How to adapt to choppy waters in biotech ecosystem

At the Outsourcing in Clinical Trials Conference in New England, experts shared insights on how the US clinical trial and pharmaceutical space could keep up with evolving challenges. Credit: OsakaWayne Studios via Getty Images.

As the US enters a new political era, experts predict that the pharmaceutical and clinical trials industry will have to weather a changing ecosystem.

There are promising signs of a rebound in private biotech venture financing, said Revati Tatake, the global head of pharma research, analysis and competitive intelligence at GlobalData Healthcare at the Outsourcing in Clinical Trials Conference, held a few weeks ago. Tatake shared insights from GlobalData’s 2024 State of the Biopharmaceutical Industry report, which discussed macroeconomic and geopolitical factors and their role in shaping the current business landscape. As per the survey, healthcare professionals said that regulatory and pricing reforms such as the BIOSECURE Act, EU pharmaceutical reform and the Inflation Reduction Act would have the biggest impact of the pharmaceutical market in the near future.

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At the clinical trials event, held from 22-23 October, key opinion leaders shared thoughts on several aspects of the pharmaceutical and clinical trials business. For example, experts said operations could be stabilised by utilising innovative approaches with artificial intelligence (AI) in tasks such as trial recruitment, or thinking outside the box while drawing up plans for rare disease research.

Adapting to instability

As layoffs have racked up in the clinical trials industry in the last few years, Dr. Kenneth Getz, MBA, the director of the Center for the Study of Drug Development at the Tufts University School of Medicine in Massachusetts, said many companies have reduced their specialty workforces for functions such as study monitoring, patient recruitment and retention. As companies deprioritise areas such as patient recruitment to stabilise their cash flows, certain disease areas are affected more than others, he added.

Due to limited patient numbers, rare diseases have been an area where a more concerted effort is needed to overcome challenges in patient recruitment, said experts at the conference. Social media has been a major tool in patient recruitment for rare disease trials in the experience of Andarix Pharmaceuticals, said Chris Adams, the company’s CEO at a talk on rare disease clinical trials. Andarix is a Somerville, Massachusetts-based biotech developing targeted oncology therapies. Adams also recommended using patient advocacy groups to reach niche communities for trial recruitment, saying that members tend to be “very knowledgeable” about their conditions and supportive of new therapeutic options.

At the conference, a clinical trials assistant at pharmaceutical services company also highlighted the need for more interaction and partnership between CROs and pharmaceutical companies. This can be difficult as often pharmaceutical companies do not involve outsourcing partners until late into the trial planning process, said Getz.

While the conference was focused on organisations located in the New England area, the potential to conduct clinical trials in other geographies was also discussed. The United Arab Emirates (UAE) government has been championing more public-private partnerships in the healthcare system to improve drug access and innovation in the region, said Rohan Simon, the associate director of business development at IROS by M42, the UAE’s first contract research organisation (CRO).

He highlighted the country’s Emirati Genome Programme, as a useful tool to identify the market size for a condition in the region. GlobalData reports that there are currently 79 ongoing clinical trials in the UAE.

A changing landscape

On the second day of the conference, Getz shared insights from Tufts University’s research studies investigating patient engagement practices in drug development. He reported that clinical trials have been getting longer over the last few decades as there has been a declining proportion of sites that achieve target enrolment. “Risk is rising [in drug development] and failure rates are higher than they have ever been,” said Getz.

Despite the challenging environment, Getz suggested the growing ability to pursue remote and virtual clinical trial activity through tools such as AI may help the industry recover. At the event, several industry professionals predicted that AI will keep growing as a major disruptor in the clinical trial space.

Consequently, there will be a higher need for recruitment of professionals with analytical skillets who can handle larger datasets, said Lazaro, the senior vice president of clinical operations and data management at the neuroscience-focused biotech Cerevel Therapeutics. This sentiment was echoed by Brian Wehrle, the vice president of R&D imaging at Clario, in a later talk. Wehrle stated that Clario already uses AI for the analysis of electronic medical records for recruitment, image de-identification, and analysis of historical trial protocols.

The conference was hosted by Arena International Events Group, a B2B events company owned by GlobalData, the parent company of Clinical Trials Arena and Pharmaceutical Technology.

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