Chutes & Ladders—Scott Gottlieb confirmed as FDA commissioner


Chutes and Ladders

Welcome to this week's Chutes and Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Eric Sagonowsky (email) or Angus Liu (email) and we will feature it here at the end of each week.

Scott Gottlieb confirmed to lead FDA

FDA logo
Scott Gottlieb

Scott Gottlieb, M.D., became FDA commissioner.

Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.

By a vote of 57 to 42, the Senate confirmed Scott Gottlieb as the head of the FDA, about four months after Robert Califf stepped down from the position. Gottlieb’s nomination and confirmation were not unexpected. A Physician, Gottlieb used to be the deputy commissioner of the FDA and later a consultant to the drug industry. The confirmation received much praise from the industry, which reasoned that his previous experience works in his favor, even though critics have argued that his relationship with biopharma were a little too cozy. Gottlieb will be responsible for implementing the recently enacted 21st Century Cures Act, which is in part designed to speed up approvals for innovative treatments. He may also move to cut back on regulations and approval process at the agency. FierceBiotech

Alphabet’s Verily loses top neuroscientist Insel

Thomas Insel

Thomas Insel, M.D., left as head of the mental health initiative.

Thomas Insel, who joined Verily—then Google X Life Sciences—in December 2015 to lead its mental health team, has left the company to start his own company, Mindstrong. Prior to Verily, the renowned neuroscientist used to serve as director of the National Institute of Mental Health for 13 years. His work at Verily included seeking a ten-fold solution to mental health challenges. And now, he’s taking that mission to Mindstrong, which intends to develop a smartphone app or computer programs to determine one’s state of mind through a process called digital phenotyping based on certain behaviors. Insel is the latest of a series of high-profile departures from Verily, including Vikram Bajaj, formerly Verily’s CSO, and Mark Lee, both headed for Grail. FierceMedicalDevices

Immunomedics’ CEO, founder gone with $2B Seattle Genetics deal

David Goldenberg

Founder David Goldenberg stepped down as CSO.

Seattle Genetics has terminated a potential $2 billion development and licensing deal with Immunomedics. The deal, reached in February, was placed on hold in March after Immunomedics’ investors, led by venBio, revolted against it, as they pushed for in-house development of IMMU-132, the drug at the center of the pact. Seattle Genetics finally lost patience and called off the deal to focus on its own pipeline. Immediately after that termination came the announcement from Immunomedics, saying that its president and CEO Cynthia Sullivan, as well as company founder and CSO David Goldenberg, were stepping down. CFO Michael Garone was named interim CEO as the biotech searches for a permanent head. FierceBiotech

> Bavarian Nordic tapped Boston Consulting Group Partner and Managing Director Tommi Kainu, M.D., Ph.D., as CBO. Release

> Alistair Macdonald, CEO of INC Research and inVentiv’s CEO Michael Bell, will become CEO and executive chairman, respectively, as the two companies merged into one. FierceCRO

> Regulus Therapeutics has axed 30% of its workforce, including CEO Paul Grint, M.D., amid an ongoing FDA hold imposed on its drug candidate, and COO Jay Hagan was named to replace him. FierceBiotech

> Josh Mandel-Brehm, senior director of business development and M&A at Biogen left the company, with plans to helm a biotech startup by Polaris. BioSpace story

> Long-time Sanofi Genzyme exec David Ford left as head of human resources. Boston Business Journal story

> Casebia Therapeutics announced three new leadership additions: Ellen Ridge became SVP of operations; Abraham Scaria, Ph.D., joined as VP of ophthalmology; and Andrew Scharenberg, M.D., will join as CSO and VP of hematology. Release

> WIRB-Copernicus Group acquired eCOA specialists MedAvante and ProPhase, and tapped Jeffrey Litwin, M.D., as the CEO of the combined organization. FierceCRO

> Novavax promoted James Cummings, M.D., as VP of clinical development and translational medicine. Release

> Nanthealth appointed Sandeep (Bobby) Reddy, M.D., as CMO. Release 

> Oncologist Sonia Quaratino, M.D., Ph.D., became Kymab's first CMO. Release

> PPD made two new appointments in product development: Stephen Peroutka, M.D., Ph.D., became VP of global product development and therapeutic area head for neuroscience; and Horacio Plotkin, M.D., joined as VP of global product development in pediatrics and rare diseases. Release

> T-cell immunotherapy-focused Tmunity Therapeutics tapped Michael Christiano as EVP and CBO. Release

> San Diego-based GenomeDx Biosciences, a specialist in urologic cancer genomics, appointed Michael Rodriguez as the company's CFO. Release

> Radiotherapy medical device company RefleXion Medical hired industry veteran Todd Powell as president and CEO. Release

> Titan Spine, a medical device company developing spinal interbody fusion implants, named Ed Graubart as VP of professional development. Release

> Heikki Mansikka, M.D., Ph.D., an expert in pain management therapeutics previously with AbbVie, came on board with Chromocell as VP of clinical development. Release