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

Michael Levy, MSc, MBA is senior vice president, Digital & Innovation, US Pharmacopeia (USP).

Pharma Logistician Using IoT Based On Blockchain | Image Credit: ©leowolfert -stock.adobe.com

The pharmaceutical supply chain is an intricate and complex system where one mistake in the manufacture of a critical drug could impact the lives of hundreds, if not thousands of people, if a shortage in that supply is the result of that mistake. Active ingredients, excipients, final drug products, packaging, and shipping are all part of the supply chain ecosystem, and regulators and standard setting organizations play a significant role in keeping that system healthy.

Drug shortages can result not just from manufacturing failures but also from natural disasters, geopolitical pressures, and policy changes. In June 2026, the US Pharmacopeia (USP) published its annual drug shortages report, which stated that while drug shortages are lasting longer, the total number of shortages decreased by 23% in 2025.

 USP also found that product discontinuation was higher, with a 60% increase from 2024 to 2025.

To help mitigate drug shortages, Michael Levy, senior vice president, Digital & Innovation, USP, believes that quality control labs need machine-readable, science-based digital standards to modernize workflows without weakening the rigor that underpins patient safety.

According to Levy, digital standards cut manual handoffs, rework, and ambiguity by building quality requirements directly into laboratory information management systems, electronic lab notebooks, and regulatory platforms. Electronic capture with version control also strengthens data integrity and auditability across a method's lifecycle.

To find out more about artificial intelligence (AI) and the digitalization of supply chain security, 

spoke with Levy about his upcoming panel presentation on October 6, The Next Phase of Pharma Supply Chains, at 

PharmTech: What's the practical difference between a digital supply chain and an AI-powered one?

 In pharmaceutical supply chains and manufacturing, digital workflows empower the humans doing the work. Digitalization helps lab workers seamlessly connect machine-readable data and methods, scaling and modernizing operations without sacrificing quality. AI can provide a decision-support function, with scientists retaining judgment and control over the process.

Regulatory compliance, geopolitical risk, and sustainability are different kinds of pressure. Does AI address them in fundamentally different ways, or is there a common thread in how these systems help companies manage all 3?

AI applications can differ, but there is a common thread in using data to improve visibility and support more informed decision-making across the supply chain. Developers, manufacturers, and regulators are collaborating to shape a global framework that prioritizes consistency, transparency, and trust. As the industry adopts AI, digitalization, and advanced manufacturing technologies, safeguarding patients’ access to quality medicines should remain at the core of every decision.

What's the biggest misconception pharmaceutical companies have about AI adoption in supply chain management, and what tends to trip them up in practice?

Technology alone is not the solution to digitalization. Scaling new technology while ensuring quality requires consistent, trusted standards that can be applied across platforms and organizations. Digital standards can provide shared, trusted building blocks, encouraging collaboration among method developers, manufacturers, technology providers, and regulators to build that trust. Collaborative development helps ensure that emerging digital standards are practical, fit for purpose, and aligned with regulatory expectations.

What roles do standards organizations like USP play in supply chain management?

At USP, we’re modernizing compendial standards to help solve industry pain points. By embedding digital standards and methods into our compendial framework, USP helps teams work faster and more reliably so patients get the medicines they depend on. Our latest solutions include 

, a machine-readable library based on verified 

United States Pharmacopeia–National Formulary

 test methods designed for use in digital laboratory systems, and 

, which streamlines nuclear magnetic resonance analysis.

USP Annual Drug Shortages Report finds rising discontinuations, hidden upstream risk. Press release. USP. June 9, 2026. 

https://www.usp.org/news/usp-2026-annual-drug-shortages-report-rising-discontinuations-supply-chain-risk

USP. 2025 USP Annual Drug Shortages Report. US Pharmacopeia. June 2026.

Levy M. Digital standards aim to modernize quality qssurance without compromising confidence. 

https://www.pharmtech.com/view/digital-standards-aim-to-modernize-quality-assurance-without-compromising-confidence

USP will be at booth #16F30 at CPHI Milan.

Mike Levy is senior vice president, Digital & Innovation at US Pharmacopeia (USP). USP works with scientific experts and global stakeholders to develop science-based standards and solutions that help strengthen regulatory systems, simplify manufacturing supply chains, enhance supply reliability, and support innovation. Used in over 150 countries, USP standards and solutions help increase the availability of quality medicines, supplements, and food ingredients worldwide.

