The service-oriented approach shifts the IT organization’s focus to providing services in a way that works best for the business. This is done by identifying services and levels of services to offer, establishing goals for managing the workflow and the organization’s resources, and creating a plan to implement the new model. For example, the organization would catalog the services it provides and benchmark those services and costs against outside competition. This helps the IT organization justify spending and funding. Another important aspect of this approach is to involve business leadership when managing and prioritizing the IT requests and projects. This takes the sole prioritizing duties off of IT’s shoulders and the requests/projects are considered from a business perspective. In this way, Rehac explained, the IT organization is set up to run as its own business.

As described in the presentation, this approach can lower costs because the focus is on efficiency and innovation; Merck’s IT group saved about $100 million in three years. Rehac reported that this approach has been a success so far at Merck, and that the company plans to implement a service-based model in several other internal service functions, such as human resources, facilities and finance.

It makes sense to run an internal service like this. So far it seems to be working for Merck, but Rehac did point out that it didn’t work for everyone. Apparently, “old-school” IT managers had trouble adjusting to this new system. A major overhaul like this can certainly take some getting used to. I’m interested to hear first-hand accounts of this kind of reorganization project. Does your company use a service-oriented approach in its IT department? If so, were you with the company as they made the change?

To read about how pharma manufacturers are integrating software and processes using service-oriented architecture, see “The New Biopharmaceutical Blueprint: Service-Oriented Architecture in Manufacturing” from Pharmaceutical Technology’s November IT Supplement.

With so much pressure, it’s no wonder harmonization efforts seem to be plagued by roadblocks. Sure, expert working groups and ICH reps continue to meet and put forward new or revised guidelines. But how “on board” are the regulatory bodies themselves? You know, the people actually responsible for implementing the harmonization guidelines once they come to fruition?

Take for example the Common Technical Document (CTD), signed off by the three ICH bodies (FDA, EU, and MLHW) eight years ago. The format is now standard for companies worldwide, but each region (and in some cases, each country) has individual supplements, annexes, etc. that have to be submitted with the CTD. So while the format is harmonized, the data or “meat” of the document is not, as pointed out by Baxter’s Kelly Davis at Interphex last week.

If the pharmaceutical industry and its regional regulatory partners truly want to harmonize, then there can’t be individual requirements. That only defeats the purpose of “harmonizing” efforts.

I used to work for an organization tied to the United Nations, so I understand how hard it is to bring people of different backgrounds and with different goals together to agree on one document or standard. But it is possible if people are willing to compromise. One major difference between UN delegates and Pharma reps of course is that revenue and competition play a much larger role in decision-making for the latter group. But at the end of the day, whether we’re talking about ending conflict or manufacturing anti-malaria drugs, safety should be on everyone’s mind. So with that in mind, is the pharma sector willing, or able, to compromise?

Posted by Michelle Hoffman for Hallie Forcinio, Packaging Forum Editor, Pharmaceutical Technology

The ELN can automate processes and make the job easier for a QA/QC department. The software can be customized to fit the procedures of a specific lab, including giving different users different levels of permission as in the case of a senior analyst having access to more functions than a junior analyst. Laboratory instruments can be registered in the system, which can provide information on each one used. For example, the system can warn users when an instrument is due to be calibrated. Calculations, data capture, and report generation can also be automated. Companies using the technology have reported increased productivity due to the time saved and the reduction of errors when using an ELN system. Paperwork is reduced, or eliminated, because data is entered and managed directly on wireless tablet PCs or wired workstations.

Come again?

Neway was as surprised by this response as I was. What do you mean there are too many other things to do? Neway argued that the result of the survey showed that the business case for QbD has not been made successfully.

So let’s give it a shot. QbD captures product and process data during the development cycle of the pharmaceutical process. These data help researchers (and, later, manufacturers) gain process understanding, which enables you to predict product-quality attributes. When process understanding grows, you gain process control. And risk decreases as well.

That sounds good, but what kind of risk are we talking about? Risk to the manufacturer, for one thing. When producers understand critical process variables, they can control them and reduce the amount of out-of-specification product they create. Consistent quality can be achieved, and downtime can be reduced. Let’s not forget the regulatory relief companies enjoy when they demonstrate understanding and control of their processes.

But patients also benefit from QbD. When companies can reduce out of spec occurrences, they also reduce the likelihood of patient adverse events. The ongoing saga of contaminated heparin illustrates the importance of understanding your process and your materials.

Let’s recap: QbD brings process understanding and process control. Process control increases efficiency, provides regulatory relief, and yields consistent quality. These results mean safe and effective products for patients, which likely translates into profits for the manufacturer.

It seems like pharmaceutical manufacturers don’t have an excuse not to make time for QbD.

Macrae emphasized the importance of external collaboration to the pharmaceutical industry as whole and to GSK specifically. Forty percent of GSK’s pipeline is derived from licensing, acquisition, or other types of partnering, he said, revealing how the pharma industry has become open to external collaborations.

With these partnerships, it is critical to “manage the marriage,” said Macrae to create a mutually beneficial relationship, emphasizing that “one size does not fit all” when working with partners of different sizes and resources.

