Kashiv BioSciences Strengthens Executive Leadership with New Chief Operating Officer and Senior Vice President of Regulatory Affairs

PISCATAWAY, N.J.--(BUSINESS WIRE)--Kashiv BioSciences, LLC (“Kashiv”), a vertically integrated biopharmaceutical company, today announced the appointment of Viet Nguyen as Chief Operating Officer and Arlene Wolny as Senior Vice President of Regulatory Affairs. Both leaders will be based in Piscataway, New Jersey.

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

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Viet Nguyen has over two decades of leadership experience, with deep expertise in building high-performing teams, scaling complex operations, and driving commercial readiness across multiple therapeutic modalities. Prior to joining Kashiv, he spent over a decade in international leadership roles across Singapore, China, and Switzerland with leading global organizations including Genentech, Roche, Merck Group, and Bayer Corp. He holds a Bachelor of Science in Pharmacy from Saint Joseph’s University and has completed his Global Leadership Management program from INSEAD / Stanford University. As COO, Viet will oversee manufacturing, quality, supply chain, and engineering across global operations, supporting Kashiv’s next phase of growth and operational scale.

Arlene Wolny brings extensive global regulatory experience with a strong track record in shaping regulatory pathways, navigating complex approval environments, enabling faster development timelines and ensuring strong life cycle management for approved products. Previously, she held senior roles at Biocon Biologics, Sandoz, Novartis, and Roche and has worked extensively abroad. She holds a Master of Business Administration from Columbia University, PhD in Pharmacology from the University of Basel, Switzerland, and MS in Veterinary Medicine from Ohio State University. At Kashiv, Arlene will lead global regulatory strategy with a focus on advancing pipeline programs efficiently across key markets.

“We are pleased to welcome Viet and Arlene to our leadership team. Their combined expertise across operations and regulatory affairs will be critical as we scale our platform and advance our pipeline,” said Dr. Sandeep Athalye, Global CEO of Kashiv BioSciences. “Their leadership strengthens our ability to execute globally and deliver high-quality biologics to patients in need.”

These appointments highlight Kashiv’s continued focus on strengthening its executive team as the Company advances its global expansion and pipeline. With enhanced leadership across operations and regulatory affairs, Kashiv is well-positioned to scale globally, support efficient development timelines, and maintain high standards of quality and compliance while expanding access to its therapies worldwide.

About Kashiv BioSciences
Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC, in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines. For more information, visit www.kashivbiosciences.com and follow us on LinkedIn.