disruptions further exemplify why it is essential.

How can public–private partnerships be structured to not only address immediate shortages but also incentivize long-term resilience in pharmaceutical supply chains?

The economic conditions of the last few years, sometimes referred to as the "biotech freeze" or "pharma freeze," have shifted the landscape. Several years ago, capital could often be raised with less robust data, sometimes based more on an idea or philosophy. Now, much more robust data is necessary to secure capital and allow clinical trials to progress.

This requirement for robust data is viewed as a positive development because the resulting products and therapies are stronger and more data-founded. This ecosystem now allows the public and private sectors to focus on the right therapies and ensure they reach commercialization. Ultimately, the patient benefits because they can have greater faith in the outcomes derived from clinical trials. While competition for market share remains relevant, there is also an opportunity for entities to focus on their core strengths.

Where do you see the greatest potential for innovation that could safeguard medicine security without significantly increasing costs?

The greatest potential for innovation lies with AI. AI is being globalized faster than electricity or the internet. If the correct AI system is implemented, it offers "almost passive knowledge" that can be continuously fed data. AI can be leveraged across all areas, including supply chain management, sales and marketing, operational efficiencies, and drug discovery. AI's ability to process, analyze, and synthesize data into a useful format allows decisions to be made in a fraction of the time, requiring fewer man hours than previously needed.

For instance, AI can be used for something as simple as authoring a Biologics License Application. It can distill the information accumulated during process validation and PPQ development to create a regulatory dossier much faster. This speed leads to cost reduction and allows products to flow through and gain approval more quickly. We view AI not as a threat of job displacement, but as an opportunity to amplify our employees' capabilities by providing a strong tool to leverage their deep expertise. I believe this is the biggest innovation opportunity we will see in my lifetime.

What barriers exist to wider adoption of AI in bio/pharma?

A major challenge is that many organizations do not fully appreciate how dispersed or disparate their systems and data are until they begin the implementation journey. Significant effort—or inertia—is required upfront to consolidate and cleanse the data before it can be leveraged to get the full benefits of AI. Companies often realize they are further away from starting than anticipated once they assess their systems.

This difficulty can make it challenging for organizations to defend the investment, as they are often looking for the ROI as quickly as possible. This situation is comparable to the introduction of electronic batch records: converting poor paper records to a digital format simply results in a poor digital format. Therefore, companies must undertake the "housekeeping and cleanup" to establish a solid foundation, focusing on data cleansing, data hygiene, and creating a good, solid data lake before they can fully realize the benefits of AI.

How can industry and governments simultaneously improve resilience and meet environmental targets?


Implementing set global standards is crucial. Operating facilities, supply chains, and shipping all impact the environment, and if everyone measures themselves against a single set of goals, it will be very important for progress.

Standardization simplifies the process for the biopharma sector when choosing CDMO partners, ensuring they operate against the same environmental criteria used in the biopharma companies' own facilities. Whether applying standards across innovators and CDMOs or across different countries and regions, this harmonization allows everyone to be "on the same sheet of music" regarding environmental impact and sustainability. When people measure using multiple scales, initiatives, and methodologies, it becomes very difficult to compare and contrast performance.

Achieving standardization is a heavy task, requiring deliberate effort. It involves getting people aligned and understanding the value of harmonization. Just like regulatory bodies striving for reciprocity, the process requires identifying the "right bar," selecting the best practices from the best actors, and creating one primary set of standards that most entities are comfortable working with.

Talk about your CPHI Frankfurt presentation.

The presentation will be an opportunity to discuss how we can better serve the sector. Other industries, like the automotive and computer industries, are much more mature when it comes to outsourcing compared to biopharma. From a cost perspective, the biopharma industry should be outsourcing more, allowing CDMOs to distribute overhead costs across multiple customers and SKUs, rather than companies building facilities to manufacture only one or two drugs.

The primary reason this hasn't happened is that the CDMO sector is still working to gain the trust of the biopharma industry. At Bora, we focus on building this trust by maintaining an extremely strong "on time in full" performance, with most of our sites exceeding 95%. Biopharma companies rely on this trust to ensure they have their product when needed for commercial distribution or clinical trials. Gaining this trust will be a key point during the presentation.

