Part 3: We asked the executives to tell us the most significant trend(s) to look out for in 2023…
Vincent Keunen, CEO Andaman7
“Patient-mediated research will be a key trend as we increasingly recognize the need to place people with lived experience as central players in the healthcare ecosystem. We have already seen large CROs recruit patients and caregivers in more active roles.
“We are also seeing a rise in ‘patient entrepreneurs’ developing tools and technologies, carrying out research, consulting and speaking at conferences. That is how Andaman7 got started. I was a patient and software engineer caring for my sick son. I built the solution I wanted to see, and I believe future innovations will be driven by others like me.”
Patrick Hughes – Chief Commercial Officer & Co-Founder at CluePoints
“Decentralized clinical trials (DCTs) are nothing new, but we are still unsure as to how they will be adopted across industry. We see many sponsors only just starting to ‘dip their toes’ into this new research model, and there doesn’t yet seem to be a standard approach to application. It is an ongoing trend, and one that is definitely here to stay, and it will be very interesting to see how it continues to be adopted over the next year.”
Sam Whitaker, Co-CEO, Co-Founder and Jason Dong, Co-CEO, Co-Founder, Mural Health
“We think that eliminating barriers which prevent people from accessing and staying enrolled in trials will continue to be a critical focus in 2023. Many different barriers make it difficult to participate (and remain) in trials.
“We see financial barriers (especially in this age of hyper-inflation), and personal logistical barriers (transportation, child care as examples) as two of the most common. These are also two of the most obvious, among a myriad of more complex issues, that work to prevent proportionate representation in research across racial and ethnic minorities.
“Fortunately, the sponsor community is receptive to adopting strategies and solutions that make studies more accessible. The investment case is clear – making trials more accessible will improve recruitment and enrollment rates and will reduce dropout rates, thereby reducing costs and ensuring the quality of the clinical data set. Participants have, historically, been treated as “subjects” rather than patients (and caregivers). We think that the industry will begin to change the dynamics so trials can be as “user-friendly” for patients as possible.
“For example, in the patient reimbursement realm, the industry standard is prepaid cards, offering no patient choice, while there are so many more efficient solutions that the average US consumer is used to, such as direct to debit, Venmo, etc. Prepaid cards also charge many hidden fees.
“We think that digital payment methods will become the norm this coming year, so that patients won’t need to receive physical cards (especially those in fully virtual trials, who will have to receive cards in the mail). This is just one of many examples of how the industry will shift in the near term to be more patient centric.”
Tarquin Scadding-Hunt, CEO, mdgroup
“A key trend in 2023 will be personalized care that utilizes technology while also keeping people’s specific needs at the forefront. We have been on a journey of decentralized clinical trials (DCTs) and developing facets so patients can have as many elements of a trial as possible at home, or in an environment they are comfortable with.
“While COVID-19 accelerated that journey, there is still much to do, and we must make sure we retain those all-important human interactions. People must always come first, and solutions must flex to meet their individual needs. To be truly successful, we must prioritize patient access and interest.”
Dr. Sheelagh Aird, Senior Director of Digital Health and Data Science, Phastar
“The ongoing developments and improvements which facilitate access to an increasingly abundant amount of digitally curated healthcare information, paired with advances in statistical and analytical tools, provide us with huge opportunities to improve our understanding of the disease process.
“At the heart of clinical diagnostics, biomarkers are indicators of the presence and severity of disease and play a vital role in early diagnosis, prevention and treatment. Tapping into the potential of digital biomarkers, i.e. those generated through digital health tools, will allow deeper insights into data from a new rich dataset of information. These data insights and the tracking of trends and patterns using digital biomarkers will allow us to move from a reactive to a proactive approach to healthcare.
“Companies are recognizing that the ability to use digital biomarkers to Identify patient populations is expected to have a higher therapeutic impact that will contribute to and speed up the drug development process by optimizing patient selection and increasing the probability of success in clinical trials.”
Ulrich Deutschmann, Chief Commercial Officer (CCO) at DFE Pharma
“The control of nitrosamines levels present in drugs is a topic which will continue to challenge the pharma industry. Risk assessments for nitrosamine impurities levels found in medicines is becoming a key focus for regulators.
“Excipients are integral to the final drug product and must be fully assessed for nitrosamines and nitrites (as potential precursors towards nitrosamine formation). To ensure patients safety and to meet the growing scrutiny of regulators, DFE Pharma, for example, has proactively assessed all its excipients regarding nitrosamines and nitrites, showing that its entire portfolio tests below the daily nitrosamine intake, as guided by the FDA and below detectable levels (<2ppb).
“Continuing to reassure formulators and pharmaceutical companies in such ways, by responsibly addressing this challenge and meeting regulatory authorities’ requirements, must become a serious focus for the industry in 2023 and beyond.”
Part 1 of this series: Senior execs weigh in on challenges for the life sciences sector
Part 2: Senior execs weigh in on greatest technological advances in 2022