P3M

Project, Program and Portfolio Management

Boston/Cambridge ● Providence ● Stamford/New Haven/New London ● New York City

P3M US LLC

"If we haven't done it..."

P3M US LLC Principals have an accomplished record of supporting discovery, research and clinical phase programs, and a demonstrated history of proficiency and on-time and on-budget delivery.

Our Principals, Associates and Collaborators utilize their expertise to assist in the development and implementation of successful strategies for life sciences businesses of any size.

We provide support for all facets of pharmaceutical research and development:

Bench (drug discovery, including partnerships, alliances and co-development)
All Phases of drug development (Phase 1 through Phase 4; post-approval commitments)
Regulatory preparations (IND, CTA, CTN; NDA/sNDA; ex-US filings)
Clinical operations (site and country identification and activation; budgeting; oversight and alliance management)
Patient interactions (patient selection; recruitment; retention; dispensing; counseling)
Integrated strategy for business technology (hardware, software, mobile devices, BYOD; controls and security)
Technology, regulatory, quality, security and legal policies and procedures, to ensure compliance with GDPR and related privacy and security regulations (e.g., SEC 8-K requirements)

Our Principals, Associates, and Collaborators leverage their knowledge and skills to evaluate the complex issues that organizations face in advancing healthcare and medicine research, development and delivery, and provide our Clients with solutions that are practical, cost effective and readily implementable; on time, on budget and within the agreed framework.

And "if we haven't done it", our Principals have extensive connections across the pharmaceutical industry, with a network of expertise that spans small, medium and large pharmaceutical companies. We have connections with experts in all drug development fields who "have done it".

Please contact us to discuss your specific situation!

Principals

Michael has extensive, senior-level experience in the healthcare and pharmaceutical industries, from bench to bedside. His expertise includes:

Therapeutic area leadership in Neurosciences (CNS), Inflammation and Immunology, Cardiovascular and Internal Medicine, Anti-infectives, Oncology, Ophthalmology, Rare Diseases
Implemented cross-portfolio analysis of existing and future portfolio in multiple organizations
Enacted an out-licensing function for a corporate business development division
Led transformation of adjudication, oversight and governance board process for global product development division, reducing required reviews and speeding development cycle times
Award-winning team development and leadership
Assembled and implemented an optimized protocol review and operational oversight processes
Chairperson for corporate clinical operations review board
Project Management group head, early development phases
Established a Business Technology function; created and implemented policies, procedures, work instructions and training; compliance monitoring
LinkedIn profile

Mary has broad, long standing experience in the pharmaceutical industry, from early discovery to research operations. Her expertise includes:

Administers business operations support for resourcing groups
Department-level support for budgets, purchases and procurement
Coordinates development of business technology tools; resolving issues, developing/testing
Oversees vendor performance metrics including compound flow, cycle time and efficiencies
Develops and implements contemporary laboratory processes and procedures
Publishes and analyzes data, manages, communicates and visualizes for senior managers
LinkedIn profile

Offerings

Adjudication and Effective Decision Making

We will critically assess your organizational decision-making processes, bringing our experience and perspective. We will identify opportunities for improving and optimizing, leading to quicker and more effective decisions.

Portfolio, Program and Technology Development Strategies

We bring extensive, validated business process and project management experience, with therapeutic area expertise, to project and portfolio optimization, and licensing and development.

Implementable approaches

We will create a business, development, or technology plan, or assist you in revising an existing one, which can be translated into an actionable, readily operationalizable strategy for your business.