Pharma's AI ROI gap isn't strategy or tech; it's the missing workforce qualification step every other regulated capability requires.

Pharma's AI ROI Problem Isn't a Tech Problem but a Qualification Problem

In this episode, we discuss AI drug discovery hype, agent security risks, and why pharma's AI workforce bets remain unproven.

Manufacturing Intelligence: Sizing Up Pharma's Biggest AI Deals, Part Two

Three regulatory actions are converging to move biologics, gene therapy, and the ATMP platform forward quickly

Regulatory Actions Impacting Biologics

Modernizing infrastructures, record drug approvals, and harmonization were all positive regulatory advancements in July 2026.

Regulatory Roundup—July 2026

This episode of Pharma Fundamentals provides an introduction to hold times in biopharmaceutical manufacturing and how they differ from hold times in small-molecule drug manufacturing.

Pharma Fundamentals: An Introduction to Hold Times in Biopharmaceuticals

The use of artificial intelligence is facing harder questions of governance and data quality

PharmTech Weekly Roundup—July 17, 2026

Three regulatory actions are converging to move biologics, gene therapy, and the ATMP platform forward quickly, say Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, technical, Parexel.

How evolving regulatory expectations are reshaping pharma development and manufacturing.

Drug Digest April 2026

TILE-X with NEBULA. Image courtesy of IMA Group.

IMA Group announced that its Pharmaceutical and MedTech divisions will present their capabilities as an all-in-one supplier specializing in the design and manufacture of innovative machines and complete lines for packaging and processing pharmaceutical, nutraceutical, and medical products at 

IMA's presence at the show will highlight the company’s continued investment in digitalization, sustainability, and customer service solutions, reflecting its broader mission to support the pharmaceutical ecosystem in becoming more efficient and responsible.

IMA Life’s TILE-X line will make its Italian debut at CPHI Milan following its world premiere at Interpack 2026. The TILE-X fill-finish technology is built to handle ready-to-use components through magnetic levitation. The system is designed for high-value pharmaceuticals, including biopharmaceuticals and advanced therapy medicinal products (ATMPs), with particular attention to cell and gene therapies. By relying on magnetic levitation, TILE-X allows for frictionless component handling with zero risk of particulate generation, while extending a level of modularity that IMA describes as unprecedented in aseptic fill-finish processing.

Also on display will be the new IMA VPHP BioIndicator, which will be featured at the IsoTech Lab, a dedicated corner for the company's Isolator Research & Development Laboratory. Developed to complement Microbiological Support Services, this next-generation biological indicator is designed specifically for VPHP bio-decontamination cycles used in isolators. It supports cycle development, performance qualification, re-qualification, and ongoing contamination control strategies, delivering 6-log sporicidal performance. The indicators are based on Geobacillus stearothermophilus spores (ATCC 12980) and packaged in VPHP-permeable packaging.

On the drug delivery side, IMA will showcase the X PEN LAB, a semi-automatic solution suited to clinical trials and small-scale production. The system offers accurate press-in assembly with monitored force distance measurement and supports multi-variant manufacturing through manual loading and offloading, making it well suited to early-stage development work. X PEN LAB is part of the broader X PEN Series, IMA MED-TECH's standard platform for pen and autoinjector final assembly. Built on a linear magnetic transport system, the X PEN platform supports production speeds ranging from 40 to 160 units per minute, with integrated options including vision inspection, no-glass-to-glass prefilled syringe handling, force-distance-controlled assembly, priming, and labeling.

These product highlights sit within IMA Pharma's broader structure as an all-in-one supplier composed of 5 specialized divisions. IMA Active focuses on solid dose solutions, offering granulation equipment, tableting machines, capsule filling machines, and coating systems, and has expanded into continuous manufacturing following its 2021 acquisition of Thomas Engineering, now Thomas Processing, a longtime leader in coating technology.

IMA Life covers aseptic processing and freeze-drying solutions across production sites in Italy, North America, Beijing, and Shanghai, with a portfolio spanning vial and ampoule washing, filling and closing systems, containment solutions, and lyophilization technologies. IMA Safe specializes in primary and secondary packaging lines for pharmaceutical, nutraceutical, and cosmetic products, while IMA BFB provides end-of-line packaging solutions, including case packing, palletizing, and robotic handling. IMA MED-TECH, part of IMA Automation, rounds out the group with turnkey assembly technologies for medical devices such as injectors, inhalers, and diagnostics.

Together, IMA’s divisions combine specialized equipment, technology, and expertise across the full pharmaceutical manufacturing and packaging chain, a breadth the company will bring into focus for attendees at this year's CPHI Milan.

 this year. In the Innovation Catalyst category, the company’s ASSEMBLA, scalable, device centric assembly platform, which enables end-to-end medical device industrialization, is nominated. And in the Manufacturing Excellence category, its tableting platform, DOMINA, is in the running. Winners will be announced on October 6 at a networking reception.

IMA Pharma and IMA MED-TECH can be found at Booth 9C2 at CPHI Milan 2026. For more of 

IMA PHARMA and IMA MED-TECH at CPHI Milan 2026. Press release. IMA Group. Email sent September 9, 2026.

