Now Really! Chasing out the horrors in oncology drug development

In continuing to think about emerging issues in oncology, regulatory will play a critical and significant role.

In the UK, you just have to wonder what to do when the National Institute for Health and Clinical Excellence (NICE) rejects Novaretis' Afinitor for second line therapy in renal cell carcinoma and recommends against using Novartis' Tasigna and BMS' Sprycel for the treatment of patients with chronic myeloid leukaemia (CML) who are intolerant to Glivec. Why? There was that little thing about insufficient clinical evidence vs. other treatment options, but, oh by the way, if Novartis or BMS are willing to risk share and compensate for their price, well then, that's okay.

Oh, really? Now really! As Seth Meyers and Amy Poehler might say on Saturday Night Live. That's really NICE!

Just how long is it okay for any of us to live if it is too costly for the government? The next thing you know the NHS will be calling up the Inuit to buy some ice floes for cancer patients so they can push them off into the North Sea. Or maybe they can get that ice from Iceland which is in enough financial trouble as it is.

The basis point is that, for companies to succeed with regulators, Overall Survival (OS) and for how long life goes on remain the key endpoint.

All in all, a focused commercial development strategy in oncology requires a tightly defined Target Product Profile (TPP) in order to win with regulators and to aid physicians in understanding their treatment choices. This narrowed approach could enable companies to get their drug on the market faster, enabling oncologists to understand how they best may employ it along with other treatment options.

Of course, after you have figured out first what you are going after, a Life-Cycle Management (LCM) strategy needs to be built off that narrowed initial indication. Here it is helpful to complete all Phase I/II studies even prior to first approval with a full Phase III plan already in place.

As these plans are being developed, it is also important for companies to understand how this asset and its development plan aligns with other drug programs in the portfolio.

Many companies get caught up in the value of one particular drug programs without fully appreciating its value on everything else going on, a major point of understanding in a world of limited, expensive resources. A company needs to be able to value its "real" portfolio as opposed to making a decision about one stand-alone asset.

The key is to understand drug program inter-dependencies around technical, revenue and cost factors. An optimized portfolio that takes into account all these factors can actually yield significant economic benefits for a company over time vs. a stand-alone portfolio of individual assets. In an optimized oncology portfolio, a company can draw on identified synergies in research, clinical and targeted synergies to maximize the overall cost of commercial development and launch.

There are so many different considerations to be successful in oncology, it can make the head spin like Linda Blair in The Exorcist. However, by carefully and diligently, laying out basic strategies and developing an integrated series of approaches that involve not just one compound, but all the others in development, internally and competitively, oncology commercial development does not have to be a horror show. The demons can be exorcised, and a happy life can be lived by patients, physician and company managers.