As Johnson & Johnson Chief Medical Officer, DIA 2019 Co-Chair Dr. Joanne Waldstreicher is responsible for the company’s collaborations in ethical science, technology, and R&D policies, including those related to clinical trial transparency and compassionate access. “When you ask people why they’re participating in a clinical trial, a big part of it is to benefit themselves, they might have a condition or a disease where they’re looking for a new treatment option,” she explains. “But a very large part of their motivation is to contribute to medical knowledge that will advance or help care for a future patient.”
The emerging digital healthcare landscape is already becoming quite visible around the world, especially in Japan. But what is the true impact of digital technology on clinical research, drug development, and healthcare? “Imaging data plus AI is one of the best combinations,” explains Dr. Kazuhiro Kanmuri, Founder and Chief Executive Officer of Inter-Professional, Inc. Dr. Kanmuri served on the Program Committee for the June 2019 DIA Japan Cutting Edge Series Workshop #1.
Conversations about disparate healthcare access often address therapies approved for market, but how can we ensure equity in the clinical R&D processes that generate these therapies? “There’s not a ‘one size fits all’ approach to overcoming all the barriers to recruiting diverse participants in clinical trials, and there may be specific considerations for various populations you’re intending to recruit,” explains CAPT Richardae Araojo, Associate Commissioner for Minority Health, and Director of the Office of Minority Health and Health Equity. “A plan to address inclusion should be developed early on; it should not be an afterthought, and it begins and ends with the patient in mind.” CAPT Araojo will help lead the Clinical Trial Diversity session at DIA 2019.
“Digitization is something that is happening to everything that we do. It’s being called the fourth industrial revolution,” explains Dr. Robert Califf, former FDA Commissioner and Vice Chancellor for Health Data Science at Duke Health. “And if we do it right, it will actually free up clinicians to spend more time directly with people and, when they become patients, with sick people, which is what we really want.”
Do changes in clinical research, driven by emerging technology, change what we mean by “evidence”? “It’s not necessarily ‘trials versus real world evidence’–that is not particularly helpful because either type of evidence, either type of data, has its place and is complementary,” explains Mr. Michael Seewald, WorldWide Head of the Center of Excellence for Real World Evidence, Novartis Pharma, and member of DIA’s Future of Evidence Workshop program committee. “The exciting development is in developing data sources over a timeframe of decades that at some point will revolutionize healthcare in a respective therapy area.”
“One critical area when you look at healthcare systems is the issue of optimizing clinical and operational effectiveness,” suggests Professor John Lim, founding Executive Director of the Duke-National University of Singapore Centre of Regulatory Excellence (CoRE). “This is an area where research in AI is developing to really inform and aid decision making by not only physicians but also then operational decisions by healthcare providers.” Professor Lim is also Chairman of the Singapore Clinical Research Institute and National Health Innovation Center.
“China joining ICH is a magnificent milestone for the pharmaceutical industry in China,” explains Dr. Jingsong Wang, Chairman and Chief Executive Officer of Harbour Biomed. “We can see clearly more and more local pharmaceutical companies adopting the international standards to have a more innovative portfolio to face the competition from their global partners or counterparts.” Dr. Wang serves on the Steering Committee for our DIA China 2019 Annual Meeting in Beijing.
Should prescription drug or device advertisements include their price? “I don’t know how patients will perceive that because they won’t really know the difference between what they may or may not end up paying,” suggests Micheline Awad, Director, Regulatory Affairs, Advertising & Promotion, Neurocrine Biosciences, Inc. “We really haven’t studied in any systematic way the impact on the patient or on drug use or on being more transparent about drug prices,” explains Wayne Pines, President, Regulatory Services & Healthcare, APCO Worldwide, Inc. Micheline and Wayne served on DIA's Advertising & Promotion Regulatory Affairs 2019 program committee.
Dr. Yoshiaki Uyama, Director of the Office of Medical Informatics & Epidemiology for the Pharmaceuticals and Medical Devices Agency (PMDA), Japan, and DIA Global Forum Regulatory Science co-editor, shares his vision for utilizing real world evidence in regulatory science. “The challenge is, we still don’t understand completely the characteristics and the limitations of those data. We are very familiar with assessing or evaluating the data of a clinical trial. But real world data is not completely of the same character as that of a clinical trial because those real world data are not primarily collected for such purposes.”
In 2018, the US FDA approved a record high number–59–of new, novel drugs. “We are at a point now where there is so much innovation in this space and the regulatory aspects are catching up, so we now have three approved gene therapy products in the US and over seven to eight hundred INDs for cell and gene therapy filed with FDA,” explains Dr. Adora Ndu, Executive Director of Global Regulatory Policy, Research & Engagement, BioMarin Pharmaceutical, and Regulatory Science Co-Editor for DIA Global Forum. “With each interaction with each product that’s filed and with each product that’s approved, the regulatory experience is broadened.”