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Tony Cucinella is the Vice President of Quality Assurance at Serán, where he spearheads quality with a focus on applying scientific rationale to complex quality challenges. Tony leads a multidisciplinary team that combines rigorous quality systems with innovative problem-solving methodologies, driving continuous improvement in pharmaceutical manufacturing processes. Under his guidance, the quality team delivers strategic oversight for regulatory compliance while fostering a culture of scientific excellence and operational efficiency.
Tony brings over 20 years of experience in manufacturing operations, technical transfer, quality operations, development, and management of pharmaceutical quality systems (PQS), organizational leadership & growth, and regulatory compliance.
Prior to joining Serán, Tony worked with multiple Commercial organizations including Selkirk Pharma, StrideBio, KBI Biopharma, Tolmar, Bristol Myers Squibb, Lonza Biologics, and Amgen. Tony has extensive experience in managing PAI inspections, securing global regulatory approvals, supporting filings, and performing regulatory remediation activities. Tony has his Bachelor of Science in Healthcare Management and his Master’s in Science with an emphasis on Strategic Leadership & Management.
Tony Cucinella
Senior Director of Quality Assurance
Dan Smithey, Ph.D.
President & CEO of Serán
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Dan Smithey, Ph.D.
President & CEO of Serán
45+ Years Drug Dev
Dr. Smithey is the President, CEO, and Co-founder of Serán BioScience with over 30 years of experience in pharmaceutical R&D. He led the development of several breakthrough therapies, including Tukysa® for metastatic breast cancer. A recognized innovator, he has founded multiple biotech ventures and holds over 50 patents.
Kevin Nepveux
Pfizer Global Commercial Manufacturing
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Kevin Nepveux
Pfizer Global Commercial Manufacturing
Years at Pfizer, other companies
Kevin is a chemical engineer with over 40 years at Pfizer, where he played key roles in both R&D and manufacturing. He contributed to the development and production of several major therapies and led global initiatives in tech transfer, scale-up, and new technology. A career highlight was his leadership in Pfizer’s COVID-19 vaccine manufacturing effort.
Will Cozean
Managing Director Bain: Capital Life Sciences
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Will Cozean
Managing Director Bain: Capital Life Sciences
Experience with life science industry
Mr. Cozean is a Managing Director at Bain Capital Life Sciences and serves on the board of Serán BioScience. He brings deep experience in healthcare investing, with prior roles at Bain Capital Private Equity and McKinsey & Co. He holds an MBA from Harvard Business School, where he was a Baker Scholar, and a BS in Commerce from the University of Virginia.
Gaurav Aggarwal
Managing Director: Vivo Capital
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Gaurav Aggarwal
Managing Director: Vivo Capital
Experience with life science industry
Dr. Aggarwal is a Managing Partner at Vivo Capital with over two decades of experience investing in the life sciences sector. He has held leadership roles across venture capital, public market investing, and biopharma operations, including as Chief Business Officer at Ocera Therapeutics. Dr. Aggarwal holds an M.D. from Columbia University and a B.S. from Cornell University.
Mike Preigh
1490 Pharma LLC
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Mike Preigh
1490 Pharma LLC
Experience with life science indusry
Dr. Mike Preigh brings over 30 years of experience in pharmaceutical development and manufacturing. He most recently served as CTO at Day One Biopharmaceuticals, where he led the CMC efforts for the approval and launch of Ojemda (tovorafenib). His career includes leadership roles at Array BioPharma and Pfizer, with a track record of advancing numerous therapies from IND through commercialization.
Aslam Malik
SK Pharmteco: Ampac
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Aslam Malik
SK Pharmteco: Ampac
Experience with life science indusry
Dr. Aslam Malik is an accomplished leader with over 35 years in the pharmaceutical and chemical industry. He was most recently CEO of SK pharmteco and previously led AMPAC Fine Chemicals. A recognized innovator with over 50 patents, Dr. Malik holds a Ph.D. in Organic Chemistry and has served on numerous industry and non-profit boards.