Dan Smithey

About Dan Smithey

Our passion at Serán is providing optimum solutions to our client’s pharmaceutical…

Experience

1. President, CEO and Founder

   Serán BioScience

   Jan 2016 — Present

   Serán is a science-focused Contract Development and Manufacturing Organization specializing in preclinical and clinical development of therapeutic compounds. Serán’s goal is to define, design, and develop the optimum drug product for our clients and their patients. We utilize state-of-the-art approaches to substantially reduce development time and cost through optimum chemistry, formulation, and manufacturing. • Development of optimal approach for therapeutic product profile • API characterization services to guide formulation development • cGMP production of clinical trial materials, including capsules, tablets, suspensions, sachets and engineered particles. • Development and cGMP production of pediatric formulations and multiparticulates. • Pharmaceutical development guidance and project management, including Discovery support, ADMET, PBPK modeling, process design and understanding, formulation, and cGMP support. • Design of NCEs with optimum and patentable structures using in-house laboratory and external collaborations. Development of these NCEs from Lead Seeking through Clinical. • Formulation of difficult-to-deliver, low-solubility, poorly permeable, and poorly stable compounds for preclinical toxicology, PK, and PD studies. • Re-formulation of compounds that are in the clinic and on the market to extend exclusivity and minimize time and cost to market. • Reducing pharmaceutical development time and cost using a comprehensive optimization platform that simultaneously identifies compounds and formulations that are stable, have acceptable metabolism, are safe, are highly absorbed, have optimum PK, and yield valuable IP. • Due Diligence assessment for potential acquisitions. Assistance with IP strategies. • Expertise in project management of complex R&D programs • Market/Competitive analysis