Elizabeth Gardiner H.E. Mao Tan Eang Maarten van Cleeff Ya Diul Mukadi Jane Ong’ang’o New Regimen Introduction Planning Panel.

Elizabeth Gardiner

H.E. Mao Tan Eang

Maarten van Cleeff

Ya Diul Mukadi

Jane Ong’ang’o

New Regimen Introduction Planning Panel

TB Regimen Introduction Planning

Elizabeth Gardiner– TB Alliance

SHA Meeting

28 October 2013

Paris, France

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Global level planningWhat 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 regimen

• Persuade manufacturers to develop FDCs, ensure BE, demonstrate stability, produce validation lots

• Design and pre-test patient kit packs

• Produce & package regimen

• Determine who will buy regimen

• Solicit bids for supply• Establish agreement(s)

between procurer(s) and manufacturer(s)

• Identify sources of funding for procurement

• Purchase product• Inspect, test and ship

products• Import product into

countries

• Assess availability of diagnostics

• Develop and get input on proposed testing algorithms

• Identify manufacturers and advocate for new DST tools

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• A plan tailored to each country– National policy approval requirements, timelines and processes for adoption– Regulatory planning: short and long-term– Questions to address and outcomes to monitor in a demonstration study– Procurement: 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 regimen

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2013

• Complete trial• Initiate data analysis• Initiate country

introduction & demonstration planning

• Determine budgets for introduction

2014

• Complete data analysis

• File US, South Africa & Europe moxi for TB approval

• Seek WHO guideline approval

• Initiate approval discussions in early adopter countries

• Develop FDCs to accompany moxi

2015

• File moxi for TB & FDCs in endemic early adopter countries

• File FDCs for WHO Prequalification & ERP

• Receive WHO guideline approval

• Introduce in US & Europe

• Finalize introduction and demonstration study plans in endemic early adopter countries

2016

• Receive waivers and approvals for FDCs & moxi for TB in endemic early adopter countries

• Introduce in endemic early adopter countries

• Conduct demonstration studies in endemic early adopter countries

Clinical, Regulatory, Manufacturing and Market Access activities in brief

Timeline for REMox Introduction

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Waves 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 change

2017-2018 2016-20172016

Strategic Considerations for Introduction of New TB Drugs

H.E. Mao Tan Eang – National TB Program, Cambodia

SHA Meeting

28 October 2013

Paris, France

Country-Level Technical Assistance for Introduction

Maarten van Cleeff - KNCV

SHA Meeting

28 October 2013

Paris, France

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.

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

Three core principles: 1. the state duty to protect against human rights abuses

by third parties2. the corporate responsibility to respect human rights 3. The need for more effective access to remedies

Better Health, Better Human Rights (2013)

“To really defeat these diseases, we have to focus onprotecting the basic human rights of the vulnerable, makingscientific advances available to everybody. This is notonly the right thing to do. It greatly increases the impact ofour investments”

Mark Dybul www.theglobalfund.org/en/blog/32491

Lessons from Xpert implementation

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

Anticipating Global policyBe prepared!!

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

• Guidance by NTP

2. Regulatory environment • Policy on a regimen change • Ethical clearance and approval around study protocals • Drug regulatory on registration importation • Building capacity for pharmacovigilance

3. Epidemiologic preparedness • Drug Resistance patters• Operational Research capacity

Anticipating Global policyBe prepared!!

4. 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….

5. Financing and its resources • Reservation for innovation• Role of GF, GDF, local budgets …..

Funding New TB Drugs

Ya Diul Mukadi - USAID

SHA Meeting

28 October 2013

Paris, France

Transitioning from Clinical Trials to Adoption Advocacy

Jane Ong’ang’o - KEMRI

SHA Meeting

28 October 2013

Paris, France

Research Life-CycleResearch Question

Protocol

Recruitment

Enrolment

Follow-up

Results

Dissemination of Results & Negotiations of Next Steps

Stakeholder Engagement

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• Identify relevant stakeholders

• Appropriate type of engagement; being informed, consulted, collaborated with, or empowered to make decisions

• Engagement methods; public meetings, workshops, sensitisation meetings

Community Engagement

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• A 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 results– All possible outcomes– Timelines for availability of results– Contacting & informing trial participants of research results

(trial closure and result dissemination)The Transition

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• Other 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