BOSTON, Mass. -- By Lee Han-soo/Korea Biomedical Review correspondent -- In pharmaceutical research, the journey from promising compound to life-saving medication is a meticulous and arduous process.

At the forefront of this pivotal phase stands early clinical drug development—a critical stage that holds the key to unlocking the potential of innovative therapies.

Early clinical drug development involves the evaluation of new drugs and therapies to determine their safety, dosage, and efficacy.

This vital phase bridges the gap between laboratory studies and large-scale clinical trials, providing critical insights into the potential benefits and risks associated with new candidates and allowing pharmaceutical companies to focus their investment on candidates that show true potential early.

To get a more in-depth knowledge of the importance of early clinical drug development, Korea Biomedical Review met with Sandeep Menon, Senior Vice President and the Head of Early Clinical Development at Pfizer, in Boston, Mass., on June 6.

As the head of early clinical development and Biomedicine AI at Pfizer, Menon’s team supports the development process from discovery to proof of concept (POC) for all therapeutic areas except vaccines.

Discussing the broader drug development process, Menon emphasized the significance of early clinical development.

He explained that Pfizer's primary focus in early clinical drug development is on ensuring patient safety and assessing the drug's properties, pharmacokinetics, and pharmacodynamics.

"Notably, our three pillars of pharmacology, which include exposure, target specificity, and downstream modulation, help us make informed decisions and increase the chances of success," he said. "As a result, Pfizer's success rate for end-to-end clinical trials has nearly doubled over the past decade, and we are now recognized as the best in the industry."

Menon also highlighted that Pfizer's enhanced productivity stemmed from a paradigm fostering early decision-making.

"By adopting a data-driven approach, Pfizer minimizes costs associated with late-stage failures and ensures that resources are invested wisely," he said. "This means, by failing early and cheaply when needed, we have significantly improved our success rates in later stages."

Such a methodology has been proven valid through a recent paper published by Menon and his colleagues.

The paper highlighted Pfizer's end-to-end clinical success rate of 21 percent, significantly higher than the industry average of 11 percent.

"This achievement represents a 10-fold increase from 2 percent in 2010 and showcases Pfizer's commitment to innovation and continuous improvement," he said.

Menon also discussed Pfizer's approach to collaboration with external partners in early clinical development.

He highlighted the company's collaborations with prestigious academic institutions such as Harvard and Boston University, where internships and fellowships provide students with valuable industry exposure. These collaborations foster knowledge exchange and enable Pfizer to tap into the latest technologies and methodologies.

"We have a pipeline of students coming in to solve interesting problems that we are trying to address in early clinical development," Menon noted. "This collaboration creates a win-win situation for both Pfizer and the academic institutions."

Furthermore, Pfizer remains open to collaboration with smaller biotech companies, fostering pre-competitive research and business development deals.

"By partnering with these companies, Pfizer gains access to novel approaches and emerging technologies, fostering innovation and driving progress in early clinical development," he said.

Regarding the assessment of a drug candidate's market value and commercial viability, Menon emphasized the need for scientific rigor and patience.

"While Pfizer's strong commercial team is involved early in the process, the company allows the science to unfold and makes informed decisions based on such science," he said. "By combining scientific excellence with a keen understanding of market dynamics, we can maximize the potential of our innovative therapies."

Menon cited the successful launch of Paxlovid, an antiviral treatment for Covid-19, as an example of Pfizer's commitment to evidence-based decision-making. In 2022, Paxlovid sold $18.9 billion worldwide.

"The drug's rapid development and regulatory approval were a result of Pfizer's strategic investments in scientific expertise and infrastructure," he said.

When discussing personalized medicine, Menon highlighted its impact in the field of oncology, where individual patients require tailored treatments.

However, he emphasized that precision medicine might be a more suitable term, reflecting the future focus on phenotype-oriented approaches across various fields.

Menon acknowledged the challenges in fully implementing personalized medicine due to the complexity of genetic factors, emphasizing Pfizer's commitment to solving these complex problems.

"Pfizer remains at the forefront of scientific advancements, continuously exploring ways to harness the power of genetics and molecular biology to deliver precision medicines," Menon affirmed. "While challenges exist, we are confident in our ability to address them and unlock the full potential of personalized medicine."

The use of AI in the drug development

Meanwhile, Menon also talked about his additional role as the Chief Scientific Officer of AI Digital Sciences, which encompasses the use of wearables, imaging techniques, machine learning, and computational sciences.

Menon emphasized the expertise of Pfizer's research lab, which focuses on machine learning, AI, and natural language processing.

When asked about the role of AI and big data in drug development, Menon acknowledged their growing importance, cautioning that responsible usage is crucial.

He highlighted the potential of AI to amplify inaccuracies or reflect human biases if not employed judiciously.

However, he recognized that AI is already becoming an integral part of Pfizer's drug development process.

"AI, like it or not, will become a part of our drug development process," Menon stated. "However, the key thing is how do we use it responsibly?"

To ensure responsible AI implementation, Pfizer places a strong emphasis on data quality and rigorous validation processes.

Menon explained that while AI can enhance drug development, it must be used in conjunction with accurate, well-labeled data that reflects scientific principles.

"Pfizer's commitment to responsible AI usage ensures that the insights gained are reliable and contribute positively to the drug development journey," he said.