AI in Pharma and Innovative Leadership Were on Display at the Biennial MMS Scientific Symposium

The Biennial Scientific Symposium at MMS is a global opportunity to bring together leading minds from within the CRO and across the industry to explore the intersection of artificial intelligence (AI) in pharma, innovative trial designs, and leadership in a tech-enabled world. Over the course of four days, thought leaders, scientists, and industry experts shared cutting-edge insights, practical applications, and forward-thinking strategies aimed at transforming the future of clinical trials.

The Scientific Symposium is an integral part of a broader set of initiatives surrounding how MMS:

• keeps its colleagues engaged,
• ensures current industry trends and regulations are shared, and
• upskills and cross-trains colleagues on critical topics that build value for sponsors.

Day one opened with a focus on the role of AI in pharma and automation throughout clinical research. Sessions showcased how AI-driven solutions are helping organizations reduce operational bottlenecks, enhance data management, and accelerate the drug development process.

For day two, MMS shifted gears to explore public health, external data integration, and regulatory submissions, as attendees gained insight into how external data sources like real-world evidence can improve the efficiency of clinical trials and the growing field of psychedelics, among others.

On day three, the MMS Scientific Symposium turned its attention to innovative clinical trial designs and data visualization, with presentations on the FDA’s Complex Innovative Trial Design Initiative and demonstrations of Datacise, the discussions emphasized the importance of flexibility, simulation, and data diversity in improving trial outcomes.

Day four emphasized the role of innovation driving growth and success through our SOUL mindset. Throughout the MMS Scientific Symposium, the common thread was clear: innovation—whether through AI, data, or leadership—is the key to advancing drug development, improving patient outcomes, and meeting industry demands.

Navigating the future of AI in pharma

Ben Kaspar, MMS Director of Regulatory Affairs and Strategic Consulting, led a pivotal session on the advances in AI and machine learning (ML) in drug development. Kaspar opened by distinguishing between machine learning and generative AI in pharma, emphasizing that while both technologies are transforming the industry, they bring unique challenges. He describes AI in pharma as a “highly intelligent but profoundly inexperienced co-worker,” highlighting the critical need for human oversight to avoid misinformed decisions and ensure that AI aligns with clinical and regulatory goals.

A major focus of Kaspar’s presentation focused on explainability and interpretability in AI models. “Without explainability,” Kaspar noted, “we are left with a black box, and you can’t take a black box to the FDA.” This is why transparent AI models in pharma are so important, especially when applied to real-world evidence and decentralized clinical trials.

Kaspar also underscored the need in balancing automation and human judgment. He warned, “If we let AI make all the decisions without human input, we risk amplifying biases and making poor choices in patient care.” As the regulatory landscape continues to evolve, Kaspar recommended that organizations engage early with global health regulators to ensure that their AI-driven strategies comply with any current or emerging guidelines.

Panel Discussion: AI and the Future of Clinical Trials

One panel discussion, moderated by Data Science Senior Manager Kris Wenzel, explored how AI is shaping the future of clinical trials. Panelists shared the following thoughts:

• Raj Bendre, Managing Director at Lindsay Goldberg, emphasized the potential of AI to optimize decentralized trials: “We’re no longer bound by physical trial sites; AI is enabling us to gather and analyze data from patients in real time, no matter where they are.”
• Irving Dark, MMS board member and former SVP at Cytel, tackled the ethical considerations of AI, stating, “We must make sure that AI models are not perpetuating bias. It’s not enough for AI to be efficient—it has to be fair.”
• Michelle Gayari, EVP of Global Operational Excellence and Innovation at MMS, expanded on the company’s AI and automation roadmap, sharing, “Our approach is simple: use AI to eliminate repetitive tasks and let our experts focus on what really matters—creating strong, data-driven solutions that move the needle in drug development.”
• Chris Schoonmaker, COO at MMS, focused on maintaining a balance between AI and human oversight, sharing, “Automation is great, but someone has to be there to catch the things AI misses.” Schoonmaker stressed that, despite AI’s growing role in clinical trials, human expertise remains critical in ensuring that data quality and reliability are maintained.

The panelists collectively agreed that while the future of AI in pharmaceuticals is bright, it requires a cautious, structured approach to avoid concerns on data security risks and over-reliance on unvalidated models, to name a few.

AI and humans need to co-exist in pharma

The MMS Scientific Symposium continued with a session led by MMS Director of Regulatory Strategy Dr. Amanda Beaster, who discussed the significant impact of technology-enabled solutions on clinical research. Rather than focusing solely on AI, Dr. Beaster highlighted how practical tools like Datacise are currently being implemented to accelerate clinical trials. “Datacise gives us the ability to streamline data management processes, allowing our teams to identify trends in clinical data and spot anomalies quickly,” she explained.

This capability enables internal teams to make proactive decisions in real time, ensuring that clinical trials progress faster and more efficiently.

Building on Dr. Beaster’s insights, Michelle Gayari elaborated on how MMS is leveraging technology to automate the clinical trial lifecycle. “We’re not just using technology to save time; we’re using it to increase accuracy and reduce the chances for human error,” Gayari stated. She highlighted how tools like Datacise help MMS automate routine tasks that many top CROs encounter, such as data entry, monitoring, and reporting.

