Our highly-trained staff is very skilled and experienced in Drug Discovery and Development, including safety, efficacy and toxicology studies for IND, NDA and BLA submission. Our scientists have many years of experience in drug development and pharmaceutical companies, are well published, and regularly participate in professional conferences and meetings.
Jaseem Anwer, PhD
Jaseem Anwer, Ph.D, is the Scientific Director at the Center for Biomedical Testing (CBT). Dr. Anwer is leading several analytical, bio-analytical, safety pharmacology, and pharmacokinetics studies in rodents, non-rodents and primates. Dr. Anwer is a highly motivated scientific professional with extensive experience in designing, performing, and supervising studies in a pre-clinical non-GLP and GLP environment. Dr. Anwer has background in studies involving general toxicity, toxicokinetics, therapeutic efficacy, and pharmacokinetics.
Dr. Anwer joined Neopharm, an oncology biopharmaceutical company, as a Study Director and Manager in 2004. There he was responsible for managing the toxicology program for the development of liposomal encapsulated cancer drugs. He investigated the safety profiles of liposomal encapsulated docetaxel, paclitaxel, doxorubicin, and oligunucleotides in rodents. He also developed a technique for intra-nasal instillation for a protein drug which has indications for pulmonary fibrosis. Dr. Anwer was also responsible for the development of human xenograft tumor models for the therapeutic efficacy of cancer drugs. Dr. Anwer received certified training to run LC-MS/MS for bioanalysis and qualified the method for the quantification of docetaxel in human plasma. During his stay in Neopharm he successfully managed to file INDs and advanced 3 drug candidates from pre-clinical studies to clinical trials.
Dr. Anwer previous positions also included Goodwin Biotechnology, a Contract Manufacturing Organization. There he was responsible for developing and validating bio-analytical assays using HPLC, ELISA, Gel Electrophoresis, and Iso-electric focusing techniques for protein characterization. He also has hands on experience in Endotoxin, Sterility, and Bio-burden techniques.
Dr. Anwer received his Ph.D. in Toxicology in 1986 from Industrial Toxicology Research Center, Lucknow, India. For his Ph.D. thesis he developed a Chick embryo model to investigate the protective roles of calcium and zinc against lead exposure during embryo development. He did his Post Doctoral work and held scientific positions at University of North Dakota, East Carolina University and Florida A & M University. His academic work involved investigating the effects of abused drugs—cocaine, marijuana, and alcohol—on glucose utilization and endorphins in different regions of the brain. Dr. Anwer has presented his research results at numerous national and international scientific meetings and has published many scientific papers in peer-reviewed journals.
Director of Toxicology & Process Validation
Matthew Lindeblad, B.S., Director of Toxicology and Process Validation, is engaged in numerous general pharmacology/efficacy and preclinical studies and will serve as a Study Director. He has approximately 12 years of GLP experience in acute, subchronic and chronic efficacy/safety studies, and pharmacokinetics/tissue distribution studies in rodents, dogs, and nonhuman primates, developmental studies in rats and rabbits, fertility studies in rats. He has served as a study director in irradiation studies in more than 500 monkeys and thousands of mice and one of the most experienced Study Director in the field of irradiation of rhesus macaques. He also has experience in conducting behavioral studies in monkeys, rats and dogs, and tissue culturing of different cells and inoculation of these cells in mice. He has been, or currently is Study Director on more than 40 GLP and non-GLP studies.
Mr. Lindeblad has 20 years of experience in conducting GLP studies. He has many years of experience with all types of test article administrations (e.g., injection, infusion, etc.) in rodents, rabbits, dogs, pigs, and non-human primates. Mr. Lindeblad has worked as study director for the last 12+ years on many research projects involving both GLP and non-GLP toxicology studies and animal model development work. Mr. Lindeblad is highly experienced in acute radiation exposure studies, including non-human primates, minipigs, mice, and rabbits. He has experience in validation of analytical methods in chemical and biological samples, including ELISA, test article formulations, and tissue analysis. He also has worked on the studies involving method validation and measurements of levels of radiolabeled drugs in different biological matrices (e.g., plasma, RBCs, urine, tissues, etc.). Mr. Lindeblad has over 6 years of prior experience in veterinary medicine where he assisted with surgical procedures and performed laboratory procedures such as blood, urine, and fecal analysis, as well as radiography. He received his B.S. in Biological Science from Northern Illinois University in 1997. Mr.Lindeblad has presented his research results at national and international scientific meetings, and has been actively publishing, including several abstracts and papers in peer- reviewed journals. Mr. Lindeblad has also been heavily involved with the information technology associated with contract research, including the new SEND initiative required by the FDA.
James H. Fischer, Pharm.D., FCCP
Director of Pharmacokinetics
James H. Fischer, Pharm.D., FCCP, Professor Emeritus, Departments of Neurology and Pharmacy Practice at the University of Illinois at Chicago. Dr. Fischer serves as a Director of Pharmacokinetics at CBT and performed many PK studies for numerous drug candidates mainly for the purpose of IND submission. He also supports clinical PK analysis of 3 ongoing clinical trials for the IND packages for drugs previously successfully developed by CBT and accepted by FDA for the clinical trials. Dr. Fischer’s research activities focus on the pharmacokinetics of anti-epileptic drugs and the effects of pregnancy on drug disposition.
