Pharmasig Newsletter 2009 07

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Project Management Institute

Newsletter

www.pharmaSIG.org July 2009

In This Issue

Problem Solving

Value Management

Monthly Communication

2010 SIG Conference

Last Month's Webinar

Next Month's Webinar

News

Looking for Authors

Quick Links

Previous Newsletters

Virtual Communities

LinkedIn PharmaSIG

Next Webinar

Webinar Recordings

Job Board

A word from our Chair

There has been a lot of recent activity

in the SIG lately. Andre Michel has revitalized the SIG communications goals and vehicles. You will see regular

and more professional newsletters and emails from the Board. This is especially critical in that the Virtual Communities Project is starting off and

we will soon be gathering our Intellectual Property, cataloguing it and preparing it for a permanent home in the PMI Virtual Communities area. Mike Berk is helping me with this activity. We will keep

you informed as we continue this journey. Randy Dunson is very active with former Board Officer, Jann Nielsen, organizing our annual Project Management

Conference for March 2010 - Put it on your calendar for March 15-17 and see Randy's article later in the newsletter. Webinars are going strong due to the diligence of both Jim Kane and Jean Lieverman. We consistently

have more then one hundred and fifty participants at these events now. On the sadder side, I have reluctantly accepted the

resignation of Steve Vinson. Steve has been a solid and consistent performer on the board and has been a diligent worker over the course of his tenure. We wish him the very best and hope he finds the time to participate again.

Steve Kuprel, Pharma SIG Chair

Problem Solving Technique By Ashraf Al-Morsy Learning problem solving techniques will help you to become a good problem solver, to anticipate potential problems, to understand how to use different approaches to problem solving, and to make decisions and assess their outcome.

Page 1 of 14Your July 2009 PharmaSIG Newsletter

A problem can be defined as an unexpected or unplanned occurrence, or a deviation (gap) between what should be happening and what actually happened. Problem-solving then can be defined as an approach to smooth out unexpected

changes. It is one of the most creative and frustrating tasks managers face. The problem solving process typically entails 6 steps:

1. Identify the problem 2. Analyze the problem 3. Generate possible solutions

4. Offer alternative solutions 5. Deciding among solutions 6. Take action and assess results

1. Identifying the problem Experts on problem solving agree that the most common reason for a poor solution is

an incorrectly defined problem. Not getting sufficient data about the problem and mistaking the symptoms for the problem are two common errors. The key is not to see the solution but to see the problem itself.

The earlier a problem is identified, the earlier it can be solved. This requires some anticipation of problems. Although some problems arise suddenly, most task-related problems and many people-related ones can been foreseen. Thus, we have to:

1. Observe people's behavior, tasks and processes to reduce the possibility of facing sudden problems from an unexpected direction.

2. Examine and monitor each stage of the project, procedures, and business

situation. 3. Create future scenarios by asking "what if." 4. Do not ignore small problems or people's remarks

2. Analyzing the problem If you try to solve a problem without a proper analysis, you could be expending your

effort in the wrong direction. Therefore, make sure that you have all the relevant information about the problem. There are two techniques which can be used to examine and evaluate a problem:

1. Visual Analysis 2. Verbal Analysis

Visual Analysis is a technique to represent a problem in diagram form. Examples include:

1. Fishbone diagram

2. Idea map 3. On contrast 4. Tree dialogue

In the Fishbone Diagram (example below), start with head of the fish and write in the main problem. Use the bones to list the main causes of the problem. Then use the

flesh of the fish to list the cause of these main causes. For each cause, ask why this happens? Carry on until you get the root of the problem.


Idea Mapping is used to create a kind of mind map by charting the problem on paper in such way to bring out all the elements.

Keep in mind the following tips when approaching a problem:

� Whether the problem is big or small, you have to solve it.

� A problem well stated is a problem half solved. � The earlier a problem is solved the better the result. � Specify and quantify all problems. � Formulate the problem in positive language.

� Take time for analysis. � Do not try to solve the problem during the analysis stage. � Break complex problems down into small parts. � Seek others' opinions in solving a problem.

� Make solving the problem your priority.

Verbal Analysis is another simple technique to analyze a problem using questions known as "The six honest serving men." These six questions have to be asked at every stage.

1. Who 2. What

3. Why 4. Where 5. How


6. When

3. Generating possible solutions If you have analyzed your problem exhaustively and identified the root cause, you may find the solution you need. On the other hand, if the solution is less obvious you can use the following to fire your imagination and generate possible solutions.

