tag:blogger.com,1999:blog-62360607887870487932024-03-05T13:47:30.348-05:00Pharma●SherpaGuiding drug development along the treacherous path toward the future
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By Craig LipsetThe PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.comBlogger31125tag:blogger.com,1999:blog-6236060788787048793.post-90159791650861117072010-08-04T17:26:00.003-04:002010-08-04T17:34:26.264-04:00Thanks! PharmaVOICE 100 Most Inspiring in the Life Sciences<a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjSL8Kmmf9NaAXaeQV_InHhlAHWlhgD9-svwKoO213p7YAsU18R78-5O-fw8g0qwox4Gi98Q8dTd_iLjGBAKbr-sfUvV2shP3-vDxWuKyglzMG6_F-G_bS4Qum2_nIBAeTNzibOCCBlXKUt/s1600/PV100.jpg"><img style="float: right; margin: 0pt 0pt 10px 10px; cursor: pointer; width: 70px; height: 70px;" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjSL8Kmmf9NaAXaeQV_InHhlAHWlhgD9-svwKoO213p7YAsU18R78-5O-fw8g0qwox4Gi98Q8dTd_iLjGBAKbr-sfUvV2shP3-vDxWuKyglzMG6_F-G_bS4Qum2_nIBAeTNzibOCCBlXKUt/s200/PV100.jpg" alt="" id="BLOGGER_PHOTO_ID_5501671257266052914" border="0" /></a><br />Very appreciative to be listed among the <span style="font-weight: bold; font-style: italic;">100 Most Inspiring in the Life Sciences</span> at <a style="font-style: italic;" href="http://www.pharmavoice.com/">PharmaVOICE</a>. They have a pretty diverse line-up, from CEOs to R&D to marketing and more.<br /><br />If you have known me for years but are still not exactly sure what I do (or why I do it), it's a nice write-up available <a href="http://viewer.zmags.com/publication/0ea8baed#/0ea8baed/112">online here</a> (the kind that would make my grandmother proud!).<br /><br />Thank you <span style="font-style: italic;">PharmaVOICE</span>!The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-58637082236266131692010-07-23T10:34:00.001-04:002010-07-23T10:36:27.835-04:00ePatients and Clinical Trials<div class="entry"> <p style="text-align: left;"><span style="font-weight: bold;">Cross-posted from Pfizer's <a href="https://science.pfizer.com/content/epatients-and-clinical-trials/"><span style="font-style: italic;">Think Science Now</span></a></span><br /></p><p style="text-align: left;"><br /></p><p style="text-align: left;">The rise of the e-patient brings great opportunities — and some unique challenges — to clinical research and the conduct of clinical trials.</p> <p><strong>Rise of the e-Patient</strong></p> <p><strong> </strong>Much has been written elsewhere about the rise of the e-patient. The white paper <a href="javascript:externallink('http://e-patients.net/e-Patients_White_Paper.pdf')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://e-patients.net/e-Patients_White_Paper.pdf');">“e-Patients: How They Can Help Us Heal Healthcare”</a> defines the e-patient as “a new breed of informed health consumer, using the Internet to gather information about a medical condition of particular interest to them.” Tom Ferguson MD, lead author of the e-patient white paper, described the e-patient as “empowered, engaged, equipped and enabled.”</p> <p>Some key points about the e-patient:</p> <p><em>e-Patients Are Everywhere</em></p> <p style="padding-left: 30px;">According to <a href="javascript:externallink('http://www.pewinternet.org/Reports/2009/8-The-Social-Life-of-Health-Information.aspx')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.pewinternet.org/Reports/2009/8-The-Social-Life-of-Health-Information.aspx');">Pew Research Center’s Internet & American Life Project</a>:</p> <blockquote> <ul><li>61% of American adults look online for health information (the “e-patient”)</li></ul> <ul><li>60% of e-patients say they or someone they know has been helped by following medical advice or health information found on the internet (just 3% say they or someone they know was harmed)</li></ul> </blockquote> <p><em>e-Patients Are Organized</em></p> <p style="padding-left: 30px;">Last year <a href="javascript:externallink('http://participatorymedicine.org')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://participatorymedicine.org');">The Society for Participatory Medicine</a> was formed to organize a field defined as “a movement in which networked patients shift from being mere passengers to responsible drivers of their health, and in which providers encourage and value them as full partners.”</p> <p><em>e-Patients Are Not a Fad</em></p> <p style="padding-left: 30px;">Earlier this year, the National Library of Medicine hosted their 2010 conference <a href="javascript:externallink('http://www.fnlm.org/Events-2010-Conf.html')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.fnlm.org/Events-2010-Conf.html');">“The ePatient: Digital and Genomic Technologies for Personalized Health Care”</a>. Leaders from academia and government agencies gathered at the National Institutes of Health (NIH) to discuss the implications of genomic, digital and wireless technologies – increasingly patient-facing tools – in the context of comparative effectiveness, innovation and personalized medicine.</p> <p style="padding-left: 30px; text-align: left;">In many ways, the e-patient is the future. Their rise brings disruptive change in the delivery of healthcare, and brings similar implications for clinical trials.</p> <p><strong>e-Patients Are Organizing Around Clinical Research</strong></p> <p>Today, many patients participate in a variety of online communities. As the <em>New York Times</em> noted earlier this year (<a href="javascript:externallink('http://www.nytimes.com/2010/05/30/business/30stream.html')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.nytimes.com/2010/05/30/business/30stream.html');">“When Patients Meet Online, Are There Side Effects?”</a>), in some of these communities patients have moved beyond chatting or posting free text. Patients are increasingly sharing structured, longitudinal health information with one another. This structured information is databased and used for searching, but is also aggregated and available for research.</p> <p>In these communities patients are essentially initiating their own research (prompting buzzwords such as Research 2.0 and Crowdsourced Research). They are filling out forms that look very much like the case report forms (CRFs) used in academic clinical research studies. But the patients are not waiting for academics or industry to take interest in their disease – they are self-organizing, collecting data, and analyzing the resulting database. In some cases, these communities have even <a href="javascript:externallink('http://www.ncbi.nlm.nih.gov/pubmed/19353722')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.ncbi.nlm.nih.gov/pubmed/19353722');">published results in peer-reviewed journals</a>.</p> <p>We may be seeing the tip of the iceberg in patient communities publishing scientific findings. Earlier this month, one organization published a paper entitled <a href="javascript:externallink('http://www.plosgenetics.org/article/info:doi/10.1371/journal.pgen.1000993')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.plosgenetics.org/article/info:doi/10.1371/journal.pgen.1000993');">“Web-Based, Participant-Driven Studies Yield Novel Genetic Associations for Common Traits”</a> in PLoS Genetics. The study was described as a novel participant-driven research program, building a community of patients sharing both self-reported clinical data and genetic information.</p> <p>Patients sharing data in a community are conducting a form of clinical research, but this should <em>not </em>be confused with a clinical trial. Clinical trials involve prospectively defined protocols (including eligibility criteria and other rules) and participants are often randomly assigned to one of several treatment options. Data generated by patient communities are an important step in the continuum of evidence and knowledge, but may be difficult to compare to a randomized clinical trial.