Downloads

We have developed white papers and an e-Book on a number of important subjects in Project and Portfolio Management, with an emphasis on Drug Discovery. The following are available now.

Please note – we now accept most currencies.  Please alert us if you have trouble using PayPal with your currency.

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Project Management for Consultants – How to Set Up and Run A Consulting Project

Consultants do projects.  The manner in which the project is performed is project management.  Thus, project management is the art of what consultants do.  It includes both “hard skills” and “soft skills”.

This white paper is about the so-called hard skills. It’s about how to set up and run a project.  It includes the following tasks.

1. Determining Your Stakeholders

2. Getting your project Started with Project Planning.  Activities include
- Goal Setting
- Project Planning, and
- Project Approval

3. Getting it Done or Project Execution. Here activities include
- Project Meetings
- Project Tracking
- Project Completion, and
- After Project Review

We invite you to download our white paper on this subject – “Project Management for Consultants – How to Set Up and Run A Consulting Project”.  We’ll delve into each of these activities as these are things you should think about with every project that you do.

 


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The Differences Between Discovery and Development Project & Portfolio Management Come Down to the Level of Risk

View the complementary white paper “The Differences Between Discovery
and Development Project & Portfolio Management Come Down to the Level
of Risk” by James Samanen, James Samanen Consulting, LLC. Click here
to download: http://www.healthtech.com/Conferences_Content.aspx?id=92154


Small Molecules, Peptides and Protein-Based Drugs – The Differences and Similarities, an e-Book

This downloadable e-Book is the definitive publication on the differences and similarities in the discovery and development of small molecule, peptide and protein-based drugs. Anyone who must interface with the biopharmaceutical industry will find this to be an invaluable resource.

The pharmacopeia has long contained drugs based on small molecules, peptides and proteins. Yet the historical preponderance of small molecules in the pharmacopeia has led many in the pharmaceutical industry to be rather unfamiliar with the discovery and development of peptide and protein-based drugs. This book is written for those in the industry who may be less familiar with peptide and protein-based drugs and feel the need to understand the growth of this important sector of biopharmaceutical R&D. Welcome then, dear readers, to the world of biopharmaceuticals! Here we will examine, compare and contrast the R&D of small molecules, peptides and proteins.

We present this to the reader as an e-Book. It is presented in the same pdf format as our other white papers, but with a book-length page count of over 50 pages. The paper is packed with figures, tables and references gleaned from our review of the literature. This manuscript has been reviewed by six respected scientists in the field.

We had previously offered a white paper “Small Molecule versus Biomolecular Drugs – The Differences and Similarities”, which subsequently appeared as “Similarities and Differences in the Discovery and Use of Biopharmaceuticals and Small Molecule Chemotherapeutics”, Chapter 5, in the “Introduction to Biological and Small Molecule Drug Research and Development: theory and case studies” edited by Stanley Roberts, C. Robin Ganellin and Roy Jefferis, Elsevier 2013.

We now offer the e-Book “Small Molecules, Peptides and Protein-Based Drugs – The Differences and Similarities”. This is an extensively rewritten work. We have significantly expanded upon the subject of peptide drugs, and offer the section on The Progression of Technologies that Fueled the Development of Small Molecule, Peptide and Biomolecular Drugs, an original observation:

Chemists are familiar with the progression of technologies that fueled the development of small molecule drugs. The early alchemical and folk remedy drugs relied on what nature provided. As the demand for these remedies grew, chemical synthesis replaced isolation from natural sources. Chemical synthesis afforded a means to explore variants of the native substances to find drugs with enhanced properties. The need to test these variants gave rise to phenotypic and later target-based screening. And as screening ramped up the need for combinatorial chemistry arose. This chapter explores how a similar progression of technologies fueled the development of peptide and biomolecular drugs.

This e-Book is organized into the following topics.
1. Introduction
2. Size
3. Peptide Drugs Fill the Gap Between Small Molecules and Biomolecules
4. Structure
5. Synthesis
6. Differences in Terminology
7. The Progression of Technologies that Fueled the Development of Small Molecule, Peptide and Biomolecular Drugs
7.1 Important Learnings from Small Molecule Drug Discovery
7.2 The Rapid Ascendency of Biomolecular Drugs
7.2.1 Important Learnings Analogous to Small Molecules
7.2.2 Which was more important in the early days – the Biotech company or the Pharmaceutical Company?
7.2.3 The Classes of Biomolecular Drugs
7.3 Peptides – Ready to Boom
8. Comparing Drug Properties
8.1 Expanding the Druggable Genome
9. Comparing Success Rates, Cycle Times and Costs
10. Comparing CMC – Chemical Manufacture and Control
11. Comparing Pricing Strategies
12. Glycoprotein IIB/IIIA Antagonists, a Case Study
12.1 Three Commercially Available Antagonists
12.2 Rational Design of Oral Nonpeptide Mimetics from Peptides
12.3 The Search for Small Molecule Protein-Protein Inhibitors
13. Insulin – the Teacher
14. Biosimilars and Biobetters versus Generics
15. Differences in Discovery and Preclinical Stages
16. Diminishing Differences in Therapy Areas
17. Small Molecule, Peptide and Biomolecular Management by Division versus Platform


