QDIS Blog

Recently Roche announced it had reached an agreement with Sanofi-aventis to produce shimikic acid by fermentation at Sanofi’s plant in Saint-Aubin-les-Elbeuf France. This is indeed good news since extraction of shikimic acid from the spice star anise (mainly in China) was the bottleneck in the process. The extraction process is about ten steps and takes quite a bit of time. Production from femermentation should alleviate this problem and is probably the only way that Roche could also announce that 13 other contract manufacturers have been identified to produce the drug in case of a world pandemic. While I’m not sure of how likely this is to happen, it is good to see that Roche is taking steps to ensure production can be increased if needed.

Technorati Tags: shikimic acid, Tamiflu

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I found this article on the Miami Herald website interesting. The article deals with the proposed merger between Andrx and Watson Pharmaceuticals to form what would be the third largest generic manufacturer. On an amusing note, the paper has a section headline stating “FAA Inspection”. Now when I first read this I was scratching my head; why exactly was the Federal Aviation Administration doing an inspection of a pharmaceutical company?? Seems it’s a typo and should really be FDA. At first, I thought maybe Andrx had added an airport at the site.

It seems MMI investments who owns 12 percent of Andrx thinks the $1.9 billion price that Watson Pharmaceuticals has offered falls short of what Andrx is truly worth. The president of MMI states they although they have had their problems (the FDA has refused to review any more of Andrxs’ drug applications until certain problems are corrected at their ) it was better for Andrx to clean up itself before being put on the market. He draws the analogy to a trophy home hit by a storm and wouldn’t it be better to fix it up before putting it up for sale. Having spent some time in pharmaceutical development, I think the analogy falls short. Fixing quality issues takes more time and is harder to fix than remodeling a home.

My guess is that the quality control problems at the Davie, FL plant may be of greater concern than the company has publicly stated. While I have been lucky enough in my career to not have been in such a situation, I do know that it takes quite an effort to make changes, especially those involving corporate culture. Leaving out the question of price, I think a merger could produce a viable company. Both have been struggling of late.

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I read today that Genentech expects to get 15 new treatments approved for a variety of diseases by 2010. I can only say I will be greatly impressed if hey can indeed pull this off. Genentech currently has 12 products on the market with Avastin being their biggest seller ($1.1 billion in 2005). From the article and other places I’ve read about it, it is unclear how many specific drugs they are talking about. It appears that they are counting the number of indications rather than the number of new biological entities. So say a new drug is used for 3 different indications, that would count as 3 towards that total. They do have about 20 potential drugs at various stages of development but given the odds in the drug development process, I wouldn’t count on all of them getting through their trials.

In the interest of full disclosure, I do own a few shares of Genentech stock. While I really hope this is the case, I’m being cautiously optimistic.

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This page explains how to use the RSS feeds on this site. RSS stands for for Really Simple Syndication and is a geeky way of saying you can subscribe to this information. RSS feeds allow you to read the stream of text in either an RSS capable browser (Internet Explorer 7.0 or later, Safari 2.0 or later, Firefox 1.5 or later, or other RSS aware browsers) or your favorite RSS reader.

Clicking on RSS or the common feed icon under the section entitled “Subscribe” will give you the full feed with all postings. Below that are several buttons allowing you to subscribe to the full feed in any of the following RSS readers: Google reader, My Yahoo, Bloglines, Newsgator, My MSN, My Feedster, or My AOL.

The next subsection is called “By Category”. These are feeds containng only posting in a given category. If you only want to see “Pharma News” then you can subscribe to a feed containing only posts I’ve marked as belowing to the “Pharma News” category. If you want to subscribe to this category, you can right click (or option click on a Mac) and copy the link and then paste that into your favorite RSS reader.

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Being a Flonase user for a couple of years now and having recently changed insurance, I’ve been keeping my eyes open with regard to the generic Flonase being brought to the market by Par Laboratories. Flonase is one of those blockbuster drugs (annual sales last year of $1.2 billion) and keeping the generic off the market for even one day would mean $3.29 million in sales, so it’s no wonder GlaxoSmithKline (GSK) tried to prevent it.

