Applied Clinical Trials Editorial Staff

Trial resumptions slow as COVID cases rise again

Clinical trials disrupted by COVID-19 are expected to resume at a much slower rate than originally anticipated, as more nations are reinforcing lockdowns due to a globally rising number of COVID-19 cases, says GlobalData.

“The general trend shows a gradual increase in the overall percentage of trials for each trial status, the biggest of which has been seen in trials that are ongoing and recruiting and those that are ongoing but not recruiting,” commented Priya Nair, trials intelligence analyst at GlobalData. “Between Aug. 17 and Sept. 21, ongoing and recruiting trials decreased from 84.7% to 82.2%, while completed trials increased from 4.5% to 6.4%.”

The number of resumed trials increased from over 600 on Aug. 17 to 741 as of Sept. 21. Out of these trials, 82.2% are currently recruiting participants, 7.9% have completed recruitment but are still ongoing, and 0.5% of trials have yet to start recruiting subjects.

GlobalData reports that there is an overall steady increase of trials resuming activity. The U.S. has the highest number of resumed trials at 70.6%, followed by France at 7.6%, the UK and Spain at 7.3% each, and Japan at 7.2%.

“As large numbers of companies shift to alternative ways to conduct trials, it is possible that the use of virtual trials may still be prominent even after the COVID-19 pandemic ends,” said Nair.

Bristol Myers Squibb and MyoKardia, Inc. have entered into a definitive merger agreement under which BMS will acquire MyoKardia for $13.1 billion, or $225 per share in cash. The transaction was unanimously approved by both the BMS and MyoKardia Boards of Directors and is anticipated to close during the fourth quarter of 2020.

MyoKardia is a clinical-stage biopharmaceutical company that discovers and develops targeted therapies for the treatment of serious cardiovascular (CV) diseases. Through the transaction, BMS gains mavacamten, a potential first-in-class CV medicine for the treatment of obstructive hypertrophic cardiomyopathy (HCM), a chronic heart disease with high morbidity and patient impact. A new drug application for mavacamten for symptomatic obstructive HCM is expected to be submitted to FDA in the first quarter of 2021. BMS expects to explore the full potential of mavacamten in additional indications, including non-obstructive HCM, as well as develop MyoKardia’s pipeline of novel compounds, including two clinical-stage therapies

Genuity Science, a genomics and data insights organization, and Ionis Pharmaceuticals, a company focused on antisense therapeutics, have struck a broad, multi-year collaboration aimed at accelerating the discovery and development of novel therapies across a range of conditions.

Genuity Science’s approach combines high-quality, whole-genome sequence and deep phenotype data resulting in better definition of the underlying disease mechanisms. This approach, when coupled with Ionis’ proprietary antisense technology, has the potential to significantly expedite the drug development process through a more direct translation of targets into drugs. Under terms of the deal, Genuity Science will receive a combination of upfront payments and development milestones, plus product royalties.

Behind its RNA-targeted antisense technology, Ionis has a pipeline of more than 40 drug candidates designed to potentially treat a broad range of disease, including neurological, cardiovascular, infectious, and pulmonary diseases.

PharmaLex Group, a provider of specialized services for pharma, biotech, and medical device industries worldwide, has completed its mergerwith Biopharma Excellence (BPE) GmbH. BPE is a consultancy based in Munich, Germany, which offers specialized biopharma consulting services, including biologicals, antibody-containing products, cell- and gene therapies/ATMPs, biosimilars, and vaccines.

Founded in 2013 by Diane Seimetz, PhD, and Gabriele Dallmann, PhD, BPE supports national and global life science companies from top 10 pharma organizations to emerging startups. The company offers integrated product development services in the EU, the US, and further territories, covering early- and late-stage scientific, regulatory, and strategic support up to submission of dossiers and lifecycle strategies.

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A compilation of recent notable news developments that pertain to the clinical trials industry.

News Notes (October)

vate today announced the release of the 2020 Centre for Medicines Research (CMR) International Pharmaceutical R&D Factbook. The factbook reveals a decrease in R&D spending for the first time since 2016. While previous predictions for 2022 expenditure exceeded $86 billion, this year, 2022 expenditure is forecasted to reach $80 billion, with new factors such as COVID-19 impacting drug development.

