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

Sun Jun 14 18:47:21 UTC 2015

Dear All,

Coming a bit late to this discussion, a couple of points from the
"practitioner" of repurposing in the OS space but also someone facing the
harsh reality of financing.

1/ repurposinhg is a relatively low hanging fruit to improve many disease
outcomes from scientific / clinical research perspective, but often a
non-starter from investors point of view

2/ Bruce Bloom and his organization have been doing fantastic work to move
repurposing to a spotlight. I just had a pleasure to participate in a
conference in Chicago which he organised - below, please find links to
presentations at this mtg. So glad to see that Bruce will be joining the
OSP gathering in September!

3/ as stated by Bernard, radical reduction of clinical trial budgets would
allow, at least in some cases, investors to see meaningful ROI

4/ at Transparency we have one repurposing clinical trials recruiting
https://clinicaltrials.gov/ct2/show/NCT02369926?term=transparency+life+sciences&rank=1
The only reason it is happening is a $1.4M SBIR grant from NCATS.

5/ another program, is a repurposing an non-approved NCE for a second rare
disease indication while first indication is still in Phase 3 trial. This
study was co-designed by over 250 patients suffering from pulmonary
sarcoidosis, and some 50 MDs who treat these patients. To our knowledge
this is by far the largest crowdsourcing input ever received in clinical
research.
We just had extremely positive mtg with FDA last Tuesday. I will be happy
to share details with you in few weeks.

As you may remember TLS' ultimate goal is to conduct regulatory sanctioned,
patient centric clinical studies at 10-20% of current budgets. We are
getting there! Such reduction of budget will make repurposing attractive to
some for profit investors, but importantly for OSP model it will facilitate
non-dilutive funding from foundations, etc.

I am looking forward to productive meeting!

Regards,

Tomasz

--------------------------------

Thank you very much for joining us in Chicago for the 4th Annual Drug
Repositioning Conference. I hope you enjoyed the conference. Below are
links to the slides that are available for download.

These files will be available for download until July 1st.

Roy Anderson

http://drugrepositioningconference.com/index/images/Anderson_Roy.pdf

Bruce Bloom

http://drugrepositioningconference.com/index/images/Bloom_Bruce.pdf

Gauthier Bouche

http://drugrepositioningconference.com/index/images/Bouche_Gauthier.pdf

Christine Colvis

http://drugrepositioningconference.com/index/images/Colvis_Christine.pdf

Daniel Czyz

http://drugrepositioningconference.com/index/images/Czyz_Daniel.pdf

Sivanesan Dakshanamurthy

http://drugrepositioningconference.com/index/images/Dakshanamurthy_Sivanesan.pdf

Chris Gibson

http://drugrepositioningconference.com/index/images/Gibson_Chris.pdf

Tim Guilliams

http://drugrepositioningconference.com/index/images/Guilliams_Tim.pdf

Raul Insa

http://drugrepositioningconference.com/index/images/Insa_Raul.pdf

Hermann Mucke

http://drugrepositioningconference.com/index/images/Mucke_Herman.pdf

Stephen Naylor

http://drugrepositioningconference.com/index/images/Naylor_Stephen.pdf

Stephen Naylor (article part 1)

http://drugrepositioningconference.com/index/images/Naylor_Stephen_addendum-article.pdf

Stephen Naylor (article part II)

http://drugrepositioningconference.com/index/images/Naylor_Stephen_addendum-article-pt2.pdf

Aris Persidis

http://drugrepositioningconference.com/index/images/Persidis_Aris.pdf

James Pickett

http://drugrepositioningconference.com/index/images/Pickett_James.pdf

Tomasz Sablinski

http://drugrepositioningconference.com/index/images/Sablinski_Tomasz.pdf

Mohamed Seleem

http://drugrepositioningconference.com/index/images/Seleem_Mohamed.pdf

E. Mitchell Seymour

http://drugrepositioningconference.com/index/images/Seymour_Mitchell.pdf

Craig Webb

http://drugrepositioningconference.com/index/images/Webb_Craig.pdf

Scott Weir

http://drugrepositioningconference.com/index/images/Weir_Scott-Summary.pdf

On Tue, Jun 9, 2015 at 12:56 PM, Bernard Munos <bhmunos at gmail.com> wrote:

