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Pharma project risk management
The document discusses risk management for pharmaceutical projects. It begins by outlining the characteristics of the pharmaceutical industry and drug development process. The drug development process takes an average of 10 years and $2.6 billion to develop a new drug. The presentation then covers risk management processes, tools and techniques for identifying, analyzing, and responding to risks in drug development projects. A case study on risk assessment for product development is presented to demonstrate how to evaluate risks and prioritize mitigation actions.
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Pharma project risk management
- 1. Pharma Project RiskManagement Essentials Megha Thakkar PMP® Project Manager - NDDS Cipla Ltd. 3rd Annual Pharma Project Management Conference, Mumbai, India 29 Jun 2015
- 2. Agenda • Identify thedistinctive characteristics of the pharmaceutical industry and drug development projects. • ‘Project risk’ and ‘Project risk management’. • Risk management processes, approaches, and assisting tools and techniques • Case Study Objective • The main focus is to develop the risk management process for drug development projects. • Risk management tools to be used with the process need to be identified to enable the implementation of the process 29 Jun 2015 23rd Annual Pharma Project Management Conference, Mumbai, India
- 3. Recent changes Special characteristicsof the pharmaceutical industry Pharmaceu tical industry Demand pattern Intellectual property rights Regulations R&D intensivenes s Industry structure 29 Jun 2015 33rd Annual Pharma Project Management Conference, Mumbai, India
- 4. Drug development process 29Jun 2015 43rd Annual Pharma Project Management Conference, Mumbai, India From drug discovery through FDA approval, developing a new medicine on average takes at least 10 years and costs $2.6 billion.* Less than 12% of the candidate medicines that make it into phase I clinical trials will be approved by the FDA. Cost of being late 1 billion USD per day *Source – PhRMA Profile - 2014
- 5. Drug Development asa Project • A Project is a temporary endeavor undertaken to create a unique, product, service, or result. • Pharmaceutical projects are huge in terms of – money and time consumed – human resources required. – In fact, a drug development project constitutes of managing many • Sub-projects performed by different line organizations such as the preclinical studies, clinical studies, process development, and marketing planning. • Even most of single studies would be regarded as big projects in other industries. • Thus, the drug • development project could also be viewed as a program 29 Jun 2015 53rd Annual Pharma Project Management Conference, Mumbai, India
- 6. 505(b)(2) 29 Jun 201563rd Annual Pharma Project Management Conference, Mumbai, India Regulatory Process 505(b)(1) 505(b)(2) 505(j) Review Classification/Timeline 9 mos.1 9 mos.1 6-12+ mos. Examples of Allowed Changes (e.g., from RLD) New Molecular (Chemical) Entity Yes Yes* No New Active Moiety Yes Yes* No New Indication Yes Yes No New Route of Administration Yes Yes* No* New Formulation Yes Yes* No* New Ester, Salt or Other Non-covalent Derivative Yes Yes* No New Dosage Form or Strength Yes Yes* No* Combination Product Yes Yes May be Rx/OTC Switch Yes Yes No Labeling NA May be No why is it different “Animal”?
- 7. What is ProjectManagement? • The application of knowledge, skills, tools and technique to project activities to meet project requirements • Project Management is accomplished through the application and integration of the processes which are grouped in the 5 process groups: – Initiating – Planning – Executing – Monitoring and Controlling – Closing • Due to the nature of change, managing project is iterative and goes through progressive elaboration throughout the project’s lifecycle 29 Jun 2015 73rd Annual Pharma Project Management Conference, Mumbai, India
- 8. Knowledge Areas • Theten knowledge areas are: – Project Integration Management – Project Scope Management – Project Time Management – Project Cost Management – Project Quality Management – Project Human Resource Management – Project Communications Management – Project Procurement Management – Project Stakeholders Management 29 Jun 2015 83rd Annual Pharma Project Management Conference, Mumbai, India Project Risk Management
- 9. Projects and Projectmanagement in drug development 29 Jun 2015 93rd Annual Pharma Project Management Conference, Mumbai, India Characteristic Projects • Consist of several sub-projects. • Technical uncertainty: lack of efficacy is the reason for 46% of project failures. • Critical importance of scientific knowledge and early detection of problems. Project Management • Industry has been slow to implement project management practices and is less mature in this respect. • Medium-sized companies perform better than bigger ones by having a stronger project-orientation both organizationally and culturally and by having senior management more closely involved with project management. • Many critical activities are incompressible. • Regulatory guidelines facilitate project planning. • Target product profiles. • Project team develops a strong sense of ownership. • Project team composed of individuals with narrow Speciality areas.