</p> <p><strong>e-Patients: Opportunities (and Challenges) for Clinical Trials</strong></p> <p>While e-patients themselves are gathering in communities and may be generating their own research findings, they also bring potential opportunities and challenges for traditional clinical trials.</p> <p style="padding-left: 30px;">Patient community initiated research is different from a clinical trial (as noted above), but the roles and tools may be very similar:</p> <ol style="padding-left: 30px;"><li>Both rely on an engaged patient as a participant</li><li>Both rely on the participant being interested in self-tracking and reporting</li><li>Both rely on the participant being willing to share data</li></ol> <p><em>#1. The engaged e-patient as a clinical trial participant</em></p> <p style="padding-left: 30px;">The most often-cited opportunity with e-patients in clinical trials is around engagement – reaching these patients, informing them about clinical trials, recruiting them to participate. There are many companies offering services in this space, and a seemingly endless number of conferences on the topic. As an example, Pfizer has <a href="https://www.pfizer.com/research/research_clinical_trials/find_a_trial.jsp">a website</a> to help patients match for trials, is <a href="javascript:externallink('http://www.youtube.com/user/PfizerClinicalTeam')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.youtube.com/user/PfizerClinicalTeam');">using YouTube</a> to share information with potential participants, and is <a href="javascript:externallink('http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20090819005806&newsLang=en')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20090819005806&newsLang=en');">building an online community</a> to increase awareness and connect patients to investigators while ensuring privacy. Certainly online patient engagement is one tool to reach patients in support of trial recruitment. But this will not be a silver bullet, and should be considered one of many tools used to execute a recruitment strategy.</p> <p><em>#2. The participant self-tracking (quantified-self)<br /></em></p> <p style="padding-left: 30px;">There is an exciting trend in healthcare described as ‘quantified self’ – well described in <a href="javascript:externallink('http://www.wired.com/medtech/health/magazine/17-07/lbnp_knowthyself')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.wired.com/medtech/health/magazine/17-07/lbnp_knowthyself');">Wired magazine</a> and online at <a href="javascript:externallink('http://www.quantifiedself.com/')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.quantifiedself.com/');">QuantifiedSelf.com</a> characterized by individuals who self-track a range of information about themselves (often in the context of measuring their health and wellness). Many of the tools these self-trackers are using begin to resemble the electronic patient reported outcomes (ePRO) or electronic diaries we look to use in clinical trials, just requiring validation.</p> <p><em>#3. Participants sharing their health data</em></p> <p style="padding-left: 30px;">Similar to patients sharing data in online communities, clinical trials have always been dependent upon the participant being willing to share data to improve scientific knowledge and public health, often without any direct benefit conferred back to the participant. Today’s e-patient, however, is highly engaged and informed in their health, appreciating their role as owner of their own health data.</p> <p><strong>Understand the Risks</strong></p> <p>The e-patient who advocates being an informed participant in their healthcare, may not be comfortable with many traits of a randomized and blinded clinical trial. This raises unique challenges:</p> <ul style="padding-left: 30px;"><li>How can we keep the e-patient engaged in a clinical trial if we are unable to share traditional “participatory” information (or even their treatment assignment)?</li><li>What happens when the e-patient is engaged with communities of patients online? Are they sharing information that may provide clues to treatment assignment? Are they sharing suspected adverse events (that may create a cascade of other participants reporting symptoms)? How does the pharmaceutical sponsor educate the study participants, or monitor or engage in this conversation?</li><li>Is the e-patient more likely to show a response to placebo (because they are more highly engaged in their health)?</li></ul> <p>I have seen online patient communities with threads dedicated to discussing participating in specific studies. Some of these discussions have included:</p> <ul style="padding-left: 30px;"><li>Coaching on how to adjust certain subjective tests to meet eligibility criteria</li><li>Sharing potential symptoms that may indicate who is on active drug (vs. placebo)</li></ul> <p>The e-patients in these instances are doing what they do best – sharing information with one another. But the scientific implications for the study can include enrolling ineligible patients, unblinding, and influencing adverse event reporting rates. Disrupting the ability to answer important questions is not in the interests of the study sponsor, investigator or the participant.</p> <p><strong>New Opportunities, New Horizons</strong></p> <p>Moving forward we cannot ignore the role of the e-patient in a clinical trial.</p> <p>Some questions to consider:</p> <ul style="padding-left: 30px;"><li>How can we participate in the online discussions and communities to answer questions about studies? Can we educate participants about online conversations that may impact the scientific integrity of the study?</li><li>Are there new opportunities for engagement with the e-patient that can help to mitigate some of the sacrifice they are making serving as a blinded participant? Specifically: <ul><li>Can we bridge the gap between the tools a self-tracking e-patient (“quantified self”) is using and the validated tools we are using in clinical trials?</li><li>How can we best share the learnings from a clinical trial back with the participant?</li></ul> </li></ul> <p>There are clearly more questions than answers. But there are incremental solutions underway. One example is Pfizer’s work with the Center for Information & Study on Clinical Research Participation (CISCRP). Working together, Pfizer and CISCRP <a href="javascript:externallink('http://www.ciscrp.org/professional/participant/newsletters/may10/ParticipantMay2010.pdf')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.ciscrp.org/professional/participant/newsletters/may10/ParticipantMay2010.pdf');">recently demonstrated a new way to share clinical research learnings and results with participants</a>. This should be just the beginning of a new relationship between participants and clinical trials.</p> </div>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com5tag:blogger.com,1999:blog-6236060788787048793.post-87098463290808316582010-06-30T09:17:00.001-04:002010-06-30T09:19:36.576-04:00Keeping Pace with Electronic Health Records to Improve Clinical Research<div class="entry"> <p><span style="font-weight: bold;">Cross-posted from Pfizer's <a href="https://science.pfizer.com/content/keeping-pace-with-electronic-health-records-to-improve-clinical-research/"><span style="font-style: italic;">Think Science Now</span></a><br /></span></p>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. <p>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?</p> <p>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.</p> <p>Now Pfizer has joined with other leading research centers, pharmaceutical companies, and health information technology organizations to announce the formation of the <a href="javascript:externallink('http://www.pacerhealth.org')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.pacerhealth.org');">Partnership to Advance Clinical electronic Research </a>(PACeR).</p> <p>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.</p> <p>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.