CPHI Milan Pharma Awards 2026 Finalists Announced. Press release. Informa Markets. September 1, 2026.

Articles

IMA Group will present its Pharmaceutical and MedTech divisions at CPHI Milan 2026 as an integrated supplier across processing, aseptic fill-finish, and packaging. The showcase emphasizes ongoing investment in digitalization, sustainability, and customer service. Key exhibits include IMA Life’s TILE-X magnetic-levitation fill-finish line for ready-to-use components targeting high-value biologics and ATMPs, plus a VPHP-specific bioindicator for isolator decontamination validation. Drug-delivery manufacturing will feature the X PEN LAB and broader X PEN platform for pen/autoinjector assembly. Two CPHI Award nominations round out the presence.

The IMA Pharmaceutical and MedTech divisions will be highlighting the TILE-X fill-finish line, a new VPHP BioIndicator, X-PEN autoinjector platform, and a range of machines from its IMA Active, IMA Life, IMA Safe, and IMA BFB divisions at the CPHI Milan event.

IMA Group to Showcase All-in-One Solutions at CPHI Milan

Sri Harsha Chakrapani is a process engineer focused on oral solid dosage validation, cleaning validation, pharmaceutical manufacturing risk, and quality systems. His work focuses on connecting validation lifecycle activities with practical manufacturing performance, batch-release reliability, and operational resilience.

Close up of white round tablets on white background. | Image Credit: ©uduhunt -stock.adobe.com

Organizations sometimes treat validation as a document trail that follows manufacturing. In oral solid dosage (OSD) operations, that view is too narrow. A batch record, protocol, or report may be the visible artifact, but the real purpose of validation is to show that the process is understood, controlled, and capable of routine performance within a defined operating space.

That distinction matters in commercial manufacturing. Tablets and capsules move through linked operations, such as dispensing, blending, granulation when applicable, drying, milling, lubrication, compression, coating, packaging, and cleaning between campaigns. A weakness in 1 part of the chain rarely stays isolated. It can become a deviation, laboratory investigation, batch hold, repeat cleaning event, or change-control question. In that sense, validation helps keep the manufacturing system stable.

The FDA’s lifecycle approach to process validation places process design, process qualification, and continued process verification into 1 connected model.

 In site language, validation should not end when the process performance qualification (PPQ) report is approved. PPQ provides evidence at a point in time. Routine production then tests whether the control strategy remains effective under normal variation in materials, operators, equipment condition, cleaning cycles, and schedule.

The business consequence of weak validation is often indirect (

). A process may not immediately fail a specification. Instead, the site may see longer investigations, more conditional batch dispositions, slower quality assurance (QA) review, or repeated technical discussions that do not resolve the underlying issue. These burdens consume manufacturing capacity and reduce confidence in the production plan.

Figure 1. Validation signals across the commercial oral solid dosage lifecycle. (Figure courtesy of the author)

How OSD Processes Create Downstream Disruption

OSD processes are especially sensitive to accumulated variation. Raw-material attributes can affect blend uniformity or granule behavior. Drying can influence residual moisture, flow, compression performance, and dissolution. Milling can change particle-size distribution. Lubrication can affect hardness, friability, and dissolution. Compression can influence weight, thickness, hardness, capping, sticking, and content uniformity. Coating can affect appearance, weight gain, stability, and release characteristics.

Manufacturing and validation teams are familiar with these examples, but they are not always translated into continuity risk. If the validation package does not explain which parameters matter, why limits were selected, and how routine monitoring should respond to adverse trends, the site has a weaker basis for decisions under pressure. During demand increases, campaign changes, equipment problems, or material variability events, that weakness becomes more visible.

Public Examples that Illustrate the Continuity Risk

Public regulatory records show why this point is practical rather than theoretical. FDA’s OSD inspection guide notes that production-scale validation problems have included dissolution, content uniformity, and potency issues.

 In commercial operations, those issues can affect batch disposition, release timing, inventory confidence, and supply planning.

A FDA warning letter involving potassium chloride extended-release capsules described several dissolution failures and questioned whether the company had sufficiently evaluated process changes and API-related explanations.

 The useful lesson is not company-specific: dissolution performance can connect formulation behavior, material attributes, process changes, investigation quality, and continuity of supply.

Cleaning validation provides a second public example. FDA warning letters have cited inadequate cleaning validation or verification on non-dedicated equipment, including residue and cross-contamination concerns.

 In shared-equipment OSD environments, that weakness can remove equipment from service, delay campaigns, increase laboratory workload, and reduce scheduling flexibility (

). Used carefully, public examples reinforce that validation gaps can become continuity risks when technical uncertainty reaches routine manufacturing.

Table 1. Examples of Weak Validation Signals and Potential Continuity Consequences

Cleaning Validation and Capacity Protection

Cleaning validation is correctly grounded in patient safety, current good manufacturing practice (CGMP) expectations, and contamination control.