Articles

The biopharmaceutical industry is undergoing significant transformation, driven by evolving supply chains, regulatory harmonization, and the integration of AI. Localized supply chains are becoming crucial to mitigate geopolitical risks, while regulatory cooperation is essential for timely access to medicines. Public-private partnerships are adapting to economic shifts, emphasizing robust data for capital acquisition. AI presents vast innovation potential, enhancing efficiencies across various domains. However, data consolidation challenges hinder AI adoption. Establishing global sustainability standards is vital for environmental goals, and building trust in outsourcing partnerships remains a priority for industry growth.

J.D. Mowery discusses boosting pharma supply resilience through localized manufacturing, AI innovation, and critical regulatory standardization.

Standardizing Operations to Meet Global Sustainability and Resilience Goals

J.D. Mowery, Bora, says tariffs localize biopharma supply chains, the "biotech freeze" mandates robust data, and AI rapidly optimizes operations.

The Key Trends Driving Supply Chain Localization and Data Scrutiny in Biopharma

In this part 1 of a 2-part interview regarding the presentation “Beyond Traditional Markets: The Strategic Importance of Emerging Pharma Trends and CDMO Innovation” at CPHI Europe 2025, held Oct 28-30 in Frankfurt, Germany, panelist J.D. Mowery, president, Bora Pharmaceuticals, offers insights into critical trends shaping the biopharmaceutical industry, drawing on his 25 years of experience in the sector. The discussion focuses on evolving supply chains, regulatory needs, macroeconomic forces, and the accelerating integration of artificial intelligence (AI).

Geopolitical concerns, particularly tariffs, are driving a pronounced shift toward localized supply chains. Mowery notes that many organizations are now seeking to conduct as much work as possible within the region where their clinical trials are executed. These pressures, similar to those experienced during COVID-related shipping constraints, are expected to remain relevant for at least the next three to five years. This environment underscores the increasing value of regulatory reciprocity among agencies. Collaboration and common standards help ensure therapies are treated equally across countries, delivering such benefits as cost savings and reduced global travel while allowing local regulators, who may be better equipped due to language considerations, to conduct facility assessments.

The biopharma sector has also faced a macroeconomic shift, sometimes termed the "biotech freeze," which demands more robust data to secure capital and advance clinical trials, according to Mowery. While earlier periods allowed capital raising based on less data and more philosophical ideas, the current climate necessitates therapies that are much more robust and founded on data, a development he sees as a positive outcome for the patient.

Discussing innovation, Mowery identifies AI as a transformative force, globalizing faster than electricity or the internet. When proper infrastructure is in place, AI acts as "almost passive knowledge," capable of optimizing everything from supply chain logistics and sales/marketing to drug discovery and operational efficiencies, he adds. One particularly impactful application is using AI to author regulatory submissions by distilling accumulated development and validation data rapidly, thus expediting approvals and lowering costs. Mowery stressed that AI should be viewed as an opportunity to augment human capabilities. "A lot of people are scared of AI and job displacement,” he notes. “We actually see it as an opportunity to amplify the capabilities of our people and hand them a strong tool to leverage the deep expertise they have."

Check out Part 2 of this interview and access all our 

*Editor’s Note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.



My name is J.D. Mowery. I'm the president of Bora Pharmaceuticals, which is our CDMO division within Bora Group. I've been with the organization a little over a year now. I've been in the sector for about 25 years. I spent half of my career as an innovator working at Genentech, Celgene Geno Therapeutics, and the other half of my career working on various CDMOs within the industry before joining Bora.

I think when we, consider the CDMO sector, the biopharma industry, and tariffs and some of those geopolitical concerns that are out there right now, you're starting to see a pivot towards localized supply chains. Many are looking to do as much within the region where they operate—where their clinical trials are being executed—as possible.

One of the things that we have the luxury of here at Bora is the ability to do that on a global scale across our different regions. We've got sites that have commonality when we think about Mississauga and Maple Grove, they're very similar. So if a country, their region of say APAC needs service, we have the ability to take care of them there, or tech transfer and be able to do it within the US region as well.

