Part 2: We asked the executives to tell us the greatest technological advances over the course of 2022
Dr. Sheelagh Aird, Senior Director of Digital Health and Data Science, Phastar
“Necessity is the mother of invention and the challenges surrounding the exponential rise in data-generating devices and digital health tools have spawned great advances in innovative solutions.
“Platforms for multi-source ‘big’ data access, ingestion and reporting environments can provide a single-source of truth facilitating the use of visualization and analytical tools in a regulated manner, while preserving data privacy agreements in line with global applicable laws.
“It’s good to see the rapid proliferation of solutions becoming increasingly available and affordable which accelerate the deployment of Machine Learning and Artificial Intelligence allowing us to gain greater insights into clinical data through high quality visualizations for oversight and monitoring and interactive data analytics and interrogation tools.”
Ulrich Deutschmann, Chief Commercial Officer (CCO) at DFE Pharma
“R&D formulators are embracing the opportunity to fully adopt new technologies and move from traditional drug development approaches toward an innovation model, based on the value provided to patients over time. As discussed, by embracing innovation and transformation, we can better meet the expectations of patients and consumers.
“DFE Pharma’s Closer to the Formulator (C2F) Center of Excellence, for example, offers formulation development and optimization for a wide range of oral solid dosage forms to meet the changing needs of patients and consumers, such as immediate-release tablets, chewable tablets, specialized dosage forms like orally disintegrating, effervescent and sublingual tablets, and minitablets among others, as well as modified released formulations.
“Personalized medicines, which demonstrate higher levels of effectiveness for specific patient populations, is another key area transforming healthcare. It requires flexible new approaches, like those offered by Continuous Manufacturing (CM), which enable manufacturers to adapt their processes and even produce in smaller volumes.
“Within pharmaceutical manufacturing, CM is one of the approaches with the potential to reshape the industry as we know it. Backed by the FDA and EMA, and aligning with the quality-by-design (QbD) paradigm for pharmaceutical development, it offers numerous advantages over batch production, including higher product quality at lower manufacturing costs.
“With research now available on how the specific properties of excipients affect CM processes, and a range of CM-enabled excipients available to support formulators transitioning from batch to continuous manufacturing, this can significantly shape the market going forward.
“Similarly, 3D printing can enable personalized medicine, offering a cost-effective way to fabricate clinical trial or rare disease product volumes.”
Sam Whitaker, Co-CEO, Co-Founder and Jason Dong, Co-CEO, Co-Founder, Mural Health
“The DCT movement to reduce patient barriers to participate in clinical trials, has continued to actualize in 2022. Many barriers still exist, however, especially logistical and financial barriers to clinical trials.
“One particular aspect that we’ve been excited to see is patients being empowered with digital methods of reimbursement and to be able to choose how they are paid, e.g. through Venmo, Paypal or direct to debit.
“It’s allowing for a much more frictionless experience for patients, especially in the remote setting, not to receive reloadable debit cards in the mail. It’s also going to be game changing for sites to no longer manage boxes and boxes of card inventory, or in the case of virtual sites, have to mail out cards all across the globe.”
Vincent Keunen, CEO Andaman7
“The emergence of easy-to-use integrated platforms which empower patients with their data is leading to a natural evolution from patient-centered research to patient-mediated research. This innovation can give the industry extraordinary insight, helping us understand patient priorities, how disease affects different people and the complex interactions influencing health in the real world.
“We are starting to see structured data that is FAIR (Findable, Accessible, Interoperable and Reusable) becoming the reality. Other key advances include the growing role of Digital Therapeutics (DTx) and the push to enable health data processing which still respects privacy through the new European Health Data Space.”
Patrick Hughes – Chief Commercial Officer & Co-Founder at CluePoints
“Risk-based quality management (RBQM) has already started to transform the market. What is exciting is that we are now seeing similar risk-based approaches being applied to other areas of the clinical trial process.
“Risk-based data management, for example, harnesses statistical analysis in tandem with artificial intelligence, machine learning, deep learning algorithms, and natural language processing to interrogate data more efficiently. By enabling improved critical thinking and decision making, it could revolutionize the existing, antiquated processes.”
Tarquin Scadding-Hunt, CEO, mdgroup
“I believe technological advances represent progress if they make people’s lives easier. Anything that improves the lives of patients in clinical trials, while also saving time and money, offers the transformative opportunity to reinvest in better health outcomes.
“Impactful products are likely to be those connecting different technologies, for example application programming interfaces (APIs), which make them easier for patients, healthcare professionals and researchers to use.
“I also believe advancements in the technology available to home health nurses which enable data to be more accurately collected and collated are key.”
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Part 1 of this series: Senior execs weigh in on challenges for the life sciences sector
Part 3 will focus on the most significant trend(s) in 2023….
