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Is the answer really R&D for the Life Sciences?

October 16, 2014

So I’m in the middle of researching a white paper on the changing role of regulatory affairs in life science organizations and have come across a focus/bias in the literature toward R&D that doesn’t sit quite right with me, i.e., all the challenges facing the life sciences can be solved, addressed, overcome, etc., by optimizing R&D.

What I’m gleaning is that a significant portion of the thought leaders out there believes that if R&D were only faster, cheaper, more effective, more patient-centric, more transparent to investors, or more responsive to regulators (or some combination of all of these), life science organizations would solve all the problems they currently face.

Here’s a list of a few of the key reports I’m talking about:

To me, this view of R&D optimization as a cure-all is too one-dimensional. To appreciate why, consider the short list of significant challenges facing the life science industry in the next five years:

    1. Current model of drug development is not financially viable long-term
    2. Life science sector set to grow substantially in rest of world (ROW), basically flat in US and EU
    3. Breakneck product innovation (3D printing, combination devices, growth of biotech, etc.)
    4. Rise of the patient/patient-centric influence on drug development
    5. Regulatory context shifting to pay for value/results
    6. Purchasing power moved from provider entities to payer entities

It seems to me that simply increasing the number of viable products in the pipeline and reducing the cost and time of getting them developed and to market would not solve any of these challenges on its own. Rather, we need fundamental, enterprise-level changes that span the life sciences value chain.

  • To make the cost of drug development more viable, failing faster during early R&D will help, but so will improving regulatory efficiency and effectiveness, improving patient recruitment and retention, and leaning out manufacturing, quality, and supply chain.
  • To maintain acceptable margins in ROW (where funds available for health care are fractions of the US and EU), more products won’t help; what’s needed is more efficient and cost-effective ways to got to market with products, starting with R&D, of course, but continuing through the rest of the value chain, from regulatory through quality, manufacturing, and supply chain.
  • To capitalize on the innovations made possible by new technology, requires regulatory innovation inside and outside the walls of the company, otherwise these products will never make it to market.
  • To make a portfolio more patient centric, R&D isn’t the answer–customer facing functions such as clinical, PV, commercial, etc. are; R&D will simply take their findings as input/steer for their activities.
  • To make an organization more focused on the value and results their products deliver has more to do with overall strategic direction and coordination across the entire value chain, not just the point at which those products are designed and developed.
  • To develop a business model that will succeed in a payer-centric marketplace requires a strategic vision at the enterprise level aimed at transforming the entire organization, not simply a change to how R&D works.

The final word

This is far from a definitive argument, but I wanted to get my impressions and early thoughts down to share them and see what others out there think, whether anyone has noticed them same R&D bias, whether you think I’m missing anything, etc. Jump in, and let’s get the conversation started!

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