Section 1Biopharma Biopharma R&D Project Management & Timeline
Lecture 1R&D Process - Discovery to Commercialization
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 5Basic concept and understanding of the Generic Drug
Lecture 6Abbreviated New Drug Application (ANDA)Â
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 TerminologiesÂ
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 IndustryÂ
Lecture 17Traditional Project Management Vs. BioPharma Project Management | Key Differences | Different ParametersÂ
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 ManagementÂ
Lecture 23Project TrackingÂ
Lecture 24Asset TrackingÂ
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 2Biopharmaceutical Management and Regulation
Lecture 29Introduction : Biopharmaceuticals
Lecture 30Classification of BiopharmaceuticalÂ
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 DevelopmentÂ
Lecture 47Bio-Manufacturing Process Information
Lecture 48Studies required for approval of biosimilar
Lecture 49REMS Strategic PlanningÂ
Lecture 50ATMPs | Types and Classification | Regulatory MechanismÂ
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 LBPsÂ
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 PrinciplesÂ
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 ManagementÂ
Lecture 60Biosimilar launch case study | Patent Dance Framework
Lecture 61Biosimilar Launch FrameworkÂ
Lecture 62Biosimilar 180 Day NoticeÂ
Lecture 633(A) List | Significance | Importance | How to interpret
Lecture 64Steps to win over innovator patents | Step wise planningÂ
Lecture 65Biosimilar Launch Project Roadmap with defined stages of project
Lecture 66Timing of Biosimilar Submission and Approvals | Two Scenario based timeline assessmentsÂ
Lecture 67Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation Â
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 LearningÂ
Section 4Biopharma Market Access & Pricing - Forecasting - Formulary Placement of brands
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 placementÂ
Section 5Biopharma Strategic Management
Lecture 99Patents Vs. exclusivityÂ
Lecture 100Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 101Orphan Drug DesignationÂ
Lecture 102USFDAÂ 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 ManagementÂ
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 & ControlsÂ
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 countriesÂ
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 DossierÂ
Lecture 123Prior Approval SubmissionÂ
Lecture 124Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 125NCE Vs. 505b2 application - Case Based LearningÂ
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 LetterÂ
Lecture 135Data Integrity issues in Pharmaceutical Industry
Section 7Biopharma International Business
Lecture 136Introduction to Pharmaceutical Export
Lecture 137Introduction of Export Documentation | Understanding of important terminologies
Lecture 138Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 139Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 140Commercial Invoice | Importance | Differences with Proforma InvoiceÂ
Lecture 141Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 142Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 143Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 144LC Discounting | How it works | How to calculate the LC discounting
Lecture 145Packing List | Importance | Things to include in packing list
Lecture 146Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 147Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 148Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 149Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 150Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Section 8Real World Data and Real World Evidence
Lecture 151Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?Â
Lecture 152RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 153RWD and RWE in Product Lifecycle Management
Lecture 154RWD and RWE - Fit to use | AssessmentÂ
Lecture 155RWD data sources | Different types | Detailed understanding of each classÂ
Lecture 156RWD Study Design
Lecture 157RWE Published Tool | Insights on commonly used tools
Lecture 158RWD Study Design
Lecture 159Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models
Lecture 160HEOR Consensus Narrative ReviewÂ
Lecture 161Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Lecture 162Active Surveillance Schemes | Active Case Finding |Sentinel Surveillance | Cohort Studies | Vaccine Safety Surveillance | Pharmacovigilance Programs | Disease Registries |Event Monitoring
Lecture 163RWD Characteristics
Lecture 164RCT vs. RWE Comparison | Case Based Analysis
Lecture 165RCT and RWE Comparison
Section 9Working on Real World Datasets
Lecture 166Introduction to Healthcare Datasets
Lecture 167Dataset 1: Claims Data (Insurance)
Lecture 168Dataset 2: Retail Pharmacy Prescription Data
Lecture 169Dataset 3: Longitudinal Patient Data
Lecture 170Characteristics of Different Set of Healthcare Data
Lecture 171Reimbursement and Pricing Datasets
Lecture 172RWE Data Sources & Quality Considerations Checklist | Case Based Analysis
Lecture 173Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing
Lecture 174RWD & RWE Case Database
Lecture 175RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness AnalysisÂ
