Early research and discovery (ERD) projects are focused to advancing the frontier of technical knowledge, ideally through a disciplined, reductionist, and hypothesis-driven experimental approach.  While the experimental approach is usually well understood, the outcome of the experiments are not, suggesting that ERD projects cannot be deterministically managed.  In contrast, business needs to plan according to the research outcomes, which poses a significant challenge, specifically:  How does an organization bridge the gap between the uncertainty of ERD and the business desire for determinism?

Positioned at the interface between the ERD team and the business is project management, who is responsible for facilitating communication across these two discrete cultures.  The approach needed to facilitate this communication requires a sophisticated balance between flexibility and discipline, a high level of understanding of the scope and how the work translates into deliverables.  In a previous meeting, a group of industry research scientists and project managers identified project scope (the work to be completed) and the project schedule (how and when it will be completed) as the significant challenges in ERD projects. 

This session will bring together industry experts who have addressed these challenges to discuss the strengths and weaknesses of discovery project management (DPM), and formulate guidelines and recommendations for the implementation of project scope and schedule development that enable ERD organizations. Join us for a highly interactive discussion and help influence and develop top level recommendations to guide the planning for discovery projects.

Panelists:

• Alu Chatterjee, Ph.D, Project Management Consultant, Integrated Project Management (IPM)
• Jo Ann Dumin, Ph.D, Senior Research Investigator, Satori Pharmaceuticals
• Stacy Price, M.S., PMP, Director of Process Development (PD) Operations, Shire HGT

Tentative Agenda:

• Networking 7:45 a.m. - 8:00 a.m.
• Welcome and review of the outcomes from April (15 min)
• Introduction of the panel members (15 min)
• Discuss approaches to scope development (30 min)

1.         How have you addressed the challenges in scope development?
2.         How do we define the work to be completed?
3.         What approaches can we use to plan research?

• Discuss approaches to schedule development (30 min)

1.         How do you schedule work for the team?
2.         What level of granularity is required?
3.         How do you communicate deadlines and commitments?

• Address additional questions from the survey (10 min)
• Developing guidelines for discovery projects (10 min)
• Closing remarks (5 min)

 
Speaker Bios:

Alu Chatterjee, Ph.D is a Project Management Consultant with Integrated Project Management (IPM), a company that provides project management consulting services to biotechs and pharmaceutical companies in the Boston area. In this role, Alu provides project leadership and operational support to research teams engaged in discovery and early development, as well as clinical teams engaged in full development of novel drug candidates.  Alu has 14 years of prior experience in the biotech and pharmaceutical industry at various levels in R&D and management.  Alu received his PhD from the University of Windsor, ON Canada, in Molecular Biology and completed 4 years of post-doctoral training at Baylor College of Medicine, Houston, TX. 

Jo Ann Dumin, Ph.D is currently a Senior Research Investigator at Satori Pharmaceuticals, a small biotech in Cambridge, MA focused on the discovering treatments for Alzheimer's Disease.  In her current role, Jo Ann leads the in vivo pharmacology effort and biomarker strategy, working closely with CROs and multiple consultants to examine PK/PD relationships.  Jo Ann has 12 years of industry experience as a project leader, experience with new target identification and biomarker development.  Jo Ann received a Ph.D. from Albany Medical College, Albany, NY in Biochemistry and Molecular Biology and completed her post-doctoral training at Washington University in St. Louis.

Stacy Price, M.S., PMP, is Director of Process Development (PD) Operations at Shire HGT, where she leads a project management office providing project management tools and business processes supporting PD team project planning and execution. Previously, Stacy was Director of Manufacturing at Transkaryotic Therapies where she managed the startup and validation of their first commercial product facility and was a Process Engineer at Serono Laboratories. Stacy earned her M.S. in Biochemical Engineering and B.S. in Chemical Engineering from Tufts University, and is a certified PMP, a lean six sigma green belt, and business process management professional.