I have an idea for a new pharmacutical product.  I have financing.  It
is an oral product that works with the human body.  I have also
already worked on trademarks for branding. I need to know what
profession of person to talk to and how to proceed? Do I need a
chemist/biologist? How do I find one?

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Request for Question Clarification by jbf777-ga on 06 Jan 2005 13:35 PST

Hello -

Thank you for your question.  Is this a prescription, or over-the-counter product?

jbf777
Researcher
Google Answers

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Clarification of Question by mcob337-ga on 06 Jan 2005 14:11 PST

It depends on the compounds necessary, that would be part of the
discovery.  It could be potentially both. I am sorry if that does not
help.

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Request for Question Clarification by jbf777-ga on 07 Jan 2005 10:27 PST

Yes, that helps.  Can you tell me, is it an actual ingested substance,
or more of a physical or topical product that resides in the mouth?

Thank you,

jbf777

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Clarification of Question by mcob337-ga on 07 Jan 2005 11:21 PST

It would need to be digested and would reside in the lower stomach/upper GI.

Hello -

Thank you for your question.  If you need any additional
clarification, please don't hesitate to ask.  Thank you.

In the broadest sense, you have a few main issues to address in
creating your new product: actual formulation, manufacturing
(including apropriate type, packaging, quality) FDA approval
(labeling, Rx or OTC suitability, clinical trials for Rx products),
and marketing (commercial viability, sales channels, geography,
commercialization etc.).

I would advise hiring an pharmaceutical engineering consultant or
consultancy that could also act as a single-source administrative
entity for the whole project or a portion thereof.  They would
coordinate the process -- from inception, to development, sourcing,
approval, and marketing -- allowing you to oversee and manage the
direction you want to take.  This person or company would have the
necessary experience, references and established contacts in the
industry to advise on the numerous issues that will arise in bringing
your idea to fruition.

I spoke to Chris at Kansas-based Beckloff and Associates, who
confirmed his company's ability to handle every last detail of your
project.  They do much of these tasks in-house as well as through
outsourcing, and can be contracted for any one aspect of your project:

Beckloff
http://www.beckloff.com/
Commerce Plaza II, Suite 300
7400 West 110th Street
Overland Park, Kansas 66210 USA
913-451-3955x215 (Chris)

-

There is an organization called the Association of Consulting Chemists
and Chemical Engineers.  It's a nonprofit group "serving the chemical
consulting needs of prospective clients and its members since 1928." 
You can freely search their member directory from their website, and
also use their free referral service, where they will locate the
appropriate consultant for you:

http://www.chemconsult.org/

When using their online member search directory, try keywords like
"oral" or "pharmaceutical" alone, and then with those most appropriate
to your product (in different combinations), and it will display all
the members whose profiles contain the word(s) you searched.  Each
member is profiled with a mini resume.  This website may be a good
place to find a "project manager" type consultant to handle the whole
project, or one more into the formulation side only.

-

There are two subscription-based, pharmaceutical classified websites
called "Hire Health" and HireRX which look to be excellent sites to
post an (inter)national advertisement for a contract
consultant/project manager/bio-engineer position(s):

HireHealth
http://www.hirehealth.com/

HireRX
http://www.hirerx.com

-

ProSavvy is another means of finding someone to hire:

ProSavvy
http://www.prosavvy.com

--

Another company I spoke to is Biotech; they work in various capacities
as well, but not quite to the extent of Beckloff above:

Biotech
http://www.biotech.com/projmanage.html
81 N. Mentor Ave., 
Pasadena, CA 91106
(626) 792-1649 (John)

--


There are several companies that specialize in the
manufacturing/formulation phase.  A very good list of contract
manufacturers is at Christopher Marrs' website:

http://members.tripod.com/~ChristopherMarrs/GMP_Drugmanufacturer.html


Once your product is developed and approved, you could then hire a
separate marketing firm to assist in bringing the product to market. 
"Brand Engineers" is such a firm:

http://www.brandengineers.com/


Note: Gaining FDA approval for a prescription drug takes anywhere from
2-10 years and millions of dollars to implement.  I'm told by a
representative of Pharmaceutical Services Corporation that FDA
approval for a prescription drug is all you would need to attract the
attention of large pharmaceutical companies (if you would be
interested in a possible licensing or buyout arrangement).


Additional Links:
  GroupAnalytica.com
  http://www.groupanalytica.com
  212.686.4100x8655

  Here's an interesting article on the topic of outsourcing:

  Formulation Development
  http://www.contractpharma.com/October024.htm


Select search strategy:
  turnkey pharmaceutical
  "pharmaceutical consulting"
  pharmaceutical "private label"
  pharmaceutical "contract manufacture" OR "contract manufacturing" marketing
  pharmaceutical "contract manufacturer" marketing
  "virtual pharmaceutical"
  "contract research organization"

This is great thank you very much!

Glad to be of help.  Thank you for the tip and rating!  Please stop by again!

jbf777