[Ip-health] Conference on Fixed-Dose Combination (FDC) Drug Products

[Mike Palmedo]

Bill Haddad asked me to post four documents to the list having to do
with the upcoming conference on the safety and efficacy of Fixed-Dose
Combinations.  The conference will be held May 29-30, and is sponsored
by UNAIDS, WHO, Southern African Development Community, and the US Dept.
of Health and Human Services.

Synopsis of meeting (Also cut-and-pasted below)
http://www.cptech.org/ip/health/botswana-synopsis.doc

Agenda
http://www.cptech.org/ip/health/botswana-agenda.doc

Registraion
http://www.cptech.org/ip/health/botswana-reg.doc

Draft Document; "Scientific and Technical Principles for Fixed Dose
Combination Drug Products"
http://www.cptech.org/ip/health/fdc-principles.pdf

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Conference on Fixed-Dose Combination (FDC) Drug Products:
Scientific and Technical Issues related to Safety, Quality, and
Effectiveness

29-30 March 2004
Gaborone, Botswana


Co-sponsors:
"    Joint United Nations Programme on HIV/AIDS (UNAIDS)
"    World Health Organization (WHO)
"    Southern African Development Community (SADC)
"    United States Department of Health and Human Services (HHS)


Background

HIV/AIDS, TB, and malaria are the foremost infectious disease threats to
public health that the world faces today and are the focus of many
global initiatives. Many consider combination therapy to be essential to
the treatment of these diseases and to the prevention of drug
resistance. An important approach to addressing the management of these
diseases has included the development of fixed-dose combinations (FDCs)
of individual components administered together to simplify treatment
regimens, improve patient adherence, and facilitate the implementation
of interventional programs and prevent the development of drug
resistance.  Notwithstanding the above, there will be cases where
individual drugs must be utilized for certain patients because of the
challenges of dose titration, allergies to one or more of the
components, different pharmacokinetic and/or pharmacodynamic profiles,
and pharmaceutical development. The development of FDCs may vary
depending on their individual active components and on the indication(s)
that they target. Currently, there are no uniform principles,
guidelines, or international standards addressing the development of
FDCs and their potential benefits or disadvantages in treating these
diseases.


Purpose of the Conference

The conference will discuss the draft Scientific and Technical
Principles for Fixed-Dose Combination Drug Products (Principles
Document) developed by the Planning Group at its preparatory meeting in
February 2004 in Cape Town, South Africa. During the opening session,
presentations will place the draft Principles Document in a global
context. Planning Group members will explain each of the various
sections of the document and highlight areas on which comments would be
especially helpful. The Conference participants will be asked by the
Planning Group for feedback about specific sections of the document. The
Planning Group will meet following the conference and make revisions to
the draft document based on the conference deliberations. The conference
co-sponsors plan to agree on the content of the final document within
approximately two weeks after the conference.



Purpose of the Document

The Principles Document focuses on aspects of the efficacy, safety, and
quality of FDCs. The document  provides points to consider when
developing, evaluating, and/or considering combination products for use
in programs that address optimum drug treatment combinations as
fixed-dose drug combinations for the treatment of HIV/AIDS,
tuberculosis, and malaria and their associated infectious diseases.

The document is not intended to be a therapeutic nor a regulatory
guideline, and it will not address specific clinical or non-clinical
quality issues or procurement and distribution of specific products. The
document will not deal with procurement per se and treatment guidelines,
patient adherence, or compliance with national regulatory requirements,
or offer direct detailed regulatory guidance.

The co-sponsors and collaborators in this initiative expect that
presenting a set of commonly agreed upon scientific and general
principles, based on current knowledge, of quality, safety, and efficacy
of FDCs for the treatment of HIV/AIDS, tuberculosis, and malaria, will
contribute substantially to international and national efforts to fight
these diseases.


Who Should Attend?
In addition to the co-sponsoring organizations and the Planning Group
members, we expect participation by government officials from drug
regulatory authorities, public health leaders, health care providers,
academia, procurement officials, the research-based and generic
pharmaceutical industry, and non-governmental organizations-including
patient groups, and international and regional organizations. The
conference will be open to the public. Registration is limited to 150.



The conference will be held on Monday and Tuesday, 29-30 March 2004,
09:00-17:00 at the Gaborone Sun Hotel, Nyerere Drive North, Gaborone,
Botswana. Phone: 267-395-1111;
Fax: 267-390-2555.