</p> <p>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:</p> <blockquote><p><em>“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.”</em></p></blockquote> <p>PACeR is a great example of working across organizations and institutions to create sustainable new models to improve clinical trial efficiency.</p> <p>Emphasizing the potential impact across clinical research, Leonard Sacks, MD (Acting Director for the FDA Office of Critical Path) <a href="http://www.pacerhealth.org/media/pdf/2010-06-14_pacer.pdf" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.pacerhealth.org/media/pdf/2010-06-14_pacer.pdf');">commented</a>:</p> <blockquote><p><em>“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.”</em></p></blockquote> </div>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com27tag:blogger.com,1999:blog-6236060788787048793.post-75415614878726510402010-06-28T20:22:00.002-04:002010-06-28T20:24:52.897-04:00The Path to Personalized Medicine [NEJM]<p><span style="font-weight: bold;">Cross-posted from Pfizer's <a href="https://science.pfizer.com/content/the-path-to-personalized-medicine-nejm/"><span style="font-style: italic;">Think Science Now</span></a></span></p><div class="entry"> <p><a href="http://content.nejm.org/cgi/content/full/NEJMp1006304v1"><strong></strong></a><strong><a onclick="javascript:pageTracker._trackPageview('/outbound/article/http://content.nejm.org/cgi/content/full/NEJMp1006304v1');">NEJM: The Path to Personalized Medicine</a></strong></p> <p>My colleague in Regulatory Affairs, Dr. Sharada Truter, was good enough to share the following regarding a <em>Perspective </em>published last week in the <a href="http://content.nejm.org/cgi/content/full/NEJMp1006304v1" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://content.nejm.org/cgi/content/full/NEJMp1006304v1');">New England Journal of Medicine</a>:</p> <blockquote><p><span style="color: rgb(51, 51, 51);">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.</span></p> <p><span style="color: rgb(51, 51, 51);"> 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.</span></p></blockquote> <p>The full-text of the NEJM article is available at <a href="http://content.nejm.org/cgi/content/full/NEJMp1006304v1" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://content.nejm.org/cgi/content/full/NEJMp1006304v1');">this link</a>.</p> </div>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com2tag:blogger.com,1999:blog-6236060788787048793.post-54960725420539499852010-06-18T10:10:00.006-04:002010-06-18T15:21:55.808-04:00FDA Commissioner's Keynote at DIA Annual Meeting<p><span style="font-weight: bold;">Cross-posted from Pfizer's </span><a style="font-weight: bold;" href="https://science.pfizer.com/content/fda-commissioners-keynote-at-dia-annual-meeting/"><span style="font-style: italic;">Think Science Now</span></a></p><p>Earlier this week FDA Commissioner <a href="http://www.fda.gov/AboutFDA/CommissionersPage/default.htm" mce_href="http://www.fda.gov/AboutFDA/CommissionersPage/default.htm">Dr. Margaret Hamburg</a> delivered the keynote address at the 46th Annual Meeting of the <a href="http://www.diahome.org/DIAHome/Home.aspx" mce_href="http://www.diahome.org/DIAHome/Home.aspx">Drug Information Association</a> (DIA) in Washington DC.</p> <p>Dr. Hamburg focused on two areas -- the need to strengthen FDA's <b>regulatory sciences</b> and the need for FDA to manage safety on a <b>global</b> basis.</p> <p>Hamburg described regulatory sciences as "the critical bridge between biomedical research and the people who need those <a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjIpauexR_MDwrez_eAbZ3hF3lpOM654s6m8VNkwgsvPLhAyihFKY7j_vKKuV_j4GXK6IzX8O_3rWi78NUXseJuH-RicSgQnr6pDMGQT3A2UkPxK9iN9Paxw6IVayJzK8aMoSMQrCj7qIt8/s1600/DIA2010-Hamburg.jpg"><img style="float: right; margin: 0pt 0pt 10px 10px; cursor: pointer; width: 200px; height: 188px;" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjIpauexR_MDwrez_eAbZ3hF3lpOM654s6m8VNkwgsvPLhAyihFKY7j_vKKuV_j4GXK6IzX8O_3rWi78NUXseJuH-RicSgQnr6pDMGQT3A2UkPxK9iN9Paxw6IVayJzK8aMoSMQrCj7qIt8/s200/DIA2010-Hamburg.jpg" alt="" id="BLOGGER_PHOTO_ID_5484116130719628338" border="0" /></a>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."</p> <p>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.</p> <p>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.</p> <p><span mce_ style="color:#808080;"><i>(And while moving into tangents -- For those who follow me on <a href="http://twitter.com/craiglipset" mce_href="http://twitter.com/craiglipset">Twitter</a> 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 </i><i><u>my </u>job!")</i></span></p>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com1tag:blogger.com,1999:blog-6236060788787048793.post-39166988112732114122010-06-18T09:35:00.002-04:002010-06-18T09:37:40.625-04:00Public Release of Alzheimer’s Clinical Trial Data by Major Pharmaceutical Researchers<div class="entry"> <p><span style="font-weight: bold;">Cross-posted from Pfizer's </span><a style="font-weight: bold;" href="https://science.pfizer.com/content/public-release-of-alzheimers-clinical-trial-data-by-major-pharmaceutical-researchers/"><span style="font-style: italic;">Think Science Now</span></a></p><p>Today Pfizer along with other major pharmaceutical researchers announced a unique data sharing agreement for Alzheimer’s Disease (<a href="javascript:externallink('http://www.c-path.org/News/CAMDPressRelease62010.pdf')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.c-path.org/News/CAMDPressRelease62010.pdf');">press release here</a>, and <a href="javascript:externallink('http://www.reuters.com/article/idUSTRE65A0JB20100611')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.reuters.com/article/idUSTRE65A0JB20100611');">media coverage here</a>). This is another exciting example of collaboration among pharmaceutical companies to advance science and address unmet medical need.</p> <p>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 <a href="javascript:externallink('http://www.cdisc.org/')" onclick="javascript:pageTracker._trackPageview('/outbound/article/http://www.cdisc.org/');">CDISC</a> to ease data sharing (a step that will also improve FDA review time).</p> <p>Is this the beginning of a new era of collaboration to make progress against some of the toughest diseases?</p> </div>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com1tag:blogger.com,1999:blog-6236060788787048793.post-2521192669206370832010-06-08T13:25:00.005-04:002010-06-08T22:04:37.789-04:00As ASCO Comes To A Close, Special Thanks To The Medical Heroes<p><span style="font-weight: bold;">Cross-posted from Pfizer's </span><a style="font-weight: bold;" href="https://science.pfizer.com/content/as-asco-comes-to-a-close-special-thanks-to-the-medical-heroes/"><span style="font-style: italic;">Think Science Now</span></a></p><p>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.</p> <p>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.</p> <p>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.</p> <p>But a special thanks must also go to the <b>patients </b>who volunteer as participants in our cancer clinical trials.</p> <p>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 <a href="http://media.pfizer.com/files/news/press_releases/2010/acrg_022310.pdf" mce_href="http://media.pfizer.com/files/news/press_releases/2010/acrg_022310.pdf" target="_blank">announced earlier this year</a>.</p> <p>It also takes partnerships with patients. This is why we sponsor organizations such as <a href="http://www.ciscrp.org/index.html" mce_href="http://www.ciscrp.org/index.html">CISCRP</a> (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.</p> <p><i> (We also have a <a href="http://www.medicalnewstoday.com/articles/162134.php" mce_href="http://www.medicalnewstoday.com/articles/162134.php">partnership underway with Private Access</a> to help inform patients about clinical trials; more on that later.)