You may wish to return to:

Small Molecule Drugs versus Biomolecular Drugs (Biologics)


Managing Risk and Value in Bio/Pharmaceutical R&D

In our downloadable PDF file, we describe a methodology that is similar to a system that was used in a major pharmaceutical company to measure risk in the Target Discovery phase for many years. We believe that the full value of this system could be exploited through all phases of drug discovery and even the entire R&D pipeline. Please order this white paper by clicking the “Buy Now” button below. You will receive the white paper in an email. Please allow up to 24 hours for delivery. If you have questions, please call 610.983.9602.


You may wish to return to:

Defining and Managing Risk in Drug Discovery

Estimating Value in Drug Discovery


Qualities of a Good Project Leader

In our downloadable PDF file, we describe the qualities of a good project leader, and pursue the following points.

  • The Project Leader and the Project Team
  • Discovery Project Leader vs. Discovery Program Leader
  • Discovery Project Leader – what to expect
    • Out of the Comfort Zone – Learning to Manage Others
    • The Boss – Needs to Value Project Leadership
    • Line Managers – The Team Line Representatives’ Bosses
    • Discovery Project Team Meeting Styles – Scientific versus business style
  • Development Project Leader – what to expect
  • Project Leader vs Project Manager

Please order this white paper by clicking the “Buy Now” button below. You will receive the white paper in an email. Please allow up to 24 hours for delivery. If you have questions, please call 610.983.9602.


You may wish to visit other sections under Project & Program Management.


NEW

Project Identifiers that Uniquely Distinguish Projects in the Portfolio

Project Identifiers are the set of descriptors that uniquely define a project in a portfolio of projects. A robust set of identifiers requires community consensus, compliance and stability. When any one of these factors changes, the corporation is at risk of losing its ability to make decisions from a portfolio perspective. The bio/pharmaceutical R&D pipeline is usually divided between two organizations, Discovery and Development, which can lead to divergence in project identifier standards and the risk of at least partial collapse of transparency between the two organizations. In this downloadable white paper we attempt to define best practice in project identifier usage. It covers the following subject.

  1. The Well-crafted Project ID number and Project Title
  2. Challenges to unique, concise project identification
    1. Project ID Number
    2. Project Title
    3. Biological Target Name
    4. Biological Target ID Number
    5. Biological Action
    6. Mechanism of Action (Target and Biological Action)
    7. Therapy Area
    8. Disease Area
    9. Indication
    10. Target Class
    11. Route of Administration
    12. Recycling Project ID numbers.
  3. Project Identifiers vs. Multiple Shots on Goal (Lead, Back-up, Follow-up)

Please order this white paper by clicking the “Buy Now” button below. You will receive the white paper in an email. Please allow up to 24 hours for delivery. If you have questions, please call 610.983.9602.



Data Supporting Portfolio Analysis in Bio/pharmaceutical R&D

Valuable Portfolio Analyses are created with accurate data – current project data on resource, progress, risk, value, etc, and historical project data on success and failure (attrition). Bold portfolio analyses will be challenged by those who defend the status quo. Such analyses will take the heat if the data is real. In this white paper we consider what it takes to create a reliable data set that takes portfolio analysis out of crisis mode and makes it routine and fun. It covers the following topics.

  1. Data Integrity (How to be fooled by Portfolio Data)
  2. Proactive Data Analysis – Having the Data Before its Needed
  3. Store Your Analyses for Future Recycling
  4. External Benchmarking Data

Please order this white paper by clicking the “Buy Now” button below. You will receive the white paper in an email. Please allow up to 24 hours for delivery. If you have questions, please call 610.983.9602.



Maintaining a Project Portfolio History in Bio/pharmaceutical R&D

A best practice relating to Project Tracking is to maintain as complete a data set of project information on inactive projects as you would for active projects. Over time this set of information becomes the project portfolio history. The Project Portfolio History can be extremely useful for the following analyses.

  • Showing changes to the portfolio over time.
  • Showing changes to the portfolio before and after a change in strategy.
  • Predicting change to the portfolio over time (best done with simulation software, but data from the portfolio history seed the simulation).

This white paper covers the following topics.

  1. Elements of a Project Portfolio History
  2. Best Practice in Maintaining a Project Portfolio History – Change Events
  3. Showing Changes to the Portfolio Over Time.
  4. Showing Changes to the Portfolio Before and After a Change in Strategy.
  5. Predicting Change to the Portfolio Over Time
  6. Impact of Reorganization Decisions on Project Portfolio History

Please order this white paper by clicking the “Buy Now” button below. You will receive the white paper in an email. Please allow up to 24 hours for delivery. If you have questions, please call 610.983.9602.