 Residue limits, sampling locations, recovery studies, visual inspection, analytical method suitability, and dirty and clean hold times must be scientifically justified. At the same time, cleaning validation also affects capacity. Commercial OSD facilities depend on predictable changeovers. When cleaning is uncertain, equipment is not reliably available for the next product or strength.

A recurring cleaning issue can delay campaign starts, increase laboratory workload, force repeat cleaning, and consume QA and manufacturing time. It may also limit flexibility when the schedule changes. A strong cleaning-validation program therefore supports both product quality and operational predictability. The point is not to treat cleaning validation as a scheduling tool; it is that scientifically sound cleaning controls help protect the schedule from avoidable uncertainty.

Continued Process Verification as an Early Warning System

Continued process verification (CPV) is 1 of the most practical links between validation and business continuity. In many organizations, CPV can become a periodic reporting exercise. The more useful approach is to treat CPV as a technical review of whether the process remains in control. For OSD products, useful signals may include assay, content uniformity, dissolution, tablet weight, hardness, thickness, friability, compression force, coating weight gain, yield, and recurring deviation themes.

The value of CPV is not that it produces charts. The value is earlier visibility. A small drift in compression behavior, a recurring moisture-related trend, or a slow change in dissolution performance is easier to manage when detected early. If the pattern is discovered only after multiple deviations or a rejected batch, the site has lost time, capacity, and options. CPV, when reviewed with process knowledge and quality risk management principles, helps technical teams act before the problem becomes repetitive.

Deviation management is another place where the validated state can either be protected or slowly weakened. A deviation investigation that closes with a narrow correction may satisfy an immediate procedural need, but it may not explain the technical cause. If similar deviations continue to appear, the site should question whether the process understanding, control strategy, cleaning approach, or training model is sufficient.

Change control has the same role. Supplier changes, equipment modifications, formulation adjustments, cleaning-procedure updates, analytical-method changes, and process-parameter revisions can all affect the validated state. A strong change-control process does more than ask whether a document must be revised. It asks whether process knowledge supports the change and whether additional validation, verification, monitoring, or risk assessment is required. This is consistent with the broader pharmaceutical quality-system expectation that knowledge and risk management should support lifecycle control.

Managing Validation as an Operating Signal

For site leadership, validation-related metrics should be viewed alongside operational metrics as part of a broader quality-system approach.

 Recurring deviations, repeat cleaning failures, late CPV reviews, unresolved adverse trends, long investigation cycle times, and unplanned batch holds are not simply compliance indicators. They are signals about the health of the manufacturing system.

This does not mean validation should be managed as a finance function. It means manufacturing, QA, technical operations, engineering, laboratory, regulatory, and supply chain teams should understand validation as a shared control system. The same validated state that supports inspection readiness also supports batch release, equipment availability, schedule reliability, and patient supply (

Table 2. Validation Lifecycle Elements and Business-Continuity Value

The Value of Disciplined Process Knowledge Validation

OSD validation should not be reduced to a successful PPQ campaign or a completed report. Those outputs matter, but they are only part of the lifecycle. The larger value is the disciplined process knowledge validation creates and maintains.

A process that is understood, controlled, monitored, and supported by effective deviation and change management is better positioned to keep working under routine commercial conditions. Public regulatory examples involving dissolution problems and cleaning validation weaknesses reinforce the same point: validation gaps do not remain inside the validation file. They can affect investigations, release, equipment availability, and supply reliability. That is why validation is also part of business continuity in commercial OSD manufacturing.

Process Validation: General Principles and Practices. Guidance for Industry.

Oral Solid Dosage Forms Pre/Post Approval Issues. Inspection Guide. FDA. January 1994.

Glenmark Pharmaceuticals Limited, Warning Letter 708270. FDA. July 11, 2025.

KVK-Tech, Inc., Warning Letter 608236. FDA. October 8, 2020.

Mylan Pharmaceuticals, Inc., Warning Letter 557903. FDA. November 9, 2018.

21 CFR Parts 210 and 211, Current Good Manufacturing Practice for Finished Pharmaceuticals.

Quality Systems Approach to Pharmaceutical CGMP Regulations. Guidance for Industry

Validation in commercial OSD manufacturing is a lifecycle control system—not merely a PPQ report—demonstrating process understanding, robustness, and capability within a defined operating space. Because dispensing through packaging are tightly coupled, unaddressed parameter uncertainty propagates into deviations, investigations, batch holds, and capacity loss. FDA’s lifecycle model underscores the need for continued process verification (CPV) as early warning for drift in critical quality attributes. Public dissolution and cleaning-validation enforcement examples illustrate how gaps undermine batch release, equipment availability, and supply reliability.

 In commercial tablet or capsule operations, validation helps protect the site’s ability to produce, release, and supply product without repeated disruption. This article discusses validation as a technical control system that supports manufacturing continuity.

Why Oral Solid Dosage Validation Is a Business Continuity Function, Not Just a Compliance Requirement

Sherry Gu, PhD, executive vice president, chief technology officer and chief client officer of WuXi Biologics.