</i></p> <p>Pfizer has over 100 cancer clinical trials underway. <a href="http://www.phrma.org/medicines_in_development_for_cancer" mce_href="http://www.phrma.org/medicines_in_development_for_cancer">According to PhRMA</a>, 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 <b>Medical Heroes</b>.</p> <p>Information about clinical trial participation can be found at websites hosted by <a href="http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/hivandaidsactivities/ucm121345.htm" mce_href="http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/hivandaidsactivities/ucm121345.htm">FDA</a> and <a href="http://clinicaltrials.gov/ct2/info/understand" mce_href="http://clinicaltrials.gov/ct2/info/understand">NIH</a>.</p> <p>To help find a trial you can contact the Pfizer Oncology Clinical Trial Information Service by phone (877-369-5793) or online (<a href="http://www.pfizercancertrials.com/" mce_href="http://www.pfizercancertrials.com">www.pfizercancertrials.com</a>). The service is free and confidential.</p>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-81675892080146345802010-06-08T08:58:00.006-04:002010-06-08T13:27:22.988-04:00Drug Development As We Know It Is Not Sustainable<p><span style="font-weight: bold;">Cross-posted from Pfizer's </span><a style="font-weight: bold;" href="https://science.pfizer.com/content/drug-development-as-we-know-it-is-not-sustainable/"><span style="font-style: italic;">Think Science Now</span></a><br /></p><p><a href="https://science.pfizer.com/">Think Science Now</a> 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.)</p> <p>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.</p> <p>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).</p> <p>To continue to develop medicines as we have in the past is simply not sustainable. The <a href="http://healthcare-economist.com/2010/02/16/cost-of-drug-development-1-billion/" mce_href="http://healthcare-economist.com/2010/02/16/cost-of-drug-development-1-billion/">time, cost,</a> and <a href="http://www.marketwire.com/press-release/Rising-Clinical-Trial-Complexity-Continues-Vex-Drug-Developers-According-Tufts-Center-1160333.htm" mce_href="http://www.marketwire.com/press-release/Rising-Clinical-Trial-Complexity-Continues-Vex-Drug-Developers-According-Tufts-Center-1160333.htm">complexity</a> 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.</p> <p>I have enough topics in my notebook to get us started. Add a comment below (or <a href="http://twitter.com/craiglipset" mce_href="http://twitter.com/craiglipset">reach me on Twitter</a>) to let me know the ideas you would like to see covered.</p>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-38527232403163801102010-04-07T11:45:00.003-04:002010-04-07T11:53:10.442-04:00Patient-Centered Trials -- The Tip of the IcebergIt looks like we are starting a revolution.<br /><br />Stakeholders from pharma to sites to patients are rallying around the concept of putting the patient back at the center of clinical trials, empowering them as true <span style="font-style: italic;">participants</span>.<br /><br />The story was covered earlier this year in my interview with Future Pharmaceuticals and this month in my interview with Centerwatch Monthly ("Moving Toward a Patient-Centered Clinical Trial Model", subscription required). And I have been evangelizing at meetings and conferences for several months (with another 3 conference presentations in the next month).<br /><br />Today you can also add the site perspective to the mix, courtesy of <a href="http://twitter.com/TheRealDanSfera">Dan Sfera</a> and his blog at <a href="http://theclinicaltrialsguru.com/blog1/">theClinicalTrialsGuru.com</a>. Take a look at his perspective in today's posting <a href="http://theclinicaltrialsguru.com/blog1/2010/04/07/patient-centered-clinical-trials/">"Patient-Centered Clinical Trials"</a>.The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-22542555397488719912010-03-15T09:20:00.009-04:002010-03-15T11:30:23.513-04:00The Rise of the ePatient -- Now on YouTubeApologies if you had difficulty accessing the video interview at Future Pharmaceuticals (Rise of the ePatient) -- it did require a free registration for log-in.<br /><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="http://s.ytimg.com/yt/img/logos/youtube_logo_standard_againstwhite-vfl95119.png"><img style="margin: 0pt 0pt 10px 10px; float: right; cursor: pointer; width: 73px; height: 26px;" src="http://s.ytimg.com/yt/img/logos/youtube_logo_standard_againstwhite-vfl95119.png" alt="" border="0" /></a><br />That same video interview is now available online at <a href="http://www.youtube.com/watch?v=dxO2t_x4CzE">YouTube </a>-- much easier!<br /><br /><br /><br /><object height="195" width="320"><param name="movie" value="http://www.youtube.com/v/dxO2t_x4CzE&hl=en_US&fs=1&"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/dxO2t_x4CzE&hl=en_US&fs=1&" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" height="195" width="320"></embed></object>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-62162441806513301332010-03-06T12:28:00.003-05:002010-03-15T11:24:35.398-04:00The Rise of the e-Patient<a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhoxuL6Hz91iH3ELJFRmWVPPkGMB4E1a1equp_CZdx0okHLqTYbE18XwPTdlDmHXlEeHj7BYp4AUKnJbmia4XPDrNgNtWRS7lNPB6VZMCtYfSCEfucKPUoxh0ldH39W6H4Ocei3m-sQhT2u/s1600-h/FP.jpg"><img style="margin: 0pt 0pt 10px 10px; float: right; cursor: pointer; width: 155px; height: 200px;" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhoxuL6Hz91iH3ELJFRmWVPPkGMB4E1a1equp_CZdx0okHLqTYbE18XwPTdlDmHXlEeHj7BYp4AUKnJbmia4XPDrNgNtWRS7lNPB6VZMCtYfSCEfucKPUoxh0ldH39W6H4Ocei3m-sQhT2u/s200/FP.jpg" alt="" id="BLOGGER_PHOTO_ID_5445574868250812370" border="0" /></a><a href="http://www.futurepharmaus.com/"><br />Future Pharmaceuticals</a> has just published a profile of some of my work around the convergence of Health 2.0 and telemedicine with clinical trials.<br /><br />Take a look at http://www.futurepharmaus.com (free log-in required).<br /><br />There is an interview (video and print) as well as a panel discussion I am moderating (podcast and print).<br /><br />Stay tuned for more coverage...The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-4655486700631612672010-01-25T17:57:00.003-05:002010-03-23T11:35:44.402-04:00Another Podcast -- Talking to BioIT World<a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEitIhmfiV5XIUZz993s6smTFpXTnjVPquX0oEeLVckQgkwoo9AC4XVMvh4wLlU0LccM4I_MdeiV6D9sd5_jgO_uCXyJvoWz2dJA2oVew4n5atAqSD15Ef_RpztTgaYVXeUc-ff4LyuQ2m4v/s1600-h/bio-it-world-conference-and-expo.png"><img style="float: right; margin: 0pt 0pt 10px 10px; cursor: pointer; width: 203px; height: 65px;" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEitIhmfiV5XIUZz993s6smTFpXTnjVPquX0oEeLVckQgkwoo9AC4XVMvh4wLlU0LccM4I_MdeiV6D9sd5_jgO_uCXyJvoWz2dJA2oVew4n5atAqSD15Ef_RpztTgaYVXeUc-ff4LyuQ2m4v/s320/bio-it-world-conference-and-expo.png" alt="" id="BLOGGER_PHOTO_ID_5451853360982148642" border="0" /></a><br /><span class="status-body"><span class="entry-content">My 2nd podcast is now up -- talking to BioIT World about engaging patients as PARTICIPANTS in clinical trials: <a href="http://bit.ly/chlpc2" class="tweet-url web" rel="nofollow" target="_blank">http://chi-imagehost.com/podcasts/CraigLipset_podcast.mp3</a><br /></span></span>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-85498181894161062822009-12-23T15:53:00.003-05:002010-03-23T11:39:03.698-04:00Podcast: Partnerships with Central Labs<span style="font-size:85%;">http://partnershipswithcros.blogspot.com/2009/12/central-labs-spotlight-craig-lipset.html<br /><br /></span><h3 class="post-title entry-title"> <span style="font-size:85%;"><a href="http://partnershipswithcros.blogspot.com/2009/12/central-labs-spotlight-craig-lipset.html">Central Labs Spotlight: Craig Lipset , Pfizer</a></span> </h3> <span style="font-size:85%;"> With Central Labs coming up in February, we've started an interview series with som</span><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg5373nR98ezKAZQBaImULo2A93erLMSOXukGY1IUeBI3DLiz7vhPtGN9Qeim3IoVgJBHPe6DMPb0EtmsXPzGX-GsZY8eZOAsfEhdHiniLNr1i5FUvG-lKdnDEbVwtVqCopj-VViOk4J9FD/s1600-h/labs.jpg"><img style="float: right; margin: 0pt 0pt 10px 10px; cursor: pointer; width: 171px; height: 84px;" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg5373nR98ezKAZQBaImULo2A93erLMSOXukGY1IUeBI3DLiz7vhPtGN9Qeim3IoVgJBHPe6DMPb0EtmsXPzGX-GsZY8eZOAsfEhdHiniLNr1i5FUvG-lKdnDEbVwtVqCopj-VViOk4J9FD/s320/labs.jpg" alt="" id="BLOGGER_PHOTO_ID_5451854165060114818" border="0" /></a><span style="font-size:85%;">e of the speakers we're looking forward to in February.