I think those pressures are going to be in place for probably at least the next 3, 4, 5 years. You never know how that's gonna play out. But I think looking at… similar to the way people reacted to COVID, to where we were trying to prevent crossing borders because of shipping constraints and things like that, I think you're dealing with a very similar situation right now in response to those tariffs.

I think when you think about the regulatory support that could come when we have constraints around tariffs or border shipping and such, I think we already understood as an industry how valuable reciprocity is for different regulatory agencies, and the common standards that can exist so that, we have modalities and therapies and treatments being treated equally within a given country. Sometimes you gotta take a look at the different countries and understand what's the right bar to measure ourselves against. The more those different regulatory bodies can work together to come up with a common standard and a common way of working, and be able to recognize what one another are doing, there's many benefits. It's a cost savings for the different countries. It cuts down on things, greenhouse emissions and things like that because they're not traveling all over the world. Many times, the local regulators are better equipped to do a proper assessment of a given facility, especially if there are language barriers. Reciprocity was always important, but I think this is another example of why it is so important.

When you think about the balance of private and public sectors and consider how that helps us, especially in the kind of macro economic conditions we're looking at. Several years ago you could have gone in to, to, whether it was a PE firm or a VC firm to raise capital, and do with probably less data, more of an idea, thought philosophy and where you were gonna head with a different therapy.

The shift in the kind of the economic conditions over the last few years, and people refer to it as the biotech freeze or the pharma freeze, has put us in a position where much more robust data is necessary to get capital, to allow clinical trials to progress.

Personally, I think that's a good thing. Because the products and the therapies that are coming out the other side of the clinical trials are much more robust. They're much more founded on data. When you look at what's happening from an ecosystem perspective, the public and private sector have the ability now to get honed in on the right therapies and make sure that they see the light of day from a commercialization perspective.

And at the end, the patient is who benefits, right? Because the patient that's laying there can have greater faith in what's happening coming out of clinical trials. I think that ability to balance the public sector, whether it's a publicly traded company, and the private sector has put us in a place where people realize that from a competition perspective, yes, it's still relevant, people are still going to be fighting for market share, but there's also an opportunity to allow people to focus on what they're really strong at doing so that others take care of what's important to them and their mission and that ecosystem.

Yeah, when you think about innovation and the opportunities that lay ahead of us, you can't ignore AI, right? If you look at AI and what's going to happen, it's being globalized faster than the internet, faster than electricity. I spoke about this last year at DCAT and we continue to be very focused on it here at Bora and the industry as a whole, as we get that infrastructure in place, the results of it, if you have the right AI system around, it's almost passive knowledge. You can use it and continue to feed data into it for anything from supply chain to sales and marketing to operational efficiencies, to drug discovery. The ability to take and process and analyze that data and put it into a useful format to make decisions in a fraction of the time with a fraction of the people or man hours that were necessary before…

I think about something as simple as the authoring of a BLA and really being able to take the information accumulated during the execution of, process validation, PPQ development, and be able to distill that down and create a dossier that can be handed over to the regulatory agencies in a fraction of the time. That allows for cost reduction, but it also allows products to flow through and get approval much more quickly.

So here we see, a lot of people are scared with AI and job displacement. We actually see it as an opportunity to amplify the capabilities of our people and hand them a strong tool to leverage the deep expertise they have. I think that's the biggest opportunity we're going to see in my lifetime, when we think about innovation.

Videos

Maggie Saykali, Cefic, explains that Western pharma vulnerability stems from market loss to Asia, caused largely by short-sighted offshoring due to environmental costs.

US and European Pharma Manufacturing Face Diverging Paths to Resilience

In this part 3 of a 3-part interview regarding the presentation “The Critical Medicines Act: Game-Changing Opportunity for a Sustainable and Resilient Supply Chain?” at 

, held Oct 28-30 in Frankfurt, Germany, Maggie Saykali, Director – Specialty Chemicals, Cefic (European Chemical Industry Council), addresses the significant geographical shifts occurring in pharmaceutical manufacturing, drawing on data shared with the European Commission during the elaboration of the 

. The discussion focuses on the pronounced loss of market shares for both the United States and Europe in the manufacturing of small molecules, while China and India have gained corresponding ground. The market share data reveal a critical disparity: Europe currently maintains approximately 33% to 34% of the market for small molecules, whereas the US market share has fallen to around 10%, according to Saykali.

