The US FDA’s CDER  has named Patrizia Cavazzoni as its permanent director. Meanwhile, there are high level changes at Rentschler Biopharma, Bone Therapeutics, and Imvax. Sit back, relax, and enjoy BioProcess Insider’s Ins & Outs.

The appointment comes after Cavazzoni has served as acting director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) for the past year after Janet Woodcock stepped away from the role to assist Operation Warp Speed (OWS) in response to the coronavirus pandemic.

 Cavazzoni has led several key projects on behalf of the FDA since joining the organization in January 2018. From January 2019 to February 2019 she served as Acting Principal Deputy Commissioner of Food and Drugs.

Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER). Image c/o FDA website

“Pleased to announce the permanent appointment of Patrizia Cavazzoni, as @FDACDERDirector, a position she has been serving in for the past year and providing exceptional leadership during this critical and unprecedented time,”  Woodcock tweeted on Monday morning. She continued: “Having spent most of my career with CDER, I have a deep appreciation of the role. Dr. Cavazzoni’s credentials are of the highest caliber, and I know she will continue to excel in advancing the FDA’s public health mission for the benefit of all.”

Woodcock left her position at OWS in January this year and has since served as acting FDA commissioner. President Joe Biden has not made a nomination yet for the role; however, it is believed that Woodcock is one of the top candidates.

Rentschler Biopharma

Contract development manufacturing organization (CDMO) Rentschler Biopharma has appointed Martin Kessler as CEO of US subsidiary and senior vice president transformation of Rentschler Biopharma SE.

According to the firm, Kessler will encourage a transformation throughout the company as it explores new technologies and fields. Furthermore, in his role as head of the US business, Kessler will chief the ongoing expansion at the CDMO’s Greater Boston area facility. This role includes expanding capacity, talent, and capabilities.

“We are delighted to welcome Martin to Rentschler Biopharma,” said Frank Mathias, current CEO of Rentschler Biopharma SE.

“He is a highly talented executive who already knows our company well, having served in a consulting capacity on critical growth projects for the past few years.” He continued: “With the further implementation of our strategy 2025, Martin will take the lead role in driving that transformation as we continue to play an important role in vaccine manufacturing to fight the ongoing pandemic and as we move into new areas like cell and gene therapy.”

 Bone Therapeutics

Anthony Ting became Bone Therapeutics chief scientific officer on April 1, 2021. Ting will be responsible for Bone Therapeutics’ research activities, expanding its pipeline and the ongoing development of its off-the-shelf, allogenic, and differentiated mesenchymal stromal cell (MSC) platform, ALLOB.

“Tony has a proven track record of driving translational research across a full range of cell and gene therapy programs,” said Miguel Forte, former CEO of Bone Therapeutics. “This experience will be invaluable for Bone Therapeutics as it broadens into a global player in specialized cell therapies for a range of targets. Tony and I have worked together for a number of years, and last year he succeeded me as Chief Commercialization Officer on the board of directors for the International Society for Cell and Gene Therapy.”

Imvax

Biotech firm Imvax expands its leadership team by appointing Sean Hemingway as chief operating officer. Prior to joining Imvax, Hemingway served as senior vice president and global head of the BioLife Plasma Services Business Unit at Takeda.

According to the company, its approach is an autologous, cell-based treatment which creates an ‘adaptive’ and ‘innate’ immune response. Currently, the company’s lead program is in glioblastoma multiforme (GBM), which is an aggressive form of brain cancer.

Hemingway’s role includes building out its cell therapy platform, overseeing the supply and manufacturing organization, and also leading the expansion of Imvax’s manufacturing facility at The Curtis in Philadelphia.

“Sean brings invaluable knowledge of project management, manufacturing operations, and network strategy to Imvax,” said John Furey, CEO of Imvax. “His experience will streamline operations, allowing us to refine our antigen-agnostic and proprietary methodology approach to treating tumors with unmet medical needs, helping hundreds of patients across the globe.”