InstructorRoyed Training
TypeOnline Course
Price$540 / 37800 INR.
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Biosimilar Development and Commercialization course by royed training

Introduction

Duration

Who should attend this course?

Core Learning Areas

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Related Courses

About Biosimilar Industry

The Advanced Certification in Biosimilar Development and Commercialization is a comprehensive online certification program designed to provide strategic, scientific, regulatory, and commercial understanding of the rapidly growing global biosimilar industry.

“Master the Complete Journey of Biosimilar Development, Regulatory Strategy & Global Commercialization.”

As biosimilars continue to reshape the biopharmaceutical market, organizations increasingly require professionals who can understand the complete biosimilar ecosystem — from product development and regulatory pathways to commercialization, market access, pricing, reimbursement, forecasting, and lifecycle strategy.

Therefore, this program has been strategically designed to bridge the gap between:

  • Biosimilar Development
  • Regulatory Affairs
  • Commercialization Strategy
  • Market Access
  • HEOR
  • Pricing & Reimbursement
  • Forecasting
  • Portfolio & Lifecycle Management

Different from traditional training

Unlike traditional biosimilar training programs that focus only on development or regulatory aspects, RYD-145 delivers an integrated industry-oriented learning approach aligned with real-world biosimilar business operations.

Furthermore, the course simplifies complex biosimilar concepts into structured and easy-to-understand learning modules, making it highly suitable for working professionals, corporate teams, and professionals transitioning into the biosimilar sector.

The program provides strategic exposure to:

  • Biosimilar Development Lifecycle
  • Analytical Similarity & Comparability
  • Immunogenicity Concepts
  • Global Biosimilar Regulatory Frameworks
  • Biosimilar CMC Strategy
  • Market Access & HEOR
  • Pricing & Reimbursement Models
  • Biosimilar Forecasting
  • Commercial Launch Strategy
  • Competitive Intelligence
  • Tender Market Dynamics
  • Portfolio & Lifecycle Management
  • AI in Biosimilar Strategic Operations

Additionally, participants will gain understanding of major global biosimilar markets including:

  • United States (FDA)
  • Europe (EMA)
  • United Kingdom (MHRA)
  • Japan (PMDA)
  • Canada
  • ASEAN
  • LATAM
  • Middle East
  • Emerging Biosimilar Markets

Course Snapshot

  • Course Code: RYD-145
  • Title: Executive PG Certification in Biopharma Global Business (EPBioGB)
  • Type of the course: Self paced Online 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, if you want to attend the session at 11 pm at night, you can do that.
  • Course Duration : 1 Month. Free extendable upto 3 month (1 month plus additional 2 month access).
  • Course Certification: Certificate will be provided at the end of the successful completion of the course.

Why Join This Program?
This executive-level course bridges science, strategy, and business — helping you transform from a scientific or commercial professional into a global biopharma business strategist.

The program follows a professionally structured online learning model supported by:

  • Real-world biosimilar case studies
  • Strategic commercialization exercises
  • Regulatory strategy simulations
  • Market access scenarios
  • Forecasting workshops
  • Industry-oriented assignments

As a result, participants will develop practical and strategic competencies required for modern biosimilar development and commercialization functions.

1-Month Intensive Program

  • Extended Learning Access: Up to 3 Months (No Additional Cost).
  • Flexible Learning Structure for Working Professionals
  • Self-Paced Professional Learning Model
  • Suitable for Individual & Corporate Enrollment
  • Additional Learning Extension Available Beyond 3 Months on Payment of Applicable Extension Fees
  • Extended Access Support Available for Continued Learning, Revision & Program Completion Requirements
  • Designed to Support Flexible Professional Upskilling & Long-Term Learning Convenience

Who should attend this course? 

  • Regulatory Affairs Professionals
  • Biosimilar & Biopharmaceutical Development Teams
  • Market Access & HEOR Professionals
  • Medical Affairs Professionals
  • Commercial Strategy & Product Management Teams
  • Pricing & Reimbursement Professionals
  • Forecasting & Market Intelligence Professionals
  • Business Development & Licensing Teams
  • IP Landscaping & Patent Strategy Professionals
  • Competitive Intelligence Professionals
  • Portfolio & Lifecycle Management Teams
  • Corporate Biosimilar Teams
  • Biopharmaceutical Industry Professionals
  • Professionals Transitioning into the Biosimilar Industry
  • Life Science & Biotechnology Professionals
  • Strategic Business & Commercial Operations Professionals
  • Professionals Seeking Biosimilar Industry Upskilling
  • Organizations Planning Corporate Biosimilar Capability Development

What You’ll Learn in This Exclusive Program:

This program designed to build strategic competencies across biosimilar development, regulatory affairs, commercialization, market access, and lifecycle management.

