Complexity of Project Management in Pharmaceutical Industry.
Pharma’s strategy of placing big bets on a few molecules, promoting them heavily, and turning them into blockbusters worked well for many years but, the R&D productivity has now plummeted while the environment is changing.
The global market for medicines is growing but, the industry must transform to capitalize on opportunities. The role of pharma project management software was never more critical!
Findings from research by PwC indicate major shifts facing the pharma companies that could amplify the complexity of project management — from new idea evaluation to drug launch.
Pharma Research
Pharma Development
Pharma Supply Chain
In the above background, Pharma companies must focus on critical areas elucidated in the following sections.
Focus area # 1: Evaluating new drug ideas and investment allocation decisions.
With significant business implications, new pharma ideas must be documented and evaluated with high rigor. New product idea evaluation teams focus narrowly on the technical aspects without comprehensive business cases. Team members struggle with spreadsheets, word documents, and emails to justify new ideas.
A lack of standardized processes leads to:
1.Idea generation and evaluation inefficiency.
2.Sloppy drug idea evaluation.
3.Lax financial decisions.
4.Significantly faster idea evaluation.
5.Meticulous, holistic, and data-driven idea evaluation.
6.Stringent investment allocation.
7.Better business cashflow.
8.Formulation
9.API Procurement
10.Pre-formulation Studies
11.Analytical Method Development
12.Packaging Development
13.Stability Studies
14.Pilot
15.Batch Size Finalization
16.Pilot Batch Manufacture
17.BE Study
18.Production, Regulatory Approval & Product Launch
19.Analytical Method Validation
20.Technology Transfer
21.Manufacture PV (Process Validation) Batches
22.Final BE Report
23.Prepare & Submit Dossier
24.FDA Registration
25.Product Launch
26.Recommendation
Leaders must deploy the power of technology-driven pharma project management software that comprehensively evaluates new drug ideas with business case templates based on the nature, value, and complexity of ideas.
Potential impact
Focus area # 2: Integrated project planning.
New Product Development projects in the pharmaceutical industry are complex by nature and involve multiple dimensions:
Numerous studies indicate that organizations plan pharma projects in a disjointed manner. Plans involving schedules, resources, costs, procurement, and risks are very ‘loosely’ defined.
Reliance on multiple forms of documentation (Spreadsheets, Documents, and Emails) does not give robustness and rigor to plans, while progress-tracking lacks discipline.
Recommendation
Digitize the NPD planning and monitoring through an integrated pharma project management tool that holistically consolidates schedules, resources, costs, procurement, and risks.
Further, automating business processes and decision workflows could eliminate non-value-adding components such as follow-ups, alerts, notifications, and go-no-go decisions. A well-designed online project management software eliminates manual documents and reliance on email-based follow-up.
Potential impact
Impeccable project planning.
Transparency drives quick bottleneck identification.
Enhanced project team productivity.
Faster project status determination.
Facilitate electronic workflow processes.
Create audit trails.
Offers ‘one version of documentation truth.’
Improve information accessibility.
Supports systems integration across business functions.
Focus area # 3: Pharma Dossier Management.
The pharmaceutical industry faces stringent documentation norms or pharma dossiers. Dossier management is one area where most organizations experience inefficiencies — document creation, versioning, and changes.
Organizations still rely on ‘disparate’ documents to manage multiple revisions that are nerve-wracking. Documentation teams end up burning the midnight oil as the project phase comes closer to document submission to regulatory authorities. The result — delayed dossier submission, lost revenue opportunities, and even missing patents to competitors.
Recommendation
Organizations must look to digitize the complete NPD cycle that includes dossier management. Today, sophisticated integrated pharma project management tools support an organization’s digital maturity — thereby eliminating all manual documentation.
Potential Impact
Focus area # 4: Cross-functional Collaboration.
Pharma NPD projects cut across multiple cross-functional teams that include R&D, PMO, resource management, finance, documentation, procurement, manufacturing, marketing, regulatory, and product launch.
Given the broad spectrum of stakeholders driving pharma projects, it is still surprising to observe signs of silo-thinking and reliance on emails — an archaic way of ‘working together.’
The results become too obvious — trust deficit, conflicts, and bureaucratic decision-making.
Recommendation
Pharmaceutical companies must foster seamless collaboration via online project management software that supports social media-like UI/UX, instant collaboration (one-on-one and one-to-many), sharing files, discussions, and integrated with NPD project management.
Potential Impact
Project team transparency.
Minimized stakeholder conflicts.
Better collaboration.
Swift decision making.
Key Takeaways
To successfully navigate a complex business world, Pharma companies must –
Lay the foundation for digital NPD project management.
Invest in an integrated pharma project management tool — from idea creation to product launch.
Foster seamless collaboration across the stakeholder spectrum.
Use digital capabilities to build and enhance a culture of NPD project management.