Recently, over more than last 5 years, he has worked with CBT scientists analyzing pharmacokinetic data from preclinical and clinical studies for anti-cancer drugs, imaging and other agents, and in designing the pharmacokinetic component of several Phase I clinical trials. He is the author of over 50 peer-reviewed research publications. His research has been funded by the pharmaceutical industry, National Institutes of Health and the US Food and Drug Administration. He has served as the Principal Investigator for over 30 clinical trials evaluating the efficacy, safety and pharmacokinetics of investigational antiepileptic drugs. Additionally, from 2002 to 2011, he led a collaborative FDA-funded research effort among four universities examining pharmacokinetic changes occurring in pregnancy for several drugs, including azithromycin, betamethasone, ciprofloxacin, gentamicin and labetalol. The application of population pharmacokinetic analyses in these studies has expanded his expertise beyond the use of traditional (two-stage approach) compartmental and non-compartmental methods. In recognition of his international teaching and collaborative research activities, he was awarded an honorary Doctor of Pharmaceutical Sciences degree from Meiji Pharmaceutical University in Tokyo, Japan in 2002. Dr. Fischer completed his BS Pharmacy degree at Drake University in 1977. He received his PharmD from the University of Minnesota in 1979 and completed a Postdoctoral Fellowship in Epilepsy and Clinical Pharmacokinetics in 1981 at the University of Minnesota.
Richard W. Shubart, M.S., MBA
Richard W. Shubart, M.S., MBA, has over 35 years of Quality Assurance experience in the Pharmaceutical Industry. An ASQ Certified Quality Engineer since 1982, he has directed "large pharma" global R&D organizations in supporting GLP, GMP, GCP, and Computer Validation activities. Prior to assuming a management position, he conducted QC activities in GLP support of both Toxicology and Pharmacokinetic Drug Metabolism (PKDM) departments. Mr. Shubart has worked at CBT for more than 5 years. He is very experienced in analytical and bioanalytical method development and validation. His responsibilities include reviewing study protocols, Standard Operating Procedures, raw data files, and report audits. Mr. Shubart also performs periodic facility inspections and oversees the CBT Quality Assurance program.
Ryan Witt serves as a Growth Advisor to CBT. Ryan started his career educating and presenting novel statutory frameworks to federal regulators in the United States to improve the adoption of molecular characterization techniques, combination medical products, and access protocols to experimental medicines. Following this, he helped high-growth startups in healthcare, backed by top venture capitalists and angel investors in the healthcare and life sciences' sectors move to their next inflection points. The products Mr. Witt has helped develop and bring to market over the years are used by tens of thousands of clinicians and millions of patients worldwide. In 2018, trade organization Biocom awarded Mr. Witt with a Catalyst Award; and, in 2014 the federal government of the United States appointed him to the Consumer Empowerment Working Group of the Department of Health and Human Services.
Mr. Witt is a mentor at KidsX (a pediatric accelerator covering over 25 hospitals across the world), Blockbuster Tokyo, and ScaleHealth; serves on Biocom’s Capital Development and Startup Resources Committees respectively, serves as Hub Director at UCLA Biodesign, and periodically volunteers with Health Extension Foundation and the Society for Participatory Medicine.
Beatriz Gomez, B.S., in Chemistry, Chemist. She has served as an HPLC and LC-MS/MS specialist at CBT for more than 7 years. She holds a Bachelor’s degree from Saint Xavier University, where she began her work in the laboratory as a research assistant. This opportunity allowed her to gain experience in Spectroscopy such as FTNMR and FTIR analysis. She then went on to volunteer at PepsiCo’s various science departments including: Research and Development, Analytical, and Forensics. This experience served as an introduction to polarized microscopy in forensics and the implementation of techniques for analysis such as pH meters, GCMS, LC, and the Kjeldahl Method for protein detection. Here at CBT under GLP compliance, she has developed and validated numerous HPLC methods for formulation analysis and purity, for solutions as well as suspensions. She has implemented such methods in analyzing stability, concentration, and purity of test articles. Previous projects include the successful completion of dosing formulation stability, formulation analysis prior to dosing and purity for Rifampicin (Oral), Doxycycline (Oral and IV), PAC-1, numerous cancer chemotherapeuticandchemopreventiondrugs. Sheisalsoveryexperiencedin LC-MS/MS method development and validation for numerous drugs quantitative evaluation in plasma, tissues and urine utilizing Agilent, Waters and Shimadzu instruments with a liquid-liquid and SPE extraction procedures. She is also experienced in LC-MS/MS in vitro tests (e.g, microsomes stability and metabolic profiling, CYP450 induction and inhibition, plasma stability, protein binding, etc.).