<br /><br />Our second podcast is with Craig Lipset, Central Labs West conference chair. During this podcast, they answer the following questions:<br /><br />-What are Craig's passion points?<br />-Why does the Central Labs West conference resonate with him?<br />-He discusses how industry continues to explore novel imaging techniques in the context of their early phase development programs.<br />-He discusses some of the standardization taking place in the industry.<br />-Lipset looks at what he sees coming in the future for this industry.<br /></span>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-59642953401010346542009-01-31T12:34:00.003-05:002010-03-15T11:26:39.392-04:00All The Simple Diseases Have Been Solved<span style="font-size:85%;"><span style="font-family:courier new;"><span style="font-family:georgia;">We have heard this claim a few times over the years. Drug discovery and development is much harder today because we have solved all of the simple problems. This quote is most recently shared by Paul Stoffels, head of drug R&D for JnJ, in <a href="http://blogs.wsj.com/health/2009/01/29/jjs-stoffels-says-open-innovation-is-the-rd-answer/">a posting at the WSJ Health Blog</a> earlier this week.<br /><br />"All simple diseases have been solved", says Stoffels, in the context of describing the need for industry to look beyond their own walls for answers.<br /><br />I agree with the conclusion -- pharma must partner to solve their current challenges. Partner with academia, and even with others in industry.<br /><br />But is it true that we have solved all of the simple diseases? Or will history prove that we are still at the tip of a much bigger iceberg?<br /></span></span></span><span style="font-size:85%;"><span style="font-family:courier new;"></span></span>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-16402220273445237842009-01-31T12:23:00.003-05:002010-03-15T11:27:47.537-04:00Medical Research Is About to Slam Into a Wall<span style="font-family:georgia;"><span style="font-size:85%;">Medical Research is at risk of slamming into a wall if smart people outside of drug development do not get engaged. This is the conclusion reached by Katie Hood, CEO of the Michael J Fox Foundation for Parkinson's Research, in <a href="http://www.huffingtonpost.com/katie-hood/as-the-biotech-bubble-pop_b_160389.html">a posting this week at the Huffington Post</a>.<br /><br />Hood does a great job of breaking down the impact of a faltering economy upon an already strained system. Pharma is axing researchers. Biotechs are at great risk for bankruptcy. Venture capitalists are retreating. Government is not prepared to pick up the slack. Private foundations lack the capital or scope.<br /><br />Is a new role for the public sector needed to ensure that the current 10-15 years to develop a new therapy does not get longer instead of shorter?</span><br /></span>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-77660029774056656952009-01-21T16:43:00.004-05:002010-03-15T11:28:01.120-04:00Impact of DTC Advertising on Clinical Development<span style="font-size:85%;"><span style="font-family:georgia;">Going back to that age-old question within pharma: Does a pharma company <span style="font-style: italic;">"make drugs" </span>or do they<span style="font-style: italic;"> "sell drugs"</span>?<br /><br />Well, the truth of course is that this is a cycle and the research and sales halves of the pharmaco are dependent on one another. The commercial organization needs new products to sell and generate revenue. The research organization needs a percent of the revenue from sales to re-invest in new R&D.<br /><br />So there is an up-side for clinical development when pharma use direct-to-consumer advertising as a tool to increase sales.<br /><br />But there is certainly a downside. And Ken Getz from Tufts does his usual outstanding job describing the<a href="http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/US/Balancing-Perceptions-of-Risk-in-Clinical-Research/ArticleStandard/Article/detail/563315?contextCategoryId=35495&searchString=balancing%20perception"> implications of public perception on clinical research</a>. How have we contributed to the public's lack of understanding the risk of medicines and clinical trials? What role has DTC advertising played in painting the image of high-benefit / no-risk?<br /><br />It may be a moot point -- if studies continue to mount showing DTC ads are <a href="http://www.msnbc.msn.com/id/28584952/">"losing their punch"</a> then the fate of DTC will be decided by the market.<br /></span></span>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-57748548161368689952009-01-21T16:42:00.001-05:002010-03-15T11:27:29.532-04:00Facebook for Clinical Trials (RU in a C/T?)<span style="font-size:85%;"><span style="font-family:georgia;">Now that the soft economy is making you think about enrolling in a clinical trial, how to best find one? At least </span><a style="font-family: georgia;" href="https://secure1.acuriantrials.com/jsp/facebook/getinvolved.html">one company</a><span style="font-family:georgia;"> is now thinking social media. While it may not hold the answer to recruitment for a specific trial, raising awareness for clinical trials can only help. (And maybe it will raise a few dollars for a good cause.)<br /></span></span>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com2tag:blogger.com,1999:blog-6236060788787048793.post-15947108735099685052009-01-21T16:40:00.002-05:002010-03-15T11:28:24.197-04:00Economy Causing Pain? Enroll in a Clinical Trial!<span style=";font-family:georgia;font-size:85%;" ></span><meta equiv="Content-Type" content="text/html; charset=utf-8"><meta name="ProgId" content="Word.Document"><meta name="Generator" content="Microsoft Word 11"><meta name="Originator" content="Microsoft Word 11"><link style="font-family: georgia;" rel="File-List" href="file:///C:%5CDOCUME%7E1%5CCraig%5CLOCALS%7E1%5CTemp%5Cmsohtml1%5C01%5Cclip_filelist.xml"><span style="font-size:85%;"><o:smarttagtype style="font-family: georgia;" namespaceuri="urn:schemas-microsoft-com:office:smarttags" name="country-region"></o:smarttagtype><o:smarttagtype style="font-family: georgia;" namespaceuri="urn:schemas-microsoft-com:office:smarttags" name="place"></o:smarttagtype></span><!--[if gte mso 9]><xml> <w:worddocument> <w:view>Normal</w:View> <w:zoom>0</w:Zoom> <w:punctuationkerning/> <w:validateagainstschemas/> <w:saveifxmlinvalid>false</w:SaveIfXMLInvalid> <w:ignoremixedcontent>false</w:IgnoreMixedContent> <w:alwaysshowplaceholdertext>false</w:AlwaysShowPlaceholderText> <w:compatibility> <w:breakwrappedtables/> <w:snaptogridincell/> <w:wraptextwithpunct/> <w:useasianbreakrules/> <w:dontgrowautofit/> <w:usefelayout/> </w:Compatibility> <w:browserlevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument> </xml><![endif]--><!--[if gte mso 9]><xml> <w:latentstyles deflockedstate="false" latentstylecount="156"> </w:LatentStyles> </xml><![endif]--><!--[if !mso]><object classid="clsid:38481807-CA0E-42D2-BF39-B33AF135CC4D" id="ieooui"></object> <style> st1\:*{behavior:url(#ieooui) } </style> <![endif]--><style> <!