Articles

A complex pharmaceutical supply chain can be disrupted by manufacturing failures, disasters, geopolitics, or policy shifts, amplifying patient risk through shortages. Recent USP findings show fewer shortages in 2025 but longer duration and sharply higher product discontinuations. Modernization efforts emphasize machine-readable, science-based digital standards to reduce manual handoffs, ambiguity, and rework while strengthening data integrity and auditability. Digitalization supports human execution; AI adds decision support grounded in improved visibility and informed choices. Standards organizations are embedding digital methods into compendia to enable interoperable, trusted adoption.

Michael Levy, senior vice president, Digital & Innovation, USP, explains the digital supply chain in a preview of his upcoming CPHI Milan panel presentation, The Next Phase of Pharma Supply Chains.

CPHI Milan 2026: Digital Supply Chains

FDA approves once-daily tavapadon, the first selective D1/D5 agonist for adults with Parkinson's

The FDA has approved AbbVie's JUVMO (tavapadon), as the first and only selective D1/D5 receptor agonist for adults with Parkinson's disease.

 The once-daily oral tablet can be taken with or without levodopa.

Currently available dopamine agonists primarily act on D2/D3 receptors, and their use can be limited by tolerability.

 Tavapadon instead selectively targets D1/D5 receptors, giving clinicians a mechanistically distinct option across the disease continuum, from early Parkinson's through the later stage when patients experience motor fluctuations.

"The approval of JUVMO marks the first dopaminergic breakthrough for Parkinson's disease in decades," said Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer, AbbVie, in a press release.

 "People living with Parkinson's and the clinicians who care for them have long faced difficult tradeoffs between motor control, treatment burden and tolerability. Clinicians now have a new treatment option that targets dopamine pathways differently and reduces the difficult tradeoffs associated with D2/D3 selective dopamine agonists."

The approval rests on the phase III TEMPO program.

 TEMPO-1 and TEMPO-2 enrolled people with early Parkinson's disease who were not taking levodopa, while TEMPO-3 evaluated tavapadon as an add-on in patients with motor fluctuations.

In TEMPO-1, both the 5 mg and 15 mg doses significantly improved activities of daily living scores at week 26 compared with placebo (−1.6 and −1.7 versus +0.9). TEMPO-2 showed a similar benefit with flexible dosing (−1.5 versus 0.0).

 In TEMPO-3, tavapadon plus levodopa increased daily on time without troublesome dyskinesia by 1.7 hours, compared with 0.6 hours for placebo plus levodopa, and reduced "off" time by 1.9 hours versus 0.9 hours.

In the open-label extension, 93% of participants on tavapadon plus levodopa had not increased their levodopa dose after 85 weeks, and 94% of those on tavapadon alone had not started levodopa.

 A marked improvement considering roughly 70% of patients have their oral levodopa dose increased within the first year of therapy. Most adverse events were mild or moderate. Nausea, headache, and dizziness were common, and the label warns of low blood pressure on standing, hallucinations, dyskinesia, and impulse-control urges.

"Parkinson's disease treatment has long required health care providers to balance the need for dependable motor symptom control with considerations around treatment tolerability," said Hubert Fernandez, MD, global principal TEMPO trial investigator, in the press release.

 "Now we have a novel therapy that selectively targets D1/D5 receptors, which addresses a longstanding need for innovation and provides health care providers with greater flexibility to tailor treatment to individual patient needs."

How Did Abbvie Build the Regulatory Package?

AbbVie submitted its new drug application in September 2025, roughly a year before the approval decision.

 The filing drew on three placebo-controlled, 27-week trials enrolling 1,340 adults aged 40 to 80. Both early-disease studies were limited to patients diagnosed within the previous three years, and participants could remain on a monoamine oxidase B inhibitor. The adjunctive study required a stable levodopa dose for at least four weeks before screening and relied on patient-completed home diaries to measure motor function. The submission also incorporated an interim data cut from the ongoing open-label extension, supporting long-term safety evidence without awaiting results.

What is the Significance of this Approval?

The approval is a return on a major neuroscience bet.

