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Were you unable to attend the 45th Annual DIA Meeting that took place in San Diego this past June 22-24? Did you happen to miss a session, specific speaker or exhibitor that you wanted to see? What ever the case may be, Applied Clinical Trials was there to cover the event. Here you will find reviews of sessions, interviews with speakers, exhibit floor buzz, and even buzz taking place off the exhibit floor.
Change in the Global Regulatory Affairs Function
Kenneth A. Getz, senior research fellow for Tufts CSDD and Chairman of CISCRP, speaks to Managing Editor Kerri Nelen about the evolving regulatory affairs function within the biopharmaceutical industry.
Site Relationship Management: Dialogue Ramps Up
Beth Harper, MBA, president, Clinical Performance Partners, offers Site Relationship Management initiative insights from the past year.
Rewards for Subjects, an Ethical Dilemma?
Felix Gyi, PharmD, MBA, CEO of Chesapeake Research Review discusses ethical rewards for patients in clinical studies and how the relationships between pharma and health care professionals affects subject recruitment and retention.
Biotech Executive Roundtable Fosters Discussion
Marie Dray, president, DIA Board of Directors, discusses the importance of networking and discussion for the biotech DIA member, as well as biotech interesting topics for the clinical trials professional to explore
Meet DIA’s Program Chair
Nancy D. Smith, PhD, former director, office of training and communications, CDER, FDA, discusses this year's meeting theme, "Better Medicines: Improving Safety with Every Step," and the CDER Town Meeting that has become a DIA staple.
DIA: Discussion for the Future
Jeff Sherman, MD, Incoming DIA President, tells Applied Clinical Trials about the successes DIA is making toward sharing knowledge in the globalization of drug development.
Data Management: Keeping it In-House
Johann Prove, PhD, Global Head, Data Management, Bayer Schering Pharma AG, Germany, offers his perspective on recent trends in data management and why it’s important to keep it in-house.
Microsoft announced the winners of its 2009 Pharmaceutical and Life Science Innovation Awards, which recognize companies within industry for their innovative use of Microsoft-based solutions. This year, Harvard Clinical Research Institute (HCRI) walked away with the award for "Clinical Development." The academic research organization was honored for its successful adoption of TranSenda's Office-Smart Clinical Trial Manager to provide a higher level of efficiency. "We're proud of this award," J. Spencer Goldsmith, HCRI's president, told Applied Clinical Trials. "As an academic research organization we rely upon many different systems. We're pleased with how we can integrate Microsoft."
PHT, Almac, and Medidata Solutions co-hosted an exhibit floor event whereby attendees would visit each booth to track a patient from randomization in Almac's IXRS integrated IVRS and Web response system, to electronic patient diary entries in the PHT LogPad system, and ending with CRF data entries in Medidata Rave, where they could view all previously entered data in one system.
Fulfilling caffiene cravings across the exhibit floor, ERT donned a cappucino machine that took little break in serving conference-goers. No doubt a clever way to draw in attendees.
Taking a somewhat different approach than its fellow exhibitors, BioClinica had Brad Pitt and Angelina Jolie look-alikes at their booth ready for pictures with conference goers. Certainly a unique method to drawing traffic!
On Monday, visitors to the CDISC booth viewed a live demo of the interoperability between EHR and EDC systems providing a true integration of clinical research data and healthcare workflow. At the time of our visit, CDISC was explaining the process to FDA members. Another demo featured ADE Spontaneous Triggered Electronic Reporting (ASTER). Vendors affiliated with the CDISC interoperability demo include Assero IPL, Cerner, Nextrials, Bioclinica, Greenway, Outcome and sponsor Pfizer.
DIA brought together FDA and biotech sponsors for a second year to discuss issues critical to biotech in regard to regulatory. Following are some quotes: Paul Eisenberg, MD, MPH, senior VP regulatory affairs and safety at Amgen, observed that science moves faster than regulatory changes in clinical trials. "It is critical to bank samples to maintain for future analysis so you can go back and ask questions when you have new science." Steven Kozlowski, MD, director of biotech products at CDER, FDA, advised biotech sponsors: "The best way to deal with agency is to tell a story; a narrative on how you see things. Provide a good rationale and tell your story well and document it." Joseph Johnson, VP, regulatory affairs and quality for Isis Pharmaceuticals, said: "It is incumbent on us to be responsive and proactive to FDA...requires a more proactive interface."
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