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 calculate
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)
Lecture 25Biological Licensing Application (BLA) | 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) - 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 Planning
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 & Controls
Lecture 38Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 39Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE)
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 Task
Lecture 47Difference between Bioreactor and Fermentor
Lecture 48Principles for Development of Similar Biologics
Lecture 49The manufacturing process for similar biologic
Lecture 50Data Requirements for Preclinical Studies
Lecture 51Post-Market Data for Similar Biologics
Section 6Biopharmaceutical Patents - Biosimilar Entry / Exclusivity - Case Learnings
Lecture 52Introduction to intellectual Property Management
Lecture 53Introduction to Patent
Lecture 54Understanding on Patent System
Lecture 55Patent Grant and Managing Patent Filing Procedure
Lecture 56Steps Know How & Key Points - Patent Application
Lecture 57Scope of Patentability
Lecture 58Patent Grant and Handling Process in India
Lecture 59Stages of Patent Grant Procedure
Lecture 60Patent search in Indian Patent Office
Lecture 61Differences in US and European Patent
Lecture 62Patent Claim | Types of Patent Claims
Lecture 63Patent Cliff | How to calculate the patent cliff
Lecture 64Terminologies related to patent, trademark, copyright and licensing
Lecture 65Patent Infringement
Lecture 66Introduction to Trademark | Trademark filing procedure
Lecture 67Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching
Lecture 68Trademark Infringement | Passing off | Practical Cases
Lecture 69Trademark Classes | How to search the right trademark class for for filing trademark application
Section 7Biopharmaceutical Market Access : PM&A, Forecasting, Pricing, Payment Methodologies, HEOR
Lecture 70Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 71Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 72Market Access Strategic Planning
Lecture 73Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 74Indication Prioritization Case Study
Lecture 75Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 76AMCP Market Access Value Dossier Preparation
Lecture 77Drug Pricing Methodologies
Lecture 78Sales Forecasting in Life Science Industry
Lecture 79New Product Forecast Algorithm
Lecture 80Patient Based Forecasting Model | Applying more filters and variables
Lecture 81Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 82Prevalence Vs. Incidence Model - Detailed Understanding | Which one to use when?
Lecture 83EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 84Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 85Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 86Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 87Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 88Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 89Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 90Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 91Simulation on Bottom-up forecasting
Lecture 92Assessment on Bottom-up forecasting
Lecture 93Oncology Brand Forecasting
Section 8Biosimilar Guidelines in Different Regions
Lecture 94WHO Regulatory Guidelines
Lecture 95European Union (EMA)
Lecture 96United States of America (US FDA)
Lecture 97Japan - PMDA
Lecture 98Korea (KFDA)
Lecture 99Canada (Health Canada)
Lecture 100China - SFDA
Lecture 101India (Central Drugs Standard Control Organization)
Lecture 102Jordan (Jordan Food and Drug Administration)
Lecture 103Middle East
Section 9Biosimilar Development to Commercialization : Case Studies
Lecture 104Biosimilar Development Timeline
Lecture 105Case Study New mAB approval: Avelumab for metastatic Merkel Cell Carcinoma (mMCC)
Section 10Biopharmaceutical Strategic Management
Lecture 106Patents Vs. exclusivity
Lecture 107Regulatory Strategies in different phases of Clinical Trial
Lecture 108Advance study on Para IV Filing
Lecture 109Para IV Notices
Lecture 110Evergreening - Patent Life Extension Strategies
Lecture 111Pay For Delay Strategy
Lecture 112In-Licensing Vs. Outlicensing
Lecture 113Leading Biologic Company's Analysis : Strategic Point of view
Lecture 114Strategic alliance Termination / Failure in strategic alliances in biopharmaceutical industry
Lecture 115Compulsory Licensing
Lecture 116Licensing & Technology Transfer
Lecture 117LOE Strategies for Innovator Brands with case study
Lecture 118Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 119Drug Repurposing
Lecture 120Summary of Regulatory & Strategic Differences
Section 11Biopahrma Business Development Topics
Lecture 121Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 122Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department
Lecture 123Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 124 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 125Numerical SWOT Practical training
Lecture 126Modelling 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 127Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 128Forecasting : Tools and Techniques
Lecture 129Market Sizing & Forecasting Case Study
Lecture 130Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 131Average Royalty Rates
Lecture 132Factor affecting the Royalty Rate in Biopharmaceutical Deal
Lecture 133Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 134Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 135Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 136SPECIAL PURPOSE VEHICLES (SPV)
Lecture 137Indication Splitting | Concept | Implementation feasibility analysis
Lecture 138Types of Deals from Discovery to Commerialication
Lecture 139Review: What are the fundamental areas of business development
Lecture 140Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 141Licensing Payment Scheduling: Different Types
Lecture 142Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales - Max-Min Approach
Lecture 143Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 144Negotiation Skill Training for Business Development and Strategic Management Professionals
Lecture 145Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 146Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 147Step By Step Implementation of Licensing Deal by Business Development Team
Lecture 148Due Diligence Activities in Pharmaceutical Licensing
Section 12Biopharma International Business | Export Documentation Training
Lecture 149Introduction of Export Documentation | Understanding of important terminologies
Lecture 150Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 151Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 152Commercial Invoice | Importance | Differences with Proforma Invoice
Lecture 153Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 154Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 155Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 156LC Discounting | How it works | How to calculate the LC discounting
Lecture 157Packing List | Importance | Things to include in packing list
Lecture 158Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 159Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 160Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 161Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 162Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
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