- 10. Risks in drugdevelopment projects 29 Jun 2015 103rd Annual Pharma Project Management Conference, Mumbai, India Technical risks Launch risks Partner/subcontractor/ contractual risks Regulatory risks Commercial risks Resource/personnel risks IPR risks Project management risks Clinical Pharmacology Formulation Analytics Process developmentIndustrialisation Toxicology Pharmacokinetics Scientific advances Competitors Markets and marketing Scientific recommendations Availability Knowledge
- 11. Risk management –Not a Management Gimmick • Helps to avoid any big disaster • Enhances revenues by saving additional expenses • Provides mental satisfaction • Ensures the successful completion of project • Gives competitive edge over others • Increases the sense of responsibility and accountability • Helps to explore new opportunities 29 Jun 2015 113rd Annual Pharma Project Management Conference, Mumbai, India
- 12. DEVELOPING A COMPREHENSIVE RISKASSESSMENT 29 Jun 2015 123rd Annual Pharma Project Management Conference, Mumbai, India
- 13. Terminology • Threat • Vulnerability •Accident • Risk • Consequences 29 Jun 2015 133rd Annual Pharma Project Management Conference, Mumbai, India The goal is not to be understood. It is to not be misunderstood.
- 14. Risk • Future Effect •Combination of Severity and Likelihood • Undesirable (Insurance Co. view) • A risk assessment attempts to discover the entire range of threats and vulnerabilities – their confluence – looking for • “what can go wrong.” 29 Jun 2015 143rd Annual Pharma Project Management Conference, Mumbai, India
- 15. How do weassess? • 3 steps to the Assessment process – Identification • What might go wrong? • Must clearly define the risk in question – Analysis • What is the likelihood? • How bad would it be? – Evaluation • What are the levels of risk criteria? • Defined in advance 29 Jun 2015 153rd Annual Pharma Project Management Conference, Mumbai, India
- 16. Risk Assessment • Asystematic process for organizing information to support a risk decision that is made within a risk management process. • The process consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards. 29 Jun 2015 163rd Annual Pharma Project Management Conference, Mumbai, India
- 17. Risk Management • “Riskmanagement is the process of measuring or assessing risk and then developing strategies to manage the risk. These strategies can involve the transference of risk to another party, risk avoidance or mitigation, and channel risk sharing. 29 Jun 2015 173rd Annual Pharma Project Management Conference, Mumbai, India
- 18. Risk Management -Responses 29 Jun 2015 183rd Annual Pharma Project Management Conference, Mumbai, India Type of Response Method of Dealing with Uncertainty Convert risk to Opportunity Avoid Plan to avoid specified sources of uncertainty Modify objectives Reduce or raise performance targets, change trade-offs b/w multiple objectives Transfer Partnership Share Partnership Prevent Change the probability of occurrence Mitigate Modify the impact of a source of uncertainty Contingency Plans Set aside resources to provide a reactive ability to cope Keep options open Delay choices and commitment, choose versatile options Monitor Collect and update data about probabilities of occurrence, anticipated impacts, and additional risks Accept Accept risk exposure, but do nothing about it Remain unaware Ignore the possibility of risk exposure, take no action to identify or manage risk Difficulties
- 19. Risk Control • Riskcontrol includes decision making to reduce and/or accept risks. – The purpose of risk control is to reduce the risk to an acceptable level. – The amount of effort used for risk control should be proportional to the significance of the risk. – The user shall use different processes for understanding the optimal level of risk control including cost-benefit analysis. 29 Jun 2015 193rd Annual Pharma Project Management Conference, Mumbai, India
- 20. Risk Reduction • Bythe implementation of risk reduction measures, – new risks may be introduced into the system – the significance of other existing risks might be increased. – Hence, it might be appropriate to revisit the risk assessment to identify and evaluate any possible change in risk. 29 Jun 2015 203rd Annual Pharma Project Management Conference, Mumbai, India
