PROJECT PLANNING, PROJECT IMPLEMENTATION, CASE STUDY, ASPECTS OF IMPLEMENTATION

1. PROJECT MANAGEMENT IN
PHARMACEUTICAL INDUSTRY
Prepared By: Guided By:
Chandani Tripathi Dr. Gayatri Patel
17MPHRA010 Associate Professor
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3. Table of Content
• INTRODUCTION
• WHAT IS PLANNING?
• WHY PLANNING?
• TYPES OF PLANNING
• STEPS INVOLVED IN PLANNING
• ELEMENTS OF PLANNING
• CHALLENGES
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4. • CONTROL AND IMPLEMENTATION
• PRE-REQUISITES FOR SUCCESSFUL PROJECT IMPLEMENTATION
• HOW DOES ONE MEASURES PROJECT SUCCESS
• CASE STUDY
• SUMMARY
• REFERENCES
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5. INTRODUCTION
• Regulatory policies and compliances -----for new drug -------tighter,
impacting product development, and registration strategies.
• The pharmaceutical industry is under pressure to accelerate the drug-
development stage to compensate for the longer wait for regulatory
approval. As a result the companies are working on new products in parallel-
-----this leads to further hurdles in management of the product at once.
• Wourms B. Pharmaceutical Organizations Discover New Way to Stay Ahead of the Game: Project Management Outsourc. Pharm Process [Internet]. 2003;(16–18).
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6. The Pharmaceutical Industry
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7. WHAT IS PLANNING?
• Analyzing the current situation
• Assessing needs
• Establishing goals
• Setting objectives & targets
• Determining the strategies & responsibilities
• Resources
• Pharmaceutical Project Management- Tony Kennedy. Published by Marcel Dekkar, inc., New York Pg no. 57-64.
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8. Why should one go for planning?
To clearly identify goals
To assess current needs and problems
To ensure wise use of available human and financial resources
To obtain additional resources
To provide a basis for evaluating effectiveness
To align staff priorities and build a sense of teamwork
Projects-Prasanna Chandra. Published by McGraw Hill Education (India) Private Limited, Pg no. 21.9-21.15.
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9. What are the types of planning ?
WORK PLANNING
Projects-Prasanna Chandra. Published by McGraw Hill Education (India) Private Limited, Pg no. 21.9-21.15.
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10. Process Program planning
Projects-Prasanna Chandra. Published by McGraw Hill Education (India) Private Limited, Pg no. 21.9-21.15.
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11. QA Dept.
Pharmaceutical Management-Sachin Itkar. Published by Nirali Prakashan Pg no. 3.1-3.2 & 15.1-15.7 11

12. Warehouse Dept.
Pharmaceutical Management-Sachin Itkar. Published by Nirali Prakashan Pg no. 3.1-3.2 & 15.1-15.7 12

13. Pharmaceutical Management-Sachin Itkar. Published by Nirali Prakashan Pg no. 3.1-3.2 & 15.1-15.7 13

14. Supply chain Management
Pharmaceutical Management-Sachin Itkar. Published by Nirali Prakashan Pg no. 3.1-3.2 & 15.1-15.7 14

15. Steps Involvedin Planning the Process
Define the target.
Prepare a list of necessary work packages
(studies).
Determine the logical sequence and estimate
durations.
Determine the critical path.
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16. Steps Involvedin Planning the Process
Optimize the plan to reduce critical path length.
Plan resources and costs and adjust for
resource and budget constraints and priorities.
Adjust plan during execution to new data, as
required.
Projects-Prasanna Chandra. Published by McGraw Hill Education (India) Private Limited, Pg no. 21.9-21.15.
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17. Elements of
Planning
Functions
Objectives
Policies
Procedure
RulesPrograms
Budgets
Strategies
Projects
Projects-Prasanna Chandra. Published by McGraw Hill Education (India) Private Limited, Pg no. 21.9-21.15.
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18. Challenges
Scope
Planning,
execution,
and
monitoring
Timeline
and budget
planning
compliance
strategies
Risk
management
Projects-Prasanna Chandra. Published by McGraw Hill Education (India) Private Limited, Pg no. 21.9-21.15.
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19. Projects-Prasanna Chandra. Published by McGraw Hill Education (India) Private Limited, Pg no. 21.9-21.15.
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20. PROJECT IMPLEMENTATION
Adequate
Formulation
Proper
implementation
planning
Advance action
Timely
availability of
funds
Judicious
equipment
tendering and
procurement
Better contract
management
Effective
monitoring
mds3-ch38-planningmgmt-mar2012. 20

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22. Project Success?
Project
Effectiveness
Project
Efficiency
Users
Interest
Product
Quality
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23. Portfolio P, Systems M. Project Portfolio Management in the Pharmaceutical Industry Do Pharmaceutical Companies benefit financially from Project Portfolio
Management Systems ? Fjóla Steingrímsdóttir Project Portfolio Management in the Pharmaceutical Industry. 23

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25. Eli Lilly
Background: Founded in 1876 in Indianapolis, USA, by Colonel Eli Lilly.
• 1st to produce insulin in 1923 + human insulin using recombinant DNA.
• Lilly is also the world's largest manufacturer and distributor of psychiatric
medications.
• 9th world's biggest pharmaceutical company.
• Crisis/ Problem: The patent expiration for Prozac as it counts 20 % of the
company's overall revenue.------ drop in sales by 23% .
• Raja BH. Open Innovation in Pharmaceutical Industry : A case study of Eli Lilly Open Innovation in Pharmaceutical Industry : A case study of Eli Lilly. 2015;
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26. • 2) Fine imposed for illegal marketing. (Zyprexa)
• 3) Distrust that turned out in more restriction for drug approvals.
SOLUTION:
1) Increase in R&D budget by 30%, ($2.2 billion), hiring 700 scientists.
2) The firm extended their areas from psychopharmacology to a larger fields like
Neuroscience, Oncology, Endocrinology, Cardiovascular etc.
3) The Office of Alliance Management, based on the idea of (I) Find it, (II) Get it,
(III) Create value.
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29. • TBDDI is Lilly’s Tuberculosis drug discovery
• TB Drug Accelerator (TBDA)
• Open innovation drug discovery program
• Public-Private partnerships (PPP)
Result: Due to these collaborations and technology transfer/ Knowledge
exchange the company has successfully regained its lost position. The new
upcoming tools like Crowdsourcing and open source drug discovery being
implemented by these company make the Outsource Licensing initiatives
multilateral all over the world making the innovation network boundary more
porous.
Raja BH. Open Innovation in Pharmaceutical Industry : A case study of Eli Lilly Open Innovation in Pharmaceutical Industry : A case study of Eli Lilly. 2015;
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30. References
Pharmaceutical Project Management- Tony Kennedy. Published by Marcel
Dekkar, inc., New York Pg no. 57-64.
Projects-Prasanna Chandra. Published by McGraw Hill Education (India) Private
Limited, Pg no. 21.9-21.15.
Pharmaceutical Management-Sachin Itkar. Published by Nirali Prakashan Pg no.
3.1-3.2 & 15.1-15.7
Portfolio P, Systems M. Project Portfolio Management in the Pharmaceutical
Industry Do Pharmaceutical Companies benefit financially from Project Portfolio
Management Systems ? Fjóla Steingrímsdóttir Project Portfolio Management in
the Pharmaceutical Industry.
mds3-ch38-planningmgmt-mar2012.
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