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Dr. Joshua Lederberg
May 6, 1988 Rockefeller University

New York, NY 10021

Memo to File - Interview with Arleen Auerbach - May 6, 1988

Dr. Auerbach came to see me -- her possibility of doing
that having been opened up by my prior conversation with Rodman
Rockefeller on whom I had urged the categorical necessity of
having the institutions involved, both with respect to IRB and
with respect to proprietary problems.

Dr. A. has no contractual relationship with the firm, whose
principal is Ted Boyce at the Memorial Hospital and in which
RR is a venture capital investor. Their concept is the use of
cells derived from cord blood as a fruitful source of progenitor
stem cells for grafts into individuals with marrow defect, like
the aplastic anemia of Fanconi's Disease (which is how Dr. A. comes
into the picture) Fanconi patients have an unexplained loss of
stem cells and there have been a number of efforts to sustain
them with marrow transplants. The best results have been achieved
at the Hospital St. Louis in Paris where they have now achieved
something like 70% survival rates. There are very delicate
questions of achieving cytoreduction that involve very careful
adjustment of the dose of cyclophosphgmide, since Fanconi cells
are much more sensitive than others. (x had a question whether
cytoreduction was necessary at all in Fanconi's Disease but that
has never been directly tested.) It is not just the marrow cells
but the other rapidly proliferating cells in the body in the

Fanconi patients that complicate the cytoreduction preparation.
Other protocols at menoritt Phe haa disastrous results
and so they have abandoned marrow transplant for Fanconi for
sometime. They have never followed the French protocol.

Ted Boyce's company is devoted to various applications of
fetal (cord blood cells) which they would bank for later use.

In some cases this would be for autologous transplantation.
The Fanconi's is one good candidate for a transplant of cord
blood cells from siblings. Apparently a number of Fanconi
patients have been clamforing about that possibility and there
are one and two cases ready to go to clinical trial.

A Dr. Gordon Douglas at NYU, former chief of their Ob-Gyn Dest,
appears to be a principal in the RR firm and has been doing the
actual collection of the cord blood. Dr. A's role has been to
do the diagnosis of Fanconi syndrome in cells received from
other places.

I reassured her that, while her obligation to keep the matter
a secret was inevitably uncomfortable, that things had not proceedeA
to any point of real difficulty as far as I could determine;
and that she should rest easy that her conduct was irreproachable
up to this point.

I outlined the necessity of connecting any involvement that

hit
she might have /with IRB approval and then attending to what the
University's proprietary rights might be. I spelled out that
whatever she did in the course of her work at the University
was University property and she could not get additional compen-

sation for that. On the other hand, her general advice about
their strategy for development of the therapy for the conduct
of clinical trials and so on was outside of her University
duties (and furthermore would have distinct social benefit) and
so I would not discourage her from being a consultant on that
basis. If on the other hand she does provide access to patients
or materials that come out of her work on Fanconi here then the
University had certain rights and those would have to be con-
sidered. Dr. A. mentioned that she had proposed to RR that

the University receive funds for the laboratory in order to
continue certain testing but that was not approved Mt that time.
I responded that my conversation with RR “Opened the possibility
of a closer relationship involving the University but we would
have to think about that very carefully.

Next steps: Dr. A. will consult with her lab chief Dr. Carter
as she is now free to do . If access to patients or patient
materials are involved Dr. Kappas will have to be informed, and
of course he would be involved in any IRB surveillance of what
they do.

My own judgement (hich Dr. A. is not in disagreement with)
is that the more crucial questions have to do with the rather
poor results that have been achieved so far with cytoreduction
except in Paris. But there, the 70% survival represents a
standard of outcome that would be very difficult for competing
therapies to match. But these are questions that the IRB's

can go into. In the present cases there might be some preference

to having used cord blood cells from recently born siblings of
(20 wea

Fanconi patients. strmee(one would net have to go to them for
sources of marrow which would also involve some delay and some
discomfort to the young child although that probably would be
approved in order to save the life of a sibling.) So there are

complex ethical issues here about whose rights are in question.