Dr. Nalamothu earned his doctoral degree in Pharmaceutics from University of the Science’s Philadelphia College of Pharmacy working under Dr. Joseph Schwartz and Dr. Rod Wigent. Prior to Tergus, he was employed with Promius Pharma, a wholly owned subsidiary of Dr. Reddy’s Laboratories, Inc., as the Global Head of Dermatology R&D. He spearheaded the development of specialty branded dermatological products from concept to commercialization including various human clinical trials in US, Europe and India. His interests include novel dosage form design and development of topical drug products, developing new disease models in animals, designing proof of concept studies in humans, animal toxicology studies, human clinical trials, and process scale-up and manufacturing. Prior to joining Promius, he served as the Head of Early Compound Assessment and Preclinical group for Sanofi-aventis Worldwide Dermatology (Dermik). His efforts over the last 18 years in various dermatological companies have led to many commercial products in the market today. His passion is to develop products that speak for themselves and provide valuable marketplace differentiations.
Dr. Nalamothu draws from this exceptional educational background that combined scientific study with pragmatic, hands-on experience to solve R&D challenges. He has co/authored numerous publications and has patents for a few of his inventions. He serves as a member of the Society for Investigative Dermatology and the American Association of Pharmaceutical Sciences and Controlled Release Society. Dr. Nalamothu also serves on the board of few Pharmaceutical and Technology companies and is a member of several pharmaceutical research focus and discussion groups.
Kailas Thakker, Ph.D. – Co-Founder
Dr. Thakker earned her PhD in Pharmaceutical Chemistry at the University of Kansas working under Dr. Higuchi. She worked at US Pharmacopeia for 12 years, where she specialized in the development and validation of dissolution methods in the Drug Research and Testing Laboratory. Subsequently, Dr. Thakker held leadership positions at Sphinx Pharmaceuticals and BioAnalytika Laboratories. In 1994, Dr. Thakker exploited her years of experience evaluating drug product performance and leading analytical organizations to launch Analytical Solutions, Inc. (later to become Tergus) with a mission to provide quality analytical services to the pharmaceutical industry. With the emergence of newer, alternative dosage forms over the past 10 years, she has surfaced as a well-recognized global leader in the development of topical drug products, providing expertise in the development and validation of performance tests used to evaluate the transport of drugs across skin and other membranes (e.g., buccal, sublingual, vaginal, rectal). Working with compendial and regulatory organizations, Dr. Thakker continues to strive toward improving public standards for topical and other dosage forms.
Since 1994, Dr. Thakker, has also had a focus on functional testing for semisolids. She has been involved with developing In Vitro Release Test (IVRT) methods for semisolid dosage forms. Her work was helpful to many of sponsors and ultimately led to the development of the SUPAC-SS guidance document that the pharmaceutical industry follows now. As a result of her pioneering work, Tergus has emerged as a leader in developing release rate methods for semisolid dosage forms. As a member of USP’s Advisory Panel to the then Biopharmaceutics Expert Committee, she helped draft chapters <3> and <1724>. Her efforts and commitments in helping to develop and maintain public standards for the semisolid dosage forms remains firm to date, and she is committed to continue these efforts as a newly elected member of USP’s Expert Committee on Dosage Forms for the revision cycle 2010-2015.
Ryan Klein, Ph.D., Director, R&D
Dr. Klein earned his bachelor’s degree in Chemistry from Wake Forest University and his doctoral degree in Pharmaceutical Sciences from the School of Pharmacy at the University of North Carolina at Chapel Hill. He has over seventeen years of experience in the pharmaceutical industry and is classically trained in drug metabolism and pharmacokinetics. Ryan has a strong analytical background with extensive experience developing and validating in vitro release testing methods, as well as HPLC assay and impurities methods for drug substance and drug products for various dosage forms.
During his fourteen years at GlaxoSmithKline, he was an integral component of their drug discovery organization designing and interpreting pre-clinical in vivo pharmacokinetic and in vitro ADME studies. He was instrumental in the development and implementation of a number of in vitro and in situ models to assess drug absorption, metabolism, and disposition. His areas of expertise include drug permeability, absorption and metabolism in the skin and gastrointestinal tract, intestinal drug transporters, and the anatomy, physiology, and pharmacology of the skin and gastrointestinal tract.
Ryan has authored/co-authored numerous scientific publications and patents, serves as a member of the American Association of Pharmaceutical Sciences as well as several pharmaceutical research focus and discussion groups.
Michael Branciforti – Vice President, Business Development
Mr. Branciforti earned his analytical chemistry degree from the State University of New York at Oneonta and is a veteran of the United States Marine Corps. Michael has extensive experience within the contract laboratory services and drug development field including business development, project management, proposal management, finance, and operations. Prior to Tergus, he was employed with AndersonBrecon, a wholly owned subsidiary of AmerisourceBergen, as Senior Director Business Development for their Laboratory Services Division.
Jeff Reynolds, Senior Manager, R&D
Jeffrey Reynolds heads the product development and clinical supplies manufacturing groups at Tergus. Jeff has supported many phases of drug product development including early phase pre-IND to phase I/II/II clinicals, and life cycle management and post approval support. He has worked with small, medium, and large companies, including GlaxoSmithKline, Church & Dwight, and KIK Custom Products. He is co-inventor on two patents, a number of patents-pending and has co-authored one article. His professional experience includes research and development of many types of pharmaceutical dosage forms including, solid and semi-solid across a broad spectrum of therapeutic areas (dermatology, GI, CNS, URT). Jeff brings a broad base of practical knowledge and experience with close to 30 years of professional experience combined with a strong academic background, which enables him to drive for solutions in both the scientific and management arenas. Jeff is a member of the AAPS, the SCC, and Delta Mu Delta as well as having served as an executive board member for the aerosol products division of the CSPA.
Larry Diesbach, MBA – Director of Quality Assurance & Compliance
Larry earned his Master in Business Administration degree from Campbell University in Buies Creek NC and a BS in Industrial Management from Washington University in St. Louis, MO. He has 30+ years of experience in the pharmaceutical industry both in Quality Assurance / Regulatory and Operations. The majority of his career has been associated with topical dosage forms (creams/gels and aerosols) with GSK and Merz Pharmaceuticals. He is the former Vice President of Quality Assurance and Regulatory Affairs for Brightstone Inc (division of SkyePharma) and Amarin Pharmaceuticals.