Exclusive Life Science Feature
One critical component of drug development that generally
seems to receive the least forethought is securing a supply of the
product for clinical trials. ACT is exceptional in having a solid
manufacturing capacity — an early priority for the company and
its investors. "The reality is that GMP manufacturing capability is
an absolute must for us to advance into human clinical trials, and
it must be in place far earlier than the commencement of the trials," says Rabin. "We needed to demonstrate to the FDA that the
RPE cells we intended to inject into human patients, when made
by our GMP process, were safe in animal studies and showed some
evidence of effectiveness."
Rabin says the company had to rely either on contract manufacturing — putting its special products in the middle of multiple,
unrelated programs at a premium price — or building its own
GMP facility where it has control over its process. "In the end,
the cost of building our own GMP space has proved to be far less
expensive than the CMO route and probably far speedier in terms
of the time to get to clinical trials."
CATCHING THE WAVES
Every micro-innovator company confronts common as well as
unique challenges. Others in the life science industry will recognize the situations and choices they share with the companies
described here. Every company must build a foundation, find
funding, focus its research, and forge through development. But
not every one must cradle a unique and original creation along the
way. Novel discovery and development are self-imposed burdens,
a singular mission requiring special skills, resources, knowledge,
and above all, persistence.
Sometimes, the persistence is in vain — spent in trolling aimlessly among endless possibilities for applying groundbreaking
research. Other times, though, when science and business find a
happy marriage, a company is able to tap the power of an unbroken, consistent, and dedicated line of development from invention
to application.
That is the point of picking three companies out of the arguably
elite club of micro-innovators to share their real-world experiences. The universe is full of business models and theories. It only
makes good common sense to take a deeper look at the details of
what happens to actual companies as they attempt the entire journey from lab to market. The surfer rises, steadies on the board, and
catches the wave — will this one make it to the shore?
January 2014
LifeScienceLeader.com
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