Businessman using laptop to manage digital document with file transfer interface, data exchange, cloud storage, workflow automation, document management system concept for modern business technology. | Image Credit: ©THAWEERAT -stock.adobe.com

Technology transfer is crucial for converting new innovations into commercially viable products that can be produced reliably and consistently, at scale, and across manufacturing sites and geographic regions. Historically, technology transfer was primarily focused on ensuring successful knowledge and process transfer between sites and manufacturing stages.

 Today, sponsors expect far more: comparable product quality, predictable timelines, commercial readiness, supply reliability, and competitive performance at speed.

Most technology transfers follow a familiar process, but outcomes differ. Some programs progress smoothly from development into commercial supply, while others encounter delays, unexpected process behaviors, scale-up challenges, or costly post-transfer remediation.

In considering the factors behind smooth versus struggling technology transfers, 4 shifts may explain why some technology transfers stay on track while others struggle. These variations shift the focus from knowledge transfer, comparability, process transfer, and experience-based decisions to risk identification, commercial readiness, value creation, and data-driven decisions (

). In practice, organizations that consistently achieve successful technology transfers are those that identify risks earlier, establish commercial readiness faster, and leverage accumulated process knowledge more effectively.

Table 1. Four Shifts Enabling Faster, Lower-Risk, And Commercially Successful
Biologics Technology Transfer

Technology transfer is often viewed as the movement of documents, data packages, and process descriptions from 1 organization to another. This explains a historical focus on knowledge transfer. However, in today’s increasingly complex biologics industry, the greater challenge is understanding what may still be unknown.

Even comprehensive transfer packages can leave important knowledge gaps. Critical process understanding may reside in development experience, manufacturing history, troubleshooting records, or tacit knowledge held by technical teams. International Council for Harmonisation (ICH) Q10 recognizes that technology transfer extends beyond documentation exchange and requires effective knowledge management and quality risk management to support product realization.

Successful technology transfer therefore begins with systematic risk identification. Many of the highest-impact risks emerge at the interfaces between process, equipment, materials, facilities, analytical methods, and operations. To address these challenges, a multidimensional risk-assessment approach should be applied to identify gaps that may not be apparent from transfer documentation alone.

Rather than relying solely on transferred information, teams should challenge assumptions through facility-fit assessments, equipment compatibility reviews, analytical bridging strategies, process robustness evaluations, and structured risk-management workflows. Standardized transfer tools, technical risk checklists, equipment databases, and harmonized documentation systems help identify gapsfaster while ensuring critical risks are evaluated consistently.

), in which process issues were successfully and proactively resolved through extensive investigations and targeted process optimization, demonstrated how successful technology transfer is not defined by the absence of risk. Rather, it is defined by the ability to anticipate and manage risk early enough to prevent it from affecting manufacturing performance.

Figure 1. Case study: Turning process uncertainty into transfer confidence. (Figure courtesy of the author)

Execution speed is a critical dimension of commercial readiness. Transfer delays can affect process performance qualification readiness, biologics license application timelines, and launch planning. Accelerated technology transfer requires eliminating uncertainty earlier and enabling faster decisions through standardized execution.

While every program presents unique challenges, standardized execution frameworks can significantly compress transfer timelines. Supported by harmonized methodologies, platform-based process knowledge, and globally aligned documentation practices, some transfers have been completed in as little as 3.5 months for commercial manufacturing programs, 50% faster than the industry average.

For example, comparability is essential in technology transfer, but it alone does not guarantee commercial success. As programs advance toward commercial supply, processes frequently transition across scales, equipment platforms, manufacturing sites, and geographic regions. Each transition introduces variables that can affect process performance, operational execution, and supply continuity.

Single-use technologies, for example, are reshaping biologics manufacturing by enabling greater agility, faster deployment, and enhanced operational flexibility throughout the product lifecycle. As organizations continue to expand and optimize their manufacturing networks, seamless transfer between stainless-steel and single-use systems has become an important capability for accelerating commercialization.

Technology transfer teams can apply standardized methodologies, engineering understanding, and accumulated platform knowledge to ensure consistent process performance while capturing the flexibility benefits of modern manufacturing systems. In an example, a biologics program was successfully transferred between manufacturing platforms while maintaining comparable process performance and product quality attributes. The program demonstrates how standardized transfer frameworks, robust process understanding, and platform expertise can translate manufacturing flexibility into faster commercial readiness (

Figure 2. Case Study: Seamless Transition from Stainless Steel to Single-Use Manufacturing. (Figure courtesy of the author)

Another urgent license-out program illustrated how, following comprehensive gap analysis and risk assessment, a customized transfer strategy was established within 2 weeks, enabling drug substance delivery only 70 days after vial transfer-in while maintaining high quality and supply continuity.

Commercial readiness also extends beyond a single manufacturing facility. Harmonized technology transfer practices, globally aligned quality systems, dual-sourcing strategies, and integrated product development, manufacturing science and technology, and manufacturing teams help support supply resilience across facilities and regions.

Ultimately, commercial readiness is about demonstrating that a process can run reliably, at scale, on the intended manufacturing platform, within the required timeline, and across a resilient global supply network.

