InstructorRoyed Training
TypeOnline Course
Price$180 USD / 7500 INR
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in licensing and out licensing in pharma

Introduction

Course Features

Duration

Eligibility

Certification

inlicensing and outlicensing in pharmaceutical and biopharmaceutical industry

Course Code: RYD-022

Course Title: Competency Development Program in Inlicensing and Outlicensing in Pharmaceutical and Biopharmaceutical Industry

Course Objective: The objective of this course is to impart knowledge and practical understanding about the licensing deals in pharma and biopharma industry

Course Description

This online course utilizes interactive learning tools to guide each participant through licensing deal and ensure that you can understand the integrities of the due diligence process and also requirements for successful licensing deal. The course will focus on portfolio analysis and strategies for successful product pipeline management. The course will adopt a practical and interactive approach that will enable you to apply what you have learned to your daily work the steps of approval process in details. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions 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.

Who should attend?

  • Pharmaceutical and Biopharmaceutical professionals working in business development department
  • Those who need to understand the licensing deals
  • Anyone wishing to update their knowledge on portfolio management strategies
  • Pharmaceutical project management professionals.

Features of the Course:

1. Orientation to practical understanding licensing deals – specifically in inlicensing and outlicensing in pharma and biopharma industry

2. Simulation to real life Regulatory Strategic planning for licensing in pharma business.

3. Practical training in drafting of licensing deals.

4. Focus on due diligence in pharmaceutical and biopharmaceutical licensing deals.

1 Month

Any body who wants to acquire drug regulatory affairs competency should attend the course.

 Certificate will be provided at the end of the successful completion of the course

Section 1Fundamental undersya
Lecture 1Introduction to Licensing
Lecture 2Regulatory Strategies in different phases of Clinical Trial
Lecture 3Patents Vs. exclusivity 
Lecture 4R&D Process & Introduction to drug discovery
Lecture 5Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 6Portfolio Management in R&D Lifecycle 
Lecture 7Evergreening - Patent Life Extension Strategies
Lecture 8Compulsory Licensing
Lecture 9Licensing & Technology Transfer
Lecture 10In-Licensing Vs. Outlicensing
Lecture 11Structuring Royalties | Royalty Splitting | Royalty Stacking
Lecture 12Types of Deals from Discovery to Commercialization
Section 2Advance understanding in Licensing Deal
Lecture 13Types 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 of big pharma firms with dedicated biotechnology firms 
Lecture 14Quick Glance: Why would a pharma company look for in-licensing deals?
Lecture 15Licensing - Advance Learning 
Lecture 16Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 17Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 18Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 19Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 20Numerical SWOT Practical training
Lecture 21Modelling 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 22Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 23Average Royalty Rate
Lecture 24Factors affecting royalty rate
Lecture 25Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 26Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 27Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 28Licensing Payment Scheduling: Different Types
Lecture 29Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 30Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 31Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 32Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 33Step By Step Implementation of Licensing Deal by Business Development Team