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 needs 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 cited 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.

Rod Ketner, Ph.D. joined Serán in early 2022 as Vice President of Business Operations. Rod heads Serán’s business development, marketing, and business operations teams, helping to bridge the gap between science and business in Serán’s day-to-day operations.

Dr. Ketner has nearly three decades of pharmaceutical drug product expertise and business development leadership. In his early career at Bend Research, he contributed to spray dried dispersion (SDD) formulations and stability innovations resulting in inventorship on more than 18 drug delivery patents.    He holds a B.S. in Chemistry (Fresno State University), a Ph.D. in Physical Organic Chemistry (UC Santa Cruz), and a post-doctoral fellowship at UC Berkeley.

Heather Hansen, J.D. is Serán’s Vice President of Corporate & Legal Affairs. 

Heather received her Juris Doctorate from the University of Oregon and has over two decades of experience in corporate law. Before joining Serán she was a shareholder and co-managing partner with the firm of Bryant Lovlien & Jarvis, and previous to that position she was a shareholder with the regional firm of Schwabe, Williamson & Wyatt.

As VP of Corporate and Legal Affairs Heather provides legal guidance and innovative solutions to drive the organization forward and assists in supervising legal and human resources matters. She also proactively engages with Serán’s clients to ensure a good customer experience and oversees Serán’s legal, human resources, and administrative teams. 

Anthony Georger joined the Serán team in 2022 as the Vice President of Finance & Accounting.  Anthony has more than 15 years of experience as a senior accounting executive managing internal auditing, cost accounting, benefits administration, budgeting, and long-term strategy implementation.  

In his previous role with United Technologies, Anthony led his department's SAP Implementation and oversaw the administration and accounting for dozens of Cost Plus and Fixed Price Contracts with the US Navy, US Air Force, and the New York Air National Guard.  

Anthony’s role at Seràn entails forecasting, budgeting, strategic planning, and cash management. His team manages accounts payable, accounts receivable, and treasury functions across Serán.

Anthony holds a B.S. in Finance from the University of Idaho and an MBA from Western Washington University.  

Vadim Eristavi joined Serán BioScience as Vice President of Quality (QA/QC) in 2022. As VP of Quality. Vadim leads both our Quality Control and Quality Assurance teams and is pivotal in our expanding our quality department.

Vadim has more than 25 years of experience in the biopharmaceutical industry, providing QA/QC oversight for CMO operations, with direct experience establishing Quality programs for clinical trials, completing commercial product transfers, and working with regulatory inspection teams. He played a lead role as a Global External Quality Emerging Markets lead at Roche/Genentech, where he was responsible for successful product launches, technology and method transfers, and in-licensing activities within Roche's commercial supplier network.

Vadim holds an MS in Chemical Engineering from the Georgian Technical University in the Republic of Georgia and an MBA degree in International Business from Lincoln University in San Francisco, California.

Erica Schlesinger is Serán’s Vice President of Technical Development. She leads a team that applies scientific rationale and engineering design to problem-solving and pharmaceutical product development. Her research interests include spray-dried biologics (mAb, Phage, Virus, Whole Cells) and controlled-release technologies for long-acting therapeutics.

Erica has over 15 years of experience in pharmaceutical formulation development, process chemistry, and the early-stage development of novel drug delivery systems, and prior to joining Serán, she worked at Genentech, Seattle Genetics, and Regeneron.

Erica holds an undergraduate degree in Chemical Engineering from Cornell University and a Ph.D. in Bioengineering from the Joint Graduate Group in Bioengineering at the University of California San Francisco and UC Berkeley.

Randy is VP; Drug Product Fellow at Serán. In this role, he leads a team that develops formulations, technologies, and manufacturing processes for immediate and modified-release dosage forms. 

The first 23 years of Randy's career were at Upjohn, during which the company navigated several mergers including Pharmacia & Upjohn, Pharmacia, and Pfizer. Throughout his tenure at Upjohn/Pharmacia/Pfizer, Randy focused on modified release approaches and poorly soluble drug delivery. Randy's responsibilities included adapting and developing new technologies, preclinical and clinical-stage product development, and commercial scale-up and production support both internally and at CMOs.   

