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  6. Frequently Asked Questions about CDER Quantitative Medicine Center of Excellence (QM CoE)
  1. CDER Quantitative Medicine Center of Excellence (QM CoE)

Frequently Asked Questions about CDER Quantitative Medicine Center of Excellence (QM CoE)

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What is Quantitative Medicine?

Quantitative medicine, or QM, is the application of quantitative methods and computational techniques to better understand diseases and treat patients. It is an interdisciplinary approach that leverages both quantitative data (from the molecular level to the population level) and mechanistic knowledge to inform drug discovery and development, regulatory decision-making, and patient care.

What is the goal of the CDER QM CoE?

The goal of the CDER QM CoE is to facilitate and coordinate the continuous evolution and consistent application of QM across CDER. The QM CoE will function as a cooperative, coordinating body that spurs innovation and fosters comprehensive integration of QM approaches to advance therapeutic medical product development, inform regulatory decision-making, and promote public health.

Who are the participants and key stakeholders of the CDER QM CoE?

The primary CoE membership includes interdisciplinary experts that work in CDER. To ensure the CoE is equipped to carry out its mission, the CoE will be governed by leadership from the Office of Generic Drugs, Office of New Drugs, Office of Pharmaceutical Quality, and Office of Translational Sciences. Staff from other FDA Centers will be key stakeholders in all activities of the CoE, including but not limited to, development of best practices, trainings, and outreach. The CoE will strategically engage with stakeholders across the drug development community, including other regulatory agencies, drug development scientists, non-profit public health organizations, healthcare providers, and patients. The CoE will leverage existing collaborations between CDER and external stakeholders, as well as create innovative partnerships to advance QM in drug development and regulatory decision-making.

What activities will be some of the CDER QM CoE’s focus areas and technical scope?

The QM CoE network of interdisciplinary scientists in biostatistics, bioinformatics, computational science, pharmacometrics, biopharmaceutical science, clinical pharmacology, and medicine will focus efforts on scientific approaches expected to make the greatest impact on patients. These include:

  • Pharmaco-statistical modeling (e.g., pharmacokinetic/pharmacodynamic modeling, exposure-response analyses, disease modeling)
  • Mechanistic modeling (e.g., physiologic-based pharmacokinetic/pharmacodynamic modeling, systems pharmacology)
  • Machine learning and artificial intelligence
  • Biomarker-endpoint development
  • Clinical trial simulations and in silico predictions

What activities will the CDER QM CoE perform?

The CDER QM CoE will introduce new activities and coordinate existing activities in three main areas: Applied Science Policy, Strategic Planning & Coordination, and Multidisciplinary Education and Exchange.

1. Applied Science Policy

  • Policy Development: Facilitate scientific exchange and lead the development and implementation of evidence-based scientific guidances, policies and best practices
  • Knowledge Management: Warehouse and promote best practices and standards related to QM; document and disseminate outcomes of QM applications

2. Strategic Planning & Coordination

  • Strategic Planning: Develop long-term strategic goals and implementation strategies to realize the goals of QM CoE
  • Coordination: Coordinate and elevate existing QM-related scientific and regulatory initiatives and outreach and educational activities within CDER

3. Multidisciplinary Education and Exchange

  • Educational Enrichment: Provide applied regulatory science educational opportunities and resources to regulatory scientists and the public to promote the implementation and uptake of QM techniques
  • Community Engagement: Convene and engage key external stakeholders to foster knowledge exchange, gather input, build consensus for advancing QM to enable patient access to new therapies, enhance clinical decision-making, and improve patient outcomes.

CDER has been involved in many initiatives to advance quantitative approaches. How does this new QM CoE differ from previous efforts in this space?

While CDER has been at the forefront of advancing QM for decades, the growth of QM-related activities, regulatory initiatives, and operations has largely been opportunistic, ad hoc, and decentralized. The lack of an organizationally coordinated effort has historically led to redundancy in stakeholder engagement activities, heterogenous application of QM approaches across drug discovery, development, and regulation, and missed opportunities for cross-Center and cross-Agency policy development and implementation.

With the ever-increasing application of QM approaches to address a wide variety of issues in drug development and clinical use, we see many opportunities to maximize synergies across CDER by centrally coordinating efforts through strategic planning and execution. The CoE provides the organizational framework to facilitate and coordinate the continual development and deployment of QM to inform drug development across the entire lifecycle and enhance regulatory decision-making across CDER.

How will QM CoE interact with and differ from other CDER-wide initiatives or programs?

Given the multifaceted application potential of QM to inform drug development and regulatory decision-making, we expect opportunities for interaction and collaboration with other CDER initiatives such as the CDER Center for Clinical Trial Innovation (C3TI), Accelerating Rare disease Cure (ARC) Program, Fit-For-Purpose (FFP) Initiative, and others. In fact, QM CoE leadership team members also serve in leadership roles on many of these complementary initiatives and other relevant governance boards in CDER and FDA. This matrix approach allows for harmonization of scientific, regulatory, and operational approaches to advancing and adopting QM.

How will the CDER QM CoE impact regulatory review?

QM tools are frequently used in CDER in the pre- and post-approval review of therapeutic products. This includes in the evaluation of new small and large molecule therapeutics and follow-on/generic products. CDER has well-established processes for interactions through existing regulatory mechanisms such as the Model-Informed Drug Development (MIDD) Meeting Program, the Complex Innovative Trial Design (CID) Meeting Program, the Fit-for-Purpose Initiative, and  Drug Development Tool Qualification Programs. Quantitative scientists are integral members of the multidisciplinary product review teams. In general, the QM CoE is not expected to alter the routine processes for these regulatory engagements. The CoE can, however, serve as a forum for deliberating and providing input on specific product development issues as needed and as requested by product evaluation teams.

How will the CDER QM CoE benefit public health?

New drug development is a multifaceted, complex, high-risk endeavor involving a range of scientific, financial, and regulatory challenges. Quantitative methods and models have been shown to streamline drug development by reducing the need for unnecessary studies, reducing the number of patients needed to make robust inferences about efficacy and safety, shortening clinical trial duration, and optimizing clinical trial designs to be maximally informative about treatment effects in patients of interest. The QM CoE is expected to help streamline drug development and generate information that will ensure timely access to treatments and empower decision-making for the benefit of patients.

How can sponsors and interested external stakeholders engage with the QM CoE?

The QM CoE encourages all stakeholders to explore how they can help the QM CoE advance and integrate QM to maximize societal benefit and patient care. Interested parties can email CDERQuantMed@fda.hhs.gov for more information.

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