NGP R & D SUMMIT

Programme

Tuesday, 29 April 2008

5:00 - 6:00pm

Registration

6:00 - 7:00pm

Cocktail Reception

7:00-9:30pm

Welcome Dinner & Keynote Speech

Dr. Francesco M Marincola

Chief Infectious Disease and Immnogenetics Section, Department of Transfusion Medicine, Clinical Center, National Institute of Health

Wednesday, 30 April 2008
7:30am	Breakfast and Late Registration
8:30am - 11:25am	Meetings	WORKSHOP 1 Do – Coop Solubilization: One of the greatest challenges for new drug formulation
8:30am - 11:25am	Meetings	WORKSHOP 2 Rules Based Medicine Following the Critical Path: Development of Novel Approaches for the Early Detection of Toxicity Leader: Dr. Ralph McDade – Strategic Development Officer Advantages monoclonal antibody drugs - antibody specificity, antibodies as a vehicle for drug delivery, antibody effectiveness Antibodies in disease - autoimmune, cardiovascular and infectious diseases, cancer inflammation Antibodies in Oncology - therapeutic antibodies The true clinical and commercial potential of monoclonal antibodies
11:30 - 12:30pm	Keynote Workshop 1 What's Missing to Enter the Era of BIOMARKERS Regulatory and reimbursement hurdles facing the implementaion of biomarkers intro drug development and marketing Need to biotech/pharma companies to offer biomarker solutions to patient care management Need to move the field forward Leader: Patrice Hugo – EVP of R&D, Caprion Proteomics Panelist 1: Dr. Samir N. Khleif – Chief Cancer Vaccine Section, Vaccine Branch, Center for Cancer Research, National Cancer Institute, National Naval Medical Center Panelist 2: Dr. Gordon Kapke – Senior Director Biomarker Services, Covance Central Laboratory Services Panelist 3: TBD
12:30- 1:25pm	Lunch
1:30 - 5:55pm	Meetings	WORKSHOP 3 Amphora Outsourcing lead generation and optimization Leader: Bill Janzen – President & COO Panelist: TBD The face of early discovery and lead generation is changing, with an increasing emphasis on outsourcing the target-to-lead process by pharma, established biotech and the new generation of 'virtual' biotechs. What are the pro's and con's to an organization and how can they best leverage this new resource to enhance their own discovery efforts?
		WORKSHOP 4 EXIQON – Gene Expression Analysis Products microRNA/microRNA isolation Real-time PCR In situ hybridisation LNA Oligo Reagents
		WORKSHOP 5 Biotherapeutics Trends What is the outlook for biologics vs. small molecules drugs? Where will biotherapeutics likely have the largest impact? How is this evolving? What disease indications will be addressed in the future? What is the next generation of biologics? What types of improvements? By what formats, methods and technologies? What are the key regulatory challenges? How do these compare with small molecules? Leader: Katherine Call – Global Head, Biotherapeutics Initiative, Sanofi-Aventis Panelist 1: Bob Lutz – Executive Director, Preclinical Director, Immunogen Panelist 2: Dan Dransfield – Senior Director, Cell Biology, Dyax Panelist 3: Mary Haak Frendscho – CSO & VP Preclinical R&D, Xoma
6:15 - 7:00pm	Cocktail Reception & Toast
7:30 - 10:00pm	Dinner & Keynote Speech

Thursday, 1 May 2008
7:00am	Breakfast
8:30 - 12:10pm	Meetings	WORKSHOP 6 Aperio and Digital Pathology Leader: Dr. Steven Potts, Aperio Monitoring the local tissue environment in discovery: examples from metabolism and oncology Angiogenesis, colocalization and phosphomarker measurements across whole slides Going digital in preclinical: getting more quantitative toxicology from your CROs and tox pathologists Digital pathology in clinical trials: eliminating geography in international trials
		WORKSHOP 7 Leader: Dr. Tom Daniel – President, Celgene Research Biosimilars The development of biosimilars for a range of recombinant protein classes Identification of licensing and collaboration trends shaping the biosimilars evironment Future trends in shaping the biosimilar regulatory environment evolution The competitive landscape - how the key players are dominating the environment Trends: target protein class, drug delivery and reformulation technology, geographical launch market Established biosimilar developers v. emerging biosimilar developers
		WORKSHOP 8 TeraDisc High performance supercomputing clusters to the drug discovery process Building the largest drug discovery computing platform in existence Genome wide "interactomics" models of cells to reduce the cost of drug discovery and accelerate the timeline
		WORKSHOP 9 SIGMA ALDRICH Zinc Finger Nucleases: Technology for Targeted Genome Editing Learn how ZFN facilitate genome editing, including target gene deletions, insertions, and modifications Learn how ZFN technology is being applied today to Pathway Analysis, Drug Discovery, and BioPharmaceutical Production See real world examples where ZFN-mediated Gene Knockouts and Knockins have been created in mammalian cell lines
12:15 - 1:15pm	Keynote Workshop 2 Adobe Gaining Competitive Advantage: Adobe Technology Streamlines Regulatory Review, Approval and Document Management Explore how PDF, along with Adobe Acrobat and LiveCycle ES can he streamline elements of the submission process, including document creation, collaboration, assembly, review, and approval. Discussion topics include: Standards-PDF/A, ISO 3200, AIIM/ASTM PDF in Healthcare, DICOM, HL7, CDISC Security-Access control, rights management, redaction Digital Signatures-SAFE digital signatures, 21 CFR Part-11, certification, E-Lab Notebooks Review and Approval features-Review tools, collaboration workflows, ECM/EDMS integration, archival Electronic Data Capture - eForms, XML, dynamic barcodes
1:15 - 2:00pm	Lunch
2:00 - 3:20pm	Meetings	WORKSHOP 10 Translational Medicine/Oncology Panelist 1: Dr. Francesco Marincola - NIH Panelist 2: Dominic Spinella - Senior Director, Translational Medicine, Global Oncology Lead, Pfizer Panelist 3: Jonathan Pachter - Senior Director, Cancer Biology, OSI Pharmaceuticals Inc
3:35pm	Farewell Drinks