Section 1Pharma R&D Management- Discovery to Development | Strategic Management for US Market
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA)Â
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)Â
Lecture 6Review on Drug Discovery and DevelopmentÂ
Lecture 7Handling of orange book
Lecture 8USFDAÂ expedited programs
Lecture 9Practical Training on INDA, NDA, ANDA filing
Lecture 10505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 11Authorized Generics: Key Understanding
Lecture 12Exploratory IND Vs. Traditional IND
Lecture 13Patents Vs. exclusivityÂ
Lecture 14Orphan Drug DesignationÂ
Lecture 15Advance Learning on 505B2 Pathway
Lecture 16Chemistry, Manufacturing & ControlsÂ
Lecture 17Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 18Clinical Trial : Detailed Understanding
Lecture 19Clinical Trial Protocol Writing
Lecture 20Ethics in Clinical Research
Lecture 21Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 22FDA Forms and How to fill the resources
Lecture 23Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 24Importance and Significance of Phase 2b Clinical TrialÂ
Lecture 25Regulatory Strategies in different phases of Clinical Trial
Lecture 26Para IV Filing - Strategic Insight
Lecture 27Para IV Notices
Lecture 28Evergreening - Patent Life Extension Strategies
Lecture 29Pay for Delay Strategy | Impact Assessment | Case StudiesÂ
Lecture 30REMS Strategic PlanningÂ
Lecture 31Compulsory Licensing
Lecture 32Licensing & Technology Transfer
Lecture 33In-Licensing Vs. Outlicensing
Lecture 34LOE Strategies for Innovator Brands with case study
Lecture 35Pediatric Exclusivity and Pediatric Study Plan Development
Lecture 36Drug Repurposing
Lecture 37Advance understanding of the portfolio ManagementÂ
Lecture 38New Indication Approval Process and PromotionÂ
Lecture 39OTC SwitchÂ
Lecture 40Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 41NCE Vs. 505b2 application - Case Based LearningÂ
Lecture 42FTF - 180 Days Exclusivity - Case Based Learning
Lecture 43Classic case study of the 505b2 filing : Case Based Learning
Lecture 44Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 45What is meaning of 'Pipeline in a Molecule'?
Lecture 46Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | FactsheetsÂ
Lecture 47Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)
Section 2Strategic Business Management - European Market
Lecture 48Introduction to EU RegulationÂ
Lecture 49Orientation to European Countries and National Regulatory Bodies
Lecture 50EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 51Overview of EU RegulationÂ
Lecture 52EMA and EMA Authorisation Process
Lecture 53EU MA Application Types and Strategic Planning
Lecture 54EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National ProcedureÂ
Lecture 55EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 56Validity of the EU MAÂ - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products
Lecture 57Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 58EU Orphan Medicinal Products Regulation
Lecture 59Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 60Summary of Product CharacteristicsÂ
Lecture 61Compassionate Use
Lecture 62MHRA - UK RegulationÂ
Lecture 63The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 64Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP) - EU Requirments
Lecture 65EU Prime Designation
Lecture 66Accelerated assessment by EMEA
Lecture 67EU Adaptive Pathway
Lecture 68European public assessment report (EPAR) - Importance, Component, Management, UpdationÂ
Lecture 69SPOR - Concept of Master Data Management Â
Section 3Pharma International Business - Product Registration, Plant Certification, Dossier Preparation and Export Documentation
Lecture 70Introduction of Export Documentation | Understanding of important terminologies
Lecture 71Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 72Difference between Proforma and Quotation
Lecture 73Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 74Commercial Invoice | Importance | Differences with Proforma InvoiceÂ
Lecture 75Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 76CHA and IFF Requirements - Roles and Conditions
Lecture 77Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 78Bank Guarantee Cycle with Example
Lecture 79LC Discounting | How it works | How to calculate the LC discounting
Lecture 80Packing List | Importance | Things to include in packing list
Lecture 81Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 82Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 83Incoterm Understanding with case study
Lecture 84Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 85Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 86Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Lecture 87Certificate of Origin (COO)
Lecture 88ISO Certification
Lecture 89Common Technical Document (CTD)
Lecture 90Electronic Common Technical Document (ECTD)
Lecture 91Dossier Preparation focusing on drug registration in export countriesÂ
Lecture 92Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 93Importance of effective dossier management
Lecture 94Detailed Understanding on ANDA Submission DossierÂ
Lecture 95Prior Approval SubmissionÂ
Lecture 96Detailed Understanding on ANDA Fees
Lecture 97Discussion on 85 common deficiency in CTD submission dossier
Lecture 98CHA Pricing - Typical CHA Pricing Structure in Pharma Import–Export
Section 4Biopharmaceutical Management and Regulation
Lecture 99Introduction to Biopharmaceuticals | Biopharma Market | OverviewÂ
