workshop on enhancing the global workforce for vaccine … · workshop on enhancing the global...

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


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






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




• 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





Vaccine Development

Scientific Leadership Scientific Leadership



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)





Scientific Leadership


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


Vaccine Development CycleVaccine Development Cycle




HL Project Selection Criteria

Projects are selected based on:

Technology Transfer to DCVMs

TechnologyTransfer


Vaccine Development CycleVaccine Development Cycle



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!

workshop on enhancing the global workforce for vaccine … · workshop on enhancing the global...

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