January 1, 2017 (Vol. 37, No. 1)
What Technologies Will Help Foster Product Innovation, Market Expansion, and Revenue Growth?
2017 not only ushers in a new year, but a new U.S. presidential administration as well. GEN interviewed top biotech/pharma CEOs to find out what they thought might be in store for the industry and what they would like to see happen in the new year. I think you will find their responses timely, thoughtful, and instructive.
This is part 5 of the GEN CEO Perspectives Roundup.
Part 1: What Would You Tell President-Elect Trump?
Part 2: Key Challenges
Part 3: Industry Growth
Part 4: Regulatory Initiatives
GEN: What disruptive technologies could be applied to healthcare research to foster product innovation, market expansion, and revenue growth?
Mr. Manzello: In light of the growing number of therapeutic proteins, the resultant immune responses, and their contribution to the initiation of neutralizing antibodies, severe allergic reactions and autoimmunity are highly problematic. The introduction and large-scale deployment of de-immunization strategies and humanization of antibodies are really a valuable enablement toward the criteria that was set forth in the question (i.e., product innovation, market expansion and revenue growth).
Dr. Cohen: The interplay between digital tech and biopharma is still at an early stage. The capabilities provided by the digital world will impact all phases of drug development and commercialization.
Mr. Leschly: I think the answer to this question is just do some of the basics correctly. Right now, we always want to talk about the new, sexy technology; when in reality some “fundamental blocking and tackling” in basic areas, such as clean water and preventive medicine, can have a dramatic impact on public health.
Regarding true innovations, it's finding a way to take them and then allowing the system to keep up. My fear is that we develop technology and that then generates clinical data. The regulators are there, but the system is not yet set up in a way to support bringing new treatment modalities to market. There's a lot of money at play and there's a lot of, let's just say, systemic challenges as it relates to shifting the behaviors of a payer; for example, one who has to look at a 12-month budget and is not incentivized to look at the lifelong benefit. At the same time, if we are going to challenge payors to change behaviors and adapt, we in industry need to make sure that we develop drugs that do not have just an incremental effect but a transformative effect, and are good stewards and partners with regulators and payers.
Mr. Connor: Mobile/wireless technologies as medical devices for remote monitoring and home healthcare for patients including wireless transmission of data from home/device to physicians and back to patients, and Adaptations of the most advanced Big Data information technologies and analytics across the full spectrum of data-dense and information-rich life-science opportunities, with a specific emphasis on genetic and epigenetic information that is actionable by physicians to deliver greater personalized care to patients
Mr. Equels: We will only be a world leader in new technology if our nation clears the path for approvals. Pharma cannot be expected to dump hundreds of millions of dollars into new technology where there is no clear path to approval.
Mr. MacMillan: There are a number of new and emerging technologies that could impact healthcare in a significant manner. Next-generation sequencing (NGS) and algorithm-based diagnostics have the potential to help us to better understand complex diseases, as well as predict and prevent them. Delivery of medicine could be revolutionized by telemedicine and app-based platforms that bring care literally into patients’ hands. Developments in software, specifically in the realm of artificial intelligence, have the potential to help radiologists interpret medical images.
Dr. Brandon: Well, I'll beat my own drum again and say that host response-based technologies for infection, sepsis, and infectious disease as a whole are absolutely critical to the future. I see those technologies as being both disruptive and complementary to pathogen-based tests for sepsis and infectious disease.
Other disruptive technologies lie at this intersection of IT, genomics, proteomics, metabolomics, etc. This is the future of diagnostics, and companion diagnostics in particular. Personalized medicine and better, targeted treatments will result from innovation, speed-to-market, and healthy market competition; and healthcare itself as a result will benefit and become more cost-effective.
Point-of-care (POC) technologies are also disruptive, and we have to make sure that these technologies deliver the same quality of clinical information as lab-based tests. POC technologies, which will revolutionize medicine, need to be first integrated within hospital laboratories as a part of their infrastructure. When available more broadly, POC methods near to the patients are going to save lives, but also help to prevent chronic illness.
Dr. Lichtenberg: Again, immunology-based treatment strategies will have a strong impact on oncology and other indications. While not disruptive (as it was for a while), but gaining substantial interest over the past two years: phenotypic drug discovery will enable a new wave of compounds and compound combinations to be discovered and developed in the coming years. With more relevant cell models, like 3D microtissues and functional assays from biochemical to high-content imaging approaches, a broad spectrum of new research possibilities is available to the life-science community.
