Member Spotlight: Q&A with IDDI

Sep 01, 2021

Every month, MassBio spotlights a member company and the great work they’re doing to advance the life sciences industry and support the patients we serve. In September, we spoke with Marc Buyse, Founder of the International Drug Development Institute (IDDI). Marc is also an Associate Professor of Biostatistics at Universiteit Hasselt in Belgium, and holds degrees in engineering and statistics from Brussels University (ULB), management from the Cranfield School of Management (Cranfield, UK), and biostatistics from Harvard University (Boston, MA). Marc Buyse remains recognized as a thought leader among his peers and is highly sought after for his expertise in the area of clinical trial biometrics.

Tell us about your organization, its mission, and current initiatives.

IDDI is an expert clinical data service and high-level, strategic consulting contract research organization (CRO) providing agile clinical trials services for pharmaceutical, biotech, and medical device/diagnostic companies.

IDDI’s mission is to optimize the clinical development of drugs, biologicals, biomarkers, and devices, using a unique combination of advanced biostatistics and innovative clinical data management technology.

Our goal: to get it right the first time! Our strongest asset is our flexible, responsive, proactive, and scientifically qualified team (over 130 employees, including 3 MDs, 12 PhDs, and several MScs).  

For over 30 years statistics has been the foundation of our processes and methods. Thanks to our scientifically-driven culture and close collaboration with industry leaders and peer groups, we remain at the forefront of methodological research specific to clinical trials.

A true multi-regional partner, IDDI has offices in Belgium, Cambridge, MA, and Raleigh (NC).

How does your organization’s activities help patients now and into the future?

A specific and prime example of IDDI’s focus on the patient can be seen in our co-development of a new statistical method, named generalized pairwise comparisons (also called GPC), which will be useful in the search for personalized treatment choices. The management of cancer patients in clinical practice relies to a great extent on the results of clinical trials. It is however not standard practice to take into account multiple endpoints to formally assess treatment results under a single metric. Very often, a new treatment yields positive results for the primary endpoint, but not for all secondary endpoints. Not incorporating the results of these other endpoints leads to an incomplete view of the benefit/risk ratio. Despite the promise of precision medicine, treatment choices could be taken one step further if patient preferences were taken into account in decision-making using IDDI’s formal statistical framework. This is truly “personalized medicine”.

What do you see as the biggest challenge facing the life sciences industry today?

Advances in big-data analytics are increasingly being employed to extract targeted information with the potential to drive life-sciences research and clinical practice closer to the goal of personalized and precision medicine. 

The life-sciences industry has seen a vast array of developments in basic and translational science and an increasing number of approvals of drugs that are indicated for subsets of patients defined by prognostic or predictive biomarkers, particularly in oncology.

Thus, big-data analytics is clearly evolving and promises to have a great impact on our understanding of the real-life benefits and harms of different treatments.  Precision medicine is the inevitable way forward as we learn more about the molecular basis of diseases and develop better medications that target pathogenic mechanisms.

IDDI provides proven expertise in helping clinical study teams define, identify, analyze, and confidently submit the right data at the right time.

What’s next for your organization / what are you focused on in the coming year? 

Our experts agree that AI and machine learning play a key — and evolving — role in analyzing the massive amounts of data that need to be processed as part of the personalized medicine development process. AI algorithms will arguably be the case for drug development and clinical practice over time. On the personalized-medicine front, the method of generalized pairwise comparisons, also known as GPC, co-developed by Marc Buyse, Chief Scientific Officer and IDDI founder, which allows patients and physicians to rank their priorities in terms of outcomes and make informed choices, will also benefit from increased computing power and data availability, and can arguably be the source of an important piece in the puzzle of big data.

IDDI is currently working to make this method available in portable devices, something that can arguably have a great impact on clinical practice and decision-making in the future.

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