Tavapadon came to AbbVie through its acquisition of Cerevel Therapeutics

. The deal was valued at $8.7 billion, and AbbVie recorded a $4.5 billion impairment charge related to emraclidine, the schizophrenia candidate that anchored the transaction. With tavapadon approved, the Parkinson's asset now carries much of the deal's commercial rationale.

The product is launching in five strengths: 5 mg, 10 mg, and 15 mg tablets, plus 0.25 mg and 1 mg tablets in a titration pack.

 Moving from approval to commercial availability within weeks points to validated oral solid dose processes and launch inventory built ahead of the decision, while the titration pack adds packaging and serialization complexity that single-strength launches avoid.

The approval also contrasts with AbbVie's previous Parkinson's launch. 

In 2024, the first subcutaneous, 24-hour infusion of levodopa-based therapy for motor fluctuations

 That product carries the sterile manufacturing and device considerations of an infused therapy. A once-daily tablet offers a far simpler route to broad patient access.

AbbVie. U.S. FDA approves AbbVie’s JUVMO™ (tavapadon) for Parkinson’s disease. Published September 28, 2026. Accessed September 28, 2026. 

https://news.abbvie.com/2026-09-28-U-S-FDA-Approves-AbbVies-JUVMO-TM-tavapadon-for-Parkinsons-Disease

AbbVie. AbbVie submits new drug application to U.S. FDA for tavapadon for the treatment of Parkinson’s disease. Published September 26, 2025. Accessed September 28, 2026. 

https://news.abbvie.com/2025-09-26-AbbVie-Submits-New-Drug-Application-to-U-S-FDA-for-Tavapadon-for-the-Treatment-of-Parkinsons-Disease

FDA approval establishes tavapadon as the first selective D1/D5 receptor agonist for adults with Parkinson’s disease, available as a once-daily oral option used with or without levodopa. Phase III TEMPO trials demonstrated meaningful improvements in activities of daily living in early disease and increased “on” time without troublesome dyskinesia with reduced “off” time in fluctuating patients on levodopa. Long-term extension data suggested delayed levodopa escalation. The approval reinforces AbbVie’s Cerevel acquisition thesis and enables a comparatively straightforward oral commercial launch.

FDA approves tavapadon, first D1/D5 agonist, validating AbbVie's $8.7B Cerevel deal and an October five-strength oral tablet launch.

Tavapadon Sets Development Benchmark for Parkinson's

Senior Director
Education, Outreach, and Digital Experience
Open Biopharma Research and Training Institute

Richard Jaenisch weighs how FDA's new NAM rule could reshape preclinical testing and what CMC teams should do now, on Manufacturing Intelligence.

Manufacturing Intelligence: What FDA's NAM Rule Means for CMC Teams

The FDA's September 22 direct final rule, which swaps "animal tests" for "nonclinical tests,"

 gives new approach methodologies (NAMs) firmer regulatory footing, but its real impact on development and CMC timelines is still taking shape. On episode 7 of PharmTech's Manufacturing Intelligence, co-host sChris Cole and Richard Jaenisch, MPH, a liver transplant recipient and patient advocate, speak about what the rule and FDA's accompanying database of roughly 25 real-world NAM use cases mean for sponsors, regulators, and manufacturing teams.

Jaenisch notes that many NAMs are themselves a form of AI, though 

models differ from the generative AI most people picture. He points to 

 model for drug-induced liver injury (DILI) through its ISTAND pilot program

 as a logical starting point, given how often liver toxicity derails development. Compared with the lengthy prep and run time of animal studies, NAMs could trim a few months from the pipeline today and potentially years in the future, depending on the difficulty of the target. On the production side, however, he does not yet see significant time savings.

Trust remains the open question. "The benefit of an organoid in this case is that it's human cells. It's a mock human organ," Jaenisch explains, though organoids cannot replicate the full body environment. Organ-on-a-chip systems link multiple organs, but the tubing connecting them raises questions about whether drugs move as they would between human organs. Drawing on his experience as a hepatitis C survivor, he recalls that chimpanzees were the only viable animal model for the virus, and that early sofosbuvir research relied on a patchwork of modified models, including zebrafish. He expects it will take a year or two for trust to be genuinely earned.

