Our intrepid contributor Emil Ciurczak is covering this week’s IFPAC 2010 show in Baltimore. What follows is his first installment, a brief summary of pre-conference activities:

A few weeks back we posted a list of the companies that were manufacturing H1N1 vaccines, and since that time many of them have been approved, either in the U.S. or abroad. Here's an update:

Animal rights groups have reportedly claimed responsibility for burning down a summer house belonging to Novartis' CEO, and desecrating the grave sites of his mother and another relative. More from a recent article in Security Management magazine. Other attacks have reportedly involved company employees. These are insane times.

And the first company to cross the finish line . . . is, unofficially, Protein Sciences Corp. of Connecticut, according to company CEO Dan Adams. What follows is the press release from AFP:

A US company that was awarded a 35-million-dollar contract
to develop an influenza vaccine using insect cell technology has produced a
first batch against (A)H1N1 flu, company boss Dan Adams said.

The Department of Health and Human Services (HHS) has awarded Novartis Vaccines a contract for up to a half-billion dollars over eight years to support the building and startup of a flu vaccine facility in Holly Springs, North Carolina.

Biswant Korrapati, CEO of Move Records which presents rapper Mekka Don (a trained lawyer), apparently used to work at Novartis. 

The Competing Globally track also featured a presentation on Quality by Design, made by Russ Somma, President, SommaTech LLC, who worked for several years at Novartis and is also an editorial advisor on PharmaQbD.com.  Mr. Somma joked that the industry never had quality by accident, "We don't just lumber along and wait to fall apart, but the question is: Did you ask the right questions at the right time?" There's a need to better define process needs and required capacity early on.

If you put credence in Swiss firm Covalence's annual ethics rankings, yes, GSK, BMS, and J&J are the most ethical companies in the Pharmaceuticals and Biotech sector. The list looks like this:

1. GSK

2. BMS

3. J&J

4. Abbott

5. Novartis

6. Roche

7. Boehringer Ingelheim

8. Astra Zeneca

9. Pfizer

The past few months have seen renewed vigor from FDA's DDMAC (Division of Drug Marketing, Advertising, and Communications) in scrutinizing manufacturers' claims of safety and efficacy. In particular, DDMAC has cracked down on makers and marketers of ADHD medications for their alleged false and misleading claims.

Ireland has had some setbacks recently, since Amgen postponed construction of a major biopharma plant in Cork.  Puerto Rico has seen some plant closures.  But for Singapore, so far, the news is all "expansion."

Novartis has recently built a tableting plant in Singapore and today disclosed that it will build a $700-million biopharmaceutical plant there.  For more, read on. Also learned recently that Brian Hanifin, Diovan Team leader at the company's U.S. Tech Ops is now leading the company's manufacturing team in Singapore. 

AMS