TypeOnline Course
Student Enrolled1
Price$180 / Rs. 8500
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Admission Process

Admission Process

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Introduction

Who should attend

Course Content

Course Deliverables

Course Code: KPE-C-061

Course Name: KPE’s Certificate Course in In-Licensing and Out-Licensing in Pharmaceutical Industry

This course is designed to provide participants with an detailed practical orientation about Drug R&D licensing  – In-licensing and Out-Licensing ,

Licensing, as is understood in plain terms, is the transfer of rights to a third party (the Licensee) to use the Intellectual Property owned by a party (the Licensor) for a fixed duration of time and under defined terms and conditions. The said terms and conditions may be, for ex., manufacturing and/or marketing rights in select geography, etc. Depending from whose perspective you see it, a licensing deal can be called an Out-Licensing deal or an In-Licensing deal. Out-Licensing means that the Licensor is ‘out’ – licensing his Intellectual Property to a third party. For the third party, the Licensee, who takes ‘In’ the Intellectual Property, it becomes an In-Licensing deal.

Coming to the Pharma domain, smaller size innovators companies are traditionally been an out-Licensing entity. They develop a drug molecule up to a certain level (generally till they identify a drug candidate from hundreds of potential ones) and then they out-license this molecule to a Big Pharma player for this molecule and then receive royalties on future sales if the drug candidate is finally marketed after passing all the regulatory steps. This benefits the Indian Pharma in two-ways: a) they do not have to invest into the high-risk business of developing a drug and b) they get a substantial amount from the one time payment they receive, which they can invest in further R&D etc.

This e-learning course provide comprehensive idea about the following:

  • Pharma R&D
  • Portfolio Analysis 
  • Strategies to strengthen Portfolio
  • Current scenario of Licensing in Pharma R&D
  • Detailed fundamental training regarding In-Licensing and Out-Licensing
  • Real Life Case Analysis in pharmaceutical, bio-pharmaceuticals and medical devices licensing
  • Terminologies regarding licensing
  • Pharma licensing deal structures
  • Confidential Disclosure Agreements (CDAs) and Materials Transfer Agreements (MTAs).
  • Practical understanding in Deal Valuation and Return Analysis
  • Detailed understanding how cross functional licensing team works in Large Innovator Companies, SMEs and Generic Drug Companies

The Pharmaceutical In and Out-licensing Course is designed for those likely to be involved in the in or out-licensing projects :
• Senior managers and scientists in companies developing or planning to develop products for out-licensing.
• Junior to mid-level managers, including scientists, commercial and legal managers.
• Business development managers, IPR teams with no formal training in licensing and staff joining the business development and licensing functions.

Introduction to Drug R&D Process
Overview of the Drug Regulations .
Introduction to Strategic Initiatives in Drug R&D
Overview of the In & out-licensing process.
In & out-licensing – Why? When? How?
Detailed understanding to different types of the deal with real life practical simulations
Deal Outcome – Co-promotion, Co-marketing
Typical Commercial Deal Structures – Milestone Payment, Royalities, Deal Incentives etc.
Deal Terminologies Analysis- Exclusivity, Sub-licenses, Field and Territory, Milestones, Royalties and Royalty stacking, Termination, Warranties and Jurisdiction.
Confidential Disclosure Agreements (CDAs) and Materials Transfer Agreements (MTAs).
Deal Valuation – Key factors affecting deal valuation
Setting Up licensing department in Pharma R&D – Cross Functional Team, Job Descriptions. How Licensing team works.
Finding Potential Partner – how to find the partner? Developing target list. Evaluations to refine the list.
Deal Announcement – PR issues

  • Upon admission you will be providing the user id and password to access all the content online.
  • You will also be receiving the soft copy of the e-module (which you can download from your dashboard).

 

Section 1Licensing: Introduction
Lecture 1Licensing in Pharma - Introduction
Lecture 2Patents Vs. exclusivity
Lecture 3R&D Process & Introduction to drug discovery
Lecture 4Investigational New Drug Application (INDA)
Lecture 5New Drug Application (NDA) 
Lecture 6Basic concept and understanding of the Generic Drug
Lecture 7Abbreviated New Drug Application (ANDA) 
Lecture 8Authorized Generics: Key Understanding
Lecture 9Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 10Portfolio Management in R&D Lifecycle 
Lecture 11Evergreening - Patent Life Extension Strategies
Lecture 12Compulsory Licensing
Lecture 13Licensing & Technology Transfer
Lecture 14In-Licensing Vs. Outlicensing
Lecture 15LOE Strategies for Innovator Brands with case study
Lecture 16Types of Deals from Discovery to Commercialization
Section 2Licensing Strategies for Big Pharma
Lecture 17Types 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 18License Agreement
Lecture 19Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 20Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 21Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 22Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 23Numerical SWOT Practical training
Lecture 24Modelling 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 25Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 26Average Royalty Rate
Lecture 27Factors affecting royalty rate
Lecture 28Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 29Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 30Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 31Licensing Payment Scheduling: Different Types
Lecture 32Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 33Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 34Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 35Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 36Step By Step Implementation of Licensing Deal by Business Development Team 
Lecture 37Due Diligence Activities in Pharmaceutical Licensing
Section 3Final Examination