Biosimilar Industry Foundation & Global Landscape

The program begins with a strong foundation in biosimilars and similar biologics, helping participants understand the overall biosimilar ecosystem and its strategic importance in the modern biopharmaceutical industry. Participants will learn the difference between innovator biologics and biosimilars, how biosimilars are transforming healthcare accessibility, and the major growth drivers shaping global biosimilar markets. The course will also provide understanding of global market trends, commercial opportunities, industry challenges, competitive market dynamics, and the future direction of the biosimilar industry.

Biosimilar IP Landscaping & Patent Dance Strategy

Following the commercialization strategy section, the program will provide detailed exposure to biosimilar intellectual property (IP) strategy, patent landscaping, and patent litigation frameworks that significantly influence biosimilar market entry and commercialization timelines. Participants will understand how patent ecosystems impact biosimilar development strategy, launch planning, competitive positioning, and global market access decisions.

Biosimilar Development Lifecycle

Participants will gain a comprehensive understanding of the biosimilar development process, starting from analytical development through clinical and commercialization stages. The course will cover analytical similarity assessment, comparability exercises, Critical Quality Attributes (CQAs), manufacturing concepts, process development, stability considerations, immunogenicity assessment, and clinical development strategy. In addition, learners will understand the scientific and operational challenges involved in biosimilar product development and lifecycle planning.

Biosimilar Regulatory Affairs & Global Compliance

This section focuses on the regulatory pathways and compliance requirements associated with biosimilars across major global markets. Participants will learn how biosimilar regulations differ from generic drug pathways and how global agencies evaluate biosimilar products. The course will cover US FDA biosimilar pathways, EMA biosimilar regulations, MHRA and PMDA expectations, emerging market regulatory approaches, biosimilar dossier strategies, CMC documentation, labeling considerations, pharmacovigilance requirements, and lifecycle regulatory management practices.

Biosimilar Commercialization Strategy

The program provides detailed exposure to biosimilar commercialization and strategic market planning. Participants will understand how biosimilar products are commercially positioned in competitive markets and how organizations develop market penetration strategies. The course will cover biosimilar launch planning, physician adoption strategy, commercial positioning, brand differentiation, multi-market expansion planning, commercialization risk management, and strategic approaches to increasing market adoption of biosimilar products.

Market Access, HEOR & Value Strategy

Participants will learn how market access and HEOR play a critical role in biosimilar adoption and reimbursement success. The course will explain how value demonstration strategies are developed for biosimilars and how payers evaluate pricing and reimbursement decisions. Learners will gain understanding of cost-effectiveness analysis, budget impact models, Health Technology Assessment (HTA), Real-World Evidence (RWE), payer evidence expectations, reimbursement pathways, and tender market dynamics used in various global markets.

Pricing, Reimbursement & Biosimilar Forecasting

This section focuses on commercial decision-making processes associated with biosimilar pricing and forecasting. Participants will understand different biosimilar pricing models, reimbursement systems, competitive pricing strategies, tender-driven pricing dynamics, and commercial access strategies. Furthermore, the course will provide exposure to biosimilar market valuation methods, demand forecasting models, revenue forecasting approaches, market opportunity analysis, and commercial analytics used for strategic business planning in the biosimilar sector.

Portfolio & Lifecycle Management

The course also covers strategic portfolio and lifecycle management concepts that are essential for long-term biosimilar business growth. Participants will understand how organizations manage biosimilar portfolios, plan lifecycle strategies, evaluate market expansion opportunities, and differentiate biosimilar products within highly competitive markets. This section will also include concepts related to patent and exclusivity considerations, strategic licensing opportunities, alliance models, and risk assessment frameworks for biosimilar business sustainability.

AI & Digital Transformation in Biosimilars

As digital transformation continues to influence the biopharmaceutical industry, the course introduces the role of AI and advanced analytics in biosimilar operations. Participants will learn how AI can support regulatory operations, forecasting, competitive intelligence, strategic documentation, market analysis, and decision-making. Additionally, the course will explore emerging digital trends that are influencing biosimilar commercialization, operational strategy, and global business management practices.

