CLINICAL DEVELOPMENT IN ONCOLOGY


innovators: “If you’re the third agent in a class, then we know a lot about what the on-target side effects of that agent are.” However, Project Optimus is particularly applicable when it comes to efficiency in understanding a selected dose in a registrational package. Typically, the agency asks companies to evaluate the dose of a cancer therapy after it has been approved for the said dosage, which is “not an ideal scenario” because the non-optimal therapy is already on the market and being used to treat patients who could be at risk for certain toxicities, explains Fouad. With the framework suggested by Optimus, a


selected dose that has completed Phase III studies and is entering registration would be supported by a chronological progression of data, and subsequently better understood in a fraction of the time.


Smaller companies will take bigger hits Project Optimus will impact the cost of the trial, the timeline of execution, and the timeline of development. “In small companies, it is always difficult because resources are constrained and the people investing and financing small companies more often want to see results as quickly as possible and confirm the hypothesis the company is built upon,” says Fouad. Smaller companies may feel the brunt of the


negative effects of this FDA initiative because they are often dependent on buying and selling parties that can allocate the necessary capital and resources. Fouad says the impacts of an initiative such as Project Optimus would have


“What we need to be thinking about is making sure that the pressure in a given area does not disincentivise researchers from taking risks and going into areas where they can make a difference”


been more keenly felt by Blueprint ten years prior.


The more significant issue at hand for Fouad,


however, is that when it comes to discussions held with the FDA on the work needed to substantiate treatment efficacy and safety in both acute and long-term settings, pharma is more involved while biotechs are less so. The effects of Optimus will be felt by pharma in the extended timelines and increased costs, but will more acutely and presently be experienced by biotechs. By pressuring and squeezing drug


development through regulation in both the clinical research phase and the post- approval stage, the subsequent risk for R&D is to bias areas of research towards what is not being pressured. “Will people working in the rare disease


space continue to be incentivised to look at diseases that are rare? Will researchers continue to take huge risks in oncology or turn to disease areas that are less risky than oncology? What we need to be thinking about is making sure that the pressure in a given area does not disincentivise researchers from taking risks and going into areas where they can make a difference,” explains Fouad. While Project Optimus will undoubtedly impact the companies developing small molecule and biologic therapies, Diakonos president and COO Jay Hartenbach finds that an initiative such as Project Optimus is less applicable to cell and gene therapies, an area on which clinical-stage biotech Diakonos focuses. The existing model of drug development—


that has established a working “equilibrium” amongst pharma, biotechs, and innovation—is a cycle where biotechs develop a product with reasonable hypotheses, de-risk it and mature it, at which point pharma acts on the product to scale and commercialise, says Fouad. “Clearly, all these projects will impact the equilibrium of when a biotech is ready to transact with pharma versus when pharma is interested in transacting with a biotech, but if we lose the model of biotech, feeding to pipelines of large pharma, then it’s going to be really a steep change in the industry, and I don’t know how or what kinds of other models are ready to replace that.”


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