Product Development Boot Camp
Recognizing that vaccine development is no longer exclusively led by industry, there is a need to familiarize all research stakeholders with concepts and tools used by industry to drive product development.
In November 2015, the Enterprise, in collaboration with Shift Health held a two-day Product Development Boot Camp featuring modules that combined presentations by product development experts, introduction to new tools and resources, and active learning through discussion with peers and experts. The Boot Camp contained five modules covering a wide variety of topics. Materials from the Boot Camp are being made available to all researchers and will be used to develop new activities to address various topics related to product development of HIV vaccine candidates.
MODULE #1: Pipeline and portfolio considerations
Description: Overview of principles behind portfolio management by governmental agencies, foundations, and industry; discussion of approaches to a more coordinated field-wide portfolio management; review and discussion of “Immune Landscape” Timely Topic deliverables.
Principles of portfolio management in industry
— Jerry Sadoff, Janssen Pharmaceutical Companies
Principles of portfolio management in foundations
— Penny Heaton, Bill & Melinda Gates Foundation
Principles of portfolio management in governments
— Mary Marovich, National Institute of Health
Integrated approaches to portfolio management
— Carlos DiazGranados, Sanofi Pasteur
The Landscape of Immune Responses Targeted by Phase I HIV Vaccine Candidates
— Yegor Voronin, Global HIV Vaccine Enterprise
MODULE #2: Target Product Profile (TPP)
Description: Introductory training on why and how to create a TPP; early- vs. late-stage TPP development; challenges of developing TPPs for HIV vaccine candidates; hands-on training in small teams by developing TPPs for fictitious vaccine candidates; comparing and contrasting different approaches. Also see “Target Product Profile” project.
Overview of TPP: why and how to create a TPP
— Jane Halpern, National Institute of Health
MODULE #3: Moving vaccine concepts from bench-to-clinic
Description: Challenges of advancing candidates from preclinical to first-in-human trials; preclinical data requirements, manufacturing, and clinical considerations; case studies to compare and contrast alternative models. Also see “Bench to Clinic” project.
Phase and goal-appropriate product development
— Michael Pensiero, National Institute of Health
Preclinical data and regulatory considerations
— Jim Ackland, Global BioSolutions
Case study: Research-oriented development
— Robin Shattock, Imperial College London
MODULE #4: Planning for Success
Description: Planning for various outcomes of late-stage trials; concept overview and main considerations; case study using Dengue vaccine development; considerations for ongoing late-stage HIV trials.
Concept Overview of Planning for Trial Success
— Anne Mullin, Shift Health
Dengue Vaccine Late Stage Development: A case study
— Sanjay Phogat, Sanofi Pasteur
P5 Development Plans
— Nina Russell, Bill and Melinda Gates Foundation
MODULE #5: Product development partnerships: best practices
Objectives. Best practices in cross-sector collaboration; lessons learned from key partnerships; multi-sector panel discussion.
Product Development Partnerships (PDPs): Overview
— Ryan Wiley, Shift Health
Contrast and compare the different approaches of Janssen and P5
— Jerry Sadoff, Janssen Pharmaceutical Companies, and Robert O’Connell, AFRIMS
We thank all organizers, speakers, and panelists for contributing to the success of this workshop. Special thanks go to the main Organizing Committee Members, who were responsible for the overarching program development and planning:
- Charla Andrews, Technical Resources International, Inc.
- Iris Corbasson, Global HIV Vaccine Enterprise
- Anne Mullin, Shift Health
- Sanjay Phogat, Sanofi Pasteur
- Yegor Voronin, Global HIV Vaccine Enterprise
- Don Walkinshaw, Shift Health
- Ryan Wiley, Shift Health