Kashiv BioSciences Appoints COO and Regulatory Chief to Support Global Growth Strategy

Kashiv BioSciences has named Viet Nguyen as Chief Operating Officer and Arlene Wolny as SVP of Regulatory Affairs to strengthen operations and accelerate pipeline development.
  • Kashiv appoints Viet Nguyen as Chief Operating Officer
  • Arlene Wolny named Senior Vice President of Regulatory Affairs
  • Both bring global experience from major biopharma companies
  • Leadership expansion supports pipeline advancement and global scaling
  • Focus on manufacturing, regulatory strategy, and commercialization readiness
  • Move reinforces company’s position in biosimilars and biologics

Kashiv BioSciences is expanding its executive leadership team with the appointments of Viet Nguyen as Chief Operating Officer and Arlene Wolny as Senior Vice President of Regulatory Affairs, as the company looks to scale operations and advance its global pipeline.

The appointments reflect Kashiv’s continued investment in leadership capabilities across operations and regulatory strategy, key areas as the company grows its footprint in biosimilars and biologics.

“We are pleased to welcome Viet and Arlene to our leadership team,” said Dr. Sandeep Athalye, Global CEO of Kashiv BioSciences. “Their combined expertise will be critical as we scale our platform and advance our pipeline.”

Operational Leadership to Drive Scale

Nguyen brings more than 20 years of experience in global operations, including leadership roles at Genentech, Roche, Merck Group, and Bayer. In his new role, he will oversee manufacturing, quality, supply chain, and engineering across Kashiv’s global operations.

His appointment is expected to support the company’s efforts to scale production capabilities and enhance operational efficiency as it prepares for further commercialization.

Strengthening Regulatory Strategy

Wolny joins Kashiv with extensive experience in global regulatory affairs, having held senior roles at Biocon Biologics, Sandoz, Novartis, and Roche. She will lead regulatory strategy across key markets, focusing on streamlining development timelines and supporting product approvals.

Her background in navigating complex regulatory environments is expected to play a key role in advancing Kashiv’s pipeline and lifecycle management strategies.

Positioning for Global Expansion

The leadership additions come as Kashiv continues to expand its global presence, supported by integrated capabilities across research, clinical development, manufacturing, and regulatory functions.

The company said the strengthened executive team will help accelerate development timelines, maintain high quality standards, and expand access to its therapies worldwide.

Information sourced from the company’s press release.