> Thanks Graham. I know Bruce Bloom. He is very good, and we should
> definitely reach out to him. The financial model hinges on the duration of
> the period of exclusivity, which has been a contentious topic in the US
> Congress. Another key factor is the emergence of biosensing technologies
> that allow rich data capture and remote patient-monitoring (i.e., outside
> hospital settings) at very low cost. This is changing the economics of
> clinical research, and will likely boost the attractiveness of drug
> repurposing.
>
> b
>
>
> On Tue, Jun 9, 2015 at 11:43 AM, Graham Dover <
> graham at mindsetfoundation.com> wrote:
>
>> Hi
>>
>> We’ve been exploring this issue for the last year - inspired by the NCATS
>> model and others - and approaching it from two different angles.
>>
>> First, we’ve spent time with Cures Within Reach
>> <http://www.cureswithinreach.org/> (nonprofit) to see if we could help
>> scale their successful repurposing model - they have recently had support
>> from RWJF to build a knowledge sharing platform
>> <http://cureaccelerator.org> (officially launched last week). Bruce
>> Bloom, the CEO of Cures Within Reach, would be excellent person to invite
>> to your September meeting as he has been working in this space for the last
>> 10 years.
>>
>> Second, a significant challenge to drug repurposing is developing a
>> sustainable financial model and so we commissioned MaRS Centre for
>> Impacting Investing <http://impactinvesting.marsdd.com/> to explore how
>> social finance tools (such as Social Impact Bonds) might be used to engage
>> governments, impact investors etc. They will produce a summary report for
>> us by mid-July. Anyone that is interested is more than welcome to have
>> access to this material or even sit in on the call when they make their
>> next presentation.
>>
>> We are also in discussions with the Canadian government over a drug
>> repurposing initiative focused on rare diseases to be launched in early
>> 2016 and I know that Bruce is in discussions with a number of governments
>> including the UK, Belgium, Israel. It could be that there is a growing
>> momentum for a global initiative.
>>
>> Many thanks
>>
>> Graham
>>
>> *Graham Dover*
>>
>> Executive Director | *Mindset* *Foundation*
>> p: 604.601.2162 ext 3 | e: graham at mindsetfoundation.com
>> w: *www.mindsetfoundation.com <http://www.mindsetfoundation.com/>*
>>
>> On Jun 9, 2015, at 8:27 AM, Bernard Munos <bhmunos at gmail.com> wrote:
>>
>> There is also an active repurposing program at UC-Davis
>> <http://ucdmc.ucdavis.edu/welcome/features/20090520_web_portal/index.html>.
>> The scientist behind the Johns Hopkins effort moved to Harvard, and I lost
>> track of him.
>>
>> b
>>
>>
>> On Tue, Jun 9, 2015 at 11:17 AM, Jaykumar Menon, Prof. <
>> jaykumar.menon at mcgill.ca> wrote:
>>
>>>  A tremendous paper Dimitrios, thanks for it.   And great  comments Mat
>>> and Bernard and Samir.
>>>
>>>
>>>
>>> To continue the thought experiment, I wonder if there is a gaping need
>>> for more effort on what is perhaps the lowest of the low hanging fruit:
>>>
>>> a)      Focused on approved drugs only
>>>
>>> b)      With no IP hurdle  (generic, or otherwise no hurdle)
>>>
>>> c)       Comprehensive or at least somewhat broad.
>>>
>>> (I see a few narrower efforts- Univ of British Columbia, and
>>> Chicago-based Cures within Reach).  The Johns Hopkins Clinical Compound
>>> Screening Initiative (JHCCSI) looks promising, though their web site seems
>>> defunct.
>>>
>>> d)      Open source and crowd powered
>>>
>>>