Achieving commercial readiness is not necessarily the end of the technology transfer journey. The next challenge isunlocking greater manufacturing value. For commercial biologics,improvement in productivity, manufacturing efficiency, material utilization, and cost of goods (CoGs) can significantly strengthen long-term competitiveness, even when product quality remains unchanged.

Technology transfer therefore represents the prospect to systematically improve manufacturing performance before commercial execution becomes locked through validation and regulatory filings.

Potential opportunities may include optimizing material consumption, improving manufacturing productivity, increasing process intensity, enhancing batch consistency, and strengthening process control. When these improvements are evaluated and implemented during technology transfer, organizations may achieve measurable long-term manufacturing benefits. Because media, resins, filters, and membranes can represent a significant portion of manufacturing costs,material optimization, load-capacity enhancement, and lifecycle extension can improve economics while maintaining process control and product quality.

Process intensification represents a second lever. Intensified fed-batch and perfusion approaches can increase productivity, improve facility utilization, and expand drug substance output without requiring proportional increases in manufacturing footprint.

For example, compared with conventional fed-batch processes, an ultra-intensified fed-batch platform can deliver 25–85 kg of drug substance per 2000 L batch while reducing CoGs to 15% to 30% of conventional fed-batch levels. Similarly, a intensified perfusion culture platform can deliver up to 40–100 kg of drug substance per 2000 L batch while reducing CoGs to 20% to 50% of conventional fed-batch levels.

A third lever is productivity improvement through deeper process understanding and process control. Advanced monitoring, process analytics, and automated control strategies help identify golden batches, establish optimal operating ranges, and improve consistency and drive for more efficient commercial manufacturing.

A commercial manufacturing program utilizing these levers demonstrated marked improvements in drug substance output and manufacturing costs. Through media optimization and the adoption of a ultra-intensified fed-batch bioprocessing platform, the optimized process delivered approximately 4-fold and 3-fold increases in product titer for 2 antibody molecules while maintaining comparable product quality attributes. The substantial productivity gains and media change translated into a 30% to 40% reduction in CoGs, demonstrating how technology transfer can serve not only as a pathway to commercial manufacturing, but also as an opportunity to enhance long-term process economics and manufacturing competitiveness (

Figure 3. Case study: Turning commercial transfer into long-term manufacturing value (Figure courtesy of the author)

As biologics become increasingly complex, technology transfer teams are facing a new challenge: how to convert growing volumes of process data into actionable decisions.

Traditionally, critical information remained fragmented across manufacturing systems, analytical platforms, and process reports. Today, digital technologies are creating a more integrated view of process performance, enabling teams to identify trends earlier, evaluate potential outcomes before implementation, and accelerate decision making throughout technology transfer and commercialization.

One emerging application is the use of digital-twin technologies to improve process understanding and control. By combining process data, predictive analytics, and mechanistic modeling, these approaches can help evaluate process performance, assess potential risks, and support decision-making before changes are implemented at manufacturing scale. For example, a digital twin platform (eg, PatroLab, WuXi Biologics) integrates in-line sensor data, Raman spectroscopy, manufacturing datasets, process models, and simulation capabilities into a unified digital ecosystem. The platform supports real-time monitoring of more than 40 in-process parameters and quality attributes while enabling 

Digital tools also provide visibility into how a process is evolving during execution. Predictive algorithms can monitor indicators such as viable cell density, glucose consumption, lactate accumulation, and product titer, helping teams recognize abnormal trends earlier and respond proactively.

Digital technologies are also increasingly being applied to facility-fit assessments, scale-up evaluations, and technology transfer planning. Increasingly, the most successful organizations will combine scientific expertise with digital intelligence, allowing the move from reactive troubleshooting toward predictive, data-driven decision-making.

Comparability, repeatability, and robustness remain the foundations of successful technology transfer, but in today's biologics industry, they are no longer enough.

Technology transfer has evolved from an operational handover to a strategic enabler of commercialization. Sponsors increasingly expect technology transfer toaccelerate commercial readiness, improve manufacturing economics, and strengthen long-term competitive advantages.

Organizations that consistently achieve these outcomes are not necessarily those executing more transfer activities. They are the ones that anticipate risks earlier, establish commercial readiness faster, create greater manufacturing value, and use digital intelligence to support better decisions.

In this new paradigm, technology transfer is no longermeasured by how effectively knowledge is transferred, but by how effectively that knowledge is transformed into a real commercial success.

Sherry Gu, PhD, is executive vice president, chief technology officer, and chief client officer of WuXi Biologics.

Technology transfer in biologics has shifted from document-focused handoffs toward a commercialization engine defined by early risk surfacing, rapid readiness, manufacturing value capture, and data-enabled decisions. High-impact risks often emerge at interfaces among process, equipment, materials, analytics, and operations, requiring structured, multidimensional assessments beyond transfer packages. Standardized execution frameworks and platform knowledge can compress timelines while maintaining comparability across sites and manufacturing platforms. Transfer windows also enable CoGs and productivity improvements via material optimization, intensification, and advanced control. Digital twins and predictive analytics increasingly convert fragmented datasets into proactive, simulation-supported decisions.