Whether NAMs actually reduce the manufacturing and quality burden, he argues, depends on the NAM. A mouse model reveals effects on the kidneys, lungs, and other organs; a single-organ system does not. AI-driven models carry their own risk: "Say that model hallucinates, and say that hallucination is now part of your record, and now that resets your entire clock," Jaenisch warns. He does not believe the rule lowers evidentiary standards, noting it is backed by the FDA Modernization Act and that the context-of-use requirement keeps the process strict yet streamlined. For rare diseases that cannot be tested any other way, the pathway holds real promise. Risk-averse sponsors may submit both NAM and animal data, adding cost but yielding richer datasets that, paired with the plausible mechanism pathway, could speed novel therapies toward commercialization.

Asked about bioprinted replacement organs, Jaenisch calls them a fantasy he would love to see realized, but estimates they remain about a decade away. Today, printed organs and organ-like cell groups are used mainly for drug testing, and implanting one raises a paradox: when the organ itself is the product, what serves as the test? With tens of thousands of US patients waiting for transplants, he is eager to see how regulators answer that.

For quality and manufacturing teams, his advice is to engage now rather than simply wait and see. Though technically a definition change, the rule is sweeping in scope. He recommends commenting on the rule, reviewing the use-case database—which spans roughly a dozen underlying methods—and mapping each relevant case to in-house production components. A DILI use case, for example, may prompt more focused toxicity testing, and whether more data means more or less work depends on its quality. Teams that do that homework now will be better positioned as NAM-influenced CMC packages arrive.

Videos

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.

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

AAPS PharmSci 360: CMC Strategies, Part 3

 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 (BMS), 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 3 of this 3-part interview, Rumondor and Singh, discuss the challenges involved in chemistry, manufacturing, and controls (CMC) risk management.

Dr. Singh argues that the biggest obstacle is organizational. There is a lack of risk tolerance that shows up culturally and in how teams are resourced. Quality assurance and regulatory careers have been shaped by the belief that more data are always safer, says Singh, so even when science supports a leaner control strategy, organizations default to adding testing back in “just in case.” This reflex, she says, quietly replaces science-based decision-making with risk aversion disguised as rigor.

On the resourcing side, companies fund execution-heavy work like running processes and assays generously but underinvest in the upfront cross-functional risk assessment that a genuine risk-based strategy requires, according to Singh. The result is thin or backfilled risk assessments that collapse under scrutiny. Singh ties this directly to recent FDA flexibility, such as no longer requiring 3 process performance qualification lots or allowing deferred phase 1 CMC data. She notes that this regulatory flexibility goes unused if a company’s internal risk tolerance hasn't caught up.

Singh and Rumondor are participating in the panel, Navigating CMC Strategy in the Current Landscape, at AAPS PharmSci 360. The panel will bring together representatives from BMS, Pfizer, AbbVie, and Merck to discuss regulatory expectations, emerging modalities, speed to market, resourcing, and AI implementation. Rumondor describes the event as a valuable in-person opportunity for cross-company collaboration, where one can compare perspectives with peers from other firms and hopes attendees leave with practical considerations they can apply to building their own CMC strategies.

Click the video above to watch the interview.

, is Director, Development Sciences Licensing and Acquisitions, at AbbVie.

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.

In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discuss the implementation of risk-based approaches for CMC.

Merck's $2.13B KRAS G12D license moves tech transfer and supply planning into the preclinical stage.

Merck has secured exclusive global rights to SPR2015, an investigational preclinical oral inhibitor targeting the active form of KRAS G12D, from Shanghai-based SciBrunch Therapeutics.

In exchange for Merck now holding worldwide rights to develop, manufacture, and commercialize the compound, SciBrunch receives a $400 million upfront payment and is eligible for milestone payments tied to development, commercialization, and other activities across multiple indications. The total potential value is $2.13 billion.

"Evidence continues to accumulate for the therapeutic potential of targeting the KRAS pathway, a well-characterized factor in tumor cell growth," said George Addona, senior vice president, discovery, preclinical development and translational medicine, Merck Research Laboratories, in a press release.

 "This agreement complements and diversifies our expanding pipeline of precision targeted candidates with SPR2015, a potent engineered inhibitor for one of the most prevalent mutant forms of KRAS found in human cancers."

What Makes KRAS G12D a Sought-After Target?

KRAS G12D is the most common oncogenic RAS mutation in human tumors.

