InstructorKnowledge Process Enhancer
TypeOnline Course
Student Enrolled4
Price$690
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Introduction

Feature

Eligibility

Career

Pharmaceutical Business Development and Licensing course trains business development professionals working in Pharmaceutical Industry. Therefore this course gives practical knowledge of the functionalities of BD Manager with practical exposure. Hence, person working in business development in pharma gets hands on training to enhance their day to day job skills.

  • Course Code: KPE-C-078
  • Course Title: Advance Diploma in  Pharma Business Development & Licensing (ADBDL)
  • Learning Mode: Online self paced e-learning

Current pharmacy syllabus does not have BD Training

The current pharmacy syllabus of most of the pharmacy courses do not provide adequate practical exposure on Business Development (BD) functionalities, licensing business models of innovator & generic companies and the BD functioning in the entire pharma R&D to commercialization cycle.

This online course is aimed to fulfill these gaps and is uniquely designed for the pharmacy students, professionals and scientists working in the pharma industry so that they can learn the essentials and can better advance in their careers.

Important Learning Features of Online Business Development and Licensing Training

  • 24×7 self paced online learning  – learn at your convenience.

  • Courses can be accessed at your own convenient time.

  • Downloadable PDF study modules.

  • E-lectures for easy understanding of the concepts.

  • Self assessment concept checkers for each lecture.

  • Simulation to real life working.

  • Access to case studies.

  • Unique personalized course tracking page with course performance analytics.

  • Flexible online final examination (Computer Based Test by secure mode).

  • Course certification –  Course completion and Course gradation certificate will be issued.

B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical marketing can pursue the course.

Career in Business Development (BD) in Pharmaceutical, Biopharmaceutical Industry 

A career in Business Development (BD) is both a challenging and highly rewarding career in pharmaceutical and biopharmaceutical industry.  Hence it opens up lot of opportunities as it covers a variety of disciplines. BD professionals involved in pipeline and portfolio management. In fact in all established pharmaceutical company there are dedicated Business Development department (BD). Indeed all pharma companies consider BD team as prime work force. Above all BD team takes care of filing of the patent, trademark, issuing and management of the licensing. Furthermore pharma business development professionals work in close proximity with strategic management, regulatory team in company.

Knowledge and Skill areas of pharma business development professionals

BD professionals should have strong orientation towards following aspects.

First of all they should have a strong knowledge and in depth understanding of R&D Discovery to Commercialization Process.

Secondly, they should have hands-on knowledge on drug discovery, development and regulatory aspects of the market.

Thirdly, understanding in core business development principles.

Moreover, they should have decision making skills to make critical business decision. To do that they should know the pharma market dynamics, and must have understanding in technical and commercial feasibility.

Lastly, they should have the advance licensing skills like identifying potential partners, distributors for new products, In-licensing, distribution, dormant licenses.

Overall, they should have the project and portfolio management skills.

To sum up, BD professionals should have a strong Business Acumen & closely partner with Business needs and requirement.

