Introduction
Duration
Core Area of Learning
Who should attend
Features
Similar Course
This online executive certification course covers hands on training on Biopharma Business Development and Strategic Management. In the first place, this 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. In fact this course covers all entire biologic development to commercialization process.
Hence, this course is ideal for the executives working in biopharmaceutical companies. Therefore, this is dedicated online training program for biopharma professionals working in R&D. Project, Portfolio management, Strategic Management department. Also this biopharma strategic management course covers Forecasting Market Access which is key learning area for strategic management 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.
Most importantly, this course is self paced learning. Hence, participants can attend the lecture sessions at own convenience. Therefore, it allows participates to learn at own pace, allowing to stop and start at their leisure.
Course Information
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
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
Key Objectives of the biopharma strategic management course
Strategy & strategic thinking is the key for biopharma strategic management professionals. Therefore, this course provides real case insights to provoke the strategic thinking.
Course Learning Area Overview
Biopharma Business Development and Strategic Management course provides in-depth study of the product life cycle for biopharmaceuticals. Hence, key focus is on learning the various stages within the life cycle from conceptualization of a biopharmaceuticals, development, approval process, market commercialization and licensing activities. Therefore, 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. Moreover, the course provides comprehensive real life simulation on different classes of therapeutic biologics.
One more thing to note, strategic understanding is focused on the biopharma pipeline management. Hence this course also provides training on risk assessment at each stage, and the decreasing productivity of the drug pipeline. Moreover, course also covers advanced licensing concepts with strong focus on biologics.
Not but not the least, course covers various tools and techniques of biopharma forecasting.
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
- Biopharmaceutical 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 forecasting
- Biopharma Market Access strategic planning
- Biopharma licensing
Who should attend this course?
This course is ideal for Biopharma Executives working in middle and top management position. Secondly, this course is ideal choice for enhancing the skills for biopharma business development and strategic management professionals. Thirdly, those who are looking to enhance in and out knowledge about the biopharma business should pursue this course. Moreover, this course is ideal for the project, portfolio management professionals working in biopharma company.
Features of the Course
- Comprehensive study material covering all important aspects of innovator biopharmaceutical and biosimilar business.
- 24×7 online access, hence user can attend from anywhere.
- Online lectures for easy understanding of the advance biopharma topics.
- Live Pharma Case Study 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.
- Course Certification: On completion of the course, course completion certificate and course gradation certificate will be provided.
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 10Moving Average | Moving Annual Total | YTD | How to calculate
Lecture 11Compound Annual Growth Rate | CAGR Calculation
Section 3Detailed Understanding of different therapeutic classes of Biologics
Lecture 12Recombinant Proteins
Lecture 13Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 14Monoclonal Antibodies : Detailed Understanding
Lecture 15Synthetic Immunomodulators
Lecture 16Production of Monoclonal Antibodies
Lecture 17Cytokines
Lecture 18Interferon
Lecture 19Erythropoiesis-stimulating agent (EPOs)
Lecture 20Insights on MAB approved or under review
Section 4Biopharmaceutical Regulatory Approval Process
Lecture 21R&D Process & Introduction to discovery, development to commercialization process
Lecture 22Investigational New Drug Application
Lecture 23New Drug Application (NDA)
Lecture 24Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 25Basic concept and understanding of the Generic Drug
Lecture 26Abbreviated New Drug Application (ANDA) - Filing Requirement
Lecture 27Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 28505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 29Priority Accelerated Review - Biologic
Lecture 30Vaccine development and approval Process
Lecture 31REMS Strategic Planning
Lecture 32PDUFA & BsUFA For Biologics
Lecture 33Clinical Trial - Advance Understanding
Lecture 34Advance Learning on 505B2 Pathway
Lecture 35FDA Forms and How to fill the resources
Lecture 36Chemistry, Manufacturing & Controls
Lecture 37Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 38Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE)
Section 5Bio Manufacturing Process
Lecture 39Stages of Biosimilar development
Lecture 40Challenges in manufacturing of biosimilar
Lecture 41Concept of Reference Biologics
Lecture 42Detailed Manufacturing Process
Lecture 43Concept of Interchangeability in Biosimilar Development
Lecture 44Studies required for approval of biosimilar
Lecture 45Demonstrating Biosimilarity: A More Complex Task
Lecture 46Difference between Bioreactor and Fermentor
Lecture 47Principles for Development of Similar Biologics
Lecture 48The manufacturing process for similar biologic
Lecture 49Data Requirements for Preclinical Studies
Lecture 50Post-Market Data for Similar Biologics
Section 6Biopharmaceutical Patents - Biosimilar Entry / Exclusivity - Case Learnings
Lecture 51Introduction to intellectual Property Management
Lecture 52Introduction to Patent
Lecture 53Understanding on Patent System
Lecture 54Patent Grant and Managing Patent Filing Procedure
Lecture 55Steps Know How & Key Points - Patent Application
Lecture 56Scope of Patentability
Lecture 57Patent Grant and Handling Process in India
Lecture 58Stages of Patent Grant Procedure
Lecture 59Patent search in Indian Patent Office
Lecture 60Differences in US and European Patent
Lecture 61Patent Claim | Types of Patent Claims
Lecture 62Patent Cliff | How to calculate the patent cliff
Lecture 63Terminologies related to patent, trademark, copyright and licensing
Lecture 64Patent Infringement
Lecture 65Introduction to Trademark | Trademark filing procedure
Lecture 66Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching
Lecture 67Trademark Infringement | Passing off | Practical Cases
Lecture 68Trademark 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 69Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 70Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 71Market Access Strategic Planning
Lecture 72Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 73Indication Prioritization Case Study
Lecture 74Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 75AMCP Market Access Value Dossier Preparation
Lecture 76Drug Pricing Methodologies
Lecture 77Sales Forecasting in Life Science Industry
Lecture 78New Product Forecast Algorithm
Lecture 79Patient Based Forecasting Model | Applying more filters and variables
Lecture 80Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 81Prevalence Vs. Incidence Model - Detailed Understanding | Which one to use when?
