1. Session 4 - Communities of practice Natural Products Drug Discovery The ICBG Program: A view from afar*
Special thanks to Joshua Rosenthal of the NIH Fogarty Center for his helpful discussions and figures on the ICBG program

2. Program goals and accomplishments
Objectives
International Cooperative Biodiversity Groups
Biodiversity exploration
Scientific and economic development
Biodiversity conservation
Modeled on CBD ABS and Merck/InBIO agreement
PIC, IP, and benefit sharing
Transitional period
New awards Philipines, Indonesia
continuing Panama, Madagascar
“ending” Uzbekastan/Kurdistan, Papua New Guinea, VietNam Laos
Fiji, Costa Rica (only two will survive)
Down to six in the end
800k/yr
Implementation
Competitive research grants (NIH/NSF/USDA)
Five years, $300 – 600k/year direct costs
Groups required academic institution and/or NFP, partner country, industrial partner
The grand challenge
Managing expectations
Technology vs. sociology

3. State of the field Commercial Competing technologies and strategies
Combinatorial chemistry
HTP and UHTP screening
Therapeutic targets/privileged stuctures
Economic pressures
Decline in new chemical entities
Biodiversity as a commodity
Transitional period
New awards Philipines, Indonesia
continuing Panama, Madagascar
“ending” Uzbekastan/Kurdistan, Papua New Guinea, VietNam Laos
Fiji, Costa Rica (only two will survive)
Down to six in the end
800k/yr
Political
Uncertainty of access
Uncertainty of provenance
Uncertainty of benefit

4. Microbial
Structure
Screening
cultures
Fermentation
Solvent
extraction
Primary assays
Synthetic compounds
Biocatalysis
Strain
improvement
Chemical
isolation
Dereplication
Secondary
assays
Bioprospecting
Safety
Assessment
Clinical
Trials
Patent
Scale-up
Medicinal
chemistry
Pharmacology
New product
Toxicology
Plants
Animals

5. Reality check # 1 N=natural product ND = natural derivatives
s’ = synthetic
S = pure syntehtic
downward trend, natural product molecular structure tends to have
All sources – total number of drugs
David J. Newman, NCI/NIH, 2005 Unpublished

6. Reality check # 2
Baltz, R., Microbe :

7. Outcomes Drug discovery Other benefits 14 years
$50 M (US govt)
12 groups
7 companies
21 countries
12,000 species
1500 bioactive compounds
0 drugs
>12,000+ spp collected
>1300 bioactive compounds isolated
>4000 people trained (350 long term)
Institutional capacity built in 16 countries
Informed bioprospecting policies in at least 6 countries
Initiated/ strengthened biodiversity reserves in 7 countries
Tested models of intellectual property rights and benefit-sharing/Established 14 Trust Funds
>500 publications

8. Market size
Approx. $100B
From A. Kuo and G.M.Garrity 2002 Exploiting Microbial Diversity,
In Biodiversity of Microbial Life, J.T. Staley and A-L Reysenbach, ed,
John Wiley

9. Why me? 1996 - present Professor, Microbiology & Molecular Genetics
Cofounder - Genomic Standards Consortium, Editor-in-Chief of SIGS (current), Bergey’s Manual ( )
Chair, International Committee on Systematics of Prokaryotes
Cofounder, NamesforLife, LLC
Merck and Co., Microbial Resources Group
Bioprospecting and culture acquisition agreements, culture collection
Natural products dereplication
Co-inventor on 22 natural product patents