Dr. Susan Bogdanowich-Knipp began collaborating with Improved Pharma as a scientific consultant shortly after establishing Ravine Pharmaceuticals, LLC in 2020. Dr. Bogdanowich-Knipp’s previous experience includes having held high profile scientific positions in both widely-recognized large pharmaceutical and outsourcing companies for over twenty-five years. Most recently, she was the Director of Analytical Technology at AMRI SSCI LLC where she was responsible for supporting SSCI’s well-known solid state analytical characterization testing for the site. Previous experience includes scientific positions in Discovery Support & Pharmaceutical Chemistry at Schering-Plough Research Institute and Analytical R&D at Bristol-Myers Squibb Corporation where Dr. Bogdanowich-Knipp supported pre-formulation, development, and both chemical and physical analytical characterization for drug substances and drug products ranging from discovery to Phase II clinical studies for both small and large drug molecules.
After joining Improved Pharma’s consulting team, Dr. Bogdanowich-Knipp stated “I am thrilled to be working again with Dr. Stephen Byrn, as well as Drs. Smith, Cowans and Purcell.” She adds, “our years of experience working together and our strong, complimentary yet diverse scientific backgrounds will enable us to address challenging problems encountered by our clients”.
Dale K. Purcell, Ph.D., has over 22 years of experience related to analyses of materials often on the order of milligram or less quantities in regulated laboratory setting of cGMP, FDA, ISO, EPA and DEA. He has expertise in a wide-range of microscopy and microspectroscopy techniques and applications. Dr. Purcell was a Visiting Scientist, sponsored by Oak Ridge Institute for Science and Education (ORISE), at the Counterterrorism and Forensic Science Research Unit (CFSRU) in the Laboratory Division of the Federal Bureau of Investigation, Quantico, Virginia, where he performed collaborative research to develop procedures using cathodoluminescence light microscopy and scanning electron microscopy with energy dispersive x-ray microanalysis. Dr. Purcell started his private consulting business in 2011 to assist with providing legal services to indigent persons charged with criminal offenses. In 2015, Dr. Purcell joined the Analytical Technology team at AMRI SSCI LLC as group lead for their Analytical Chemical Microscopy and Microanalysis. Dr. Purcell has provided assistance in Hatch-Waxman (pharmaceutical patent) litigation and Markman Hearing support. His research interests include thermomicroscopy and polymorphisms, glass delamination, identification of unknown foreign particulate materials, and efficient analytical microspectroscopy methods.
Dr. Brett Cowans brings thirty years of experience as a solid-state analytical chemist including over twenty years serving the pharmaceutical industry as an expert in the solid forms of small molecules, i.e. polymorphs, salts and cocrystals.
Ruba brings expertise in regulatory and quality compliance along with hands-on experience in microbiology, cell culture, molecular biology, protein purification, Raman spectroscopy and chemometrics. She started independent consulting work right after getting her second MS degree from Stephen Byrn’s lab in 2015, applying multivariant analyses and spectroscopy to answer questions in Bioanalytics.
Her graduate work at Virginia Tech focused on protein purification and characterization. At Purdue, she expanded into drug discovery utilizing mammalian and bacterial cell cultures for screening, in addition to drug monitoring and quality control. For the last five years, Ruba was with SSCI, the solid-state research company founded by Dr. Byrn in 1991. She managed solid-state analytical projects, developed analytical methods, and cultivated a reputation for delivery of results and customer satisfaction.
Stephan Parent has more than two decades of solid-state chemistry experience in numerous scientific and management roles. As an expert who specializes in both early and late stage pharmaceutical development and assists in intellectual property protection, Stephan has successfully helped develop more than 400 active pharmaceutical ingredients (API) and published more than 50 patents and patent applications on crystallization engineering and solid form science.
His work encompasses polymorph, salt, and cocrystal screening, crystallization process development and optimization, chiral resolution through salt screening, solid-state characterization, and ternary phase diagram development. Stephan received his BS in Chemical Engineering from Purdue University. Currently, as the founder and owner of Solsta Consulting LLC, Stephan provides consulting services to clients in the pharmaceutical and natural product industry.
Dr. Leonard “Len” Chyall brings to Improved Pharma over 20 years of experience as an organic chemist and pharmaceutical researcher. Len has extensive expertise in the identification, characterization, and development of solid forms of pharmaceutical drug substances, including polymorph, salt and cocrystal screening technologies. He is highly competent in a variety of techniques used to characterize pharmaceutical products, with particular emphasis on those used for solid materials. In addition, Len has substantial expertise in the area of pharmaceutical formulations and the manufacture of drug substances.
Prior to joining Improved Pharma, Len worked for over a decade as a pharmaceutical research chemist at SSCI, Inc. and then at Aptuit Consulting as a research chemist, project manager and business leader. He subsequently founded Chyall Pharma, where he continues to provide research and consulting services to the pharmaceutical industry. Len received an AB from Oberlin College with a major in chemistry, and a Ph.D. in chemistry from the University of Minnesota. Len was a postdoctoral fellow in the chemistry department at Purdue University. He has authored or co-authored 23 publications in peer-reviewed scientific journals, and is a co-inventor on five patents granted by the United States Patent and Trademark Office. Len has also testified as an expert witness in United States courts and abroad.
John brings 20 years of experience in the pharmaceutical industry, specializing in UPLC / HPLC and LC-MS/MS method development and characterization of APIs, drug products, and biologics. He also has significant experience in reverse-engineering, investigational testing, and structural elucidation of unknowns.
John received his Ph.D. in Physical Chemistry from Purdue University and immediately began his career in the pharmaceutical industry by joining BASi where he honed his skills in the analysis of early discovery candidates, APIs, peptides and endogenous compounds extracted from biological and non-biological matrices. In 2012, he moved to SSCI (now called Curia) where he obtained the bulk of his experience in solving problems for pharmaceutical clients at all stages of development, including litigation support and testing for intellectual property protection.
“Solid state chemistry is the underpinning of many of the most exciting advancements in drug development and quality in the past two decades. By utilizing synchrotron technology many new advances are possible, as we move into a new golden age of pharmaceuticals and attack many of the most difficult and troublesome diseases. By attacking these diseases, we have a chance to improve longevity and quality of life on a global scale”
Solid-State Form Studies
“Strategies for understanding the solid-state landscape of a drug”
Analytical Testing Services
“Testing, understanding, monitoring, and controlling drug development”
Microscopy
“Combining microscopy and analytical instrumentation to probe drug substances and
products on a micron level”