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Good Word
03-02-2006, 02:50 AM
Chemist?

Drug developer?

Pharmaceutical scientist?

waylander
03-02-2006, 02:56 AM
Pharmacist, toxicologist, clinical researcher?

Its such a long process and involves so many people. What do you want this character to be able to do?

I work as a drug discovery scientist for a pharmaceutical company and my training is in chemistry

Good Word
03-02-2006, 03:34 AM
Well, waylander, you sound like just the kind of person that could help with this! Thanks for responding.

My character works for a big pharmaceutical company and makes drugs.

He also knows a lot about DNA.

His boss calls him "our DNA man."

He wanted to work on developing drugs that cure Parkinson's, and is brilliant, but ends up getting assigned to projects that he doesn't really want. So he's kinda frustrated.

Hmm. Maybe I need to come at this fron a different angle. What does a drug discovery scientist do?

Also, once drugs formulas are determined, are they ever mixed by hand, or is it all mechanized. Or does it depend on the drug? Is aspirin made differently than, say, a rabies shot that gets administered in a hospital? Would one be made in a manufactuing facility, while the other is made in a lab in small quanitities?

When I was a kid, I got allergy shots every week, in the form of a serum that was administered at the doctors office based on the allergy tests I had that showed what I was allergic to. This formula was obviously mixed by hand somwhere, no?

Thanks.

Peggy
03-02-2006, 04:51 AM
My character works for a big pharmaceutical company and makes drugs.

He also knows a lot about DNA.

His boss calls him "our DNA man." My info is more from knowing people at biotech firms than personal experience so take what I say with a grain of salt, but I would call a person who had expertise in manipulating DNA for gene therapy or creating recombinant DNA for the production of drugs a "Molecular Biologist". If the person is an expert in the structure and chemistry of DNA, I would call him a "chemist". I think a generic "Research Scientist" would work as well.
Maybe I need to come at this fron a different angle. What does a drug discovery scientist do?waylander can give you an insider's perspective, but my understanding is that there are lots of different kinds of projects that fall into the category of "drug discovery" - some extract and test naturally occuring compounds from plants, some are chemists who synthesize completely new molecules, some use DNA and the machinery in cells to produce potential pharmaceutical compounds, etc. It's usually a team effort, with a number of people with different types of expertise (including chemistry, molecular biology and other biological sciences, toxicology and medicine, and even engineers if a device is involved) involved in creating and initially testing the drugs. A different team might be involved in putting together the manufacturing process, and still yet others might be involved in clinical trials.

My question is what do you want your character to be able do? Is he the head of a research project or is he just one among equals on the team? Is he working in the initial stages of drug discovery or trying to get a drug through clinical trials?
Also, once drugs formulas are determined, are they ever mixed by hand, or is it all mechanized. Or does it depend on the drug? Is aspirin made differently than, say, a rabies shot that gets administered in a hospital? Would one be made in a manufactuing facility, while the other is made in a lab in small quanitities? I believe that drugs that are injected in liquid form are often supplied as a powder, to which water is added at the pharmacy or hospital. I think that the drugs themselves - the powder or the pill - would have to be made in a FDA-approved manufacturing facility. However, all this would be after the long process of clinical trials, which can take years. Presumably the drugs would be made in much smaller quantities while they were being tested - I don't know if that would be by hand or not.

Maybe your character could have a MD+PhD in a biological science, so he has both "DNA" and "medicine" expertise - seemingly a natural for leading a team to work on a treatments for a disease like Parkinson's if he weren't thwarted by the short-sighted managers of his company. (The journal Nature has a web page (http://www.nature.com/drugdisc/nj/nj_dd_arch.html) devoted to careers in drug discovery that might give you some ideas).

Peggy
03-02-2006, 05:10 AM
Just to be clear, my answer assumed that by "makes drugs" you meant "develops new drugs", rather than "manufactures drugs", which would probably be more the domain of chemists and engineers than biologists and physicians. I hope I didn't misunderstand.

Good Word
03-02-2006, 06:22 AM
Peggy, your info is terrific, and I appreciate it. I'm kind of figuring this guy (my character) out.

