Safety: the competitive asset
Required by the latest round of FDA PDUFA regulations, pharmacovigilance compliance now occupies the time of departments bursting
with experienced professionals; in an era of retrenchment, headcount for this function continues to grow. Several years of
multi-billion dollar fines has convinced most companies that the FDA is serious about receiving process validation (PV) reports
that are complete and on time. It has not been all bad, as a poor record on PV gives firms with rival therapies the opportunity
to steal market share.
The end game
In 2020, what has always been true about the industry remains true. Health is a universal value, and medicines are an essential
good with no expiration date on expectations. Returns continue to flow for those who combine good science and focused investments
in human capital with a little bit of luck to deliver on that value. Compared to other sectors, biopharmaceuticals remain
profitable, with well-supported specialty biologics continuing to find acceptance in the mature markets, while traditional
small molecule drugs and branded generics find new buyers in emerging markets. Another windfall is the steady flow of prescription
drugs that have switched to OTC status, where firms with strong consumer marketing capabilities have done extremely well.
Biosimilars have met the regulatory, reputational, and cost challenge; a modest but thriving market is underway.
Finally, many foreign countries have reversed course and are falling into line with the TRIPS agreement, respecting intellectual
property rights as they work to incentivize their own industries around a pro innovation industrial policy.
The most exciting chapter in the story remains the promise of innovation. The long-promised results from our improved understanding
of molecular biology and the genetic pathway of disease are paying off with more breakthrough drug approvals, particularly
in rare and orphan diseases as well as hard to treat cancers.
Insurer reluctance to pay for these advanced treatments has been eased through cooperative efforts among industry, academia,
government and patient groups to invest in companion diagnostic tests that allow for targeting those patients most likely
to benefit. As such, M&A activity is no longer limited to therapeutics but now includes robot surgery and nanotechnology geared
to better drug delivery. Likewise, nearly a decade-long recovery in vaccine investment is finally yielding a rich harvest:
several versions of an AIDS vaccine are slowing the HIV infection rate, and a new vaccine for malaria is making inroads despite
persistent challenges of infrastructure.
But best of all is the revival of the human part of the enterprise. The pharma community now more resembles the global mosaic,
with a far more diverse workforce. The membership of corporate boards is also less insular, which has been an important factor
in helping women break into the CEO suite. As a result, people now want to work in the industry again, and total employment
is up after the loss of more than a quarter of million workers in the decade up to 2013, though it is far from the level of
the golden era of the 1990s. For older workers, their stock options are now worth something, and bright young university graduates
are again looking toward pharma industry careers.
Albert Wertheimer is a Pharm Exec Editorial Advisory Board Member and a Professor of Pharmacy Sciences at Temple University. He can be reached at albertw@erols.com
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