This erosion of manufacturing capability carries significant implications for supply chain resilience, she continues. The US, despite remaining powerful in the creation of innovative molecules, faces overwhelming dependence on external sources for generic drugs, with reliance exceeding 90%, states Saykali, adding that a market share as low as 10% indicates a severe loss of infrastructure, talent, and know-how, leaving the country highly vulnerable and requiring substantial financial investment to achieve a sustainable position.

Europe, however, still retains the necessary talent, know-how, and infrastructure due to its higher market share. While the situation was drastically different 40 years ago, Europe is now facing a crucial window to act, lest it reach a point where necessary recovery costs become prohibitive, Saykali says. The core difference between the current challenges facing the two regions lies in the amount of investment required to reverse the manufacturing decline.

The shift away from Western production was initially driven by economic factors, specifically the cheaper cost of manufacturing elsewhere. "But don't forget that… 30 years ago, it was also because we started in Europe and in in the US to have very strong environmental laws… It takes a lot of money to make it clean and environmentally sustainable, so one of the options was ship it off. But that was a short-sighted decision, and we are paying the price now."



This is the interesting difference between the US and Europe. So, the study that we shared with the European Commission when we were elaborating the Critical Medicines Act shows the loss of market shares for the US and for Europe, and of course, in the case of China and India, it's a gain of market share. and you could see that the US actually are now at more or less 10% market share for small molecules. Europe is at around 33-34%, and of course China and India have picked up all the slack.

So, if you go back 40 years ago, the situation was completely different. At 30-something percent market share, we still have the talent, we still have the know-how, we still have the infrastructure in Europe. 10% is too low. There you have lost the infrastructure or big parts of it. You've lost the talent, the know-how, and you're much more vulnerable or you have to put a lot more money on the table to be able to go back to a sustainable position.

Whereas for us in Europe, it's really time to act now if we don't want to go to a point… it's not the point of no return, it's the point where the return will cost you too much. So, that is where we are now and that's the essential difference between what's happening in the US and what's happening in Europe.

And the US are still very strong in making innovative molecules, but generics, totally dependent. I think the number is above 90% dependence on external sources for generics, because essentially, it's cheaper. But don't forget that a few years ago, 30 years ago, it was also because we started in Europe and in in the US to have very strong environmental laws and some of the production of some of the active ingredients and intermediates is not… I mean it takes a lot of money to make it clean and environmentally sustainable, so one of the options was ship it off. But that was a short-sighted decision, and we are paying the price now.

Tug of war. Hands pulling rope to opposite sides | Image Credit: © Bits and Splits - stock.adobe.com

We spoke with Nigel Langley, Global Technical Director of Life Sciences at gChem and immediate past chair of IPEC-Americas, regarding his presentation, “Challenges to the Sustained Availability of Excipients” at CPHI Frankfurt 2025, held Oct 28-30 in Germany. Langley addresses major industry concerns, including regulatory scrutiny over traditional excipients (such as titanium dioxide and talc), strategies for enhancing supply chain security and sustainability, and the urgent necessity of overcoming barriers to novel excipient innovation.

PharmTech: What is gChem exhibiting and promoting at CPHI 2025?

Langley: At CPHI this year, we will be promoting Procipient dimethyl sulfoxide, which is our high-purity, pharmaceutical-grade DMSO. Procipient has applications as both an API and an excipient. We support this product with a Type II Drug Master File in the US with the FDA, and a Type I Drug Master File in Health Canada. In addition to Procipient, we will also be promoting two other grades of DMSO in our portfolio:

1. Synthesis grade: Targeted toward API synthesis as a solvent, and also peptide synthesis, which is a growing area.

2. ACS grade: Our analytical grade, which is focused towards laboratories for reagent grades and diagnostics.

What is the most pressing regulatory shift currently threatening excipient availability?