And waylander, Peggy or anyone else:

Are there manufacturing facilities/labs that are in the same building as the development labs?

Are there ever any positions where someone (a low-level manager or worker bee chemist/developer) might have responsibility that would overlap, giving them access to both development labs and manufacturing facility labs that would not look suspicious?

waylander
03-02-2006, 02:18 PM
Peggy, your info is terrific, and I appreciate it. I'm kind of figuring this guy (my character) out.


Are there manufacturing facilities/labs that are in the same building as the development labs?

Are there ever any positions where someone (a low-level manager or worker bee chemist/developer) might have responsibility that would overlap, giving them access to both development labs and manufacturing facility labs that would not look suspicious?

In some companies manufacture might be on the same site as research facilities, but most likely in separate buildings. Access would most likely be restricted to these buildings (swipe card or something similar).

Someone who might be able to access both areas might be a technician who services the analytical instruments.

Your DNA man would most probably have a background in molecular biology (PhD + post Doc) and could be involved in developing models of the disease process so that experimental drugs can be screened. In this role he might well talk to clinicians as well as drug discovery scientists and behavioural pharmacologists.

Good Word
03-04-2006, 12:31 AM
How would I find out how a specific drug is manufactured?

waylander
03-04-2006, 12:49 AM
The process would be patented and in the public domain. Though some of the precise details remain trade secrets and would be closely guarded. In many cases the chemical route by which a product is prepared has been published and discussed in detail in a chemistry journal.

Peggy
03-04-2006, 02:10 AM
How would I find out how a specific drug is manufactured?In addition to the patent information (which you can find on the USPTO web site (http://www.uspto.gov/patft/index.html)) , the FDA drug database (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/) has some useful information for recently approved drugs. See the "Approval History and Related Documents" after doing a search for a particular drug. They have, for example, the medical (http://www.fda.gov/cder/foi/nda/2004/021647_000_Vioxx_Medr.pdf), chemistry (http://www.fda.gov/cder/foi/nda/2004/021647_000_Vioxx_Chemr.pdf), statistical (http://www.fda.gov/cder/foi/nda/2004/021647_000_Vioxx_Statr.pdf) and clinical pharmacology (http://www.fda.gov/cder/foi/nda/2004/021647_000_Vioxx_Biopharmr.pdf) reviews for Vioxx, as well as the approval letter (http://www.fda.gov/cder/foi/nda/2004/021647_000_Vioxx_Approv.pdf) and administrative documents (http://www.fda.gov/cder/foi/nda/2004/021647_000_Vioxx_AdminCorres.pdf). (WARNING: all the vioxx links are pdf files).

The exact manufacturing procedure would probably be a trade secret, but information about the basic process might be found in medical or chemical journals. For example, a search of the journals (http://pubs.acs.org/wls/journals/query/subscriberSearch.html) put out by the American Chemical Society for the terms "drug" and "manufacture" in the title (parameters; "all journals" and timeframe "all") gives a couple of possiblities. Note that the full articles must be purchased (or found in the library), but the first page can be viewed free. Another place to search is Pubmed (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi), which is a database of biology, medical and some chemistry journals, some of which are available for free online. I would think you could find more specific articles by searching for a drug name with the term "manufacture" or "production" or "synthesis". Note that the articles you find in these databases are likely to be highly technical, and may be more information than you need.

rtilryarms
03-04-2006, 02:40 AM
Around here they are "Candyman"

MadScientistMatt
03-04-2006, 05:50 PM
Someone who might be able to access both areas might be a technician who services the analytical instruments.

And possibly outside contractors, such as the sort who would help prepare a facility for FDA inspection.

There's a very wide range of ways drugs are prepared. Some drugs are synthesized from petrochemical ingredients, like asprin. (http://en.wikipedia.org/wiki/Aspirin#Synthesis_of_aspirin) Others are still commonly extracted from plant or animal sources, such as cocaine or insulin. And some have really elaborate production methods, such as the way they make flu vaccines by injecting a virus into chicken eggs.

waylander
03-04-2006, 08:10 PM
Most insulin is prepared by recombinant DNA techniques these days.