Introduction
Course Type
Course Duration
Learning Area
Eligibility
Duration
Who should attend
Certification
Related Courses
Biopharma Business Development course is designed to train BD and licensing job in biopharmaceutical industry. The course covers basics of biopharma, different classes of biopharmaceuticals, biopahrma trade knowhows, biopahrma market access, licensing. Moreover course covers step by step development of the biopharma business development techniques. Above all Biopharma Business Development course provides new biologic forecasting, market sizing and valuation hands on training. Hence this course provides comprehensive skill training for business development managers working in 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 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 biopharmaceutical business development course provide detailed training on valuation tools and techniques.
Course Code: RYD-059
Course Title: Advance Certification in Biopharma Business Development (ACBBD)
Online distance learning course. Hence, this course can be accessed online across anywhere 24×7. Moreover, you can attend the course at your convenience in your flexible time. For example, you want to attend the session at your 11 pm at night, you can do that.
1 Month
Core learning areas of Biopharma Business Development course
The Course covers following :
- Biopharmaceutical basics and different classes of biopharmaceuticals.
- Discovery Development to commercialization of biopharmaceutical.
- Biopharma Market Access.
- Forecasting of Biopharmaceuticals.
- Pricing of biologics.
- Strategic Management of biopharmaceutical products.
- Regulatory affairs (regulation, marketing authorization, variation, etc) of innovator biologics and similar biologics.
- Business Development, Valuation, Licensing of biopharmaceutical deals.
- Biopharmaceutical Brand Management.
Graduation in any discipline.
1 Year from the date of initiation of the course.
Who should attend this program?
- First of all this biopharma business development course provides hands on knowledge to those who seeks Biopharma fundamental to advanced knowledge.
- Secondly, this course is ideal for the Biopharma business development professionals seeking to improve their skills.
- Moreover this is also ideal for those who are working on biopharma strategic business deals and want detailed understanding on strategic processing.
- At the same time, this course will be excellent tool for those who wishing to update their knowledge on strategic valuation and various valuation tools and techniques.
- Above all 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.
Some of the related courses
- Biopharma Global Business
- Biopharma Valuation
- Basics of Biopharma
- Biopharma Market Access
- Training on Monoclonal Antibodies
- Training on Interferon
- Training on Erythropoiesis Stimulating Agent
Other Business Development courses
Section 1Biopharma Fundamental | Basics of Biologics | Classes | Regulations | Keynotes
Lecture 1Introduction to Biopharmaceuticals | Biopharma Market | OverviewÂ
Lecture 2Classification of BiopharmaceuticalÂ
Lecture 3Chemical Drugs Vs. Biologic Drugs
Lecture 4Principle of Naming of Biologic | Understanding on MAB naming systemÂ
Lecture 5Global Biologics Market – By Product
Lecture 6Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 7Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 8Monoclonal Antibodies
Lecture 9Synthetic Immunomodulators
Lecture 10Production of Monoclonal Antibodies
Lecture 11Cytokines
Lecture 12Interferon
Lecture 13Erythropoiesis-stimulating agent
Section 2Biopharma R&D Fundamentals - Discovery, Development and Regulation of Biologics
Lecture 14Introductory Session - R&D Fundamental
Lecture 15Investigational New Drug Application (INDA)
Lecture 16New Drug Application (NDA)Â
Lecture 17Biological Licensing Application (BLA)Â | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 18Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 19Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 20Purple Book: Significance | Searching | Assignments
Lecture 21Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE)Â
Lecture 22Training on Basic Finance | Understanding Financial Statement | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 23Introduction to EU RegulationÂ
Lecture 24Orientation to European Countries and National Regulatory Bodies
Lecture 25EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 26Overview of EU RegulationÂ
Lecture 27EMA and EMA Authorisation Process
Lecture 28EU MA Application Types and Strategic Planning
Lecture 29EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National ProcedureÂ
Lecture 30EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 31Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 32Portfolio Management in R&D LifecycleÂ
Lecture 33Evergreening - Patent Life Extension Strategies
Lecture 34Pay For Delay Strategy
Lecture 35Compulsory Licensing
Lecture 36Licensing & Technology Transfer
Lecture 37In-Licensing Vs. Outlicensing
Lecture 38LOE Strategies for Innovator Brands with case study
Lecture 39Advance study on Para IV Filing
Lecture 40Para IV Notices
Section 3Biopharma Market Access | Forecasting Pricing and Commercialization
Lecture 41Introduction to Biopharma Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 42Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 43Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development
Lecture 44Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 45Indication Prioritization Case Study
Lecture 46Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 47AMCP Market Access Dossier PreparationÂ
Lecture 48Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Lecture 49Drug Pricing Methodologies
Lecture 50Drug Pricing Methodologies
Lecture 51Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 52Pharma Market Access Pricing Case Study : Lantus interchangeable PricingÂ
Lecture 53Sales Forecasting in Life Science Industry
Lecture 54Biopharma Forecast Algorithm
Lecture 55Patient Based Forecasting Model | Applying more filters and variables
Lecture 56Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 57Prevalence Vs. Incidence Model
Lecture 58EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 59Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 60Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 61Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 62Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 63Oncology Brand Forecasting
Lecture 64Portfolio Based Forecasting | Forecasting Model Development in ExcelÂ
Section 4Advanced Learning sessions on Biopharma Business Development
Lecture 65Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 66Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 67Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 68Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentiality - CDA | MTA
Lecture 69Numerical SWOT Practical training
Lecture 70Modelling 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 71Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 72Forecasting : Tools and Techniques
Lecture 73Market Sizing & Forecasting Case Study
Lecture 74Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 75Average Royalty Rates
Lecture 76Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 77Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 78Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 79Join Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 80Special Purpose Vehicles (SPV)
Lecture 81Indication Splitting | Concept | Implementation feasibility analysisÂ
Lecture 82Types of Deals from Discovery to Commercialization
Lecture 83Review: What are the fundamental areas of business development
Lecture 84Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 85Licensing Payment Scheduling: Different Types
Lecture 86Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 87Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 88Negotiation 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 89Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 90Types 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 91Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projectsÂ
Lecture 92Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Section 5Biosimilar Development | CMC Requirements
Lecture 93Biosimilar Development Process
Lecture 94Strategic Consideration for Biosimilar DevelopmentÂ
Lecture 95Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 96Comparability of Biologics | Different Categories of Comparability | General PrinciplesÂ
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