 Substitution of aspartate for glycine at position 12 leaves KRAS in an active state, continuously signaling for cell proliferation and survival.

SPR2015 is described as a molecular glue inhibitor that engages the ON form of the mutant protein.

 It showed nanomolar antiproliferative activity across multiple KRAS G12D-mutant cell lines while maintaining selectivity over wild-type cells, and it demonstrated monotherapy antitumor efficacy in cell-derived and patient-derived xenograft models. 

The RAS field has advanced quickly in 2026

. Molecular glues, meanwhile, remain an emerging modality; 

developers are still working to overcome the off-target effects of first-generation therapies.

"Since our founding, SciBrunch has remained focused on advancing innovative therapies targeting the RAS pathway and is committed to delivering transformative treatment options for patients with pancreatic, colorectal, lung, and other major malignant tumors," said Tao Hu, founder, chairman and CEO, SciBrunch.

 "This agreement with Merck not only validates the R&D strength of our platform but also underscores the potential of SPR2015 in addressing longstanding unmet medical needs in oncology. We are excited that Merck, a global leader in oncology, will take SPR2015 forward."

With SPR2015 originating in Shanghai and not yet in human testing, where Merck conducts its early studies may carry regulatory weight.

, the leaders of four FDA centers said FDA is adding resources for foreign inspections, including more phase I and early-stage trials, and will apply heightened scrutiny to foreign studies not conducted under an investigational new drug application. The agency also warned that sites denying or conditioning inspection access can jeopardize data acceptance, urging sponsors to treat inspectability as a material factor in regulatory strategy and to discuss data provenance at early pre-submission meetings.

The agreement reflects a sourcing pattern that increasingly shapes R&D pipelines at large pharmaceutical companies: 

licensing early assets from China-based developers

Because Merck acquired manufacturing rights at the preclinical stage, synthetic routes, analytical methods, and specifications developed by SciBrunch will likely need to be transferred to Merck's internal network or contract manufacturing partners ahead of first-in-human studies. For compounds that rely on precise three-dimensional interactions to stabilize protein complexes, control of stereochemistry, impurity profiles, and solid form can be central to demonstrating consistent performance across sites and scales.

The oral small-molecule format is notable as unlike antibody-drug conjugates or cell therapies, SPR2015 can draw on established drug substance and oral solid dose infrastructure, which may simplify scale-up if the program advances.

 Still, a $400 million upfront commitment for a preclinical asset signals how aggressively large companies are competing for differentiated RAS-directed candidates, and how early development and manufacturing planning may need to begin.

Merck & Co., Inc. Merck enters into exclusive global license agreement with SciBrunch Therapeutics for SPR2015, an investigational oral KRAS G12D (ON) inhibitor. Published September 28, 2026. Accessed September 28, 2026. 

https://www.merck.com/news/merck-enters-into-exclusive-global-license-agreement-with-scibrunch-therapeutics-for-spr2015-an-investigational-oral-kras-g12d-on-inhibitor/

Davis M, Mikhail K, Tarver M, de Claro RA. Good clinical practices are not optional: the FDA’s commitment to human subject protections and gold standard science in an era of global clinical research. 

. Published September 2, 2026. Accessed September 28, 2026. 

https://www.fda.gov/news-events/fda-voices/good-clinical-practices-are-not-optional-fdas-commitment-human-subject-protections-and-gold-standard

Merck obtained exclusive worldwide rights to preclinical SPR2015, an oral KRAS G12D (ON) molecular-glue inhibitor, from SciBrunch for a $400 million upfront payment plus milestones up to $2.13 billion. KRAS G12D, the most prevalent RAS mutation, remains a high-value target given constitutive signaling. SPR2015 demonstrated nanomolar, mutant-selective antiproliferative activity and monotherapy efficacy in CDX/PDX models. Regulatory strategy may be influenced by FDA’s heightened scrutiny of foreign early-stage data. Early CMC transfer and control of stereochemistry and solid form will be pivotal.

Merck licenses SciBrunch's preclinical KRAS G12D inhibitor for $2.13B, raising tech transfer and scale-up questions for oral cancer drug development.

KRAS G12D Inhibitor's $2.13B Deal Tests Cross-Border Tech Transfer

Ronald Piervincenzi, USP, urges drugmakers and purchasers to act on supply chain resilience to curb drug shortages and shape better policy.

