IDBS Blog

IDBS Blog | 16th June 2021

Adapting to the Challenge COVID-19 Presents to Create a New Biopharma Normal

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In a recent Forbes article, Danaher’s Chief Science officer, Jose-Carlos Gutierrez-Ramos, described the impact of the COVID-19 pandemic as follows:

“I believe the biopharma business model has fundamentally changed. The changes are irreversible because we are not going back to the old ways of silos in biopharma. Our patients and society demand faster solutions. We have seen when this partnership happens between science and technology, and you get rapid acceleration. The mRNA vaccines and diagnostic tools for COVID-19 being deployed quickly is one example.”

  • Jose-Carlos Gutierrez-Ramos, ‎Chief Science Officer, Danaher Corporation

COVID-19 presented global biopharma with the ultimate unmet medical need.  It is broadly appreciated that the pace of development of COVID-19 testing, therapeutics, and vaccines exceeded both all precedent and all expectations as to what can be delivered on a compressed and urgent timeline. It is also worth remembering that not every COVID-19 biopharma initiative led to an FDA-authorized and marketed product. The ability to ‘fail-fast’ played a role here.  When timelines are tight, resources are limited, and community spread is unchecked, the insight required to terminate an unproductive effort is critically important. This rapid data-driven decision making will be a permanent feature of the post-pandemic discovery and development landscape.

Another feature of the pandemic-oriented biopharma landscape is the collaboration with regulatory authorities to speed relief to the market.  While maintaining integrity and remaining apolitical, regulatory authorities leveraged their discretion in the deployment of Emergency Use Authorizations (EUA) in unprecedented scenarios, ranging from resourceful testing schemes on university campuses to the sequential application of EUAs for the use of vaccines in adults to, now, adolescents from 12-15 years of age.

As such, there has never been so much public interest in the BioPharma Lifecycle, from discovery, to development, and even into manufacture.

As one scientist working on the Pfizer effort noted in the New York Times: “Rarely do you work on something in the lab and go home and turn on your TV and see the top ten headlines are about the thing that you were working on today.”

Vaccination rates occupy onscreen tickers on around-the-clock cable news, and widely available information (and misinformation) impacts vaccination rates.  Sometimes these concerns highlight the system working as it should.  Media attention to clinical trial data inconsistencies and drug manufacturing episodes, detected by regulatory authorities, has impacted the public uptake of vaccines. In short, the BioPharma Lifecycle now unfolds in the public eye.  While vendors such as IDBS stress the importance of transparency among colleagues, among collaborators (and with regulators) the consequences of this transparency now extend into the town square.

And yet, so much of the change has impacted the individual lab level. One lab leader I spoke to noted: “In a structureless time, it became my job to provide that structure that otherwise would have been provided by our physical presence in the lab.”  He continued, “In that period, we didn’t talk about the thirty-thousand-foot view — because that’s not what people needed. The lab has come back stronger, because now the communication that was initially forced became much, much easier.”  The lab has resumed in-person activity.

Meanwhile, on the web, shared lessons of the pandemic continue to emerge even as localized infection flare-ups continue.  A BioSpace feature highlighted several.  Some congratulated themselves on foresight that mitigated the impact of the pandemic, such as taking in-house their manufacturing capability. Speaking of the shift to remote work, Linda Fitzpatrick of Sutro Biopharma reminded conference attendees that while “you can’t manufacture medicine in a GMP environment at your home… we’ll have a bit more openness to what I’m going to call a modified hybrid model”, heavily implying that lab-based activity, and in-person collaboration, are crucial. A Bayer executive, like the lab leader I spoke with, cited his “heightened appreciation for communication”.  And another biotech CEO marveled at the readiness with which barriers “between competitors, regulators, academia, patients, and government [were removed and] the focus centered on the disease”.

The author of the Forbes piece, interestingly, is the founder of SynBioBeta, a conference and growing community laser-focused on innovative biotechnology accelerating the BioPharma Lifecycle.  The vaccines and therapeutics enabled by the global imperative of COVID-19 will permit this meeting to be held this year with the tagline “Because Being in the Same Room is Better Than Being on the Same Zoom”.

The Danaher Life Science platform will be well-represented at this conference, and we look forward to seeing you there.

#biopharmaceuticallifecyclemanagement #IDBSPolar

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