Elizabeth Gardiner - PowerPoint Presentation

Slide1

Elizabeth GardinerH.E. Mao Tan EangMaarten van CleeffYa Diul MukadiJane Ong’ang’o

New Regimen Introduction Planning PanelSlide2

TB Regimen Introduction Planning

Elizabeth Gardiner–

TB Alliance

SHA Meeting

28 October 2013

Paris, FranceSlide3

3Global level planning

What it takes to introduce a new regimen

Agreement with WHO to review, to establish a timeline

Prepare and submit data package to WHO

Develop and submit application to Essential Medicines List

Establish timelines and processes for review by FDA, EMA, WHO PQ, ERP

Prepare and file submissions to FDA, EMA, WHO PQ, ERP

Develop and implement

pharmacovigilance

plan

Design and implement demonstration study

Identify 1 or more manufacturers of all products in regimenPersuade manufacturers to develop FDCs, ensure BE, demonstrate stability, produce validation lotsDesign and pre-test patient kit packsProduce & package regimen

Determine who will buy regimenSolicit bids for supplyEstablish agreement(s) between procurer(s) and manufacturer(s)Identify sources of funding for procurementPurchase productInspect, test and ship productsImport product into countries

Assess availability of diagnostics

Develop and get input on proposed testing algorithms

Identify manufacturers and advocate for new DST toolsSlide4

4A plan tailored to each countryNational policy approval requirements, timelines and processes for adoptionRegulatory planning: short and long-termQuestions to address and outcomes to monitor in a demonstration studyProcurement: supply of

product for introduction

Diagnostic algorithm

Interest

and Commitment

Partnerships

Scope and timeline of implementation

Training

requirements Budget

Country level planningWhat it takes to introduce a new regimenSlide5

5

Clinical

,

Regulatory,

Manufacturing

and

Market Access

activities in brief

Timeline for

REMox Introduction Slide6

6Waves of Global REMox Adoption

Early Adopters

Convinced Mid-term Adopters

Global Adopters

High TB burden

Open to change

Politically stable

MDR testing and/or low MDR rates among new patients

----------------------

Regulatory leads

Convinced by the early adopters’ success

Longer decision-making processes

Greater challenges with changeSlide7

Strategic Considerations for Introduction of New TB Drugs

H.E. Mao Tan

Eang

– National TB Program, Cambodia

SHA Meeting

28 October 2013

Paris, FranceSlide8

Country-Level Technical Assistance for Introduction

Maarten van

Cleeff

- KNCV

SHA Meeting

28 October 2013

Paris, FranceSlide9

UN General Assembly on 10 December 1948 Everyone has the right:Article 25: to a standard of

living adequate for the health and well-being of himself and of his family, including

food, clothing, housing and

medical care

…..

Article 27: freely to participate in the cultural life of the community, to enjoy the arts and

to share in scientific advancement and its benefits.

 Slide10

The UN Ruggie Principles (2011); clarifying responsibilitiesof states and non-state actors with respect to human rights.

Three core principles:

the state duty to

protect

against human rights abuses by third parties

the corporate responsibility to

respect

human rights

The need for more effective access to

remediesSlide11

Better Health, Better Human Rights (2013)“To really defeat these diseases, we have to focus onprotecting the basic human rights of the vulnerable,

making

scientific advances available to everybody.

This is not

only the right thing to do. It greatly increases the impact of

our investments”

Mark

Dybul

www.theglobalfund.org/en/blog/32491Slide12

Lessons from Xpert implementationSlide13

Lessons from Xpert implementation

Countries were not prepared

The tool was there but not the full package for implementation

training, trial protocols, algorithms …

Didn’t anticipate downstream implication

matching diagnosis with treatment capacity

Lab experts implemented the tool

i.s.o

a multi-disciplinary (programmatic) approach Slide14

Anticipating Global policyBe prepared!!

Multi-stakeholder Technical Working group for introducing (drug) innovation

Guidance by NTP

Regulatory environment

Policy on a regimen change

Ethical clearance and approval around study

protocals

Drug regulatory on registration importation

Building capacity for

pharmacovigilanceEpidemiologic preparedness Drug Resistance pattersOperational Research capacity  Slide15

Anticipating Global policyBe prepared!!

Programmatic preparedness

Implementation trial trials in own country; become demonstration sites (COE) for scaling up

Pre-condition in place: Health services, patient support, (e-) M&E surveillance system, Lab DST capacity….

Financing and its resources

Reservation for innovation

Role of GF, GDF, local budgets …..Slide16

Funding New TB Drugs

Ya

Diul

Mukadi

- USAID

SHA Meeting

28 October 2013

Paris, FranceSlide17

Transitioning from Clinical Trials to Adoption Advocacy

Jane

Ong’ang’o

- KEMRI

SHA Meeting

28 October 2013

Paris, FranceSlide18

Research Life-Cycle

Stakeholder Engagement

18Slide19

19Identify relevant stakeholdersAppropriate type of engagement; being informed, consulted, collaborated with, or empowered to make decisionsEngagement methods; public meetings, workshops, sensitisation meetings

Community EngagementSlide20

20A transparent process essential to build/sustain trust and to lay a positive foundation for future research. (to give the answers)Trial closure meeting with research team, study participants and the relevant community stakeholders.Expectations about trial resultsAll possible outcomes

Timelines for availability of results

Contacting & informing trial participants of research results

(trial closure and result dissemination)

The TransitionSlide21

21Other relevant stakeholders (Broader stakeholders to enhance access); NTP, Local TB Advocates, Parliamentary HC, media Continue informing/updating community stakeholders of their rights, the access plan, factors influencing access (regulatory approvals, pricing)

Dissemination Plan