Practices
Two ways we work with oncology sponsors.
Clinical Asset Development
Most oncology assets reach a point where the next step commits significant money and years of work. Before that point, a sponsor needs a clear view of whether the program should go forward, where it should run and what regulators will expect to see.
We work through those questions with the sponsor’s team: whether the right patients can be found at the right sites, which route through the FDA and India’s DCGI makes sense, and what the evidence package has to show.
When India is part of the plan, we prepare the team for the Subject Expert Committee and see the application through review. Once the program is cleared to proceed, we stay involved as sites are selected and the first patients are enrolled.
Oncology KOL Advisory
Experienced oncologists see problems in a protocol that are hard to spot from inside a development team: an eligibility criterion that excludes most real patients, an endpoint a regulator is unlikely to accept, a comparator that has fallen out of practice.
We bring those people to a program while it can still change. Depending on the question, that may be a small advisory board of physicians who treat the indication, a focused review of the protocol by investigators and former regulators, or direct conversations with the clinicians who will enroll the patients.
Sponsors come away with specific changes and the reasoning behind them.