How USP Will Shape Procurement Decisions

In part 2, of a 3-part interview, Ronald T. Piervincenzi, CEO, US Pharmacopeia (USP), argues that drug supply chain resilience has drawn more headlines than concrete action. Purchasers and manufacturers, he says, should not wait for policymakers to catch up.

Access Part 1 of this interview, in which Piervincenzi explains how benchmarking could reward reliable generic drug suppliers.

"There have been more news items than actions taken so far, and I suppose that's probably typical when you have a topic that's become a hot topic among policymakers," Piervincenzi says. He points to European laws that are making small but real differences on onshoring like the Critical Medicines Act 

encourages local production and resilient infrastructure.

 He also cites ongoing friendshoring discussions, where USP serves as an information provider to policymakers, and a growing overlap between resiliency and security. With roughly 2,000 different medicines on the market, making everything in every country is impossible and prohibitively expensive. Delaying more reasonable measures, however, risks policy that goes too far or is less well informed.

"So what we're advocating is for both the purchasers of medicines, as well as industry, to start taking some of those early actions now, and to help to create and lead to creating better policy," he says.

Those early actions start with data. The 

USP Medicine Supply Map traces where medicines originate.

 It covers finished dose, active pharmaceutical ingredients (APIs), and, increasingly, key starting materials. According to Piervincenzi, most shortages trace back to familiar drivers: quality issues and overreliance on a single location or manufacturer. 

USP has also previously flagged geographic concentration, manufacturing complexity, and low prices as vulnerabilities.

"The difference now is we have the map that can show us exactly where that is," Piervincenzi says. Procurers can then shift sourcing toward suppliers with stronger quality track records. He calls these changes relatively near term, although their full effect across the supply will take longer to arrive.

That approach underpins the newly launching USP Resiliency Center. USP has built a proof of concept for a benchmarking methodology and is now moving to implementation. It plans to develop resilience benchmarks through its transparent, open standard-setting process. It will then work with public- and private-sector procurers to build those benchmarks into buying decisions.

CPHI Milan: How USP Will Shape Procurement Decisions

PharmTech’s Weekly Roundup—September 25, 2026

This week, new modalities keep raising the manufacturing bar even as regulators race to modernize the rules around them, and artificial intelligence (AI) is showing up in validated environments as both a promised efficiency and a complication for quality teams. From weekly insulin to oral oncology combos to a new EU-cleared triple-therapy inhaler, the chemistry, manufacturing, and controls (CMC) complexity keeps climbing, right alongside the debate over how much oversight AI-assisted work needs.

direct final rule swapping "animal studies" for "nonclinical studies"

 throughout its regulations, which gives sponsors clearer footing to submit data from organ-on-chip and other new approach methodologies in investigational new drug (IND) and marketing applications.

, branded Onswik, which is a treatment that can cut patients’ basal insulin injections from 365 a year to just 52 while setting a new high-concentration formulation benchmark for biologics CMC teams.

 for ESR1-mutated breast cancer, which more than doubled progression-free survival to 11.1 months, but the 2-pill oral regimen also leans hard on ESR1 diagnostic testing and coordinated supply planning across separately manufactured products.

AstraZeneca’s clearance in the European Union of 

 extends single-inhaler triple therapy beyond chronic obstructive pulmonary disease (COPD), adding pressure on canister, valve, and actuator suppliers just as respiratory manufacturers race to requalify formulations for near-zero-global warming potential (GWP) propellants.

In conference news, CPHI Milan’s return of its invitation-only 

 puts supply-chain resilience front and center, with event director Tara Dougal noting that manufacturers are making strategic sourcing and location decisions against what she called an “evolving backdrop” of geopolitical fragmentation.

 launched its new AI Pulse Check video series. In the first episode, 

 flagged deviation reports as generative AI’s easiest entry point into manufacturing documentation, warning that the speed gained from automating form-filling can come at the expense of the judgment those reports are supposed to capture.

, independent regulatory advisor Florin Muraru argued multi-agent AI systems can be allowed to communicate freely on the plant floor as long as humans sign off on every GxP-critical action before it executes.

 episode, Parexel’s Siegfried Schmitt and Nelson Labs’ Susan Schniepp walked through 

how to plan for post-approval CMC changes

, reminding manufacturers that production is never static and that choosing the right regulatory pathway starts with anticipating what's coming before the original filing goes in.