Examples of Portfolio Views in Bio/pharmaceutical Discovery

Among the set of activities that portfolio managers tend to perform is to categorize projects and provide views of the portfolio. A portfolio view is a graphical representation of the project portfolio that answers a unique question about the portfolio. Depending on the question that needs to be answered, the portfolio view may range from a simple table to three dimensional displays and executive dashboards.

We have created a downloadable PDF file on this subject. The following are subjects covered by this white paper.

  1. Why Portfolio Management Views of the Portfolio are Important
    1. Portfolio Views Answer Questions about the Project Portfolio
    2. Portfolio Views Provoke Questions About the Project Portfolio – Portfolio Experiments
  2. What’s Needed Before a View of the Portfolio is Created
  3. Examples of Portfolio Views
    1. Functions Served by Portfolio Views
    2. Types of Portfolio Views
  4. Most Portfolio Views Need to be Shown Periodically – Is the Infrastructure in Place?
  5. Boring versus Exciting Portfolio Views

Please order this white paper by clicking the “Buy Now” button below. You will receive the white paper in an email. Please allow up to 24 hours for delivery. If you have questions, please call 610.983.9602.



Asset Tracking in Bio/pharmaceutical R&D

If the corporation finds it worthwhile to track certain assets, a separate asset tracking system needs to be established. We have created a white paper entitled “Asset Tracking in Bio/pharmaceutical R&D” that explores the details of establishing an asset tracking system. It covers the following subjects.

  1. Challenges to Project Tracking
  2. What is a Campaign and how does it relate to a Project
  3. The Value of Campaign Tracking
  4. The Art of Campaign Tracking
    1. Campaign Identifiers
    2. Campaign Tracking System
    3. Electronic tracking system
  5. Data and Analyses that can be Generated from a Lead Identification Campaign Tracking System

Please order this white paper by clicking the “Buy Now” button below. You will receive the white paper in an email. Please allow up to 24 hours for delivery. If you have questions, please call 610.983.9602.



Resource Tracking in Bio/pharmaceutical R&D

We have created a downloadable PDF file on Resource Tracking that you may wish to consider. In this white paper we discuss the following subjects.

  1. Elements of a Robust Resource Tracking System
  2. Best Practice in Resource Tracking
  3. Discontinuous Application of Resource – the Reality
  4. As-Required versus Dedicated Resource
  5. Stage and Project Independence of Resource Application
  6. Resource Analysis and Capacity Planning

Please order this white paper by clicking the “Buy Now” button below. You will receive the white paper in an email. Please allow up to 24 hours for delivery. If you have questions, please call 610.983.9602.



Portfolio Decision Analysis in Bio/pharmaceutical R&D

Most decisions about the portfolio have more than one option. Decision Analysis examines all the options. Decision Analysis is a structured approach to informed decision making.

We have created a downloadable PDF file on this subject. It covers the following topics.

  1. What is Portfolio Decision Analysis, Where is it Used and Who Does It?
    1. What is Portfolio Decision Analysis?
    2. When is Portfolio Decision Analysis Used?
    3. Who Does Portfolio Decision Analysis? Role of Portfolio Management
  2. Tools that Support Decision Analysis
  3. Storing Portfolio Analyses
  4. Analyses Need to be Available before the Decision
  5. Views of the Analyses
  6. Factors Mitigating Against Informed Decision Making

Please order this white paper by clicking the “Buy Now” button below. You will receive the white paper in an email. Please allow up to 24 hours for delivery. If you have questions, please call 610.983.9602.



Combining Portfolios From Mergers & Acquisitions in Bio/pharmaceutical R&D

Mergers and acquisitions (M&A) are becoming an ever increasing part of business in Bio/pharmaceutical R&D. M&A can involve the combining of two project portfolios. When the two portfolios are relatively large the process of combination can be a considerable challenge.

We have prepared a white paper on this subject. It covers the following topics.

  1. The Challenge of Nomenclature
    1. Determine the titles and definitions for Stages of Work and the Milestones
    2. Develop a common system for naming projects.
    3. Determine or develop a common IT structure for storing project portfolio data.
    4. Develop a method for identifying target and project overlaps from the contributing companies
  2. Identifying Overlaps
  3. Defining Stages & Milestones and Criteria for Progression
  4. Sorting Into Stages
  5. Merging Projects and Associated Assets
  6. Developing Protocols to Ensure Data Integrity

Please order this white paper by clicking the “Buy Now” button below. You will receive the white paper in an email. Please allow up to 24 hours for delivery. If you have questions, please call 610.983.9602.