Summary: Stat News asks a variety of experts in the fields of science, medicine, policy, and education to weigh in on what themes they expect to see emerge in their respected fields throughout 2019. MAPS Founder and Executive Director Rick Doblin, Ph.D., contributed to the conversation by stating, “In 2019, more scientific research will be happening into the therapeutic uses of psychedelic compounds than at any time in history. My organization, MAPS, the Multidisciplinary Association for Psychedelic Studies, will be in the midst of our much-anticipated phase 3 clinical trials of MDMA-assisted psychotherapy for the treatment of post-traumatic stress disorder (PTSD), with an eye toward FDA approval in 2021.”
Originally appearing here.
It has been a tumultuous year for science and medicine, and also for the business and politics of both. And with CRISPR babies still in the headlines, Donald Trump still in the White House, and the Dow down again, 2019 is shaping up to be just as turbulent. We asked a whole host of experts — scientists, CEOs, policymakers, and professors — to weigh in on what themes they expect to see emerge in the next 12 months.
We’re getting closer to a universal flu vaccine
I think we’ll see substantial progress in the quest for improved influenza vaccines that get us closer to the goal of a broadly protective, durable “universal vaccine.” We will not have a true universal influenza vaccine by any stretch of the imagination in 2019. However, we will likely see positive results from clinical trials underway, including serological data from Phase 1 studies that will give us a sense of how well vaccines aimed at “broader coverage” will work. We’ll also see strong preclinical data from exciting new vaccine constructs.
I suspect 2019 will also be a year in which long-acting anti-HIV agents (injectable antiretroviral agents and monoclonal antibodies) show indications of being protective against the acquisition of an HIV infection.
— Dr. Anthony S. Fauci, director, National Institute of Allergy and Infectious Diseases
The CRISPR story is just getting started …
In 2019, we predict that advances in CRISPR gene editing and phage therapy will coalesce, and we will witness the first genetically modified phage cocktails being used to cure patients with multidrug-resistant bacterial infections. This will attract new players in the biotech and pharma space and will provide new momentum to bring phage therapy into clinical trials in the U.S.
Separately, we also predict that cities in the U.S. that are bold enough to embrace supervised injection facilities will witness a decline in overdose deaths.
— Steffanie Strathdee, associate dean of global health sciences, University of California, San Diego, and co-director of the Center for Innovative Phage Applications and Therapeutics
And so is the focus on China.
The biopharma industry relies heavily on outside investment to fuel its research and development. Foreign investment, especially from China, is now making up a larger chunk of those dollars. In 2019, we’re going to see increased interest in our sector from Chinese investors. But new regulations and greater federal scrutiny of foreign investments, like the CFIUS regulation, may hamper or even stop the flow of this capital if they are not executed thoughtfully. As the CFUIS pilot program creates greater uncertainty for both investors and early-stage biotechs that rely on these funds, we may see some investments go to other industries or other countries.
– Robert K. Coughlin, CEO, MassBio
The opioid crisis isn’t slowing down, either.
The triple-wave crisis, of opioid pill to heroin to fentanyl overdose, continues to grow and change. There is some good news: Deaths from opioid pills have begun to decline. However, deaths due to synthetic opioids (i.e. fentanyls) continue to peak. Follow these trends for 2019: use of and overdose from stimulants, including methamphetamine and cocaine, continues to rise; contamination of stimulants with fentanyls continues to confound; and fentanyls overall continue to plague. Compassion fatigue and polarization confront us at the community level, yet the policy conversation is getting increasingly creative with harm-reduction notions including drug checking, supervised consumption, and cannabis substitution.
— Dr. Dan Ciccarone, professor of family and community medicine, UCSF
Speaking of cannabis (and psychedelics) … it’s only heating up.
Changes in federal laws regarding medical cannabinoids will substantially expand scientific research in 2019 in that arena. Scientific evidence is essential to guide the growing use of “medical marijuana” products, which are expected to increase and become even more mainstream in 2019 (as more companies will get into the cannabis market targeting consumer goods and health care). There will, however, be more demands by the public to have better guidance about how to use such cannabis compounds to alleviate their particular symptoms/disease. Physicians will also demand more knowledge in order to guide and treat their patients. As such, there will be more pressure for preclinical and clinical research that has unfortunately lagged behind the growing medical marijuana craze.