Parr and Roxane both started to ship the product on Feb 23 one day after the FDA ruled for their ANDA, but stopped when the US District Court in Maryland issued a temporary restraining order. They resumed shipments on March 7 after the court ruled against GSK and it looks like GSK will not challenge this further.

Mongabay.com has a good timeline of news articles regarding Flonase (fluticasone propionate).

Technorati Tags: Flonase

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In preparing for a talk recently about the FDA and drug development, I looked at the timeline for FDA Commissioners over the last nine years (since David Kessler). Ends up that for six of the last nine years or 66% of the time the FDA was without someone to head up the agency. Just look at the FDA’s own website: Jane Henney served from 1/17/99 - 1/19/2001 two days past two years; Mark McCellan served from 11/14/2002 - 3/26/2004 or just a little more than 16 months, and then Lester Crawford served from 7/18/2005 - 9/23/2005 or just a few days over 2 months. So in the last 108 months (9 years), there has been someone heading up the FDA for only 42 months or 39.2% of the time. Now having spent 14 years in the industry, I know there have been acting commissioners but my point is, can someone in the acting position truly make a difference, lobby congress and set a culture and view of the future?

Technorati Tags: FDA

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This is my first post to this blog and I thought I’d set out to describe what this blog is all about. First, about the name. QD Information Services is the name of my consulting company with the “QD” coming from the LIbrary of Congress classification for chemistry. This blog will cover issues related to chemistry in general with a focus on organic chemistry and the drug development process since I’ve spent all my professional life working in development. By development, I mean the timeframe after drug discovery up to and including commercialization. So I’ll mention articles related to development, chemistry articles from major journals of interest to me, and general pharmaceutical news. i’ll also cover tips on searching the internet with a focus on finding sources of science and chemistry information.

I’m also a long time Macintosh user so I’ll occasionally mention Mac related software that I think may be of interest as well as the occasional rants. Other tech news such as podcasts and the use of RSS will be mentioned again with a focus on how they apply to science.

If you want to know more about me, read the About Ed Vawter page under internal links on the left. The page About this blog will give a tour of the functionality of this blog setup as well as some of the topics it will cover.

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The QDIS Blog covers a variety of topics related to science and technology with a focus on chemistry and drug development. It also covers search engine tips and hints, chemistry articles, news, and other items that relate to science and technology.

Here’s a run down on the features of the blog. In the left column, the first section is called “Internal Links”. These links are for major areas of the blog and include a link to the primary website. QDIS Blog Home takes you to the main page for the blog. There also a page about myself and this one about the blog and its features.

Below that are the categories. This gives you only the posts in a certain category. this is useful if you only find certain post of interest to you.

Next is the section “Search Blog”. If you want to find something specifc in this blog this is the way to do it.

Next is “Archives” which will give you acess to all the older posts based on the date they were posted.

The final section on the left is “Subscribe”. This is the area to get the RSS 2.0 feeds. Web feeds are simply a way to subscribe and be notfied automatically when there is new content. The main feed is at the top followed by the comments feed; this feed includes all the comments to all the posts. Then there are the subscribe buttons so you can subscribe to the mani feed in the feed reader of your choice. If your favorite reader isn’t listed, you can right click (or control click on a Mac) and copy the link. Then paste this link into whatever RSS reader you use. Here is more information about the RSS feeds on this site. You can alos subscribe to posts via emial using FeedBlitz. just enter your email address, respond to an emial sent to you to verfiy and then enjoy a daily email with all that days posts.

In the right column at the top is the section “General Links”. This has links to websites of interest to readers of this blog such as the American Chemical Society and other chemistry related sites.

Next is the “Blog Links” section which has links to the web sites of some of the blogs I find interesting and read on a regular basis.

