In the fast-changing world of pharmaceutical drug development, new digital twin technologies are beginning to make a significant impact. These technologies use advanced simulations, modeling, artificial intelligence, and big data to transform drug development. Luca Emili, CEO of InSilicoTrials, and Dr. MaryAnne Rizk, CEO of Rizk Management AI Advisors, leverage advanced technologies to accelerate the timeline for bringing new treatments to market and ensure cost-efficiency and compliance with global regulatory standards, especially in fields like personalized medicine and rare diseases.

Moe: How does technology contribute to accelerating the drug development process?

Luca Emili: The industry is seeking innovative solutions in the face of rising R&D costs and the need for faster, more efficient drug development. Our solution leverages simulation, modeling, AI, and big data to significantly reduce time and costs, a universal requirement in today’s pharmaceutical landscape.

By harnessing these advanced technologies, we aim to revolutionize drug development, especially in areas like personalized medicine and rare diseases where traditional trial recruitment is particularly challenging. Our tools enable partners to make informed, data-driven decisions, optimize trial designs, and reduce reliance on traditional, costly trials. This not only aids in reducing overheads but also accelerates the pace at which new treatments can reach the market, contributing to a healthier ecosystem for pharmaceutical innovation.

Could you share some case studies demonstrating the unique savings and acceleration in drug development?

Luca Emili: In a notable collaboration with a French biotech firm, our biosimulation technology proved its value by enabling the company to navigate the drug development process more efficiently than traditional methods allow. Using our platform, they could de-risk their clinical plan and discover a lucrative new market opportunity without conducting physical trials. This approach resulted in significant savings of approximately €30 million and reduced the company’s drug development timeline by three years

This case highlights the power of biosimulation in streamlining drug development. It allowed the company to simulate the drug’s efficacy and

Luca Emili, CEO, InSilico Trials
Luca Emili, CEO, InSilicoTrials

safety and explore untapped market potentials, optimizing their clinical strategy with minimal resource expenditure. Such advancements save time and money and open new pathways for innovation in the pharmaceutical sector, demonstrating the critical role of technologies like InSilicoTrials in the future of drug development.

Moe: How does InSilicoTrials ensure its platform remains innovative while complying with global regulatory requirements?

Luca Emili: We blend innovation with regulatory compliance by leveraging our global network of over 70 model and data partner providers. This network ensures our models and simulations are not only cutting-edge but also meet the highest standards of reliability and accuracy. By fostering collaboration across this ecosystem, we stay at the forefront of technological advancements while adhering to regulatory guidelines, ensuring our solutions are both innovative and compliant.

Our active involvement with regulatory bodies like the FDA, particularly in developing good simulation practices, demonstrates our dedication to shaping the future of drug development. This collaboration aligns our platform with regulatory expectations and allows us to contribute to setting new standards within the industry. Through these efforts, InSilicoTrials is helping to pioneer a future where drug development is faster, more efficient, and fully compliant with global standards.

How does your platform address the unique challenges of conducting trials for rare diseases or life-threatening conditions?

Dr. MaryAnne Rizk: In silico evidence is the process of generating synthetic populations also known as “Digital Patients” to augment a patient population sample size and simulate the predictive results of clinical trials. This is particularly significant for chronic diseases where patient recruitment poses a significant challenge, e.g., Rare disease, Oncology, CNS, Women’s Health. This approach significantly broadens the diversity and increases the size of study populations, making research more inclusive and representative. Using digital twins and predictive modeling, we can accurately simulate patient responses, thereby accelerating the drug development process and ensuring a greater emphasis on patient safety. The Digital Twins in Healthcare Market is rapidly gaining momentum, with a projected worth of $21.1

Maryanne Rizk, Clinical Trial Technology Expert
Dr. MaryAnne Rizk, CEO of Rizk Management AI Advisors

billion by 2028. Several factors drive this remarkable growth, including the increasing focus on personalized medicine, drug discovery, medical education, and workflow optimization.

A methodology is needed to strategically adopt this type of data science in advanced AI modeling.  The recent February 2024 publication of “Toward Good Simulation Practice” includes guidance from collecting evidence and education from highly regarded scientific and regulatory experts across an ecosystem of 150+ contributors, including 13+ from the FDA, and leveraging a technology platform to overcome traditional barriers in clinical research by providing a virtual yet realistic environment for trial simulations. This not only speeds up the development of new treatments but also reduces the risks associated with early-phase clinical trials. By integrating these advanced simulation techniques, InSilicoTrials is at the forefront of enhancing efficiency and safety in the pharmaceutical industry.

Moe: How do you see computational modeling evolving in the context of drug development?

Luca Emili: InSilicoTrials are shaping the future of drug development with computational modeling. This innovation significantly saves time and costs while promoting an ethical approach by minimizing physical trials. It also enhances efficiency and adheres to ethical standards by reducing the need for traditional trials, which can be logistically and ethically challenging.

Our collaborative ecosystem, built alongside researchers, regulatory bodies, and biotech companies, demonstrates our role in steering the industry toward more efficient, safe, and ethical practices. By championing computational modeling, we’re improving our platform and pioneering a shift in drug development towards more patient-centric and sustainable methods. This marks a significant step forward in our mission to revolutionize the pharmaceutical industry by making drug development more accessible, faster, and ethically sound.

Moe Alsumidaie
Website | + posts

Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.