Lecture 100Classification of BiopharmaceuticalÂ
Lecture 101Chemical Drugs Vs. Biologic Drugs
Lecture 102Principle of Naming of Biologic | Understanding on MAB naming systemÂ
Lecture 103Global Biologics Market
Lecture 104Recombinant protein
Lecture 105Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 106Monoclonal Antibodies
Lecture 107Synthetic Immunomodulators
Lecture 108Production of Monoclonal Antibodies
Lecture 109Cytokines
Lecture 110Interferon
Lecture 111Erythropoiesis-stimulating agent
Lecture 112Biological Licensing Application (BLA)Â
Lecture 113Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 114Purple Book: Significance | Searching | Assignments
Lecture 115Vaccine development and approval Process
Lecture 116Biosimilar Development Process
Lecture 117Strategic Consideration for Biosimilar DevelopmentÂ
Lecture 118Bio-Manufacturing Process Information
Lecture 119Studies required for approval of biosimilar
Lecture 120Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 121Comparability of Biologics | Different Categories of Comparability | General PrinciplesÂ
Lecture 122CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)
Lecture 123ATMPs | Types and Classification | Regulatory MechanismÂ
Lecture 124CAR-T Therapy | Different Types of CAR-T Therapy | Mechanism of action | Challenges | Brainstorming on Concept of Personalized Medicine | Understanding on marketed formulation
Lecture 125Live Biotherapeutic Products | LBPs | Class | Mechanism | Indication Positioning | Regulatory Requirements for LBPsÂ
Lecture 126Biosimilar Approval and Patent Management | Strategic Pathway of Patent Negotiation and Litigation in Biosimilar Approval | Patent Dance | FAQs on Biologic Patent ManagementÂ
Lecture 127Biosimilar launch case study | Patent Dance Framework
Lecture 128Biosimilar Launch FrameworkÂ
Lecture 129Biosimilar 180 Day NoticeÂ
Lecture 1303(A) List | Significance | Importance | How to interpret
Lecture 131Steps to win over innovator patents | Step wise planningÂ
Lecture 132Biosimilar Launch Project Roadmap with defined stages of project
Lecture 133Timing of Biosimilar Submission and Approvals | Two Scenario based timeline assessmentsÂ
Lecture 134Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation Â
Lecture 135How to work on RPS’s Patent | Walkthrough | Case Study
Lecture 136Biosimilar Launch Project With Milestones
Lecture 137Analysis of Biologic Patents | Work Assignments
Lecture 138Biologic Patent Insight Worksheet
Lecture 139Patent Thickets | Concept | Implication | Case Based LearningÂ
Section 5Business Development | Licensing
Lecture 140Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 141Moving Average | Moving Annual Total | YTD | How to calculateÂ
Lecture 142Compound Annual Growth Rate | CAGR Calculation
Lecture 143Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 144Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning DepartmentÂ
Lecture 145Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 146Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 147Numerical SWOT Practical training
Lecture 148Modelling 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 149Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 150Forecasting : Tools and Techniques
Lecture 151Market Sizing & Forecasting Case Study
Lecture 152Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 153Average Royalty Rate
Lecture 154Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 155Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 156Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 157Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 158SPECIAL PURPOSE VEHICLES (SPV)
Lecture 159Indication Splitting | Concept | Implementation feasibility analysisÂ
Lecture 160Types of Deals from Discovery to Commercialization
Lecture 161What are the fundamental areas of business development
Lecture 162Licensing Term Sheet | Importance | Significance | Content of the Term Sheet | Sample Predesigned Term Sheet of Pharma Licensing DealÂ
Lecture 163Licensing Payment Scheduling: Different Types
Lecture 164Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |Â Peak Sales - Max-Min Approach
Lecture 165Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 166Negotiation 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 167Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 168Types 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 169Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projectsÂ
Lecture 170Value Share Principle | Discounting of licensing deal | Discount RateÂ
Lecture 171DCF Calculation : Concept and Calculation - Step by step understanding
Lecture 172Net Present Value (NPV) method : Calculation
Lecture 173Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk PremiumÂ
Lecture 174Valuation Metric - P/E Ratio and EPS : Calculation
Lecture 175Comparable Company Analysis method : Calculation
Lecture 176EBITDA 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 177Pipeline Benchmarking | Significance and Importance in Bio Pharma BD&L | Analyzing sample portfolio | Comparative outcome in business developmentÂ
Lecture 178Comparative pipeline benchmarking analysis | Level of Benchmarking | Primary - Secondary - Tertiary Benchmarking Metrics | Case Based Analysis of three companies comparative pipeline benchmarking
Lecture 179Pipeline Diversity Scores | Significance | How to Calculate | Comparative Study of Pipeline Diversity Scores
Lecture 180Real Time Portfolio and Pipeline Tracker
