Keeping tabs on pharma: Synthetic data unlocks potential in clinical trial development and dietary supplements renders coronavirus less infective

In this week’s round up, pharma experts explore how data can reduce patient recruitment burdens in clinical trials and new a dietary solution that could protect the immune system from coronavirus

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Pharma companies urged to make use of synthetic data in clinical trials

Phesi, a data-driven solution provider, and Accenture, a global consulting company, have released a report exploring the use of synthetic data in clinical development to create a faster, cost-effective and more ethical approach to clinical trials.

In recent years, the volume of data created through clinical trials and electronic patient records has increased exponentially, as has the ability to process and analyze these data sets. The report outlines that life science companies should take advantage of synthetic data’s access to real-world data sets and deploy a virtual cohort in a clinical trial to overcome patient recruitment burdens, resource cost measures and increase the pace of getting drugs to market.

Dr. Gen Li, Founder and President of Phesi, said: “Clinical trials are a known cost center in clinical development. For many years, sponsors and regulators have sought new approaches that reduce expenditure, shorten times and, most importantly, accelerate the delivery of new therapies to patients. Synthetic data offers many such advantages and reduces the ethically questionable use of placebos in clinical trials.

“To realize the many benefits of synthetic data in trials, large volumes of data are required,” Li continued. “Biopharmaceutical companies typically only have access to their own data which is not enough for rigorous analysis. Sponsors must seek to partner with both data and analytics providers to close this gap.”

The report gave two industry case studies in oncology and gastroenterology where synthetic data made significant improvements to the process of the clinical trials. In oncology, for example, clinical trials are often extremely costly and time-intensive because patient recruitment is particularly challenging. The use of synthetic data proved to help overcome recruitment challenge by reducing patient numbers and eliminating placebos, helping to speed up the process.

Dr. Boris Bogdan, Managing Director at Accenture, said: “It is important to limit the burden on patients participating in a clinical trial. Many avoid clinical trials altogether as worries over receiving a placebo treatment dissuade them. Synthetic patient data minimizes the need for placebos and accelerates the development process.

“At Accenture, we are dedicated to helping companies deliver better patient outcomes through differentiated approaches – and we see synthetic data as a key element. Working with Phesi on this report has underlined how clinical development would greatly benefit from adopting a data led approach in future trials.”

Covid-19 studies highlight importance of vitamins and fatty acids in daily diet

Medical studies conducted by the University of Bristol in the UK indicate dietary supplements and compounds could bind to the coronavirus viral spike protein rendering it less infective.

Medical experts at Endoverse, an organization dedicated to endocannabinology, has backed the results of studies performed by the University of Bristol, which highlight the importance of fatty acids and vitamin intake.

A medical expert at Endoverse said: “We believe the key to optimum health is ensuring the correct balance of the endocannabinoid system." 

The first dietary study by the University of Bristol identified that linoleic acid binds to part of the coronavirus’s spike protein and in turn reduces its ability to infect. The second study discovered the potential for fat-soluble vitamins D, K and A to bind in the same way.

The research could be used to improve treatments of Covid-19 but also help in the development of anti-viral small molecules to defeat the disease. 

Dr. Deborah Shoemark, Senior Research Associate for Biomolecular Modelling in the School of Biochemistry at the University of Bristol, who modelled the spike in the second study, said: “Our findings help explain how some vitamins may play a more direct role in combating Covid-19.

“Our research suggests that some essential vitamins and fatty acids, including linoleic acid, may contribute to impeding the spike interaction. Deficiency in any one of them may make it easier for the virus to infect.”

Dr. Kristina Ranna Chief Medical Officer at Endoverse seconded Shoemark’s remarks, adding: “These findings fit in with our philosophy of ensuring diet has an adequate intake of essential fatty acids in the appropriate ratio.

“The role of fats in our bodies is extremely complex and it is still really important to eat natural unprocessed food with a balanced amount of all macro and micronutrients to support the human immune system.”

Join experts from Pfizer, Takeda, West Pharmaceuticals, and MasterControl on May 18 to discuss strategies in adopting automation in pharma manufacturing. Sign up to Pharma Manufacturing Automation for free and come away with insights that will pave the way for smoother good manufacturing practice compliance and operational excellence.