Section 10Biopharma Business Development | Licensing
Lecture 176Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 177Moving Average | Moving Annual Total | YTD | How to calculateÂ
Lecture 178Compound Annual Growth Rate | CAGR Calculation
Lecture 179Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 180Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 181Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 182Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 183Numerical SWOT Practical training
Lecture 184Modelling 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 185Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 186Forecasting : Tools and Techniques
Lecture 187Market Sizing & Forecasting Case Study
Lecture 188Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 189Average Royalty Rate
Lecture 190Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 191Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 192Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 193Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 194SPECIAL PURPOSE VEHICLES (SPV)
Lecture 195Indication Splitting | Concept | Implementation feasibility analysisÂ
Lecture 196Types of Deals from Discovery to Commercialization
Lecture 197What are the fundamental areas of business development
Lecture 198Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 199Licensing Payment Schedule | Case StudyÂ
Lecture 200Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 201Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 202Negotiation 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 203Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 204Types 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 205Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projectsÂ
Lecture 206DCF Calculation : Concept and Calculation - Step by step understanding
Lecture 207Net Present Value (NPV) method : Calculation
Lecture 208Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk PremiumÂ
Lecture 209Valuation Metric - P/E Ratio and EPS : Calculation
Lecture 210Comparable Company Analysis method : Calculation
Lecture 211EBITDA 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 212Pipeline Benchmarking | Significance and Importance in Bio Pharma BD&L | Analyzing sample portfolio | Comparative outcome in business developmentÂ
Lecture 213Comparative pipeline benchmarking analysis | Level of Benchmarking | Primary - Secondary - Tertiary Benchmarking Metrics | Case Based Analysis of three companies comparative pipeline benchmarking
Lecture 214Pipeline Diversity Scores | Significance | How to Calculate | Comparative Study of Pipeline Diversity Scores
Lecture 215Assignment: Prepare real time tracker
Lecture 216Research Productivity Index | Concept | Significance | Calculation Methodology | Comparative RPI benchmarking ExerciseÂ
Lecture 217WACC in Biopharma Valuation | Significance | WACC benchmarkingÂ
Lecture 218WACC Calculation | Step by Step Calculation | Insight on WACC components
Lecture 219rNPV Model | Step by Step Calculation | Insight on Probability and Cumulative Probability | Factoring WACC for DiscountingÂ
Lecture 220Probability and Cumulative Probability | Calculation | Benchmarking | Factoring for WACC and rNPVÂ
Lecture 221Real 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 222ROV Scenario Based Case Study
Lecture 223Biotech Decision Tree Model with Decision Reasoning
Section 11Biopharma Digital Marketing
Lecture 224Introduction to Digital MarketingÂ
Lecture 225Inbound and outbound marketing in pharma | Types of inbound and outbound marketingÂ
Lecture 226Digital Media Marketing Macro-Environment Analysis | Mapping of online market place | Internet marketing conversion process | Conversion Process Digital VS. Traditional | Publisher revenue model | Affiliate revenue model
Lecture 227Digital Media Marketing Micro - Environment Analysis | Web server | Web browser | http vs. https - Significance and hands on understanding | Privacy and ethical issues in internet marketing
Lecture 228Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 229Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 230Campaign planning for digital media | Goal setting | Tracking | Campaign insight | Segmentation and targeting | Message Development | Media Mix Selection | Media scheduling | Practical understanding to campaign performance matrics | CPC | CPA | PPC | ROI | CPS
Lecture 231Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 232Web Host - Check the hosting detailsÂ
Lecture 233Page Speed- importance and practical understanding | Check the web speedÂ
Lecture 234Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 235Mobile Responsive | Tracking the SiteÂ
Lecture 236HCP sites and Patient Site
Lecture 237Google Ad - Practical Training on Campaign Development and Execution
Lecture 238Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 239Brand Portal Development
Lecture 240Relationship Marketing : KOL Management and Patient Advocacy GroupÂ
Lecture 241Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 242Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 243Difference between FMCG and OTC Brand Ad
Lecture 244Digital Marketing Techniques
Lecture 245Video Marketing
Lecture 246Video Marketing Techniques For Small Business Owners
Lecture 247Promoting Brand through Article Advertising and Marketing