Finding Synergies in R

1
Finding Synergies in RD and increasing dialogue
between constituencies

• Opokua Ofori-Anyinam

2
Industry Is Doing More

• because it is expected
• Tres Cantos as an example- RD investment
• progress in education, science and technology
• new rules of global access are being defined
• new partners are emerging (GAVI
  alliance/PDPs/Regulatory agencies .)
• recognition in government that health equals
  wealth

3
Long Way To Product Development
4
Challenges of Clinical Development in
disadvantaged communities

• Accuracy of rates of disease to guide product
  development
• Competing research at the sites on same
  population
• Ethical challenges
• informed consent when formal education levels are
  low
• avoiding inducement by ensuring health care is
  available to the population
• ensuring that the product under evaluation is
  appropriate to the population

5
Challenges of Clinical Development in
Disadvantaged Communities

• Safety evaluation challenges
• safety signals are obscured by high background
  morbidity, particularly HIV
• attributing cause to SAEs is limited by the
  availability of diagnostic facilities
• HIV challenges
• HIV causes high morbidity in the general
  population in many areas
• Ensuring availability of treatment as per
  government policy
• Delivering data on use in HIV infected
  populations
• Ensuring an adequate regulatory strategy
• High cost of trials - associated with the need
  to fund infrastructure

6
Public Private Partnership/Product Development
Partnerships

• Ensure pipeline of products
• The public partner lowers the risk of development
  to the industrial partner by reducing their
  capital investment and ensuring market/access
  higher chance of success
• The public partner
• Funds infrastructure and capacity building at
  investigator sites, funds part of clinical
  development,
• The industrial partner
• Brings expertise in process development,
  manufacturing, clinical development, regulatory
  experience, distribution and marketing
• Both work in partnership to ensure market/access

7
A Product That Sits On the Shelf Is Useless
Uptake and Implementation

• Engagement of scientific community, policy
  makers and payers (funding organizations) -
  global, local recommendation and funding needs to
  allow implementation
• The lag time between availability and uptake
• Accurate forecasts of uptake impact on
  manufacturing
• Education to ensure that the environment will be
  receptive and supportive of the product to
  maximize implementation- choice- glut of new
  products all vying for integration in existing
  systems and funding
• Ensure rapid launch in at least some early
  adopter countries and extend the implementation
  across SSA as quickly as possible
• Financing Mechanisms

8
We have to build a consensus around the value of
the product
9
Acknowledgment

• To our many partners and colleagues in product
  development
• Communities and families who have participated
  clinical trials