Part 1: We asked the executives to tell us the biggest challenge facing professionals in their corner of the life-sciences industry…
Tarquin Scadding-Hunt, CEO, mdgroup
“Patient engagement and diverse recruitment continue to challenge some pharma companies and CROs. Sufficient budget is often a barrier to engagement; however, we know meeting the individual needs of patients leads to greater retention, which in turn results in time and resource savings in the long run.
“We therefore need to ensure research includes particular patient populations, even if they are difficult to reach. For example, we have helped people in refugee camps who are living with rare diseases take part in clinical trials. No one should be excluded if we are to achieve fair and proportional representation in medical research.”
Patrick Hughes – Chief Commercial Officer & Co-Founder at CluePoints
“Certainly, both the biggest ‘buzz’ and associated challenge is in the realm of Decentralized Trials (DCT). There is a huge amount of promise in this area but many Sponsors and CROs are struggling to really define how this is going to work best for them.
“It appears that the most favorable approach so far is in the form of a hybrid approach that marries a traditional methodology using brick and mortar sites with a virtual site process. It is far from clear how this brave new world of trial conduct will play but the good news is that there is still a keen focus on how best to reap the rewards from the paradigm shift.
“The good news for the industry as a whole is that there is already a proven RBQM technology that will help mitigate and risk from DCT allowing all clinical and operational data to be interrogated remotely. This will be instrumental to the success of DCT in future, especially when there is no physical site to monitor in the time-honored fashion.”
Vincent Keunen, CEO Andaman7
“There has been a feeling of cautiousness limiting new projects and investments. Challenges around data complexity, standardization and exporting in unique formats have been compounded by privacy concerns and evolving, strict regulation.
“While the US has made real steps forward and the NHS in the UK offers standardization, in Europe there are no standards and no uniformity. There are also remaining difficulties around interoperability. So, while real-world data presents a huge opportunity it also presents a huge challenge.
“We are operating in a market where regulators increasingly demand real-world evidence, but some regions cannot collect or process it. However, some patient facing solutions like Andaman7 strongly put the patients first and thereby enable “patient mediated interoperability”.”
Sam Whitaker, Co-CEO, Co-Founder and Jason Dong, Co-CEO, Co-Founder, Mural Health
“Like all businesses, remote 2022 has been challenging. This has provided interesting and exciting challenges for us as a young business in the life sciences software sector. We have had unprecedented access to talent across the globe, but we also have to work extra hard to make sure employees feel engaged and challenged by the work they do and feel connected to each other.
“We try to build a great culture that folks are excited to show up to every week. This means regular happy hours, ‘onsite’ working sessions that include talent shows, sports games, etc., and time to relax and bond as a team. This also means regularly appreciating folks’ cultures across our team members in Brazil and New Zealand. This has made for a richer experience for all of us.”
Ulrich Deutschmann, Chief Commercial Officer (CCO) at DFE Pharma
“The key to strategic growth in these challenging times is cultivating a real innovation-driven culture, while also securing the production and supply of high quality products, which in DFE Pharma’s case are excipients. Maintaining reliability, speed and excellence is more critical than ever as we all seek to adapt to this fast-changing world.
“At DFE Pharma, through our robust Business Continuity Plan, we can secure our production and supply, no matter what issues arise in whatever region or business area. This covers all our key areas from sourcing, planning, manufacturing, IT/OT, to distribution.
“And also, we are fostering continuous improvement by investing in, and developing, new solutions and services for our customers, such as our “Closer to the Formulator” (C2F) Center of Excellence, recently opened in India, collaborative partnerships such as Inhalation Together (INTO) which accelerates inhaled drugs development or the expansion of our production capacity for microcrystalline cellulose (MCC ) excipients next year.
“Health equity globally is another key challenge across the industry. To ensure all communities can access much-needed medications, the pharmaceutical industry must move towards agile manufacturing approaches. Speed-of-launch and first-time-right formulation development are crucial to drive efficiency, lower costs and make medicines more affordable for everyone that needs them.
“Enhancing collaboration and sharing expertise definitely plays a key role in this, such as DFE Pharma working with companies from all over world to significantly reduce formulation costs and get drugs faster to market through the services of our new C2F center.”
Dr. Sheelagh Aird, Senior Director of Digital Health and Data Science, Phastar
“The plethora of sources of clinical data in a multi-provider, decentralized, digitally enabled environment has become an increasing challenge for data analyst professionals and their need to leverage the data to support a wide variety of clinical research needs.
“Emerging, scalable, telemedicine solutions such as apps, AI-enabled sensor devices, and virtual doctor-patient consultations have changed the requirements for data curation, storage and analysis tools.
“The capability to aggregate such large volumes of data from disparate data sources in diverse formats can be challenging. In addition, the capacity to repeat processes routinely and reproducibly 1000s of times to ensure those who need it have access to real time data for effective decision making can further exacerbate the challenge.”