Randy then moved out West to join Bend Research, which was eventually acquired by Capsugel and then Lonza.  During his 13-year career at Bend Research/Capsugel, Randy served in various roles as scientist, director, and research fellow. His achievements included establishing and building Bend Research/Capsugel's oral solid dosage form and clinical manufacturing capabilities, as well as developing enabling technologies for drug products spanning preclinical, clinical, and commercial scaleup.   

Following his tenure at Bend Research/Capsugel, Randy devoted the next two years to working on FDA and NIH grant projects involving multi-stage biorelevant dissolution, microneedles, and inhalation products at the University of Michigan Pharmaceutical Sciences department and TSRL. Inc.

After wrapping up his work at Michigan and TSRL, Randy joined Serán in 2019. He holds a BS in Pharmacy from the University of Minnesota.

James joined Serán BioScience in early 2022 as Senior Director for Product Commercialization to support our leadership in building Seran’s commercial manufacturing capabilities (facility/process)—a critical element in positioning Serán as a complete turnkey CDMO.  

Since joining Serán, his role has been expanded to building the Manufacturing, Science and Technology group, which is the team responsible for supporting the current clinical operations, and to accelerate the development of technical and validation programs. Specifically for technical transfer and scale-up of Phase 2/3 clinical processes to the commercial facility. 

James has over 30 years of pharmaceutical experience working with global Brand and Generic companies (Syntex, Roche, Schein-Watson, Actavis, Purdue Pharma and Dechra).  He began his career in manufacturing operations, and then transitioned to the technical services and validation section; where he worked closely with the Development group as well as other key cross-functional teams involved in new product introduction projects, multi-site technical integration, and process optimization. James holds a Bachelor of Science in Industrial Engineering and has held leadership roles in Manufacturing Operations, Pharmaceutical Technical Services, Validation, and Quality. 

Mark Kastantin is the Senior Director of Process Engineering and Head of Innovations Research at Serán. In this role, he leads the team that conducts particle engineering and process development studies.  He is heavily involved in the development of new technologies and processes. 

After an NIH postdoctoral fellowship and a term as an Assistant Research Professor at the University of Colorado, Mark took a position at Lonza to lead a team in early-phase process development.

He has published over 30 peer-reviewed articles in diverse fields including protein behavior at interfaces, microfabrication techniques, polymer physics, and single-molecule microscopy.

Mark graduated from MIT in 2003 with dual degrees in chemical engineering and brain and cognitive sciences. He also holds a Ph.D. in chemical engineering from the University of California (Santa Barbara) with a focus in self-assembled nanoparticles that mimic protein-like behaviors.

Laura Wilke is Senior Director of Project Management at Serán and a key member of Serán’s management team.   The team she leads plays an essential role to the success of Serán’s client’s programs by interacting effectively and transparently with both internal and external stakeholders to advance our clients new medicines.  

Prior to joining Serán, Laura spent 25 years at Lonza (formerly Bend Research/Capsugel) where she started her career as a research chemist synthesizing novel materials before transitioning into the pharmaceutical research and development industry.  Laura played an integral role in developing new drug delivery technologies and test methodologies across multiple platforms to successfully formulate challenging compounds.  As she grew in her career and developed an interest in serving a role where she could support a project from initiation through completion, she transitioned into project and client management, where she has since held positions of increasing responsibility.  

Mandy Galarza is the Senior Director of Quality Assurance at Serán. She has the distinction of being the very first employee hired at Serán. In her role, she helped build and implement the quality management system (QMS) and oversees its continuous improvement. She personally manages quality inspections and audits and communicates performance of the QMS to all levels of management.

Mandy began her pharma career in the quality control laboratory of a well-known CDMO. This led to a position on their pre-approval inspection team. She has had high-level participation in worldwide regulatory inspections as a member of that Company’s quality assurance department and the approval of its first commercial product.