Health Care, Biotechnology, Life Science NIST Strategic Plan

VCAT Break-Out Session: Biosciences/Health Care VCAT: Tom Baer Jim Serum Lou Ann Heimbrook NIST Senior Staff: Willie May Cita Furlani Hratch Semerjian Bill Ott NIST VCAT 3/6/2007 VCAT Productivity Model Assumptions* Pvcat (t ) = ∑ P (t ) i vcat i Spong Cassidy Serum Baer etc. αi .999 .999 .95 .28 Pvcat (0) = ∑ α P i i Heimbrook .999 i i vcat * Gebbie, Furlani, Baer (2007) NIST VCAT 3/6/2007 VCAT Productivty Standard Model Bill Jeffrey’s Presentation Pvcat 160 140 120 100 Pvcat 80 60 40 20 Pvcat 160 140 120 100 80 60 40 VCAT Productivity Predicted vs Time 20 0 0 50 100 150 0 800 -20 200 900 1000 1100 1200 1300 1400 1500 1600 1700 250 300 350 Time PPT Slide/Hour Lunch NIST VCAT 3/6/2007 VCAT Actual Productivity vs Time VCAT Productivity (measured) vs Time 140 120 100 80 Pvcat 60 40 20 Bill Jeffrey’s Presentation 900 1000 1100 1200 Time 1300 1400 1500 1600 1700 0 800 NIST VCAT 3/6/2007 Biosciences/Healthcare Breakout Group NIST staff comments on VCAT subgroup activities • What would be most constructive way to interact? Group discussion on NIST history of supporting the biomedical industry Current NIST initiatives in this area • Current process for developing and prioritizing initiatives Industry overview (VCAT) and discussion (all) • Outline • Roadmap Examples Diagnostics Drug development Formulate Action Plan NIST VCAT 3/6/2007 Health Care, Biotechnology, Life Science NIST Strategic Planning: Strawman Process Outline industrial sectors Define critical measurements/technologies in sector Identify opportunities for advances in measurement science and development of critical standards Prepare summary Solicit input and comment from industry leaders Work with NIST staff to develop implementation plan NIST VCAT 3/6/2007 Major Industry Sectors Based on Bio and Medical Sciences Health Care • • • • Health Care Biotechnology Biotechnology Life Science Research • Energy • Food products Homeland Security • Materials Life Science Research Homeland Security • Forensics • Biometrics • Biohazard detection NIST VCAT 3/6/2007 Diagnostics Drug Development Medical Devices Services • Instrumentation, devices, and reagents for research Example: Health Care Industry sub-Sector Health Care • • • • • • • Diagnostics Drug Development Medical Devices Services Energy Food products Materials Biotechnology Life Science Research Homeland Security • • • Forensics Biometrics Biohazard detection • Instrumentation, devices, and reagents for research NIST VCAT 3/6/2007 Health Care Dollar Spending Phrma Annual Report 2006 NIST VCAT 3/6/2007 Health Care Sub-sector Application Areas Health Care IVD • Diagnostics • Blood/Tissue Chemistry Trace heavy metals Macromolecules: DNA, RNA, Protein Metabolites • Infectious diseases Micro-organisms Micro• Blood products: bone marrow, plasma, platelets • Immuno-histochemistry Immuno• ELIZA • FISH • • • • • • • Blood pressure Body temperature O2 sat EKG,EEG Respiration Blood glucose Blood coagulation Pathology Vital Signs Monitoring Imaging • Arthroscopy • Non-invasive imaging NonCT, MRI, PET, US, thermal • Biomarkers NIST VCAT 3/6/2007 Definitions What is Bioscience? • The study of the cause of diseases, the development of therapeutics and the diagnosis and treatment of diseases The study of biological materials for food, energy, environment, forensics and biohazard detection • VCAT Healthcare Subcommittee Life Sciences Industry Profile Academic Research Biotechnology Research Pharmaceutical Value Chain Basic Research Disease Discovery Drug Discovery Drug Develop Clinical Trials Manufacturing Patient Medical/Diagnostics Value Chain NIH NCI, etc Medical Research Chemical Diagnostics Imaging Diagnostics Gene Therapy Doctor’s Office Hospital VCAT Healthcare Subcommittee Pharmaceutical Value Chain Basic Research Academic Disease Discovery Business Strategy Disease Understanding Government Target Identification Private •Structural genomics •Genetics •Biomedical Research •Mammalian natural products research Drug Discovery Assay Development Lead Compound Selection Generate Compounds •Historical Libraries •Natural Products •Combinatorial Chemistry •Targeted Synthesis •Rational Design Drug Development Process Research Scale Up •Evaluate Mfg Process •Environmental safety •IP Clinical Trials Manufacturing & Post Market Surveillance. Phase I Trials •Initial testing of humans (50) •Normal population •Safety profile •Human metabolism •Pharmacokinetics Manufacturing •Process Monitoring •QA/QC •Troubleshooting Stability & Formulation Testing Safety Testing -InVivo •Animal testing •Toxicity Testing (side effects) •Metabolism (DMPk) •Pharmacokinetics •ADME Phase II Trials •Human testing (100-300) •Control studies - patients •Efficacy (does it work?) •Dosage (amount, frequency) •Safety and Metabolism •Final mfg process definition Evaluate Compounds •Characterize compounds •Screen for activity •Hi Thru-put Screening Post Market Survey •Ongoing monitoring of patients TargetValidation •Prior validation •Functional genomics •Human genetics •Animal genetics (knockouts & transgenics) •Exploratory clinical studies (academic reearch) •Research –Transcriptional Profiling –Proteomics –Biomedicine (Hits) Optimize Compounds •Late stage synthesis •Identification/Purification •Secondary screening •Testing in animals •Prelim bioavailability •Specificity, Metabolism •Pharmacology Phase III Trials •Human testing (1000's) •Safety testing, long duration •Multicenter studies •Comparative trial (to existing therapeutics) •3 years Clinical Plan Exploratory Drug Candidate (EDC) (Clinical Candidate) Phase IV Clinical Trials •New indications •New dosages Generics/ OTC •Bioequivalence to existing drugs (Leads) Development Candidate Discovery Investigational New Drug (IND) (CTX) New Drug Application (NDA) (PLA international) Informatics VCAT Healthcare Subcommittee Phrma Annual Report 2006 VCAT Healthcare Subcommittee Pharmaceutical Industry Needs Basic Basic Research Research Disease Disease Discovery Discovery Drug Drug Discovery Discovery Drug Drug Develop Develop Clinical Clinical Trials Trials ManuManufacturing facturing Measurement Requirements Current Techniques em T Measurement Issues lat p e VCAT Healthcare Subcommittee NIST in Biosciences/Healthcare Characterize industry segments and identify FOCUS, FOCUS, FOCUS Know where you want to make a contribution and prioritize your choices It takes a lot of money/resources to succeed in addressing the most critical measurement issues in Bioscience Dare to be “great”. Think big, think BOLD Assemble an organization that leverages the resources Set a goal to “be the recognized leader” for measurements and standards in your chosen segments of the industry… and make it a passion VCAT Healthcare Subcommittee Health Care, Biotechnology, Life Science NIST Strategic Planning: Strawman Process Outline industrial sectors Define critical measurements/technologies in sector Identify opportunities for advances in measurement science and development of critical standards Prepare summary Solicit input and comment from industry leaders Work with NIST staff to develop implementation plan NIST VCAT 3/6/2007