The most pressing challenge, particularly seen through IPEC-Americas and IPEC in general, is the constant shift in deciding what to focus on next. There have been concerns regarding the safety of traditional excipients, such as titanium dioxide (TiO2). There have also been issues concerning nitrosamines and their possible connection to excipients and drug products, as well as challenges related to microplastics and PFAS (per- and polyfluoroalkyl substances). These issues, some driven from Europe and some from the US, involve various impurities. More recently in the US, there is an initiative to scrutinize and ban certain synthetic color additives. Talc is also currently "on the microscope". Dealing with these continuous issues keeps IPEC and the industry busy.

How can pharma companies better anticipate the next regulatory challenge?

It is challenging for pharma companies to know how to proactively react in these situations. Ideally, the science should prevail, and decisions should be based on the wealth of science in a particular area. However, recently, decisions have been made based on isolated scientific papers that may not be representative of the bulk of knowledge on a certain topic, leading to questions about the strength of the science cited.

A successful proactive strategy was demonstrated by the industry's response to the TiO2 concern that came from Europe. When TiO2 was banned in food, it looked like it would be banned in pharmaceutical products. If that ban had occurred, 90,000 drug products in Europe would have had to be reformulated. Many of these products, particularly generics, would likely not have been reformulated due to a lack of economic incentive, potentially leading to drug shortages. Furthermore, there is "no good alternative for TiO2," meaning reformulations would have required an inferior excipient.

The industry responded effectively by challenging the citations presented in Europe using sound science. Although the safety of TiO2 was debated (the FDA saw no issues, while certain European countries did), "common sense" ultimately prevailed. The appropriate proactive strategy is to present the facts and good science to tackle the challenge, rather than being melodramatic.

What proven strategies exist for strengthening excipient supply chains against global disruptions?

All pharma companies must consider the risks of single sourcing for raw materials, including excipients. To overcome this, supply opportunities should be provided, either by using a company that manufactures the same product at multiple global sites or by maintaining safety stock in different parts of the world to compensate for potential supply chain challenges.

Regarding sustainability, I see an opportunity for DMSO (gChem’s product) as a much safer, greener solvent alternative because it is a Class 3 solvent. This contrasts with Class 2 solvents currently used in drug synthesis and formulation, such as dimethylformamide (for API and peptide synthesis) and N-methylpyrrolidone. In terms of sustainability, there is no reason for formulators to choose more toxic Class 2 solvents in the future when a safe alternative exists, meaning sustainability can be rectified by alternative, safer materials that lead to much better patient outcomes.

Where are the best opportunities to integrate sustainable practices into excipient production without compromising performance?

Many companies are already working on sound ways of assessing their carbon footprint of manufacturing. Sustainability on raw materials sourcing is critical. This requires having excellent communication with suppliers and knowing where the material is being made and where the raw materials used by the excipient company are sourced.

The move toward safer solvents is also a key area of sustainability. In my opinion, the safer approach avoids Class 2 solvents, as they potentially face future bans. For instance, dichloromethane (a Class 2 solvent) has been banned, and dimethylformamide is now being banned in certain industries and by REACH in Europe. If there is a threat that these solvents will not be available in the future, they are not sustainable, especially given that many drug products are formulated with them.

How can novel excipients be introduced quickly while still ensuring safety and efficacy?

Novel excipients are needed now more than ever, but there are still very big barriers to their implementation. Without excipient innovation, the industry faces a major problem because drug modalities are increasingly complex, yet companies often rely on excipients that are 60, 70, or 80 years old. It is difficult to mold these older excipients into the desired functionality when what is truly needed is something designed fit for purpose.

Excipient innovation has not kept pace with drug innovation. There was hope three years ago when the Prime process was introduced by the FDA, as it offered a potential mechanism for new chemical entities used as novel excipients to be reviewed independently from the drug product submission. However, IPEC has not received confirmation from the FDA on whether this pilot program will proceed, and it is suspected to be either on hold or stopped.

To foster innovation, pharma companies need to have a much closer collaborative relationship with excipient suppliers. Suppliers should not be viewed merely as a vendor or a source of excipients. Collaboration requires early communication regarding formulation challenges and the specific need for an excipient to meet that challenge.

