Introduction
Feature
Who should attend
Key learning area
This course provides training on the pharma and biopharma R&D discovery, development and commercialization pipeline, project and portfolio management.
This online Pharmaceutical and Biopharmaceutical Project Management training course utilizes interactive learning tools to guide each participant through the steps of the project management process which takes place in the pharmaceutical, biotech keeping in view both in innovative and generic industry.
The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course. The course can be completed at any pace, allowing the user to stop and start at their leisure.
- Course Title: Advance Certification in Pharmaceutical Project Management
- Course Code: RYD-047
- Nature of the course: Online distance learning course. Course can be accessed online across anywhere 24×7.
- Duration of the course: 1 Month
- Eligibility: Graduation in any discipline.
- Course Certificates: Certificate will be provided at the end of the successful completion of the course.
- Deliverables: Attend the course 24×7 by login to your dashboard. You can attend lectures, simulation, self assessment tests and final certification examination. You will also eligible to receive the course study modules, which you can download by login to your course page.
Features of Pharma Project Management Course
- This pharma project management covers all aspects of the project and portfolio management from drug discovery development, regulatory, commercialization of the innovator drugs, innovator biologics, generics and biosimilars.
- The course provides orientation to job related practical aspects of the pharmaceutical project managers. Therefore, on completion of the course, the participants will develop the hands on understanding how Project Management Professionals works in pharmaceutical and biopharmaceutical company..
- One of the important feature of the course is real life simulation on project related critical decision making process. Hence, these simulations help to enhance the decision making skills which is the core aspects of the pharmaceutical project manager’s working.
Who should attend this course?
- First of all, this course is ideal for Pharmaceutical & Bio-Pharmaceutical professionals seeking to enhance or update knowledge about pharmaceutical project management.
- Secondly, this course will be great help to those who are moving into pharmaceutical project management.
- Moreover, Pharmaceutical R&D scientist, Regulatory Affairs Professionals, and strategic management professionals will learn much needed key skills in Pharma Project Management.
- Above all, this course will be ideal for those who will be working at portfolio management projects of pharmaceutical companies.
Key Areas of Learning:
- Drug Development to Commercialization – R&D management and related strategic planning.Â
- Basics of Biopharmaceutical – Development to commercialization
- Advanced training on various classes of biopharmaceuticals.Â
- Understanding on the biopharmaceutical regulatory affairs, registration requirements.Â
- Biopharma strategic management training
- Biopharma market access | Market sizing | Forecasting | Valuation | Pricing | Reimbursement
- Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio
- Objective – Strategy – Tactics | Portfolio constraints | SWOT | Numerical SWOT Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques – Web Search | Conference | Confidentiality – CDA | MTA
- Life cycle extension / Loss of Exclusivity – LOE strategies.
- Pharma Marketing and branding Strategic Planning.Â
- Generic Drug Strategic Planning
- Strategic Pathways for marketing authorization of the pharmaceutical and – biopharmaceutical products in various business regions – US, EU, LATAM, GCC, rest of the world.
- Exclusive training on Biopharmaceutical and biosimilar management.
- In depth training on Licensing in the pharmaceutical industry – In Licensing Vs. Out licensing, Co-development, co-marketing, Co-promotion, Reverse Copromotion,Â
- Financial Planning and Management for pharma strategic management professionals
- Modelling and Deal Valuation – Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
- Royalty Management – Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking – Concept and Calculation | Minimum Annual Royalties | Reach through royalties
- Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses.
- Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process.
- Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales – Max-Min Approach.
- EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Section 1Fundamental Understanding of Project Management
Lecture 1Introduction and definition
Lecture 2Difference between Project and Program
Lecture 3Phasing of Projects for better effectiveness / outcome of the ProjectÂ
Lecture 4Project Management Constraint
Lecture 5Review Test
Lecture 6Introduction to Pharma Project Management - PERT, CPM, Critical Path, Project Diagram and its components
Lecture 7Pharma Project Management Terminologies
Lecture 8Project TrackingÂ
Lecture 9Asset TrackingÂ
Section 2Pharma and Biopharma R&D Project and Portfolio Management
Lecture 10Fundamental of Pharma R&D - Discovery to Commercialization Process
Lecture 11Investigational New Drug Application (INDA)
Lecture 12New Drug Application (NDA)Â
Lecture 13Biological Licensing Application (BLA)Â | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 14Basic concept and understanding of the Generic Drug
Lecture 15Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 16Handling of orange book
Lecture 17Purple Book: Significance | Searching | Assignments
Lecture 18USFDAÂ expedited programs
Lecture 19505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 20Advance Learning on 505B2 Pathway
Lecture 21Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projectsÂ
Lecture 22Project Terminations
Lecture 23Market Access - Understanding key terminologies and various key steps in market access
Lecture 24Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 25Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 26Indication Prioritization Case Study
Lecture 27Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 28Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 29Cycle Times (Stage or phase lengths)
Lecture 30Importance of The proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 31Milestone chart
Lecture 32Levels of Project and Portfolio Management
Lecture 33Types of deal from discovery to commercialization
Lecture 34First-in-class | Best-in-class | Market Access Strategic Decision MakingÂ
Lecture 35Introduction to Health Economics | Key terminologies related to health economics
Lecture 36HEOR Application in Pharmaceutical and Biopharmaceutical Industry
Lecture 37Introduction to Pharmacoeconomics | Different Types of Economic Evaluation | Cost-effectiveness plane | Economic modeling |Sensitivity Analysis | One way sensitivity analysis | Probabilistic sensitivity analysisÂ
Lecture 38Economic Evaluation Methods | Various methods | Importance of perspective in health economics | Discounting | UncertaintyÂ
Lecture 39Core fundamentals of Health Economics | Clinical and economic burden | Public Health Care Payer Vs. Patient and Societal | Positioning a new treatment with the current treatment | QALY | ICER | Threshold value | Clinical trials vs health economics assessment
Lecture 40Pharmacoeconomic Evaluation Checklist | Health Economics Map | Economic evaluation cycle | Checklist of economic evaluation | Costs and Outcome relevant to different groups | Comparators | Problem of choosing the comparators
Lecture 41Pharmacoeconomic Evaluation - Resource and Cost | Fixed, Variable and Total Cost | Calculation | Average vs. marginal cost | Importance of marginal cost | Discounting | Discounting calculation | Preferable discounting rate | Sources of unit cost data | Reference costs
Lecture 42Pharmacoeconomic Evaluation - Benefits and Outcome | C/E Ratio | Intermediate Vs. Final Outcome | Sources of Effectiveness Data | QALY | Utility Weight | WTP | VPF | ATP | Difference between WTP & ATPÂ
Lecture 43Pharmaco-economic evaluation – analysis and results | Different Types of Models | Understanding Decision Tree - Components with practical Example | Markov modelÂ
Lecture 44CER and PCOR
Lecture 45QALY | How to calculate QALY | Importance and SignificanceÂ
Lecture 46ICER | How to calculate ICER | Importance and Significance | Incremental Effectiveness determinationÂ
Section 3Concepts related Portfolio Management
Lecture 47Strategic Planning During Clinical Trials
Lecture 48LOE Strategies for Innovator Brands with case study
Lecture 49Evergreening - Patent Life Extension Strategies
Lecture 50Fundamental Understanding of Patent, Trademark Licensing, Project Management and related terminology
Lecture 51In-Licensing Vs. Outlicensing
Lecture 52Licensing - Advance LearningÂ
Lecture 53Drug Repurposing
Lecture 54Advance study on Para IV Filing
Lecture 55Para IV Notices
Lecture 56Pay For Delay Strategy
Lecture 57REMS Strategic PlanningÂ
Lecture 58Compulsory Licensing
Lecture 59Licensing & Technology Transfer
Lecture 60Pipeline in a Molecule
Lecture 61Patent Cliff
Lecture 62Due Diligence Activities in Pharmaceutical Licensing
Lecture 63Paediatric Exclusivity and Paediatric Study Plan Development
Section 4Strategic Project Planning and Portfolio Management
Lecture 64Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheetsÂ
Lecture 65Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 66Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 67Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 68Numerical SWOT Practical training
Lecture 69Modelling and Deal Valuation - Top Down Modeal | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 70Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 71Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 72Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 73Negotiation Skill Training for Project Management Professionals
Lecture 74Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 75Step By Step Implementation of Licensing Deal by Business Development TeamÂ
Section 5Forecasting, Market Sizing, Market Potential Analysis
Lecture 76Sales Forecasting in Life Science Industry
Lecture 77New Product Forecast Algorithm
Lecture 78Patient Based Forecasting Model | Applying more filters and variables
Lecture 79Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 80Prevalence Vs. Incidence Model
Lecture 81EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 82Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 83Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 84Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 85Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 86Bottom-up or Top-down Forecasting | LRx | Significance of LRx data analysis
Lecture 87Market Sizing & Forecasting Case Study
Lecture 88Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 89Forecasting : Tools and Techniques
Section 6Royalty Management
Lecture 90Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 91Average Royalty Rates
Lecture 92Factors affecting Royalty Rates
Section 7Finance and Valuation Management
Lecture 93Training on Basic Finance | Understanding Financial Statement | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 94Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 95Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 96Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 97Licensing Payment Schedule | Case Study
Section 8Evidence based decision making | Real World Data (RWD) | Real World Evidence (RWE)
Lecture 98Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?Â
Lecture 99RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 100RWD and RWE in Product Lifecycle Management
Lecture 101RWD and RWE - Fit to use | AssessmentÂ
Lecture 102RWD data sources | Different types | Detailed understanding of each classÂ
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