Pharma Strategic Management

Introduction

Duration

Core Learning Area

Features

Eligibility

Pharma Strategic Management course provides training in drug discovery-to-commercialization, business development, brand management. The objective of the course is to provide extensive advanced training to middle-top management professionals in pharmaceutical and biopharmaceutical industry.

Course Code: KPE-C-008

ProgramTitle: KPE’s Advanced Diploma in Pharma Strategic Management [ADPSM]

1 Year.

Key Learning Area for the course

Drug Development to Commercialization – R&D management and related strategic planning.
Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio
Objective – Strategy – Tactics | Portfolio constraints | SWOT | Numerical SWOT Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques – Web Search | Conference | Confidentiality – CDA | MTA
Life cycle extension / Loss of Exclusivity – LOE strategies.
Pharma Marketing and branding Strategic Planning.
Generic Drug Strategic Planning
Strategic Pathways for marketing authorization of the pharmaceutical and – biopharmaceutical products in various business regions – US, EU, LATAM, Middle East, GCC, rest of the world.
Exclusive training on Biopharmaceutical and biosimilar management.
In depth training on Licensing in pharmaceutical industry – In Licensing Vs. Out licensing, Co-development, co-marketing, Co-promotion, Reverse Copromotion,
Financial Planning and Management for pharma strategic management professionals
Modelling and Deal Valuation – Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Bechmarking | Benchmarking through consortim
Royalty Management – Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking – Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses.
Acquisition in Pharma | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process.
Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV | Peak Sales – Max-Min Approach.
EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation

1. Orientation to job related practical strategic business management related activities from different discipline of Pharmaceuticals.

2. Simulation to real life Strategic Management.

3. Access to Industry Databank of case studies. Hence, this coursehelps the professionals to get the real life job simulation.

4. Access to Pharmaceutical Case Studies

5. Attend Live Lectures of all different chapters / study content.

Graduation in any discipline. Work experience in pharmaceutical sector will be preferred.

Course Flow

Section 1R&D to commercialization Strategic Management discovery [US]

Lecture 1Drug Discovery, Development Process

Lecture 2Investigational New Drug Application

Lecture 3New Drug Application (NDA)

Lecture 4Basic concept and understanding of the Generic Drug

Lecture 5Abbreviated New Drug Application (ANDA)

Lecture 6Review on Drug Discovery and Development

Lecture 7Orange Book

Lecture 8Expedited Drug Development Program

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. exclusivity

Lecture 14Strategic Learning from New Drug Development

Lecture 15Orphan Drug Designation

Lecture 16Advance Strategic Learning on 505B2 Pathway

Lecture 17Chemistry, Manufacturing & Controls

Lecture 19Clinical Trials fundamental and Terminologies

Lecture 20Clinical Trial Protocol Writing

Lecture 21Ethics in Clinical Research

Lecture 22Informed Consent

Lecture 23Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !

Lecture 24FDA Forms and How to fill the resources

Lecture 25Importance and Significance of Phase 2b Clinical Trial

Lecture 26Regulatory Strategies in different phases of Clinical Trial

Lecture 27Advance study on Para IV Filing

Lecture 28Para IV Notices

Lecture 29Evergreening - Patent Life Extension Strategies

Lecture 30Pay For Delay Strategy

Lecture 31REMS Strategic Planning

Lecture 32Compulsory Licensing

Lecture 33Licensing & Technology Transfer

Lecture 34In-Licensing Vs. Outlicensing

Lecture 35LOE Strategies for Innovator Brands with case study

Lecture 36Paediatric Exclusivity and Paediatric Study Plan Development

Lecture 37Drug Repurposing

Lecture 38Licensing - Advance Learning

Lecture 39Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning

Lecture 40NCE Vs. 505b2 application - Case Based Learning

Lecture 41FTF - 180 Days Exclusivity - Case Based Learning

Lecture 42Classic case study of the 505b2 filing : Case Based Learning

Lecture 43Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning

Lecture 44Advance Training on effective management of Establishment Inspection Report | 483 Observations | USFDA Warning Letter | FDA inspection | Closing of Warning Letter

Lecture 45Data Integrity issues in Pharmaceutical Industry

Lecture 46What is meaning of 'Pipeline in a Molecule'?

