Workshop on Enhancing the Global Workforce for Vaccine Manufacturing
Parimal R Desai, Ph.D.CEO (interim), Hilleman Laboratories
Friday, December 2, 2011
Presentation Structure
Technology Transfer Technology Transfer
Scientific LeadershipScientific Leadership
Business Plan Business Plan
Business Model Business Model
About HillemanAbout Hilleman
Date of Inception 17 September 2009
Headquarters Jamia Hamdard University, New Delhi, India
Vision Developing vaccines for global health
Mission To develop high impact, affordable vaccines for people in developing countries in an innovative and sustainable manner
Partnerships Joint Partnership between MSD Laboratories India LLC (a wholly owned subsidiary of the Merck Group) and Wellcome Trust, UK
InvestmentsBoth partners will invest equally towards the R&D efforts of thelaboratories over the first seven yearsStaff of approximately 50 scientists
We endeavor to create a novel immunization platform with vaccine thermo stability using newer methods of delivery in developing countries, by targeting:
Hilleman Fast Facts
About Hilleman
Business ModelBusiness Model
Vaccine DevelopmentVaccine Development
Scientific LeadershipScientific Leadership
Technology TransferTechnology Transfer
Business PlanBusiness Plan
Thermostability& Affordability
Ease of Administration
Package size & novel delivery model
Reduced cost of goods and distribution chain related costs
Apply world-class vaccine development technologies and know-how to develop
safe and effective vaccines
Focus on novel vaccines in areas of high unmet
medical need and existing vaccines that can be
optimized to better meet the needs of developing
countries
Build partnerships that enable the widest possible access to these products
Our Values
The Purpose
Collaboration
Innovation Speed in Execution
Courage& Candor Value Focus Collaboration
MSD Laboratories’
expertise in vaccine
development Hilleman Laboratories India ‐Will bridge gap that
exists between academia and clinical studies, to take promising leads to proof‐of‐concept stage.
About Hilleman
Business ModelBusiness Model
Vaccine DevelopmentVaccine Development
Scientific LeadershipScientific Leadership
Technology TransferTechnology Transfer
Business PlanBusiness Plan
Project Driver Human Immunization in Developing Countries
7 million children, under the age of 5, die every year as the result of infectious diseases. 99% of those children in developing countries around the world.
Factors responsible for the poor performance of vaccines:•Expanding populations•Poverty and lack of education•Cold-chain defects•Inadequate facilities for transportation of vaccines
We at Hilleman Laboratories, endeavor to create a novel immunization platform with vaccine thermo stability using newer methods of delivery in developing countries by targeting:•Thermo stability•Ease-of-administration•Reduced footprint•Affordability
The Objectives
Key Competencies of Hilleman Laboratories
The Options
& Choice
Model to Succeed
Translational Biology, Bioprocess, Formulation and Analytical Research
Clinical Development through Phase I/II (Immune/Clinical Proof of Concept)
Project Management
Advocacy and Fund Raising
Impact Assessment
Communications / Public Affairs
Licensing and Business Development
Collaborate with scientists, clinicians and international
funders
Apply innovations and skills
from industry
StrongNGO /
government relationships ?
6
Business ModelAbout HillemanAbout Hilleman
Vaccine Development Vaccine Development
Scientific LeadershipScientific Leadership
Technology TransferTechnology Transfer
Business PlanBusiness Plan
• Provide transformational vaccine research and technologies that will deliver new age preventive healthcare to the developing world.
• Help scientists in resource-limited environments to re-think new ways to prevent death by disease to the fullest.
