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Executive Interview: Scaling Complex Orals to Launch

Kurt Nielsen, Ph.D., talks with Dan Smithey, Ph.D., CEO of Serán Bioscience, about oral drug innovation, large language models, complexity, and how flexibility can create new pathways to reach market quickly.

About the Speakers

Smithey (1)

Dan Smithey, PhD

President, CEO and Co-Founder

Dr. Smithey is the President, CEO and Co-founder of Serán BioScience.  Over his 30-year career, he has led multiple research and development projects in a broad range of therapeutic areas.   His work has led to the successful development of several novel medicines, including Tucatinib (Tukysa®) for the treatment of metastatic breast cancer.  Dr. Smithey has extensive experience building entrepreneurial organizations that embrace a strong science and engineering approach to solving unmet need in drug development and biotechnology.  Previously, Dr. Smithey led a team at Bend Research (now Lonza®) directed at research and development of novel pharmaceutical technologies, including the industry leading spray-dried dispersion technology that is broadly in use today.  Subsequently, Dr. Smithey co-founded Agere Pharmaceuticals, a specialty CDMO, which was acquired by Patheon in 2015.  He is an inventor in over 50 patent and patent applications in numerous technology and therapeutic areas.  Dr. Smithey obtained a Ph.D. in Quantum Information and Optical Physics from the University of Oregon.


Kurt-Nielsen

Kurt Nielsen, PhD

CEO | Leadership | Strategy | Sales & Marketing | CDMO | Mergers & Acquisitions | Execution

Formerly President and CEO of Pharmaceutics International, Inc. (Pii), a science-driven contract development and manufacturing organization (CDMO), with partners ranging from major multinationals to virtual pharmaceutical companies. My previous leadership roles were President of Lupin Somerset (an Operating Division of Lupin, Inc). Lupin Ltd. (BOM:500257) is an innovation led transnational pharmaceutical company which is the 6th largest generics pharmaceutical company, VP of US Development, Portfolio and Launch Management at Sandoz Inc, part of the Novartis group (NYSE:NVS), Senior Vice President of R&D and Chief Technology Officer for Catalent Inc. (NYSE:CTLT), Executive Vice President of Pharmaceuticals for URL Pharma and Executive Director of Generic R&D for TEVA Pharmaceuticals (NYSE:TEVA).


About Serán

Analytical QC

Serán's Science-First Approach

Serán Bioscience is a sci­ence-based CDMO that specializes in a variety of drug delivery and formu­lation approaches suited to optimizing bioavailability. Our experienced formulation team will work with you to identify an appropriate technology and formulation strategy to meet your program’s unique needs. We take a comprehensive approach to formulation design that considers the physiochemical properties of the API, the target product profile, and your program’s objectives and constraints to develop scalable formulations using efficient and material-sparing approaches.

What Our Customers Are Saying

Delivering you the simplest approach to meet your program's needs.

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When I think of Solubility Problems, I think of Serán.

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Consultant

Consultant, Multiple Clients
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Make a batch on time. Reliable CDMO, quality product within the timelines.

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Large Pharma

Large Pharma
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Customers come for the flexibility and stay for the dedication.

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Small Biotech

Small Biotech
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I’ve been impressed with Serán. One of the things we really look for is flexibility. They are a good combination of flexibility and technical competence.

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Medium Size Pharma

Medium Size Pharma
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The scientists we met at Serán were top notch.

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Large Pharma

Large Pharma