“Getting away with murder” is a harsh condemnation of an industry dedicated to improving and saving lives, but that is what President-elect Donald Trump said of the pharmaceutical industry at his first post-election news conference earlier this month. He further criticized the industry for not manufacturing in the United States and promised to change the way the U.S. government buys drugs.
Trump’s aggressive posture sent shockwaves through the industry and the markets. The NASDAQ Biotechnology Index – iShares Nasdaq Biotech ETF (IBB.O) – closed down 3 percent and big pharma lost almost $25 billion in market value on the day of the press conference. While pharmaceutical stocks have since recovered some of the losses, the industry and analysts are still trying to understand how the incoming Trump administration’s policies will affect the pharmaceutical industry.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
While Trump strongly criticized the pharmaceutical industry for both not manufacturing in the U.S. and high prices in his press conference, his position up to this point has been focused on pricing and not manufacturing. His Healthcare Reform position paper, published when Trump was still a candidate, focused on drug prices and alluded to easing importation of drugs to improve pricing and competition. Trump similarly focused on drug pricing in his Time Magazine Person of the Year interview in December 2015 by saying, “I’m going to bring down drug prices. I don’t like what has happened with drug prices.”
Even though Trump’s recent focus on pharmaceutical manufacturing has the industry in a panic, some think that focusing on manufacturing will increase, not reduce prices. Moreover, it’s likely that Trump is using manufacturing as leverage to influence the pricing discussion and it may be working. AbbVie chief executive, Richard Gonzalez, speaking at the annual JP Morgan Healthcare conference said that his company will raise prices only once in 2017 and limit those increases to single digits. Ken Frazier, CEO of Merck made a similar pledge in an interview in December.
While these pledges to curb price increases are understandable, focusing on price alone will ultimately hurt the industry and the public because lower prices will result in cost cuts (read job losses) and reduction in R&D, resulting in fewer lifesaving treatments coming to market. Instead, by zeroing in on innovation, the pharmaceutical industry can change the conversation and let market forces determine pricing.
Still, it’s not all bad news for the pharmaceutical industry. There is reason to believe that a Trump administration wants a faster and less stringent drug approval process. Trump made cutting regulations a cornerstone of his candidacy, and short-listed candidates for his U.S. Food and Drug Administration commissioner – Jim O’Neill and Dr. Scott Gottlieb – have strong views on the need to change the FDA drug approval process with the goal of achieving lower costs and increased choices.
An easier regulatory environment creates an opportunity for the industry to accelerate the process of new drug approvals by focusing on clinical trials. These trials, however, are complex, costly and inefficient. Moreover, the process and workflow of randomized clinical trials haven’t changed since the 1990s. Trump’s push for fewer regulations and more consumer choices creates a perfect setting to streamline and optimize the clinical trial process.
Here are four strategies that the industry can pursue to make clinical trials simpler, friendlier, faster and cheaper:
Pursue virtual and direct-to-patient trials to augment traditional site-based trials
Why? Access to patients is the single biggest gating factor for running clinical trials. Nearly 20 percent of clinical trial sites don’t recruit a single patient and more than 48 percent of clinical trial sites under-enroll.
Traditional clinical trials leave it to the principal investigators they use to recruit patients, but this leaves a huge population of potential patients untapped. In direct-to-patient trials, pharmaceutical companies can find patients first and then connect them with investigators, thereby creating a new stream of patient volunteers. Companies such as Science 37 and Elligo Health Research are pioneers in direct-to-patient trials and poised for significant growth.
Use eSource to speed up and optimize clinical trial processes
Why? Although clinical trials use technology to manage and collect data, clinical trial sites still collect data on paper first and then enter it into the system. This is not only costly and inefficient, it creates significant delays. On average, sites take 22 days to enter data collected on paper, and further delays and costs are incurred to verify the accuracy of the entered data (source data verification).
Collecting data in electronic form using tablets and computers eliminates the paper step, reducing costs and speeding up the clinical trial as delays to enter and verify data are eliminated. But for this to happen, data collection tech needs to enable direct entry of data using tablets, allow for physicians to take notes, produce electronic medical records and provide integration with labs and instruments. There are already solution providers doing just that, such as ClinicalInk (provides a complete eSource solution) and ClinicalResearch.io (focuses on site workflows and integrates with eClinical solutions), but expect new entrants with additional offerings in the coming year.
Put the patient at the center of trial design and execution
Why? Pharma companies bring treatments to market for the benefit of patients and need voluntary participants in order to run clinical trials. Regrettably, patients are often an afterthought in clinical trials as the focus tends to be on investigators and trial results.
The FDA has started to engage directly with patients and is encouraging the industry to focus on patient outcomes and treatments that meet patients preferences and needs instead of simply focusing on disease management from a medical perspective. However, the industry has traditionally viewed patients in clinical trials as subjects, not as partners or clients. The industry needs to engage with patients in protocol design, assist them along the way as patients participate in trials, and treat them as partners. The pharma industry also needs to keep them informed about their role in the trial and the overall status of the trial drug even after their direct participation has ended.
Take a fresh look at the clinical trial technologies
Why? Clinical trials are getting more complex. The cost of running clinical trials has more than doubled since the 90s. Clinical trials need to be patient-centric and support newer execution models such as direct-to-patient. The existing clinical trial solutions are unable to adapt to the changing needs.
Clinical trial technologies haven’t changed much since the current categories — clinical trial management systems, electronic data capture, and interactive voice response, — were established in the late 1990s. While most of these solutions have been repeatedly upgraded, there is usually a complex web of interconnected solutions that need to be integrated to run clinical trials resulting in delays, cost overruns, data errors, poor usability and low satisfaction.
Moreover, these solutions haven’t adapted to the modern-day, mobile-first/cloud-first mindset where users expect the same experience that they get using apps on their mobile phones. Look for simpler, integrated, mobile and tablet enabled solutions that provide great user experience and flexible workflows.
Photo: Getty Images
