logo
International Conference and Exhibition on
Biowaivers and Biosimilars
September 10-12, 2012 Hilton San Antonio Airport, USA
Biosimilars-2012

    Previous Events
     
     

    Organizing Committee Members


     
    Michael Retsky
    BioMedical Imaging Laboratory
    Harvard School of Public Health
    USA
    Tel: +1-617-432-3472
     
    		  
    Biography :
    Michael Retsky is Research Associate at Harvard School of Public Health Professor Adj at UANL Monterrey Mexico Member Manager at Electron Optics Development Co LLC www.elopt.com He is a founder and on the Board of Directors of Colon Cancer Alliance www.ccalliance.org and Connecticut Optics and Photonics Association www.ctopa.org He received a PhD in Physics from the University of Chicago in 1974 He is Guest Editor at the journal Cancers and has been Guest Editor at the journal Sensors and Algorithms He reviews papers in a number of journals He is CoPI of a 3year 600k cancer research grant from Komen Foundation He has published over 50 papers in cancer research and physics     BIOGRAPHY
    Research Interest :
    Cancer research
    Charged particle optics
    Early detection of cancer and delayed detection of cancer    RESEARCH INTEREST
    Network
    Publications
     
    Barry Rosenblatt
    President
    SME Biotech Consulting
    USA
    Tel: 215-694-2925
     
    		  
    Biography :
    Dr Rosenblatt is a subject matter expert in the chemistry and manufacturing controls (CMC) of biotheraputics with a proven 27+ year track record in biotechnology, pharmaceutical, and contracting industry, including positions at Centocor, Johnson and Johnson and Charles River Laboratories. In his various roles with these organizations he worked with C-level executives on the strategic planning and implementation of organizational initiatives that improved expense to earning ratios (OI). His accomplishments include:
    •Developed, transferred and validated purification processes for multiple new molecular entities through all stages of drug development, including licensure by the application of an innovative and comprehensive approach. This includes the licensure of a biological drug with current annual sales exceeding $6 billion.
    •Experienced in international regulatory submissions (IND, CTX, and BLA).
    •Participated in IND and BLA meetings with the FDA.
    •Assisted in the design, build out and validation of biopharmaceutical manufacturing plants capable of the production of a metric ton of monoclonal antibody per annum.
    •Managed an ISO-5 cGMP cell culture and Vaccine pilot scale production facility
    •Performed due diligence on Contract Manufacturing Organizations (CMO) including assessment of technical ability, and QA/regulatory status.
    •Participated in PDA white paper on Virus production.
    •Presented concept paper to the FDA
    •Performed technical and regulatory due diligence on potential acquisition candidates and venture capital investment opportunities.
    •Served on scientific advisory boards for scientific conference organizations and chaired multiple conferences.
    •Currently serving as a CMC consultant to the industry covering both originator molecules and biosimilars as well as Cell Therapy.
    •Academic credentials include a Ph.D. in Cell Biology/Immunology from the Albert Einstein College of Medicine, Bronx, NY.
    Both a strategic and operational thinker, Dr Rosenblatt has demonstrated his ability to build new ventures and ignite growth in existing operations. He has the ability to simultaneously grasp the large overview (40,000 foot view) and immediate need (1 foot view). His strengths include technical program development and implementation, multi-tasking and communication. He has a proven track record in problem solving, scientific communication, client relations, and product development. Dr Rosenblatt is known for his catch phrase “the difficult takes a while; the impossible just takes a little longer.”     BIOGRAPHY
    Research Interest :
    Strategic development of Biopharmaceuticals from Bench top to Commercial. Development of programs designed to introduce Biosimilars into the US and EMA markets.    RESEARCH INTEREST
    Network
    Publications
     
    Edward T. Maggio
    President and Chief Executive Officer
    Aegis Therapeutics LLC, USA
    Tel: 858-618-1400
    Fax: 858-618-1441
    Mobile: 858-967-6840
     