Lecture 82EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 83Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 84Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 85Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 86Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 87Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 88Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 89Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 90Simulation on Bottom-up forecasting
Lecture 91Assessment on Bottom-up forecasting
Lecture 92Oncology Brand Forecasting
Section 8Biosimilar Guidelines in Different Regions
Lecture 93WHO Regulatory Guidelines
Lecture 94European Union (EMA)
Lecture 95United States of America (US FDA)
Lecture 96Japan - PMDA
Lecture 97Korea (KFDA)
Lecture 98Canada (Health Canada)
Lecture 99China - SFDA
Lecture 100India (Central Drugs Standard Control Organization)
Lecture 101Jordan (Jordan Food and Drug Administration)
Lecture 102Middle East
Section 9Biosimilar Development to Commercialization : Case Studies
Lecture 103Biosimilar Development Timeline
Lecture 104Case Study New mAB approval: Avelumab for metastatic Merkel Cell Carcinoma (mMCC)
Section 10Biopharmaceutical Strategic Management
Lecture 105Patents Vs. exclusivity
Lecture 106Regulatory Strategies in different phases of Clinical Trial
Lecture 107Advance study on Para IV Filing
Lecture 108Para IV Notices
Lecture 109Evergreening - Patent Life Extension Strategies
Lecture 110Pay For Delay Strategy
Lecture 111In-Licensing Vs. Outlicensing
Lecture 112Leading Biologic Company's Analysis : Strategic Point of view
Lecture 113Strategic alliance Termination / Failure in strategic alliances in biopharmaceutical industry
Lecture 114Compulsory Licensing
Lecture 115Licensing & Technology Transfer
Lecture 116LOE Strategies for Innovator Brands with case study
Lecture 117Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 118Drug Repurposing
Lecture 119Summary of Regulatory & Strategic Differences
Section 11Biopahrma Business Development Topics
Lecture 120Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 121Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department
Lecture 122Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 123 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 124Numerical SWOT Practical training
Lecture 125Modelling 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 126Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 127Forecasting : Tools and Techniques
Lecture 128Market Sizing & Forecasting Case Study
Lecture 129Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 130Average Royalty Rates
Lecture 131Factor affecting the Royalty Rate in Biopharmaceutical Deal
Lecture 132Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 133Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 134Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 135SPECIAL PURPOSE VEHICLES (SPV)
Lecture 136Indication Splitting | Concept | Implementation feasibility analysis
Lecture 137Types of Deals from Discovery to Commerialication
Lecture 138Review: What are the fundamental areas of business development
Lecture 139Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 140Licensing Payment Scheduling: Different Types
Lecture 141Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales - Max-Min Approach
Lecture 142Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 143Negotiation Skill Training for Business Development and Strategic Management Professionals
Lecture 144Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 145Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 146Step By Step Implementation of Licensing Deal by Business Development Team
Lecture 147Due Diligence Activities in Pharmaceutical Licensing
Section 12Biopharma International Business | Export Documentation Training
Lecture 148Introduction of Export Documentation | Understanding of important terminologies
Lecture 149Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 150Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 151Commercial Invoice | Importance | Differences with Proforma Invoice
Lecture 152Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 153Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 154Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 155LC Discounting | How it works | How to calculate the LC discounting
Lecture 156Packing List | Importance | Things to include in packing list
Lecture 157Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 158Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 159Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 160Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 161Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
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