Transcript Public Private Partnerships - Gill Samue[...]

Public Private Partnership
Issues
in
Communicable Diseases
Dr Gill Samuels
Executive Director Science Policy & Scientific Affairs
Pfizer Global Research & Development
Sandwich Laboratories UK
Agenda
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Global Healthcare Challenge
Features of Pharmaceutical Industry R&D
The Challenge of Infectious Disease
The Therapeutic Gap
Bridging the Gap
Features of PPPs
Metrics of Success
Recommendations/conclusions
Agenda
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Global Healthcare Challenge
Features of Pharmaceutical Industry R&D
The Challenge of Infectious Disease
The Therapeutic Gap
Bridging the Gap
Features of PPPs
Metrics of Success
Recommendations/conclusions
Changes in global causes of death 1990 to 2020
Disorder
Ischaemic heart disease
Cerebrovascular disease
Lower respiratory infection
Diarrhoeal disease
Perinatal disorders
COPD
TB
Measles
Road-traffic accidents
Pulmonary cancers
Malaria
Self inflicted injuries
Cirrhosis of the liver
Stomach cancer
Diebetes mellitus
P
Violence
War Injuries
Liver Cancer
HIV
Ranking
1990
2020
Change in rank
1
1
0
2
2
0
3
4
-1
4
11
-7
5
16
-11
6
3
+3
7
7
0
8
27
-19
9
6
+3
10
5
-5
11
29
-18
12
10
+2
13
12
+1
14
8
+6
15
19
-4
16
14
-2
20
15
+5
21
13
+8
30
9
+21
Agenda
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Global Healthcare Challenge
Features of Pharmaceutical Industry R&D
The Challenge of Infectious Disease
The Therapeutic Gap
Bridging the Gap
Features of PPPs
Metrics of Success
Recommendations/conclusions
The Principal Contributors to the
Biomedical Knowledge Base
Government-Funded Basic Research
For example:
National Institutes of Health
Centre National de la Recherché Scientifique (France)
Academic Universities and Teaching Hospitals
The Medical Research Council (UK)
Privately Funded Basic Research
For example:
Academic Universities and Teaching Hospitals
Wellcome Foundation
Howard Hughes Medical Institute
Weizmann Institute of Science (Israel)
Research-Based Pharmaceutical Companies
World-wide Biomedical Knowledge Base
Applied Research by
Research-Based Pharmaceutical Companies
New Treatments for Disease
P
Select Disease Target
does it have a high unmet medical need?
can we do it in the laboratory?
can we test in patients?
return on investment?
P
Drug Discovery and Development
in cerebro
in silico
in vitro
in vivo
in homo
P
Pharmaceutical R&D - a Multi-Disciplinary Team
Administrative Support Analytical Chemistry Animal Health Anti-infective Disease Bacteriology
Behavioral Sciences Biochemistry Biology Biometrics Cardiology Cardiovascular Science Clinical Research
Communication Computer Science Cytogenetics Developmental Planning DNA Sequencing Diabetology
Document Preparation Dosage Form Development Drug Absorption Drug Degradation Drug Delivery
Over 100
Different
Disciplines
Working Together
Electrical Engineering Electron Microscopy Electrophysiology Environmental Health & Safety Employee Resources
Endocrinology Enzymology Facilities Maintenance Fermentation Finance Formulation
Gastroenterology Graphic Design Histomorphology Intestinal Permeability Law Library Science Medical Services
Mechanical Engineering Medicinal Chemistry Molecular Biology Molecular Genetics Molecular Models
Natural Products Neurobiology Neurochemistry Neurology Neurophysiology Obesity
Oncology Organic Chemistry Pathology Peptide Chemistry Pharmacokinetics Pharmacology Photochemistry
Physical Chemistry Physiology Phytochemistry Planning Powder Flow Process Development
Project Management Protein Chemistry Psychiatry Public Relations Pulmonary Physiology
Radiochemistry Radiology Robotics Spectroscopy Statistics Sterile Manufacturing Tabletting Taxonomy
Technical Information Toxicology Transdermal Drug Delivery Veterinary Science Virology X-ray Spectroscopy
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Patient
Population
High
Medium
hypertension
g.i. (acid disorders)
arthritis (NSAIDs)
bacterial infection
sedation
analgesia
angina
lipid lowering
epilepsy
migraine
diabetes type 1
endometriosis
thrombosis
fungal infection
heart failure