    		  
    Biography :
    Edward T. Maggio, Ph.D., is Chief Executive Officer and Director of Aegis Therapeutics, San Diego, CA. Prior to co-founding Aegis, Maggio was founder and Chief Executive Officer of Structural Bioinformatics Inc., subsequently renamed Cengent Therapeutics. He was founder and CEO of ImmunoPharmaceutics, Inc. (IPI), which developed a number of endothelin antagonists, including Pfizer (formerly Encysive Pharmaceuticals) Thelin® (Sitaxsentan), approved in 2006 for sale in Europe for cardiovascular disease. Maggio has been a founder and board member of seven public and private life science companies in the San Diego area and one in Copenhagen, Denmark. He received his Ph.D. from the University of Michigan and was an NIH postdoctoral fellow at the University of California, San Francisco (UCSF) Department of Pharmaceutical Chemistry. He is a member of the Advisory Board of the Polytechnic Institute of New York University, Department of Chemical and Biological Sciences; the University of California, San Diego, Dean Board of Advisors for Biological Sciences; the California State University, San Marcos, Biotechnology Programs Advisory Board; and the Industry Council of the San Diego Consortium for Regenerative Medicine; the Editorial Board of the Journal of Excipients and Food Chemicals, and a reviewer for the journal of Diabetes, Obesity and Metabolism. Maggio has edited and coauthored a number of books and scientific articles in the biotechnology area and is an author of more than fifty issued and pending U.S. and foreign patents.    BIOGRAPHY
    Research Interest :
    1.Non-invasive systemic delivery and stabilization of peptide and protein drugs
    2.Oral delivery of metabolic disease related peptides, GLP-1 analogs, OB-3, exendin-4, liraglutide, octreotide
    3.Immunogenicity reduction of protein drugs
    4.Novel peptide drugs for treatment of cancer, diabetes, Alzheimers disease
    5.Non-invasive CNS drug delivery
    RESEARCH INTEREST
    Network
    Publications
     
    Brian R. Dorn
    Of Counsel
    Barnes & Thornburg LLP, USA
    Tel: +1-612-367-8728
    Fax: +1-612-333-6798
     
    		  
    Biography :
    Brian R. Dorn, Ph.D., is of counsel in Barnes & Thornburg LLP’s Minneapolis office and is a member of the Intellectual Property Department. Dorn has an array of experience in the field of intellectual property with particular emphasis on patent prosecution and opinion work. He has advised clients regarding patent filing strategy, clearance searching, patentability searching, validity analysis, and infringement analysis. Dorn’s practice has also included international work, where he has worked with patent attorneys in other countries to obtain patents in those specific countries and in the U.S. for non-U.S. applicants. Prior to joining Barnes & Thornburg, he served as an associate attorney at Merchant & Gould, P.C., in Minneapolis where he concentrated his practice in the firm’s Life Science practice area. His work included application drafting and prosecution, opinions, portfolio management and strategic planning, litigation support, interferences, and licensing. He has also served as a law clerk for Saliwanchik, Lloyd & Saliwanchik, P.A., in Gainesville, FL and a legal intern for the University of Florida Office of Technology Licensing. Active in the community, he serves on the advisory board for the University of Minnesota’s Joint Degree Program in Law, Health & the Life Sciences, where he aids in counseling the program and mentoring joint degree students. He also sits on the Board of Directors of the American Israel Chamber of Commerce of Minnesota, as well as the Board of Directors for the Jewish Community Relations Council for Minnesota, North Dakota, and South Dakota. He also serves as an advisor to NanoVox, a regional organization that helps connect researchers, businesses, etc., in its diverse field. He received his J.D. magna cum laude from the University of Florida College of Law in 2003, where he was a member of the Order of the Coif, and served on the Florida Law Review and Journal of Technology Law and Policy. He also received his Ph.D. in Biomedical Sciences – Microbiology/Immunology from the University of Florida College of Medicine in 2003, as well as his M.S. in Biomedical Sciences in 1998. He received his B.S. from the University of Michigan in 1993. He is a member of the Minnesota State and Minnesota Federal Bar Associations. He is admitted to practice in U.S. Supreme Court, U.S. Court of Appeals for the Federal Circuit, U.S. District Court of Minnesota, and the U.S. Patent and Trademark Office.     BIOGRAPHY
    Research Interest :
    His patent prosecution and opinion experience includes stem cells, humanized antibodies, therapeutic peptides, small molecule pharmaceuticals, diagnostic and immuno-assays, therapeutic delivery systems, antimicrobials, phage display systems, microarrays, transgenic animals, transgenic plants, nanobiotechnology, medical devices, and medical device coatings.     RESEARCH INTEREST
    Network
    Publications
     
    Carl K. Edwards
    PCIR Laboratory
    University of Colorado Denver
    USA
    Tel: 303-724-4043
    Fax: 303-724-4048
     
    		  
    Biography :
    Carl K Edwards, PhD is currently Associate Professor Department of Dermatology since November 2004 and Visiting Professor Department of Infectious Diseases since January 1995 located at the University of Colorado Denver UCD School of Medicine Anschutz Medical Campus Aurora CO USAHe obtained his BS Colorado State University 197680 MA University of Colorado 198285 and PhD from University of Illinois198689Dr Edwards serves on the Scientific Advisory Boards of Western States Biopharmaceuticals Inc since 2008 and Caveo Therapeutics Inc since 2007; he has provided professional consultation to Apro Biopharmaceuticals Inc 2007 SelectX Pharmaceuticals Inc 2005 2006 Ascent Therapeutics Inc 2006 and Amgen Inc 2005     BIOGRAPHY
    Research Interest :
    Cutaneous Inflammation, Pathogenesis of Rheumatic Diseases, Molecular and Cellular Regulation of Proinflammatory Cytokines and Translational "Bench-to-Bedside" Clinical Reseaech    RESEARCH INTEREST
    Network
    Publications
     
    Cecil Nick
    Vice President (Technical),
    PAREXEL Consulting,
    United Kingdom
    Tel: + 44(0)189-561-4589
    Fax: +44(0)189-561-4375
     
    		  
    Biography :
    Cecil Nick is the Vice President (Biotechnology) at PAREXEL Consulting. He is a BSc Biochemistry graduate from University of Cape Town and regulatory professional with over 25 years experience specializing in the clinical development of biological and biotech products. He was the Regulatory Manager at Novo Nordisk A/S from November 1987 till December 2000. He offers extensive expertise to clients particularly with respect to biosimilars, comparability, clinical development, orphan drugs and training. He has published articles on his expertise.    BIOGRAPHY
    Research Interest :
    Offers extensive expertise to clients particularly with respect to biosimilars, comparability, clinical development, orphan drugs and training     RESEARCH INTEREST
    Network
    Publications
     
    Laszlo Endrenyi
    Department of Pharmacology and Toxicology
    University of Toronto, Canada
    Tel: 416-978-8620
    Fax: 416-978-6395
     
    		  
    Biography :
    Laszlo Endrenyi, Ph.D., D.Sc. is Professor Emeritus of in the University of Toronto, Canada. He has served the university in various senior positions. He has been recognized as a Fellow of both the American Association of Pharmaceutical Scientists and the Canadian Society for Pharmaceutical Sciences, in recognition of his contributions to pharmacokinetic modeling and its applications to drug development; he is currently president of the latter. He has served on grant review committees and editorial boards of research journals. He has received several recognitions, including an honorary doctorate. He published a book and over 160 research papers. He has consulted with the Food and Drug Administration and Health Canada and served on their advisory committees. He has widely consulted with industry.    BIOGRAPHY
    Research Interest :
    Assessment of Bioavailability and Bioavailability of Drugs     RESEARCH INTEREST
    Network
    Publications
     
    Wendy Louise Hulse
    Biopharmaceutical Formulation Scientist
    University of Bradford, UK
    Tel: +44(0)1274 236 156
     