- 21. Risk Acceptance • Riskacceptance is a decision to accept risk. – Risk acceptance can be a formal decision to accept the residual risk or it can be a passive decision in which residual risks are not specified. – This acceptable level will depend on many parameters and should be decided on a case-by-case basis. 29 Jun 2015 213rd Annual Pharma Project Management Conference, Mumbai, India
- 22. Risk Review 29 Jun2015 223rd Annual Pharma Project Management Conference, Mumbai, India Risk management plan Risk identification Risk assessment Risk response planning Monitoring and control
- 23. Tools and Techniquesfor Risk Review • Ishikawa Model • SCORE model • Failure Mode Effects Analysis (FMEA) 29 Jun 2015 233rd Annual Pharma Project Management Conference, Mumbai, India
- 24. Ishikawa Model 29 Jun2015 243rd Annual Pharma Project Management Conference, Mumbai, India
- 25. Failure Mode EffectsAnalysis (FMEA) • FMEA is a prevention tool used to assess, manage, and reduce risk associated with failure or potential failure of products, processes, services, and other systems. • A quantitative characterization of failures is then undertaken • • This is comprised of the assignment of probabilities to three factors - the likelihood of occurrence, the likelihood of detection of failures and the severity of a failure. • As part of this assessment each characteristic is assigned a value. These values are then multiplied with the resultant risk priority number (RPN). 29 Jun 2015 253rd Annual Pharma Project Management Conference, Mumbai, India
- 26. Occurrence 29 Jun 2015263rd Annual Pharma Project Management Conference, Mumbai, India RANKING CRITERIA 1 Remote probability of failure. One occurrence every one to three years or one occurrence in one million events. 2 Low probability of failure. One occurrence every six months to one year or one occurrence in 10000 events 3 Moderate probability of failure. One occurrence every three months or three occurrences in 1000 events 4 High probability of failure. One occurrence per week or a probability of 5 occurrences in 100 events 5 Very High probability of failure
- 27. Severity • Severity (S)refers to an assessment of the seriousness of a failure as it affects the end user. • A higher severity rating may be assigned to process steps that involved manual operations or interventions as compared to done by automatic machine The higher rating is necessary because of quality failure or introduction of contamination during these steps will result in a higher risk to the product safety and the end-user. 29 Jun 2015 273rd Annual Pharma Project Management Conference, Mumbai, India
- 28. Severity 29 Jun 2015283rd Annual Pharma Project Management Conference, Mumbai, India RANKING CRITERIA 1 Product quality is not affected 2 Very Low severity. A lesser deviation from the requirements which calls for moderate action (i.e. higher frequency of tests of the final products, additional tests, etc.) 3 Low severity. A deviation from the requirements which calls for strong action (i.e. quarantining of a batch, product recall, OOS-Situation etc.) 4 High severity. Affect to the patient in some way. 5 Very High severity. Threat to the life of patient
- 29. Detection • Detection (D)refers to the ability to detect the failure mode for contamination risk prior to the customer receiving the finished product. • The rating scale for determining the detection level is shown in Table 29 Jun 2015 293rd Annual Pharma Project Management Conference, Mumbai, India
- 30. Detection 29 Jun 2015303rd Annual Pharma Project Management Conference, Mumbai, India RANKING CRITERIA 1 Assured detection of failure mode. The defect is obvious or there is 100% automatic inspection with regular calibration and preventive maintenance of the inspection equipment 2 Chances of Detection are high. An effective Statistical Process Control (SPC) program is in place 3 Detection possibility is moderate. Some SPC is used in process and the product is final inspected off-line 4 Difficult to detect .Product or failure is accepted on the basis of no defectives in a sample 5 The failure is not inspected or the failure is not detectable