Dr. Liu: CRISPR gene editing for gene-based therapy, and the combined sectors of wearables and medical informatics may be the most disruptive because 1) they will treat previously untreatable disorders, and 2) they will improve the efficiency and delivery of healthcare.
Dr. Wilson: A significant number of clinical trials fail to meet recruitment goals, which leads to delays, early trial termination, or the inability to draw conclusions at trial completion due to loss of statistical power. A recent analysis found that 19% of registered trials that closed or terminated in 2011 either failed to meet accrual goals (85% of expected enrollment) or were terminated early due to insufficient accrual. Insufficient recruitment results in missed opportunities for patients who can benefit from clinical trials, and wastes time, funds and other resources.
Disruptive technologies, including social media, which could increase awareness of clinical trials among physicians and patients in an ethically responsible manner could facilitate the industry’s ability to evaluate the critical, therapeutic hypotheses that are necessary to advance drug discovery and development.
Dr. Schwieterman: I think that disruptive technologies will come chiefly in the form of diagnostic markers for patient sub-populations. So being able to predict not just the prognosis of a patient, but also a treatment that interacts with a diagnostic test, whether it be a blood test, a tumor sample, or some kind genomic marker. Something that helps the industry improve its treatment for that patient population, and makes it easier to do adequate clinical studies, is going to be key.
The disruptive technology that's going to make the biggest difference is when we routinely start pairing diagnostic and predictive markers in clinical trials so that we now have enriched (in other words, enrolled) the best possible patients—most likely to have a treatment benefit—for demonstrating treatment effects. This is going to create a practice of medicine that will be much, much different from what it was 30 or 40 years ago. It’s all very exciting.
Ms. Cournoyer: In oncology, I am most excited about the development and enhancement of the liquid biopsy, a technology whereby tumor DNA can be assessed through peripheral blood with a simple blood draw, instead of an invasive biopsy. Liquid biopsies are having a tremendous impact on how we think about cancer diagnostics.
Another positive about liquid biopsies is that aside from being easier on the patient and potentially less expensive it could actually be more sensitive in the identification of potential driver mutations. The implications of this treatment, in terms of finding new resistance mutations, will help physicians to determine when to change the treatment strategy for the patient in a timelier manner.
I am also very excited about immune therapies, which are showing incredible promise and producing some impressive and sustained responses for patients. But, the persistent challenge here is how to predict which patients will benefit. Again, I come back to testing. The emergence of a test that can accurately predict which patients will dramatically respond to immunotherapy could have a game-changing impact on cancer treatment.
Dr. Clarke: Immuno-oncology, CAR T cells, CRISPR Cas9 and gene therapy are the future for the potential cure of many diseases. In the case of something more what Pulmatrix has, a novel inhaled drug delivery platform, it would be advantageous for us to be able to take our disruptive technology and apply it more quickly to patients in need. We would like to see other approaches, besides just getting fast-track designation, that could be done with the government to try and get therapeutic products to the market in a more timely manner.
Mr. Farrell: The biggest potential we see moving forward is the role of data analytics in changing the way healthcare is delivered and how patients are managed. If we can truly understand all of the points in which patients interact with their therapies, and the steps along the way in which providers need to intervene, data can point to an increasingly efficient way of coordinating care so that patients are treated at the precise moment of need. It isn't just Big Data, though—it is actionable information, delivered to a physician and a provider at the right time so that they can make a real difference in their patients’ quality of life. We will need a lot of interoperability within medtech, biopharma and digital tech companies to make this happen. Cloud-level interoperability is a necessity and we would like to see strong support from our government agencies to help us unlock this value for all patients, across all major chronic diseases.
Dr. Gruber: The Internet is certainly the disruptive technology of our era, and it holds major potential benefits for healthcare. Several examples come to mind. The advent of the Internet has opened an important new channel for highly targeted trial recruitment. For example, with Google and Facebook analytics, drug developers have the ability to reach specific audiences, drilled down to location and interests. This accelerates trial recruitment efforts and reduces trial costs in a highly effective manner.
Patients should be allowed to own and share their data, and with a simple click of a button. They could take this data to clinical trial sites, for example.
Lastly, as mentioned before, as the cost of sequencing continues to decrease to the point of commoditization, bioinformatics will drive logarithmic advances in how we think about new target discovery and drug development.