1. Brainstorming 2. Lateral thinking

3. Analogical thinking

Brainstorming describes any group session in which people are invited to throw in ideas or a particular topic or problem. To have an effective brainstorming session, everyone must suspend judgment so ideas can flow without evaluation until all ideas are on the table. Typically this process entails the following steps:

1. Set out the problem or subject (written & visible)

2. Ask for any ideas from audience 3. Write all of these ideas down 4. Analyze which are feasible and which are not 5. Cluster the feasible ideas

6. Evaluate each and choose the one to be implemented 7. Implement

Lateral Thinking. Logical step-by-step thinking is useful both at the problem analysis stage and during the evaluation of possible solutions. Thinking laterally means making new conceptual jumps, creating a new track for the mind to travel along. This requires:

� Time and a relaxed atmosphere � An open mind to look at the things in a different way

� Willingness to change � Making a new connection: turning ideas around and looking at them from the

opposite side

Analogical Thinking. Sources of inspiration for new ideas are all around us but we may not see them. Using analogical thinking means applying solutions from one area

to another. For example:

� From home to work � From one department to another � Borrowing ideas from one person to another

4. Offer alternative solutions

It is important to have more than one solution at each stage of problem solving in order to keep yourself in the right track.

� Solution

� Alternative 1 � Alternative 2 � Alternative 3

5. Deciding among solutions Once you have several possible solutions, you need to evaluate them, choose the best

solution and be able to support the choice. It is important to use a systematic method to compare and decide among solutions that include (method - timing - activities - cost


- people involved). Among the possible methods for choosing a solution are:

1. Fishbone diagram 2. Using a grid 3. Positive and negative forces

Grid

Positive and Negative Forces It is important to know that when doing something new there will always be driving forces pushing us on and restraining forces holding us back. The positive/negative forces approach can be a useful means of quantifying the

decision. An example of this is below: Problem: Disappointing performance of an established consumer product Possible solution: Repackage the product

6. Taking action and assessing results

Once you have chosen your solution it is important to plan your course of action carefully. Usually this is done in two stages:


1. Planning stage

2. Action stage

Planning Stage - At this stage you need to consider the following:

Who is involved? Who will be affected? Who do you need to consult? What actions need to be taken?

What resources needed? When will you start? How will you cope with difficulties?

Action Stage - In this stage you have to consider:

What is my timeframe? What will I monitor? How will I monitor and evaluate the success of my approach?

How do I measure success? Who will do it? What are the alternatives?

Conclusion:

Learning from mistakes. Fear of failure or of the unknown is one risk faced by managers when solving problem. You can reduce this risk by building in regular reviews, analyzing mistakes, being creative and thinking of alternatives, and motivating

yourself to look for positives. If things do go wrong, find out why, but do not waste time or energy placing blame. Build on mistakes - what do you know as a result that you did not know before. And finally, salvage anything that went right.

Dr.Ashraf Al-Morsy, PMP is Project Manager at Zahrat Al-Rowda Planet association in Saudi Arabia and have been working in the pharmaceutical industry since his graduation in 2003 from Mansoura University in Egypt.


Value Management

The Power of the Word "How" By Joe Pona President, BioPharm Associates LLC

The Wall Street Journal (6/30, Johnson) reports, "The widespread use of expensive


cancer drugs to prolong patients' lives by just weeks or months was called into question

by an article published Monday in the Journal of the National Cancer Institute." The study showed that "treating a lung-cancer patient with, a drug that costs $80,000 for an 18-week regimen, only prolongs survival by 1.2 months." The authors noted that "based on that estimate, extending the lives of the 550,000 Americans who die of

cancer annually by one year would cost $440 billion." The authors also "questioned the cost-benefit calculus for other big sellers," calling "for changes in the testing and practice of medicine."

Pharma is continually looking for new ways to re-invent itself. Maybe we should look at companies in other industries to see how they changed their business strategy.

IBM moved from mainframe computer sales to IT business solutions, UPS from parcel delivery to supply chain services, T. Boone Pickens from oil to energy supplier, and Apple from personal computers to business mobility solutions.

In the above examples the companies evolved to grow out of mature businesses in a very competitive environment. But just having a great business strategy is no guarantee of success. That's where value management (also known as value analysis or value engineering) becomes a powerful tool. In value analysis we link functions to

the overall business strategy to provide the highest value to the customer. IT business solutions, supply chain services, etc. are known as the higher order function. Value Management Defines:

� Decreasing costs while maintaining performance

� Increasing performance while maintaining costs. � Increasing performance while reducing costs.

Value analysis was developed in the late 1940's at GE. Value analysis identifies, quantifies, and rectifies weaknesses in products and processes. The underlying principle behind this is customers/consumers focus on the functional properties and all costs in products are incurred in providing functionality.

Value management accomplishes this by linking functions to strategic objectives through FAST ( Functional Analysis Systems Techniques):

� Communicates clearly how a complex system such as an organization should work.

� Links functions to strategic objectives.

Defines the product attributes and features important to the customer.

