Archive for the 'INTERPHEX 2008' Category

Don’t Argue with Steven Burrill about the Cost of Wellness

hoffman.jpgSteven Burrill, head of one of biotech’s earliest and largest sources of venture capital, shared his vision of the healthcare landscape in the future in his keynote address, entitled, “Biotech 2008: A 20/20 Vision to 2020.” Pointing out that US consumers spend some $200 billion each year on wellness products, without having a single penny of that reimbursed, Burrill intoned, “Don’t ever argue with me that we’re not willing to spend money on wellness.”

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Plug and Play Skid Workshop

Alexis Brekke Pellek PharmTech editorIn a Wednesday afternoon Technology Enablers session at INTERPHEX 2008, Scott Sommer of Jacobs Engineering Group presented a workshop titled “Automation of ‘Plug and Play’ Process Skids and Components.” The central question was: what if your automation system understood the device that you just plugged in? Read more »

Global Outsourcing by Virtual Companies

Patricia Van Arnum Pharmtech editorThe factors to consider in outsourcing by a virtual pharmaceutical company were addressed by Zhengming Chen, senior director of chemistry and CMC of Dov Pharmaceutical in his presentation, “Optimized R&D Outsourcing Business Model: From PreClinical to Development: A Case Study,” at Interphex. Read more »

The Purpose Behind Continuous Improvement

drakulich.jpgFred Larimore’s (Cook Pharmica) presentation at Interphex 2008 covered continous improvement and the role QbD and quality risk management play. He gave great examples of how a pharma company can increase througput and capacity, while saving time and reducing costs. As part of his talk, he defined “continuous improvement” as “reducing cost,” and pointed out that industry needs to realize our endgame is all about fixed costs in today’s environment and economy. Read more »

INTERPHEX Sessions Explore QBAS and 2D Barcoding

Alexis Brekke Pellek PharmTech editorINTERPHEX 2008 kicked off today, and I spent the morning attending two sessions from the conference’s Technology Enablers track.

The first, “The Role of Industrial Automation in Qualified & Non-Qualified Building Automation Solutions,” discussed the importance of a validated environment. Joe Evans of Rockwell Automation said in his presentation that ”QBAS” is the big buzzword right now. Treating this the same way you treat your process can be beneficial when it comes to validation–you only have to vaildate one system if you use a common platform. Read more »

Industry Doubts About Harmonization

drakulich.jpgI attended a session this morning at Interphex 2008 and the speaker pointed out that there are clear doubts among industry about harmonization. Will all three regions–the US, Europe, and Japan–really be able to pull off this massive effort? Industry doubts about harmonization have been around since, well, the idea of harmonization was introduced, but what is interesting to consider, is, does it matter? If FDA is fully behind harmonization and QbD, specifically ICH Q 8, Q9, and Q10, it may not matter whether or not Europe and Japan are also on board.

One case in point, I recently toured a manufacturing facility overseas that’s about half-way built. They have had a few inspections already and are gearing up for more before they become fully operational. I asked the manager which inspection he was most fearing–FDA’s, the UK’s, or any of the other national inspectors that may be stopping by to take a look around. He answered, “Well, FDA’s inspection is really the only one that matters.” And this was coming from a UK company at a UK plant.

If this is the feeling among plant managers worldwide, how important is harmonization? Now I’m not trying to downplay the importance of harmonization–in fact, I fully support it. In this global industry, global collaboration is a must. But playing devil’s advocate for a minute here, what if everyone just followed FDA’s rules and took its approvals or nonapprovals as final word?

Adding Flexibility to Containment in Bulk-Solids Handling

Patricia Van Arnum Pharmtech editorFlexibility in bulk-solids handling is an important trend in pharmaceutical manufacturing of active pharmaceutical ingredients and dosage forms, an issue addressed by Richard Denk, director of the pharmaceutical department for Hecht Anlagenbau (Pfaffenhofen/Ilm, Germany) at the conference session, “Disposable Containment Technologies for Bulk Solids,” at Interphex. Read more »

Attendees’ Forum

Do you have a general comment about INTERPHEX 2008? Feel free to let us know about it. Here’s what INTERPHEX attendees are saying about the show…

From Chuck at Burns Eng’g | cbragg@burnsengineering.com | burnsengineering.com/BEblog |

Awesome!!

It is a thrill to see the blog activity form INTERFEX2008! The list of presentors and exhibitors does read like a “Who’s Who” of the Biopharma world. Burns Engineering is excited to be part of the swirl.

There is a P.I.A. agent roaming the Exhibit floor. (visit: BEblog at: www.burnsengineering.com/BEblog/. He doesn’t represent any of the classic Standards setting or regulating organizations. His goal is to create interaction and conversation on the various challenges and issues that the Pharma industry deals with day to day. It’s Burns’ objective to engage in creative solutions from a temperature measurement point of view to assist in the success of others dealing with these challenges.

From the Interphex web site I noticed this statement:
“…accelerating regulated products for patient care globally.”

It is a profound opportunity to see so many organizations concerned about caring for others on a global scale.

Thanks for the commitment.Chuck Bragg
Burns Engineering: www.burnsengineering.com/BEblog

Welcome to PharmTech’s INTERPHEX Blog

hoffman.jpgINTERPHEX for our industry is like the Academy Awards to the movie business or the Detroit Car Show to the automotive industry. It’s an event that manufacturers and industry experts plan for all year. We at Pharmaceutical Technology are no different. We produce a special issue that includes a foretaste of the exhibitions and conferences one can expect to see, and we do a wrap-up both in print and online following the conference.

But those reviews cannot possibly capture the sensation of being at the event itself—no more than Read more »

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