Hoffman-LaRoche has decided to end its relationship with PhRMA, the industry's largest and most influential lobbying group, in favor of BIO, the biotech industry organization. The move speaks volumes about not just Roche's plans for the future and how it wants to be seen and represented, but also about the ongoing shift of the industry's power base from big Pharma to biopharma.

Roche has begun to make cuts at Genentech, in South San Francisco and at other sites. Roche maintains that it plans to cut "little or no" manufacturing workers.

--PWT

It's always fun to have a look inside any new facility. Roche has posted an album of photos from the newly opened galenical production facility near Basel. They're not all great shots (plenty of people standing around in suits), but plenty of facility photos as well.

--PWT

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 weeks have seen a dramatic increase in mergers and acquisitions, with the generic drug manufacturer Teva buying Barr and Roche bidding for Genentech.  Frost & Sullivan analyst Rhenu Bhuller, pharma industry VP, shared these perspectives. Click here to watch brief video.

 Installment 3 (and, no, sorry, that is not me)

ISPE announced the Facility of the Year 2007 winners at its annual meeting in Las Vegas.

One of our competitors is part of this competition, but there is room for many awards in this sphere. Excellence is excellence, and the Facility of the Year winners have changed the way they handle facilities operations and engineering projects, particularly Genentech, whose NIMO (for New Idec Manufacturing Operations, if you must go there) project in Oceanside, California, won first place this year.

Teamwork has been essential to the project's success, but also helped the company get through the recent California fires. In accepting the award, Genentech’s vice president and general manager of the Oceanside facility, David Broad praised all his colleagues, particularly [apologies if I have misspelled anyone's name] Christophe Label and Victor Vasquez (on the project side), Johannes Robers (who has since left the company), as well as contractors including DPR, CRB Engineering.

"We had three owners and three different processes during the course of this project, but we had great teamwork, “ Broad said.  Apparently, that teamwork came into play recently during the fires, when one quarter of the company's staff had been evacuated. "Despite challenges, we kept operating," Broad said.

At the opening of the Las Vegas meeting, Clive Mullins, Chair of Facility of the Year committee, announced the competition’s groundrules and categories, the winners for 2007 and why they won.

Below, a distillation:

As he said, the awards recognize facilities and projects that use innovative technologies to improve quality and lower production cost. Eligible are any and all pharmaceutical and biopharma facilities that began operation between January 2005 and December 2006… new freestanding facilities, additions, or interior renovations.

Overall categories are:

• Process Innovation
• Project Execution
• Equipment Innovation
• Facility Integraton
• Energy Efficiency
• Operational Excellence

"It’s not a beauty contest,� Mullin asid. “We’re trying to identify innovation and recognize it. He also mentioned that companies needn’t build anything to qualify for the Op Ex Award." (Aside - COPYCATS!)

The team of judges this year was led by Andrew Skibo of Amgen, and entries came from 20 countries.  And the winners are...

Project Execution
Genentech Oceanside Product Operations, NIMO, in Oceanside California, developed an innovative project delivery, “hybrid design build� in which civil, architectural and structural engineering are executed via the traditional design, bid build method, and mechanical, electrical process and instrumentation and controls are completed using the design-build model. The project made use of advanced technology including superskids, wireless technology. Its layout also made maximum use of grey space…

Especially significant was the fact that the facility changed ownership and product focus several times during the scope of this project, yet the team was able to deliver to each owner (Idec, for Tysabri and Genentech, for Avastin) ahead of time and on budget. The plant now produces the cancer therapy Avastin at the facility, and will also manufacture Rituxan, a non-Hodgkins lymphoma treatment.

Equipment and CIP processes are dedicated for each functional area within the facility, and CIP is fully automated, while buffer preparation and storage and valves have been designed to enhance flexibility.

 

Regional Excellence for Project Execution
Shanghai Roche High Potent Production Project (SHIP) – This project was awarded because of its innovative use of technology to ensure dust containment at all workstations. The budget for this project was extremely limited by U.S. standards, at just over $16 million, yet the facility was able to meet international safety standards and to be completed in a short timeframe, despite cultural, geographical, and language barriers entailed.

Equipment Innovation
Taiyo Pharma Industry Co. won for a prefilled syringe manufacturing facility in Takayama city, Japan.The facility uses innovative technologies, including RABS, SCADA systems, and an advanced monitoring system for coated silicon….various apparatuses are used to inspect dimensions, shapes and tip strength. Transfer preventing direct human intervention….

