Monday , 13 – December, 2010

 

9:00-9:10

Opening and welcome:

 

Zora Dawood, OSF-SA

 

 

9:10-9:50

Introduction and Objectives of the meeting

 

Els Torreele, OSF NY, with Eloan Pinheiro, Brazil and Krisana Kraisintu, Thailand

 

 

 

-       Presentation of the meeting and its aims

 

-       Presentation of the participants and their background in short.

 

-       Presentation of the agenda,

 

-       The participants’ expectations out of the seminar: a quick round

 

-       Any final recommendations or new inputs into the final agenda?

 

 

 

Chair morning session: Nicoletta Dentico

9:50-11:00

Definitions - what is needs-driven innovation for health?  

 

Padmashree Gehl Sampath, Switzerland: 15 minutes presentation

 

Mira Shiva, India: 10 minutes feedback on Padma and other thoughts

 

45 minutes plenary discussion

 

 

 

ð   The CIPIH report clearly states that “the market is not a determinant of value” when you respond to needs. The problem, though, remains: how to balance needs and market dynamics? Can or should we embrace a market approach, given that the production and incentive structure, as well as the scientific and economic culture are built on purely market forces today? Most of the few R&D and access initiatives that have been created in recent years still largely operate within a market logic (see AMC, UNITAID, IAVI, CHAI). Can or should R&D for global health be profitable? Is it possible to explore a different path? What new “business models” can be tailored to better respond to needs in a geopolitically changing world increasingly hit by global issues (climate change, economic downturns, financial shortages)?

 

ð  Also, is innovation R&D, i.e. science and technology? What is innovation and how can we place R&D into a needs-driven innovation context? Can R&D function in isolation if you do not have all the related policies (fiscal policies, industrial policies, academic policies, regulatory policies, etc.) that can enable innovative R&D approaches function and be sustainable? What are the pre-requisites to contribute to a needs-driven innovation process? And what are the essential elements of a sustainable innovation effort?

 

 

11:00-11:20

Coffee and Tea Break

 

 

11:20-11:50

Short presentations of 3 initiatives of south-driven capacity

 

What is the mission? Where did it originate – who was/were the key driver(s)? And what is the current status?

 

-       Saigon Hi-Tech Park, Vietnam: Thai D. Nguyen

 

-       DNDi, global: Monique Wasunna

 

-       CAPRISA, South Africa: Andy Gray

 

 

11:50-13:00

Facilitated panel discussion: Needs-driven approaches for health: how can the global south

 

make a difference?

 

Discuss the role that countries in the South have played, are playing, can play into needs-driven innovation for health, in particular the different actors and sectors, and how they can interact (Government, civil society, private sector, academia)

 

Facilitator: Roxana Bonnell, OSF NY

 

Panelists:

 

Ahmed Ogwell, AFRO

 

Renata Reis, ABIA, Brazil

 

Sudip Chaudhury, Indian Institute of Management

 

S. Srinivasan ('Chinu'), LOCOST, India

 

 

13:00-14:00

Lunch

 

 

 

Chair afternoon session: Andy Gray

14:00-14:30

Short presentations of 3 initiatives of south-driven capacity

 

What is the mission? Where did it originate – who was/were the key driver(s)? And what is the current status?

 

-       PAHO regional innovation platform: Analia Porras

 

-       CNRST/IRSS, Burkina Faso: Drabo Maxime

 

 

14:30-15:30

Needs-driven approaches in Action: Q&A ongoing initiatives (Working groups)

 

In 3 smaller working groups, participants will discuss the already presented initiatives, as well as others as appropriate, with the goal of identifying common themes, challenges, or other issues that are relevant to the success of such an initiative, especially as it relates to the policy environment (local or international).

 

Each working group will have a chair and rapporteur.

 

 

15:30-16:00

Restitution from the working groups to the plenary

 

3 rapporteurs

 

 

16:00-16:20

Coffee and tea break

 

 

16:20-18:00

The R&D process explained : looking for adequate solutions for existing needs

 

Understanding the Needs and developing a target product profile (bringing the end goal to the R&D beginnings): 

 

Bhawna Sharma and Leena Menghaney (35’, incl 20 for discussion, Q&A)

 

 

 

Complementary approaches to address these needs:

 

Els Torreele (35’, incl 20 for discussion, Q&A)

 

-       Making better use of existing drugs and compounds: combinations, new formulations, extension of indications

 

-       New drug discovery: needs-driven versus market (patent)-driven

 

 

 

Challenges and opportunities in Formulation and Manufacturing

 

Krisana Kraisintu and Eloan Pinheiro (35’, incl 20 for discussion, Q&A)

 

 

18:30

Wine tasting & Dinner at The Green Dolphin

 

 

Tuesday, 14 – December, 2010

 

 

 

Chair morning session: Sudip Chaudhuri

 

 

9:00-9:30

Short presentations of 3 initiatives of south-driven capacity

 

What is the mission? Where did it originate – who was/were the key driver(s)? And what is the current status?

