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

Stephanie Pasas-Farmer, PhD

Founder and President

Expertise: Cell and Gene Therapy, Large Molecule, Laboratory Buildout, and Business Strategy

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.

Gwen Wise-Blackman, PhD

Senior Advisor

Expertise: Large Molecule, Cell-Based Assays, Laboratory Buildout, and Scientific Training

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.

Katelyn Crizer, PhD

Advisor

Expertise: Small and Large Molecule and Vendor Management

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.

Ruth Ziegler

Associate Advisor

Expertise: Small and Large Molecule Quality Control (Consulting and Software) and Vendor Management

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.

Sarah Raper

Associate Advisor

Expertise: Cell and Gene Therapy Products and Large Molecule Quality Control and Project Management

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.

Charles Gu, PhD

Biostatistician

Expertise: Mixed-effect models, Design of experiment, Nonparametric statistics

Charles Gu, PhD, is a dedicated biostatistician with a passion for utilizing statistical methods to drive impactful decisions in the fields of healthcare and life sciences. With a profound understanding of both statistical theory and practical applications, Dr. Gu specializes in designing experiments, analyzing complex data sets, and interpreting results to support evidence-based decision-making.

He holds a PhD in Statistics from Western Michigan University, where he developed a strong foundation in statistical methodologies and research practices. Before graduating, he gained practical experience as a biostatistician intern at Charles River Laboratory, where he supported several preclinical statistical analyses.

After joining Biodata Solutions, Dr. Gu has supported multiple consulting projects, including comparability studies, outlier detections, and in-vivo and in-vitro studies. His expertise includes multivariable regression, survival analysis, mixed-effects models, and mixture models, which he has applied to various projects.

He also supports the software division of the company, in charge of the cut-point analysis module and is now in the process of developing the random effects model for cut-point analysis. In addition to his technical abilities, his knack for translating complex statistical concepts into actionable insights has been instrumental in driving the success of numerous projects.

Kaia Sartori

Senior Advisor

Expertise: Cell and Gene Therapy Products, Large Molecule, Laboratory Buildout, and Regulatory Submission Strategy/Document Preparation

An expert in Bioanalysis with over 22 years of experience in the pharmaceutical industry, including previous roles in both large pharmaceutical companies, biotechnology companies, and CROs.  Currently, I am a Senior Advisor at BioData Solutions specializing in Bioanalytical Strategies, Lab Operations, Laboratory Construction, Business Strategies, and Regulatory Strategy and Response. Former site-head and Vice-President of Bioanalysis and Biomarkers for Amador Bioscience and former Head of CA-GxP Laboratory for AstraZeneca. Led Bioanalysis Strategy of numerous large molecules and Global Submission for AstraZeneca, including 8 new drug approvals from 2020-2022.

Anthony Chilton, PhD

Senior Advisor

Expertise: Small Molecule and Biomarker

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.

Luca C. Matassa, PhD

Senior Advisor

Expertise: Small/Large Molecule, Oligonucleotide and Vendor Assessment

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.

Shailesh Pandey

Director of Software Development

Expertise: Solutions architecture and software development, AI, and Security, compliance, and validation

Shailesh Pandey is a Software Architect/Director. He focuses on developing machine learning systems and models and implementing appropriate architecture to drive and support business solutions. Shailesh brings expertise in natural language processing, image processing and deep knowledge of cloud-based big data technologies. His background includes a range of software development projects supporting insurance industries, government and civic operations and academia with data governance, predictive analytics and high throughput stream processing.

Shailesh earned dual master’s degrees in data analytics and computers from Pennsylvania State University and Birla Institute of Technology, respectively.

Melissa McGuigan

Director of Quality Control and Data Analysis

Expertise: Drug discovery and development, GMP manufacturing compliance and regulation, and Quality control and technical writing

Melissa McGuigan is the Director of Quality Control and Data Analysis. With over 15 years of related industry experience in a contract research organization setting, Melissa has a profound understanding of regulatory requirements in the field of bioanalysis for drug development. She is committed to providing her professional expertise for ensuring the highest level of quality and compliance at all stages of drug development.

Melissa earned her BS degree in chemistry from Ursinus College.

Liam Heins

Senior Application Developer

Expertise: Application Development, Project Management, Technical Sales

Liam Heins is a Senior Software Developer at BioData Solutions. Leveraging his 7 years of experience in software development, he currently leads development on the cut point and sensitivity module of Red Thread and supports other projects related to automating statistical analysis of assay data, including tools for non-linear regression and random effects models. He also provides expertise in application and data security, modern DevOps workflows, and cloud services to design and manage fast and compliant software solutions for our clients.

Previously to joining BioData Solutions, he worked in web development for large scale ecommerce businesses, managing database operations and ETL solutions. He also built performance-oriented applications for the purposes of scientific computing and simulation in the field of evolutionary biology.
He earned his bachelor’s degree (B.A.) from the University of Chicago.

Allie Renfro

Junior Application Developer

Expertise: Software development and customer support

Allie is a Junior Application Developer at BioData Solutions. She helps maintain existing Red Thread modules, develop new features, and provides support to Red Thread users.

Allie is passionate about building software that makes life easier while maintaining high quality, reliable operations. Before joining BioData Solutions, she played a crucial role in designing and building software to automate data collection and retrieval processes for biological field samples during a research experience for undergraduates (REU) at Baker University. She joined the BioData team as an intern, and now contributes to aspects of development from documenting and developing new features to testing and validation.

Allie earned her BS in mathematics and computer science from Baker University in 2023.

Brittany Taylor, MBA

Head of Operations

Expertise: Strategic planning, Operations, and Marketing

Brittany Taylor serves as the Head of Operations for BioData Solutions. With past experience in strategic planning, operations, and marketing, her primary goal is to continuously improve internal processes and company efficiency.

Prior to joining the team at BioData Solutions, Brittany served as the marketing director for a non-profit agency, as well as the head of operations for a marketing firm in the financial services space. Additionally, Brittany has worked in the international youth exchange industry for the past 10 years and enjoys coaching a variety of youth sports.
She earned her bachelor’s degree in English Literature (B.A.) at Washburn University, and her master’s degree in business administration (MBA) from Baker University.

Rashi Jain, MSTC

Head of Marketing and Product Management

Expertise: Market assessment, Product launch and commercialization, and Product and marketing strategy and management

Rashi Jain brings nearly 15 years of experience to the business side of the biotechnology industry, and is dedicated to fostering innovation and market success. She excels in product management and marketing, driving successful product launches and market expansions, especially in startups and early-stage organizations. Rashi’s expertise in technology and market assessments contributes significantly to scalability and organizational growth. Currently serving as the Director of Marketing and Software Product Management at BioData Solutions, she also plays a crucial role in ensuring compliance, security, and validation within the organization.