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Launching New Drugs A Stepwise Process to Launch October 19, 2004 Launching New Drugs Launching New Drugs A Stepwise Process to Launch October 19, 2004 Launching New Drugs PMCQ Training Day

Learning Goals • “Not gonna train you in 30 minutes” • Provide a corporate Learning Goals • “Not gonna train you in 30 minutes” • Provide a corporate perspective – Differs from one company to another • Help you find your role • Give some useful tips and information Launching New Drugs PMCQ Training Day

New Drug Development Timeline Development • Can take 12 -15 years for the whole New Drug Development Timeline Development • Can take 12 -15 years for the whole process • Can cost $857 million • Only one in 5 -10, 000 make it to launch • Not a lot of room for error Launching New Drugs PMCQ Training Day

The Dilemma Launching New Drugs PMCQ Training Day The Dilemma Launching New Drugs PMCQ Training Day

11. 5 months 27 months 34 months 12 months • You usually come in 11. 5 months 27 months 34 months 12 months • You usually come in here • 4 -5 years after the process has started • How do you fix the errors? Launching New Drugs PMCQ Training Day

What do you do? • Phase IIb – give input on product profile • What do you do? • Phase IIb – give input on product profile • Phase IIIa – give input on global marketing strategy – develop 3 year forecast • Registration – local marketing strategy (based upon global plan) – Negotiate pricing & reimbursment Launching New Drugs PMCQ Training Day

Who has done what? Development • R&D – Product Development • Corporate Marketing – Who has done what? Development • R&D – Product Development • Corporate Marketing – Global Marketing Development • Global Supply Chain – Product Supply • Country Marketing Launching New Drugs PMCQ Training Day

The Errors • The wrong indication – Viagra was originally a CNS project • The Errors • The wrong indication – Viagra was originally a CNS project • Worked on the wrong ‘brain’ • Caught in time to avoid missing a major opportunity • Incomplete A/E profiles – Prepulsid didn’t see the cardio effects coming – Felbamate didn’t look closely enough at aplastic anemia • Carter lost half of their market cap, got out of Rx and eventually sold the company – Etc. • The wrong galenic form – The French love their suppositories – They won’t accept conventional packaging Launching New Drugs PMCQ Training Day

Why can you fix the errors 1. Because you have to A. The company Why can you fix the errors 1. Because you have to A. The company cannot afford to make the mistake B. Your career can depend on it • 2. If you’re on new products, you already have a high profile Because you control the ‘budget hammer’ 2003 CEI Research from 22 major pharma companies; Small / Specialty through blockbusters • 61% of the marketing budget is spent at Phase IIIa and launch Launching New Drugs PMCQ Training Day

Copyright 2003 – Cutting Edge Information Launching New Drugs PMCQ Training Day Copyright 2003 – Cutting Edge Information Launching New Drugs PMCQ Training Day

What are the key success measurements? What are the key steps & milestones in What are the key success measurements? What are the key steps & milestones in your pre-launch marketing process? What are the key success measurements for pre-launch marketing? Phase IIa: Understand market & players. Phase IIb: Communication strategy & prelaunch activities. Phase IIIa: Shift ownership to country units. Pricing strategy & health economics are key – they give early direction – global brand positioning & product plan, message, & trademark. Uses four stage gates through the clinical process; marketing gets involved at stage 3, the Phase II/Phase III transition. Traditional clinical & regulatory milestones. List of steps changes with every product. Try to stick with big development, clinical & regulatory milestones. Phase IIIa: Countries plan IIIb & IV. Copyright 2003 – Cutting Edge Information Launching New Drugs PMCQ Training Day Besides clinical milestones: Developmental Strategy Document, Interim Clinical Evaluation, Pricing, Regulatory Documents

What makes for successful market penetration? What are three overarching principles for successful market What makes for successful market penetration? What are three overarching principles for successful market preparation? 1 -Secure early alignment between marketing & development strategy -stick with strategies & avoid changes. 2 -Maintain active communication with experts, KOLs or any other peoples 3 -Secure early buy -in from major countries 1 -Know your marketunderstand what customers feel, believe, think & want. 2 -Know your competition. 3 -Be focused – choose strategic direction & stick with it. 1 -Understand your marketplace. Approaches vary by therapeutic area, newness & competitive landscape. 2 -Have a commercially focused clinical development program. 3 -Be a ruthless organization looking for places to invest – figure out what you want to optimize (contribution, earnings per share) then go after it. Copyright 2003 – Cutting Edge Information 1 -Understand the market. 2 -Resource early & accurately. 3 -Take calculated risks. 1 -Get senior management’s total commitment on projects to gain resources. 2 -Understand resource needs throughout therapeutic area & organization as a whole. 3 -Understand what competitors are doing to ensure that your efforts are on par or better than theirs. Launching New Drugs PMCQ Training Day 1 -Understand market needs & build unified commitment to brand strategy. 2 -Deliver longterm resource allocation & aggressive timing. Launch in all affiliates within the same time-frame. 3 -Build strong, unified leadership within the brand team & development team.

Market Research is KEY • Can help you fix some of the errors before Market Research is KEY • Can help you fix some of the errors before you get to market • Can help ensure success • Again, you have the tools… Launching New Drugs PMCQ Training Day

Copyright 2003 – Cutting Edge Information Launching New Drugs PMCQ Training Day Copyright 2003 – Cutting Edge Information Launching New Drugs PMCQ Training Day

Use Market Research Effectively • Need creativity – stay away from the ‘tried and Use Market Research Effectively • Need creativity – stay away from the ‘tried and true’ with part of the budget – find a creative MR partner – Look at new tools • When you find something interesting… …sell, sell!!! Launching New Drugs PMCQ Training Day

Build an informal network • Clinical – Your team knows both the skeletons and Build an informal network • Clinical – Your team knows both the skeletons and the goodies – If you can influence one endpoint… • Regulatory – How valuable is this team? • Manufacturing – Another path to the light • Sales … Launching New Drugs PMCQ Training Day

Get Sales on-side ASAP • Remember when you thought marketing was stupid? • We Get Sales on-side ASAP • Remember when you thought marketing was stupid? • We are still a ‘push’ industry • Go beyond the National Sales Director – S/he normally comes on board 1 year ahead of time – Be careful not to go too far • Waiting too long will put you in ‘launch chaos’ Launching New Drugs PMCQ Training Day

Who does it best? What pharmaceutical companies do you regard as being best in Who does it best? What pharmaceutical companies do you regard as being best in class in managing global marketing launches? Pfizer – its Pfizer, marketing Roche in resources oncology turn every drug into a significant revenue stream. Merck, also Pfizer, Astra. Zeneca. Merck & Pfizer – Their competitive intelligence capabilities allow them to move earliest. Pfizer Maybe you could work for them for awhile Copyright 2003 – Cutting Edge Information Launching New Drugs PMCQ Training Day

What’s your take-away? • • • Find the ‘potholes’ Be creative with your market What’s your take-away? • • • Find the ‘potholes’ Be creative with your market research Build the informal network Get sales on-side Remember that you won’t be thanked for saving money… … but you will be judged if you fail. Launching New Drugs PMCQ Training Day

Thank you for your time Launching New Drugs PMCQ Training Day Thank you for your time Launching New Drugs PMCQ Training Day