 

-       Pharmanguinhos, Brazil: Eloan Pinheiro

 

-       iThemba (including the GSK knowledge pool): Chris Edlin

 

-       PECET, Colombia: Ivan Velez

 

 

9:30-10:40

The R&D process explained (continued) : looking for adequate solutions for existing needs

 

Regulatory requirements: why are they needed, how are they set, who decides upon an “appropriate” risk-benefit ratio (is context dependent: other therapeutic options, cost and delay of doing additional studies vs urgency of medical need, etc), how does that influence study design?

 

Peter Folb (35’, incl 20 for discussion, Q&A)

 

 

 

Clinical development and access/delivery: (35’, incl 20 for discussion, Q&A)

 

Andy Gray and Chalermsak Kittitrakul

 

 

10:40-11:00

Coffee and Tea break

 

 

11:00-12:30

Q&A on the R&D process and which elements/challenges/constraints are most relevant for implementing needs-driven innovation (working groups) 

 

In 3 working groups, participants will discuss according to “classical” stages of development, which elements in the process stand out as opportunities, or challenges, to specifically build on to foster needs-driven innovation

 

-       Discovery and Preclinical Development

 

-       Clinical development

 

-       Formulation/Manufacturing

 

Each working group will have a chair and rapporteur

 

 

12:30-13:00

Restitution from the working groups to the plenary

 

3 rapporteurs

 

 

13:00-14:00

Lunch

 

 

 

 

Chair afternoon session: Jonathan Berger

14:00-14:30

Short presentations of 3 initiatives of south-driven capacity

 

What is the mission? Where did it originate – who was/were the key driver(s)? And what is the current status?

 

-       GPO, Thailand: Krisana Kraisintu

 

-       EDCTP: Thomas Nyirenda

 

-       Brazilian government PPP and technological development capacity building: Eloan Pinheiro

 

 

14:30-16:00

Facilitated panel discussion: What constitutes an enabling environment for needs-driven innovation?

 

Facilitator: Roxana Bonnell, OSF NY

 

Analia Porras, PAHO

 

Padmashree Gehl Sampath, PHI, WHO

 

Monique Wasunna, DNDi Africa

 

Kajal Bhardwaj, Indian civil society

 

Andy Gray, University of Kwazulu Natal

 

 

16:000-16:20

Coffee and tea break

 

 

16:20-17:30

Further discussion in working groups on what an enabling environment for needs-driven innovation would look like

 

In 3 working groups organized per region (Latin-America, Africa, Asia), participants will discuss which opportunities exists, which barriers need to be overcome, what needs to change to get there, and which role can each other stakeholders play to get there?

 

What are the major obstacles for governments, private sector, civil society, academia that slow down actions/developments? What are major opportunities?

 

 

18:00

Cape Town city tour and dinnerat Sal Restaurant

 

 

Wednesday, 15 – December, 2010

 

 

 

Chair morning session: Kajal Bharwaj

9:00 – 9:30

Presentation on other initiatives of south-driven capacity participants wish to share?

 

What is the mission? Where did it originate – who was/were the key driver(s)? And what is the current status?

 

-       Technology transfer for local production in Africa, Thailand: Krisana Kraisintu

 

-       Other?

 

 

9:30-10:00

Restitution from yesterday’s working groups to the plenary

 

3 rapporteurs

 

 

10:00-10:20

Coffee and tea break

 

 

10:20- 11:50

Plenary discussing major themes coming out of working groups and identifying/articulating clear opportunities

 

This needs to be organized to some degree the evening before in consultation with the facilitators

 

 

11:50-13:00

Small groups working on development of next steps needed based on identified opportunities

 

 

13:00-14:00

Lunch

 

 

 

Chair afternoon session: Marine Buissonniere

14:00-16:00

Final plenary session

 

-       report back on next steps identified in small group work

 

-       drawing the conclusions of the meeting

 

-       agreeing on the continuation of the process, and

 

-       defining the next steps forward