Advantage India
LandscapeAbout HillemanAbout Hilleman
Vaccine Development Vaccine Development
Scientific LeadershipScientific Leadership
Technology TransferTechnology Transfer
Business PlanBusiness Plan
About HillemanAbout Hilleman
Vaccine Development
Scientific Leadership Scientific Leadership
Technology TransferTechnology Transfer
Business PlanBusiness Plan
Business Model Business Model
Vaccine Development Cycle at Hilleman
Stage
Basic Research Target ‐> Lead Candidate
Early Development Lead –> Phase
I /II
Clinical Trial
Late Development
Phase III
Clinical Trial ‐> Registration
Large Scale
Manufacturing Marketing and Distribution
Stage Stage
Partner & Outreach Support
• External Scientists
• Merck and Other Pharma Companies
• Hilleman Laboratories
• Multi-National Pharmaceutical Manufacturer
• Developing Country Vaccine Manufacturers (DCVM)
Stage StageStage
Success Factor for Developing Vaccines
Collaborate with scientists, clinicians and international funders
Apply innovations and skills from industry
Coordinate with NGOs / Governments
Disease:Strong awareness backed by sound epidemiology dataPrioritized for health investment for citizensControl plan is amenable to vaccination
Profile:Safe & efficacious against local types/strains Robust technologies suitable for large scale productionInexpensive / affordable and sustainableEasy to ship/store (e.g. heat stable, small package)Easy to use (e.g. simple administration, follow up and disposal)
Launch and Delivery:Local manufacturing (increase local capacity)Collaboration with local governments and NGOs to assess demand and plan for introductionSupported with demonstration programs as needed
The Strategic Advisory Group advises the CEO and Board of Directors of the Hilleman Laboratories regarding how they might best pursue its mission
CEO & Board Members
Executive Leadership
Other advisors also invited in selective review meetings to guide executive leadership
Scientific Direction
Strategic Advisory Group (SAG) Focus: Top line Strategic Issues and meet at regular intervals
Detailed medical input on chosen disease areas
Business Excellence
Detailed scientific and development inputs
Members Role
Chair: Dr. David L. Heymann(Chairman of Health Protection Agency, UK)
Ms. Joy Phumaphi(Chairman, African Leaders Malaria Alliance and Chairman, Board of an AIDS fund)
Dr. Rafi Ahmed(Director of the Emory Vaccine Center)
Dr. Zulfiqar Bhutta(Professor & Chairman, Department of Pediatrics and Child Health, Aga Khan University Medical Center, Pakistan)
Dr. Alan Shaw(President & Chief Executive Officer, Vaxlnnate)
Ms. Alice Albright(Executive Vice President and Chief Operating Officer of Export-Import Bank of the United States)
Dr. Keith Klugman(Professor of International Health at the Rollins School of Public Health)
Dr. K. Srinath Reddy (President, Public Health Foundation of India)
Timothy Nielander (Board Member and Advisor for foundations based in Switzerland, Uganda, Thailand and the US)
About HillemanAbout Hilleman
Vaccine DevelopmentVaccine Development
Business PlanBusiness Plan
Technology TransferTechnology Transfer
Scientific Leadership
Business ModelBusiness Model
Scientific Leadership
11
•Desirability of vaccines and feasibility of production•Aligned to HL vision, mission & developing world requirement•Clear line of sight through manufacturing and marketing•Follow NRA and WHO guidelines•Partnering with MNC, DCVMs, and technology providers•Consultation with stakeholders and peer-groups
Business Plan
About HillemanAbout Hilleman
Vaccine Development CycleVaccine Development Cycle
Technology TransferTechnology Transfer
Scientific LeadershipScientific Leadership
Business ModelBusiness Model
HL Project Selection Criteria
Projects are selected based on:
Technology Transfer to DCVMs
TechnologyTransfer
About HillemanAbout Hilleman
Vaccine Development CycleVaccine Development Cycle
Business PlanBusiness Plan
Scientific LeadershipScientific Leadership
Current ProjectsCurrent Projects
• HL will develop both Drug Substance (DS) and Drug Product (DP) at clinical scale
• Pre-clinical evaluation and early clinical trials (phase I/II) will be carried out by HL
• The clinical-scale process developed at HL will use unit operations similar to the commercial process
• HL team will identify Critical Process Parameters (CPP’s) and perform process validation
• HL team will be involved with the technology transfer to the commercial manufacturer:
• Share all SOPs with the manufacturer• Share development reports with the manufacturer• Share analytical procedures with the manufacturer• Share history of all clinical lots with the manufacturer
• HL team members will be at the manufacturer location to train the respective counterparts and establish the baseline process
• HL team members will be available for any interaction with the regulators and for scale up operations if required
• Will provide long-term technical support for the project
Thank you!