Section 1US BD Fundamental - Drug Discovery to Development
Lecture 1Drug Discovery - Development Process
Lecture 2Investigational New Drug Application
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Detailed learning on clinical trials and related terminologies
Lecture 7Practical Training on Handling of orange book
Lecture 8USFDA Expedited Programs (Detailed Understanding)
Lecture 9505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 10Authorized Generics: Key Understanding
Lecture 11Exploratory IND
Lecture 12Patents Vs. exclusivity
Lecture 13Advance Learning on 505B2 Pathway
Lecture 14Chemistry, Manufacturing & Controls 
Lecture 15Orphan Drug Designation 
Lecture 16Advance Strategic Learning on 505B2 Pathway
Lecture 17Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Section 2EU BD Fundamental - Drug Discovery, Development & Strategic Planning
Lecture 18Introduction to EU Regulation 
Lecture 19Orientation to European Countries and National Regulatory Bodies
Lecture 20EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 21Overview of EU Regulation 
Lecture 22EMA and EMA Authorisation Process
Lecture 23EU MA Application Types and Strategic Planning
Lecture 24EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 25EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 26Validity of the EU MA  - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products
Lecture 27Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 28EU Orphan Medicinal Products Regulation
Lecture 29Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 30Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 31EU variation - Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 32EU Prime Designation 
Lecture 33Accelerated assessment by EMEA
Lecture 34EU Adaptive Pathway
Lecture 35European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 36SPOR  - Concept of Master Data Management  
Lecture 37The 'sunset clause' for marketing authorisation of pharmaceuticals
Section 3IPR Management in Pharma and Biopharma Industry
Lecture 38Patent office - Introductions
Lecture 39Patent - Understanding Patentability, Novelty And Non-Obviousness, Conditions For Obtaining A Patent, Who can apply
Lecture 40Patent Application Process - USPTO
Lecture 41Trademark Search and Registration in US
Lecture 42Steps Know How & Key Points - Patent Application
Lecture 43IPR - Patent Grant and Handling Process in India (Optional)
Lecture 44Patent Search in Indian Patent Office (Optional)
Lecture 45Trademark - Practical on TM Search & Registration Process in India (Practical)
Lecture 46 Trademark Search assignment
Lecture 47Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Portfolio & Strategic Management
Lecture 48Portfolio Management in R&D Lifecycle 
Lecture 49Advance study on Para IV Filing
Lecture 50Para IV Notice
Lecture 51Evergreening - Patent Life Extension Strategies
Lecture 52Pay For Delay Strategy
Lecture 53REMS Strategic Planning
Lecture 54Compulsory Licensing
Lecture 55Technology Licensing
Lecture 56In-Licensing Vs. Outlicensing
Lecture 57Loss of Exclusivity (LOE) Strategies for Innovator Brands with case study
Lecture 58Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 59Drug Re-purposing
Lecture 60Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 61NCE Vs. 505b2 application - Case Based Learning 
Lecture 62FTF - 180 Days Exclusivity
Lecture 63Classic case study of the 505b2 filing
Lecture 64Strategic Planning in Combating 30 months stay strategies of innovator compan
Section 5Licensing in Pharma Industry (Advance Practical Understanding)
Lecture 65Types of Strategic Alliances: Unilateral technology licensing | Cross technology licensing | R&D contracts | R&D collaborations | Minority-equity-based R&D alliances | JV | Manufacturing and marketing agreements | big pharma firms with dedicated biotechnology firms 
Lecture 66Licensing and Technology Transfer (TT)
Lecture 67In-Licensing Vs. Outlicensing
Lecture 68Licensing agreement Types - Advance Learning
Section 6Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Section 7Project Management Skill Training for Business Development professionals
Lecture 70Definition Review
Lecture 71Difference between Project and Program
Lecture 72Phasing of Projects for better effectiveness / outcome of the Project 
Lecture 73Project Management Constraint
Lecture 74Key to Project Success
Lecture 75PROJECT MANAGEMENT TOOLS AND TECHNIQUES - PERT, CPM, CRITICAL PATH, PROJECT DIAGRAM AND ITS COMPONENTS
Lecture 76Qualities of a Good Project Leader
Lecture 77Qualities of a Good Team Representative
Lecture 78Project Tracking in Drug Discovery Projects
Lecture 79What to Track in project?
Lecture 80Project Benchmarking through a Consortium
Lecture 81Cycle Times (Stage or phase lengths)
Lecture 82Importance of The proof of concept (POC) milestone in pharma Drug Development Projects
Lecture 83Challenges to Milestone Dates
Lecture 84Project Terminations
Lecture 85Project Re-initiations
Lecture 86Asset Tracking
Lecture 87Levels of Project and Portfolio Management
Section 8Business Development Strategic Planning Process
Lecture 88Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 89Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 90Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 91Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 92Numerical SWOT Practical training
Lecture 93Modelling 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 94Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 95Forecasting : Tools and Techniques
Lecture 96Market Sizing & Forecasting Case Study
Lecture 97Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 98Average Royalty Rates
Lecture 99Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 100Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 101Acquisition in Pharmaceutical and Biopharmaceutical Brands and Business
Lecture 102Joint Venture - Key Insight
Lecture 103Special Purpose Vehicle (SPV)
Lecture 104Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 105Types of Deals from Discovery to Commerialication
Lecture 106Review: Fundamental Problem Area in Pharma Business Development
Lecture 107Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 108Licensing Payment Scheduling: Different Types
Lecture 109Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 110EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 111Negotiation Skill Training for Business Development and Strategic Management Professionals
Lecture 112Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 113Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 114Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 115Due Diligence Activities in Pharmaceutical Licensing
Lecture 116Pharma Business Development - Competency Test
Section 9Final Examination
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