Wednesday, June 30, 2010

Keeping Pace with Electronic Health Records to Improve Clinical Research

Cross-posted from Pfizer's Think Science Now

Electronic health records (EHRs) have gained a great deal of attention in the United States, with financial incentives under the American Recovery and Reinvestment Act and expectations for quality and cost factored into healthcare reform.

But what about the potential for electronic health records to impact clinical research? How may EHRs impact our ability to match patients for trials, select optimal investigator sites, or even test the feasibility of our study protocols?

Many have seen great opportunity to improve clinical research by accessing these emerging databases. But they have been challenged by large amounts of data coming from disconnected systems each with limited access. Concerns have also surrounded how to ensure privacy.

Now Pfizer has joined with other leading research centers, pharmaceutical companies, and health information technology organizations to announce the formation of the Partnership to Advance Clinical electronic Research (PACeR).

This is another in a growing list of examples of pharmaceutical companies working together to address common challenges – PACeR includes Pfizer along with Johnson & Johnson and Merck. They are also joined by Quintiles, a contract research organization.

PACeR is about health data improving research, and so the partnership includes the Healthcare Assocation of New York State (HANYS) along with a dozen leading New York hospitals and medical centers. To ensure patient benefit while maintaining patient protection (including privacy), the partnership includes the Hastings Center and the Legal Action Committee. Additional PACeR partners include FDA along with CDISC and HL-7, the former to provide regulatory guidance and the latter two focused on sharing data and interoperability.

One of my colleagues at Pfizer – David Leventhal (Director of Health Informatics) has been instrumental in executing this vision and assembling this consortium. From David:

“Clinical research is one of the most critical aspects of getting innovative medicines to patients. It has been extremely challenging to conduct high quality clinical research on a timely basis. We see the PACeR initiative as a unique collaborative opportunity to move beyond talking about the challenge, and to fundamentally change the way clinical research is conducted. This is an effort and outcome where everyone wins.”

PACeR is a great example of working across organizations and institutions to create sustainable new models to improve clinical trial efficiency.

Emphasizing the potential impact across clinical research, Leonard Sacks, MD (Acting Director for the FDA Office of Critical Path) commented:

“In tackling issues such as the role of electronic health records in clinical research, the potential to personalize medicine using bioinformatics, and the safeguarding of medical privacy, HANYS’ Partnership to Accelerate Clinical Electronic Research has embraced the task and we enthusiastically support their effort.”

Monday, June 28, 2010

The Path to Personalized Medicine [NEJM]

Cross-posted from Pfizer's Think Science Now

NEJM: The Path to Personalized Medicine

My colleague in Regulatory Affairs, Dr. Sharada Truter, was good enough to share the following regarding a Perspective published last week in the New England Journal of Medicine:

FDA Commissioner Margaret Hamburg and NIH Director Francis Collins write that the initiatives will support the advancement of personalized medicine through rapid development, review and approval of safe and effective genetics-based disease therapies.

More specifically, the NIH initiative calls for the agency to invest in research that will support scientists’ efforts to translate genetic-marker discoveries into effective diagnostic tests and disease therapies, while the FDA’s program will work to develop an effective and timely pathway for the review and approval of new gene-therapy drugs.

The full-text of the NEJM article is available at this link.

Friday, June 18, 2010

FDA Commissioner's Keynote at DIA Annual Meeting

Cross-posted from Pfizer's Think Science Now

Earlier this week FDA Commissioner Dr. Margaret Hamburg delivered the keynote address at the 46th Annual Meeting of the Drug Information Association (DIA) in Washington DC.

Dr. Hamburg focused on two areas -- the need to strengthen FDA's regulatory sciences and the need for FDA to manage safety on a global basis.

Hamburg described regulatory sciences as "the critical bridge between biomedical research and the people who need those products." She noted how science and R&D are rapidly evolving with innovative products, citing examples such as stem cells, an artificial pancreas, and combination therapies. But she raised concerns about the agency's ability to keep pace in evaluating the safety and efficacy of these innovations. Hamburg called for academia, industry, and government to embrace the field of regulatory sciences noting that "We need new approaches. The truth is, this is not a task we can approach on our own."

She then expanded on the need to operate globally, noting the volume of food, drugs and devices being imported from abroad. Solutions from FDA include collaborations among the global regulatory community, harmonizing global regulatory requirements, and more frequent foreign inspections.

