Breaking Industry Standards with Lightspeed

Through focused efforts since 2010, Pfizer transformed its R&D output to achieve industry-leading end to end clinical success.¹

It can take more than 10 years to bring a vaccine or treatment from discovery through regulatory approval. The urgency of COVID–19 forced us all to think differently and challenge the typical discovery and development timeline while maintaining our high standards for safety and quality, which led to the development of an authorized vaccine in less than a year and a treatment in less than 18 months.

However, long before the pandemic—over the course of the last decade—Pfizer has been transforming our research and development approach, revving up our engine of innovation and making profound changes across multiple dimensions to empower our scientists for critical decision-making. This important evolution laid the foundation for responding with “lightspeed” in the pandemic and continues to usher in a new wave of breakthroughs at Pfizer. Specifically:

  • Since 2019, we’ve decreased our median first-in-human to approval development timeline for new medicines and vaccines from nine years to approximately five years in 2022. We have ambitious goals to reduce timelines even further so we can get medicines to patients even faster.
  • By the end of 2022, Pfizer achieved an end-to-end success rate of 18 percent—from first-in-human to approval at a new molecular entity level—which is nearly 10 times our 2010 performance.
  • By the end of 2021, we demonstrated a durable performance on Phase 2 success rates for New Molecular Entities of 60% versus an industry median of 37%.1
  • We’re proud of our achievement to date and intend to maintain our focus in industry leading success rates, enabling us to continue to deliver breakthroughs to patients.

“There is no greater indicator of our commitment to delivering breakthroughs for patients than clinical success rates,” said Mikael Dolsten, MD, PhD, Chief Scientific Officer and President, Worldwide Research, Development and Medical at Pfizer. “And while there is much that goes into making a successful medicine or vaccine, taking bold steps to safely accelerate development timelines of these innovations is the real difference-maker that our lightspeed mindset has had on our organization.”

Lightspeed includes searching for opportunities that upend the standard approach to clinical development in areas with a high unmet need, where Pfizer can make a big impact through our science, capabilities, and thoughtful risk-taking. Lightspeed is how we instill a pioneering spirit across our teams so that we can keep pushing innovative thinking further and move at the speed of science.

Leveraging lessons learned from the COVID–19 pandemic, we’ve solidified the lightspeed approach, which entails pulling multiple levers and deploying different strategies to move faster through the process for the benefit of all patients. While not all levers can be pulled for every program, there are certain elements that are at the core of the lightspeed paradigm and are being applied to key programs across our pipeline:

  • Parallel testing. This is the ability to design multiple constructs or formulations of a therapy or a vaccine and test them in parallel studies so that the candidate with the best safety, tolerability and/or efficacy can be identified. Parallel instead of sequential testing is perhaps one of the most defining traits of lightspeed.
  • Expert dose selection. It is important that our vaccines and therapies are meticulously designed and tested so that we are enabled to optimize safety, tolerability, and efficacy.
  • Streamlined governance for rapid decision-making. A key tenet is to ensure there is a simplified governance model which allows decisions to be made nearly in real-time.
  • Investment at risk. Guided by the urgency of the need and the ability to roll out certain medicines and vaccines faster, Pfizer could invest in building up commercial manufacturing capabilities early in the development process, as was the case for the Pfizer-BioNTech COVID–19 Vaccine.
  • Faster regulatory collaboration. We have witnessed significant regulatory innovation by regulators during the pandemic, which has opened doors to greater digital collaboration and global harmonization of standards to help drive innovation “at light speed.” There is now an opportunity for industry and regulators to emerge stronger than before by applying the lessons that this crisis has taught us and by proactively considering which of those learnings could be adopted permanently in regulatory practice to help create a more efficient and patient-centric “new normal.”
Pfizer scientist at machine

Lightspeed is how we instill a pioneering spirit across our teams so that we can keep pushing innovative thinking further and move at the speed of science.

For instance, applying some of these principles, for our Phase 2b study of oral glucagon-like peptide-1 Danuglipron (PF- 06882961) for type 2 diabetes mellitus (T2DM) and obesity, we were able to reduce clinical development timelines by 12 months. Similarly, the lightspeed mindset was applied to accelerate the development of our Phase 3 vaccine candidate for respiratory syncytial virus (RSV), currently being evaluated for both adults aged 60 and older and pregnant people to help protect their newborns. We look forward to applying the lightspeed approach across key Pfizer clinical programs in the pipeline to bring safe, effective treatments and vaccines to patients faster because we know they are waiting and every day matters.

  1. The Pharmaceutical Benchmarking Forum