Competitive Intelligence & Strategic Business Understanding

Participants will gain understanding of how biosimilar organizations analyze competitive markets, monitor industry movements, and develop strategic business plans. The course will cover competitor benchmarking, market intelligence approaches, opportunity mapping, strategic positioning, commercial risk evaluation, and business expansion strategy. This section is designed to strengthen strategic thinking capabilities within biosimilar commercial and regulatory functions.

Practical Industry Learning & Simulations

The program is designed with a strong practical learning orientation. Therefore, participants will be exposed to real-world biosimilar case studies, commercialization exercises, forecasting workshops, regulatory simulations, market access scenarios, lifecycle strategy exercises, and strategic planning activities. These practical components are intended to help professionals understand how biosimilar concepts are implemented within actual pharmaceutical and biopharmaceutical industry environments.

Why This Course Stands Out

Most biosimilar courses primarily focus on scientific development or regulatory pathways alone.

However, the global biosimilar industry today requires professionals who can understand both development and commercialization dynamics simultaneously.

Therefore, RYD-145 has been specifically designed to integrate:

  • Development
  • Regulatory Affairs
  • Commercialization
  • Market Access
  • HEOR
  • Pricing
  • Forecasting
  • Strategic Lifecycle Management

within one comprehensive executive certification program.

This integrated approach makes the course highly aligned with real-world biopharmaceutical industry operations and corporate upskilling requirements.

Career in Biosimilar Industry

The biosimilar industry is rapidly emerging as one of the fastest-growing segments within the global biopharmaceutical sector. As healthcare systems increasingly focus on improving affordability and access to biologic therapies, the demand for biosimilars continues to expand across major global markets including the United States, Europe, Asia-Pacific, LATAM, and emerging economies.

Consequently, pharmaceutical and biopharmaceutical organizations are actively seeking professionals who possess integrated understanding across biosimilar development, regulatory affairs, commercialization, market access, pricing, HEOR, forecasting, and lifecycle management.

Unlike conventional pharmaceutical careers that are often limited to specific functional roles, the biosimilar industry offers multidisciplinary career opportunities across scientific, regulatory, strategic, and commercial domains.

Why Biosimilars Are Creating Massive Career Opportunities

Biologics represent one of the largest and fastest-growing therapeutic categories globally. As major biologic products lose patent exclusivity, biosimilars are becoming critical for reducing treatment costs while expanding patient access.

Therefore, companies worldwide are investing heavily in:

  • Biosimilar Development
  • Manufacturing Expansion
  • Regulatory Submissions
  • Commercial Launches
  • Market Access Strategy
  • Global Commercialization
  • Portfolio Expansion
  • Strategic Licensing & Partnerships

This rapid expansion is generating strong demand for skilled biosimilar professionals across multiple functions.