While on the topic of DIA, I would like to thank the organization for awarding me this year's Outstanding Service Award. DIA is an organization of over 18,000 drug development professionals from 80 countries, providing a neutral forum for sharing knowledge. I have supported DIA in a number of ways over the past decade, and have appreciated the opportunity to network with the global drug development community to test and share new ideas, improve how we do our work and ultimately impact human health.

(And while moving into tangents -- For those who follow me on Twitter it is true that I gave up my seat for the Chairman of the Federal Reserve on the Acela from Washington back to New York. Sitting in front of Mr. Bernanke for the 2 1/2 hour train ride, he quietly read his Kindle and failed to share any tips other than noting "There are no perks that come with my job!")

Public Release of Alzheimer’s Clinical Trial Data by Major Pharmaceutical Researchers

Cross-posted from Pfizer's Think Science Now

Today Pfizer along with other major pharmaceutical researchers announced a unique data sharing agreement for Alzheimer’s Disease (press release here, and media coverage here). This is another exciting example of collaboration among pharmaceutical companies to advance science and address unmet medical need.

Data from over 4,000 Alzheimer’s patients that participated in 11 industry-sponsored trials will be made available to researchers around the world (patient identifiers are removed to protect individual privacy). Each company will also use common data standards from CDISC to ease data sharing (a step that will also improve FDA review time).

Is this the beginning of a new era of collaboration to make progress against some of the toughest diseases?

Tuesday, June 8, 2010

As ASCO Comes To A Close, Special Thanks To The Medical Heroes

Cross-posted from Pfizer's Think Science Now

Today marks the final day of the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO). Meetings such as ASCO are an important gathering place for researchers, clinicians, and patients to share the latest data on new treatments. With high unmet medical need remaining for cancer patients, a great deal of energy and hope hovers over ASCO.

At this year’s meeting, Pfizer and other pharmaceutical companies shared data from experimental drugs and biologics for cancer of the lung, brain, and more.

This progress is a result of the dedication of researchers at Pfizer and our partners from academia and other companies, working side-by-side with physicians serving as investigators to understand how these new treatments work in their patients.

But a special thanks must also go to the patients who volunteer as participants in our cancer clinical trials.

We know that it takes partnerships to address diseases as important as cancer. Sometimes these are Partnerships of drug companies working together, such as the collaboration in cancer research between Pfizer, Merck, and Lilly announced earlier this year.

It also takes partnerships with patients. This is why we sponsor organizations such as CISCRP (The Center for Information & Study on Clinical Research Participation) a non-profit created to inform the public about clinical research. CISCRP created the Medical Heroes program to honor and thank those who have given by taking part in clinical research.

(We also have a partnership underway with Private Access to help inform patients about clinical trials; more on that later.)

Pfizer has over 100 cancer clinical trials underway. According to PhRMA, our industry has over 800 medicines and vaccines in testing against cancer. But all of this progress will stop if not for patients serving as participants – and Medical Heroes.

Information about clinical trial participation can be found at websites hosted by FDA and NIH.

To help find a trial you can contact the Pfizer Oncology Clinical Trial Information Service by phone (877-369-5793) or online ( The service is free and confidential.

Drug Development As We Know It Is Not Sustainable

Cross-posted from Pfizer's Think Science Now

Think Science Now is an exciting evolution for Pfizer enabling scientists and researchers to talk to you directly. There are no strings attached from Pfizer on this site. We are free to talk about most anything of interest. (There is a policy from Pfizer on blogging, but most of the rules are not unique to social media -- we can not talk about undisclosed information, off-label use of products, and other topics that are regulated by various government entities.)

I work in clinical research, and I am looking forward to engaging with you around my area of passion -- how we are innovating in drug development at Pfizer.

Some describe pharmaceutical R&D as highly innovative. In practice, much of our innovation happens in research when we are exploring a new target or a new way to impact a disease pathway. Clinical trials are highly regulated with many processes to ensure compliance. There is well-spent energy on operational excellence to do our work the best it can be done. But many do not see opportunities for innovation (either incremental or radical changes).

To continue to develop medicines as we have in the past is simply not sustainable. The time, cost, and complexity of developing new medicines is tremendous. And the strains on the pharmaceutical industry are featured in the business news on a regular basis. If we are going to continue to meet the needs of patients around the world, dug development as we know it has to change.

I have enough topics in my notebook to get us started. Add a comment below (or reach me on Twitter) to let me know the ideas you would like to see covered.