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
Section 3Detailed Understanding of different therapeutic classes of Biologics
Lecture 14Recombinant Proteins
Lecture 15Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 16Monoclonal Antibodies : Detailed Understanding
Lecture 17Synthetic Immunomodulators
Lecture 18Production of Monoclonal Antibodies
Lecture 19Cytokines
Lecture 20Interferon
Lecture 21Erythropoiesis-stimulating agent (EPOs)
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 31Nomenclature of biosimilars
Lecture 32Vaccine development and approval Process
Lecture 33REMS Strategic PlanningÂ
Lecture 34PDUFA & BsUFA For Biologics
Lecture 35Clinical Trial - Advance Understanding
Lecture 36Advance Learning on 505B2 Pathway
Lecture 37FDA Forms and How to fill the resources
Lecture 38Chemistry, Manufacturing & ControlsÂ
Lecture 39Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 40Learning from New Drug Approvals
Lecture 41Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE)Â
Lecture 42USFDAÂ expedited programs for Biologic Approval
Section 5Bio Manufacturing Process
Lecture 43Stages of Biosimilar development
Lecture 44Challenges in manufacturing of biosimilar
Lecture 45Concept of Reference Biologics
Lecture 46Detailed Manufacturing Process
Lecture 47Concept of Interchangeability in Biosimilar Development
Lecture 48Studies required for approval of biosimilar
Lecture 49Demonstrating Biosimilarity: A More Complex TaskÂ
Lecture 50Difference between Bioreactor and Fermentor
Section 6Biopharmaceutical Patents - Biosimilar Entry / Exclusivity - Case Learnings
Lecture 51Practical Training on understanding of Biopharmaceutical Patent
Lecture 52Biopharmaceutical Exclusivity / protections
Lecture 53Patent Protection Small Molecules Vs. Innovator Biologics
Lecture 54Regulatory Exclusivity for Small Molecules Vs. Biosimilars
Lecture 55Steps Know How & Key Points - Patent Application
Lecture 56Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 7Principles for Development of Similar Biologics
Lecture 57Selection of Reference Biologics
Lecture 58Manufacturing Process Development for Biosimilar
Lecture 59Quality Based Considerations for Similar Biologics
Lecture 60Data Requirements for Preclinical Studies
Lecture 61Post-Market Data for Similar Biologics
Section 8Biosimilar Guidelines in Different Regions
Lecture 62WHO Regulatory Guidelines
Lecture 63European Union (EMA)
Lecture 64United States of America (US FDA)
Lecture 65Japan - PMDA
Lecture 66Korea (KFDA)
Lecture 67Canada (Health Canada)
Lecture 68China - SFDA
Lecture 69India (Central Drugs Standard Control Organization)
Lecture 70Jordan (Jordan Food and Drug Administration)
Lecture 71Middle East
Section 9Biosimilar Development to Commercialization : Case Studies
Lecture 72Biosimilar Development Timeline
Lecture 73Case Study New mAB approval: Avelumab for metastatic Merkel Cell Carcinoma (mMCC)
Section 10Biopharmaceutical Strategic Management
Lecture 74Patents Vs. exclusivity
Lecture 75Regulatory Strategies in different phases of Clinical Trial
Lecture 76Advance study on Para IV Filing
Lecture 77Para IV Notices
Lecture 78Evergreening - Patent Life Extension Strategies
Lecture 79Pay For Delay Strategy
Lecture 80In-Licensing Vs. Outlicensing
Lecture 81Leading Biologic Company's Analysis : Strategic Point of view
Lecture 82Strategic alliance Termination / Failure in strategic alliances in biopharmaceutical industry
Lecture 83Compulsory Licensing
Lecture 84Licensing & Technology Transfer
Lecture 85LOE Strategies for Innovator Brands with case study
Lecture 86Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 87Drug Repurposing
Lecture 88Summary of Regulatory & Strategic Differences
Section 11Biopahrma Business Development Topics
Lecture 89Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 90Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 91Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 92 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 93Numerical SWOT Practical training
Lecture 94Modelling 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 95Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 96Forecasting : Tools and Techniques
Lecture 97Market Sizing & Forecasting Case Study
Lecture 98Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 99Average Royalty Rates
Lecture 100Factor affecting the Royalty Rate in Biopharmaceutical Deal
Lecture 101Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 102Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 103Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 104SPECIAL PURPOSE VEHICLES (SPV)
Lecture 105Indication Splitting | Concept | Implementation feasibility analysisÂ
Lecture 106Types of Deals from Discovery to Commerialication
Lecture 107Review: What are the fundamental areas of business development
Lecture 108Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 109Licensing Payment Scheduling: Different Types
Lecture 110Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 111Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 112Negotiation Skill Training for Business Development and Strategic Management Professionals
Lecture 113Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 114Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 115Step By Step Implementation of Licensing Deal by Business Development TeamÂ
Lecture 116Due Diligence Activities in Pharmaceutical Licensing
351a vs 351k, 351k biosimilar pathway, approved biosimilars, biologic approval process, biologic drugs, biologic manufacturing, biologic regulatory affairs, biologics and biosimilars, biologics biosimilars, biologics drugs, biologics manufacturing process, biologics manufacturing process phases, biopharma, biopharma business, biopharma business development, biopharma online certification course, biopharma regulation, biopharma regulatory affairs, biopharmaceutical companies, biopharmaceutical examples, biopharmaceutical industry, biopharmaceutical industry analysis, biopharmaceutical manufacturing, biopharmaceutical manufacturing companies, biopharmaceutical manufacturing operations, biopharmaceutical production technology, biopharmaceutical products, biopharmaceutical regulations, biopharmaceutical technology, biopharmaceutical vs pharmaceutical, biosimilar, biosimilar antibody, biosimilar approval, biosimilar approval pathway, biosimilar approval process, biosimilar biological products, biosimilar clinical trials, biosimilar companies, biosimilar development, biosimilar development cost, biosimilar development process, biosimilar drug companies, biosimilar drug development biosimilar biologics, biosimilar drugs, biosimilar guidance, biosimilar guidelines, biosimilar guidelines fda, biosimilar industry, biosimilar interchangeability, biosimilar law, biosimilar legislation, biosimilar manufacturers, biosimilar manufacturing companies, biosimilar manufacturing process, biosimilar pathway, biosimilar pharmaceuticals, biosimilar pipeline, biosimilar products, biosimilar regulation, Biosimilar regulatory challenges, biosimilar studies, biosimilar switching, Biosimilar training course, biosimilarity, biosimilars 2016, biosimilars and biologics, biosimilars and interchangeable biologics, biosimilars canada, biosimilars conference, biosimilars definition, biosimilars europe, biosimilars fda, biosimilars in development, biosimilars in europe, biosimilars in india, biosimilars in us, biosimilars market, biosimilars vs generics, biotech companies, course in biosimilar regulation, development of biosimilar, development of biosimilars, EU Biosimilar Registration and Marketing Requirements, fda approved biosimilars, fda biosimilar approval, fda biosimilar guidance 2015, fda biosimilar interchangeability, global biosimilar market, importance of biosimilar, indian biosimilar market, interchangeability biosimilars, interchangeability of biosimilars, list of biosimilars, new biosimilars, nomenclature of biosimilar, prescription, regulation of biosimilar, Regulation of Generic Pharmaceutical and Biosimilar, Strategy for Entering the Biosimilars Market, top biosimilar companies, upstream and downstream processing in biotechnology, what is biosimilar
