In observing the pharma industry over the years it has yet to cease to amaze me. As it should, and not solely because the industry is a source of products that, for many, are miraculous in their life-changing abilities. My amazement stems more from how the industry accomplishes all that it does in the face of intensive societal, regulatory, scientific and commercial challenges.

Imagine committing to a course of action that ultimately represents an investment of $2.6 billion, what Tufts says it takes to bring an approved category-defining drug to market. Obviously, it takes incredible willpower to carry on, and motivation well beyond profit to assure the world’s safe, reliable supply of effective, affordable drugs.

Pharma’s never been for the faint-hearted. Beginning about 2005, the financial community and the consulting class were clearly warning pharma’s leadership that the gravy train from their product portfolios would soon be ending along with the expiry of their patents. Meanwhile, a whole new class of competitors matured as patients and payers turned to generics for economic relief from high drug prices.

But where were the next generation of blockbusters to take their place? Analysts attributed the gap to a number of factors but pointed to the diminishing ability of the R&D dollar to identify and develop class-leading, standard of care drug candidates — abetted by regulators that seemed bent on finding new ways to strangle drug development — as the chief culprit. Even the FDA admitted that its slow, underfunded and undermanned bureaucracy was holding the industry back, with internal policy and legacy regulation thwarting its own institutional approaches to a safe, effective and reliable drug supply. 

Ten years later, it’s clear that pharma is in its reformation, one that’s driving a scientific, technical and operational renaissance, re-energized by Bio Pharma’s game-changing potential to create category-leading therapies. The FDA’s internal reforms are bearing fruit as well, dramatically speeding and rationalizing the drug-approval process while instituting sustainable novel drug development pathways. 

Pharma’s renaissance is being driven by more focused research & development spending; smarter approaches to the patient, product and process; and more effective operational and quality strategies for proactive compliance. The “Pharma 3.0” business model’s patient-centric tenants are key to sustaining the industry’s revival over the long term. How is the industry pursuing Pharma 3.0’s consumer-driven strategy? What follows in this issue of Pharma’s Almanac may offer insight on how some of the industry’s keenest players are implementing Pharma 3.0’s strategy. Recent Nice Insight studies, the 2016 CRO, CDMO Outsourcing and Pharmaceutical Equipment Surveys, confirm pharma’s executive and operational leadership. This leadership is shaping strategic relationships with contract service providers to manage development risk and planning to spend increased capital on modern, flexible, efficient capacity to reach the patient-centric goals of their post-patent-cliff business plans.

Nice Insight is the market research division of That’s Nice LLC, the leading marketing agency serving life sciences.