The Centre for Medicines Research, a subsidiary of Clarivate, has released the report to help pharma and biotech companies assess R&D productivity and provide insights into industry trends which will inform drug development efforts. It provides insights on R&D expenditures, cycle times, pipeline growth and more to allow Pharma and Biotech companies to access and analyze success rates and key activities from drug discovery through commercialization.

The 2020 CMR International Pharmaceutical R&D Factbook reveals drug development continues to be complex, challenging, and time consuming. The burden of existing diseases and the recent COVID-19 pandemic has also had an impact on drug development. While inroads have been made to tackle these complex communicable and non-communicable diseases, delivering new treatments in an accelerated and cost-efficient manner remains a significant challenge.

Pharmaceutical R&D industry report provides insights into what’s behind decline in global NME outputs and reveals implications of decreased projected expenditures.

New Centre for Medicines Research Report from Clarivate Indicates Drug Development Timelines are Shortest Since 2013 

Parexel and Pfizer enter next phase of partnership

Parexel has signed a new master service agreement (MSA) with Pfizer to continue the CRO’s decade-long partnership with the big pharma company. The agreement is for a three-year term with an option to extend for an additional two years.

The strategic focus of the new arrangement is focused on driving cycle times for Pfizer’s development efforts. Parexel will provide Pfizer clinical development services via full-service, hybrid, and functional service provider (FSP) models across all therapeutic areas, including rare diseases, oncology, inflammation, and immunology, and internal and hospital-based medicines.

Regeneron Pharmaceuticals and Roche are joining forces in the fight against COVID-19 to develop, manufacture, and distribute REGN-COV2, Regeneron’s investigational anti-viral antibody cocktail, to people around the globe. REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic. This collaboration is expected to increase supply of REGN-COV2 to at least three and a half times the current capacity, with the potential for even further expansion.

If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S.

Bayer will acquire KaNDy Therapeutics Ltd, a UK clinical-stage biotech company, to expand the pharma company’s drug development pipeline in women’s healthcare. Under the terms of the deal, Bayer will pay an upfront consideration of $425 million, potential milestone payments of up to $450 million tied to KaNDy’s lead investigational compound, followed by potential additional triple-digit million sales milestone payments.

Trialbee, a provider of patient matching and engagement technology in clinical trials, has entered into a partnership with medical data informatics company Clinerion designed to accelerate time to market by shortening patient recruitment and enrollment timelines. The deal combines Clinerion’s focus in leveraging real-time, real-patient, and real-world electronic health record data for clinical research with Trialbee’s multiple-step qualification process, which includes online qualification and nurse practitioner interviews to ensure patient matches prior to obtaining consent and enrollment.

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Decentralized Trials: Opening New Opportunities in Clinical Research

Throughout the global COVID-19 pandemic, clinical research activity has morphed and changed through the shut down and eventual reopening of research sites and studies. During this webcast, experts will discuss how to prioritize in this “new normal”, whether that involves reopening sites, catching up on a backlog of work, or fully implementing remote capabilities. In addition, we plan to discuss some of the important aspects of clinical trial management from a sponsor/CRO level and what mindset shifts may need to occur to proactively create study plans. A few areas of focus will include resuming activity for ongoing studies, planning upcoming studies, and adjusting budgets for sites and CRO teams.

Information Systems in Clinical Trials: Pragmatic Validation of EDC Systems

Computer System Validation is a key regulatory requirement and one which challenges the understanding and resources of many research organizations. Achieving the validated state means managing an ever-changing environment of servers, operating systems, EDC software, security patches etc, some or all of which may be outside the direct control of the organization. And all this needs consideration before you have even started developing your study database. GCP expects a risk-proportionate approach, but how can this be approached pragmatically? During this webcast, experts will explore the scope of EDC system validation and offer practical ways of dealing with change overload and surviving a visit from the inspectors.

The Future of Precision Medicine: How Biomarkers Have Influenced Clinical Trial Designs and Outcomes

Precision medicine has proven to be successful in treating cancers as it is tailored to a patient’s specific needs. Because of this custom approach to treatment, however, planning a clinical trial for precision medicine is markedly more challenging than more conventional treatments, as it must consider patients’ variability in genes. As a result, biomarker use in precision medicine has been critical for defining patient segments, selecting trial locations, and measuring trial success.

A compilation of ACT's most popular content from the previous month plus a look at upcoming webcasts.

Author | Applied Clinical Trials Editorial Staff

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