Elizabeth Gardiner H.E. Mao Tan Eang Maarten van Cleeff Ya Diul Mukadi Jane Ong’ang’o New...
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Transcript of Elizabeth Gardiner H.E. Mao Tan Eang Maarten van Cleeff Ya Diul Mukadi Jane Ong’ang’o New...
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
3
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
4
• 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
5
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
6
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
18
19
• 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
20
• 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
21
• 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