-- /* Font Definitions */ @font-face {font-family:"MS Mincho"; panose-1:2 2 6 9 4 2 5 8 3 4; mso-font-alt:"Arial Unicode MS"; mso-font-charset:128; mso-generic-font-family:roman; mso-font-format:other; mso-font-pitch:fixed; mso-font-signature:1 134676480 16 0 131072 0;} @font-face {font-family:"\@MS Mincho"; panose-1:0 0 0 0 0 0 0 0 0 0; mso-font-charset:128; mso-generic-font-family:roman; mso-font-format:other; mso-font-pitch:fixed; mso-font-signature:1 134676480 16 0 131072 0;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-parent:""; margin:0in; margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:12.0pt; font-family:"Times New Roman"; mso-fareast-font-family:"MS Mincho";} @page Section1 {size:8.5in 11.0in; margin:1.0in 1.25in 1.0in 1.25in; mso-header-margin:.5in; mso-footer-margin:.5in; mso-paper-source:0;} div.Section1 {page:Section1;} --> </style><!--[if gte mso 10]> <style> /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman"; mso-fareast-font-family:"Times New Roman"; mso-ansi-language:#0400; mso-fareast-language:#0400; mso-bidi-language:#0400;} </style> <![endif]--> <p class="MsoNormal" style="font-family:georgia;"><span style="font-size:85%;">This month <a href="http://www.forbes.com/feeds/ap/2009/01/05/ap5879758.html">Forbes notes</a> an interesting up-side for clinical development coming out of a down economy – individuals feeling a pinch in their wallets increasingly interested in participating in paid studies.<o:p></o:p></span></p><p class="MsoNormal" style="font-family:georgia;">
<br /><span style="font-size:85%;"><o:p></o:p></span></p> <p class="MsoNormal" style="font-family:georgia;"><span style="font-size:85%;"><o:p></o:p>Studies that pay for enrollment are generally for health volunteers, and are typically performed at dedicated Phase I / clinical research units.<span style=""> </span>Such units often have databases of subjects in their catchment area – including their “professional patients”.<o:p></o:p></span></p><p class="MsoNormal" style="font-family:georgia;">
<br /><span style="font-size:85%;"><o:p></o:p></span></p><p class="MsoNormal" style="font-family:georgia;"><span style="font-size:85%;"><o:p></o:p>But healthy volunteer studies, as with much of clinical research, was seeing a trend moving outside of the <st1:country-region st="on"><st1:place st="on">United States</st1:place></st1:country-region>.<span style=""> </span>The ability to recruit a more diverse sample of subjects at a reasonable cost and with good speed will quickly sum to reverse that trend.</span></p> <span style="font-size:85%;">
<br /></span>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-54215304098906039632008-12-30T08:10:00.002-05:002008-12-30T08:30:02.718-05:00Do Clinical Trials Take "Immoral Advantage of Patients"?<span style="font-size:85%;"><span style="font-family: georgia;">At least one patient thinks so. And he writes about it today in the Wall Street Journal's Opinion Journal under the title "</span><a style="font-weight: bold; font-family: georgia;" href="http://online.wsj.com/article/SB123059825583441193.html">The FDA Is Killing Crohn's Patients.</a><span style="font-family: georgia;">"</span><br /><br />Do patients have a moral right to know their treatment group at the end of the study?<br />Do patients (in particular those from a placebo arm) have a moral right to access the experimental therapy when the study ends?<br />If such a moral obligation exists, does an informed consent absolve a sponsor?<br /><br />In each of the stories that have come to the mainstream media over the past few months (<a href="http://www.fiercehealthcare.com/story/prominent-political-donor-receives-experimental-drug-without-permission/2008-10-17">including the case of Fred Baron seeking off-label Tysabri</a>), there is seems the assumption that the experimental therapy is not only known to be safe but assumed to be effective.<br /><br />As argued in the WSJ, the constitution should be interpreted to allow "a crtitically ill patient...access to a potentially lifesaving drug that has been deemed safe for human consumption, if the patient agrees to bear the risks involved."<br /><br />But an IND to initiate human trials is based only on preclinical/animal testing -- a barometer few would interpret as a stamp of being deemed safe for human consumption. In fact, it's the very clinical trial being conducted that is meant to demonstrate safety during the drug's life as an experimental medicine.<br /><br />And is a patient's signature on a consent going to be adequate to demonstrate that the "patient agrees to bear the risks involved"? In fact, didn't the patient sign a very similar consent agreeing to risks involved when signing on to the clinical trial (including those of placebo use)?<br /><br />Patient rights are a moral obligation. But so too is patient safety, which much be the priority. Finding a common ground in the coming year will be important for ensuring patients feel both safe and not-abandoned in clinical trials.<br /><br />Now Washington is stepping forward with the "Access, Compassion, Care and Ethics for Seriously Ill Patients Act." Is Washington best suited to solve matters of morality and ethics?<br /></span><span style="font-size:85%;"></span>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-14245755471981910692008-12-18T21:29:00.003-05:002008-12-18T21:35:44.335-05:00An Example of What is Not Innovation -- Uncontrolled Outsourcing to India<a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="http://www.tampabay.com/multimedia/archive/00049/A4S_indiamoms121408_49256c.jpeg"><img style="margin: 0pt 0pt 10px 10px; float: right; cursor: pointer; width: 201px; height: 134px;" src="http://www.tampabay.com/multimedia/archive/00049/A4S_indiamoms121408_49256c.jpeg" alt="" border="0" /></a><span style="font-size:85%;"><span style="font-family:georgia;">A frightening article, one that should be a wake-up call to those quickly outsourcing trials to BRIC (Brazil, Russia, India, China) without ensuring adequate controls:<br /></span> <a style="font-family: georgia;" href="http://www.tampabay.com/news/business/article934677.ece"><br /><span style="font-weight: bold;">The Latest Industry Being Outsourced to India: Clinical Drug Trials</span></a><span style="font-family:georgia;"> -- From the St. Petersburg Times</span></span>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-85239227560261292762008-12-17T21:47:00.005-05:002008-12-18T18:21:02.889-05:00All Knowledge Begins With The Beginner's Mind<a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="http://farm1.static.flickr.com/114/302227345_31b9577431.jpg?v=0"><img style="margin: 0pt 0pt 10px 10px; float: right; cursor: pointer; width: 109px; height: 164px;" src="http://farm1.static.flickr.com/114/302227345_31b9577431.jpg?v=0" alt="" border="0" /></a><meta equiv="Content-Type" content="text/html; charset=utf-8"><meta name="ProgId" content="Word.Document"><meta name="Generator" content="Microsoft Word 11"><meta name="Originator" content="Microsoft Word 11"><link style="font-family: georgia;" rel="File-List" href="file:///C:%5CDOCUME%7E1%5CCraig%5CLOCALS%7E1%5CTemp%5Cmsohtml1%5C01%5Cclip_filelist.xml"><!--[if gte mso 9]><xml> <w:worddocument> <w:view>Normal</w:View> <w:zoom>0</w:Zoom> <w:punctuationkerning/> <w:validateagainstschemas/> <w:saveifxmlinvalid>false</w:SaveIfXMLInvalid> <w:ignoremixedcontent>false</w:IgnoreMixedContent> <w:alwaysshowplaceholdertext>false</w:AlwaysShowPlaceholderText> <w:compatibility> <w:breakwrappedtables/> <w:snaptogridincell/> <w:wraptextwithpunct/> <w:useasianbreakrules/> <w:dontgrowautofit/> <w:usefelayout/> </w:Compatibility> <w:browserlevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument> </xml><![endif]--><!--[if gte mso 9]><xml> <w:latentstyles deflockedstate="false" latentstylecount="156"> </w:LatentStyles> </xml><![endif]--><style> <!