Academia has an important role in developing new chemical entities for future drug formulation, but the translation and commercialization of these ideas remain difficult. New materials must undergo the tox cycle and safety aspects before being adopted by a pharma company. Currently, pharma companies tend to be "first to be second," waiting for another company to successfully take a novel excipient through to completion (Phase III and drug approval). This is because a novel excipient is perceived as a significant risk; if a company already has a new API, adding a novel excipient is almost a "double risk". Much closer collaboration between the two parties is the way to combat this perceived risk.

Nigel Langley, Global Technical Director at gChem, highlights key challenges in excipient availability, including regulatory scrutiny and supply chain vulnerabilities. He emphasizes the importance of scientific evidence in addressing regulatory shifts, as seen in the titanium dioxide debate. Langley advocates for sustainable practices, such as using safer solvents like DMSO, and stresses the need for innovation in excipient development to keep pace with complex drug modalities. He calls for closer collaboration between pharma companies and excipient suppliers to overcome barriers to novel excipient implementation and ensure safety and efficacy.

Excipient Innovation and the Regulatory Tug-of-War: Navigating Threats to Availability and Safety

Big data technology and data science illustration. Data flow concept. Querying, analysing, visualizing complex information. Neural network for artificial intelligence. Data mining. Business analytics | Image Credit: © NicoElNino - stock.adobe.com

In an interview regarding his presentation “Harnessing AI in Clinical Practice to Drug Development and R&D. From the Bedside to Benches” at 

, held Oct 28-30 in Frankfurt, Germany, Gustavo Ferrer, MD, CEO of Dr. Ferrer BioPharma and Moxie Health Group, discusses how artificial intelligence (AI) is rapidly reshaping how drug development and pharmaceutical manufacturing operate, compressing timelines, reducing costs, and enabling unprecedented real-world data integration. He explores how platforms like Moxie-Link—an AI-powered, Fast Healthcare Interoperability Resources (FHIR)-compliant clinical and research platform—are turning every clinical encounter into actionable intelligence, all while navigating the remaining barriers to wider AI adoption and maximizing innovation through cross-disciplinary collaboration.

PharmTech: How is AI supercharging drug development, discovery, and manufacturing?

Dr. Ferrer: AI is compressing timelines and reducing costs across the drug development lifecycle:

Target discovery and molecule screening: Predictive modeling identifies promising candidates thousands of times faster than traditional methods.

Protocol optimization: AI learns from studies to shape inclusion/exclusion criteria that improve enrollment speed and site performance.

Decentralized clinical trials: Remote patient monitoring, telemedicine, ePRO/eTRO, and automated documentation increase retention and diversity.

Manufacturing efficiency: AI-based anomaly detection, yield prediction, and supply chain forecasting reduce batch failures and downtime.

Device performance, usability studies, and human factors: This includes identifying patients, optimizing the protocol, and tracking patients carefully.

Platforms like Moxie-Link take this further by integrating the care environment directly into research operations, producing real-world datasets that inform formulation, device design, and post-market surveillance. This turns every clinical encounter into a regulated, research-grade signal, without burdening clinicians.

How can AI translate real-world patient data into actionable intelligence for drug development and R&D?

AI’s true power lies in pattern recognition across messy, real-world data:

Natural language processing extracts phenotypes, comorbidities, and device usability feedback from unstructured clinical notes.

Predictive analytics detect adverse trends earlier than traditional reporting.

Human-factors telemetry quantifies how patients actually interact with medical devices in the wild.

Dynamic eligibility algorithms identify trial candidates at the point of care.

In Moxie-Link, these insights automatically feed dashboards that can refine protocols, identify responder subpopulations, optimize endpoints, and flag new safety signals. This shortens the feedback loop between bedside observations and R&D decisions.

How do you measure the real-world impact of AI platforms compared with traditional R&D methods?

Enrollment velocity: AI-assisted eligibility and digital recruitment accelerate accrual in decentralized or hybrid designs.

Data completeness & fidelity: Continuous remote monitoring outperforms episodic site visits.

Diversity & representation: Digital recruitment expands access to historically underserved populations.

