Welcome to the 6th Annual Meeting of ISMPP

Delivering Value and Driving Advocacy in Medical Publications

April 19-21, 2010

The Global Outsourcing of Medical Writing

Visions of What “Value” Means in a Flat World

The 6th Annual Meeting of ISMPP:

Delivering Value and Driving Advocacy

in Medical Publications

April 19–21, 2010

• Moderator

Mark J. Fedele, PhD, MBA

Clinical Communication Leader

Novartis Pharmaceuticals Corp.

• An Overview of the Outsourcing Landscape

Donald Samulack, PhD

VP, Medical Affairs and Strategic Partnerships

Cactus Communications, Inc.

• Global Outsourcing in the Real World

Keith Veitch, PhD

Head of Global Publications

Novartis Vaccines

• Writing Teams – New Models of Professional

Adjustment/Development: Evolution of Personal Value

Renu Juneja, PhD

Senior Director, Strategic Scientific Communications (SSC)

Novo Nordisk Inc.

An Overview of the Outsourcing Landscape

Donald Samulack, PhD

VP, Medical Affairs and Strategic Partnerships

Cactus Communications, Inc.

The 6th Annual Meeting of ISMPP:

Delivering Value and Driving Advocacy

in Medical Publications

April 19–21, 2010

The Global Outsourcing of Medical Writing

Visions of What “Value” Means in a Flat World

Disclosure

• Potential for bias

• The presenter heads the North American

operations and is an employee of Cactus

Communications, a global medical

communications company whose business

model involves the outsourcing of medical

writing, scientific editing, transcription, and

English-language training services, with

offices in the US, India, and Japan.

Summary of Talk on the Street

• What the…

• Who moved the cheese?

• The train has left the station.

• Hold on to your hat!

• Don’t look now, but…

Change Happens

The Flat World

The General Landscape

Technological Facilitation

• E-mail, FTP, secure data transfer

• WebEx, GoToMeeting, etc.

• Skype, ooVoo, etc.

• VoIP telephone

The technological facilitation of communication and data transfer has

opened the door for outsourcing models, worldwide.

Breaking the Iron Triangle

Cost

Pros

• Cost (short term)

• Cost (long term)

• Low facility overhead

• Scope flexibility

• Parallel teams

• Tandem teams

• Distribution of work

• Tiered work

Pros and Cons

Cons

• Time zone differences

• Geographic distance

• Language barriers

• Communication

• Experience

• Pharma exposure

• Inefficient workflow

• Re-work documents

• Quality?

The Traditional Model

Pharma

Freelance

Medcom

A Viewpoint of a New Model

Pharma

Freelance

Global Outsource

MedcomAuthors

“Smartsourcing”

Writing Teams

New Models of Professional Adjustment/Development: Evolution of Personal Value

Renu Juneja, PhD

Senior Director, Strategic Scientific Communications (SSC)

Novo Nordisk Inc.The 6th Annual Meeting of ISMPP:

Delivering Value and Driving Advocacy

in Medical Publications

April 19–21, 2010

The Global Outsourcing of Medical Writing

Visions of What “Value” Means in a Flat World

Disclaimer

• This presentation is made at the request of

International Society for the Medical

Publication Professionals (“ISMPP”). The

presenter, although an employee of Novo

Nordisk Inc., is presenting on her own

behalf. The information provided and any

views expressed during this presentation are

those of the author and may not be

attributed to Novo Nordisk Inc.

SSC in the CMR Department

Clinical Dev.Medical &

Reg Affairs(CMR)

Medical AffairsDiabetes

MedicalOperations

Clinical Trial Operations

CTO

RegulatoryAffairs

LibraryProfessional

EducationSSC

MedicalInformation

Biostatistics

Clin Res/Medical Affairs

BioPharm

Clinical ResDiabetes

Hiring Strategy since 1998

• PhDs in life sciences

• 2-3 years of postdoctoral experience preferred

• Previous medical writing experience not required

• Good personality match

• People with diverse backgrounds

• Excellent presentation and writing skills

• Able to think on their feet

Pool of 11 writers

Project-Based Structure for SSC

RenuJuneja

Director

ManagerObesity and

Diabetes publications

ManagerBiopharm

ManagerInsulins

ManagerGLP-1

ManagerTraining,Quality,

Outsourcing

Sharing of Workload amongst Various Affiliates

• Global Medical Writing Board (GMWB)– Consists of managers of the medical writing groups from

Denmark, USA, Japan, China, and International Operations

– Meets face-to-face once-a-year

– Teleconference every quarter

• Global Medical Writers meeting every two years– Workshops to align processes and share best practices

– Ideas to share information and workload

• Outsourcing of projects– Increase in headcount not proportional to increase in

workload

– Evaluated and selected vendors in India

Data Analysis –Stats

Assisting

Assisting Reviewing Assisting

Prepare slides

Writing

Writing WritingAssisting Writing

CTR Writing Prepare slidesPrepare SlidesAssisting

Expanded Role of the SSC Group

Advisory Board

MeetingsProtocol

LPLV DBR RRC

Study SlidesInvestigator

MeetingCTR

FPFV

Results Meeting

PACT

clinicaltrials.gov

Author’s / Advisory

Board Meeting

PrimaryManuscripts

Investigator-Initiated Studies

Abstracts Posters

Secondary & Meta-

Analysis

Review Articles

Secondary Abstracts Posters

Secondary Manuscripts

Abstracts @ Local/other

Writing to get data into the public domain

IND, IB,End-of-Phase 2

FDA Submission Documents

Medical Writing Prepares You Well

• Strategic thinking, and execution

• Project management, vendor management, budget management

• Working in multi-functional teams

• Knowledge of various therapeutic areas

• Interpersonal skills

• Good knowledge of other functional areas: regulatory, marketing, clinical research

Welcome to the 6th Annual Meeting of ISMPP

Delivering Value and Driving Advocacy in Medical Publications

April 19-21, 2010