PROMOTING AN EFFECTIVE MEDICAL COUNTERMEASURES ENTERPRISE
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1 PROMOTING AN EFFECTIVE MEDICAL COUNTERMEASURES ENTERPRISE Gerald R. Kovacs, PhD Director, Division of Chem/Bio/Rad/Nuc Medical Countermeasures Biomedical Advanced Research and Development Authority Assistant Secretary for Preparedness and Response US Department of Health and Human Services Institute of Medicine Workshop June 4, 2012
2 1 Outline BARDA s Mission and Strategic Plan Key Legislation Product Development Models Core Services Successes in Public-Private Partnerships Top Ten Lessons Learned
3 PRODUCT PIPELINE 2 PHASES Preclinical Development Drug Development is Expensive, Lengthy, & Risky IND NDA/BLA Discovery Phase I Phase II Phase III Licensure Production & Delivery NIH ($13.9 NIH ($11.8B) Valley of Death BARDA ($1.6 ($540M) B) Project BioShield ($5.6B) Licensed Product 1-3% 5-17% 10-25% 18-35% 45-70% 90% PROBABILITY OF SUCCESS TO LICENSURE TIME PIPELINE PHASE COST 3-7 yr yr 1-2 yr yr yr 1-2 yrs $100M -130M $60-70M $70M-100M $130M-160M $190M-220M $18M-20M
4 BARDA Mission and Modus Operandi Develop and provide countermeasures for CBRN threats, pandemic influenza, and emerging infectious diseases by product development, stockpile acquisition/building, manufacturing infrastructure building, and product innovation. If a product fails, it should only be the result of failure of the product to achieve the desired safety or efficacy thresholds, and not as a function of our inability to provide the proper support from a technical, business and regulatory perspective 3
5 4 BARDA s Strategic Plan Goal 1: An advanced development pipeline replete with medical countermeasures.. emphasizing innovation, flexibility, multipurpose, broad spectrum application, and long-term sustainability Goal 2: Provide core services to MCM innovators Goal 3: Agile, robust and sustainable U.S. manufacturing infrastructure Goal 4: Responsive and nimble programs and capabilities to address novel and emerging threats Goal 5: Capabilities to develop, manufacture and facilitate distribution of MCMs during emergencies
6 5 Legislation: The Basics Project BioShield Act (JUL 2004) Established Special Reserve Fund Established Emergency Use Authorization (EUA) PAHPA (DEC 2006) Established the Office of Assistant Secretary for Preparedness & Response (ASPR) Established BARDA and provided authority to invest in advanced product development PREP Act (DEC 2005) Limitation of liability related to countermeasures Declarations for specific countermeasures Goals: accelerate research, development, purchase, storage and distribution of medical countermeasures
7 6 Evolution of the MCM Enterprise Implementing and improving legislation Establishing governance structures Requirements setting Developing products Facing challenges with Emergency Use and Animal Rule Establishing stockpiles 2011 and Beyond Lessons learned from the Pandemic MCM Enterprise review New initiatives for all agencies Focus on Public/Private Partnerships Novel broad-spectrum and repurposing drugs Core services Sustainment models
8 Commitment to MCM Development Developing & providing MCMs for CBRN, pandemic influenza, and emerging infectious threats Over 125 product candidates in pipeline across a wide array of threats 9 products available under Emergency Use Authorization 3 licensed products Supporting establishment of domestic manufacturing infrastructure to produce products against pandemic influenza and known or unknown emerging infectious threats Supporting development of novel antibiotics for use against emerging public health threats and bio-threat agents Providing core services to product developers at all stages
9 Product Development Model Truth Seeking Emphasis on Proof of Concept Early R&D Integration of platforms, CROs, CMOs Relies on tech-transfers, data and model sharing Rapid Go/No Go Success-Seeking Emphasis on licensure and stockpiling Scale-up, validation of manufacturing Phase II/III, pivotal animal studies Life cycle and sustainment important 8
10 BARDA Core Services Regulatory & Clinical Affairs Technical Expertise Animal Studies Network Strategic Investor? Fill Finish Mfg Network Centers for Innovation in Advanced Development & Manufacturing 9
11 New CBRN Medical Countermeasures Smallpox Anthrax Radiation Botulism 10
12 11 Public-Private Partnerships Infrastructure Development Novartis Holly Springs, NC PanFlu Vaccine Emergent BioSolutions Lansing, MI Anthrax Vaccine
13 Public-Private Partnerships Novel Antimicrobials New approach for development of multi-purpose drugs Cost-sharing models implemented Biodefense and antibiotic resistance indications sought Supported by Pandemic and All Hazards Preparedness Act and the Secretary s MCM Enterprise Review Four partnerships initiated Achaogen - plague/tularemia/ventilator-induced pneumonia/catheter-induced UTI GSK - anthrax/plague/tularemia/hap/vap/uti CUBRC anthrax/plague/hap/vap Chimerix - broad spectrum antiviral against double-stranded DNA viruses (e.g., smallpox and adenovirus) 12
14 13 Top Ten List Lessons Learned Personnel need experienced professionals Bureaucracy limit it to a minimum (progress over process) Decisions establish infrastructure of accountability (Source Selection, Milestone Decision) Don t reinvent connect with other agencies (especially FDA) Project management Project Coordination Teams, clearly defined metrics Contracting contracting staff is integral to process Project evaluations Interagency In-Process Reviews, transparency Solicitations Broad Agency Announcement open 24/7, White Paper process Open door policy TechWatch brings in ideas/projects Congress establish firm relationships early
15 Contact Us URL: BARDA Upcoming Events PHEMCE Strategy and Implementation Plan CBRN and Pan Flu Programs Business Toolkit Tech Watch program Federally-sponsored conferences Funding opportunities Resources 7 core service programs Regulatory guidance Federal strategies and reports
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