Advancing Therapies from Bench to Bedside
I

n 2018, DIA continued to provide a unique forum for advancing the field of translational science by collaborating and exchanging fresh insights with leading health authorities, industry, regulators, patients, and academics.

  • Together with the Tufts Center for the Study of Drug Development we started a PharmaTech research study to identify the most promising and analytical digital platforms currently used or planned in healthcare. The first detailed outcomes have been submitted as a peer-reviewed article.
  • We continued our successful collaboration with the National Center for Advancing Translational Sciences (NIH-NCATS) in 2018 to address two important topics in clinical research: tissue chips and rare diseases.
    • A working group of experts from across the healthcare sector explored how tissue chips and clinical trials on chips (CToCs) could best be used to move the development of rare disease therapies forward.
    • Industry and government representatives took on rare diseases in a workshop where discussions centered on how to bring advocacy organization together with industry and government to advance rare disease clinical research.
  • For the fourth time since its inception in 2015, the Drug Discovery Innovation (DDI) Conference in Suzhou, China brought together representatives from internationally renowned pharmaceutical companies, local start-ups, and academia.
  • Members discussed cutting-edge topics within the field of translational science in DIA meetings around the world, numerous publications and podcast, and our DIA Communities.
Why we care: Translational science turns laboratory, clinical, and community findings into interventions that improve the health of individuals and the public. DIA works closely with researchers at the forefront of this rapidly advancing field to break through the roadblocks and accelerate therapies from bench to bedside.

For an overview of translational science advances in 2018, listen to this podcast featuring Drs. Gary Kelloff and David Parkinson.

AI in Drug Development: The DIA-Tufts PharmaTech Study
Kicked off in May 2018, the DIA-Tufts PharmaTech Study comprised a series of workshops, expert interviews, and landscape surveys with a total of 366 companies and CROs, as well as literature case studies to provide a comprehensive landscape analysis of the use of AI and other trendy IT technologies in drug development. The study was conducted in collaboration with eight major pharmaceutical and biotechnology companies: Amgen, Bayer, Eli Lilly, Genentech/Roche, Johnson & Johnson, Merck & Co, Novartis, and Pfizer. In addition to reaching a consensus on how to define AI and providing an overview of overall AI adoption within organizations, the study also identified the biggest roadblocks to implementing AI technologies as well as areas where AI applications are currently piloted or most widespread and effective. The detailed outcomes of this study are described in a peer-reviewed article recently submitted to Therapeutic Innovation & Regulatory Science (TIRS). Next, we will take the study a step further and examine specific use cases and their impact on drug development performance and efficiency.

Bridging Gaps in Rare Disease Research
Since our efforts in 2017 to initiate feedback from industry leaders on NCATS’ Trial Innovation Network, our collaboration with NCATS has focused on closing the gap between how government, academia, and industry view, discuss, and ultimately address important issues in clinical research. With its government and academic ties, NCATS continued to be an important partner for us in 2018, fostering conversations with representatives from across the healthcare sector on the complexities of rare disease clinical research:

  • Thus far, the NCATS-led and -supported organs-on-chips program has focused primarily on deploying the tissue-chip technology towards more predictive in vitro tools for safety and efficacy assessments of potential rare disease therapeutics. In a collaborative effort, DIA and NIH-NCATS expanded this initial focus towards the development phase of therapeutics, convening a working group of experts from industry, academia, and FDA as well as patient representatives to consider how tissue chips could best be used to move the development of rare disease therapies a significant step forward. The working group addressed questions related to disease setting, test agents for MPS, study design and feasibility, data collection and use, the benefits and risks associated with clinical trials on chips (CToCs), and how to engage different stakeholders. The key points of these working group discussions are currently summarized in a white paper.
  • The DIA-NCATS Rare Diseases Research workshop, on the other hand, focused on how to bring advocacy organization together with industry and government to advance rare disease clinical research and improve access to data and information. Introducing the NCTAS Rare Diseases Clinical Research Network (RDCRN) as an important resource for patients, industry, and the medical community, the working group addressed questions related to public-private partnerships and identified strategies for overcoming challenges in data sharing between RDCRN and industry.
A diverse panel of scientists, clinicians, government regulators, industry, and patient advocates are sharing their perspectives on the fast-developing field of precision medicine at the DIA 2018 Global Annual Meeting.
A diverse panel of scientists, clinicians, government regulators, industry, and patient advocates are sharing their perspectives on the fast-developing field of precision medicine at the DIA 2018 Global Annual Meeting.
Sharing What We Know

Translational science is a rapidly evolving field. As in previous years, we worked with experts to keep you up to date on the latest advances in precision medicine, gene and stem cell therapy, immuno-oncology, organs-on-chips, and regenerative medicine. Our members contributed their knowledge and expertise not only in our many meetings around the world, but also in numerous publications and podcasts, drawing you into lively discussions on numerous topics, such as:

  • the use of real word evidence to complement clinical trials,
  • applications of CRIPSR-Cas9 technology to treat diseases,
  • the potential of wearables and other technologies to advance affordable precision medicine,
  • the identification and use of disease state biomarkers, and
  • advances in rare disease clinical research and tissue chips.