Partnerships in drug discovery and development for diseases of the developing world

Ken DuncanBioDundee, Dundee29 May, 2013

2

TOPICS

1. Introduction to the work of the Bill & Melinda Gates Foundation

2. Drug discovery portfolio

3. Importance of partnerships in TB drug discovery and development

3

TOPICS

1. Introduction to the work of the Bill & Melinda Gates Foundation

2. Drug discovery portfolio

3. Importance of partnerships in TB drug discovery and development

© 2010 Bill & Melinda Gates Foundation |

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Bill and Melindaread an articleabout rotavirus

They officially create the foundation

Warren Buffettdecides to

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Bill joins Melindafull-time at the

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Global Health Program

Global Development

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For the year ended December 31, 2011. Amount in thousands.

(by Program Area)

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TOPICS

1. Introduction to the work of the Bill & Melinda Gates Foundation

2. Drug discovery portfolio

3. Importance of partnerships in TB drug discovery and development

Drug discovery priorities

Malaria Helminths

Diarrheal Disease

TB

Platforms

Drug discovery priorities

Malaria

Bell et al. Nature Reviews Microbiology 4, S7–S20 (2006)SERCaP(Single Encounter Radical Cure and

Prophylaxis)

Target Product Profile

Drug discovery priorities

Helminths

Onchocerciasis: "River Blindness"Onchocerciasis: "River Blindness"

Lymphatic Filariasis: "Elephantiasis"Lymphatic Filariasis: "Elephantiasis"

Macrofilaricide

Kill Adult wormsSafe in Loa loa regions

Target Product Profile

Drug discovery priorities

TB

Novel combination

Shorter, safer treatmentOvercome MDR-TB

Target Product Profile

Drug discovery priorities

Diarrheal Disease

Adapted from The Global Burden of Disease: 2004 Update; WHO

Anti-secretory

Boost ORS effectivenessIncrease ORS compliance

Target Product Profile

Drug discovery priorities

Platforms

Grantees and partnersTarget Lead Candidate

LeadOptimisation

Targetvalidation

Pre-clinical ClinicalDevelopment

LeadIdentification

Targetidentification

Product Development Partnerships

Academia, Institutes

Pharma

Biotech

TOPICS

1. Introduction to the work of the Bill & Melinda Gates Foundation

2. Drug discovery portfolio

3. Importance of partnerships in TB drug discovery and development

TB treatment today

6-24 months

Multiple drugs

Isoniazid

Rifampicin

Pyrazinamide

Ethambutol

Complexity: DOTS

Safety, drug-drug interactions

The World needs a shorter, safer drug regimen

Bedaquiline, first new TB drug approved in over 40 years

December 31, 2012

Importance of Partnerships

Target Lead Candidate

LeadOptimisation

Targetvalidation

Pre-clinical ClinicalDevelopment

LeadIdentification

Targetidentification

TBDA

CPTR

24

CPTR: A new development paradigm

TBDA

Next generation therapy

Goal:A new first line drug regimen that works in one month or less

Problem:Few new drug candidates, little diversity

Solution:An integrated cross-industry-academia discovery partnership

Challenge:

TBDA

The TBDA is a groundbreaking partnership between seven pharmaceutical companies and six research institutions collaborating on early TB drug discovery

The TB Drug Accelerator

How it works…

Company Compound

Libraries

Collaborative Discovery Research 5 new preclinical candidates

2016

1 month regimenproof of concept

2021

• Hit and Lead Generation• Target Identification

• Lead Optimization

Research Institutions: Pharmaceutical Companies: With support from:

TBDA

The TBDA is a New Paradigm For Drug Discovery

The TBDA offers a new approach that addresses many of the bottlenecks in the way TB drugs are currently developed

ONLY THE BEST CANDIDATES ADVANCE

Early Collaboration

Avoid Redundancy

Data Sharing

MaximizeEfficiency

Overcome Competitive

Barriers

Companies Work on Each Other’s

Compounds

TBDA

• Partnerships such as the TBDA show how industry and others can work together in new ways to support global health innovation

• The TBDA model could be applied to other disease areas that lack incentives for research or require combination drug therapies

The TBDA Offers a Model for Other Initiatives

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