Section 1Biosimilar Development Project Management & Timeline
Lecture 1R&D Process - Discovery to Commercialization
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 5Basic concept and understanding of the Generic Drug
Lecture 6Abbreviated New Drug Application (ANDA) 
Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 8505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 9Vaccine development and approval Process
Lecture 10Handling of orange book
Lecture 11Purple Book: Significance | Searching | Assignments
Lecture 12Clinical Trials Terminologies 
Lecture 13Clinical Trial Protocol Writing
Lecture 14Ethics in Clinical Research
Lecture 15Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 16Importance of Project Management in Biopharmaceutical Industry 
Lecture 17Traditional Project Management Vs. BioPharma Project Management | Key Differences | Different Parameters 
Lecture 18Key Comparison of Traditional and Pharma Project Management
Lecture 19Regulatory Influences on Biopharma Project Timelines and Deliverables
Lecture 20Case Study: Managing a New Drug Development Project with Strict Regulatory Timelines
Lecture 21Core Identified Phases of the Pharmaceutical Project Lifecycle
Lecture 22Terminologies of Pharmaceutical Project Management 
Lecture 23Project Tracking 
Lecture 24Asset Tracking 
Lecture 25Role and Responsibility of Project Leader
Lecture 26Project Constraint & Effective management of Project Constraint | Role of Project Manager
Lecture 27Critical Success Factor in Drug Development Projects
Lecture 28Project Management Case Study | Exploring the Project Tools Used in real life project
Section 2Biosimilar Management and Regulation
Lecture 29Introduction : Biopharmaceuticals
Lecture 30Classification of Biopharmaceutical 
Lecture 31Important Concept regarding Biopharmaceuticals
Lecture 32Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 33Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs
Lecture 34Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 35Global Biopahrma Market Trends
Lecture 36Recombinant protein
Lecture 37Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 38Monoclonal Antibodies
Lecture 39Synthetic Immunomodulators
Lecture 40Production of Monoclonal Antibodies
Lecture 41Cytokines
Lecture 42Interferon
Lecture 43Erythropoiesis-stimulating agent
Lecture 44Vaccine development and approval Process
Lecture 45Biosimilar Development Process
Lecture 46Strategic Consideration for Biosimilar Development 
Lecture 47Bio-Manufacturing Process Information
Lecture 48Studies required for approval of biosimilar
Lecture 49REMS Strategic Planning 
Lecture 50ATMPs | Types and Classification | Regulatory Mechanism 
Lecture 51mAB - At a glance
Lecture 52ATMPs - at a glance
Lecture 53CAR-T Therapy | Different Types of CAR-T Therapy | Mechanism of action | Challenges | Brainstorming on Concept of Personalized Medicine | Understanding on marketed formulation
Lecture 54Live Biotherapeutic Products | LBPs | Class | Mechanism | Indication Positioning | Regulatory Requirements for LBPs 
Lecture 55Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 56Studies required for approval of biosimilar
Lecture 57Comparability of Biologics | Different Categories of Comparability | General Principles 
Lecture 58CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)
Section 3Biosimilar Market Access
Lecture 59Biosimilar Approval and Patent Management | Strategic Pathway of Patent Negotiation and Litigation in Biosimilar Approval | Patent Dance | FAQs on Biologic Patent Management 
Lecture 60Biosimilar launch case study | Patent Dance Framework
Lecture 61Biosimilar Launch Framework 
Lecture 62Biosimilar 180 Day Notice 
Lecture 633(A) List | Significance | Importance | How to interpret
Lecture 64Steps to win over innovator patents | Step wise planning 
Lecture 65Biosimilar Launch Project Roadmap with defined stages of project
Lecture 66Timing of Biosimilar Submission and Approvals | Two Scenario based timeline assessments 
Lecture 67Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation  
Lecture 68How to work on RPS’s Patent | Walkthrough | Case Study
Lecture 69Biosimilar Launch Project With Milestones
Lecture 70Analysis of Biologic Patents | Work Assignments
Lecture 71Biologic Patent Insight Worksheet
Lecture 72Patent Thickets | Concept | Implication | Case Based Learning 
Section 4Biosimilar Pricing | Formulary Placement
Lecture 73Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 74Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 75Market Access Strategic Planning
Lecture 76Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 77Indication Prioritization Case Study
Lecture 78Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 79AMCP Market Access Value Dossier Preparation
Lecture 80Drug Pricing Methodologies
Lecture 81Sales Forecasting in Life Science Industry
Lecture 82New Product Forecast Algorithm
Lecture 83Patient Based Forecasting Model | Applying more filters and variables
Lecture 84Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 85Prevalence Vs. Incidence Model
Lecture 86EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 87Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 88Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 89Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 90Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 91Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 92Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 93Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 94Simulation on Bottom-up forecasting
Lecture 95Assessment on Bottom-up forecasting
Lecture 96Oncology Brand Forecasting
Lecture 97Authorized Geenric
Lecture 98Branded Generics | Differences from Authorized and Unbranded Generics | Strategic planning for formulary placement 
Section 5Biosimilar Advanced Strategic Management
Lecture 99Patents Vs. exclusivity 
Lecture 100Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 101Orphan Drug Designation 
Lecture 102USFDA expedited programs
Lecture 103Advance study on Para IV Filing
Lecture 104Para IV Notices
Lecture 105Evergreening - Patent Life Extension Strategies
Lecture 106Pay For Delay Strategy
Lecture 107Compulsory Licensing
Lecture 108Licensing & Technology Transfer
Lecture 109In-Licensing Vs. Outlicensing
Lecture 110LOE Strategies for Innovator Brands with case study
Lecture 111Drug Repurposing
Lecture 112Advance understanding of the portfolio Management 
Section 6Advance Biopharma Regulations and Submission Management
