Alliance Pharma has hired Dr. Ryan Klein as Director of Business Development. Dr. Klein has more than 20 years of experience in the pharmaceutical industry developing both oral and topical dosage forms for a range of indications. Dr. Klein began his career at GlaxoSmithKline, where he was an integral component of their drug discovery organization providing drug metabolism and pharmacokinetic expertise to project teams. He was instrumental in the development and implementation of a number of in vitro and in situ ADME models to assess drug absorption, metabolism, and disposition.

After leaving GSK, Dr. Klein joined Tergus Pharma, a CRO providing topical R&D services to the pharmaceutical industry. At Tergus, Ryan filled various roles including leadership positions as the Head of Research & Development and Head of In Vitro Sciences, as the company grew from five employees to approximately seventy five over a seven year period.

Dr. Klein’s areas of expertise include drug permeability, absorption and metabolism in the gastrointestinal tract, liver and skin, intestinal drug transporters, and the anatomy, physiology, and pharmacology of the skin and GI tract. He also has a strong analytical background with extensive experience developing and validating in vitro release testing methods for semi-solid dosage forms, as well as developing and validating HPLC assay and impurities methods.

Leveraging Dr. Klein’s experience on the client side allows Alliance Pharma to collaborate on a higher level with Sponsors, using his in-depth knowledge and vast experience to align the best team of scientists to support each project.

Ryan earned his bachelor’s degree in Chemistry from Wake Forest University in Winston-Salem, North Carolina, and earned his doctoral degree in Pharmaceutical Sciences from the School of Pharmacy at the University of North Carolina at Chapel Hill. Ryan has authored & co-authored numerous scientific publications and patents, and serves as a member of several pharmaceutical research focus and discussion groups.

To read more or to connect with Ryan, view his LinkedIn profile https://www.linkedin.com/in/ryanrklein/

Colin Barry, Ph.D. & Scott Ugrin, Ph.D.

Alliance Pharma’s bioanalytical team provides comprehensive services for both small and large molecules using a variety of platforms from mass spectrometry to ligand binding assays using an assortment of specialized instrumentation. Our analytical laboratories boast thirteen LC-MS/MS systems from three different manufacturers and include various platforms. Nine systems from AB Sciex are each coupled to Shimadzu UHPLC systems, including two API4000 QTRAP systems, two API4000 triple quad systems, three 5500 triple quad systems, and two 6500 triple quad systems. Each system is designed for high sensitivity quantitative analysis of small molecules generated from either in vitro or in vivo studies and in various matrices.

Alliance Pharma’s small molecule mass-spec based bioanalytical team specializes in:

• Development, optimization, and transfer of bioanalytical assays
• Method Validation
• Sample analysis to support clinical (GLP) and non-clinical studies
• Plasma, serum, whole blood, and all tissue types
• Biomarker assay development, validation and sample analysis
• High throughput screening from in vitro ADME assays
• Metabolite identification

The newest additions to the bioanalytical lab include two Agilent 6545 XT Q-ToF high resolution mass spectrometers coupled to Agilent 1290 Infinity II UHPLC systems with PDA and FL detectors. These new systems add additional capacity to our existing high-resolution accurate-mass (HRAM) systems: 1) a Dionex RSLCnano, 2-D nano/micro/cap UHPLC system coupled to a Q Exactive Plus, and 2) an Orbitrap XL from Thermo Scientific. The newest HRAM systems are ideally suited for analysis of proteins and peptides and will allow generation of highly detailed information for intact proteins and antibodies, confirmation of sequence at the peptide level, and sophisticated analysis of both simple and comprehensive post-translational modifications.

The combination of mass accuracy (> 1 ppm) and high resolution (up to 280,000 at m/z 200) allow for increased specificity and sensitivity in extremely complex matrices. The additional capabilities position Alliance Pharma to continue to expand our large molecule qualitative and quantitative analysis capabilities.

Chunying Gao, Ph.D.

Drug transporters play a key role in the absorption, distribution, metabolism, elimination and toxicity (ADME-Tox) of many drugs by controlling the entry or exit of drug molecules into and out of tissues or organs. Due to the importance of drug transporters in these processes and the potential drug-drug interactions among drug molecules on these transporters, in vitro transport studies on a standard panel of drug transporters are recommended by the FDA, EMA, and PDMA regulatory agencies to evaluate the potential interactions as substrates and/or inhibitors among the investigational drugs. The current panel includes P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1 and MATE2-K; although regulatory agencies are routinely requesting data on additional transporters outside of the current group. 

According to the FDA guidance,^[1] several in vitro models are recommended for each transporter:

Alliance Pharma has established a set of cell- or membrane vesicle-based assays to support filing packages for the studies recommended by regulatory agencies. For ABC transporters, a membrane vesicle assay (for P-gp and BCRP) and MDR1/MDCK bidirectional permeability assay (for P-gp) has been established. For SLC transporters, an assay platform based on transiently transfected HEK293 cells has been optimized and validated, and can be used for both screening of substrate/inhibitor and K_m/IC₅₀ determination.

[1] https://www.fda.gov/downloads/Drugs/Guidances/UCM581965.pdf

This method was validated by following the US FDA guidance for bioanalytical method validation. To read more about the Validation of an LC-MS/MS method for simultaneous quantification of venlafaxine and its five metabolites in rat plasma and its application in a pharmacokinetic study click here.

Guodong Gua,⁎, Michelle Blacka, Colt Cooksona, Anna Fiorellaa, Yinghe Lib, Steven H. Gormanc, Ray Bakhtiarc

a Alliance Pharma, Inc., Malvern, PA, United States

b GlaxoSmilthKline (GSK), Collegeville, PA, United States

c Teva Branded Pharmaceutical Products R&D, West Chester, PA, United States

Journal of Chromatography B 1087–1088 (2018) 29–35

In 2016, Alliance Pharma conducted a Customer Survey to measure satisfaction of our bioanalytical, biopharmaceutical, and drug metabolism services to our clients. Our goal was to assess how we were performing in relation to our business philosophy. Since we measure our success based on the success of our clients, it is important that we understand the areas of our business that are working and the areas that need improvement.

Overall, 100% of clients who responded to our survey gave Alliance Pharma a rating of SATISFIED or higher in regards to questions about services, personnel, performance, support, management, and costs. In fact, 75% of clients stated that they are VERY SATISFIED with Alliance Pharma.

The Customer Survey went out to Scientific Directors, Senior Research Directors, Assistant Scientists, Senior Managers, and Professors. When these clients were asked, “How satisfied are you with the performance of our technicians?” 70% replied that they are VERY SATISFIED. In addition, 65% of our clients responded that they are VERY SATISFIED with our management’s commitment to assist.

Customer Survey Data

We also used the survey to understand why our clients are choosing to partner with us. We know that there are many CROs in the marketplace, so we value each and every client. The replies showed that our network is strong and that referrals are the number one factor for our clients choosing to partner with us. The survey also revealed that our clients are choosing us for other reasons, as follows:

• Timing
• Cost
• Quality
• Location
• Assay Capability

Customer Focused Improvements

Based on the results of the survey, we plan to update our website design and functionality. We will also create new company literature to describe the full extent of our services, especially those that we have added this year, such as the Laboratory Animal Facility and Large Molecule Bioanalysis.

Alliance Pharma would like to thank all of our customers for their time in completing the survey to help us understand how we can better serve all your needs! We are committed to delivering the highest quality services at a competitive price, and thus build a lasting partnership. Thank you for your continued patronage.