1. An introduction to Medical Communications
Andy Shepherd
Senior Medical Writer

2. Who We Are
New York Oxford Sydney
Global, European, and US full-service medical communications agency
Offices in Oxford, Macclesfield New York, and Sydney
~60 staff of writers, editors, account managers, account directors, graphic designers, conference specialists, and support staff
Established for over 20 years
Enduring client partnerships from early clinical development to lifecycle management including other client partners
Part of the Complete Medical Group Worldwide Network

3. Caudex Medical – Part of the Complete Medical Group Worldwide Network
Approx 70% of our current business is with Global/HQ clients, 30% with domestic clients
Currently: people in North America in Europe in Asia Pac
We are in the process of establishing capabilities in France and Latin America 3

4. Some of our clients…

5. EMA/FDA review process
Drug development
EMA/FDA review process
Post marketing
Phase III patients
Phase II patients
Phase I healthy volunteers
SALES
Preclinical laboratory and animal testing
Discovery 2 4 6 8 10 12 14 16 18
20 years
Patent
Patent expires
EMA = European Medicines Agency FDA = (US) Food and Drug Administration

6. What is medical communications?
Market
and KOL
development
Medical
writing
expertise
Strategic publication planning
International meetings management
Creative design
Multimedia

7. What is it really?
Getting information about new or existing drugs to the people that use or prescribe them, from the people that make them
Pharmaceutical companies
Doctors, nurses, pharmacists, payers, patients

8. What do doctors need to know about the new drug?
What is the condition the drug treats?
Why should I treat this condition?
How does the drug work?
Is the drug effective and safe?
How is this drug different from the others?
Are there any health economic implications?

9. Communicating a major trial
Congress abstract, e.g. safety
Congress abstract, e.g. sub-analyses
Congress abstract on other analyses
Congress abstract, e.g. efficacy
Primary publication (efficacy and safety)
Primary publication on other analyses
Congress abstract, e.g. protocol
Series of satellite symposia
Time
Results available
Scene-setting reviews
Editorial
Review articles in peer-reviewed journals
Letters to the Editor

10. Highly experienced in publication planning and meetings
Projects delivered in 2010
Communications plans 10
Publication plans 11
Papers 88
Abstracts 170
Posters/presentations 167
Satellite symposia 7
Advisory boards 5
Stand-alone meetings 6
Steering committees 13
Acceptance rates:
Abstracts 92%
Manuscripts 98%
Reviews 100%

11. Ghost-writing: Caudex position statement
Caudex is committed to working in accordance with the principles of Good Publication Practice and does not engage in ghost-writing

12. What are we looking for? Education Writing skills
Minimum first degree in medicine, pharmacy or life sciences
A higher degree and/or research experience is advantageous
Writing skills
Demonstrated ability to produce high quality, scientifically accurate, copy
A positive, can-do attitude
Ability to work independently and as part of a team
Well organised and able to plan work effectively
Proficient in standard software packages (Word, Excel, PowerPoint, Outlook)

13. Caudex trainee programme
Trainees are usually recruited in pairs
Training syllabus, delivered through:
Formal training sessions (internal/external)
One to one mentoring and feedback
On site experience
Clear objectives for promotion

14. Ongoing training Ongoing company and department training for all staff
Recent examples:
Medical writing skills
CMPP programme
Values workshops
Drug development process
Copyright law
Software training
Social media

15. Compared to working in a lab
Pros... Cons...

16. Medical Writer career structure
Medical Director
Scientific Director
Scientific Advisor
Principal Medical Writer
Senior Medical Writer
Medical Writer
Trainee Medical Writer
4 years
2 years
2 years
2 years
1 year

17. For more detailed information about starting salary and salary scale, please speak to me afterwards

18. Any further questions about Caudex or MedComms in general, please feel free to contact me: