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Innovation in Drug Research and Development for Prevalent Chronic Diseases Proceedings of a Workshop (2021) / Chapter Skim
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7 Reflections and Final Thoughts
Pages 63-72

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From page 63...
... (Colón, Drake, Schaeffer) • Including diverse populations is crucial throughout the research process, from basic exploratory research to clinical trials.
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From page 64...
... Anantha Shekhar from the University of Pittsburgh and Carlos Garner from Eli Lilly and Company moderated a panel discussion in which Susan ­Schaeffer and Bettina Drake of the Washington University School of Medi cine, Howard Rosen from BonVelo Ventures, and Grace Colón summarized workshop key themes and highlighted some of the cross-cutting strategies discussed over the course of the workshop. ENGAGING PATIENTS THROUGHOUT THE RESEARCH PROCESS Schaeffer recognized that "knowledge gaps that are discouraging investment in R&D for prevalent chronic diseases are far too big for any one company or institution to fill." Instead, developing treatments for prevalent chronic diseases will require broad systemic collaborations to reduce cost and risk.
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From page 65...
... She reiterated Veasley's point that by communicating what is most important to patients, patient advocacy organizations can help establish research priorities and identify where new tools and more knowledge are needed. Another way that patient advocacy organizations can help tackle research issues, she said, is by helping to organize and fund collaborations aimed at answering some of the big questions about prevalent chronic diseases.
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From page 66...
... However, if their goal is to generate knowledge that can be translated into patient care that improves lives and improves outcomes, then it is actually faster to work with patients. CONSIDERATIONS FOR DESIGNING CLINICAL TRIALS A major theme cutting across several of the workshop sessions, Drake said, was the importance of a patient-centered approach in designing clinical trials.
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From page 67...
... NEW TECHNOLOGIES AND INNOVATIVE APPROACHES Given the many uncertainties associated with the progression of chronic diseases, the use of artificial intelligence could play a useful role in unravelling the mysteries of pathogenesis and analyze large volumes and types of data, said Rosen. As John Ngai explained in his remarks, NIH's BRAIN Initiative is generating large amounts of data, as are a variety of other programs, which can be analyzed using AI approaches to inform drug discov 1  For more information, see https://www.fda.gov/media/121317/download (accessed July 16, 2021)
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From page 68...
... Overall, Rosen concluded, the workshop left him optimistic about the potential for formulating new techniques to speed the drug development process and having an impact on prevalent chronic diseases. LESSONS LEARNED Colón summarized examples of past success that could offer lessons learned for innovation in drug R&D for prevalent chronic diseases going forward.
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From page 69...
... She added that because metabolic syndrome has many different implications, it is important to look at realworld evidence and understand what is happening in patients' lives in order to understand the types of innovations that will be most valuable. The good news, Colón said, is that a variety of companies are looking to put innovative technologies to work in every aspect of clinical trials, from risk mitigation to novel biomarkers and composite endpoints, "and so there is a lot of optimism about the future." Potential Opportunities for the Future The panelists proposed a few areas in which investment and attention could spur innovation in drug R&D for prevalent chronic diseases: • There are opportunities to rethink the overall patient journey and to develop new treatment paradigms enabled by new technologies and approaches, including modalities and routes of delivery, the optimization of formulations and device combinations, novel bio markers, and digital health technologies.
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From page 70...
... (Schaeffer) • Defining and validating novel endpoints for clinical trials can help reduce the overall cost of prevalent chronic disease clinical trials and improve the relevance of studies for patients, clinicians, and payers.
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From page 71...
... REFLECTIONS AND FINAL THOUGHTS 71 characterized the nation's response to COVID-19, as a positive example of collaboration. He suggested that prevalent chronic diseases could benefit from applying that same transparent communication and sense of urgency to address the nation's most pressing health problems.
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Key Terms

  • prevalent chronic
  • clinical trials
  • chronic disease
  • patient advocacy
  • include patients

  • diverse populations
  • chronic pain
  • lent chronic
  • improve patient
  • including diverse

  • engaging patients
  • drug development
  • research process
  • help establish
  • systemic collaborations

  • require broad
  • health insurance
  • eli lilly
  • warp speed
  • brain metastases

  • developing treatments
  • workshop sessions
  • basic exploratory
  • broad systemic
  • disease management

  • advocacy organizations
  • schaeffer added
  • spurring innovation
  • operation warp
  • drug research


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