09h00-09h30

Opening session

09h30-13h00

Experiences with Fixed-dose Combinations

Objective

This session provides an overview of experiences with the use of FDC products for the treatment of TB, malaria and AIDS. The different papers and presentations highlight the issues related to selection, production, quality assurance, bioavailablity and stability. The issues of field research on packaging and co-blistering will provide practical examples of attempts to address this delivery problem

09h30-10h00

Fixed-dose combinations for tuberculosis: lessons learned from a clinical, production and regulatory perspective (R. Panchagnula) Comments/Feedback
Bernard Fourie to comment

10h00-10h30

Fixed-dose combinations for malaria: translating clinical recommendations to product supply (Peter Olumese and Andrea Bosman) Comments/Feedback
Clive Ondari to comment

10h30-11h00

Discussions

11h00-11h30

Coffee break

11h30-12h00

Fixed-dose combinations for HIV/AIDS: the pros and cons of experiences to date (Sanjay Pujari) Comments/Feedback
Joep Lange to comment

12h00-12h30

Analysis of the impact of introduction on Fixed-dose combinations on supply management and security when compared with separate dispensing and/or co-blistering (Jane Masiga) Comments/Feedback
Cécile Macé to comment on field experiences with FDCs and co-blistered products

12h30-13h00

Discussion

13h00-14h00

Lunch

14h00-17h15

Public Health Needs for Fixed-dose Combinations

Objective

This session reviews the evidence available related to the value of FDC’s in improving compliance and outcomes as well as the effect on the emergence of antimicrobial resistance.

14h00-14h30

Review of the evidence on better compliance and treatment outcomes with Fixed-dose combinations when compared with separate dispensing and/or co-blistering (Jennie Connor) Feedback/experience

14h30-15h00

Review of the evidence on effect of fixed-dose combinations on the development of clinical resistance when compared with separate dispensing and/or co - blistering (Warren Kaplan) David Lee to comment on both papers

15h00-15h30

Discussion

15h30-15h45

Tea break

15h45-16h15

Field research on packaging, co-blistering; and experiences with other combinations (Jane Kengeya Kayondo) David Hoos to comment on the use of co-blistering for the MTCT+ program

16h15-16h45

Comparison of the product cost of Fixed-dose combinations in comparison with separate dispensing and/or co-blistering (Robert Bwire) Comments/Feedback Yolanda Tayler to comment on cost and FDC procurement issues Harvey Bale to comment on effect of tariffs and taxes on drug costs

16h45-17h15

Discussion

18h00

Reception/Cocktail

09h00-13h00

Public Health Priorities

Objective

These three presentations in the morning are designed to lay out the issues and experiences relating to the production, procurement, quality assurance and use of ARV FDCs.

09h00-09h30

Preferred fixed-dose combinations of ARVs for first line use in HIV/AIDS (Joseph Perriens/Marco Vitoria) Comments/Feedback

09h30-09h45

Clinical perspective from the field on dosing flexibility (Joep Lange)

09h45-10h00

Clients perspective on Fixed-dose combinations versus dosing flexibility

10h00-11h00

Discussion Bernard Pécoul to comment

11h00-11h30

Coffee break

Objective

This session will highlight the experiences faced in bringing FDC anti malarials to the stage of them being widely supported and promoted. The process which was used of undertaking clinical trials to demonstrate efficacy and additionality will be presented. The lessons learned about dealing with regulatory hurdles will be highlighted.

11h30-12h00

Additional fixed-dose combinations for malaria (Piero Olliaro and Robert Taylor) Comments/Feedback Andrea Bosman and Tom Kanyok to comment

12h00-13h00

Discussion

13h00-14h00

Lunch

14h00-17h00

Intellectual Property Rights and Legal Options

Objective

This session will address the legal and practical issues around patent barriers. The first paper and discussion will focus on the issues, the definitions and the options. The discussion will allow different perspectives to be expressed. The second part of this session will be an opportunity for members of industry to present the key results of the meeting held the previous Friday in Washington DC.

14h00-14h30

Legal options for overcoming patent barriers of fixed-dose combinations (Warren Kaplan)

14h30-15h00

Discussion led by Richard Wilder Ellen t Hoen and Cecilia Oh to comment Cynthia Cannady (WIPO) to comment

15h00-15h45

Summary of Gates Foundation sponsored meeting on FDCs held in Washington DC December 12^th 2003 Panel Presentation and Discussion

15h45-16h00

Tea break

Objective

These two sessions will focus on country experiences around the procurement of ARVs particularly FDC ARVs and also issues around TB FDCs. This will be done from the perspective of the major UN Pharmaceutical supplier and a major NGO responsible for both TB and AIDS treatment programmes.

16h00-16h15

Country level experience (Hanne Bak Pedersen)

16h15-16h30

MSF’s experience in procuring ARVs. Lessons from the field (Bernard Pécoul)

16h30-17h00

Discussion

09h00-13h00

Pharmaceutical Development and Quality Assurance and Regulatory Requirements

Objective

The sessions for the morning will all address the issues around formulation and registration and regulation of FDCs. The first presentation will outline the range of issues to be addressed in planning to produce an FDC product. The next session will report on practical experiences gained in producing FDCs from the perspective of a manufacturer. Issues around prequalification assessments will be presented by a regulator closely involved in this process. Thorny issues around when clinical trials are needed to validate FDCs and which comparators should be used for assessing bio availability will be addressed.

09h00-09h30

Development of Fixed-dose combinations; pharmaceutical considerations (Susan Walters)

09h30-09h50

Product formulation of Fixed-dose combinations; practical experiences (Vinod Arora)

09h50-10h30

Discussion

10h30-11h00

Coffee break

11h00-11h30

Assessment Experiences with fixed-dose combinations (ARVs and Tuberculosis) (János Pogány)

11h30-11h50

When are new clinical trials needed? (Leonard Sachs)

11h50-12h10

What comparator products should be used for bioequivalence? (Roger Williams)

12h10-13h00

Discussion Jérôme Barré to comment

13h00-14h00

Lunch

14h00-17h00

General Discussions

Objective

The afternoon session will be devoted to synthesizing what has been covered in the meeting, identifying areas of clear agreement, areas of dispute that could be investigated further and areas where further work is needed to clarify the issues. After the tea break a session will be held for WHO staff to agree on conclusions and recommendations for WHO actions.

14h00-15h30

Discussion by all participants Overview of main observations and recommendations for each of the main subject areas

15h30-16h00

Tea break

16h00-17h00

Conclusions and recommendations for WHO actions Note: This final session will be WHO staff members only. Identification of next steps (action points, research priorities, etc.) facilitated by Robert Ridley