>>>
>>> j
>>>
>>>
>>>
>>> *From:* Dimitrios Tzalis [mailto:dtzalis at taros.de]
>>> *Sent:* Tuesday, June 09, 2015 5:50 AM
>>> *To:* Jaykumar Menon, Prof.
>>> *Cc:* opensourcepharma at lists.okfn.org; Peter Kolb
>>> *Subject:* Re: [opensourcepharma] OSP @ RHH 2015 will happen Sep 1-3
>>>
>>>
>>>
>>> Dear Jay,
>>>
>>>
>>>
>>> this indeed is a very interesting approach and has gotten quite some
>>> attention for quite some time for obvious reasons.  There are ongoing
>>> activites in this area in the US as well as in Europe. There are quite a
>>> few initiatives where ADMET data is being made available on potential drug
>>> candidates in an Open Source approach. There was last year good review in
>>> 2013 on this topic by Minna Allarakhia
>>>
>>>
>>>
>>>
>>> http://www.academia.edu/4964147/Open-source_approaches_for_the_repurposing_of_existing_or_failed_candidate_drugs
>>>
>>>
>>>
>>>
>>>
>>>
>>>
>>> *From:* SKB IGIB EMAIL [mailto:skb at igib.res.in]
>>> *Sent:* Tuesday, June 09, 2015 3:32 AM
>>> *To:* Bernard Munos; Jaykumar Menon, Prof.
>>>
>>> *Cc:* opensourcepharma at lists.okfn.org
>>> *Subject:* Re: [opensourcepharma] OSP @ RHH 2015 will happen Sep 1-3
>>>
>>>
>>>
>>> Dear Bernard, I completely agree with you. We have taken this up as a
>>> low hanging fruits. I am in Weizmann Institute attending an International
>>> Conference Deep Sequencing Meets Structural biolology. Ada Yonath. Gave
>>> some new idea on combination drugs to combat drug resistance. regards. Samir
>>>
>>>
>>>
>>> Sent from my BlackBerry 10 smartphone.
>>>
>>> *From: *Bernard Munos
>>>
>>> *Sent: *Tuesday, June 9, 2015 09:53
>>>
>>> *To: *Jaykumar Menon, Prof.
>>>
>>> *Cc: *opensourcepharma at lists.okfn.org
>>>
>>> *Subject: *Re: [opensourcepharma] OSP @ RHH 2015 will happen Sep 1-3
>>>
>>>
>>>
>>> Jay,
>>>
>>>
>>>
>>> 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.
>>>
>>>
>>>
>>> b
>>>
>>>
>>>
>>>
>>>
>>> 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
>>>
>>>
>>> _______________________________________________
>>> opensourcepharma mailing list
>>> opensourcepharma at lists.okfn.org
>>> https://lists.okfn.org/mailman/listinfo/opensourcepharma
>>>
>>>
>>>
>>>
>>>
>>> --
>>>
>>> Follow me on *Forbes* <http://blogs.forbes.com/bernardmunos/> and
>>> *Fastercures*
>>> <http://fastercures.tumblr.com/post/62722481036/give-me-your-innovators-yearning-to-breathe-free#!>
>>>
>>>
>>>
>>>
>>> _______________________________________________
>>> opensourcepharma mailing list
>>> opensourcepharma at lists.okfn.org
>>> https://lists.okfn.org/mailman/listinfo/opensourcepharma
>>>
>>>
>>
>>
>> --
>> Follow me on Forbes <http://blogs.forbes.com/bernardmunos/> and
>> Fastercures
>> <http://fastercures.tumblr.com/post/62722481036/give-me-your-innovators-yearning-to-breathe-free#!>
>>  _______________________________________________
>> opensourcepharma mailing list
>> opensourcepharma at lists.okfn.org
>> https://lists.okfn.org/mailman/listinfo/opensourcepharma
>>
>>
>> _______________________________
>>
>>
>>
>>
>
>
> --
> Follow me on Forbes <http://blogs.forbes.com/bernardmunos/> and
> Fastercures
> <http://fastercures.tumblr.com/post/62722481036/give-me-your-innovators-yearning-to-breathe-free#!>
>
> _______________________________________________
> opensourcepharma mailing list
> opensourcepharma at lists.okfn.org
> https://lists.okfn.org/mailman/listinfo/opensourcepharma
>
>
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://lists.okfn.org/pipermail/opensourcepharma/attachments/20150614/fcfc8aa6/attachment-0002.html>