National Biotechnology Conference 2011 Preliminary Program - (Page 6) Monday Conference Program Monday, May 16 7:00 am – 6:00 pm REGISTRATION important to understand the key uses and limitations of these tools. If used appropriately these tools can help inform molecule selection, early estimation of human activity, demonstration of mechanistic/biological activity, early go or no go decisions, selection of maximally effective dosing regimens and patient selection/stratification. This session will focus on real-world examples where biomarkers have been used to help inform drug development. Moderator Paul J. Fielder, Ph.D. Genentech, Inc. Using PD Biomarkers in Early Development of Immunological Therapies Heleen Scheerens, Ph.D. Genentech, Inc. Patient Stratification in Oncology Clinical Development Ian McCaffery, Ph.D. Amgen, Inc. Pharmacodynamic Modeling of Biomarkers in Drug Development Donald E. Mager, Pharm.D., Ph.D. University at Buffalo, SUNY How Biomarkers Can Shorten Knowledge Turns in Drug Development and Regulatory Decisions Lawrence Lesko, Ph.D. (invited) U.S. Food and Drug Administration safe drugs and therapies. This symposium will highlight and discuss research accomplishments and commercialization challenges in this cutting edge and rapidly evolving area. Moderators Giovanni M. Pauletti, Ph.D. University of Cincinnati Panayiotis P. Constantinides, Ph.D. Biopharmaceutical and Drug Delivery Consulting, LLC Homing Peptides as Targeting Elements to Deliver Nanoparticles into Tumors and Other Disease Sites Erkki Ruoslahti, M.D., Ph.D. University of California, Santa Barbara Show and Act: Pinpointed Optical Diagnosis and Targeted Molecular Therapy Using Stimulitransforming Multi-modal Nanotheragnostics Young J. Kwon, Ph.D. University of California, Irvine Tuning Nanoparticle Surfaces for Delivery, Imaging and Sensing Applications Vince Rotello, Ph.D. University of Massachusetts Medical School Commercialization Challenges with Targeted Nanotheragnostics Panayiotis P. Constantinides, Ph.D. Biopharmaceutical and Drug Delivery Consulting, LLC 8:30 am – 11:30 am Plenary Session Funded by a Grant from Welcome and Opening Remarks Philip L. Mayer, Ph.D. 2011 AAPS President Mr. John Lisack, Jr., C.A.E. AAPS Executive Director Binodh S. DeSilva, Ph.D. Bristol-Myers Squibb 2011 National Biotechnology Conference Chair Falk Ehmann, M.D., Ph.D., M.Sc. European Medicines Agency Joseph Miletich, M.D., Ph.D Amgen, Inc. 11:00 am – 3:00 pm LUNCH CONCESSIONS OPEN 11:00 am – 6:30 pm AAPS Exposition 11:00 am – 6:30 pm Contributed Papers Poster Session Authors are present to answer questions from 5:30 pm – 6:30 pm 1:30 pm – 4:00 pm Targeted Nanotheragnostics: Scientific Achievements and Commercialization Challenges SYMPOSIUM There have been significant and promising advances in nanobiotechnology and the most promising scientific strategies and approaches are those that combine disease diagnosis with therapy (Nanotheragnostics). Nanodevices are being developed for tissue engineering and organ development along with bio-inspired materials for self-healing and repair. Multifunctional nanoparticle-based molecular diagnostics and drug delivery systems for small molecules and macromolecules are progressing from bench to clinic to commercialization with the potential to profoundly affect human health. There are still safety concerns on the interaction of nanomaterials and nanoparticles with the human body. Other areas of concern and future development are issues related to the pharmacokinetics and biodistribution of nanoparticles as well as formulation, processing and manufacturing. Drivers for future growth and commercialization include: availability of funding, patent landscape, increased understanding of the pathophysiology of disease and increased requirements for 1:30 pm – 4:00 pm Requirements and Challenges in the Development of Biosimilars/Biobetters SYMPOSIUM The expiration of patents on the first wave of biotech medicines and the development of enabling regulatory approval pathways are contributing to increasing interest and investment in the development of biosimilars. This symposium is intended to stimulate a wide and open discussion on the development of biosimilars/biobetters and to promote/embrace a new era of rapid growth in biosimilars/biobetters. Moderators Wei Wang, Ph.D. Pfizer Inc. Suzanne M. Sensabaugh, M.S., M.B.A. HartmannWillner LLC Regulatory Guidelines and Key Areas of Emphasis in the Development of Biosimilars Falk Ehmann, M.D., Ph.D., M.Sc. European Medicines Agency Challenges, Lessons, and Recommendations in the Development of a Successful Biosimilar Mark McCamish, Ph.D., M.D. Sandoz 12:00 pm – 1:00 pm Monday Afternoon Symposia Funded by a Grant from 1:30 pm – 4:00 pm Using Biomarkers to Inform Decision Making in Drug Development SYMPOSIUM One of the major goals of preclinical pharmacology and translational medicine is to quickly and efficiently translate novel scientific discoveries into new clinical therapies. To do this effectively, it is critical to enter clinical development with the scientific knowledge and tools to maximize therapeutic success and to enable informed decision making at key times in a molecule’s lifecycle. Pharmacodynamic and predictive biomarkers are important tools to help realize these goals. Although these are powerful new tools for drug development it is also equally 6 2011 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE Table of Contents for the Digital Edition of National Biotechnology Conference 2011 Preliminary Program NBC 2011 - Pre-Program Table of Contents Sessions at a Glance Conference Program Pre-conference Workshop Pre-conference Training Course Post Conference Open Forums Post Conference Short Courses Registration Information ‘Points of Interest’ in San Francisco Map of Downtown San Francisco Hotel/Site Information Travel and Transportation Call for Papers Exhibiting Opportunity Advertising Opportunities General Information Sponsorship Opportunities Conference Planning Committee Upcoming AAPS Meetings Short Course Application Form Training Course Application Form Conference Registration Form National Biotechnology Conference 2011 Preliminary Program http://www.nxtbookMEDIA.com
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