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 4Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs
Lecture 5Principle of Naming of Biologic | Understanding on MAB naming system
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 10Blockbuster Biologic - Classifications, Indications, Global Sales
Lecture 11Moving Average | Moving Annual Total | YTD | How to calculateÂ
Lecture 12Compound Annual Growth Rate | CAGR Calculation
Section 3Detailed Understanding of different therapeutic classes of Biologics
Lecture 13Recombinant Proteins
Lecture 14Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 15Monoclonal Antibodies : Detailed Understanding
Lecture 16Synthetic Immunomodulators
Lecture 17Production of Monoclonal Antibodies
Lecture 18Cytokines
Lecture 19Interferon
Lecture 20Erythropoiesis-stimulating agent (EPOs)
Lecture 21Insights on MAB approved or under review
Section 4Biopharmaceutical Regulatory Approval Process
Lecture 22R&D Process & Introduction to discovery, development to commercialization process
Lecture 23Investigational New Drug Application
Lecture 24New Drug Application (NDA)Â
Lecture 25Biological Licensing Application (BLA)Â | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 26Basic concept and understanding of the Generic Drug
Lecture 27Abbreviated New Drug Application (ANDA)Â - Filing Requirement
Lecture 28Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 29505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 30Priority Accelerated Review - Biologic
Lecture 31Vaccine development and approval Process
Lecture 32REMS Strategic PlanningÂ
Lecture 33PDUFA & BsUFA For Biologics
Lecture 34Clinical Trial - Advance Understanding
Lecture 35Advance Learning on 505B2 Pathway
Lecture 36FDA Forms and How to fill the resources
Lecture 37Chemistry, Manufacturing & ControlsÂ
Lecture 38Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 39Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE)Â
Section 5Bio Manufacturing Process
Lecture 40Stages of Biosimilar development
Lecture 41Challenges in manufacturing of biosimilar
Lecture 42Concept of Reference Biologics
Lecture 43Detailed Manufacturing Process
Lecture 44Concept of Interchangeability in Biosimilar Development
Lecture 45Studies required for approval of biosimilar
Lecture 46Demonstrating Biosimilarity: A More Complex TaskÂ
Lecture 47Difference between Bioreactor and Fermentor
Section 6Biopharmaceutical Patents - Biosimilar Entry / Exclusivity - Case Learnings
Lecture 48Practical Training on understanding of Biopharmaceutical Patent
Lecture 49Biopharmaceutical Exclusivity / protections
Lecture 50Patent Protection Small Molecules Vs. Innovator Biologics
Lecture 51Regulatory Exclusivity for Small Molecules Vs. Biosimilars
Lecture 52Steps Know How & Key Points - Patent Application
Lecture 53Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 7Principles for Development of Similar Biologics
Lecture 54Selection of Reference Biologics
Lecture 55Manufacturing Process Development for Biosimilar
Lecture 56Quality Based Considerations for Similar Biologics
Lecture 57Data Requirements for Preclinical Studies
Lecture 58Post-Market Data for Similar Biologics
Section 8Biosimilar Guidelines in Different Regions
Lecture 59WHO Regulatory Guidelines
Lecture 60European Union (EMA)
Lecture 61United States of America (US FDA)
Lecture 62Japan - PMDA
Lecture 63Korea (KFDA)
Lecture 64Canada (Health Canada)
Lecture 65China - SFDA
Lecture 66India (Central Drugs Standard Control Organization)
Lecture 67Jordan (Jordan Food and Drug Administration)
Lecture 68Middle East
Section 9Biosimilar Development to Commercialization : Case Studies
Lecture 69Biosimilar Development Timeline
Lecture 70Case Study New mAB approval: Avelumab for metastatic Merkel Cell Carcinoma (mMCC)
Section 10Biopharmaceutical Strategic Management
Lecture 71Patents Vs. exclusivity
Lecture 72Regulatory Strategies in different phases of Clinical Trial
Lecture 73Advance study on Para IV Filing
Lecture 74Para IV Notices
Lecture 75Evergreening - Patent Life Extension Strategies
Lecture 76Pay For Delay Strategy
Lecture 77In-Licensing Vs. Outlicensing
Lecture 78Leading Biologic Company's Analysis : Strategic Point of view
Lecture 79Strategic alliance Termination / Failure in strategic alliances in biopharmaceutical industry
Lecture 80Compulsory Licensing
Lecture 81Licensing & Technology Transfer
Lecture 82LOE Strategies for Innovator Brands with case study
Lecture 83Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 84Drug Repurposing
Lecture 85Summary of Regulatory & Strategic Differences
Section 11Biopahrma Business Development Topics
Lecture 86Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 87Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 88Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 89 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 90Numerical SWOT Practical training
Lecture 91Modelling 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 92Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 93Forecasting : Tools and Techniques
Lecture 94Market Sizing & Forecasting Case Study
Lecture 95Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 96Average Royalty Rates
Lecture 97Factor affecting the Royalty Rate in Biopharmaceutical Deal
Lecture 98Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 99Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 100Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 101SPECIAL PURPOSE VEHICLES (SPV)
Lecture 102Indication Splitting | Concept | Implementation feasibility analysisÂ
Lecture 103Types of Deals from Discovery to Commerialication
Lecture 104Review: What are the fundamental areas of business development
Lecture 105Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 106Licensing Payment Scheduling: Different Types
Lecture 107Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 108Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 109Negotiation Skill Training for Business Development and Strategic Management Professionals
Lecture 110Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 111Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 112Step By Step Implementation of Licensing Deal by Business Development TeamÂ
Lecture 113Due Diligence Activities in Pharmaceutical Licensing
Section 12Biopharma International Business | Export Documentation Training
Lecture 114Introduction of Export Documentation | Understanding of important terminologies
Lecture 115Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 116Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 117Commercial Invoice | Importance | Differences with Proforma InvoiceÂ
Lecture 118Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 119Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 120Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 121LC Discounting | How it works | How to calculate the LC discounting
Lecture 122Packing List | Importance | Things to include in packing list
Lecture 123Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 124Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 125Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 126Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 127Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
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