Expert insight

Biopharma industry updates on COVID-19 treatments progress and warns about upholding regulatory standards of quality

14 September 2020
  • Thomas Cueni Director General

On 3rd September, CEOs from five companies – Pfizer, Roche, MSD, Gilead, and Lilly took part in the latest IFPMA COVID-19 virtual media briefing dedicated to the on-going efforts to find a treatment for COVID-19.

During the course of the pandemic, we have witnessed a remarkable show of solidarity, partnership, and collaboration within the industry because companies are also really concerned about access, about inequality, about scaling up, and ultimately, no one entity alone can combat the pandemic. Pfizer Chairman and Chief Executive Officer Dr Albert Bourla eloquently stated “The only rival is the virus and the other competitor is time”.

The quest continues for COVID-19 therapeutics

Seven months into the pandemic, the innovative biopharmaceutical industry continues to step up work on researching and testing therapeutics that could lower mortality rates and alleviate the burden of COVID-19. Over recent months, the results of rigorous clinical trials of repurposed medicines to achieve quick wins have been mixed, but the pipeline for new treatments does hold promise. Today, 22 IFPMA member companies are involved in R&D for therapeutics and together have enacted or are conducting 81 clinical trials evaluating therapeutics’ effectiveness. The main COVID-19 treatments being looked at are antivirals, antibodies and convalescent plasma, as well as anti-inflammatories. This is encouraging as the clinical response to help patients with COVID-19 requires multiple treatment options.

Scaling up manufacturing capacities

Daniel O’Day, Chairman of the Board and Chief Executive Officer at Gilead explained that “Long before we knew Remdesivir was going to be successful, we began investing not only in the clinical trial program, working with partners around the world to find a way to ramp up supply. Because we knew that if this medicine in these extraordinary times was going to work, we had to be prepared. There is a complex supply chain”. Considerable efforts are going into planning to scale up and share manufacturing capacity should treatments prove safe and effective.

Pfizer Chairman and Chief Executive Officer Dr Albert Bourla added “One thing is science to develop a solution. And the other thing is technology to be able to scale up in a manner that is appropriate for the pandemic so that people have access to the vaccines and therapeutics, everything. There is a need for collaboration”.

When asked about Roche’s collaboration with Regeneron, Dr Severin Schwan, Chief Executive Office of Roche said “It’s very difficult to scale up manufacturing capacities for antibodies. So Roche is actually the company with one of the biggest capacities for antibodies. It’s drive in this collaboration has been to help make the necessary production capacities available if one of those antibody treatments really works. I mean, just imagine what a tragedy it would be if every company would sit on its own manufacturing capacities”.

Upholding regulatory standards

IFPMA members are strongly committed to rigorous regulatory standards for approval of COVID-19 treatments and vaccines. No matter how urgently action is needed against the coronavirus public health emergency, it is imperative that the highest standards of quality, safety and efficacy are upheld everywhere. IFPMA member companies are fully committed to transparency in reporting clinical trial results whatever they may be, and they support the need to inform the public about updates regarding vaccines in development. Throughout the media briefing we heard from the companies that it has been amazing how regulatory agencies have adapted to the need to speed up to work without compromising quality from the industry.

As Kenneth C. Frazier, Chairman of the Board and Chief Executive Officer of MSD said: “Partnerships have already been key and even greater collaboration will be required to end the pandemic. Our industry is playing a critical role in this response, uniquely positioned to address the public health challenge on a global scale and importantly, to prepare for more similar threats in the future, which is something we need to do”.

Earlier last week, nine biopharmaceutical companies working on COVID-19 vaccines signed a Vaccine Maker pledge urging regulatory agencies to uphold high regulatory and ethical standards when a COVID-19 vaccine becomes available. The pledge aims to uphold public confidence in the rigorous scientific process by which COVID-19 vaccines are evaluated and approved.

Regulatory agencies have adapted to the new normal by accelerating timelines without jeopardising safety measures. Eli Lilly & Company Chairman David A. Ricks explained “We are seeing as an industry good engagement with the FDA, EMA, etc. […]. COVID related therapies are discussed in real time. The procedural innovation has been strong, and I think both the industry and the regulators should get credit for adapting quickly under these conditions. And what we have to do, though, is to make sure that standards we are used to are met, which is randomized control trials that show proof of efficacy and safety in the context of a pandemic”.

When asked about the regulatory standards of COVID-19 vaccines and treatments, Dr Severin Schwan, Chief Executive Office of Roche strongly stated “There is no way that we can lower the standards in conducting our trials and actually the results of those trials demonstrate that very point. Many people thought that Actemra would be useful as a monotherapy and only in a very robust, well conducted trial we could show that it’s actually not the case. So, it demonstrates how important that is”.

People will only trust new vaccines if they believe that they have been approved by independent regulators based on pure science. Undermining that trust would further fuel the anti-vaccine movements, which are already disrupting immunisation programmes, and endanger all of us.