Introduction
Course Type
Course Duration
Feature
Eligibility
Duration
Who should attend
Certification
Course Deliverable
Certification
Related Courses
Biopharma Business Development course is designed to train the practical working knowledge and skill-set of Business Development job in biopharma companies. This course provides comprehensive skill training for business development managers working in pharmaceutical and biopharmaceutical industry.
Self Paced Learning
This biopharma business development course utilizes interactive learning tools to guide participant to understand of the Business Development working in a biopharma company. The course will focus on understanding business development skills which is required for effective functioning as BD personnel in business development department. This online training 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 will challenge the students to apply what they have learned through the use of interactive exercises, reflection questions, simulation and a final assessment at the end of the course.
This bio pharmaceutical business development course provide detailed training on biopharma valuation tools and techniques.
The course can be completed at any pace, allowing the user to stop and start at their leisure.
Course Code: RYD-059
Course Title: Advance Certification in Biopharma Business Development (ACBBD)
Online distance learning course. Course can be accessed online across anywhere 24×7.
1 Month
- 24×7 Online Access – Access anytime from anywhere across globe.
- Prinatable booklet provided to all course participants.Â
- Access the e-lectures, case studies, self assessment modules and practical sessions through personalized web page.Â
- Flexible online final examination (Computer Based Test by secure mode)
- Real life Case Study module will be provided along with the course, material.Â
Graduation in any discipline.
1 Year from the date of initiation of the course.
- Biopharma business development professionals seeking to improve their skills.
- Those who are working on biopharma strategic business deals and want detailed understanding on strategic processing.
- Anyone wishing to update their knowledge on strategic valuation and various valuation tools and techniques.
- This course is ideal for the biopharma strategic portfolio management tools and techniques and licensing techniques.
 Certificate will be provided at the end of the successful completion of the course
- Attend the course 24×7 by login to your dashboard. You can attend lectures, simulation, self assessment tests and final certification examination.
- You will also eligible to receive the course study modules, which you can download by login to your course page.
Certificate will be provided at the end of the successful completion of the course.
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Section 1Biopharma Fundamental Sessions | R&D - Discovery Development | Regulatory Basics | Basic FinanceÂ
Lecture 1Introductory Session - R&D Fundamental
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA)Â
Lecture 4Biological Licensing Application (BLA)Â | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 5Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 6Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 7Purple Book: Significance | Searching | Assignments
Lecture 8Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE)Â
Lecture 9Training on Basic Finance | Understanding Financial Statement | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 10Introduction to EU RegulationÂ
Lecture 11Orientation to European Countries and National Regulatory Bodies
Lecture 12EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 13Overview of EU RegulationÂ
Lecture 14EMA and EMA Authorisation Process
Lecture 15EU MA Application Types and Strategic Planning
Lecture 16EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National ProcedureÂ
Lecture 17EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 18Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 19Portfolio Management in R&D LifecycleÂ
Lecture 20Evergreening - Patent Life Extension Strategies
Lecture 21Pay For Delay Strategy
Lecture 22Compulsory Licensing
Lecture 23Licensing & Technology Transfer
Lecture 24In-Licensing Vs. Outlicensing
Lecture 25LOE Strategies for Innovator Brands with case study
Lecture 26Advance study on Para IV Filing
Lecture 27Para IV Notices
Section 2Advanced Learning sessions on Biopharma Business Development
Lecture 28Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 29Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 30Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 31Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentiality - CDA | MTA
Lecture 32Numerical SWOT Practical training
Lecture 33Modelling and Deal Valuation - Top Down Modeal | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 34Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 35Forecasting : Tools and Techniques
Lecture 36Market Sizing & Forecasting Case Study
Lecture 37Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 38Average Royalty Rates
Lecture 39Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 40Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 41Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 42Join Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 43Special Purpose Vehicles (SPV)
Lecture 44Indication Splitting | Concept | Implementation feasibility analysisÂ
Lecture 45Types of Deals from Discovery to Commercialization
Lecture 46Review: What are the fundamental areas of business development
Lecture 47Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 48Licensing Payment Scheduling: Different Types
Lecture 49Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 50Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 51Negotiation Skill Training for BD personnel | Mind Mapping Tools | Practical Case Based Learning | Do and Don’ts in Pharma Business development Negotiations | Role of Scribes
Lecture 52Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 53Types 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 firmsÂ
Lecture 54Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projectsÂ
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