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Discovery vs Development
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Overall Outline
Introduction
A Best Practice Website
Building a Blog on Bio/pharmaceutical Discovery Management
Bio/pharmaceutical – why we use this term
Website Reference Material, Navigation and Comments
Discovery Management in relation to Project and Portfolio Management
The Science of Bio/Pharmaceutical R&D
It’s all Science
This Site is about the Organization and Management of Bio/pharmaceutical R&D, not the Science
The Organization of Bio/pharmaceutical R&D
Managing Small Molecule, Peptide and Protein-Based Drug R&D in the Same Company
What is Bio/pharmaceutical R&D?
Bio/pharmaceutical R&D is Drug Discovery and Drug Development
The Logical Organization of Bio/pharmaceutical R&D
Common Goals Between Discovery and Development
The Desired Product Profile (Target Product Profile)
The Impact of Expenses on Revenues
Innovation
NME Output versus R&D Expense – Perhaps there is an explanation
Innovation as Measured by the New Molecular Entity – it’s the First but Not Necessarily the Best
Why Drugs Cost So Much
Small Molecule, Peptide and Protein-Based Drugs
The Ideal Organization
Many disciplines are required in Bio/pharmaceutical R&D
Stage-Gate Organization
Challenges to Project Progress
Not all Projects Start at the First Stage
Stage Related Goals
Target Discovery
Lead Discovery (Target to Lead)
Lead Optimization (Lead to Candidate)
Target to Candidate – one phase or two – where to make the split?
Preclinical Evaluation (Candidate to Phase 1)
Proof of Concept, POC (Phase 1-2)
Full Development (Phase 3,4)
Registration and Launch (Reimbursement)
Attrition
An Unprecedented View of Attrition in a Corporate Portfolio – AstraZeneca
Another Unprecedented View of Attrition in a Corporate Portfolio – Chorus
Factors that Influence Attrition Rates
Attrition – Reasons for Failure
Ways to Improve Attrition in Phase II and Phase III
Living with Attrition – Ways to Compensate
Association of Resource with Stage – Matrix of Work
Association of Resource with Business Units – Overarching Organization
Business Units
Therapy Areas (TAs)
Non-aligned Resource – Platform Technologies
The Project Pipeline
The Attrition-Based Pipeline
In-house vs. Out-source; Vertical Integration vs. Vertical Disintegration
Maximal Outsourcing – Virtual Discovery and Development
From FIPCO to FIPNET to VIPCO – Say What?
In-house vs. In-license
The Virtual Pipeline
In-house vs. Out-license
The Sustainable Pipeline Myth
Big vs. Small
Bureaucracy in Decision Making, Approval and Authorization
The Start Up Company
Project & Program Management in Bio/pharmaceutical R&D (PROJECT LEADER SOLUTIONS)
What is a project? What is a program?
Program/Project Leadership versus Stage
Program/Project Authority versus Organizational Structure
Discovery vs Development
Roles of a Project Team Leader
Dealing with Scientists on a Project Team
Qualities of a Good Project Leader
Qualities of a Good Team Representative
Portfolio Management in Bio/pharmaceutical R&D (PORTFOLIO MANAGEMENT SOLUTIONS)
Why You Need Portfolio Managers
Facilitate Decision Making In Support of Corporate Strategy
Portfolio Goals and Metrics
How Portfolio Managers Support Decision Making
Role in Portfolio Management Meetings
Level of Centralization (Portfolio Management Office)
Role in Periodic Portfolio Reviews
The Value of Portfolio Prioritization
The Diplomacy Behind Presenting Bad News
Factors Mitigating Against Informed Decision Making
Data Supporting Portfolio Analysis
Examples of Portfolio Views
Portfolio Decision Analysis
Combining Portfolios From Mergers & Acquisitions in Bio/pharmaceutical R&D
Portfolio Manager at the Eye of the Storm
Other Areas where Portfolio Managers can Help
Managing Risk and Value in Bio/pharmaceutical R&D (PORTFOLIO MANAGEMENT SOLUTIONS)
Risk is Related to the Probability of Failure, the Inverse of POS