Monthly Archives: September 2008

Orphan Drugs – FDA/EMEA single application process

Many of you will know about orphan drugs and the assistance available from the regulatory bodies should you be awarded an orphan registration.

Applying for orphan registration is a straight forward process, however there are ways of making it even more simple. The FDA and EMEA have combined their application processes into a single form, so it is now possible to fill in a single form and submit it to both regulators.

It is possible to get twice the return for your orphan application effort. But why would you want to do this you may ask what is the benefit? There are a number of commercial benefits from obtaining an orphan registration:

  • scientific assistance (get your development plan rubber stamped)
  • easy development requirements (more attractive to investors)
  • a chance to get some much needed publicity
  • demonstrates your team have the capability to deliver in the drug development environment.

if you have any questions about orphan registration then just drop me an e-mail, damien.bove@idaconsultants.com and I will be sure to help.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com

Book Review – Graviational Marketing

This book by Jimmy Vee, Travis Miller and Joel Bauer is an interesting marketing read. They are proponents of the sell intelligence and expertise rather than sell offers and a low price.

They tell us what we have all suspected for a long time: Traditional Marketing does not work, people hate being sold to, they love to buy though, and this is the critical point.

The start of the book revolves around why marketing does not work, and what they call the five lies about marketing:
Fib1 – “you’ve got to pay your dues”
Fib2 – “if you want to be successful, You’ve got work your tail off”
Fib 3 – “its about getting your name out there”
Fib 4 – “advertising is expensive”
Fib 5 – “all you need is a good product, good service and low price”

Instead they lay out a bunch of strategies for using your expertise (or perceived expertise), to get customers to want to talk to you, and how you can cut through the usual marketing guff to get your message across.

I have to say that 50% of the book is good reading and the rest a bit wooly or too specific, however it is well worth a read. But as I always say about business books they are good as long as you read lots of them.

if you want to know more about the guys their work and don’t want to buy the book have a look at their blog at http://www.gravitationalmarketing.com/

ISBN 978-0-470-22647-6
gravitational marketing1 254x300 Book Review   Graviational Marketing

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com