, Charles River’s Aleksandra Zuraw explained why 

digital pathology is becoming a validated, Part 11-compliant data system

 rather than a lab convenience, with traceable tissue data now spanning everything from early toxicology to post-market diagnostics.

 found early-stage innovation across CNS, cell and gene therapy, and rare disease accelerating since mid-2025, fueled by out-licensing deals and strategic tie-ups with the likes of Lilly and Roche.

Taken together, this week’s stories show that new modalities and combinations are pushing CMC complexity higher, regulators are modernizing decades-old rules, and AI is arriving in validated workflows as both a promised efficiency and a fresh risk to manage.

Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry. 

Dennis Cantellops is an independent GMP and data integrity consultant and a former consumer safety officer for the US Food and Drug Administration.

Digital document validation and quality assurance concept with checkmark symbol and data icons over businessman using laptop in futuristic interface. | Image Credit: ©ImageFlow -stock.adobe.com

, the regulatory framework, inspectional findings, and governance considerations for master production and control records (MPCRs) and batch production and control records (BPCRs) were evaluated, including the role of standardized templates and spreadsheet-based systems in supporting data integrity and compliance. Part 2 focuses on risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.

Risk-Based Governance and Lifecycle Implications for MPCR Systems

The findings of this evaluation demonstrate that the design, control, and lifecycle management of MPCRs and BPCRs are critical to ensuring consistent manufacturing operations and maintaining data integrity in current good manufacturing practice (CGMP)-regulated environments. Deficiencies in documentation completeness, standardization, and reproducibility highlight the importance of applying quality risk management (QRM) principles to manufacturing documentation systems.

From a risk management perspective, MPCRs and BPCRs serve as primary controls to ensure that manufacturing processes are executed consistently and in accordance with validated procedures. Incomplete or poorly controlled MPCR templates increase the risk of operator error, omission of critical process parameters, and inconsistent documentation practices. These risks may compromise batch traceability, impair manufacturing performance evaluation, and reduce confidence in product quality.

Application of structured documentation controls, including standardized templates, defined data-entry fields, calculation controls, and appropriate verification steps, reduces the likelihood of documentation errors and improves the reliability of production records. These controls represent the practical implementation of risk-based documentation design principles consistent with International Council for Harmonisation (ICH) Q9 expectations.

 The hierarchy of documentation controls is illustrated in 

 Risk-based documentation control pyramid model illustrating the application of quality risk management principles to MPCR and BPCR systems. Documentation controls, structured data entry, validation mechanisms, audit trails, and electronic signature capabilities support data integrity and regulatory compliance throughout the MPCR lifecycle, consistent with the pharmaceutical quality system principles described in ICH Q9 and ICH Q10. (Figure courtesy of the author)

The evaluation also demonstrated that documentation format and system design significantly influence the effectiveness of documentation controls. Paper-based systems, particularly those relying on manually completed templates, were more frequently associated with legibility issues, transcription errors, and inconsistencies in record completion. Hybrid systems provided incremental improvements but required careful coordination between paper and electronic components. Fully electronic systems, when properly validated and implemented with appropriate access controls and audit trail functionality, demonstrated improved traceability, legibility, and documentation consistency in accordance with 21 

Control of Paper-Based, Electronic Spreadsheet, and Fully Electronic Batch Records During Manufacturing Operations

Control of batch records during manufacturing is essential to ensure data integrity, traceability, and compliance with CGMP requirements. In paper-based systems, control is achieved through physical document management, including defined ownership, controlled movement between processing areas, and the use of operator initials linked to a signature manifestation page. The batch record must remain with the process to support contemporaneous documentation and prevent loss, unauthorized access, or retrospective entries.

In electronic spreadsheet-based systems, control is achieved through validated system functionality rather than physical handling. Batch records should reside within a secure, access-controlled environment, with operators entering data at the point of use using unique credentials. Audit trails must capture all data entries and modifications, and templates should be protected to prevent unauthorized changes. These controls ensure that electronic records are trustworthy, reliable, and equivalent to paper records, consistent with 21 

Fully electronic batch record systems (eg, manufacturing execution systems/electronic batch record systems [MES/EBR]) provide higher control through system-enforced workflows, real-time data capture, and integrated process controls.