“By automating these processes, we can focus our expertise on more critical aspects of trial design and execution, ultimately accelerating the time it takes to bring new therapies to market,” Gayari said.

Kris Wenzel, Data Science Senior Manager at MMS, added that the strength of MMS as a data-focused CRO lies in its ability to combine advanced technology with human oversight. “For us, technology is not about replacing people; it’s about empowering them to do more with the right tools,” Wenzel emphasized.

Dr. Beaster concluded the session by reinforcing that collaboration between clinical experts and technology teams is essential for maximizing the benefits of these technological tools. “Technology can optimize and accelerate processes, but clinical expertise is still needed to guide these innovations and ensure that they are applied effectively to improve patient outcomes,” she reminded attendees.

The risk and reward of external data in clinical trials

MMS biostatisticians Japie Lowings and Charl van Rensburg spoke to the growing role of external data in clinical trials. Based on a poster presented at the PSI 2024 Conference in Amsterdam, the two explained that these external sources, such as previous clinical studies, natural history studies, and real-world data, are increasingly being used to enhance trial design and improve study efficiency. “External data provides us with a unique opportunity to supplement control groups, especially in cases where traditional placebo controls are not ethical or feasible,” Lowings said.

“External data can significantly reduce recruitment time and costs, but it’s not without its risks. The key challenge is ensuring that baseline differences and potential biases do not compromise the validity of the clinical trial results,” van Rensburg said.

The presenters cautioned that while external data offers considerable advantages, it requires a careful, methodical approach to maintain the integrity of the clinical trial. “You cannot simply plug in external data and expect it to work seamlessly,” van Rensburg shared. “We must be vigilant about maintaining the causal relationship between treatments and outcomes.”

Lowings and van Rensburg noted that while some clinical trials benefited from faster timelines and more robust datasets, others encountered issues related to data comparability and regulatory acceptance. “The goal,” Lowings added, “is to use external data as a tool, not a crutch. It can enhance your clinical trial, but it must be used with care.”

Drug development and psychedelics

A panel discussion on drug development in the psychedelic space, featured experts Dr. Amanda Beaster, Dr. Kevin Chartier, and Ritchie Patton, moderated by Jennifer Perrin. Patton began by addressing the unique challenges of developing psychedelic drugs, particularly the abuse potential and psychotropic effects associated with these therapies.

“One of the key issues we face is documenting adverse events like euphoria and hallucinations. These are not just side effects; they are integral to the mechanism of action but also raise serious concerns about abuse potential within the FDA,” he noted.

View our on-demand psychedelics webinar here.

Dr. Beaster elaborated on the evolving regulatory landscape, stressing the need for more specific guidelines. “While the FDA has issued general guidance on psychedelics, it doesn’t adequately address the differences between these compounds and their varying safety profiles,” she explained. Dr. Beaster highlighted the particular challenges in developing psychedelics for conditions like PTSD, adding, “It’s not just about the drug; psychotherapy plays a significant role, and that’s a regulatory gray area that needs to be clarified.”

Overall, the panelists agreed that while the field holds immense promise, there are still significant hurdles to overcome in ensuring the safety and efficacy of these therapies.

FDA’s Complex Innovative Trial Design Initiative

Dr. Eric Harvey, Sr. Director of Biometrics and Data Science at MMS and Triangle Business Journal Healthcare Hero, delivered a session on the FDA’s Complex Innovative Trial Design (CID) Initiative, emphasizing the growing need for creative trial designs to improve efficiency and reduce patient numbers. “Data collection is only getting more expensive,” Dr. Harvey explained. “Innovative designs like Bayesian methods and adaptive clinical trials help us make more informed decisions without biasing the results, allowing for real-time adjustments during a trial.”

Dr. Harvey went on to discuss how Bayesian approaches integrate prior knowledge, such as historical data, into ongoing clinical trials. “With Bayesian methods, we are not just waiting for the trial to end to learn what worked—we are continuously learning and improving as we go,” he said. He explained that adaptive clinical trials offer flexibility by enabling researchers to adjust elements like sample sizes and dosages based on interim results.

“If we see early signs that a particular dose is more effective, we can pivot to focus on that, saving both time and resources,” Dr. Harvey noted. “The FDA recognizes the value of these approaches, but sponsors need to be clear and transparent in their designs. While complex designs aren’t a quick fix, they provide smarter, more efficient ways to conduct trials—especially in cases of rare diseases or unmet medical needs.”

Scientific leadership on display

As the 2024 MMS Scientific Symposium drew to a close, it was clear that the breadth of innovation, expertise, and forward-thinking strategies presented over the course of four days extended far beyond what could be captured in a single article. From the transformative role of AI in pharma to groundbreaking approaches in drug development, each session offered detailed insights and methodology that will shape our internal team and provide greater value to sponsors for the years to come.

One colleague who attended all four days shared, “After this week, I feel more confident than ever in bringing new thinking and proactive solutions to my daily work!”

While we have highlighted just a few of the incredible presentations, MMS wants to acknowledge the hard work of every speaker, participant, and organizer who made this symposium a success. The contributions of our cross-functional teams, working together across the globe, continue to drive our commitment to excellence and innovative leadership.

To learn more about any of the aforementioned presentations, request a call at https://mmsholdings.com/contact/