After questioning Lilly/Incyte's baricitinib, FDA director jumps ship to AstraZeneca

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Before making the switch, Chowdhury raised several questions regarding Eli Lilly’s baricitinib, scheduled for an FDA advisory committee meeting April 23. (FDA)

The FDA’s Badrul Chowdhury is moving to AstraZeneca in the same week that he made a series of critical remarks against Eli Lilly and Incyte's long-delayed baricitinib, which is set for an adcomm on Monday. 

His exit also follows a string of FDA personnel jumping to the pharma within the past year, with AstraZeneca alone poaching Sarah Pope Miksinski, former acting director of CDER’s office of new drug products, and Geoffrey Kim, director of the center’s division of oncology products. 

Miksinski has served as AZ’s senior director for global regulatory affairs since February, while Kim was named vice president of oncology and head of oncology strategic collabs last July.

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Now Chowdhury is added to that FDA alumni list, and becomes SVP for research and development at AstraZeneca's biologics unit Medimmune, and as head of its innovative medicine early development unit, which is focused on respiratory, inflammatory and autoimmunity diseases. This caps off a 21-year stint at the FDA, where he has been focused on pulmonary drugs, as well as arthritis and cystic fibrosis.

This also comes two years after MedImmune's head of research Dr. Yong-Jun Liu, one of the world's most prolific researchers in immunology, was poached by rival European Big Pharma Sanofi.

The division’s deputy director, Lydia Gilbert-McClain, is planning to retire April 28 after over 20 years of federal service. Sally Seymour, the deputy director for safety, will assume the role of acting division director, the FDA tells FierceBiotech.

In a letter from the FDA's Mary Thanh Hai, M.D., seen by FierceBiotech, the regulator said: “It is with mixed emotions that we announce upcoming changes to the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP).

“Dr. Badrul Chowdhury will be leaving FDA to take on the role of Senior Vice President of Research Development at AstraZeneca and MedImmune. It is beyond the scope of this announcement to adequately sum up Badrul’s achievements during his FDA tenure which included oversight of therapies to treat highly prevalent diseases such as asthma, chronic obstructive pulmonary disease, and rheumatoid arthritis, to the less common but life-threatening diseases such as idiopathic pulmonary fibrosis and cystic fibrosis. 

"His work extended far beyond the White Oak campus as he led the FDA team in the Montreal Protocol negotiations, an international treaty to protect the ozone layer that included the transition from chlorofluorocarbons (CFCs) to non-CFC inhalers.”

But before making the switch, Chowdhury raised several scientific questions regarding Lilly/Incyte's rheumatoid arthritis drug baricitinib, which is scheduled for an FDA advisory committee meeting April 23 and comes a year after the regulator knocked back the med over safety concerns. 

RELATED: FDA stuns Lilly and Incyte with CRL for much-anticipated RA drug baricitinib

Lilly is seeking approval of 2-mg and 4-mg doses of baricitinib, also known as Olumiant, for rheumatoid arthritis. Though it’s approved in Europe, the drug is seeking the all-important U.S. approval, where the bulk of sales will likely flow. 

Back in a March review memo, which was published this week, the departing Chowdhury walked back his previous recommendations for the 2-mg dose over the 4-mg dose, saying that he had begun to question the reported safety of the 2-mg dose at all, particularly relating to thrombosis events.

Chowdhury's concerns will remain on record for Monday's adcomm. Now, however, his attention turns to drug development. 

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