Lecture 113505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 114Advance Learning on 505B2 Pathway
Lecture 115Chemistry, Manufacturing & Controls 
Lecture 116Common Technical Document (CTD)
Lecture 117Introduction to Electronic Common Technical Document (ECTD)
Lecture 118Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 119Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 120Importance of effective dossier management
Lecture 121Certificate of Analysis
Lecture 122Detailed Understanding on ANDA Submission Dossier 
Lecture 123Prior Approval Submission 
Lecture 124Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 125NCE Vs. 505b2 application - Case Based Learning 
Lecture 126FTF - 180 Days Exclusivity - Case Based Learning
Lecture 127Classic case study of the 505b2 filing : Case Based Learning
Lecture 128Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 129Discussion on 85 common deficiency in CTD submission dossier
Lecture 130Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 131PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 132Bioequivalence Study | Study design | Different types of BE Studies
Lecture 133Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalization | Confidence interval acceptance criteria
Lecture 134Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 135Data Integrity issues in Pharmaceutical Industry
Section 7Real World Data and Real World Evidence
Lecture 136Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence? 
Lecture 137RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 138RWD and RWE in Product Lifecycle Management
Lecture 139RWD and RWE - Fit to use | Assessment 
Lecture 140RWD data sources | Different types | Detailed understanding of each class 
Lecture 141RWD Study Design
Lecture 142RWE Published Tool | Insights on commonly used tools
Lecture 143RWD Study Design
Lecture 144Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 145HEOR Consensus Narrative Review 
Lecture 146Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 147Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 148RWD Characteristics
Lecture 149RCT vs. RWE Comparison | Case Based Analysis
Lecture 150RCT and RWE Comparison
Section 8Working on Real World Datasets
Lecture 151Introduction to Healthcare Datasets
Lecture 152Dataset 1: Claims Data (Insurance)
Lecture 153Dataset 2: Retail Pharmacy Prescription Data
Lecture 154Dataset 3: Longitudinal Patient Data
Lecture 155Characteristics of Different Set of Healthcare Data
Lecture 156Reimbursement and Pricing Datasets
Lecture 157RWE Data Sources & Quality Considerations Checklist | Case Based Analysis
Lecture 158Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing
Lecture 159RWD & RWE Case Database
Lecture 160RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis 
Section 9Biosimilar Business Development and Licensing
Lecture 161Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 162Moving Average | Moving Annual Total | YTD | How to calculate 
Lecture 163Compound Annual Growth Rate | CAGR Calculation
Lecture 164Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 165Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 166Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 167Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 168Numerical SWOT Practical training
Lecture 169Modelling 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 170Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 171Forecasting : Tools and Techniques
Lecture 172Market Sizing & Forecasting Case Study
Lecture 173Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 174Average Royalty Rate
Lecture 175Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 176Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 177Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 178Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 179SPECIAL PURPOSE VEHICLES (SPV)
Lecture 180Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 181Types of Deals from Discovery to Commercialization
Lecture 182What are the fundamental areas of business development
Lecture 183Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 184Licensing Payment Schedule | Case Study 
Lecture 185Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 186Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 187Negotiation 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 188Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 189Types 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 190Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Lecture 191DCF Calculation : Concept and Calculation - Step by step understanding
Lecture 192Net Present Value (NPV) method : Calculation
Lecture 193Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk Premium 
Lecture 194Valuation Metric - P/E Ratio and EPS : Calculation
Lecture 195Comparable Company Analysis method : Calculation
Lecture 196EBITDA Multiples | Importance in Pharma Biopharma BD&L | Calculation | Benchmarking EBITDA multiplies | Sourcing EBITDA multiples | Decoding EBITDA multiples value in different types of pharma and biopharma organizations
Lecture 197Pipeline Benchmarking | Significance and Importance in Bio Pharma BD&L | Analyzing sample portfolio | Comparative outcome in business development 
Lecture 198Comparative pipeline benchmarking analysis | Level of Benchmarking | Primary - Secondary - Tertiary Benchmarking Metrics | Case Based Analysis of three companies comparative pipeline benchmarking
Lecture 199Pipeline Diversity Scores | Significance | How to Calculate | Comparative Study of Pipeline Diversity Scores
Lecture 200Assignment: Prepare real time tracker
Lecture 201Research Productivity Index | Concept | Significance | Calculation Methodology | Comparative RPI benchmarking Exercise 
Lecture 202WACC in Biopharma Valuation | Significance | WACC benchmarking 
Lecture 203WACC Calculation | Step by Step Calculation | Insight on WACC components
Lecture 204rNPV Model | Step by Step Calculation | Insight on Probability and Cumulative Probability | Factoring WACC for Discounting 
Lecture 205Probability and Cumulative Probability | Calculation | Benchmarking | Factoring for WACC and rNPV 
Lecture 206Real Options Valuation (ROV) for Biopharma assets | Model Development | Calculation | Case Based Insight in the context of inlicensing and outlicensing | Early stage asset valuation with ROV
Lecture 207ROV Scenario Based Case Study
Lecture 208Biotech Decision Tree Model with Decision Reasoning