Pharmaceutical Research Thinking that Needs Rethinking
NIH (not invented here) is probably dead or at least dying at most Big Pharma today as is the thinking that companion diagnostics are not commercially interesting because they imply smaller market opportunities. But, are there other research maxims that need to be reevaluated in the context of the evolving new healthcare market? Here are 5 to consider changing if your company still thinking this way:
- “kill early, kill fast”
This has been intended to encourage researchers to cut losses by quickly identifying drug candidates that have a high probability of failing in later trials because of safety concerns or lack of efficacy. Poor Phase 1 or Phase 2 results may raise concerns about mass market use of the product but may not necessarily reflect how the drug candidate might perform in a more targeted population. Think personalized medicine with companion diagnostics. A more comprehensive understanding of the disease, product pharmacokinetics, and pharmacogenomics may be needed to avoid killing promising compounds for smaller, targeted patient groups with significant unmet medical needs.
- “what’s the fastest, commercially viable indication that will get us to market”
The thinking behind this was that “we can use the scientific literature and medical education to expand the market.” This will become increasingly difficult as the FDA, CMS, and the managed market become more demanding for label indications and data to support claims for use and reimbursement. Relying on traditional sales and marketing tactics to fill the label claim or data voids to expand market opportunities will be less likely and less tolerated in the evolving new healthcare market.
- “if we do that study or analyze that data, we might find something we don’t want to know”
Product liability cases continue to make headlines and the ability for pharmaceutical companies to “bury” findings, mislead the market, cover-up or ignore potential safety issues or inferior efficacy results is becoming increasingly difficult. Research organizations might as well assume that if they know or suspect an issue, they will need to explore it, get the science behind it, and be forthcoming about the findings.
- “our research is built around (you name the biological target) program”
As many “target-based” biotechnology companies and Big Pharma research programs have found, this is a very high risk strategy of “either it works or it doesn’t work” (betting black or red at the roulette table). In the evolving new healthcare market where proven innovation and differentiation are going to be essential for commercial success, I believe companies that take a more comprehensive approach to understanding the pathophysiology of the disease will have more opportunities to discover and develop ways to intervene in the disease process, will better understand how different targets interact with each other, and will reduce the risk of betting on a single target.
- “we can do it cheaper and better in house”
Market expectations for innovative and differentiated product profiles will make research pipelines more variable than they have been in the past. The days of merely bringing any safe and effective product through the regulatory development process and onto the market are gone. Disciplined research portfolio management will eliminate those products that will not meet market expectations, creating more dramatic time gaps, and making pipeline flow less consistent than in the past. This will require research flexibility of facilities, equipment, and staffing. While a core team of research expertise is essential to retain in-house, most laboratory, preclinical, and clinical work can now be outsourced to well staffed, competent CROs that often have as much if not more expertise, capabilities, and capacity than the research teams at Big Pharma. Even at higher per project costs, these incremental expenses will be far lower than the inevitable up-sizing and downsizing of staff or the carrying costs of intermittently idle facilities, equipment, and staffing.