Lecture 47Emergency Use Authorization : Case Based Learning

Lecture 48Patent Cliff | Sales Forecast Formulae after patent expiry

Section 2R&D to commercialization Strategic Management discovery [EU]

Lecture 49Introduction to EU Regulation

Lecture 50Orientation to European Countries and National Regulatory Bodies

Lecture 51EU Drug Discovery Development to Commercialization (Step By Step)

Lecture 52EMA and EMA Authorisation Process

Lecture 53EMA and EMA Authorisation Process

Lecture 54EU MA Application Types and Strategic Planning

Lecture 55EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure

Lecture 56EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application

Lecture 57Validity of the EU MA - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products

Lecture 58Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae

Lecture 59EU Orphan Medicinal Products Regulation

Lecture 60Conditional marketing authorisation | Marketing authorisation under exceptional circumstances

Lecture 61Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)

Lecture 62Summary of Product Characteristics

Lecture 63Compassionate Use

Lecture 64MHRA - UK Regulation

Lecture 65The 'sunset clause' for marketing authorisation of pharmaceuticals

Lecture 66EU variation - Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation

Lecture 67EU Prime Designation

Lecture 68Accelerated assessment by EMEA

Lecture 69EU Adaptive Pathway

Lecture 70European public assessment report (EPAR) - Importance, Component, Management, Updation

Lecture 71SPOR - Concept of Master Data Management

Section 3Intellectual Property Management

Lecture 72Patent and Trademark Office - How they work?

Lecture 73Patent

Lecture 74Application For Patent

Lecture 75Trademark

Lecture 76Steps Know How & Key Points - Patent Application

Lecture 77Fundamental Understanding of Patent, Trademark Licensing and related terminology

Section 4Pharma Marketing - Brand Management

Lecture 78Introduction to Pharma Marketing

Lecture 79Market Research in Pharma Business

Lecture 80Product Life cycle

Lecture 81Advance - Strategic Planning in Product Life cycle Management

Lecture 82Segmentation, Targeting and Positioning

Lecture 83Pricing Strategies

Lecture 84A Pharmaceutical Segmentation outlook

Lecture 85Distribution Channel in Pharmaceutical Industry

Lecture 86Promotion in Pharmaceutical Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process

Lecture 87Setting and Quantifying Promotional Objectives

Lecture 88Promotional Budget Setting : Tools and Techniques

Lecture 89Practical understanding on Prescription Accelerating Materials used in pharmaceutical promotion

Lecture 90Method of Promotional Budgeting

Lecture 91Basics of Advertising : Introduction

Lecture 92The Advertising agency Selection Process with Case Based Learning on Creative Brief Preparation

Lecture 93Moving Annual Total (MAT)

Lecture 94CAGR

Lecture 95Brand Potential

Lecture 96Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?

Lecture 97Advertising Planning - ATL, BTL, TTL activities

Lecture 98Target Audiences for Pharma Promotion : Types and Specialization

Lecture 99Business segments of Pharmaceutical Companies

Lecture 100Target Audience Selection Based on Products

Section 5Pharma Brand Strategy Management

Lecture 101PRATICAL TRAINING SESSION : BRAND NAME, BRAND LOGO, TRADEMARKING

Lecture 102Purpose of Pharma Brand Logo

Lecture 103Component of brand logo

Lecture 104Brand Name and TM Registration Process

Lecture 105How to design excellent brand logo?

Lecture 106Case study in brand name finalization

Lecture 107Brand Name Simulation

Lecture 108Traditional Vs. Non-Traditional trademark

Lecture 109Global Protection of the Pharma Brand

Lecture 110Rebranding in Pharmaceuticals

Lecture 111Brand Logo Development: Real Life Simulation

Lecture 112Fundamental of Pharma Marketing Plan

Lecture 113Basic Know-How: Marketing Campaign Development

Lecture 114How to prepare a Pharma Brand Plan

Lecture 115Decide about brand USP -What to promote

Lecture 116How to prepare promotogram. Download sample Promotogram

Lecture 117Indications for Drugs: Approved vs. Non-approved

Lecture 118Guideline of Visual Aid Designin

Lecture 119Practical Sample to understand visual aid contents and effective placement of the texts

