Berlin, Germany, 20 May, 2023— Biotech industry professionals have long since headed home from BIO-Europe Spring 2023 in Basel, Switzerland, many with new ideas and inspiration sparked by the conference. Media coverage of the event was featured in a broad swath of publications but there is always more to say. In appreciation of Clinical Trials Day today, MC Services (MCS) thought it would be useful to share some of the insights we gained on what’s changing in clinical development from speaking with members of the clinical research community in attendance.
Data Science
To grapple with the collection and management of large datasets, the need for smart approaches in data science is becoming ever clearer. Throughout the R&D process from discovery to pre-clinical to late-stage development, quality data makes the difference in realizing the full value of investigative compounds.
“Clients often come to us when they are stuck with large amounts of scattered data and no means to structure it or simply an overwhelming amount of data that they can’t process,” Liesbeth Ceelen, CEO of BioLizard told MCS. “Datasets these days are often still messy and need a lot of scientists to clean them up and analyze the points.”
Based in Ghent, Belgium, BioLizard is a data science consulting company with an expertise in scientific and biomedical data analysis, data mining, machine learning and artificial intelligence and bioinformatics. The company was founded in 2018 with five employees and currently employes 40 people.
“It’s rather logical that when you start a biotech company you don’t think yet about spending time and money on a long term data management and analytics strategy but when you start to become more successful as a company, it can already have become a missed opportunity,” Ceelen said.
BioLizard helps clients better understand their clinical and molecular data and supports them with comprehensive data analytics expertise such as multi-omics data analysis and data integration. This allows the biotech company to focus more on the core, i.e. drug development and clinical development.
“Sometimes a company is triggered by something they noticed in the ecosystem leading them to believe the drug development process can be improved and need AI to identify a potential breakthrough or sometimes they just have so many data, including omics data—it can be proteomics, genomics, lipidomics, epigenomics, transcriptomics—and finding it very difficult to combine.”
Target identification is becoming key in BioLizard’s offering. “Bioinformatics is essential in target identification because it enables researchers to analyze and interpret vast amounts of biological data efficiently. Bioinformatics techniques help identify molecules or proteins that interact with disease-associated targets, aiding in the discovery of novel therapeutics,” she said.
Currently, BioLizard offers mainly customized solutions, but it also sees value in developing standardized platforms, Ceelen said. “But I don’t believe one platform can be right for every research question,” she said.
Extractables & Leachables
Over the past 20 years, extractables and leachables evaluations have evolved and taken on a larger role in the drug development process, Nick Morley, Principal Scientist at Element Materials (Element) told MCS at the BIO-Europe Spring conference.
“Generally, the evaluation of extractables and leachables in drug products has been performed largely during late-phase development,” he said. However, there is an increased interest from regulators to see some information earlier in development “Insufficient data can put clinical trials on hold which is costly and time-consuming.”
The impact of extractable and leachable substances on product safety and drug product interactions can be studied and evaluated throughout the drug development process to ensure drug efficacy and patient safety are not compromised by the materials used to manufacture, store and administer products, Morley explained.
Element is a leading global Testing, Inspection and Certification (TIC) company, and in March launched a global offering for its extractables and leachables services. The new service brings together capabilities across Europe and North America through the recent acquisitions of Avomeen, Hall Analytical and VR Analytical totaling over 75 experts across laboratories in Ann Arbor, Michigan and Bend, Oregon in the US, Toronto in Canada and Manchester in the UK.
It is important to risk assess and select the appropriate materials early in a products development to minimize delays to early-phase clinical trials, this is particularly important for high risks product types, Morley said. For these products, a streamlined study design can help answer or avoid requests for early-phase data.
Element delivers tailored extractable and leachables studies of pharmaceutical, biologic, medical device, combination products and more. Its scientific experts support the world’s leading healthcare brands in establishing the safety of materials across administration, formulation, dosage, container-closure systems, and drug delivery device requirements ensuring patient safety and expediting time to market.
“The global team within Element has an in-depth understanding of regulatory expectations, from materials assessment to toxicological evaluations, through decades of experience developing and executing extractables and leachables programs,” Morley said.
Recruitment
Other key factors often causing a clinical trial delay or even failure (besides missed efficacy and safety) are patient cohort selection and recruiting mechanisms which fail to bring the best suited patients to a trial in time. MCS spoke to Antonia Schultze, director of business development at Ergomed about what the pharma services provider is doing to address these problems.
Ergomed has developed a unique approach to trial management, called a “site management model,” Schultze said.
“Our approach goes beyond the traditional monitoring model,” she said. “This model provides specialized support for investigative sites through a team of on-site managers and specially trained nurses who later become research nurses within their area of specialization.”
The program has created a network of 400 to 500 trained staff, as well as a group of medical doctors with a deep understanding of clinical research, the ‘Study Physician Group’. The model has helped Ergomed offer better recruitment outcomes and better trial timelines.
“Both our in-country and regional site management team members understand the local practice, health systems, cultural environments and patient habits,” Schultze said.
As nursing or medical professionals, their track record in building good relationships with sites is seen in the improvements made to overall site compliance with the study protocol and ICH-GCP, she added.
In addition to its innovative site management model, Ergomed has been implementing technologies and solutions to reach hard-to-find patients in the most remote locations. As pioneers in orphan drug research, the company knows that every p-value counts and that there can be no barrier to enrolment and retention.
As a result, it has developed strategies to connect patients with investigators in the most pragmatic ways. The increase in technologies and the proliferation of specialist service providers have allowed decentralized clinical trials can drive efficiency and reduce costs, especially for larger clinical studies.
“Applied technologies – such as wearables, artificial intelligence (AI), cloud computing, and the deployment of 5G – can make the trial process more effective, adaptable, and convenient,” Schultze said. “The key is to introduce greater flexibility and efficiency while ensuring high-quality data and enhanced safety for patients. Our approach also places patients at the center of the research,” she concluded.