Introduction
Duration
Core Area of Learning
Features
Admission Process
Similar Course
KPE’s Executive Program in Biopharma Business Development and Strategic Management course utilizes interactive learning tools to guide each participant through the steps of the innovator biopharmaceutical and biosimilar business development, strategic management and licensing process. This is dedicated online training program for biopharma professionals.
The course is designed to challenge users 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 Code: KPE-C-122
Types of Course: Executive Advance Diploma Program, Online Certification Course, Distance & e-Learning
Course Title: KPE’s Executive Program in Biopharma Business Development and Strategic Management
The course provides in-depth study of the product life cycle for biopharmaceuticals. Focus is on the various stages within the life cycle from conceptualization of a biopharmaceuticals, development, approval process, followed by, market commercialization and licensing activities. This course is ideal for the biopharmaceutical professionals who are handling regulatory submission, approval, production, and the postmarket environment for biologic drug manufacturing, marketing companies. The course provides comprehensive real life simulation on different classes of therapeutic biologics. Strategic understanding is focused on the biopharma pipeline management. Course also provides training on  risk assessment at each stage, and the decreasing productivity of the drug pipeline. Advance training on licensing of biologic is also incorporated in the course.
Our Registrants are in Takeda, Pfizer, Apolonia d.o.o., ITC-Pharma, GSK, Lipoxen (UK), Patheon, Mylan, Biocon, Micro Lab, GE Lifesciences, Orchid, Sanofi, AstraZeneca, Hospira, Ranbaxy, Julphar, Jhonson and Jhonson, Ethicon, Dr. Reddy’s Laboratory, MSD, Medo Pharma, Nestle, Ind-Swift, Panacea, Bal Pharma, Aristo, Reliance Lifesciences, Quality Pharma Pvt Ltd, Cipla, Ipca, Sherya Lifesciences, Promed, Torrent Pharmaceuticals, Zydus Candila, Himalaya Herbal Healthcare, Bangalore Pharmaceutical and Research laboratories, Teru Technomed, Indocoar Pharma, Fortis Hospitals, VRPL Healthcare, Medreich, Hospira, Indospectrum, Wintac Limited, Faveo Pharmaceuticals, Enzem, Leo Pharma, Accenture, Shaigan Pharmaceutical, Ceutica & Chemie, Medxplor Healthcare, Systopic Laboratories and many more companies across the pharma industry.
1 Year
Core Area of Learning
- Biopharma market understanding
- Understanding of different therapeutic classes
- Biopharmaceutical Development Process
- Regulatory approval process, strategic pathways
- Strategic planning for market access
- Biomanufacturing process
- Biosimilar development process
- Biopahrmaceutical product life cycle management, Patent, Exclusivity, Portfolio management, LOE training
- Data exclusivity
- Market commercialization strategies and Marketing for Bio-pharmaceuticals
- Biopharma business development training
- Biopharma licensing
Features of the Course
- Comprehensive study material covering all important aspects of innovator biopharmaceutical and biosimilar business.
- 24×7 online access, attend from anywhere.
- Online lectures for easy understanding of the advance biopharma topics.
- Live Pharma  Case Study –  File for easy understanding in biologics-biosimilar strategic business planning.
- Simulation based real life case presentations.
- Attend online final examination at your own time and convenience.
- Get Certified: On completion of the course deadline, course completion certifiate will be issued. On successful completion of the final examination, course gradation certificate will be issued.
1 Month Certificate Course in Biopharma Regulatory Affairs and Strategic Management
Section 1Introduction to Biopharmaceuticals
Lecture 1Introduction: Biopharmaceuticals
Lecture 2Classification & Detailed Understanding on Biopharmaceuticals
Lecture 3Introduction to Biosimilar
Lecture 4Chemical Drugs Vs. Biologic Drugs
Lecture 5Principle of Naming of Biologics
Section 2Global Biopharmaceutical Market
Lecture 6Current Trends in Biopharmaceutical Market
Lecture 7Dynamics of Biopharmaceutical Market
Lecture 8Challenges of Biopharmaceutical Industry
Lecture 9Biopharmaceutical Market Segmentation
Lecture 10Market Share of Different Class of Biopharmaceuticals
Lecture 11Blockbuster Biologic - Classifications, Indications, Global Sales
Lecture 12Market Understanding: Leading Biosimilar Companies
Lecture 13Market Understanding: Top Leading Brands
Lecture 14Moving Average | Moving Annual Total | YTD | How to calculateÂ
Lecture 15Compound Annual Growth Rate | CAGR Calculation
Section 3Detailed Understanding of different therapeutic classes of Biologics
Lecture 16Recombinant Proteins
Lecture 17Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 18Monoclonal Antibodies : Detailed Understanding
Lecture 19Synthetic Immunomodulators
Lecture 20Production of Monoclonal Antibodies
Lecture 21Cytokines
Lecture 22Interferon
Lecture 23Erythropoiesis-stimulating agent (EPOs)
Section 4Biopharmaceutical Regulatory Approval Process
Lecture 24R&D Process & Introduction to discovery, development to commercialization process
Lecture 25Investigational New Drug Application
Lecture 26New Drug Application (NDA)Â