Process Innovations
Vetter Pharma Fertigung won for its contract filling facility (liquid and lyophilized drugs), which uses automation extensively, as well as RABS.

Facility Integraton
Cook Pharmica LLC won for incorporating disposable technologies throughout the manufacturing area. Dubbed “Project Phoenix,� this $70-million project involved facilities that had been abandoned by a television assembly plant before Cook acquired them.

Hallmarks of the project included: unidirectional flow of operators, equipment, supplies and product, use of web cameras, client-dedicated offices and viewing corridrdors providing clients the ability to view production from any location.

There were apparently no winners in either of the following categories: Energy Efficiency or Operational Excellence

Our congratulations to all the winners and others who participated.

Some observers in the non-engineering or science portion of the industry, including the whistleblower behind the PharmaFraud blog, have commented that the award seems boring. 

Well, it may seem that way to the uninitiated, but drugs are not made by some invisible band of globally dispersed Oompa Loompas. This work is bringing down the cost of medications and will make them more accessible throughout the world so...

Hurray for the winners, and to the sponsors for an important award that, despite the "Facilities" in its name, recognizes the people behind drug manufacturing.

For more on Wyeth's Prevnar team and others who won the 2007 Pharmaceutical Manufacturing Team of the Year award, click here.

AMS

The Financial Times reported yesterday that Boehringer-Ingelheim and Roche have both had to recall drugs in the U.S. and Europe within the past few weeks due to manufacturing quality issues. 

Roche recalled its HIV treatment, Viracept, in Europe and some developing nations a few weeks ago because the drug contained chemical impurities, and higher than normal levels of methane sulfonic acid ethylester.

B-I's recall  of its pet arthritis drug, Synoquin, is particularly interesting, since it was reportedly motivated by a competitor, the Nutraceuticals supplier Vet Plus.  Vet Plus ran lab tests on the B-I product which found that it contained less than the required amount of active ingredient.

...More arguments for use of process analytical technologies during manufacturing.

But, as competition in the industry intensifies,  could more companies adapt Vet Plus' "guerilla" pharma marketing strategy? Analyze the competitor's product,  then publicize any quality problems discovered... cGMPs as marketing tool...

When it comes to human rights, what responsibility does, or should, a bio company have? An entire session was devoted to trying to answer that question yesterday at BIO 2007. The question is already complicated but will only get more so in the future , agreed an expert panel consisting of companies, professors and associations.

Human rights must really be considered as including many separate issues. According to George Annas, a professor at Boston University, working conditions, non-discrimination, and child labor are fairly easy for most companies to address. Far more difficult is the issue of"right to health" and determining essential needs for patients. In the bio industry, the controversial topics of cloning  and stem cell research are adding additional complexity.

Jeffrey Elton of Novartis explained that right to health should really be addressed by the state and international community. Novartis, he said, feels that the company has a complementary responsibility but that the real work must be done through governments.

As far as its own employees are concerned, Elton says Novartis has a  benchmark for a "living wage" at all its facilities that is established by an outside organization to sufficiently meet family needs in each given location.

For questions of world health,  Novartis has established the Novartis Institute for Tropical Disease to work on Leporsy, Malaria and TB. According to Elton, Novartis spends a little over 2% of sales to fight these diseases.

Finley Austin of Roche agreed with Elton that human rights is a societal issue and society is represented by governments. Roche tries to be responsible by not enforcing patents (e.g., for HIV drugs) in developing countries, by protecting the environment and by actually showing third world nations how to make the drugs and transfer the technology.

Steven Holtzman of the small, startup bio company Infinity Pharmaceuticals saw things a little differently. He feels companies have a responsibility to make important drugs reasonably priced so all can benefit. As he pointed out, this was easy for him to say because none of his drugs have been approved yet.

Simon Best of the Bioindustry Association (UK) says that it is important that even small companies not cut corners when developing drugs. "You can't do human experiments (clinical trials) on the cheap." He also doesn't want to see politics get in the way of scientific advances. He feels that this is what has happened to the European Court of Human Rights, where people don't try to fight their cases on legal grounds. But he doesn't want the UN - the guardian of human rights law -  to go down this path. He points out that in 2002, Bush made cloning a political issue with the UN.

All the panelists agreed that basic human health is important, but exactly what constitutes this basic health is open for debate. Are sanitation, clean water and nutrition the most basic needs? Because you make money selling drugs, do you have a special obligation to the public that for example, a car manufacturer or oil producer doesn't?

 Bill Swichtenberg