Strengthen TeamWork between IP Managers and Scientist: GALVmed, Commercialization of
Vaccines in the Developing World
Intellectual Property Management to support SECOPI-AGRO’s Agricultural Innovation ProcessBogota, August 11-12th 2010
Monica Alandete-Saez,University California Davis, PIPRA
Technology TransferPublic
ResearchPrivate SectorPublic-Private
Partnership (PPPs)
Tech Transfer OfficeIP Management
Invention Investment CapitalRegulatory steps
Manufacture, etc.
Commercialization of a lucrative product (Agricultural or Health)
Interest in Profitable Market
Vaccine Commercialization
Regulatory Process has increased the cost of the vaccine development to very high IP Management
$$ Attract Private Sector
IP rights are essential for mobilizing the funds necessary
to meet the regulatory requirements
Vaccine Discovery
Registration
Commercialization
4.5 Years
Phase II
$8 M3 Years
Phase I
$4 M4 Years
Phase III
$160 M
R&D
Global Pharmaceutical Market and Neglected Diseases
Chapter 17.19. IP handbook of best practices
Availability: Vaccine needed predominantly by the poor do not receive high priority for R&D by the private sector
Cost: New vaccines are sold at prices beyond what the poor or their representatives can afford to pay
Chagas disease, malaria, tuberculosis, leishmaniasis, African sleeping sickness, schistosomiasis,…
Private Sector
Public Research
$$ FOUNDATIONS
Product Development Partnerships: PDPs
Public Benefit
Program for Appropriate Technology in Health
International non-for-profit organizations help provide appropriate health technology to the poorest countries by collaborating with
public and private partners
Objectives to meet with potential partners:1- Availability: Guarantee supply for the developing world
2- Accessibility: Right channels to actually reach the target
3- Affordability: Negotiate upfront prices for different markets
Drugs for Neglected Disease initiative
PARTNERS DISEASE PRIVATE SECTOR PUBLIC SECTOR
NEGOTIATION/ LICENSE WHERE
DNDi & European Comision (EC-INCO
DEV)
Malaria- FACT treatment sanofi-aventis Industrial validation,
production & distribution Africa
DNDi African
Sleeping Sickness
University of California (UCSF)
Royalty-free-license for commercialization
All disease-endemic countries
PATH and Bill & Melinda Gate Foundation
Cervical Cancer Screening
Two companies (IP portfolio)
Low cost, simple use and acceptable
production & distribution ov HPV diagnostic test
Africa
PATH and Bill & Melinda Gate Foundation
Meningococcal A Vaccine
SynCo Bio Partners BV & Serum Institute of India Limited (SIIL)
US Food and Drugs
Administration (FDA)
Production of vaccine (charitable mssion) for
$0.40/doseAfrica
Product Development Partnerships
Global Access Strategies to introduce vaccine into developing countries
Discovery Research Development Registration Commer-
cialisationSustainedDelivery
Lack of funding for development
studies - high risk,
high cost.
Poorly designed, poorly controlled
field trials.
Unclear and varied
regulatory requirements.
Multiple regulatory authorities.
Inconsistent supply
Counterfeit products.
Lack of patent protection.
Poor quality and efficacy.
• R&D programs• IP Management and
licensing
• Safety regulations• Manufacture standards
GALVmed- The Global Alliance for Livestock Veterinary Medicines
A Global Not for Profit Organization
established under UK law based in Scotland
in 2005
GOAL: To develop, register and launch 4 to 6 vaccine, pharmaceutical, or diagnostic product by 2015 that meets the
needs of the world’s poorest livestock keepers
East Coast Fever Newcastle Disease Rift Valley Fever Porcine Cysticercosis
PIPRA:Freedom to Operate Reports Negotiations & Contracts with third parties
AcademyIndustry
GALVmed
PIPRA
• Pro Poor • Small dose package• Low price• Registered vaccine• Good Practice Manufacture• Sustainable Production
Animal vaccines
Public Sector
Introduction of ALL PARTIES involved in the project in a conference call
PIPRA
GALVmed
Very Important for success of the
projectto clarify
humanitarian mission from the
beginning
Vaccine Discovery
Registration
Commercialization
4.5 Years
Phase II
$8 M3 Years
Phase I
$4 M4 Years
Phase III
$160 M
FTO Analysis or IP Report
DE-CONSTRUCTION of Vaccine Development and Future Manufacture Process
IP Manager needs ALL details of invention, including location of MTAs. Long and could be a Frustrating
process
FTO Analysis or IP Report will have three possible outcomes:
2 - Continue project after CHANGING commercialization STRATEGY
3 - FINALIZE project
1 - Continue project after negotiating LICENSES
FTO Analysis is TERRITORIAL based in the commercialization strategy
Lower IP constraints Retain local talent and expertise Raise awareness in the community Support and enhance local research capacity Infrastructure remains in the community
Global Access Strategies. Benefits of Site R&D and Commercialization
Discovery Research Development Registration Commer-
cialisationSustainedDelivery
Types of VaccinesLive attenuated organisms which have been passed repeatedly
in tissue culture or chick embryos so that they have lost their capacity to cause disease, but retained an ability to induce antibody response. Potential reversion.