Operational efficiency: Integrated documentation, billing, telemedicine, and monitoring reduce administrative burden and protocol deviations.

In deployments across 55+ facilities, we’ve seen marked improvements in screening-to-randomization conversion, documentation accuracy, protocol compliance, and retention, all of which translate into accelerated therapeutic timelines.

How should cross-disciplinary collaboration be structured to maximize innovation while ensuring accountability and security?

Success requires distributed expertise with centralized governance. Clinical leadership ensures AI outputs align with safety, clinical nuance, and regulatory requirements. Data science teams validate models, monitor drift, and maintain explainability. Human-factors engineers ensure usability for medical device submissions. Security & compliance officers oversee data governance, consent, and audit trails. Regulatory affairs map evidence requirements across FDA, EMA, and MDR pathways.

What unresolved barriers slow wider AI adoption in pharmaceutical manufacturing?

Regulatory ambiguity: Evolving expectations for AI/ML lifecycle management and change control for software-as-a-medical-device.
Solution: Continuous dialogue with regulators and adoption of transparency frameworks.

Data fragmentation: Heterogeneous electronic medical records, siloed registries, incomplete device telemetry.
Solution: FHIR-compliant architectures, bidirectional integration, and standardized data models.

Trust & explainability: Operators must understand why a model recommends an action. This is why we use human intervention as quality assurance to double-check the performance of AI.
Solution: Human-in-the-loop design and bias-detection dashboards.

Workforce readiness: Manufacturing teams need digital fluency. At Moxie, we created an academy with interactive courses to train staff and improve the customer experience.
Solution: Embedded training and intuitive user experience designed 

AI is revolutionizing drug development and pharmaceutical manufacturing by compressing timelines, reducing costs, and integrating real-world data. Platforms like Moxie-Link transform clinical encounters into actionable intelligence, enhancing protocol optimization, decentralized trials, and manufacturing efficiency. AI excels in pattern recognition, extracting insights from unstructured data to refine protocols and identify trial candidates. Real-world impact is measured through enrollment velocity, data fidelity, diversity, and operational efficiency. Cross-disciplinary collaboration with centralized governance is crucial for innovation. Barriers to AI adoption include regulatory ambiguity, data fragmentation, trust, and workforce readiness.

Gustavo Ferrer, MD, explains how AI accelerates drug development and manufacturing, streamlining clinical data into actionable pharma insights.

Turning Real-World Data into Actionable Drug Development Insights With AI

AI’s Impact on the Pharma Workforce and Hiring: From Obsolescence to Opportunity

During the panel discussion " AI’s Impact on the Pharma Workforce and Hiring: From Obsolescence to Opportunity" at 

, Andrew Mears, CEO of Lead Candidate; Manuela Herrlein, managing partner at Alpine One GmbH; and Neil Kelly, CEO of Vector Talent dissected the profound impact of artificial intelligence (AI) on pharmaceutical talent, skills development, and organizational structure. The discussion was moderated by Vivian Xie, pharma editor at Informa Markets. The conversation spanned critical themes, such as the urgent requirement for upskilling, the challenges of attracting technology specialists against competition from “big tech,” managing organizational resistance to change, and mitigating biases introduced by automated AI processes in recruitment.

How are skills and organizational agility evolving?

The pharmaceutical sector, especially in manufacturing, is rapidly moving away from purely mechanical operations toward data-intensive, technologically advanced processes, according to the discussion. The panelists note that while the industry’s maturity is "increasing fast," the skills needed to support this evolution are lagging. Historically, manufacturing relied on "people on the lines trying to get the status and how things went wrong." Now, the integration of AI, robotics, and supercomputing is expected to "amplify how your workforce can manage."

In response to this accelerated change, organizations must fundamentally rethink their approach to talent management. Instead of relying on rigid "succession bonds," companies need to be highly agile, the speakers state. One key challenge is defining future needs by asking: "‘What kind of problems do I need to solve for the future? And then I need to define what is the most important skill, and then slice and dice it." This agile approach also necessitates resource fluidity, asking if a needed skill exists in another business unit and if you "can.. just borrow it."

