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