Pfizer’s Dolsten Plans Exit, Ushering In R&D Transition

Mikael Dolsten, the steadfast R&D leader at Pfizer Inc., will depart the company after 15 years, having helped take the company to new heights during the COVID-19 pandemic and credited with more than 35 drug and vaccine approvals during his tenure, with more than half of them being new molecular entities.

Pfizer announced on 9 July that Dolsten, chief scientific officer and president, Pfizer Research & Development, will leave the company in the coming months after a successor is found.

Pfizer will initiate an external search for a new chief scientific officer, and Dolsten will assist in the search, continuing in his current role until the transition is complete, likely through early next year, the company said.

Dolsten has been a steady leadership figure at the big pharma through multiple CEO transitions and business reorganizations. He maintained the company’s strength in vaccines, including leading the charge in the unprecedented race against COVID-19 and the development of a vaccine for respiratory syncytial virus (RSV), and steered Pfizer deeper into immunology and oncology, with some success, but also disappointments. 

Dolsten joined Pfizer with the $68bn acquisition of Wyeth Pharmaceuticals, where he led R&D, though only for a short time before Pfizer acquired the company in 2009. Before that, he was head of worldwide research at Boehringer Ingelheim GmbH from 2003-2008 and global VP of R&D at AstraZeneca PLC from 1997-2003.

He worked initially for Pfizer as head of biologics R&D after the close of the Wyeth acquisition under CEO Jeff Kindler, but was quickly tapped to lead research and development of all compounds through Phase II or proof of concept in May 2010 when Pfizer’s then head of R&D Martin Mackay departed for AstraZeneca. (Also see "R&D Swapping: AstraZeneca Lures Mackay From Pfizer To Head Global R&D" - Pink Sheet, 26 May, 2010.)

Over the next 14 years, Dolsten led Pfizer’s research organization through multiple iterations, facing the first big obstacle in 2011 with the loss of the mega-blockbuster Lipitor (atorvastatin), which led to cost cuts and a reorganization under a business strategy developed by the CEO at the time, Ian Read. (Also see "For Pfizer Chief, The First Order Of Business Is Research" - Pink Sheet, 1 Feb, 2011.)

A COVID-19 Legacy

Pfizer is now navigating another period of transition triggered, in large part, by the COVID-19 pandemic and Pfizer’s success in delivering the first mRNA-based vaccine, Comirnaty, developed with BioNTech SE, and the antiviral Paxlovid (nirmatrelvir/ritonavir).

The development of an effective vaccine for COVID-19 that helped end the pandemic will undoubtedly be the legacy Dolsten is most remembered for from his time at Pfizer. Though credit goes to many others including CEO Albert Bourla, former head of vaccines R&D Kathrin Jansen and leaders at BioNTech, Dolsten stood out among big pharma R&D leaders during the early days of the pandemic for setting a confident tone and aggressive development timeline for developing a vaccine. Dolsten talked to Scrip in an interview in 2022 about the experience and what he called a “life-changing moment.” (Also see "Pfizer R&D Chief Mikael Dolsten Reflects On The COVID-19 Pandemic Experience" - Scrip, 1 Nov, 2022.)

But Pfizer’s inability to sustain the unprecedented growth from COVID-19 and looming patent expirations for multiple blockbuster drugs like Eliquis (apixaban) and Ibrance (palbociclib) have ushered in yet another period of uncertainty for Pfizer, including big cost cuts. (Also see "More Cost Cuts At Pfizer Bring Total Savings To $5.5bn" - Scrip, 22 May, 2024.) 

Last year the company acquired the antibody-drug conjugate specialist Seagen Inc.  for $43bn, a substantial merger intended to offset some of the LOEs, and appointed Chris Boshoff to oversee cancer drug research as chief oncology R&D officer, while Dolsten was left responsible for non-oncology therapeutic areas. (Also see "Pfizer Shakes Up R&D Leadership, Streamlining Oncology Ahead Of Seagen Merger" - Scrip, 27 Jul, 2023.)

Despite the acquisition of Seagen and lots of other business development activity, investors aren’t certain about the growth drivers Pfizer has to leverage in its pipeline and portfolio to get through a multi-year patent cliff in which it is expected to lose $17bn in revenues. (Also see "Pfizer Lays Out A Growth Plan To Offset $17bn In Coming Exclusivity Losses" - Scrip, 13 Dec, 2022.)

Two recent clinical development setbacks have further put a spotlight on pipeline challenges. Last year, Pfizer discontinued development of a closely watched twice-daily oral GLP-1 drug danuglipron for obesity due to tolerability and earlier this year, the company announced a Phase III trial failure for a gene therapy for Duchenne muscular dystrophy. (Also see "Pfizer’s Mixed Readout Places Doubt On Oral GLP-1 For Obesity" - Scrip, 1 Dec, 2023.) and (Also see "Sarepta Retains DMD Gene Therapy Lead As Pfizer Stumbles" - Scrip, 13 Jun, 2024.)

The company’s stock price is down about 22% from where it was trading one year ago, closing on 9 July at $27.69, suggesting investors want to see even more new changes at Pfizer.