Lecture 120VISUAL AID PRINTING

Lecture 121Detailing and e-detailing

Lecture 122Marketing Plan followed by Visual Aid Development

Lecture 123Creativity to develop brand essence

Lecture 124Increase the brand reach with advance segmentation

Lecture 125Concept of uniform branding for better brand acceptability

Lecture 126Concept of Brand Differentiation

Section 6Biopharmaceuticals and Biosimilar Development Process

Lecture 127Introduction : Biopharmaceuticals

Lecture 128Classification of Biopharmaceutical

Lecture 129Introduction to Biosimilar

Lecture 130Chemical Drugs Vs. Biologic Drugs

Lecture 131Current Trends in Biopharmaceutical Market

Lecture 132Dynamics of Biopharmaceutical Market

Lecture 133Complexity of biopharma supply chain and operations

Lecture 134Biopharma - Market Segmentation

Lecture 135Blockbuster Biologic - Classifications, Indications, Global Sales

Lecture 136Recombinant protein

Lecture 137Monoclonal Antibodies Vs. Polyclonal Antibodies

Lecture 138Monoclonal Antibodies

Lecture 139Synthetic Immunomodulators

Lecture 140Production of Monoclonal Antibodies

Lecture 141Cytokines

Lecture 142Interferon

Lecture 143Erythropoiesis-stimulating agent

Lecture 144Biological Licensing Application (BLA)

Lecture 145Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements

Lecture 146Exclusivity Protections for Biopharmaceuticals

Lecture 147REMS Strategic Planning

Lecture 148Biosimilar Development Process

Lecture 149Strategic Consideration for Biosimilar Development

Lecture 150Bio-Manufacturing Process Information

Lecture 151Studies required for approval of biosimilar

Section 7Advance Portfolio Management

Lecture 152Co-promotion & Co-marketing strategy

Lecture 153Reverse co-promotion

Lecture 154New Indication Approval Process and Promotion

Lecture 155Publication Management for strategic positioning of the brands

Lecture 156Juxtapid Case Study

Lecture 157OTC Switch

Section 8Advance Strategic Portfolio Management Skill Training

Lecture 158Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets

Lecture 159Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department

Lecture 160Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT

Lecture 162Numerical SWOT Practical training

Lecture 164Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market

Lecture 165Forecasting : Tools and Techniques

Lecture 166Market Sizing & Forecasting Case Study

Lecture 168Average Royalty Rates

Lecture 169Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal

Lecture 170Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses

Lecture 172Join Ventures in Pharmaceutical and Biopharmaceutical Industry

Lecture 173SPECIAL PURPOSE VEHICLES (SPV)

Lecture 174Indication Splitting | Concept | Implementation feasibility analysis

Lecture 175Types of Deals from Discovery to Commercialization

Lecture 176Licensing Term Sheet | Content Structuring | Sample Term Sheet

Lecture 177Licensing Payment Scheduling: Different Types

Lecture 178Training on Basic Finance | Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement

Lecture 180Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation

Lecture 181Negotiation Skill Training for BD / Project / Strategic Management Professionals

Lecture 182Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model

Lecture 184Step By Step Implementation of Licensing Deal by Business Development Team

Lecture 185Due Diligence Activities in Pharmaceutical Licensing

Section 9Final Certification Examination

Accreditation Management and PR strategies for pharmaceutical firms, Drug Development to Commercialization, Drug Registration overseas, Financial Planning and Management for pharma strategic management professionals, Generic Drug Strategic Planning, Human Resource strategic planning for pharmaceutical company, Innovation Management in pharmaceutical industry, International Marketing strategic planning in pharmaceutical, Licensing in pharmaceutical industry – In Licensing Vs. Out licensing, Managing pharmaceutical SBU revenue model, marketing strategy for pharmaceutical products, marketing strategy in pharmaceutical industry, New Opportunities & Strategies in the Pharmaceutical Industry, opportunities in pharmaceutical industry, pharma business opportunities, Pharma Management Courses‎, Pharma Marketing Strategic Planning, pharma strategy course, Pharmaceutical Business Audit, pharmaceutical company strategy, Pharmaceutical Lifecycle Management Strategy, pharmaceutical merger acquisition, pharmaceutical strategic management course, Product Lifecycle Management for the Pharmaceutical Industry, Production Planning and Strategic Management in pharmaceutical industry, QA/QC Team – Differentiator of Today’s pharmaceutical manufacturing organization, role of ict in pharmaceutical industry, Strategic management aspects of the world pharmaceutical industry, strategic management in pharma, Strategic management of Pharmaceutical Company, strategic planning pharmaceutical industry, strategies used by pharmaceutical companies, Web strategies for Pharmaceutical companies

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Introduction

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Core Learning Area

Features

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Course Flow

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Download Course Catalogue and Request for Demo Access

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Introduction

Duration

Core Learning Area

Features

Eligibility

Course Flow