MES/EBR systems functionality are database-driven platforms that manage manufacturing workflows and capture batch documentation in real time. Data entry is guided by predefined sequences that prevent out-of-order execution, enforce completion of required fields, and restrict user actions based on defined roles and permissions. Audit trails are automatically generated, secure, and non-modifiable, ensuring complete traceability.

While handwritten initials are acceptable in paper records, electronic systems require enhanced controls to ensure equivalent or greater accountability. In spreadsheet-based systems, operator initials may be used for routine entries when supported by authenticated access and audit trails; however, electronic signatures should be applied at defined critical process steps, verification activities, and approval points. In fully electronic systems, electronic signatures are embedded within system workflows and enforced at each required step.

A risk-based approach should define which steps require enhanced controls, such as material additions, weighing operations, and process-critical decisions. In spreadsheet-based systems, this may include step-specific re-authentication or electronic signature prompts. In fully electronic systems, such controls are inherently managed through workflow configuration, system validation, and role-based permissions. Any modification to critical data should require documented justification supported by audit trail entries, consistent with the FDA’s data integrity principles (attributable, legible, contemporaneous, original, accurate; ALCOA+).

Electronic systems should not replicate paper practices but enhance control through authentication, audit trails, and structured workflows. Fully electronic, database-driven systems provide the highest level of control by integrating process execution with data capture and review, thereby reducing opportunities for error and improving inspection readiness. When properly implemented, all 3 approaches (paper-based, spreadsheet-based, and fully electronic) can support compliant manufacturing operations; however, fully electronic systems offer the most robust and sustainable solution for data integrity and lifecycle management. 

illustrates the progression of batch record control from paper-based to fully electronic systems.

 Evolution of batch record control systems from paper-based documentation to spreadsheet-based hybrid systems and fully electronic database-driven platforms (eg, MES/EBR), illustrating increasing levels of control, traceability, and data integrity assurance. (Figure courtesy of the author)

These observations are consistent with established pharmaceutical quality system principles emphasizing lifecycle management, change control, and continual improvement.

 MPCRs represent controlled manufacturing instructions that must remain accurate and current throughout the product lifecycle. Effective change management processes ensure that revisions to manufacturing processes, equipment, materials, or procedures are appropriately reflected in MPCR templates and consistently implemented during BPCR execution.

Systems that support controlled template revision, version management, and documented approval processes facilitate compliance with lifecycle management expectations described in ICH Q10.

The risk-based lifecycle governance model illustrating the development, approval, execution, review, and change-controlled maintenance of MPCRs within the pharmaceutical quality system is shown in 

 Risk-based lifecycle governance model for Master Production and Control Records (MPCRs) within the pharmaceutical quality system. The model illustrates the lifecycle management of MPCR templates from design and development through Quality Unit approval, batch record execution, review, and change-controlled maintenance. Quality risk management principles described in ICH Q9 and lifecycle management principles described in ICH Q10 are applied throughout the documentation lifecycle to support data integrity, manufacturing consistency, and regulatory compliance. (Figure courtesy of the author)

The model integrates lifecycle management principles described in ICH Q10 with QRM principles described in ICH Q9, supporting structured documentation governance and continuous improvement throughout the manufacturing documentation lifecycle.

The findings also underscore the importance of quality unit (QU) oversight in ensuring the completeness and accuracy of production records. Consistent with 21 

Risk-based lifecycle governance of MPCRs and BPCRs is positioned as a primary control for consistent CGMP manufacturing execution and durable data integrity. Poorly designed or weakly controlled templates elevate operator-error risk, missing critical parameters, and traceability gaps. Standardized templates, structured fields, calculation controls, and verification steps operationalize ICH Q9 principles and improve reproducibility. System format materially affects performance: paper is prone to legibility and transcription failures; hybrid adds coordination risk; validated electronic and MES/EBR systems strengthen workflows, audit trails, and 21 CFR Part 11 compliance with enhanced QU review efficiency.

This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.

Risk-Based Life Cycle Management of Master Production and Control Records to Strengthen Data Integrity and GMP Inspection Readiness Part 2: Practical Considerations for CGMP Documentation Systems

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