In an evolving drug development landscape, the pace and direction of progress depends on sponsors, outsourcing partners, and investors establishing strong foundational relationships.
Experts shared this sentiment at the 13th Annual Clinical Trials in Oncology East Coast 2024 conference, held on 9 – 10 July in Burlington, Massachusetts, while outlining the operational roles that each party must play to usher drug development down the right path.
Strong outsourcing relationships
The study of promising therapies begins at the site, and efficient and successful site performance ultimately relies on thorough feasibility processes, said Dr. Claudia Hesselmann, founder and CEO of the German early phase trial expert ARENSIA Exploratory Medicine.
However, feasibility, which means conducting the critical due diligence work that can direct trialists towards a target population, can change with a single variable, she added. “If a single person, like a study coordinator, is changed, the performance from previous studies is irrelevant. You need to understand the team behind the study and what resources they have,” said Hesselmann.
Expediting a clinical trial’s lifecycle also depends on sponsors and partners utilising the available resources, said senior director of Oncology Global Clinical Development at GSK, Steve Dunlap while emphasising the value of these resources for patient populations where recruitment is more difficult.
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By GlobalDataVendors and partners are the backbone of clinical trials, and the partnership between them and sponsors must be a functional relationship, said Kevin Stephenson, Executive Director, Data Management, at Karyopharm Therapeutics. Furthermore, vendors are set apart by what they bring to the relationship outside of the applied skills they have on paper; and determining whether those qualities are a good fit comes down to direct communication between the sponsor and partner, Stephenson added.
Establishing a strong relationship with vendors also enables a study to be operationally efficient and cost saving, which is relevant in a post-pandemic inflationary environment, said Hesselmann. However, more often than not, it is bureaucracy and inefficiency that drive increased costs, she added.
David Sherris, PhD, who sits on the board of directors for SiVEC Biotechnologies, agreed that establishing trust between the CRO and sponsor is critical. Though as an early company, it is important to define “what you have, what you can afford, and what you’re going to be able to pay,” he elaborated.
Role of regulators in the evolving biotech landscape
While sites, recruitment, and study initiation rest in the hands of the sponsors and site staff, regulatory agencies like the US Food and Drug Administration (FDA) also steer the operations behind drug development. Agency initiatives such as the FDA’s Project Optimus were prominently discussed at the two-day conference.
Previously, developmental paradigm for cytotoxic agents correlated higher doses with increased probability of tumor burden reduction. However, more is not necessarily better, said Jim Eamma, Executive Director, Therapeutic Strategy Lead, Oncology & Hematology at Worldwide Clinical Trials. This project essentially flips the traditional developmental paradigm on its head, he added.
Project Optimus was launched in 2021 with the intent to reform dose optimisation and dose selection for oncology candidates. The impact of the initiative will be demonstrated in the [reduced] time it takes to increase dose escalation levels, employ backfill cohorts, and ultimately take a product to market, Eamma explained.
While venture funding deals were at a high in 2021, the number of such deals has dipped since. Venture capitalists have become more cautious in an increasingly crowded oncology landscape, and the perspective of one reverberates within the whole group and “dampens the appetite for investment” as a whole, said Sally Wang Liang, Venture Partner at HighLight Capital.
Despite the caution, Liang finds that the industry is “reawakening” with select IPO windows opening, biotechs entering mergers and acquisition deals, and a few companies raising larger financing rounds to secure capital. But in the current environment trends point to waning investor interest in oncology, she added.