    		  
    Biography :
    Wendy is a Lecturer in Biopharmaceutical Innovation within the School of Pharmacy at the University of Bradford, UK. She received her B.Sc. in Chemistry with Pharmaceutical and Forensic Science in 2001, before completing her PhD in Biopharmaceutics in 2005. Here she studied the effect of excipient combinations to stabilize both solid and liquid protein formulations for pulmonary delivery. From there Wendy moved to GlaxoSmithKline to take up a position as Physical Properties Scientist. However, it was her passion for biopharmaceutical research that led her back to academia in 2008 to undertake her Research Lectureship. In this role, Wendy has already successfully developed a novel sizing technology to determine low level aggregates for biopharmaceutical development. Here, BFGs expertise was evident as the only academic collaborator in the £1.2million Technology Strategy Board (TSB) award for this development.    BIOGRAPHY
    Research Interest :
    Polymorphism
    Co-crystals
    Crystal engineering
    Nanometric molecular solid
    Biopharmaceutical formulation, Taylor dispersion analysis and UV area imaging     RESEARCH INTEREST
    Network
    Publications
     
    Hareesh B. Nair
    Staff Scientist I
    Southwest National Primate Research Center
    Texas Biomedical Research Institute
    USA
     
    		  
    Biography :
    Hareesh B. Nair, M.S is currently a Staff Scientist I at Southwest National Primate Research Center, Texas Biomedical Research Institute, USA. He pursued B.S Biological Sciences from Mahatma Gandhi University, India and M.S Biological Sciences from University of Kerala, India. His research interest includes developing therapeutic nanoparticles and targeted delivery of chemotherapeutic agents for breast cancer and melanoma. Improving the bioavailability of therapeutic agents by rational design and surface engineering of therapeutic molecules. He was awarded the AACR Minority Serving Institution Faculty Scholar Award for three consecutive years (2008-2010). In 2007, Dr. Nair was awarded Novartis Basic Science Research Scholar Award, SABCS. He was awarded Young Scientist Award-4th national Congress on Medicinal plants in 2000. His research focus on UV-B induced cutaneous malignant melanoma in Monodelphis domestica; Role of dietary fats, hormonal regulation and predisposition risk of melanoma; In utero exposure of endocrine disrupting agents in mammary gland development and tumorigenesis in adulthood in Monodelphis domestica. He has published 17 papers and is the editorial board member for Journal of Bioequivalence and Bioavailability.    BIOGRAPHY
    Research Interest :
    Research interest include developing therapeutic nanparticle and targeted delivery of chemotherapeutic agents for breast cancer and melanoma. Improving the bioavailability of therapeutic agents by rational design and surface engineering of therapeutic molecules.     RESEARCH INTEREST
    Network
    Publications
     
    Sudhakar Akul Yakkanti
    Associate Professor
    University of Nebraska Medical Center
    USA
    Tel: 402-498-6681
    Tel(O): 402-498-6322
    Fax: 402-498-6331
     
    		  
    Biography :
    Sudhakar Akulapalli is a Director of Cell Signaling and Tumor Angiogenesis Laboratory Boys Town National Research Hospital Omaha NE USA Clinical Professor Creighton University and Nebraska Medical Center He did his postdoctoral training at Harvard Medical School Boston USA 2003 He has received PhD 2001 MPhill 1997 and MSc1995 degrees in life sciences from University of Hyderabad; and BSc in Biology from SK University 1993 from India He was received President’s fellowship GATE and CSIR fellowships from government of India He received Mahindra Mahindra Travel Award and YCS Award from FAMRI He received BioBio Young Scientist Award from OMICS and RO1 grant award from NIH/NCI He is serving as AIBS/NIHGrant reviewer He has published more than 30 research articles including Science JCI Cancer Cell PNAS Blood etc He is serving as an Executive Editor and editorial board member of reputed journals and serving as reviewer of 20 scientific journals     BIOGRAPHY
    Research Interest :
    Extracellular matrix and Integrin Signaling
    Biology and significance of type IV collagen derived angioinhibitors
    Endogenous angioinhibitors role in Cancer and tumor microenvironment
    Hypoxic tumorangiogenesis
    Mechanism of endothelial apoptosis
    Bioequivalence & Bioavailability of endogenous circulating angioinhibitors
    He is serving as an editorial board member of reputed    RESEARCH INTEREST
    Network
    Publications
     
