Mission

BioData Solutions, LLC aims to brings safer and innovative drugs to the market faster.

Vision

BioData Solutions, LLC provides appropriate strategic and developmental guidance along with high-quality data to improve pharmaceutical decision-making during drug discovery, development, and post-market approval.

Values

The Why:

• Uncompromising decision making to bring safer drugs to the market faster

The How:

• Develop & incorporate new technology: Find innovative solutions to achieve efficiencies in bioanalytical processes
• Teamwork and collaboration: We achieve more and find more robust solutions when we work together as a team
• Invest in our employees: Value and develop our employees’ talents, encourage new initiatives and inculcate leadership skills

The What:

• We deliver results efficiently and with proficiency
• Compliance and Security: We understand the importance of security and compliance for your data and incorporate regulatory guidance and security frameworks at the root of every program and every decision
• Integrity: We build trust by incorporating integrity in our actions and data
• Teamwork and collaboration: We achieve more and find more robust solutions when we work together as a team

Anthony Chilton, PhD

Dr. Chilton has over 30 years of experience in drug development and senior leadership in the life sciences industry. With a career spanning more than 20 years in contract service and innovative pharma companies, he has gained exceptional operational and regulatory experience in Canada, US and Europe as well as led several bioanalytical/DMPK programs. Drawing on his expertise, as a consultant at BioData Solutions, he supports a variety of large and small molecule bioanalytical programs, including biomarker assay development, managing challenging method development, validation, resolving technical and regulatory issues in non-clinical pre-IND and clinical programs for Alzheimers, TB, Cystic Fibrosis, pediatric renal disease, atherosclerosis and diabetes.

Most recently, he served as the President/CEO of a midsize public traded CRO that provided bioanalytical, toxicology and pharmaceutical development services. Previously, during his 15-year tenure at Glaxo Group Research UK (now GSK), Dr. Chilton was involved in ADME/bioanalytical support to drug discovery, preclinical and early clinical phase development programs, working with new compounds in various therapeutic areas, including but not limited to Gastrointestinal, Pulmonary, and Cardiovascular. He played a key role in introducing bioanalytical applications of LC-MS/MS to support Research and Development functions at Glaxo.

Katelyn Crizer, PhD

Katey Crizer, PhD is a Senior Consultant at BioData Solutions, specializing in bioanalysis. With experience in management of bioanalytical programs spanning from discovery to regulated analysis of small and large molecules alike, she is passionate about bringing treatments to patients, particularly in the areas of rare diseases.

She currently serves as a bioanalytical consultant on programs utilizing LBA and hybrid LBA-LC‐MS/MS approaches to quantify large molecules, nanoparticles, and antibody-drug conjugates. She also brings subject matter expertise on small molecule LC-MS/MS programs from method development through validation and sample analysis.

Prior to joining BioData Solutions, Dr. Crizer worked at pharmaceutical and biotechnology companies, including Novan Inc, Roivant Sciences, and Altavant Sciences, where she oversaw bioanalysis programs from early discovery through clinical trials and focused on the development of biomarker assays, including method development and fit-for-purpose validation. During this time, she also worked in nonclinical research, including overseeing early toxicology studies and designing and implementing nonclinical pharmacology studies.

She earned her PhD in analytical chemistry at the University of North Carolina, Chapel Hill and a BS in chemistry at the University of Richmond.

Luca C. Matassa, PhD

Dr. Matassa is a Consultant at BioData Solutions. He has nearly 30 years of experience in the CRO and pharmaceutical industry including leadership roles in science, project & operational management, P&L management, process improvement, outsourcing and business development in the bioanalytical laboratory in support of pre-clinical (GLP & non-GLP) and clinical (small & large molecule) studies and in drug development.

He also serves as the Chief Operating Officer (COO) at Vision Bioanalytics, LLC. In his previous positions as the VP of Bioanalytical & Client Services at Frontage Labs and Vice President Bioanalytical and Global Head of Process Development of QPS, LLC, he was responsible for overall management of P&L including overall program management, process improvement, client interaction, and financial and strategic goals. Prior to these roles, he had established bioanalytical labs and led several teams to provide senior-level scientific, operational, regulatory and management leadership in contracting and monitoring clinical bioanalysis studies for small and large molecules alike. He has contributed his knowledge and expertise to the community by publishing numerous scientific papers, posters, and publications focused primarily on the bioanalytical laboratory and the use of LC-MS/MS for quantitative bioanalysis.

