>> Hi I'm Dr. Ira Lawrence.
I am currently a consultant to the Pharmaceutical and Device Industry,
previously was Chief Medical Officer at Alphaeon and Medicis
and Senior Vice President of RND at Fujisawa and Astellas.
Generally, because I do international consulting, it's really a combination
of regulatory advice because we have clients that develop products, devices and drugs all
over the world so I have clients in Europe and Asia, in the U.S.,
as well as understanding clinical trial design and really doing clinical research
and development to bring new products to the market.
Well currently right now I am.
Unfortunately I can't talk about a lot of them because they're not yet approved.
But in the past I developed drugs such as Tacrolimus
which is the number one transplant drug in the world.
I also developed a drug called Dysport, which is the European Botox, and Restylane and Perlane
which are anti-wrinkle drugs that are used
and actually are the number one drugs in the world, as well.
So a wide variety from something as life threatening
as transplant all the way up to dealing with wrinkles.
Well I think one of the challenges is the fact that there are a number
of my [inaudible] associated with clinical research.
You can design a trial very well but things happen, people do what they do.
I mean, life is life.
I think though one of the real challenges to us is really keeping up with regulatory changes.
The regulatory environment is very different.
It's a very regulated industry.
So you have to be current and at the same time very conversant with dealing
with government regulatory bodies that are not always interested in working
from a business standpoint but have a job to do.
So the idea is learning to compromise and negotiate.