chronic bronchitis
schizophrenia
Parkinson’s
psoriasis
drug/alcohol abuse
sexual dysfunction
wound healing
arrythmias
cirrhosis
hepatitis
Gaucher’s
irritable bowel syndrome
Crohn’s disease
ulcerative colitis
unstable angina
AIDS
multiple sclerosis
emphysema
cystic fibrosis
transplant rejection
septic shock
Low
P
obesity
dementia
arthritis (disease
modifying)
artherosclerosis
periph. vasc. disease
oral peptide delivery
AIDS vaccine
urinary incontinence
stroke/MI prophylaxis
cancers
allergies
herpes
hemophilia
chlamydia infection
emesis
Low
Source: Lehman Brothers
asthma
anxiety
depression
osteoporosis
prostate hypertrophy
diabetes type 2
male pattern baldness
acne
influenza
Medium
Medical Need
High
Driven
by
Medical
Need
New Medicine Timeline
Discovery & Development Process
12-15 Years and $5 - 800 Million
Discovery
Exploratory Development
Phase I
0
Idea
P
Phase II
Phase III
15
10
5
3 - 11 years
Full Development
7- 9 years
12 -15 years
2- 4 years
Drug
Attrition
Complex Disease Targets
Not Sufficiently Selective
Too Long in Body
Most
Adverse Reactions
Compounds
Unsafe
Do Not Become
Unstable
Poor Absorption
Low Levels in Body
Not Effective Enough
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Medicines
Side Effects
Competition
Impractical To Make
~100 Discovery Approaches
Attrition in the
R & D Process
7,000,000
Compounds Screened
1,000
Screening Hits
12 Candidates
1 Product
6 Candidates
Discovery
Exploratory Development
Phase I
0
Idea
P
Full Development
Phase II
Phase III
10
5
12 -24 Years
15
Drug
Agenda
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Global Healthcare Challenge
Features of Pharmaceutical Industry R&D
The Challenge of Infectious Disease
The Therapeutic Gap
Bridging the Gap
Features of PPPs
Metrics of Success
Recommendations/conclusions
Medicines Developed for Tropical Diseases
Disease
fP
Drug
African Trypanosomiasis
eflornithine
Chagas’ Disease
benznidazole, nifutrimox
Cysticercisis
albendazole, praziquantel
Fascioliasis
triclabendazole
Giardia, moebiasis
secnidazole, tinidazole
Giardia, Helminths & Amoebiasis nitazoxanide
Helminthiasis
albendazole, flubendazole, levamisole
mebendazole, pyrantel pamoate
Hydatid
albendazole
Leishmaniasis
amphotericin B
Leprosy
clofazimine, ofloxacin
Lymphatic Filariasis
albendazole, ivermectin
Malaria
Amodiaquine, atovaquone/proguanil
halofantrine, co-artemether
mefloquine, pyrimethamine, sulfadoxine/
pyrimethamine
Onchocerciasis
ivermectin
Schistosomiasis
metriphonate, niridazole, oxaminiquine
praziquantel
Strongyloidiasis
ivermectin
TB
various
Trachoma
azithromycin
Source: FIIM-IPFMA, December 2000
Agenda
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Global Healthcare Challenge
Features of Pharmaceutical Industry R&D
The Challenge of Infectious Disease
The Therapeutic Gap
Bridging the Gap
Features of PPPs
Metrics of Success
Recommendations/conclusions
Infectious Disease Burden in Developing
Countries
Every infectious disease is different
- for some, products exist and are accessible
- for many, products exist, but problems with access,
affordability or acquired drug resistance
- for some, R&D underway, but has yet to deliver new
medicines
- in other, limited R&D because insufficient science base
- for some doubts on ROI to support ongoing R&D
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Agenda
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Global Healthcare Challenge
Features of Pharmaceutical Industry R&D
The Challenge of Infectious Disease
The Therapeutic Gap
Bridging the Gap
Features of PPPs
Metrics of Success
Recommendations/conclusions
Defining Medical Need
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Mortality/Morbidity
Disease trends
Cost to society
Percentage accessible to treatment
Availability of non-drug interventions
Limitations of existing products
Alternative potential interventions
Scientific challenge
Extent of current industry engagement
Agenda
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Global Healthcare Challenge
Features of Pharmaceutical Industry R&D
The Challenge of Infectious Disease
The Therapeutic Gap
Bridging the Gap
Features of PPPs
Metrics of Success