Inactivated or killed organisms which have been killed by heat or chemicals but retain and ability to induce antibody response. They are generally safe but less efficacious than live vaccines and require multiple doses.
Recombinant vaccines DNA sequences are inserted by molecular engineering techniques into a virus grown in cell culture.
Antigen Molecule recognized by the immune system capable to trigger an immune response.
Case Study I. Recombinant Vaccine: DNA sequence cloned into an inactivated virus
Case Study II. Diagnostic method
University created a recombinant vaccine that immunize animals and wanted to donate it to GALVmed, but did NOT PATENT it
Recently another University obtained a patent for use of such DNA sequence to develop vaccines in the territories chosen.
University is developing an immunoassay that detects the presence of an antigen that correlates with a disease.
R&D and Manufacture process used a cell expression system and a purification method covered by TPRs and IPRs
Case Study III. East Coast Fever Vaccine in Tanzania in 2010
Experimental vaccine against ECF was developed 30 years ago with major funding of UK’s Government Department of International
Development (DFID) and Bill & Melinda Gate Foundation
Aim is to REGESITER a vaccine to secure sustainable supply through commercialization
GALVmed is leading the registration, commercial distribution and delivery of the vaccine ($28M donated by DFID and Bill &
Melinda Gate Foundation)
The new ECF vaccine is an “infection-and treatment method”
Plant-Made Vaccines or TherapeuticsDefinition: Protein products with clinical or veterinary applications produced in recombinant plant systems
Major advantage of plant expression systems over the traditional vaccine production:• Reduced manufacturing Cost• Eliminates cross-contamination with animal diseases
1- Oral delivery. Vaccine ingestion (stable plant transformation)
3- Bioreactor using plant cells
2- Transient or stable plant expression (vaccine is purified)
Three plant systems:
Plant-Made VaccinesCOMPANY TECHNOLOGY PRODUCT STAGE
Dow AgroSciences (Indianapolis)
Plant Cell Culture Animal Vaccine
(NewCastle Disease)
Registered
Protalix (Israel)Transgenic carrot and Tobacco Plant
Cell Culture
Ceremyze for Gaucher's Disease
Waiting FDA approval
Kentucky BioProcessing
(Kentucky)
Non-transgenic Tobacco Plant
Aprotinin for cardiopulmonary bypass surgery
Research
Plant Biotechnology (Hayward, CA)
Transgenic Tobacco Plant
Dental caries, Hair loss, Rhinovirus (common cold)
Phase I/II Clinical Trials
Simbiosis (Canada)
Transgenic and non-transgenic Saffloers seeds
Apo A-I Milano (cardiovascular
disease) and Insulin (diabetes)
Phase I/II Clinical trials
iBio (Delaware) Non-transgenic Tobacco Plant
Influenza, Anthrax, MAb Pre-Clinical
iBio (Delaware) Non-transgenic Tobacco Plant
Influenza, Anthrax, MAb Pre-Clinical
Biolex (Norh Carolina) Lemma Plants Interferon Alpha for
Hepatitis CPhase II Clinical
Trials
Ventria BioScience (Colorado)
Plant Cell Culture (Rice and Barley)
Lysozyme, Lactoferring
(proteins found in breast milk)
Sales for Research
Nomad BioScience (Germany)
Non-transgenic Tobacco Plant
Biosimilars for European and
AsianResearch
Medicago (Canada)
Non-transgenic Tobacco Plant
Influenza (Seasonal, H5N1,
H1N1)Pre-Clinical
Plant-Made Vaccines in Southern Africa
Partnership to produce cost-effective animal and human
VACCINES
Vaccine Commercialization in Developing Countries requires a Global Access
StrategyIP Management is an important Tool for
reinforcing vaccine development and marketing strategy
Public & Private sector should use Best IP Practices to directly address Global Public
Interest
Royalty-free Humanitarian Licenses for pharmaceutical products for Developing
Countries
THANK YOU
Intellectual Property Management to support SECOPI-AGRO’s Agricultural Innovation ProcessBogota, August 11-12th 2010
Monica Alandete-Saez,University California Davis, PIPRA