Pharma IT Moves Further Into the SaaS Era

Symyx has announced that it will begin offering its electronic laboratory notebooks in a hosted, software-as-a-service (SaaS) model. The company's press release suggests that this move is in response to economic pressures to offer cheaper, more flexible options, but the trend towards web-based IT offerings is one that will dovetail nicely with pharmaceutical companies' needs for better ways of integrating the work of their scientists worldwide.

The hosted Symyx Notebook will enable "medicinal chemists, synthetic chemists and biologists to manage, explore, share and reuse experimental information and intellectual property (IP). Using a hosted ELN service, R&D organizations can deploy and leverage the electronic notebook quickly and efficiently without added IT infrastructure and resources while collaborating more effectively with partners in today’s information-driven R&D environment."

Information security is a key concern, of course, which Symyx addresses in its announcement.

--Paul Thomas

The Challenges of Developing Alzheimer's Therapies

A quick note: From this month's Nature, an insightful look at the complexity of Alzheimer's Disease and the challenges (and limitations) of developing drugs that target the disease early enough in its progression to make a difference.

--Paul Thomas

Where Lies QbD's Competitive Advantage?

I've had the good fortune of speaking this week with Volker Eck, senior director of science and technology at PDA, and a day later with Graham Cook, Wyeth's senior director for process knowledge/Quality by Design. Both men were integral participants in late September's workshop in Frankfurt,  hosted by PDA, to unveil and discuss EFPIA's mock examples of Quality by Design implementation.

By all accounts, the mock examples were well received and the meeting was an important step toward helping manufacturers not just interpret ICH guidances but grasp how QbD might look for their products and processes. The mock examples are now being finalized, following input from the Frankfurt meeting and one earlier with EMEA in London, and are expected to be made public later this year.

You can read my summary of Eck's take on the meeting here, and I hope to have a podcast of my interview with Cook available within a week or two. Eck was insightful in that he said that many manufacturers at the Frankfurt meeting were still clearly struggling to "translate" the ICH documents, and the mock examples, to their own operations. With QbD, manufacturers can only truly learn by doing and thus will have to dive in

Studying Dogs Alongside Humans, to Develop Cancer Drugs for Both

National Cancer Institute researchers are undertaking a project to conduct comparative oncology drug trials in humans and dogs, with the hopes of providing an improved perspective upon how clinical drugs will perform in later-stage trials. An offshoot of the project is to accelerate the development of efficacious cancer drugs for dogs. The Comparative Oncology Trials Consortium maps out its mission in the Public Library of Science online. Here is some of the rationale behind their work:

Current drug development pathways are frequently unidirectional. Novel agents are assessed in conventional preclinical models of efficacy and toxicity before moving into human clinical trials where they either fail or succeed. Particularly with novel targeted therapies the conventional paradigms of toxicity studies conducted in healthy animals followed by Phase I and Phase II human trials leave unanswered many important questions on the “best use” of these drugs [6]. Translational drug development studies in pet dogs with cancer provide an opportunity to answer these questions by serving as an intermediary between conventional preclinical models and human clinical trials [7]–[9]. In these dogs, cancers develop naturally in the context of an intact immune system and with a syngeneic host and tumor microenvironment. Similar environmental, nutrition, age, sex, and reproductive factors lead to tumor development and progression in human and canine cancers. They share similar features such as histologic appearance, tumor genetics, biological behavior, molecular targets, therapeutic response, and unfortunately, acquired resistance, recurrence, and metastasis.

--Paul Thomas

QbD for Generics: Considerations and Questions

Quality by Design has great relevance for generic drug manufacturing, and this article is a summary of discussions held last summer with FDA's Lawrence Yu (of the Office of Generic Drugs) and Helen Winkle, and representatives of the generics industry. Most of the discussion deals with general thoughts and questions, and thus it's a useful overview of current understandings and questions surrounding Quality by Design for non-generics manufacturers as well.

--Paul Thomas

S-P'S Hassan: Small Developers Losing Clout, and Risk Losing Innovative Spirit

Speaking recently, Schering-Plough's Fred Hassan lamented the fact that small drug developers are not only seeing their market valuations decline, making them easier, less expensive takeover targets, but also that they face the prospect of losing their "innovation power" once they are swallowed up by larger companies. The comments were part of a longer speech by Hassan on the need to create more flexible pathways to bring cancer and other critical drugs to market sooner.

--Paul Thomas

What Lessons Will We Take Away from H1N1 Vaccine Development and Approvals?

Cutting Edge Information specializes in paid research reports for pharmaceutical decisionmakers, but yesterday sent out a press release not plugging a new report but simply opining on what lessons will be learned from the rapid and, it appears, successful development of new vaccines to tackle the swine flu pandemic. And what's to be gleaned from how quickly these drugs were approved by global regulators?

CEI raises some salient issues: if H1N1 vaccines can be successfully fast-tracked, shouldn't this open the door for more rapid and favorable regulatory review of oncology drugs and other products that clearly