Push vs. Pull: Finding Better Ways to Incentivize Development of Antibiotics

There's an excellent, balanced summary of the pros and cons of "push" and "pull" forms of incentivizing drug development (focused on antibiotics), by Kurt Karst on the FDA Law Blog. Karst quotes and links to a London School of Economics paper that urges governments to take more proactive roles in working with industry to establish viable incentives for those who develop promising antibiotic medicines, in light of "superbugs" and the issue of resistance to current antibiotics.

The report itself is exhaustive but worth a look. Don't be put off by the "Confidential" label at the bottom of each page, since the PDF is easily found in many places on the web.

Treasure Trove: Merck, Lilly, Amgen, Pfizer, and More from EMEA/EFPIA London Workshop

Milestones in the evolution and acceptance of Quality by Design were the recent meetings/workshops in London and Frankfurt bringing together regulators, industry professionals and other concerned parties (namely, EFPIA) to discuss the challenges confronting QbD and, more importantly, drilling down and assessing how QbD will play out for specific types of drugs, specific processes, and specific manufacturers--a growing recognition that there is no one-size-fits-all QbD--far, far from it.

What's also encouraging is that plenty of materials and presentations are being shared with the industry. The mock QbD examples that were the focus of the Frankfurt meeting (sponsored by PDA and EFPIA) will be made public in the coming months, following final revisions. (Click here for my discussion with PDA's Volker Eck on the key learnings from Frankfurt.)

Now, the key presentations from the EMEA/EFPIA meeting in London have been posted to the web. (Thanks for Alicia Tebar Perez of dTC Consulting for calling our attention to this.) Included are contributions from Gert Thurau of Merck, Pfizer's Liz Coulson, Wyeth's Graham Cook, Lilly's Martin Diller, and others. Enjoy!

Should We Call It an ELNLIMS?

We won't call it the holy grail, but the announcement by Thermo Scientific and Symyx regarding the release of an integrated LIMS/ELN product is a significant step towards a fully integrated, electronic laboratory. Researchers should have more power and functionality at their fingertips, with fewer obstacles towards accessing and sharing data. That spells more efficient development efforts.

In a press release last spring announcing the Thermo-Symyx partnership, Symyx president Trevor Heritage boasted that lab professionals will have the “ability to record and execute experimental protocols, capture results, access and analyze data, build reports and collaborate with colleagues seamlessly."

Given that it's now just six months since the partnership was announced, clearly there will be bugs to be worked out of the new offering, but that's to be expected.

Another intriguing question: What do we call something that combines a three-letter and four-letter acronym? ILMS (Integrated Lab Management System)? I'll have a chance to speak with representatives of both

Lessons Learned from 20 Years of Drug Development

Have the past 20 years been a bit hazy for you, or perhaps you'd just like a reminder of what we've learned from drug development's successes and many failures? Deloitte is hosting a free webinar on Nov. 10 on the lessons of the past couple decades.

--Paul Thomas

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