This need for adaptation impacts the traditional concept of skill refresh cycles, which have drastically shortened, according to the panel. In the past, refreshing skills took three to five years, or even ten years; now, it is needed "every six to 12 months." This constant need for development is challenged by employee mindset, as upskilling is difficult because "people don't know what's in it for [them, asking] ‘Why should I upskill [my employees]?’" However, companies are beginning to reward and recognize proficiency through programs that offer awards or badges for certain skills.

How can pharma compete with tech talent and overcome regulatory inertia?

As the panel discussed, a major hurdle for the biopharmaceutical industry is attracting high-tech talent, who now have more choices than ever due to advancements in technology. The industry has "lost talent to other industries," and the traditional path of "you go to university, you do chemistry, you move up… doesn't exist anymore." It is difficult to attract these professionals when "everybody wants to work at Microsoft.” The concept of "taking talent from technology in particular is really difficult."

To manage technological gaps, smaller players in particular should strategically leverage partnerships, continued the discussion. Instead of trying to "be more things than what we wanted to be doing," companies should focus on what they are good at and utilize partners for "the technology pieces," the speakers agree.

Beyond talent competition, the industry faces inertia rooted in its operating environment, the panelists stated. When asked why the industry is often "too traditional," the most common response to is the regulatory framework within which the industry operates, they said. This framework is often cited despite highly regulated industries like automotive already operating plants 20 years ago that "were more advanced than plants in the pharma industry that are being built today." Achieving change requires momentum "at a regulatory framework level," alongside building a convincing "business case of why should we be doing something?"

What is AI’s role in recruitment and bias mitigation?

The discussion turned to vital role of the human element despite AI’s increasing integration into recruitment. Recruiting leaders use AI to reduce administrative tasks, thereby giving them free time to speak with the candidates. AI should be seen as an opportunity to amplify human capabilities, the panelists note.

However, the rapid adoption of AI introduces significant bias risks, with the key to mitigation lying in AI design. It was stated that if the AI is designed around a company’s "most common unconscious bias that people do as they recruit in their own design," the resulting tool will perpetuate that bias. To counteract algorithmic biases and "Chat GPT bias" from candidates who optimize their applications, companies are increasingly utilizing "assessment centers where you basically invite the candidates... and then you let them interact, give them case studies, so that you really can see, without using a tool, how good they are."

How is IP protected while preparing the next generation?

The speakers note that a central challenge for “big pharma” in leveraging collective data is the protection of intellectual property (IP), adding that companies are "very conscious about opening up," maintaining a "very close environment" around their organization. The solution to balancing technological advantage with IP protection relies on partnerships, they say. This approach allows companies to feed AI infrastructure within their established economic framework, offering a level of comfort that avoids exposing internal IP to a broader, global tool. Furthermore, new regulatory frameworks are needed to protect IP while allowing "the advantage of the technology and its capabilities."

New entrants graduating into this environment must recognize that the future career path is not vertical but horizontal, embracing "gig work," according to the panelists’ discussion. While academics often struggle with the concept of non-linear careers, the greatest predictor of success for young adults is "the adaptability to learn." Networking is essential, and graduates "need to have a very, very good network."

Looking ahead, the speakers stated that while generative AI is now "at a plateau," having yielded significant productivity gains, the "next development space" is "agentic AI." This next phase will lead to scenarios in which employees have a machine, avatar, or agent as a "colleague." Despite these accelerating changes, efforts toward standardizing the collective use of AI technology across the sector are not currently visible, meaning "everybody here is slightly different."



AI is reshaping the pharmaceutical workforce, necessitating rapid upskilling and organizational agility. The industry faces challenges in attracting tech talent due to competition from big tech companies and regulatory inertia. AI's role in recruitment is growing, but it introduces bias risks that need careful management. Protecting intellectual property while leveraging AI requires strategic partnerships. The future workforce must adapt to non-linear career paths and embrace networking. As generative AI reaches a plateau, the next phase, agentic AI, will further transform the industry, though standardization remains elusive.

A panel at CPHI Frankfurt discussed how AI is transforming pharma talent, necessitating rapid upskilling, bias mitigation, and regulatory changes.