David King, former CEO of BioRexis Pharmaceuticals, who also spoke at the keynote session, echoed that point from the perspective of a small biotechnology company. Pfizer acquired BioRexis in 2007.

King said that he began building his relationship with Pfizer and other pharmaceutical companies early in the company’s development and multiple years before the time the company was eventually acquired.

Both executives emphasized relationship-building and building an working environment in which both company’s cultures and processes can be assimilated into a successful collaboration.

What would you identify as critical success factors for external collaboration, including in outsourcing? Leave a comment below.

Although microscopy may be used for detecting contaminants, this method has certain disadvantages in terms of the time to perform the test and conduct the analysis and its dependence on the skill of the analyst in detecting the particles.

Using an optical particle counter based on light obscuration, it was possible to detect the particles and count the number of particles in sizes as low as 1.4 microns. The advantages of the approach was reduced time for testing, consistency of results, immediate data availability, and having a method that was independent of the technician’s skill level.

What type of methods do you use or suggest to use in detecting contaminants in inhaled drug products? Leave your comment below

The developer said that respiratory delivery is the vogue, as far as he can see. It makes sense, from a patient’s perspective. Aerosol delivery seems convenient, and it would likely encourage compliance.

Of course, the switch to respiratory delivery (e.g., from a solid oral dose) helps the drug company, too. It allows them extended patent protection for an old drug. Also, regulatory hurdles for a new delivery method are not as intimidating as they are for a brand new drug.

On the other hand, new delivery methods for old drugs can’t be a long-term solution for the industry. Another vendor reminded me that twenty years ago, everyone thought that transdermal delivery would leave everything else in the dust. No more pills to pop or injections to stick in your arm. Slap on a patch, and you’re a happy and healthy camper. Obviously, transdermals haven’t taken over the drug world, but they have supplemented companies’ options.

The vendor drew a parallel between transdermals and respiratory delivery. Although respiratory delivery has advantages for certain therapies, they won’t make other delivery methods obsolete.

For Big Pharma to stay competitive, it must return to innovation. The specialty pharma companies are creating the new drugs, according to the contract developer. Niche companies that are “three men and a molecule,” in his words, are producing the new drugs. Big Pharma has to figure out why these groups are successfully innovating products while they themselves flounder.

Stephens went on to describe how some 60 FDA investigators are undergoing PAT training this year so they can be better prepared for inspections (and ideally avoid a repeat of the validation inspection process of the 1980s and early 1990s when computer validation came into play). (I find it quite strange, by the way, that FDA has been rolling out and pushing PAT initiatives while still learning about it themselves. Seems like the order of things here is somewhat backward.)

Anyway, Stephens’ presentation focused on the benefits of PAT which ultimately come down to a company’s return on investment. Production life cycle time might be reduced by 40%, he said, with PAT applications. Multi-instrumentation might reduce process cycle time by 50%, electronic storage of information might reduce QA costs by 15%, and yield might increase with the help of design space and getting manufacturing right “the first time.” In addition, companies might be able to save millions of dollars by implementing PAT. For example, said Stephens, a $10b company that improves its efficiency by even just 1% can ultimately save $25m a year.

But what can’t companies bank on? “Regulatory relief.” The two little words FDA began throwing around when talks of QbD and PAT became mainstream. Those two little words soon transformed into “regulatory flexibility.” And now even those are heading out the door. It seems, from what I’ve heard in tidbits here and there at Interphex, that FDA needs to treat companies implementing QbD on a case-by-case basis. There won’t be a formal agreement or guideline coming anytime soon (or probably ever) that outlines the regulatory “relief” or “flexibility” that companies can expect. While cleaner audit trails and processes may make inspections smoother or quicker, points out Stephens, companies looking to start up PAT in their manufacturing units should probably focus on how they can save money with PAT, not get out of FDA oversight.

In the first category, speedy, design and manufacture, engineers who designed and built Pfizer’s plant in in Illertissen, Germany, and those who managed the project for Roche’s new facility in Basel, Switzerland, completed their projects four to six months ahead of schedule and remained under budget. Pfizer’s plant is almost totally automated, and requires only two human operators per shift, earning the plant’s engineering team the award for process innovation. The Roche project was completed in record time, earning its project manager the award for project execution.

Flexibility was a theme addressed by engineers and designers responsible for the New Brunswick, NJ, facility just constructed for Bristol-Myers Squib (BMS), and for Boehringer Ingelheim’s new plant in Biberach, Germany. The BMS plant, which won the award for equipment innovation, is configured to manufacture materials for clinical trials of  almost any type of product, small molecule, biological, or sterile in batch sizes ranging from 100 grams to 400 kilograms. 

Engineers responsible for designing the Boehringer Ingelheim facility, which won the award for facility integration, grappled with the problem of containment. The engineers designed the plant such that air curtains could surround a piece of equipment when it processes high-potency materials, eliminating the need to duplicate machinery inside and outside containment rooms.

Finally, the plant built for IDT Biologika GmbH in Dessau-Rosslau, Germany, which won the award for operational excellence, took a novel approach to constructing an entirely clean facility. They built it out of glass. That, they said, makes the plant literally transparent to inspectors and keeps plant workers mindful of the need to maintain sterile conditions.

Please click here for more detailed information about the awards and awardees.