— Yasmin Hurd, neuroscientist and the director of the Addiction Institute at Mount Sinai
In 2019, more scientific research will be happening into the therapeutic uses of psychedelic compounds than at any time in history. My organization, MAPS, the Multidisciplinary Association for Psychedelic Studies, will be in the midst of our much-anticipated phase 3 clinical trials of MDMA-assisted psychotherapy for the treatment of post-traumatic stress disorder (PTSD), with an eye toward FDA approval in 2021. Early in the year, we’ll finally have the results from our now-completed phase 2 clinical trial of marijuana for symptoms of PTSD in U.S. veterans, the first study of whole plant marijuana for PTSD. The new year will also see the expansion of our MDMA-assisted psychotherapy for PTSD drug development program to Europe, with our European phase 3 trials starting late next year. We can also expect — though it’ll take lots more work! — the continuing destigmatization of psychedelic research worldwide, including (hopefully) more funding support for nonprofit psychedelic research from individuals and institutions across the political spectrum. Our work is cut out for us, but psychedelic science is here to stay.
— Dr. Rick Doblin, founder and executive director, MAPS
Cancer research will increasingly focus on organoids.
During the past year, tumor organoids have continued their rise into the spotlight, with new validated cancer models, and more and more data supporting their capability to mimic a patient’s tumor characteristics, as well as drug responses, and methodologies to rapidly screen drugs.
The new year will see tumor organoids starting to approach the clinical arena as avatars for identification of effective, personalized therapies, as well as tools to facilitate patient selection for specific trials, with efforts by institutions and scientific societies to streamline standard procedures, define regulatory mechanisms, and support clinical implementation.
We are also likely to see a significant increase in the development of models that include a tumor organoid together with an immune system component. These dual models are not only invaluable tools to study the interaction of tumors with immune cells in humans but are also likely to have a transformative impact on the development and testing of immuno-oncology drugs.
— Alice Soragni, assistant adjunct professor of hematology-oncology, UCLA
You’ll get more control of your health data.
I believe in 2019 we will see a dramatic increase in people acquiring their health data. There have been some exciting technological changes that enable easier access to information such as medical records, lab values, and pharmacy data. With that data in hand, I believe consumers will be better empowered to make decisions about their health and increase their ability to stay healthy!
— Anne Wojcicki, CEO, 23andMe
Broadly, though, expect a reckoning in the AI space.
Health care’s digital transformation will gain momentum in 2019, but health systems will be reluctant to look beyond their electronic health record vendors to try new AI software and other products. There is a lot of hype around AI. The vendors are going crazy. People don’t even know what AI means anymore. Depending on who you ask, you get a different definition. Lots of people in health care are confused by the buzz. They understand that AI is an important part of the future. But what is not clear is what kind of technologies they should be investing in and how reliable the returns will be. So I think you’ll see health care executives become more discerning about what they can use these tools to accomplish.
— Paddy Padmanabhan, chief executive, Damo Consulting
None of this will keep prices down.
In 2019, health care costs are going to continue to rise, especially among the employer-sponsored population where employers continue to lack sufficient negotiating power against the rapidly consolidating provider industry and predatory pharmaceutical industry pricing. I’m also predicting that in 2019, increased price transparency, while a worthy endeavor, will not be the panacea that many people expect it to be in terms of lowering health care spending.
— Niall Brennan, president and CEO, Health Care Cost Institute
We’ll get a clearer picture on antibiotic resistance threats.
The Centers for Disease Control and Prevention is poised to release an updated “Antibiotic Resistance Threats in the United States” report in the fall of 2019. The original report, published in 2013, sparked action to address antibiotic overuse in human health care and agriculture. Its conservative estimates showed that at least 2 million Americans get sick from antibiotic-resistant infections, and 23,000 die every year. The updated report will likely have a clearer picture of how many people are affected by antibiotic-resistant infections in the U.S., which will fuel efforts to reduce antibiotic use.
— Matthew Wellington, antibiotics program director, U.S. PIRG and U.S. PIRG Education Fund
Pharmacies may have to change to stay relevant.
From a pharmacy perspective, I think we are going to see a shift in mindset in terms of how we view the traditional role of the pharmacist. The standard definition of a drug is something that treats an illness or a disease. However, we’re seeing now that digital therapeutics and apps can have similar benefits as traditional medications and improve clinical outcomes when used in conjunction with standard therapies. Thus, I predict we’ll see more front-line pharmacists becoming involved with data science and remote patient monitoring programs, which will enable the pharmacist to synthesize data gleaned from pharmacogenomic testing, wearable or digestible sensors, and connected health devices like blood pressure cuffs. All of these findings taken in concert will provide the pharmacist with a holistic view of the patient and ultimately help the community pharmacist better manage patients suffering from chronic diseases.
— David Berkowitz, assistant director of clinical pharmacy, Newton-Wellesley Hospital