06Jun

Mega-deals were few last year, but pharmaceutical deal-making hit record levels. Nearly 2,000 transactions were recorded in 202 with a value of almost $200 billion.

One in five deals involved some aspect of COVID treatment or prevention, though these accounted for less than 3% of the total deal value,” says a new report from the biosciences intelligence group Cortellis. “Consistent with the historic trend, oncology remains the most attractive therapeutic area for deal making.”

A blockbuster year for biopharma deal making says that 2020 “ended up being a solid year for the biopharmaceutical industry. Records were broken by financing transactions, and several deals and M&As fell within the highest values on record.”

The biggest M&A deal was AbbVie’s $63 billion acquisition of Allergan. Though it closed during the year, the purchase was announced well before the SAR-CoV-2 virus first appeared. A second mega-deal — AstraZeneca’s buyout of Alexion Pharmaceuticals for $39 billion – was announced in December but won’t close until late this year.

However, most of the 147 M&A transactions were smaller, collectively totaling $181.3 billion, far below the banner $256 billion in 2015 and 19% below 2019. The report says “About 82% of the M&As were “bolt-ons” or those in which an acquirer was attaching itself to needed technology. The rest were financial, expansion and mega-deals.”

Though M&A activity was slower than in the past, the1,580 financing transactions were 42% higher than 2019. According to the report, “Collectively, global public and private biopharmaceutical companies raised approximately $134 billion, which is almost double the previous record of approximately $69 billion set in 2015. It is also greater than the combined amount generated in 2018 and 2019.”

The largest share of the global financings (70%) went to US companies, with firms based in California and Massachusetts capturing $34.1 billion and $26.8 billion, respectively. New York trailed the two leaders with $6.7 billion.

Summarizing the year, the report points to the “culture of collaboration that developed between competitors” driven by the need to develop COVID treatments and vaccines.

“It will be interesting to see whether this newfound enthusiasm for cooperation can be adapted to tackle other major unmet medical needs. Continued deal-making can only strengthen this collaborative spirit within the biopharma ecosystem, benefiting shareholders and patients alike.”

Photo by JOSHUA COLEMAN on Unsplash

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Jun 6, 2023

New Group Will Promote Decentralized Clinical Trials

Several of the world’s healthcare, bioscience and pharmaceutical firms, including such global leaders as AstraZeneca, Pfizer and Biogen have joined together to accelerate the adoption of decentralized clinical trials and research.

In the planning stage before the coronavirus pandemic, the Decentralized Trials & Research Alliance (DTRA) formally announced its founding this month. With an initial membership of some 50 organizations, the alliance declared its mission to “make clinical trial participation widely accessible by advancing policies, research practices and new technologies in decentralized clinical research.”

Explained Amir Kalali, MD, co-convenor of DTRA, “The benefits of decentralized research methodologies have been apparent for some time, but adoption has been slow due to many factors including culture and the lack of a forum for stakeholders to collaborate.

“The COVID-19 pandemic has forced organizations to adopt decentralized methodologies which have the potential to broadly accelerate drug development.”

Decentralized trials, also (imprecisely) referred to as virtual trials, allow patients to participate without the need to regularly or ever visit a research site. Through telemedicine visits, remote monitoring, wearables and smartphones, researchers can often collect as much or more data in many cases, and often more reliable data, than by requiring in-person visits.

Several months ago we blogged about the increasing use of decentralized trials – those that are entirely remote and those that include occasional face-to-face visits. In that June post we noted that “prompted by the COVID-19 pandemic, and given the blessing of the FDA, broad acceptance of decentralized trials is becoming a reality.”

Speaking at the virtual BIO 2020 conference, panelists agreed that the foothold COVID gave to decentralized trials will continue to grow, in large part because of its patient benefits. With participants freed from having to travel to research sites, it opens opportunities to recruit underrepresented populations. One example, cited by a panelist, was the potential now to include autistic patients.

DTRA, in its founding announcement, said, “Inclusion of representative patient populations in clinical trials by race, age, and geographic location has long been an operational challenge. Decentralized approaches to conducting research facilitate participation by a more diverse patient population and could ease COVID-19-imposed difficulties for both patients and clinical investigators.”

Added Craig Lipset, DTRA co-convener, “Now is the time to share ideas and insights that will chart the future course of clinical trials, accelerating drug development and saving lives.”

Image by PublicDomainPictures

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Jun 6, 2023

Technology Is Transforming the Clinical Research Workforce

The clinical research workforce is facing a transformation brought about by the rapid changes in how clinical trials are conducted.

New roles are already emerging, while traditional roles are evolving as decentralization and the technology to support the trend require new skills to effectively manage a trial where researchers and patient may rarely, if ever, meet in person.

new whitepaper from the Association of Clinical Research Professionals details these trends, providing a glimpse at what it means for the workforce and what the industry – researchers and the companies that support them – must do to be ready for the fast arriving future.

“Spurred in part by the ongoing COVID-19 pandemic, [decentralized clinical trials] are bringing more technology to clinical research and along with it the promise of greater efficiency, productivity, and effectiveness,” says Jim Kremidas, ACRP’s executive director. “But to fully realize that potential, roles will need to evolve and operate differently to accommodate this new environment.”

Produced by a group that included representation from technology suppliers, contract research organizations, sites, and more, the whitepaper reached four major conclusions:

  • The majority of clinical trials that implement decentralization, at least in the short term, will be hybrid trials, and aspects of decentralization (e.g. virtual visits) will be leveraged more often and receive more overall acceptance by industry due to COVID-19.
  • Increased use of technology will impact nearly every role. But rather than being a threat to job roles, it will generate the need for the evolution of existing roles and bring unprecedented flexibility and efficiency.
  • New roles likely to emerge include Tech Trainer for CROs, Site Tech Support, Remote Trial Coordinator, Decentralized Investigator, Virtual Patient Guide, and more.
  • Technology training must be standard practice and written into each site manual and delegation log.

In addition to highlighting the growing use of technology – including remote monitoring devices — The Impact of Increased Technology Use on the Clinical Research Workforce defines fully decentralized and “hybrid” trials, discusses the impact of technology workforce roles and details the emerging new jobs.

Photo by Lucas Vasques on Unsplash

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