Lecture 27Biological Licensing Application (BLA)Â | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 28Basic concept and understanding of the Generic Drug
Lecture 29Abbreviated New Drug Application (ANDA)Â - Filing Requirement
Lecture 30Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 31505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 32Priority Accelerated Review - Biologic
Lecture 33Nomenclature of biosimilars
Lecture 34Vaccine development and approval Process
Lecture 35REMS Strategic PlanningÂ
Lecture 36PDUFA & BsUFA For Biologics
Lecture 37Clinical Trial - Advance Understanding
Lecture 38Advance Learning on 505B2 Pathway
Lecture 39FDA Forms and How to fill the resources
Lecture 40Chemistry, Manufacturing & ControlsÂ
Lecture 41Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 42Learning from New Drug Approvals
Lecture 43Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE)Â
Lecture 44USFDAÂ expedited programs for Biologic Approval
Section 5Bio Manufacturing Process
Lecture 45Stages of Biosimilar development
Lecture 46Challenges in manufacturing of biosimilar
Lecture 47Concept of Reference Biologics
Lecture 48Detailed Manufacturing Process
Lecture 49Concept of Interchangeability in Biosimilar Development
Lecture 50Studies required for approval of biosimilar
Lecture 51Demonstrating Biosimilarity: A More Complex TaskÂ
Lecture 52Difference between Bioreactor and Fermentor
Section 6Biopharmaceutical Patents - Biosimilar Entry / Exclusivity - Case Learnings
Lecture 53Practical Training on understanding of Biopharmaceutical Patent
Lecture 54Biopharmaceutical Exclusivity / protections
Lecture 55Patent Protection Small Molecules Vs. Innovator Biologics
Lecture 56Regulatory Exclusivity for Small Molecules Vs. Biosimilars
Lecture 57Steps Know How & Key Points - Patent Application
Lecture 58Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 7Principles for Development of Similar Biologics
Lecture 59Selection of Reference Biologics
Lecture 60Manufacturing Process Development for Biosimilar
Lecture 61Quality Based Considerations for Similar Biologics
Lecture 62Data Requirements for Preclinical Studies
Lecture 63Post-Market Data for Similar Biologics
Section 8Biosimilar Guidelines in Different Regions
Lecture 64WHO Regulatory Guidelines
Lecture 65European Union (EMA)
Lecture 66United States of America (US FDA)
Lecture 67Japan - PMDA
Lecture 68Korea (KFDA)
Lecture 69Canada (Health Canada)
Lecture 70China - SFDA
Lecture 71India (Central Drugs Standard Control Organization)
Lecture 72Jordan (Jordan Food and Drug Administration)
Lecture 73Middle East
Section 9Biosimilar Development to Commercialization : Case Studies
Lecture 74Biosimilar Development Timeline
Lecture 75Case Study New mAB approval: Avelumab for metastatic Merkel Cell Carcinoma (mMCC)
Section 10Biopharmaceutical Strategic Management
Lecture 76Patents Vs. exclusivity
Lecture 77Regulatory Strategies in different phases of Clinical Trial
Lecture 78Advance study on Para IV Filing
Lecture 79Para IV Notices
Lecture 80Evergreening - Patent Life Extension Strategies
Lecture 81Pay For Delay Strategy
Lecture 82In-Licensing Vs. Outlicensing
Lecture 83Leading Biologic Company's Analysis : Strategic Point of view
Lecture 84Strategic alliance Termination / Failure in strategic alliances in biopharmaceutical industry
Lecture 85Compulsory Licensing
Lecture 86Licensing & Technology Transfer
Lecture 87LOE Strategies for Innovator Brands with case study
Lecture 88Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 89Drug Repurposing
Lecture 90Summary of Regulatory & Strategic Differences
Section 11Biopahrma Business Development Topics
Lecture 91Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 92Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 93Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 94 Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 95Numerical SWOT Practical training
Lecture 96Modelling and Deal Valuation - Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 97Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 98Forecasting : Tools and Techniques
Lecture 99Market Sizing & Forecasting Case Study
Lecture 100Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 101Average Royalty Rates
Lecture 102Factor affecting the Royalty Rate in Biopharmaceutical Deal
Lecture 103Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 104Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 105Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 106SPECIAL PURPOSE VEHICLES (SPV)
Lecture 107Indication Splitting | Concept | Implementation feasibility analysisÂ
Lecture 108Types of Deals from Discovery to Commerialication
Lecture 109Review: What are the fundamental areas of business development
Lecture 110Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 111Licensing Payment Scheduling: Different Types
Lecture 112Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 113Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 114Negotiation Skill Training for Business Development and Strategic Management Professionals
Lecture 115Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 116Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 117Step By Step Implementation of Licensing Deal by Business Development TeamÂ
Lecture 118Due Diligence Activities in Pharmaceutical Licensing
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