This article explains the 4 shifts enabling faster, lower-risk, commercially successful biologics technology transfer.

Technology Transfer: Success Drivers and Obstacles Explained 

Christy Owings is Vice President and General Manager, Clinical Trials, Americas, at Thermo Fisher Scientific. With more than 20 years of progressive leadership experience in drug development support, 16 of them at Thermo Fisher Scientific, she has built deep expertise across quality assurance, client services, program management, sales and general management. In her current role, she leads 18 sites across North and South America, overseeing clinical trials services, global supply management, and government operations for the Americas region.

Christy Owings, Thermo Fisher, talks on why importer of record strategy and vetted local partners are key to reliable clinical trial supply chains.

How to Vet Importer of Record Partners for Clinical Trials

Managing customs and importation in global clinical trials requires more than logistics contracts, according to Christy Owings, vice president and general manager of the Americas business unit at Thermo Fisher Scientific. Owings connected with 

to discuss how sponsors should approach importer of record planning at the protocol design stage rather than treating it as an afterthought.

Owings emphasizes that clinical trial sponsors need local, on-the-ground expertise when navigating customs authorities in unfamiliar markets. Clinical materials carry regulatory and patient-safety stakes that demand a different level of oversight.

That oversight comes down to relationships and accountability. "I want to know that I can contact a person who knows the process and is able to leverage and advocate on my behalf there in country," Owings says. She points to a depot's track record with customs officials as a factor sponsors should weigh: repeated importations tied to a known, compliant address build the kind of trust that keeps shipments moving without delay.

Owings' broader point centers on partner selection. Working with an organization that has physical infrastructure, such as brick-and-mortar depots, in the regions where a trial operates gives sponsors direct lines of communication when customs questions arise, rather than relying on intermediaries unfamiliar with local requirements.

For CMC, quality, and clinical operations teams weighing importer of record strategy, the discussion underscores a recurring theme in global trial logistics: early planning and local presence reduce the risk of costly customs delays down the line.

Videos

Christy Owings, Thermo Fisher, speaks on why importer of record strategy and vetted local partners are key to reliable clinical trial supply chains.

Silvia Forroova is the director of Partnerships & Sustainability for the CPHI portfolio at Informa Markets. With more than 18 years of experience in global events, she specializes in strategic partnerships within the pharmaceutical industry.

Silvia leads sustainability initiatives across the CPHI portfolio of events, developing strategies that drive positive environmental impact for trade events and the wider pharmaceutical industry. She is also the founder of the Sustainability Collective, an impact network that brings together change-makers from across the pharmaceutical industry to foster collaboration, share insights, and drive tangible progress on sustainability challenges.

Silvia Forroova, Director of Partnerships & Sustainability at CPHI, and founder of the CPHI Sustainability Collective

Sustainability efforts have become a part of the pharmaceutical manufacturing landscape and play into regulatory requirements for environmental assessments.

 Driven by multiple factors, such as supply chains, regulations, and consumer expectations, actions to reduce emissions and responsible sourcing have entered into product design.

 Ingredient selection, packaging material choice, and supply chain decisions all play a role in a sustainable manufacturing.

In 2026, Informa Markets is introducing the Sustainability Summit to CPHI Milan, which is being held from October 6-8, to help those working in drug development and manufacturing better navigate the sustainability landscape. 

spoke with Silvia Forroova, director of Partnerships & Sustainability at CPHI, and founder of the 

 and how it can help organizations meeting their sustainability goals.

PharmTech: What key challenges are pharmaceutical companies facing today in trying to make their sustainability initiatives commercially viable, not just environmentally sound?

The biggest challenge I see a lot of times is sustainability gets treated as a cost and not as an investment. And, what I hear when I talk to pharma leaders, and all of this is fair as well, is that there are regulatory complexity and short-term financial pressures within organizations, supply chain opacity, and very much also lack of standardized metrics.

The companies really winning now are the ones reframing sustainability as risk mitigation and competitive advantage and kind of focusing on that co-creation with, for example, their supplier groups, looking at tools to apply and compare with peers and partners to see how they can find ways to work together and thinking about medium-to-long-term strategy around sustainability and resilience and value creation around their businesses.

Why is knowledge sharing among pharmaceutical stakeholders so critical to advancing sustainability initiatives industry-wide, and what gaps currently exist in how that knowledge gets exchanged?

I think the reality is that sustainability in pharma isn’t a competitive advantage anymore.

It’s an imperative, and regulators like the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), now require environmental risk assessments as part of product authorizations.

And investors are considering and sometimes scrutinizing Scope 3 emissions within organizations and companies in the industry, and patients and healthcare systems are demanding greener medicines.

So, knowledge is still fragmented, and sometimes companies are trying to reinvent the wheel.

I really have seen gaps in data collection and sharing. There is a lot of talk about supplier engagement, cross-functional collaboration, really getting the buy-in from different parts of the pharmaceutical businesses.

