Building Global HIV/AIDS Clinical Pharmacology Research Capacity

1. Building Global HIV/AIDS Clinical Pharmacology Research Capacity Establishing Regional Centers of Excellence Kimberly Scarsi, PharmD, MS Northwestern University, Feinberg School of Medicine Division of Infectious Diseases Center for Global Health

2. Establishing Regional Centers of Excellence Presentation Outline • Regional Planning for HIV Clinical Pharmacology Capacity • Establishing Centers of Excellence to Meet Training and Resources Needs • Developing an integrated research capacity building through the Center of Excellence approach

3. Establishing Regional Centers of Excellence What is a Center of Excellence? • A team of people that promotes collaboration and best practices around a specific focus area to drive results. • Hubs for knowledge sharing and capability building in a specific area of expertise. • Centralize resources, standardize processes, share strategic knowledge and more importantly, put in place a roadmap to sustain and develop operational excellence. • Where there are very high standards of work.

4. Establishing Regional Centers of Excellence Components of a Clinical Pharmacology Center of Excellence • Clinical pharmacy specialists • Drug information • Pharmacovigilance • Medication management • Outcomes research • Laboratory capacity • Analytical methods • Quality assurance systems • Research Capacity • Design and implementation • Analysis and evaluation • Grantsmanship • Manuscript writing • Training and Education • Using innovative and diverse methods

5. Establishing Regional Centers of Excellence Components of a Clinical Pharmacology Center of Excellence • Clinical pharmacy specialists • Laboratory capacity • Research Capacity • Training and Education While a Center of Excellence may strive to include all components, this is not practical in the beginning. Regionalization: A Practical Solution Capitalize on a specific area of expertise within a region, then link several Centers to provide the whole package

6. Establishing Regional Centers of Excellence Benefits of Regionalization • Capitalizes and places emphasis on regional strengths • Allows for outreach within the region for onsite support • Provides ease of visitation to the Center of Excellence by stakeholders and trainees • Contributes to improved regional clinical care and medical education through capacity building • Utilizes informatics and distance based collaboration to enhance the Center and further develop the areas it can support

7. Establishing Regional Centers of Excellence Objectives of a Pharmacology Center of Excellence (1) Provide services or subject matter experts to those in need • Serve as a referral laboratory for analytic methods • Provide evaluation of pharmacokinetic results • Remote provision of drug information via phone or email-based query submission SUPPORT http://agileelements.wordpress.com/

8. Establishing Regional Centers of Excellence Objectives of a Pharmacology Center of Excellence (2) Act as standards, methodology, tools and knowledge repositories • Promote laboratory and clinical capacity building throughout the country or region • Serve as a resource for various facilities, governments, and other partners • Provide pharmacology expertise in curriculum development at the local and national level GUIDANCE http://agileelements.wordpress.com/

9. Establishing Regional Centers of Excellence Objectives of a Pharmacology Center of Excellence (3) Offer training and certifications, skill assessments, and team building opportunities • Develop online or CD-ROM based curriculum for those in remote settings unable to reach the Center • Offer reciprocal professional exchanges • Develop regional certificate or training programs to allow for professional growth and opportunity SHARED LEARNING http://agileelements.wordpress.com/

10. Establishing Regional Centers of Excellence Objectives of a Pharmacology Center of Excellence (4) Demonstrate successful delivery of valued results • Monitoring and evaluation programs specific to clinical pharmacology • Professional development of center: • Grant submission and receipt, presentation at national/international meetings, manuscript publication MEASUREMENTS http://agileelements.wordpress.com/

11. Establishing Regional Centers of Excellence Objectives of a Pharmacology Center of Excellence (5) Allocating limited resources (money, people, time, etc.) • Personnel often assume multiple roles • Avoid duplication within a country/region and streamline procedures • Efficient use of resources through collaboration GOVERNANCE http://agileelements.wordpress.com/

12. Establishing Regional Centers of Excellence Examples of potential locations • Zimbabwe • ACTG International Pharmacology laboratory • Collaboration with University of Buffalo • Uganda • Pharmacology laboratory with developing capacity for antiretrovirals and antimalarials • Collaboration with numerous institutions in the US and Europe • Medicines information center has been active for over 5 years • Nigeria • Two AIDS International Training and Research Program (AITRP) fellows have trained at NU and UB • Two pharmacokinetic studies have been completed and are pending presentation • Drug Information Center is in development

13. Panel Discussion - Audience Q&A