-- /* Font Definitions */ @font-face {font-family:"MS Mincho"; panose-1:2 2 6 9 4 2 5 8 3 4; mso-font-alt:"Arial Unicode MS"; mso-font-charset:128; mso-generic-font-family:roman; mso-font-format:other; mso-font-pitch:fixed; mso-font-signature:1 134676480 16 0 131072 0;} @font-face {font-family:"\@MS Mincho"; panose-1:0 0 0 0 0 0 0 0 0 0; mso-font-charset:128; mso-generic-font-family:roman; mso-font-format:other; mso-font-pitch:fixed; mso-font-signature:1 134676480 16 0 131072 0;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-parent:""; margin:0in; margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:12.0pt; font-family:"Times New Roman"; mso-fareast-font-family:"MS Mincho";} @page Section1 {size:8.5in 11.0in; margin:1.0in 1.25in 1.0in 1.25in; mso-header-margin:.5in; mso-footer-margin:.5in; mso-paper-source:0;} div.Section1 {page:Section1;} --> </style><!--[if gte mso 10]> <style> /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman"; mso-fareast-font-family:"Times New Roman"; mso-ansi-language:#0400; mso-fareast-language:#0400; mso-bidi-language:#0400;} </style> <![endif]--> <p class="MsoNormal" style="font-family:georgia;"><span style="font-size:85%;">I recently hosted a meeting of several international key opinion leaders representing a number of innovative technologies with applications for drug development.<span style=""> </span>One spoke to a clever computer algorithm – an artificial neural network – that was being used for clinical purposes (as an example, identifying patients likely to develop Alzheimer’s Disease).</span></p><p class="MsoNormal" style="font-family:georgia;"><span style="font-size:85%;">
<br /></span></p> <p class="MsoNormal" style="font-family:georgia;"><span style="font-size:85%;">If you are not familiar with neural networks, then you may want to turn elsewhere for a primer (as I am hardly an expert).<span style=""> </span>What I will say is that these are computer programs designed to act like the human brain and adapt – or learn – as they are shown more data.<span style=""> </span>In the example above, show the algorithm more patient cases and it will be increasingly likely to predict who would get Alzheimer’s.</span></p><p class="MsoNormal" style="font-family:georgia;"><span style="font-size:85%;">
<br /></span></p> <p class="MsoNormal" style="font-family:georgia;"><span style="font-size:85%;">The speaker then showed a slide entitled “<span style="font-weight: bold;">Over-Training</span>”.<span style=""> </span>In over-training, if one shows the computer too many cases they actually can start to see error rates <span style="font-style: italic;">increase</span>.<span style=""> </span>To be honest, I tuned out much of the conversation after this slide.<span style=""> </span>I became fixated on the concept that over-training does not cause a plateau in the error, but that too much training actually causes <span style="font-style: italic;">more </span>mistakes.<span style=""> </span>The system becomes overly focused on individual cases and can no longer see the big picture.</span></p><p style="font-family: georgia;" class="MsoNormal"><span style="font-size:85%;">
<br /></span></p> <p style="font-family: georgia;" class="MsoNormal"><span style="font-size:85%;">Artificial neural networks were designed to mimic the construction of the human brain and our neural networks.<span style=""> </span>But what can we learn from the lessons of over-training the artificial system?</span></p><p style="font-family: georgia;" class="MsoNormal"><span style="font-size:85%;">
<br /></span></p> <p style="font-family: georgia;" class="MsoNormal"><span style="font-size:85%;">Can we be over-trained?<span style=""> </span>If we see too many cases or focus too sharply on one task, do we lose the ability to see the big picture? If so, how can we innovate and advance drug development?<span style=""> </span>Are those on the “inside” too narrowly focused – and over-trained?</span></p><p style="font-family: georgia;" class="MsoNormal"><span style="font-size:85%;">
<br /></span></p> <p style="font-family: georgia;" class="MsoNormal"><span style="font-size:85%;">Expertise can be of value – but perhaps all knowledge being with the beginner’s mind.</span></p> The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com1tag:blogger.com,1999:blog-6236060788787048793.post-15714167097548390132008-12-17T21:26:00.006-05:002008-12-18T06:53:40.806-05:00Consortia -- Pre-Competitive Is In the Eye of the Beholder<font size="2"><font face="georgia">It is hardly news that drug development is high-cost and high-risk. What is relatively new is for pharma to lower their guard and begin to share information that action together that may potentially reduce cost and risk. Enter the era of the pharma industry consortia.</font> <font face="georgia"><br /><br />Perhaps the grandparents of this space are groups such as the <a href="http://www.biomarkersconsortium.org">Biomarkers Consortium</a> and the <a href="http://www.saeconsortium.org">SAE Consortium</a>. The <a href="http://www.c-path.org/">C-Path Institute</a> was created, in-part, to create consortia to act upon the <a href="http://www.fda.gov/oc/initiatives/criticalpath/">FDA's Critical Path Initiative</a>. Where there has been a lack of sound business models for creating new tools for drug development, consortia have been a good solution.</font><br /></font><font size="2"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="http://i51.photobucket.com/albums/f361/lilprincess4026/playground.jpg"><img style="margin: 0pt 0pt 10px 10px; float: right; cursor: pointer; width: 165px; height: 94px;" src="http://i51.photobucket.com/albums/f361/lilprincess4026/playground.jpg" alt="" border="0"></a></font><br /><font size="2"><font face="georgia">The ability for otherwise competitors to suddenly collaborate is based upon what some have cal</font></font><font size="2"><font face="georgia">l</font></font><font size="2"><font face="georgia">e</font></font><font size="2"><font face="georgia">d the “pre-competitive space”. At least <a href="http://www.biotechtransferweek.com/issues/2_28/features/148228-1.html">one group</a> has defined this as “technologies that aren’t really t</font></font><font size="2"><font face="georgia">he basis on which they are competing but helps them do their jobs.”<br /><br /></font><font face="georgia">But there is an inherent conflict. By their very design, consortia are meant to be inclusive and bring representatives from various related areas around the table. But what is pre-competitive to one stakeholder is likely a key revenue source, business opportunity, or competitive differentiator to another stakeholder. In most cases, “pre-competitive” is in the eye of the beholder.</font> <font face="georgia"><br /><br />Today it seems not a week goes by without another new industry-wide initiative being launched. Each requires an investment of resources and a commitment to see value ultimately generated.</font><br /><br /><font face="georgia">Impact on drug development? Consortia have emerged as important mechanism for improving the clinical development toolbox (biomarkers may be a good example). But each initiative must start with an honest discussion among stakeholders around the table about what is truly pre-competitive, and whether everyone sees the same opportunity in the same light.</font> </font>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-26669941440247017752008-12-17T20:46:00.006-05:002008-12-17T22:13:00.089-05:00Dude Where’s My Bailout: US- and UK-biotech edition<a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="http://www.ratemyeverything.net/image/13892/0/Dude_Wheres_My_Bailout_T-shirt.ashx"><img style="margin: 0pt 0pt 10px 10px; float: right; cursor: pointer; width: 193px; height: 193px;" src="http://www.ratemyeverything.net/image/13892/0/Dude_Wheres_My_Bailout_T-shirt.ashx" alt="" border="0" /></a><meta equiv="Content-Type" content="text/html; charset=utf-8"><meta name="ProgId" content="Word.Document"><meta name="Generator" content="Microsoft Word 11"><meta name="Originator" content="Microsoft Word 11"><link style="font-family: georgia;" rel="File-List" href="file:///C:%5CDOCUME%7E1%5CCraig%5CLOCALS%7E1%5CTemp%5Cmsohtml1%5C01%5Cclip_filelist.xml"><span style=";font-family:georgia;font-size:85%;" ><o:smarttagtype namespaceuri="urn:schemas-microsoft-com:office:smarttags" name="place"></o:smarttagtype><o:smarttagtype namespaceuri="urn:schemas-microsoft-com:office:smarttags" name="country-region"></o:smarttagtype><o:smarttagtype namespaceuri="urn:schemas-microsoft-com:office:smarttags" name="State"></o:smarttagtype><o:smarttagtype namespaceuri="urn:schemas-microsoft-com:office:smarttags" name="City"></o:smarttagtype></span><!