A Global Network for Clinical Research— Really? Greg Koski, PhD, MD, CPI (Honorary) Associate Professor of Anesthesia Harvard Medical School Senior Scientist James Mongan Institute for Health Policy Co-Founder, Alliance for Clinical Research Excellence and Safety

 Drug development has been entirely proprietary and conducted largely in corporate silos  Clinical trials are not “global”—they are international  Harmonization is a euphemism for failure to standardize!  One cannot keep doing things the same way and expect different results 2

3 “The current approach to drug development is inefficient, ineffective and unsustainable.” DIA Europe 2010

4 *The development time data point for 2009 includes data from 2008 and 2009 only Source: CMR International & IMS Health

5 The development time data point for 2009 includes data from 2008 and 2007 only Major companies are defined as those spending ≥US$ 2 billion in 2009 on ethical pharmaceutical R&D.

 For many, the current approach to drug development has lost its way  At one time, the foundation of pharmaceutical industry was its desire to develop new medicines and devices to treat and prevent disease  That foundation has been undermined by financial motives  The industry has lost public trust and respect as a result  The industry is repeatedly charged with unethical conduct and exploitation 6

 The failing silo business model must be reconsidered in light of dwindling pipelines, spiraling costs, growing regulatory burdens and declining productivity.  The erosion of public trust in the pharmaceutical industry must be addressed and the practices that have taken us down the current path must be changed. 7

THE GLOBAL AIR TRANSPORTATION SYSTEM Global Network of Airports and Air- Traffic Controllers Standardized Policies and Operating Procedures Shared Information and Communications Infrastructure

A GLOBAL AIR TRANSPORT “SYSTEM” Airports Travel Agencies & other Travel and Tourism intermediaries Freight ForwardersIndustry Suppliers Airlines

IATA - INTERNATIONAL AIR TRANSPORT ASSOCIATION The IATA was founded in Havana, Cuba, in April It is the prime vehicle for inter-airline cooperation in promoting safe, reliable, secure and economical air services -- for the benefit of the world's consumers. The international scheduled air transport industry is now more than 100 times larger than it was in Few industries can match the dynamism of that growth, which would have been much less spectacular without the standards, practices and procedures developed within IATA.

INTERNATIONAL AIR TRANSPORT ASSOCIATION to promote safe, reliable and secure air services. Safety & Security to achieve recognition of the importance of air transport worldwide social and economic development. Industry Recognition to assist the industry to achieve adequate levels of profitability, by optimising revenues while minimising costs (fuel, charges and taxation). Financial Viability to provide high-quality, value for money, industry required products and services that assist the airlines in meeting the needs of the consumer. Products & Services to develop const-effective, environmentally-friendly, standards to facilitate the operations of international air transport. Standards & Procedures to identify and articulate common industry positions and support the resolutions of key industry issues (congestion, infrastructure). Industry Support

THE GLOBAL AIR TRANSPORTATION SYSTEM Global Network of Airports and Air- Traffic Controllers Standardized Policies and Operating Procedures Shared Information and Communications Infrastructure

A GLOBAL CLINICAL RESEARCH SYSTEM Global Network of Accredited Research Sites and Research Ethics Committees Standardized Policies and Operational Procedures Shared Information Infrastructure and Pharmacovigilance System

 A global network of accredited, sustainable clinical research sites  Trained and certified professional research teams  Standardized operating policies and procedures  Committed to highest standards of performance  Trusted in their communities and by their global partners 14

 A shared infrastructure for clinical research that aligns good business practices with ethical principles to enhance safety and efficiency while reducing the cost and time required to bring new medical products to market.  Supported by a robust information technology platform to ensure safety and continually monitor and improve performance  The network would provide a framework for quality assurance and regulatory reform that would benefit the entire industry 15

 Drives and rewards standardization  Drives regulatory simplification and compliance  Enhances performance  Increases efficiency  Reduces redundancy  Promotes and enhances safety  Reduces costs  Increases transparency and improves public trust  Promotes investment in sustainable, self- supporting professional clinical research capacity in emerging nations and markets 16

IF WE BUILD IT, THEY WILL COME…  The Alliance for Clinical Research Excellence & Safety (ACRES), modeled after the International Air Transport Association(IATA), would:  positively align ethics, scientific integrity and good business practices  provide appropriate opportunities and incentives to further the mission of drug and device development  in a safer, scientifically sound, socially responsible manner that rewards all participants and stakeholders

IF WE BUILD IT, THEY WILL COME…  An independent, non-profit, non-governmental organization  Established/incorporated in an appropriate ‘international’ venue  Funded through an independent global trust fund supported by grants, donations, and user fees  Promote the use of existing tools, policies and processes rather than re-inventing them—  Facilitate abs streamline clinical research while improving safety and quality

ACRES NETWORK ARCHITECTURE—THE CORE Site Development & Operations Support Safety & Pharmacovigilance Quality Management & Systems Improvement Information Systems Management ACRES Secretariat

ACRES NETWORK ARCHITECTURE—THE SITES Site Director Principle Investigators Study Coordinators Data Manager Operations Manager Administrative Support Specialists Principal Investigators

ACRES NETWORK INFRASTRUCTURE— THE NEURAL NET  Web-enabled, “cloud-based” integrated information system with central data warehouse and knowledge engines  System support/facilitation of all operations  Point-of-entry EDC, including AE reporting  SOP driven continuous compliance/quality control  Shared data-base for trial initiation and support  Centralized quality assurance and safety monitoring