An introduction to Medical Communications

Andy Shepherd

Senior Medical Writer

• 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

Who We Are

New York Oxford Sydney

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: 60 people in North America 290 in Europe 60 in Asia Pac

3We are in the process of establishing capabilities in France and Latin America

Some of our clients…

Phase I 20-80 healthy volunteers

Drug development

0 2 4 86 1210 14 16 18 20 years

Discovery

Preclinical laboratory and animal testing

EMA/FDA review process

Post marketing

Phase II 100-300 patients

Phase III 1000-5000 patients

EMA = European Medicines Agency FDA = (US) Food and Drug Administration

Patent Patent expires

SALES

What is medical communications?

Market and KOL

development

Multimedia

Medical writing

expertise

Strategic publication planning

International meetings

management

Creativedesign

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

companiesDoctors, nurses,

pharmacists, payers, patients

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?

Time

Congress abstract,e.g. efficacy

Primarypublication

(efficacy andsafety)

Resultsavailable Editorial

Series of satellite symposia

Review articles in peer-reviewed journals

Communicating a major trial

Primary publication on other analyses

Letters to the Editor

Congress abstract, e.g. safety

Scene-setting reviews

Congress abstract, e.g. sub-analyses

Congress abstract on other analyses

Congress abstract, e.g. protocol

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%

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

What are we looking for?

• Education• 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)

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

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

Compared to working in a lab

Pros...

Cons...

Medical Writer career structureMedical Director

Scientific Director

Scientific Advisor

Principal Medical Writer

Senior Medical Writer

Medical Writer

Trainee Medical Writer

1 year

4 years

2 years

2 years

2 years

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

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

andy.shepherd@caudex.com