Value Management - The Power of the Word "How" (continued)

Below is an example of a FAST Diagram. The vertical dashed lines define the scope. To the far left is the Higher Order Function (strategic objective). To the right of that is the Basic Function or principle reason for the product. As a FAST diagram is created

from left to right the question "How" is asked to obtain the next function.


Each functional block in the FAST follows a special protocol. We want to change a condition so we use a verb-noun description of functions. This prevents the team from describing solutions and tends to miss the opportunity

� Verb - what action is to be done? � Noun - what object is being acted on?

Verb/Noun Example - "Improve health"

Below is an example of a FAST for a pencil. How do you Record Data (higher order function) - Make Marks (basic function), how do you Make Marks - Contrast Color, etc.

An overview of the value analysis phases is shown below.

The phases are:

Information Phase - Identify Opportunities


� Who owns the problem? � Who or what are affected?

� Where did the problem originate? � What are the consequences if not solved? � What makes the problem better or worse? � What is the strategic objective?

Information Phase - Understand Needs and Define Higher Order Function

� User - Owner - Stakeholder Analysis. � Identify the value your customers find in the product.

� Define criteria/limits for functions.

Creativity Phase

� Brainstorm ideas.

� Affinity analysis

Analysis Phase

� Does it fit the basic function?

� Measure Against Criteria � Evaluate Using SWOT � Collate into similar features

Development Phase

� Assign team members as "champions" to further investigate ideas. � Proposals identified by team consensus.

� Identify value for each proposal. � Development recommendations to executive management.

It now costs the pharmaceutical industry over $1 billion to bring a product to market. Imagine the benefits if we can reduce that to $700 million and in two thirds the time to market. Imagine employing value analysis prior to finalizing a TPP? Would it help our prioritization?

So how do we apply this to the pharmaceutical industry or project management? For big pharma maybe our real higher order function is healthcare solutions as opposed to

drug development. For smaller companies and startups its main function could be innovation centers and for CROs program execution services or resource leveling. We can define project management as the sustained, integrated managerial attention to complex organizational ventures. Linking this to corporate strategy now expands the

role of project management to a value creator for the organization The pharma industry is unsophisticated relative to other industries in terms of management utilization, portfolio prioritization, and capital management. Value

analysis is a process which will raise its level of sophistication. Summary - The Power of the Word "How"

NASA needed a writing instrument suitable for the conditions of zero gravity. Normal pens relying on gravity to get the ink to the ball would not work in space. NASA engineering spent $10,000 to design a new pen and then presented their idea to the steering committee. They indicated each pen would cost in the six figures.


One of the steering committee members thinking this would be a costly option asked the question "how do the Russians write in space?" One of the team members said - "they use a pencil".

Biography BioPharm Associates LLC is a Project Management Consulting Company whose focus is on improving business results and value for corporations. The company develops the

skills and managerial attention needed to create business success for biopharmaceutical corporations across the globe. We accomplish this through our proven track record in building global project management organizations,proactively managing change, cross cultural sensitivity, human capital alignment and using value analysis methods to

provide the optimum solutions to our customers. www.biopharmassociatesllc.com

Your monthly communication Last month you received your first monthly communication since a while. It took me a while to get integrated and understand the group needs but we finally got there. Now it is your turn to communicate with

us and let us know what you are interested in and what you want this communication to be. We will always ensure we keep you informed of what the board is doing and what is coming up at PMI. However we will adjust to your suggestion for additional articles.

Sincerely, Andre Michel, Communication Director, PMI Pharma SIG

Annual Biopharmaceutical Project Management Conference

We are pleased to formally announce that our 5th annual conference will convene in Philadelphia on March 15-17, 2010!

The 2010 conference will be solely sponsored by the SIG so we hope that we can count on a significant number of you attending. As always we plan these conferences not only for the biopharmaceutical project community as a whole but with what will provide the most value to you, our members!

Our Program Committee has been meeting weekly since March and has made significant progress in developing a robust program and format based on feedback from past conference attendees and our membership. Currently our working title and overall

theme are as follows: Title: Innovative Project Management to Succeed in the Dynamic Biopharmaceutical Environment

Theme: The maturity of project management techniques within the biopharmaceuticals has steadily improved over the last few years. This year's program will acknowledge some of the significant strides being made in the management of projects across the

life sciences sector. The increasing pressures on biopharmaceutical sectors from regulators, governments, and patients as well as competitive pressures require organizations to be more agile in the way they manage their drug development


projects. The program will touch upon many of the aspects of project management

important to project managers working within the biopharmaceutical industry. There will also be presentations from project management professionals outside of the biopharmaceutical industry, who will bring some alternative perspectives to the conference.

Here are a few quick FAQs. Please stay tuned for regular updates via our SIG emails, conference flyers, LinkedIn, and others as our planning continues.

� Target attendance: 125 � 2-day conference w/pre-conference workshops/tutorials & networking dinner the

day before (Mon-Wed)

� Goal to keep registration fee at $1,000 or below with at least a 20% discount for SIG members

� Your feedback is always welcome & we will need volunteers to assist our Program Committee prior to, during, & after the conference

Please mark your calendars now so that you may join us in March

2010!

If you have any questions or would like to help please let us know.

Randy Dunson, MBA, PMP

Program Committee Chair

SIG First Vice Chair

July's Webinar

On July 17, Steve Rigby and Michalle Adkins discussed the project management processes of Project Scope Control leading to the successful completion of projects in

the Life Science Industry's automation area. There, pressures continue to rise to deliver a high quality, flexible product at a low cost under tight timelines while reducing risks and long-term support costs. The following strategies were discussed:

� Set Expectations. Setting clear expectations and defining project procedures at the beginning of the project will minimize risks during project execution.

� Prototype. A prototype allows the customer an opportunity to better understand system capabilities and visualize functionality. This reduces the risk of changes.

� Project Guidelines. Establishing Guidelines allows parallel development activities resulting in an efficient and timely project execution and mitigates risks

associated with inconsistencies. � Global Standards. Using global standards and a modular design approach can

reduce system life cycle costs. � Testing. Testing can be leveraged to provide the customer with a timely, cost

effective product. Early development of testing strategies can reduce risks during project execution.

The Webinar has been recorded and is available to our members on our website at Webinar.

August's Webinar


Accelerating Teamwork: Making Good Pharma Teams Better

Ruth Dubinsky, MS OD

August 13, 2009 and August 14, 2009 (12:00 to 1:00 PM EDT)

Global, cross-functional teams are the primary engines of pharmaceutical product development. While most teams are extremely skilled technically and scientifically,only the top performing teams are able to navigate the compressed deadlines, unforeseen

changes of clinical, commercial, and regulatory direction, and inevitable cross-functional conflict. Less effective teams struggle and become stuck in a loop of conflict, rework and fire fighting. This unproductive behavior results in lost time against already challenging deadlines.

Although in principle everyone is interested in becoming more productive as a team, the scientists, physicians, strategic marketers, and engineers who are key members on

these teams are frequently skeptical about the value of investing time for "team building". However, when team development is approached in the context of the work, the payoff

is significant and long lasting. There are foundational strategies and tactics that can be applied immediately to help teams assess and recover from breakdowns, deal with inevitable conflict, make better, faster decisions - and accelerate their work. Effective teaming is a discipline that takes skill and practice. Participants are invited to consider

what they can do operationally and behaviorally to take their team to a level of higher performance. This webinar is being held both Thursday night (for our Asian/ Australian members) and

Friday at noon (EDT). Bio - Ruth Dubinsky Ruth Dubinsky, MS founder of Clarity Consulting, Inc. works with pharmaceutical, biotech, device and CRO clients, specializing in team development and performance. As a former bench scientist, drug developer and clinical

researcher, Ruth brings over 30 years of practical real life industry experience to her consulting practice. She understands the unique challenges and intense pressure facing global, matrix pharma teams. Her work focuses on

helping teams assess and recover from breakdowns, deal with inevitable conflict, make better, faster decisions - and accelerate their work. Teams walk away with clarity about what they can do differently - both behaviorally and

operationally - that will have meaningful impact on progress.

She's led the development of the requisite team structures, governance, roles and competencies needed by management, team leaders and team members for large, global healthcare organizations.

She is a co-leader and author of a research study designed to identify specific behaviors and strategies of the highest performing teams within Johnson & Johnson. The study characterized drivers of top team performance, and

was published in the Organization Development Journal, Summer 2007. These findings will be the foundation of her session on Accelerating Teamwork - Making Good Pharma Teams Better.

Ruth holds a Masters degree in Organization Development and Psychology.

To register click here

News From the Industry

Under settlement, FDA has to pre-approve Merck ads Analysts: Amgen most at risk from biogenerics

FDA launches Xolair safety probe


PhRMA backs new Harry-and-Louise ads

Nycomed seeks financing for Solvay buy Can vaccine makers deliver on flu shot deals?

Actelion accelerates late-stage trials for hypertension drug HGS shares soar as market waits for lupus data

Luna Innovations files for bankruptcy protection For more news or to read related articles , please visit our news page on

LinkedIn.

Looking for Authors If you have authored an interesting article on biopharmaceutical

project management or wish to share an interesting new project management tool or concept, we would like to hear from you and publish your article in the newsletter.

Please contact Andre Michel @ [email protected]

PharmaSIG | Address | Any City | MI | 48103

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