And so more than ever before, I think sharing, collaborating, and co-creating are critical for the industry.

What role can a Summit like this play in helping organizations move from sustainability ambition to measurable, commercially viable solutions?

This is where events like the CPHI Sustainability Summit become gamechangers. We are not here to talk about why sustainability matters anymore. Everyone knows that. We're here to tackle the how.

And the summit, does three things, well. CPHI is the place known for bringing buyers and suppliers together and bringing together wonderful community and different parts of the supply chain. And so, the summit, first, creates a safe space for honest conversations, and that's where real innovation and collaboration happen.

Secondly, it also connects dots across the value chain because you have different parts of the value chain present at CPHI. This year, we are expecting 60 to 70,000 people at the 3-day exhibition, and so you've got your key players there, and you've got green chemistry experts. You have packaging innovators, supply chain strategists, and regulatory specialists all in these rooms at the event.

And, the third piece is really about accountability, taking the learnings, connections back to your business and applying them, that we will do via, for example, hackathon at the event.

So, you know, we are really trying to create something that is beyond a conference, and it's really about creating spaces for these conversations that lead to action being taken.

How can a forum like the Summit help bridge the gap between sustainability planning and practical, on-the-ground implementation?

I have been saying this for a while, and I keep to this. We did not want to create a conference where you go into sessions, and you leave and you've heard some fantastic stuff. The summit won’t be a lecture series. It is a working session. We’ve designed it around the pillars of peer learning and meeting with people you want to meet, matchmaking style, and actionable frameworks.

And I think also the secret sauce will be follow-up. So, the Sustainability Collective, for example, doesn’t end when the summit does. We’ll follow up with reports and updates via the Sustainability Collective for our members, so the community can really carry on the good work and apply what they heard from peers on stage and while networking at the event, and I think that's how you can move from planning to implementation.

We really want to ensure that people leave with key takeaways of each session that they can bring back to their jobs, their businesses, their work with partners.

What does success look like in terms of measurable outcomes coming out of an event like this, and how should organizations track progress after they leave?

I think success for the summit is about what changed after the delegates and attendees left in their businesses and in the industry as well, whether that is immediate outcomes and adoption of shared frameworks or looking at medium-term outcomes such as reductions in their scope 1, 2, and 3 emissions, cost savings around waste reduction, energy efficiency or circular packaging, for example. [There are] longer-term outcomes as well when it comes to regulatory compliance ahead of mandates, market differentiation through sustainability leadership, thought leadership in general, and industry-wide adoption of best practices, pioneered, shared, spoken of at the summit, then being taken further into the pharma industry.

Across manufacturing, supply chains, packaging, and green chemistry, where do you see the greatest opportunity for the Summit to help translate sustainability ambitions into tangible business outcomes?

The delegates will be able to join diverse sessions focusing on anything from green chemistry to data to packaging to sustainable clinical trials, and many more. And consideration application, of course, depends on the industry actors themselves.

We know that strides are being taken in many areas and parts of the supply chain already, and we've been working with, amazing, thought leading organizations via the Sustainability Collective, such as PSCI, BioPhorum, Alliance to Zero, My Green Lab, HPRC, CiPPPA, and many more.

My humble recommendation is that if you are a pharma sustainability practitioner, decision-maker, or influencing decisions within your organizations, the summit is the place to meet your peers old and new and really hear from industry experts and giants on the latest of what's happening in pharma sustainability.

So, you can take it back to your work. You can consider, discuss, plan, strategize, get investment and apply after the summit. I really feel that the pharma industry has been in the last handful of years at an inflection point, and sustainability is a regulatory, financial, and reputational necessity.

It really belongs to that resilience piece for the industry and for the organizations within. And so, we designed the summit to enable exactly this and turning ambition into action and action into measurable business outcomes.

Environmental risk assessment of medicinal products for human use - Scientific guideline. European Medicines Agency. Accessed August 11, 2026. 

https://www.ema.europa.eu/en/environmental-risk-assessment-medicinal-products-human-use-scientific-guideline#current-version-effective-from-1092024-7647

Environmental Assessment of Human Drug and Biologics Applications. Guidance for Industry.

 FDA. July 1998. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/environmental-assessment-human-drug-and-biologics-applications

Sustainability in the pharmaceutical industry. ABPI. Accessed August 11, 2026. 

https://www.abpi.org.uk/reputation/sustainability-in-the-pharmaceutical-industry/

Lin L and Devadas P. Strengthening sustainability through smarter ingredients: designing resource-efficient formulations. 

 eBook. March 28, 2026. https://www.pharmtech.com/view/strengthening-sustainability-through-smarter-ingredients-designing-resource-efficient-formulations

Sustainability has become embedded in pharmaceutical manufacturing through product design choices spanning ingredients, packaging, and supply chains, increasingly shaped by regulations and stakeholder expectations. Commercial viability is often hindered by short-term financial pressures, supply-chain opacity, and nonstandardized metrics, reinforcing the misconception of sustainability as a cost rather than an investment. A new Sustainability Summit at CPHI Milan 2026 aims to shift focus from “why” to “how” via cross–value chain engagement, practical working sessions, and post-event follow-up through the Sustainability Collective to drive measurable emissions, waste, and compliance outcomes.

