CureVac has named Klaus Edvardsen as its chief development officer. Meanwhile, there are changes at Gamida Cell and AavantiBio. Sit back, relax, and enjoy BioProcess Insider’s Ins & outs.

Up first in this week’s Ins & Out’s we have mRNA firm CureVac, which has appointed Edvardsen as chief development officer effective from August 1, 2021.

“We are very pleased that Klaus is joining us in highly dynamic times for the company,” said Franz-Werner Haas, CEO of CureVac.

Image: iStock/marchmeena29

“He brings a wealth of experience in both clinical development and product development, with a specific focus on oncology and therapies. Looking ahead, his expertise will be of great value to us as we expand our pipeline, advance our technology platform and further grow our company.”

Edvardsen previously served as senior vice president and head of Global Oncology Development at Merck KGaA.

Before this he served at AstraZeneca as senior vice president and Head of Global Medicines Development Oncology, where he led the overall development strategy for oncology and hematology programs.

CureVac’s mRNA COVID-19 vaccine candidate CVnCoV is currently in Phase II/III (HERALD) study with approximately 40,000 participants enrolled to demonstrate its efficacy.

Gamida Cell

Coming in second we have Gamida Cell, an advanced cell therapy firm that develops cures for blood cancer and other serious blood diseases.

The firm has appointed Vladimir Melnikov to serve as senior vice president, global operations, and manufacturing.

Melnikov has over 25 years in the biopharmaceutical industry and will be based at the firm’s commercial manufacturing plant located in Israel.

Melnikov will be responsible for the Gamida Cell global operations and manufacturing. This includes the company’s Israeli manufacturing facility and oversight of the company’s contract manufacturing partnership with CDMO Lonza.

Prior to joining Gamida Cell, Melnikov acted as general manager at Omrix Biopharmaceuticals and biologic technical operations lead at Ethicon Biosurgery. Both are part of a Johnson & Johnson company.

“With Vladimir on board, we feel even more confident that we are making positive steps toward bringing Omidubicel, our proprietary advanced cell therapy, to patients in need of an allogeneic hematopoietic stem cell transplant,” said Julian Adams, CEO of Gamida Cell.

The Israeli cell therapy firm raised $60 million (€55 million) in May through a public share offering. The money will be used to support the approval application and manufacturing capabilities of its cell therapy products.

AavantiBio

Last but certainly not the least is gene therapy firm AavantiBio, which has selected Jessie Hanrahan as chief regulatory officer.

Hanrahan brings just shy of 15 years’ experience in the biotech industry to AavantiBio and in this role she  will oversee global regulatory affairs for the company’s pipeline of gene therapy programs, which target rare diseases with significant unmet medical need.

Most recently, she was Vice President of Regulatory Science at Bluebird Bio where she was responsible for the global regulatory strategy for the severe genetic disease franchise.

While at Bluebird Bio, Hanrahan played a major role in the Marketing Authorization Application (MAA) submission and authorization of Zynteglo, the first gene therapy product for transfusion-dependent beta-thalassemia patients.

“Jessie brings to AavantiBio robust global regulatory and development expertise along with a proven track record of contributing to the development of innovative drug products. We are thrilled to welcome her to what we believe is a best-in-class leadership team,” said Bo Cumbo, president and CEO of AavantiBio.

He continued: “With Jessie and the rest of the executive team in place, we are well-positioned to execute on our vision to leverage the transformative science of gene transfer therapy and other technologies to deliver the next generation of life-changing medicines for patients and families affected with rare, devastating diseases.”

This week, AavantiBio hired Resilience to make its gene therapies candidates, including a therapy for the currently untreatable progressive disorder Friedreich’s Ataxia (FA).

That’s all we have time for on this week’s Ins & outs, we can’t wait to have you back here next time!