About

Biostudy Solutions is a pharmacokinetics and biostatistics consulting firm with clients across the globe.

Our staff has worked with hundreds of companies, helping them advance their generic and new drug submissions to U.S. and foreign regulatory authorities.

Depth of experience – combined with a vast partner network within the industry – allows BSS to provide complete solutions to a wide range of pharmacokinetic and statistical needs, including eCTD report preparation.

Biostudy Solutions bases its operation around the expertise of its founder, the late, legendary Chuck Bon. Since the company opened its doors in 2005, Chuck and his growing team of statisticians and scientists have built a solid name in the industry, not only in the United States and Canada, but around the world. In fact, their combined knowledge, versatility and experience have identified Biostudy Solutions as a leader for pharmacokinetic and biostatistics services.

Philosophy

When it comes to steering a drug product to market, our mission is to provide the best counsel as possible. If that means we handle the project in house, or refer to one of our many expert partners in the field, you’re joining an elite network with a proven track record.

Alison Baxendell

Manager, Biostatistics

Alison is a senior biostatistician providing pharmacokinetic and statistical evaluations and consulting services to Biostudy Solutions’ clients. Alison is deeply involved with sample size estimation for Clinical Equivalence trials. She holds a B.S. in Statistics from The University of North Carolina-Wilmington. After finishing her internship in May, 2012, Alison decided to stay with Biostudy Solutions full-time.

Charity del Sol

Senior Biostatistician

Charity is a Biostatistician that assists with providing pharmacokinetic and statistical evaluations and consulting services to Biostudy Solutions’ clients. She holds a B.S. with distinction in Mathematics and Statistics from The University of North Carolina-Wilmington. After completing her internship with PharPoint Research, Charity joined the team in 2015.

Jeff Knight

Senior Biostatistician

Jeff is a biostatistician providing pharmacokinetic and statistical evaluations services to Biostudy Solutions’ clients. In addition, he also assists with quality control, data entry and the creation of pilot and pivotal designs with PK endpoints. Jeff joined Biostudy Solutions in 2014 after serving in the United States Marine Corps where he was deployed twice and is a Purple Heart recipient. He holds a B.S in Statistics and a B.A in Mathematics from the University of North Carolina-Wilmington.

Steve Bon

President / Co-owner

Stephen focuses on business development, operations and client care. The son of founder Chuck Bon, Steve watched - and took plenty of notes – as his father built the incredible Biostudy Solutions team around his unwavering scientific principles. The two worked alongside each other for more than 17 years. Today, Steve's honored to carry on Chuck's legacy as one of the industry's brilliant statistical minds, with an even more-impressive heart.

Sarah Bon

Co-owner

Sarah focuses on business operations and client care. The daughter-in-law of Chuck -- and Steve's better half -- she makes sure the trains at Biostudy Solutions run on time. Together, the Bons proudly represent the name and character of their dad.

Charles "Chuck" Bon 

May 27, 1949 - June 18, 2024

President/Founder

Chuck launched his vision for Biostudy Solutions some 17 years ago. At the time, He set out to create a statistical firm that would lead the Pharma industry by way of critical thinking, data-driven enthusiasm and human warmth.

He built exceptional procedures and mentored a team of data-minded experts over the years. Though we’re saddened by his passing, were honored to continue the legacy of our leader.

As many of you know, Chuck could chat! Whether in person, by phone, or through the computer screen, he loved to talk science and life. All the same, he could listen — really listen. When you were in front of him, he was present in a way that’s very rare these days. In every conversation, he’d dig deep to relate — empathize if he could not — but always commit to lending value to the moment.

Scientific Advisory Board

Charles "Charlie" DiLiberti

President, Montclair Bioequivalence Services, LLC

Charlie DiLiberti has over 40 years’ experience in the pharmaceutical industry, much of which (17 years) was at Barr Laboratories (later acquired by Teva Pharmaceuticals). Charlie built and oversaw Barr’s cutting-edge bioequivalence and pharmacokinetics program for generic drugs, small molecule proprietary drugs, and biologics. Charlie left his position as Vice President of Biopharmaceutics at Teva Women’s Health Research in 2010 to start his own firm, Montclair Bioequivalence Services, LLC, which provides strategic consulting services around the world in generic, innovative, and biological drug development, biostudy planning/risk management, formulation development guidance, and advanced troubleshooting methods, with a focus on difficult/complex products. Charlie has given numerous public presentations, in the US and internationally, on a wide variety of topics, including pharmacokinetics, bioequivalence, BCS waivers, biosimilars, highly variable drugs, narrow therapeutic index drugs, complex drugs, locally-acting drugs, adaptive sequential bioequivalence designs, analytical chemistry, physicochemical characterization of biological products, generic drug development, etc. In 2018, along with several colleagues, Charlie co-founded Scientists Advancing Affordable Medicines, Inc. (SAAMnow). Charlie holds a BA in Biochemical Sciences from Princeton University and an MS in Chemistry from Stevens Institute of Technology.

Keith Gallicano, Ph.D.

Pharmaceutical Consultant

Keith Gallicano, Ph.D. (Chemistry) is a consultant in clinical pharmacology and biopharmaceutics with expertise in the areas of bioequivalence, drug-drug interactions, and pharmacokinetic, pharmacodynamic and clinical endpoint trial design and data analysis/interpretation. He has 36 years of diverse experience working in the pharmaceutical field, including various positions in government (Senior Research Scientist, Health Canada), academia (Assistant Professor of Medicine, University of Ottawa; Adjunct Professor of Pharmacology and Therapeutics, University of British Columbia), the pharmaceutical manufacturing industry (Head, Clinical and Regulatory Affairs, Axar Laboratories, Inc.; Director, Biopharmaceutics, Watson Laboratories, Inc.) and the CRO service industry (Chief Scientific Officer, Novum Pharmaceutical Research Services; Vice President, Research and Development, Axelson Biopharma Research, Inc.; Scientific Director, CroMedica Prime and Prime Trials). Dr. Gallicano has co-authored 80 publications, including research papers, reviews, and book chapters. He was a member of the Editorial Board of the Journal of Chromatography and the British Journal of Clinical Pharmacology. Dr. Gallicano has given numerous invited lectures on bioanalytical, pharmacokinetic, clinical and pharmacostatistical aspects of drug interaction and bioequivalence studies, as well as chaired or co-chaired international meetings on these topics. He is a Founder and President of Scientists Advancing Affordable Medicines (SAAMnow), which is a non-profit organization founded in 2018 that provides a dedicated platform for scientists to share cutting-edge research that facilitates the development and approval of high-quality affordable medicines.
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228 N Front St
Suite 302
Wilmington, NC 28401
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