Silvia Forroova, director of Partnerships & Sustainability at CPHI, and founder of the CPHI Sustainability Collective, provides a preview of the new Sustainability Summit at CPHI Milan 2026.

Putting Sustainability to Work in Pharma

Alfred Rumondor, PhD, CMC Support for Due Diligence for External Assets at AbbVie.

Swita Singh, PhD, Senior Director and Strategic CMC Leader at Bristol Myers Squibb. Dr. Swita Singh holds a Ph.D. in Pharmaceutical Sciences and brings over fifteen years of distinguished expertise in Chemistry, Manufacturing, and Controls (CMC) development across biologics, antibody drug conjugates, and small molecules, with a proven record of driving strategic initiatives, optimizing complex business processes, and leading cross-functional teams to achieve regulatory and operational excellence. Recognized for delivering innovative, end-to-end CMC strategies that guide programs from early clinical development through successful commercialization, she has cultivated talent and shaped organizational culture throughout her career, while her commitment to stakeholder communication and cross-functional collaboration has consistently advanced program objectives across the industry. Having built her expertise at Pfizer and Eli Lilly and Company, Dr. Singh currently serves at Bristol Myers Squibb (BMS), where she continues to lead CMC strategy in support of transformative therapeutic development.

AAPS PharmSci 360: CMC Strategies, Part 2

 spoke with Alfred Rumondor, PhD, director, Development Sciences Licensing and Acquisitions,at AbbVie, and Swita Singh, PhD, senior director and strategic CMC leader at Bristol Myers Squibb, to learn more about their upcoming panel discussion, Navigating CMC Strategy in the Current Landscape, at 

, which is being held from October 25-28 in New Orleans. In part 2 of this 3-part interview, Rumondor and Singh, discuss how chemistry, manufacturing, and controls (CMC) teams navigate modalities with little regulatory precedent, plus where AI is delivering real value in CMC work.

Singh addresses the challenge facing cell and gene therapy products, in vivo gene editing, and cell-based combination products, which is that modalities often lack established regulatory guidance. Singh suggests that when precedent doesn't apply, teams should return to the core statutory and quality standards of identity, strength, quality, purity, and potency, then build a control strategy around the modality’s specific risk factors.

She also recommends deliberately leveraging adjacent precedent, even without direct guidance for a given modality, relevant precedent from related modalities may still apply. She urged sponsors to engage the FDA early and often through formal pathways like INTERACT meetings and Type B pre-investigational new drug approval meetings, rather than waiting for guidance documents to be issued; these programs exist specifically for precedent-free scenarios, and proactive engagement helps bring the agency along the development journey.

Finally, Singh advised planning for iteration from the outset: new, precedent-free modalities inevitably require more comparability work as manufacturing is refined, so companies should establish a comparability protocol and a banked reference material strategy from day one rather than reacting later.

Rumondor provided his insight on how AI is reshaping CMC work by simplifying tasks once considered labor- and resource-intensive, using computational approaches to accelerate work that previously took significant time and effort. He emphasizes that AI doesn’t eliminate the need for experimentation but enhances it. As an example, he points to solid-form selection during development, where AI—paired with computational modeling—can help investigate potential stable forms, dramatically cutting the number of required experiments and enabling faster, more comprehensive form selection. He notes this is just one of many role-specific applications, all pointing toward smarter, faster work with fewer resources.

Click the video above to watch the interview.

In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discuss navigating CMC requirements for new modalities and AI’s involvement in CMC. 

Christy Owings, Thermo Fisher, on how customs delays and import complexity risk clinical trial supply chains in Latin America.

Managing Global Trial Supply Risk: Insights From Thermo Fisher

Christy Owings, Vice President and General Manager of the Americas business unit, Thermo Fisher Scientific, connected with 

 to discuss the growing complexity of global clinical trial supply chains. Owings has spent more than 16 years with the company, all within clinical supplies delivery, and now oversees 18 sites across North and South America.

"I think what we see is that clinical trials as a whole are becoming ever globalized and more complex,” Owings says. Rising complexity puts a premium on early planning and a solid global supply chain infrastructure, she adds.

Owings points to Latin America as a region where sponsors often underestimate the logistics involved in bringing investigational product across borders. Sponsors need a green-light-to-ship process in place before importation, plus documentation staying consistent across every filing. Without this, a shipment can sit in customs, exposed to temperature excursions putting drug product and trial timelines at risk.

Mexico's random screening process illustrates the stakes, Owings says, since transportation timelines can extend with little warning. When a large quantity of bulk drug product intended for patients is held up with no clear point of contact, the effects ripple across an organization.

"It's stressful for the supplies organization, it's stressful for the clinical organization, it's stressful for the entire company," she says.

Christy Owings, Thermo Fisher, discusses how customs delays and import complexity risk clinical trial supply chains in Latin America.

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