The next two sections are both collections of feeds. These are RSS feeds to either chemistry journals or other chemisdtry related feeds. Clicking on these in non-RSS aware browsers will give a site that doesn’t look friendly. however, you can right click (or control click on Macs) to copy that feed and then paste it into your favorite RSS reader.

The middle section is where the main content is. After each post there is a list of the Technorati tags for this entry. This will take you to Technorati and show what other blogs have used the same tag. after that is an email link to contact the Ed Vawter; it will open a new email in your email application with the title of the post as the subject of the email. Next is Yahoo’s Possibly Related Stuff. This will give you a yahoo search of similar items to the post. It doesn’t always work well but can give interesting results. Next is the possibly related posts. This gives other posts in the blog that are similar. Then there is the bookmarkit section. This is a list of popular social bookmarking sights and automates adding this post to your bookmarks. The last line gives several options. Print This Post gives a printer friendly copy of the post to print out. Email It gives you the opportunity to send the post to someone else you think might be interested in the post. The last two items give you comments and a permanent link to the post.

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QDIS was founded in 2003 by Edward Vawter, PhD. We offer a variety of services including consulting, informational searches, and training courses. For those interested, the name comes from the Library of Congress classification code for chemistry information; QD.

About Edward Vawter

Edward Vawter brings well over a decade of experience in research and development in the pharmaceutical industry with both large and small companies. He has a PhD in organic chemistry from Purdue University and has been involved in the synthesis of multi-step complex pharmaceuticals including polymer drug conjugates through all stages of development. He has managed the outsourcing of development and manufacturing for multi-million dollar projects on an international basis. Edward also has five years of experience with development of polymer based drug conjugates as well as extensive analytical development knowledge related to polymers. He has experience with experimental design and data analysis; not only statistical analysis but also exploratory data analysis and building of models to represent behavior of chemical systems. His business experience as well as his solid technical background can help your company succeed.

Work Experience

10/03 to present President, QD Information Services LLC

• Responsible for all areas of operation for a consulting and information services business
• Attract and develop relationships with various potential clients
• Developed business plan for operations of the company
• Provide reports and data for clients on various topics related to science, marketing, and competitive intelligence.

08/98 – 12/03 Senior Staff Chemist, Cell Therapeutics, Inc.

• Responsible for planning the development work for poly-glutamate polymer-paclitaxel conjugate (CT-2103) for four years
• Participated and presented information for several due diligence potential partnerships
• Responsible for manufacturing campaigns under current Good Manufacturing Practice at various vendor sites
• Responsible for initial vendor audit and selection
• Extensive knowledge of the chemistry of Paclitaxel
• Responsible for chemistry manufacturing and controls CT-2103 cross functional group (analytical development, process development, formulation development, quality control, quality assurance, document control, Active Pharmaceutical Ingredient manufacturing, Finished Product manufacturing)
• Core team member for CT-2103 (poly-glutamic acid paclitaxel polymer conjugate) on cross functional team (regulatory, marketing, research, preclinical/toxicology, project management, clinical) representing manufacturing, and quality control
• Responsible for three years for multimillion dollar budgets directly related to manufacturing and development; indirectly responsible for tens of millions of budget dollars and came within 3% of budget

04/97 - 08/98 Senior Process Development Chemist, Synthetech

• Designed and refined synthetic schemes for the synthesis of specialty amino acids and peptide building blocks
• Optimized and improved existing synthetic sequences
• Executed synthetic schemes and clarified results both at bench scale as well as pilot plant scale
• Analyzed and interpreted information to decide the further course of projects
• Performed troubleshooting of operations in the pilot plant when problems occurred
• Pilot plant experience (22 L flasks and 50-500 gal reactors)

06/92 – 04/97 Research Scientist, Bristol-Myers Squibb

• Designed and refined synthetic schemes for the synthesis of key targets
• Optimized and improved existing synthetic sequences for utilization in a kilo-lab
• Executed synthetic schemes and clarified results
• Analyzed and interpreted information to decide the further course of projects

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