Dr. Matassa earned his Doctorate in Organic Chemistry from the University of Windsor, Ontario, Canada in 1989.

Stephanie Pasas-Farmer, PhD

Stephanie Pasas-Farmer, PhD is a recognized bioanalytical expert in the areas of discovery and regulated bioanalysis for pharmaceutical, biologics and hybrid technologies, including antibody-drug conjugate technology. Relying on insights gained over a 20-year career focused on bioanalytical operations across global biopharmaceutical companies, contract research organizations and consulting, Stephanie founded Ariadne Software in 2018 and led development of Red Thread, guiding it from inception to production as an artificial intelligence (AI)-enabled solution for common challenges in bioanalytical data review.

Prior to Ariadne Software, Stephanie created BioData Solutions, a scientific advisor firm whose aim is to help sponsors advance early-stage molecules into potential new drug candidates with bioanalysis support and regulatory compliance planning. Before founding BioData Solutions, she led a team of scientists at a global bioanalytical laboratory focused on the support of large molecule and antibody drug conjugate programs using LBA, LC‐MS/MS, and cell-based assays. Earlier career roles included management responsibility for quality control functions of bioanalytical laboratory operations, in addition to business development and research scientist positions.

Stephanie earned her PhD and MSc degrees with honors in pharmaceutical chemistry from the University of Kansas. She received a BS degree in chemistry from St. Mary’s College of Notre Dame.

Sarah Raper

Sarah Raper is a Bioanalytical Consultant at BioData Solutions.  She has 12 years of GxP assay development, qualification, and execution experience in all areas of the biotechnology industry (with 5+ years being in the pharmaceutical industry).  With a focus on protein biochemistry and molecular biology, she has worked for large and small organizations alike.
With an extensive experience in the execution of bioanalytical assays to the group, she offers an eye for bench level engineering controls to ensure the highest quality bioanalytical assays are being developed for clients.  She also has an eye for scientific detail in written protocols, SOPs, and data presentations.

She graduated, with honors, with a BSc in Molecular Biology and a minor in Chemistry from Meredith College.

Gwen Wise-Blackman, PhD

Dr. Wise-Blackman is a consultant and project lead at BioData Solutions. Her attention is devoted to providing guidance to small and large biotechnology and pharmaceutical companies in support of drug development. Her work includes supporting regulatory approval of large molecule therapeutics.

She has over 24 years of experience in both mid-size pharma companies and contract research organizations. She has led detail-oriented teams to successful completion of client projects. Her focus is on pharmacokinetic (PK), pharmacodynamic (PD) biomarker, immunogenicity, neutralizing antibody, and cell-based assays.

Dr. Wise-Blackman earned her Doctor of Philosophy degree in pharmacology from the University of Virginia. She received her Bachelor of Science in Biology from the Massachusetts Institute of Technology.
She is a sought-after trainer for bioanalytical method development and validation, technology transfer, and implementing process controls for challenging cell-based assays.

Ruth Ziegler

Ruth Ziegler is a bioanalytical consultant at BioData Solutions.  She brings 5 years’ experience in the bioanalytical industry supporting drug development and regulated work.  Her background includes bench-top laboratory experience where she helped develop and validate small molecule (LC-MS/MS) assays as well as analyze samples for different sponsor studies, quality control review of data and documentation, and report writing of method validations and bioanalytical reports in a contract research organization (CRO) setting.  Her current role as a consultant includes supporting the lead, senior consultants on clinical and non-clinical bioanalytical programs, as well as providing program oversight, assisting in technical audits of laboratory vendors, reviewing bioanalytical data, documentation, and reports for quality and regulatory compliance.

Ruth earned her bachelor’s degree in biology (B.S.) at Neumann University and her master’s degree in public health (MPH) from West Chester University of Pennsylvania.