Lecture 181Research Productivity Index | Concept | Significance | Calculation Methodology | Comparative RPI benchmarking Exercise Â
Lecture 182WACC in Biopharma Valuation | Significance | WACC benchmarkingÂ
Lecture 183WACC Calculation | Step by Step Calculation | Insight on WACC componentsÂ
Lecture 184rNPV Model | Step by Step Calculation | Insight on Probability and Cumulative Probability | Factoring WACC for DiscountingÂ
Lecture 185Probability and Cumulative Probability | Calculation | Benchmarking | Factoring for WACC and rNPVÂ
Lecture 186Real 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 187ROV Scenario Based Case Study
Lecture 188Biotech Decision Tree Model with Decision Reasoning
Section 6Pharma Digital Marketing
Lecture 189Introduction to Digital MarketingÂ
Lecture 190Inbound and outbound marketing in pharma | Types of inbound and outbound marketingÂ
Lecture 191Digital 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 192Digital 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 193Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 194Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 195Campaign 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 196Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 197Web Host - Check the hosting detailsÂ
Lecture 198Page Speed- importance and practical understanding | Check the web speedÂ
Lecture 199Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 200Mobile Responsive | Tracking the SiteÂ
Lecture 201HCP sites and Patient Site
Lecture 202Google Ad - Practical Training on Campaign Development and Execution
Lecture 203Digital Marketing Strategies for innovator brand | Pre launch - comuing soon, DSE Marketing | Launch activities - Day of approval (DOA) site | FDA Compliance | FDA 2253 Filing
Lecture 204Brand Portal Development
Lecture 205Relationship Marketing : KOL Management and Patient Advocacy GroupÂ
Lecture 206Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 207Developing Ad - Pharmaceutical Prescription, OTC Vs FMCG Brands
Lecture 208Difference between FMCG and OTC Brand Ad
Lecture 209Digital Marketing Techniques
Lecture 210Video Marketing
Lecture 211Video Marketing Techniques For Small Business Owners
Lecture 212Promoting Brand through Article Advertising and Marketing
Section 7Omnichannel Integrated Business Development Marketing
Lecture 213Introduction to Omnichannel Marketing | Importance | Significance | Implementation outcome of Omnichannel Marketing
Lecture 214OMM Implementation Framework | Step By Step | Key Activities in each step | 3 Case Study on OMM
Lecture 215Download OMM Implementation Framework ChecklistÂ
Lecture 216OMM terminologies | Explanation of important digital marketing termsÂ
Lecture 217OM Brand Plan Development | Practical Brand Plan with different sections with touchpoints
Section 8Pharma and Biopharma API Business Development
Lecture 218API Market Insight | Global API Market | Key Drivers and ChallengesÂ
Lecture 219Case Insight: Evolution of China and India as dominant API PlayerÂ
Lecture 220Post Covid-19 API Era: How API industry impacted | Changes observed in post covid-19 era
Lecture 221API Production Trends | API Outsourcing Strategic Planning | Key Strategies and Trends in API Outsourcing
Lecture 222API Industry Key Trend Metrics | Case Based Assessment on Dual SourcingÂ
Lecture 223API Manufacturing and Development | Understanding critical steps in manufacturing and development of APIÂ
Lecture 224Key Milestones and Stages of API Development | API Process Research | API Scale Up | Risk Management | QbDÂ
Lecture 225API Registration Pathways | Requirements from Different regions | Focus on API Regulatory Framework | API pathways for US EU Japan and China
Lecture 226General Framework for API Registration | Two case study on API registration and framework
Lecture 227CAS Number | Importance of API Sourcing | Case study
Lecture 228API Sourcing | Checklist Development | How to work step by step in API sourcing?
Lecture 229API BD Tool Training 1 | Case Based Analysis | How to work on the toolÂ
Lecture 230Leading API Sourcing Platforms / Tools
Lecture 231Strategic Alliances in API Business | Types of Alliances | Case studiesÂ
Lecture 232Licensing Models in the API IndustryÂ
Lecture 233Co-Development and Co-Marketing Agreements | Scenario Analysis
Lecture 234API Supply Agreements and Distribution Strategies | API Distribution Models | SimulationsÂ
Lecture 235API Classification | Commodity API | Speciality API | Strategic Insight on Specialty API | Case Based AnalysisÂ
Lecture 236API Pricing Model | Strategic Insight on each model | 3 Case Study Â
Lecture 237API Market Entry Strategic Planning for EU Market | Strategic FrameworkÂ
Lecture 238API Monograph | Importance | Regulatory Requirements for API registration | Vendor Management
Lecture 239Monographs | Characteristics and Usage
Lecture 240Certificate of Suitability (CEP) | Significance | Importance | Understanding Regulatory Compliance and Submission Process | Walkthrough
Lecture 241ASMF Filing - Preparation | Documentation and Management | Key ComponentsÂ
Lecture 242API Global Trade-off SimulationÂ
Lecture 243API Review Test | Check your API Business Competency | Difficulty Level - EasyÂ
Lecture 244CEP Dossier DMF - Differences
Lecture 245Key differences in API regulatory approval pathways for APIs (Active Pharmaceutical Ingredients) across the US, EU, and emerging markets
Lecture 246Precision in API Weighting | Importance | How effectively Plan and Monitor API weight | API Weight Calculation Methods | Vendor Management