    Shivanand P. Puthli
    Panacea Biotec Ltd
    India
     
    		  
    Biography :
    Shivanand P. Puthli, Ph. D earned his Ph.D. from University of Mumbai (India) and Post-doctorate from Kyoto Pharmaceutical University (Japan). He has published and presented several original research papers, articles and abstracts in peer reviewed journals and conferences. He has conceptualized innovative drug delivery platform technologies and is an inventor in number of patents. He is an invited speaker at international scientific meetings and conferences. He serves as reviewer for more than 30 scientific international journals and is on Editorial/Advisory board of various journals.    BIOGRAPHY
    Research Interest :
    Pharmaceutics, Drug delivery, Pharmaceutical technology, Pharmacokinetics, Pharmaceutics and Regulatory affairs    RESEARCH INTEREST
    Network
    Publications
     
    Shen Steven Li
    PK/PD Scientist
    Quintiles Inc.,
    USA
     
    		  
    Biography :
    Steven Li, Ph. D is involved in Developing or overseeing the development of protocols, statistical analysis plans, PK/PD analysis, and clinical study reports for Phase I-IV clinical pharmacology studies, as well as population PK/PD studies.     BIOGRAPHY
    Research Interest :
    Clinical Pharmacology, PK/PD Modeling and Simulation, Clinical Trials.    RESEARCH INTEREST
    Network
    Publications
     
    Su Chen
    Chief Executive Officer
    The Chainon Neurotrophin Biotechnology Inc.
    USA
     
    		  
    Biography :
    Su Chen (Chief Executive Officer at the Chainon Neurotrophin Biotechnology Inc, Texas USA) got his Ph..D. in Mario Negri Institute for Pharmacological Research in Milan of Italy, and was a post doctoral research fellow in Italian National Research Council at Padova. After his research position as Senior Research Fellow at Department of Chemistry of the University of Warwick in UK, he joined in Department of Pharmacology at Rush University School of Medicine as assistant professor, and then Quest Diagnostic Nichols Institute as departmental associate scientific director in the US. He has contributed significantly in areas of chemistry, biochemistry and pharmacology of marine phospholipids， particular in development of docosahexaenoic acid (DHA) - containing phospholipids for treatment of neurodegenerative disorders and infertility. He already published more than 44 articles and 3 book chapters in the field of lipids. He is now the Secretary-General of the International Society of Dietary Supplement and Phytotherapy from 2011 – 2014.     BIOGRAPHY
    Research Interest :
    His current interest is to investigate bioavailability of highly abundant docosahexaenoyl phospholipids and prepare or use the lipids as brain DHA donors for prevention and treatment of Alzheimer disease. Dr. Chen has obtained a Chinese patent and applied for three US utility patent applications in this particular field.    RESEARCH INTEREST
    Network
    Publications
     
    Joshua Ikoni Ogaji
    Senior Lecturer
    Department of Pharmaceutics and Pharmaceutical Technology
    University of Jos
    Nigeria
     
    		  
    Biography :
    Ikoni Ogaji worked in a number of pharmaceutical manufacturing companies for fourteen years as production pharmacist, good manufacturing practice pharmacist or Production Manager. He has over 17 articles in peer review journals (local and international)     BIOGRAPHY
    Research Interest :
    Excipients characterization, Drug Formulation and Industrial Pharmacy Practice    RESEARCH INTEREST
    Network
    Publications
    follow
    Conference Secretariat: Biosimilars-2012, OMICS Group Conferences
    5716 Corsa Ave., Suite 110, Westlake, Los Angeles, CA 91362-7354, USA
    Tel: +1-650-268-9744 | Fax: +1-650-618-1414
    Toll free: 1-800-216-6499 (USA & Canada), 1-800-651-097 (Australia), 0805-080048 (Europe)
    Email: biosimilars2012@omicsgroup.com
    Operated by: Editors- Journal of Bioanalysis and Biomedicine, Journal of Bioequivalence and Bioavailability, Pharmaceutica Analytica Acta
    The Organizers reserve the rights to make changes and adjustment to the information in this website
    Copyright � 2008-2012 OMICS Group - All rights reserved
    Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version