Launching New Drugs

PMCQ Training DayLaunching New Drugs

PMCQ Training Day

Launching New Launching New DrugsDrugs

A Stepwise Process to A Stepwise Process to Launch Launch October 19, 2004October 19, 2004

Launching New Drugs

PMCQ Training Day

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

DevelopmentDevelopment

• Can take 12-15 years for the whole process• Can cost $857 million

• Only one in 5-10,000 make it to launch

New Drug Development New Drug Development TimelineTimeline

• Not a lot of room for error

Launching New Drugs

PMCQ Training Day

The Dilemma

Launching New Drugs

PMCQ Training DayLaunching New Drugs

PMCQ Training Day

11.5 months 12 months34 months27 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

• 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

DevelopmentDevelopment

• R&D – Product Development

• Corporate Marketing – Global Marketing Development

• Global Supply Chain – Product Supply

Who has done what?Who has done what?

• Country Marketing

Launching New Drugs

PMCQ Training Day

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 toA. The company cannot afford to make the mistake

B. Your career can depend on it• If you’re on new products, you already have a high profile

2. 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 DayCopyright 2003 – Cutting Edge Information

Launching New Drugs

PMCQ Training Day

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 & pre-launch activities.Phase IIIa: Shift ownership to country units. Phase IIIa: Countries plan IIIb & IV.

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.

Besides clinical milestones: Developmental Strategy Document, Interim Clinical Evaluation, Pricing, Regulatory Documents

What are the key success measurements?

Copyright 2003 – Cutting Edge Information

Launching New Drugs

PMCQ Training Day

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 anyother peoples3-Secure early buy-in from major countries

1-Know your market-understand what customers feel, believe, think & want.2-Know your competition.3-Be focused – choose strategic direction & stick with it.

1-Understand yourmarketplace. 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.

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.

1-Understand market needs & build unified commitment to brand strategy.2-Deliver long-term resource allocation & aggressive timing. Launch in all affiliateswithin the same time-frame.3-Build strong, unified leadership within the brand team & development team.

What makes for successful market penetration?

Copyright 2003 – Cutting Edge Information

Launching New Drugs

PMCQ Training Day

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 DayCopyright 2003 – Cutting Edge Information

Launching New Drugs

PMCQ Training Day

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, sell!!!

Launching New Drugs

PMCQ Training Day

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 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?

Copyright 2003 – Cutting Edge Information

What pharmaceutical companies do you regard as being best in class in managing global marketing launches?Pfizer – its marketing resources turn every drug into a significant revenue stream.

Pfizer, Roche in oncology

Merck, also Pfizer, AstraZeneca.

Merck & Pfizer –Their competitive intelligence capabilities allow them to move earliest.

Pfizer Pfizer

Maybe you could work for them for awhileMaybe you could work for them for awhile

Launching New Drugs

PMCQ Training Day

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