Day One
Workshop attendees were welcomed by Raphael Sanchez Pereira, Health Regulation and Surveillance Specialist for ANVISA, and Flavia Firmino, Senior Director, Global Regulatory Policy, Latin America region at Eli Lilly & Company for ISPE.
Gregory Rullo, Executive Director, Regulatory Affairs-CMC at AstraZeneca, presented an overview of ISPE’s Enabling Pharmaceutical Innovation initiative and survey. Rullo noted that over the last decade industry has experienced a proliferation of regulatory divergence with respect to the interpretation and implementation of the International Council for Harmonisation’s (ICH) guidelines and control strategies across geographic regions. Rather than the adoption of globally harmonized regulatory criteria, localized interpretations have served as a barrier rather than an incentive to develop innovative manufacturing technology, new medicinal modalities, and continual improvement initiatives. In response, ISPE’s Enabling Pharmaceutical Innovation initiative was launched in 2022 to catalyze consistent and harmonized interpretation and implementation of ICH guidelines with the intention of improving patient access to innovative medicines and technology. As a first action under the initiative, ISPE surveyed the industry to understand the extent and magnitude of challenges or barriers companies experience in implementing innovative technologies. The survey revealed that:
- Return on Investment is a critical factor in decisions regarding the development and implementation of innovative technologies.
- Even at the early stage of evaluating an innovation, global regulatory divergence is a consideration with an associated cost.
- Regulatory challenges are the most significant factors influencing decisions to proceed with innovations.
- Regulatory reliance/alignment among regulatory authorities would effectively offset the investment risk.
The complete survey results were published in “Enabling Pharmaceutical Innovation: A report on the Barriers to Innovations Survey.”
Following Rullo’s introduction, three case studies were presented.
Timothy Graul, PhD, Senior Director, Global CMC Advisory Office at Pfizer, and Jenna Pasko, Scientist at Pfizer, introduced a case study, “Pfizer’s Continuous Manufacturing Module (PCMM),” highlighting its alignment with ICH Q12 and Q13 guidelines. The presenters outlined the control strategy for a continuously manufactured drug product, emphasizing the use of criticality assessment to define established conditions as well as science- and risk-based approaches to regulatory decisions which promote transparency, flexibility for post-approval changes, and foster trust between industry and health authorities. Full implementation of ICH Q12 will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the pharmaceutical sector, thereby strengthening quality assurance and improving supply of medicinal products.
The second case study, “In Silico Modeling,” was presented by Fabrice Schlegel, PhD, Director, Data Sciences, Transformative Digital Capabilities Process Development, Amgen. The presentation provided a comprehensive overview of in silico modeling use in pharmaceutical development and manufacturing, with a focus on regulatory alignment, risk-based validation, and lifecycle management. The presentation emphasized that ICH Q8/Q9/Q10 and Q-IWG guidelines are sufficient and flexible, and that voluntary standards support model qualification. Additionally, detailed model information should reside in the PQS rather than the CTD. It also underscored the importance of computer systems validation (CSV) for GMP-deployed models and the shift toward more agile, data-centric quality systems.
Process modeling and artificial intelligence (AI) was the topic of the third case study, presented by Benjamin Stevens, PhD, Director of CMC Policy and Advocacy, GSK. The case study, titled “Vaccine Formufilling Digital Twin and Real-Time Process Control,” explained how GSK proposed using a digital twin model for process control that does not replace end-product testing. Feedback from the European Medicines Agency (EMA) Quality Innovation Group (QIG) indicated that they are open to GSK's proposal for using a digital twin model in continuous manufacturing, even without reducing end-product testing, provided the model's performance is verified through small-scale or in silico experiments rather than full commercial-scale validation. The QIG acknowledges that performance-based process control strategies—like GSK’s digital twin model—can be justified even if they don’t rely on fixed process parameter ranges, provided the overall control strategy ensures product quality.
Rullo summarized the presentations and the first day’s session adjourned.
