[opensourcepharma] OSP @ RHH 2015 will happen Sep 1-3

Bernard Munos bhmunos at gmail.com
Tue Jun 9 06:55:16 UTC 2015


Drug repurposing is a powerful innovation model that should definitely be
part of our remit. It is championed by NIH because for many diseases --
especially rare ones -- it is the most economical way to speed new
therapies to market.

For the record, folks who are steeped in this thing distinguish between
drug repurposing (the use of an *approved* drug for an entirely new
indication) from drug rescue (the resurrection of a drug candidate that was
abandoned *before it was approved*, but has been subsequently found to have
activity against an entirely different disease).

The scientific rationale for drug repurposing is compelling. I keep a
database of all the drugs approved that have been found to work on
something else, and their number is in the hundreds. This is often the
result of drugs modulating multiple targets that impact various diseases.

IP is not an issue with drug repurposing (at least not in the US) because
many molecules are generic, and for those that are not, a decades-old
Supreme Court case allows scientists to perform research on patented
compounds. It also allows them to make and trade such compounds for
research purposes -- something known as the Bolar exemption, after the
now-defunct generic company that fought this case in court.

Drug rescue is more complicated because much of what is known about these
candidates has not been published. (Sometimes, even the structure has not
been disclosed.) Yet, that knowledge is key to figuring out what the drug
might be good for. So, whoever wants to rescue a drug has to seek the
collaboration of the patent owner. Pharma companies have recently become
more open to this. I recently asked 5 big pharma companies whether they
would entertain letting scientists from academia and other companies rescue
some of their abandoned drug candidates, if the deal were structured to
allow them to reacquire the candidate down the road for a "fair value" --
i.e., right of first refusal. They all said yes, although some stipulated
that they wanted no liability and no obligation to supply trial material.

A big challenge in drug repurposing is building a library of approved
compounds. When NCATS started its efforts some years back, it could not
even get a list of approved drugs from FDA. (No kidding: it did not exist!)
It took a couple of years to get that data. When it set out to buy the
compounds, it found out that many were not available. They had been
discontinued, or superseded by newer drugs. In quite a few cases, the
recipe had been lost, and had to be recreated. If the compounds were
available, the purity was not always acceptable; or the minimum order
quantity was way too high; or re-supply was haphazard.

The drug repurposing industry has made big strides in the last couple of
years. There are now specialized search engines to facilitate the discovery
of new indications, and companies have been created to supply approved
drugs "to anyone with an assay". So this is definitely something worth
considering. If we go that route, we should leverage the experience of the
pioneers who have been doing it -- e,g., NCATS or scientists such as Atul
Butte at UCSF.

Hope this helps.


On Mon, Jun 8, 2015 at 8:02 PM, Jaykumar Menon, Prof. <
jaykumar.menon at mcgill.ca> wrote:

>  Dear Peter,
> Thanks for the note and all the superb effort!
> And dear all,
> There is so much to discuss and plan and make sense of, as the open source
> meme seems to be catching on.  (And a quick personal apologia - I’ve been
> buried in things operational – trying to add some heft and muscle to this
> discussion and movement, so sorry for my relative silence of late on the
> email list-serv.)  For the meeting at the Castle, as you can see from the
> spreadsheet, we are already at 14 attendees, a mix of  “new” and “old”
> blood (i.e. those who attended Bellagio and those who did not), hailing
> from San Francisco (Linux Foundation) to Seattle (a special person from
> Gates) to Oxford (Structural Genomics), with some heavy hitters, so let us
> know if you are interested soon, as this is again a small venue, and we are
> trying to get the optimal mix.  Suggestions of people are also welcome.
> As those of you who were at Bellagio remember, this is a special group,
> and a special colloquy and movement, operating in a realm that is at the
> cutting edge of the cutting edge, yet animated by human need.  It is a
> union of those adept at concretizing dreams.  And it is superfun, a bonding
> experience.  Thanks again to Peter for securing such an unbelievable spot.
> And as a precis and discussion starter, a question, perhaps foolish and
> ill-informed, considering the vast expertise in this group, but posed in
> the spirit of risk-taking and thinking big, is appended below.
> With warm regards,
> Jaykumar
> *Repurposing (admittedly imprecise and perhaps inaccurate description):*
>   Repurposed drugs offer the prospect of huge cost savings.  The goal of
> repurposing is to deploy approved drugs or abandoned clinical candidates in
> new disease areas.  Directing such drugs – particularly those that are
> fully approved and off patent - towards new diseases can deliver cures at a
> fraction of the cost of developing a new drug.  This is due to savings in
> R&D expense and reduced clinical trial requirements.
> A question came up recently in a discussion with a funder, and we novices
> didn’t know the answer, and I thought I’d take it to the group mind.
> Would it make any sense to have a grand and almost comprehensive
> repurposing project, an Apollo project of sorts, where we look at
> essentially all/large numbers of generic drugs, to see their applicability
> against a particular condition (or many) of (public) health need?  Has it
> already been adequately done?  (There have been  efforts from NIH NCATS,
> working with under-patent drug candidates from pharma companies, but
> evidently not with generics and approved drugs, and other efforts too).
> Would it be at all needed, feasible and fruitful?  If so, crowdsourcing and
> openness would seem to be essential.  It is thus a natural fit for those
> intrigued by open source pharma.
> j
> *From:* Peter Kolb [mailto:peter.kolb at uni-marburg.de]
> *Sent:* Monday, June 08, 2015 1:50 PM
> *To:* opensourcepharma at lists.okfn.org
> *Cc:* Jaykumar Menon, Prof.; Matthew Todd
> *Subject:* OSP @ RHH 2015 will happen Sep 1-3
> Dear past and future OSP participants,
> The 2015 meeting will take place on September 1-3, 2015, in castle
> Rauischholzhausen <https://goo.gl/maps/TmERX>, near Marburg (greater
> Frankfurt area), Germany.  Here are some key facts to assist in your
> planning:
>    - Arrival is possible from Aug 31, 10am. Departure is on Sep 3 after
>    lunch. The conference program will run from Sep 1 morning until Sep 3 noon.
>    - Please sign up at http://tinyurl.com/osprhh by June 30 in order to
>    participate. This spreadsheet also allows you to record dietary preferences
>    as well as arrival and departure times.
>    - The easiest travel option is to fly into Frankfurt airport (FRA),
>    then take a train <http://www.bahn.de/p_en/view/index.shtml> to
>    Marburg (approx. 90 mins), followed by a short cab ride to the castle. More
>    detailed instructions will follow to participants at a later time.
>    - Accommodation as well as meals and coffee breaks will be provided at
>    the castle.
>    - We have secured some sponsorship and are trying to secure more.  The
>    worst-case scenario, in case we completely fail to do so, will be a lodging
>    fee of EUR 250 per person (covering all accommodation and meals for the 3-4
>    days, which is quite reasonable). Please do not let it be an impediment to
>    registering initially; if you need to drop out later, that will be all
>    right.
> If you have any questions, please do not hesitate to write!
> Looking forward to a fruitful meeting in September,
> Jay, Mat & Peter
>  --
> P e t e r   K o l b
> Emmy Noether Group Leader
> Pharmaceutical Chemistry @ Philipps-University Marburg
> Tel +49 6421 28 25908 | Fax +49 6421 28 28994
> http://www.kolblab.org
> Chair | GLISTEN: COST Action CM1207
> http://www.glisten-gpcr.eu/
> Editor | Journal of Postdoctoral Affairs
> http://www.postdocjournal.com
> _______________________________________________
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