- 31. Risk Score 29 Jun2015 313rd Annual Pharma Project Management Conference, Mumbai, India Risk Priority Number = O x S x D Where O = Occurrence S = Severity D = Detection Risk priority number evaluates the overall risk. Helps to identify focus area to help improve overall system reliability
- 32. Steps of FMEA •Step 1： Review of the process (Process mapping) • Step 2： Determine failure mode • Step 3： Determine potential risk of the failure modes • Step 4： Evaluate severity of the risks (S) • Step 5： Evaluate probability of the failure modes (P) • Step 6： Evaluate the detection of the failure modes and/or risks (D) • Step 7： Calculate Risk Priority Numbers (RPN) • Step 8： Prioritize the failure modes need to be mitigated • Step 9： Decide elimination and/ or avoidance of the failure modes • Step 10： Re-calculate the RPNs after mitigation 29 Jun 2015 323rd Annual Pharma Project Management Conference, Mumbai, India
- 33. Risk Matrix –Probability Impact Matrix 29 Jun 2015 333rd Annual Pharma Project Management Conference, Mumbai, India Low Medium High Severity Probability High Low Medium Risk Class ONE Risk Class TWO Risk Class THREE
- 34. Risk Matrix –Risk Classification 29 Jun 2015 343rd Annual Pharma Project Management Conference, Mumbai, India THREE TWO ONE Detection RiskClassification High Low Medium HIGH priority MEDIUM priority LOW priority
- 35. Risk evaluation -Risk Severity / Probability Classification 29 Jun 2015 353rd Annual Pharma Project Management Conference, Mumbai, India 5. Frequent X1 X4 X4 X5 X5 4. Probable X1 X3 X4 X4 X5 3. Occasional X1 X2 X3 X4 X4 2. Remote X1 X2 X2 X3 X4 1. Improbable X1 X1 X1 X1 X1 RATING 1 - None 2 - Negligible 3 - Marginal 4 - Critical 5 - Catastrophic ProbabilityClassification Risk Severity
- 36. Risk Severity+Probability VsDetection 29 Jun 2015 363rd Annual Pharma Project Management Conference, Mumbai, India X5 X1 X4 X4 X5 X5 X4 X1 X3 X4 X4 X5 X3 X1 X2 X3 X4 X4 X2 X1 X2 X2 X3 X4 X1 X1 X1 X1 X1 X1 RATING 1 - Assured 2 - High 3 - Moderate 4 - Difficult 5 - Not detectable RiskSeverity+Probability Detection
- 37. Risk Management –Action plan 29 Jun 2015 373rd Annual Pharma Project Management Conference, Mumbai, India Level of Risk Category Action No risk X1 No action reqd. Small risk X2 Training Moderate Risk X3 Cost effective / selective controls Unacceptable Risk X4 Control irrespective of cost involved Severe X5 Immediate change of process design/ Control required
- 38. CASE STUDY 29 Jun2015 383rd Annual Pharma Project Management Conference, Mumbai, India
- 39. Risk Assessment –Product Development 29 Jun 2015 393rd Annual Pharma Project Management Conference, Mumbai, India Sr. no. Risk Occurrence O Severity S Detection D Risk priority # OxSxD Category Risk Mitigation Plan 1 API unavailability 1 3 1 3 X3 Alternate Vendor Development 2 API Supplier doesn’t qualify regulatory requirement 1 2 1 2 X2 Dossier review 3 Product Development 1 5 1 5 X5 Two different approaches 4 Packaging Material Failuer 1 3 1 3 X3 Two different approaches 5 Pre-clinical Study failuer 1 4 1 8 X4 Two different formulations to be given for Pre-Clinical 6 Commercilization Mfg. Site availability 1 5 1 5 X5 Identifiation of Mfg. site immediately once Formulation approach is finalized
- 40. Risks involved inNDDS and Platform technologies 29 Jun 2015 403rd Annual Pharma Project Management Conference, Mumbai, India Risks Risk involved Risk Mitigation Technical risks • Development More Time consuming • Less experience • POC to be developed first Industrilization • It is difficult at times due to new technology. Lead time of such specialized machines can be anywhere between 14 to 24 months. With high cost • Identification of requirement to be done right in the beginning. Changes in regulatory requirement • Dynamic environment • Regular and close analysis is required Market acceptance • It can be either boom the market or get doomed. • Shared risks
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