Day Two
Workshop attendees were welcomed by Carlos Gomes, Specialist in Health Regulation and Surveillance for ANVISA, and Juliana Perlow, Executive Director, International CMC – Latin America team, MSD, on behalf of ISPE.
A case study, “Predictive Stability Models,” was presented by Daniel Skomski, PhD, Principal Scientist, Analytical R&D and MSD. New predictive stability modeling regulatory approaches were presented in the context of evolving industry guidelines (ICH Q1 Revision), which are expected to lead to increased usage in clinical trials and market applications. Case studies for all modalities and many critical quality attributes were broadly covered. Model methodologies and mitigations also were explained. It was proposed that global regulatory harmonization would be important to facilitate the application of this innovative technology. Altogether, it was suggested that predictive stability holds promise for accelerating patient access to new medicines by overcoming stability-related bottlenecks while further enhancing scientific understanding and product robustness.
The final case study of the workshop, “End-to-End Digital Post Approval Changes (PAC) Reliance Cloud-based Submission,” was presented by Nina Cauchon, PhD, Director Regulatory Affairs – CMC, Amgen. To provide an end-to-end solution, a CMC PAC dossier was delivered to the reference country and 25 participating health authorities simultaneously via a cloud-based platform. This strategy aims to redefine the regulatory landscape by expediting global approvals while setting a new benchmark for transparency and efficiency. The dossier was created using proprietary AI and novel Structured Content and Data Management (SCDM) software. Each health authority involved has real-time access to all regulatory information, from submission details to ongoing questions, answers, and updates, as available. This approach will enable more efficient review and approval timelines, and thus speed medicine access to patients globally. Application of these principles to collaboration on innovation was discussed.
Rullo recapped the case studies that had been presented over the two days and initiated a discussion on the regulatory landscape in Latin America and opportunities for fostering innovation through greater collaboration. A recurring theme expressed by the ISPE participants was the strong interest in aligning regulatory requirements across the region, particularly in areas such as regulatory review and GMP standards. However, it was acknowledged that existing frameworks within individual countries often pose challenges to adopting reliance mechanisms or other collaborative approaches.
The ISPE participants proposed the concept of dedicated forums where industry and regulators can openly discuss emerging innovations. Such platforms would help build a shared understanding of novel technologies and clarify how companies should communicate with regulatory authorities in Latin America. The participants noted that without insight into regulators’ perspectives, companies often struggle to align their strategies and move forward with confidence. Scientific concepts like predictive stability, digital twins, and continuous manufacturing were identified as key areas where harmonization is essential. Advancing mutual understanding of these innovations requires consistent and transparent communication between industry and regulators.
While large-scale innovations tend to attract attention, the participants emphasized that smaller, incremental changes also hold significant value. For instance, a process model that improves manufacturing yield by just 5 percent may seem modest, but its cumulative impact across batches can significantly enhance cost efficiency and product quality. Unfortunately, even these smaller innovations may be abandoned if companies fear inconsistent regulatory feedback across different countries, reinforcing the perception that the pharmaceutical sector is slow to innovate.
Participants pointed to existing mechanisms, such as the EMA QIG and the US Food and Drug Administration’s (US FDA) Emerging Technology Program as successful models for joint scientific advice. Currently, Latin America lacks similar platforms, but there is interest in developing such initiatives to support innovation.
Ultimately, there was consensus regarding the importance of continuing dialogue, building regional forums, and exploring collaborative platforms. These efforts would not only support innovation but also strengthen regulatory alignment and improve patient access to high-quality medicines across Latin America.
The next steps for the ISPE Enabling Pharmaceutical Innovation team are to continue the dialogue with ANVISA and look for opportunities where ISPE can facilitate educational and engagement activities tailored to Latin America.
Learn more about ISPE Regulatory Operations.
This is an informal summary of a virtual workshop held on 20-21 October 2025. It has not been vetted by any of the regulators or agencies mentioned in this article, nor should it be considered the official positions of any of the agencies mentioned.
