Tuesday, June 30, 2009

What Sapphire and SQL*LIMS Customers Can Expect from LIMS Merger

LabVantage announced today that it is purchasing Applied Bio's SQL*LIMS business. While he couldn't comment at length yet, LabVantage VP of Corporate Development Ron Kasner offered a few thoughts via email:

PharmaQbd: What is the plan for integrating SAPPHIRE and SQL*LIMS? How quickly will this happen?

R.K.: Until the closing date, both companies will operate in a business-as-usual mode. More information about the integration plan, including product integration will be available post closing.

PharmaQbD: What will SAPPHIRE customers likely to get that they didn't have before, from a technology standpoint? What will SQL*LIMS customers get?

R.K.:
All of our customers will gain access to a broader portfolio of software products and services, with our ongoing commitment to world-class customer service. We will continue to execute against our strategic product direction for SAPPHIRE. Our intent is to expand functionality within SAPPHIRE™ by leveraging the SQL*LIMS team’s domain knowledge and the robust product functionality within SQL*LIMS. At the same time, we will maintain our commitment to support the SQL*LIMS product and customers.

Sunday, June 28, 2009

Forbes: Scale is the Real Reason for Big Pharma Mergers

Interesting article from Forbes, which posits that the real reason that big pharma companies are merging is not to shore up their weak pipelines, but to increase their scale in order to increase the likelihood of bringing more products to market, faster, and in more parts of the world. No longer is approval by the U.S. FDA the preeminent goal for any drug, but rather getting approved in many markets as quickly as possible.

--Paul Thomas

Thursday, June 25, 2009

PDA Releases Dossier for Paradigm Change Initiative

PDA has instituted a new "Paradigm Change in Manufacturing Operations" (PCMO) initiative, based largely on encouraging ICH guidance within its organization and the industry. Here is the PCMO dossier, and we'll be following up with PDA in the near future.

--Paul Thomas

Tech Transfer Blues: U of Iowa Sues Abbott Over Humira

The University of Iowa's research arm has filed an intellectual property lawsuit against Abbott Labs, saying that the company had "willfully and deliberately" infringed on its patents that have been essential in the manufacturing of Humira. Abbott, not surprisingly, says it has done no wrong and will "vigorously defend" itself. GenomeWeb has the story. Stay tuned . . .

--Paul Thomas

Wednesday, June 24, 2009

Put Nashville in November on Your QbD Calendar

Over the years, AIChE's annual meeting has developed one of the strongest lineups of QbD sessions around. This year, from Nov. 9-13 in Nashville, is no different, headed by a plenary session featuring FDA's Christine Moore and Eli Lilly's Kevin Seibert. Here's a rundown of the QbD in Pharmaceutical Development and Manufacture sessions on tap: http://aiche.confex.com/aiche/2009/webprogrampreliminary/TI.html.

--Paul Thomas

Tuesday, June 23, 2009

How Conformia Will Help Oracle

Oracle's purchase of Conformia is sure to further enhance Oracle's growing reputation in the life sciences space. Here's one account of what the marriage will mean, as well as some thoughts from Agnes Shanley on Conformia's resurfacing after a dormancy.

--Paul Thomas

Explorations in QbD and Lab Automation

Tunnell Consulting's Sandy Weinberg has written a very nice two-part series for Scientific Computing on QbD for the laboratory:

Here are
Part 1
and Part 2.

--Paul Thomas