Welcome to the 6 th Annual Meeting of ISMPP

Transcription

1 Welcome to the 6 th Annual Meeting of ISMPP Delivering Value and Driving Advocacy in Medical Publications April 19-21, 2010

2 The Global Outsourcing of Medical Writing Visions of What Value Means in a Flat World The 6 th Annual Meeting of ISMPP: Delivering Value and Driving Advocacy in Medical Publications April 19 21, 2010

3 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.

4 The Global Outsourcing of Medical Writing Visions of What Value Means in a Flat World An Overview of the Outsourcing Landscape Donald Samulack, PhD VP, Medical Affairs and Strategic Partnerships Cactus Communications, Inc. The 6 th Annual Meeting of ISMPP: Delivering Value and Driving Advocacy in Medical Publications April 19 21, 2010

5 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.

6 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

7 The Flat World

8 The General Landscape

9 Technological Facilitation , 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.

10 Breaking the Iron Triangle Cost

11 Pros and Cons Pros Cost (short term) Cost (long term) Low facility overhead Scope flexibility Parallel teams Tandem teams Distribution of work Tiered work Cons Time zone differences Geographic distance Language barriers Communication Experience Pharma exposure Inefficient workflow Re-work documents Quality?

12 The Traditional Model Pharma Medcom Freelance

13 A Viewpoint of a New Model Pharma Authors Medcom Freelance Global Outsource Smartsourcing

14 The Global Outsourcing of Medical Writing Visions of What Value Means in a Flat World 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 6 th Annual Meeting of ISMPP: Delivering Value and Driving Advocacy in Medical Publications April 19 21, 2010

15 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.

16 SSC in the CMR Department Clinical Dev. Medical & Reg Affairs (CMR) Clinical Res Diabetes Clin Res/ Medical Affairs BioPharm Medical Affairs Diabetes Medical Operations Clinical Trial Operations CTO Regulatory Affairs Library Professional Education SSC Medical Information Biostatistics

17 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

18 Project-Based Structure for SSC Renu Juneja Director Manager Obesity and Diabetes publications Manager Biopharm Manager Insulins Manager GLP-1 Manager Training, Quality, Outsourcing Pool of 11 writers

19 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

20 Expanded Role of the SSC Group Advisory Board Meetings IND, IB, End-of- Phase 2 Protocol Investigator Meeting Results Meeting CTR Study Slides Author s / Advisory Board Meeting FDA Submission Documents Assisting Assisting Data Analysis Stats CTR Writing Prepare Slides Prepare slides Writing Prepare slides FPFV LPLV DBR RRC Abstracts Posters Primary Manuscripts PACT Secondary & Meta- Analysis Review Articles Secondary Abstracts Posters Secondary Manuscripts Local/other Investigator -Initiated Studies Writing Assisting Writing Writing Assisting Reviewing Assisting clinicaltrials.gov Writing to get data into the public domain

21 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

22 Welcome to the 6 th Annual Meeting of ISMPP Delivering Value and Driving Advocacy in Medical Publications April 19-21, 2010