Hired and Retired: Regulatory turbulence shakes the space

Hired-and-Retired.jpg
(Image: Getty/Liountmila Korelidou) (Getty Images/iStockphoto)

The end of the summer sees several leading companies, including Regeneron, Novartis, and Bayer, experience changes in their leadership.

The end of the summer sees several leading companies, including Regeneron, Novartis, and Bayer, experience changes in their leadership.

The operations of the US Food and Drug Administration (FDA) have had a significant impact on the changes made during the past month, either due to regulatory action leading to companies removing their executives, or with moves from a governmental to an industry office.

The biopharmaceutical market saw a major company facing strong compliance burdens, leading to the removal of two of its executives.

Hired and Retired
Hired and Retired (Liountmila Korelidou/Getty Images/iStockphoto)

The end of the summer sees several leading companies, including Regeneron, Novartis, and Bayer, experience changes in their leadership.

The operations of the US Food and Drug Administration (FDA) have had a significant impact on the changes made during the past month, either due to regulatory action leading to companies removing their executives, or with moves from a governmental to an industry office.

The biopharmaceutical market saw a major company facing strong compliance burdens, leading to the removal of two of its executives.

Regeneron, Edward Cox
Regeneron, Edward Cox

After having spent over 20 years at the FDA, Edward Cox resigned from the position of director of the Office of Antimicrobial Products (OAP), which he held for 12 years, to make the jump into the biotech industry.

A spokesperson for Regeneron confirmed to BioPharma-Reporter that Cox had been appointed VP of regulatory affairs at the company, beginning his new role on August 26. Cox is reporting to the SVP of regulatory affairs, Ned Braunstein.

During his service at the FDA, Cox was responsible for divisions that reviewed antibacterial, antiviral, antifungal, antiparasitic and antimycobacterial products.

Sensorion, John Furey
Sensorion, John Furey

French biopharmaceutical Sensorion announced the appointment of John Furey, former COO of Spark Therapeutics, as an independent member of its board of directors.

According to the company, the appointment will be effective by the next meeting of its board of directors this month.

Furey resigned from Spark at the end of December 2018. During his two-year service as the company’s COO, he led the launch of Spark’s Luxturna (voretigene neparvovec-rzyl), as it became the first gene therapy to be approved by the US Food and Drug Administration (FDA).

In his role as Spark’s COO, Furey was responsible for global commercial operations, medical affairs, technology development and technical operations.

Before joining Spark, Furey was SVP and head of global operations for Baxalta, and also spent two years as general manager of Pfizer’s vaccine business in China.

Chairman of Sensorion board, Patrick Langlois, commented on the appointment by saying that it is ‘very timely’ considering the company’s stage of development, as Sensorion currently aims to advance its gene therapy portfolio for inner ear disorders.

Apart from his role at Sensorion, Furey is also currently a non-executive director of T-cell therapy developer Adaptimmune.

Correction: A previous version of this article stated John Furey worked at the FDA, this has been removed.

CLSA, various
CLSA, various

California Life Sciences Association (CLSA) announced the appointment of nine executives, coming from leadership teams of top pharmaceutical and biotechnology companies, including Amgen, DuPont and Boehringer Ingelheim, as members of its board of directors:

  • Victoria Blatter, SVP, US government affairs, Amgen
  • Elizabeth Grammer, EVP, general counsel and head of human resources, Ardelyx
  • Jennifer Johnson, associate general counsel, DuPont Nutrition & Biosciences
  • Casey Lynch, CEO, co-founder and chairman, Cortexyme
  • Joshua Ofman, chief of corporate strategy and external affairs, GRAIL
  • Matthew Plunkett, SVP and CFO, Nkarta Therapeutics
  • Stacey Pugh, VP and general manager, neurovascular, Medtronic
  • Fran Schulz, partner, assurance services – Life Sciences Practice, Ernst & Young
  • Bridget Walsh, VP, government affairs and public policy, Boehringer Ingelheim

The association’s CEO, Mike Guerra welcomed the new members, saying that California’s life sciences sector is currently going through a period of ‘strong growth’, which the ‘diverse’ group of executives added to the board are expected to help sustain.

AveXis, Brian and Allan Kaspar
AveXis, Brian and Allan Kaspar

Earlier this month, Novartis and its wholly-owned subsidiary, AveXis, were put in the spotlight after the FDA’s announcement about data manipulation issues during the development of Zolgensma (onasemnogene abeparvovec-xioi), which were revealed less than three months after the product’s approval by the agency.

In a brief statement released only one week later, AveXis announced that its founder, Brian Kaspar (pictured), and his brother, Allan Kaspar, who had held the positions of AveXis’ CSO and SVP of R&D, respectively, had been removed from the company.

Specifically, the announcement stated that the two executives “have not been involved in any operations at AveXis since early May 2019 and are no longer with the company.”

Novartis executive of 10 years, Page Bouchard, who most recently was the global head of preclinical safety for Novartis Institutes for BioMedical Research (NIBR), was appointed SVP of research and CSO, effective August 5, 2019, replacing AveXis’ founder and his brother.

Nordic Nanovector, Lars Nieba
Nordic Nanovector, Lars Nieba (scyther5/Getty Images/iStockphoto)

Lars Nieba leaves Bayer where he spent two years as VP and strategic product lead to join Nordic Nanovector, a clinical stage developer of cancer therapies, as its chief technology officer.

Prior to Bayer, Nieba spent 13 years at Roche, holding several leadership roles in clinical supply and biologics development.

Nieba’s role at Nordic Nanovector will be to oversee all chemistry, manufacturing and controls (CMC) strategic and operational for the company’s pipeline, including Betalutin (lilotomab), the lead product in development.

Nieba’s appointment will be effective on 1 December 2019.