Recommendations/conclusions
Types of PPPs
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Generate basic knowledge/research
Product discovery and development
Improvement of access to health products
Global co-ordination mechanisms, including funding
vehicles
Health Service strengthening
Public education and advocacy
Regulation, quality assurance and standards
Features of R&D - PPPS
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Use some private-sector approaches to attack research
and development challenges
Target one or more ‘neglected diseases’
Use or intend to use variants of the portfolio
management approach
Primary objective is public health rather than a
commercial goal
Are focused on developing products specifically suited
for use in developing countries
Agenda
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Global Healthcare Challenge
Features of Pharmaceutical Industry R&D
The Challenge of Infectious Disease
The Therapeutic Gap
Bridging the Gap
Features of PPPs
Metrics of Success
Recommendations/conclusions
How to Maximise Chance of Success
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Clearly defined mission with a well articulated goal
Adequate financing for the initial phases of mission and projection
of total financing required to meet the end goal
Top management team with access to the best science and a
track-record in product development
Plan which identifies the steps to be taken, by whom and when, in
order to achieve the mission
Real collaboration from partners with the expertise required
Active and independent oversight from an experienced board
Robust portfolio with rigorous portfolio management processes
Indirect and Direct Measures of Success
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Direct fund raising success
Early pipeline successes
New attention to some neglected diseases by some major
pharmaceutical companies and selected biotechnology firms
Early advocacy and education successes
Development of some infrastructure including clinical trial networks
New collaborations between the North and South and some
emphasis on capacity building
Development of a cadre of management talent, able and willing to
apply private-sector models to public-sector neglected-disease
challenges
The Long Road to a New Medicine
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Agenda
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Global Healthcare Challenge
Features of Pharmaceutical Industry R&D
The Challenge of Infectious Disease
The Therapeutic Gap
Bridging the Gap
Features of PPPs
Metrics of Success
Recommendations/conclusions
Recommendations/Conclusions
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Partnerships should be neither over-competitive with each other,
nor monopolistic
A sense of common purpose and direction is needed that
facilitates cross-linkages and synergies where appropriate
The product profiles being sought by PPP’s should be in line with
global health need
Exploratory research, and early product R&D – translational
research – needs to be supported to ensure that product R&D
pipelines are maintained
Appropriate mechanisms need to be in place to ensure the
continued and sustainable production and distribution of useful
new products
Recommendations/Conclusions cont.d
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Appropriate downstream research – implementation research –
needs to be undertaken to optimise product use and provide
evidence for policy
Conflicts of interest should be minimised
Capacity building and capacity utilisation in developing countries
should be integrated into product R&D activities
There should be strong stakeholdership from developing countries
within the context of product R&D, product use and product
delivery
The Millennium Development Goals
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Eradicate extreme poverty and hunger
Achieve universal primary education
Promote gender equality and empower women
Reduce child mortality
Improve maternal health
Combat HIV/AIDs, Malaria and other diseases
Ensure environmental sustainability
Build a global partnership for development