Biomedical Engineering Reference
In-Depth Information
and R&D programs. LTI support meant what was considered a large
grant at that time, which would allow us to continue our OLV-DOX
research, and especially the “first in man” clinical trial. So, it seemed
we had a deal, the small details of which still needed to be finalized.
At about that time, I was approached by another US company that
proposed to license from us the OLV-DOX technology and product.
Their proposal was tempting, as it involved what I considered then
a large sum of money up front and reasonable royalties. However,
this company requested that Alberto and I would be used only as
consultants and not be involved in the research and development of
the product. I did not like this idea, as we looked upon the product
as a baby we have to nurture to maturity. I preferred LTI to the
other company as I believed that our day-to-day involvement in the
product development is crucial to the program's success. The future
would show that I was right. So I convinced Moshe Vigdor, CEO of
Yissum (the Research and Development Company of The Hebrew
University of Jerusalem), to accept LTI's proposal. It did not take
Nick long to come to Israel and finish the first license agreement,
between LTI and Yissum, which was the basis of a master agreement
that continued for 21 years. It started with LTI, with Nick as CEO, and
went all the way to Johnson & Johnson. After Doxil's approval by the
FDA, there was a change of management at LTI, and Craig Henderson,
a top-level oncologist from UCSF (who had been involved in Doxil's
clinical development), became LTI CEO. Then the company name was
changed to Sequus. Craig and others sold Sequus to ALZA, Mountain
View, CA (a major drug delivery company), with Doxil (due to its
increasing sales) being one of the main reasons for the deal. It did not
take a long time for ALZA to be bought by Johnson & Johnson, which
until then was hardly involved in drug delivery systems. Again, Doxil
was one of the main reasons for the deal. The rest is history!
During this fantastic very long voyage of 43 wonderful years
of active research, I met many fascinating people, with whom I
interacted and/or collaborated, and many of them remain lifelong
friends. The 15 years I worked on liposomal doxorubicin, of which
50% was dedicated to Doxil development, was a unique experience I
will never forget. It enabled me to be involved in a very complicated
and complex process of drug development and to see its approval
worldwide. The reward in terms of satisfaction is unmatched by any
of my other achievements. I am trying hard to transfer my experience,
part of which is summarized in this review, to many students and
others worldwide.
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