Yuan Chen is a Principal Scientist in the Department of Drug Metabolism and Pharmacokinetics at Genentech. Yuan has nearly 20 years of experience in the drug metabolism and pharmacokinetics discipline working at Roche and Genentech. She has been DMPK project lead for many drug discovery and development projects, and contributed to many clinical candidate nomination and filing of IND to the regulatory authorities. Yuan’s current research focus is on physiologically-based pharmacokinetic (PBPK) modeling for the prediction of human PK, absorption, and CYP-and transporter-mediated drug-drug interactions. She leads PBPK effort at Genentech and has been active member on IQ PBPK expert working groups.
Dr. Choi has worked with great enthusiasm and endeavor for developing functional foods or pharmaceutical ingredients from animal and plant resources and commercializing them. Currently, He is interested in developing the system inferring functional properties of natural extracts (Bio-FINE). The system is based on bio-information that can be extracted by comparing differently expressing genes between normal and natural extracts fed animals. Through the system, various functional properties of single as well as combinatorial natural extracts can be ranked and further utilized for commercialization.
Although luteolin is known to have potent anti-inflammatory activities, much less information has been provided on such activities of its hepatic metabolites. Luteolin was subjected to hepatic metabolism in HepG2 cells either without or with catechol O-methyl transferase (COMT) inhibitor. To identify hepatic metabolites of luteolin without (LMs) or with COMT inhibitor (LMs+CI), metabolites were treated by ß-glucuronidase and sulfatase, and found that they were composed of glucuronide and sulfate conjugates of diosmetin in LMs or these conjugates of luteolin in LMs+CI. LMs and LMs+CI were examined for their anti-inflammatory activities on LPS stimulated Raw 264.7 cells. Expression of iNOS and production of nitric oxide and pro-inflammatory cytokines such as TNF-α, IL-1ß and IL-6 were suppressed more effectively by the treatment with LMs+CI than LMs. Our data provide a new insight on possible improvement in functional properties of luteolin on target cells by modifying their metabolic pathway in hepatocytes
- Emerging Bioavailability & Bioequivalence Studies | Advances in BA&BE | BA/BE of Biologic & Biosimilar | Drug Metabolism | New Approaches to Beat Multi-Drug Resistance: Natural and QSAR-designed Antimicrobial Peptides Bioequivalence Protocol: In-Vitro / In-Vivo Studies
He holds a PhD in Pharmacology from the Royal College of Surgeons of England (University of London, 1986) and holds a PhD in Pharmacology from the University of SAo Paulo at RibeirAo Preto Medical School (1981). He has been a titular member of the National Academy of Medicine since 2003 and the National Academy of Pharmacy since 2009. He is currently an adjunct professor in the Department of Pharmacology of the Faculty of Medical Sciences of the State University of Campinas (UNICAMP) and a full professor of the Pharmacology Department of the Instituto de Biomedical Sciences of the University of SÃ£o Paulo. Has experience in the field of Clinical and General Pharmacology (cardiovascular and inflammation).
I have diverse leadership experience as a health services professional with significant accomplishments in all aspects of pharmacovigilance, clinical development, medical affairs, regulatory affairs, primary health care, project management & international health programs. I have vast experience of working in diverse therapeutic areas including rare diseases, novel preventive & therapeutic vaccines, monoclonal antibodies, cardiovascular, oncology, neurology, nosocomial diseases, generic and OTC medicines. I am currently working as Disease Area Cluster Lead for Biosimilars & Drug Delivery Devices at Pfizer. Currently Pfizer has the largest biosimilars portfolio in the industry that includes projects on Inflammation, Oncology, Hematology, ophthalmology etc. My past experience includes working as Associate vice president PV and Therapeutic Area Head (Rare Diseases) for Sanofi Genzyme, working as Senior Director & Director for vaccines PV at Sanofi Pasteur, working as Medical Consultant for Apotex Inc Canada. Prior to joining industry I had worked as Joint Executive Director for Pakistan Institute of Medical Sciences (PIMS), Registrar of the Post graduate medical institute PIMS and as Deputy Director General, Ministry of Health Pakistan. I have also worked on various primary healthcare, public health, health planning & development programs as well World food, UNICEF, WHO & JICA assisted programs on drug safety, emergency preparedness, and primary healthcare.
Advances in biotechnology have ensured a world of opportunities for biosimilars to enter the market and serve the needs of patients in a cost-effective manner. However, Pharmacovigilance and risk management for biosimilars present a significant challenge that arise from their unique characteristics as biologics as well as from their differences with the reference innovator products. Traditional PV processes may not incorporate sufficient provisions to meet the particular requirements for biosimilars. While a biosimilar and its reference drug can show similar efficacy, it can exhibit a different safety profile with respect to the nature, seriousness, or incidence of reported adverse events (AEs). Therefore, there is a need to clearly identify the specific product associated with the AE. Hence, product naming is an important consideration for biosimilars traceability. The potential for immunogenicity represents an important safety concern with all biologics, including biosimilars. The nature and severity of immunogenic reactions may differ from those observed for the reference innovator and immunogenicity data from the reference product may not be directly extrapolated to the biosimilar. Given the relatively small number/size of clinical trials required for regulatory approval of biosimilars, full characterization of the immunogenicity profile of a biosimilar may not be established at the time of regulatory approval. Continued post-marketing surveillance of biosimilars is critical for effective risk management. Also, the unique nature of biosimilars requires a labeling approach that combines data on the reference product with data specific to the biosimilar due to differences in their source materials, manufacturing processes and impurities. Finally, the safety specifications in the RMP of a biosimilar should include the identified and potential risks of the reference innovator product as well as risks identified from studies on the specific biosimilar product.
Jonathan Cho is a Clinical Assistant Professor at the University of Texas at Tyler College of Pharmacy and serves as the Director of the Antimicrobial Stewardship Program at Longview Regional Medical Center in East Texas. Dr. Cho provided many infectious diseases-related presentations at various international, national, and regional professional meetings. He has published over 30 peer-reviewed abstracts and manuscripts. Dr. Cho received several awards for his practice and research efforts including the University of Texas’ Crystal Talon Award and the East Texas Society of Health-System Pharmacists (ETSHP) New Practitioner Award. He currently serves as the President of ETSHP.
Antimicrobial resistance remains a global health threat. Judicious use of antimicrobials has been a key strategy in preventing the development of antimicrobial resistance, largley due to the lack of antimicrobial agents needed to treat resistant pathogens. However, several antimicrobial agents have been recently approved with various indications and spectrums of activity. Using these antimicrobial agents inappropriately will contribute to the development of antimicrobial resistance and lead to less treatment options in the future. Reviewing the clinical implications for these antimicrobial agents and using them appropriately in the clinical setting is crucial for preventing unintended consequences of antimicrobial use. This presentation will cover the pharmacology, spectra of activity, adverse reactions, drug interactions, and potential role in therapy for each discussed antimicrobial as well as the advantages and disadvantages of these newer antibiotics compared to existing agents.