--[if gte mso 9]><xml> <w:worddocument> <w:view>Normal</w:View> <w:zoom>0</w:Zoom> <w:punctuationkerning/> <w:validateagainstschemas/> <w:saveifxmlinvalid>false</w:SaveIfXMLInvalid> <w:ignoremixedcontent>false</w:IgnoreMixedContent> <w:alwaysshowplaceholdertext>false</w:AlwaysShowPlaceholderText> <w:compatibility> <w:breakwrappedtables/> <w:snaptogridincell/> <w:wraptextwithpunct/> <w:useasianbreakrules/> <w:dontgrowautofit/> <w:usefelayout/> </w:Compatibility> <w:browserlevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument> </xml><![endif]--><!--[if gte mso 9]><xml> <w:latentstyles deflockedstate="false" latentstylecount="156"> </w:LatentStyles> </xml><![endif]--><!--[if !mso]><object classid="clsid:38481807-CA0E-42D2-BF39-B33AF135CC4D" id="ieooui"></object> <style> st1\:*{behavior:url(#ieooui) } </style> <![endif]--><style> <!-- /* Font Definitions */ @font-face {font-family:"MS Mincho"; panose-1:2 2 6 9 4 2 5 8 3 4; mso-font-alt:"Arial Unicode MS"; mso-font-charset:128; mso-generic-font-family:roman; mso-font-format:other; mso-font-pitch:fixed; mso-font-signature:1 134676480 16 0 131072 0;} @font-face {font-family:"\@MS Mincho"; panose-1:0 0 0 0 0 0 0 0 0 0; mso-font-charset:128; mso-generic-font-family:roman; mso-font-format:other; mso-font-pitch:fixed; mso-font-signature:1 134676480 16 0 131072 0;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-parent:""; margin:0in; margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:12.0pt; font-family:"Times New Roman"; mso-fareast-font-family:"MS Mincho";} a:link, span.MsoHyperlink {color:blue; text-decoration:underline; text-underline:single;} a:visited, span.MsoHyperlinkFollowed {color:purple; text-decoration:underline; text-underline:single;} @page Section1 {size:8.5in 11.0in; margin:1.0in 1.25in 1.0in 1.25in; mso-header-margin:.5in; mso-footer-margin:.5in; mso-paper-source:0;} div.Section1 {page:Section1;} --> </style><!--[if gte mso 10]> <style> /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman"; mso-fareast-font-family:"Times New Roman"; mso-ansi-language:#0400; mso-fareast-language:#0400; mso-bidi-language:#0400;} </style> <![endif]--><span style="font-size:85%;">This was going to be a posting a few weeks back when the <st1:country-region st="on">US</st1:country-region> automakers were heading (back) to <st1:place st="on"><st1:state st="on">Washington</st1:state></st1:place> in search of billions.<span style=""> </span>Unlike the Wall Street package, most believed the financial struggles from <st1:city st="on"><st1:place st="on">Detroit</st1:place></st1:city> were based only in-part on current economic turmoil and largely based on a flawed and unsustainable business model.</span><span style="font-size:85%;"><o:p>
<br />
<br /></o:p>And so I penciled a what-if posting about pharma heading to <st1:state st="on"><st1:place st="on">Washington</st1:place></st1:state>.<span style=""> </span>Sure the largest players in the industry are sitting on billions in cash, but the coming struggles are well-known as some will lose over 40% of their revenue over the next 2 years with key products coming off-patent.<span style=""> </span>Could they get in line for a bailout?</span><span style="font-size:85%;"><o:p>
<br />
<br /></o:p></span><span style="font-size:85%;">But before I could get back on-line and move from pencil to keyboard, <a href="http://www.nytimes.com/2008/12/10/business/10biobail.html?_r=1">BIO beat me to it</a>.<span style=""> </span><a href="http://www.nytimes.com/2008/12/10/business/10biobail.html?_r=1"></a></span><span style="font-size:85%;"><o:p>
<br />
<br /></o:p>Despite the headlines, the BIO request is perhaps more a cash-advance than a bail-out<st1:city st="on"><st1:place st="on"></st1:place></st1:city>.<span style=""> </span>Currently companies can use today’s operating losses to offset future taxes when they are profitable.<span style=""> </span>The request in <st1:state st="on"><st1:place st="on">Washington</st1:place></st1:state> is to let companies receive money from the government today in exchange for giving up those future tax deductions.</span><span style="font-size:85%;"><o:p>
<br />
<br /></o:p></span><span style="font-size:85%;">And BIO cites a direct linkage to the financial crisis – lack of access to capital coupled with roughly 25% of publicly-traded biotechs having less than 6 months of cash equals an inability to fund expensive clinical trials (or even stay afloat altogether).<span style=""> </span>As the NY Times article notes, “the change, if <st1:place st="on"><st1:state st="on">Washington</st1:state></st1:place> approved of it, could enable the industry to receive potentially hundreds of millions or even billions of dollars, on the condition that the money would be used for research and development.”</span><span style="font-size:85%;"><o:p></o:p></span>
<br />
<br /><span style="font-size:85%;"><o:p></o:p></span><span style="font-size:85%;">Meanwhile, a <a href="http://business.timesonline.co.uk/tol/business/industry_sectors/health/article5289523.ece">similar story from the <st1:place st="on"><st1:country-region st="on">UK</st1:country-region></st1:place></a> -- although here perhaps more of a bail-out compared with a tax reshuffle.</span><span style="font-size:85%;"><span style=""> As proposed, </span>first there would be a £500 million ($740M USD) government fund set-up to support consolidation among smaller biotechs.<span style=""> </span>Then there would be a £100 million ($146M USD) VC-backed fund to enable larger biotechs to pursue acquisitions and fund clinical trials.
<br />
<br /></span><span style="font-size:85%;">Impact on drug development – Increasing the potential for companies and trials to survive the economic chaos...especially as proposals in the US and UK stipulate applying funds toward R&D.</span><span style="font-size:85%;"><o:p></o:p></span>
<br /><span style=";font-family:georgia;font-size:85%;" ></span>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-9397034206141683232008-12-05T16:18:00.003-05:002008-12-05T16:21:06.161-05:00More attention in the news: Health2.0 Patients as Partners<span style="font-size:85%;"><a href="http://www.businessweek.com/magazine/content/08_50/b4112058194219.htm?chan=top+news_top+news+index+-+temp_news+%2B+analysis"><span style="FONT-WEIGHT: bold">Health 2.0: Patients as Partners</span></a> -- at BusinessWeek.com<br /><br />Media attention around the potential for Research 2.0 continues to swell...<br /></span>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0tag:blogger.com,1999:blog-6236060788787048793.post-83232421484942745392008-12-03T21:11:00.003-05:002008-12-03T21:18:46.027-05:00In the news: Patient-led drug trials defy medical establishment<span style="font-size:85%;"><a style="font-weight: bold;" href="http://www.ft.com/cms/s/0/e92f9d3c-c0db-11dd-b0a8-000077b07658.html?nclick_check=1"></a><a href="http://news.yahoo.com/s/ap/20081126/ap_on_he_me/med_patients_take_charge"><span style="font-weight: bold;">Patient-led drug trials defy medical establishment</span></a> -- at Yahoo! News<br /><br />Whether or not the scientific and clinical communities accept the trend, Web 2.0 will continue to enable and empower patients to share information and initiate their own research. (Once upon a time the medical community also dismissed the role of the Internet for patients to find health information.) Can we take measures to strengthen the tools available to patients, to make their efforts in generating research data a source of value (rather than fear) to scientists and clinicians?<br /></span>The PharmaSherpahttp://www.blogger.com/profile/12369650947500352750noreply@blogger.com0