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June 8, 2007 @ 11:00am – 1:00pm EDT
Patient Retention in Orphan Drug Studies

SPEAKERS FOR THIS EVENT:
- Lisa A. Ward, MPH Clinical Research Manager, Genzyme Corporation Learn More
- Gail Adinamis, President, CEO, Clinical Resource Network, Inc. Learn More

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Patient recruitment is a significant and often complicated element of clinical trial process. Challenges that companies may experience include timing of product approval and adaptive design implementation as well as regional differences and participant expectations.

Join Lisa A. Ward, MPH Clinical Research Manager from Genzyme Corporation who is sharing her case – study on “A Randomized, Double-Blind, Multicenter, Multinational, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of Myozyme, Recombinant Human Acid Alpha-Glucosidase (rhGAA), Treatment in Patients with Late-Onset Pompe Disease.”

Take away points:

  • Site selection and recruitment strategies
  • Importance of patient advocacy support
  • Regional differences and participant expectations
  • Acknowledge and address barriers to participation & moral concerns
  • Retention strategies

THIS PROGRAM IS INTENDED FOR:

VPs, Directors, Heads & Managers of:

  • Clinical Trials
  • Clinical Development
  • Recruitment Services
  • Clinical Trial Recruitment
  • Study Leaders
  • Outsourcing
  • R&D
  • Clinical Operations

Within the pharmaceutical and biotech industries

SPONSORING PARTNERS:

Clinical Resource Network, Inc.

Clinical Resource Network, Inc. is a leading national provider of specialized in-home and alternate-site nursing, pharmacy and phlebotomy services for phase I-IV studies conducted in the US and Canada. These services decrease development time by accelerating patient enrollment, enhancing compliance and reducing dropouts. CRN supports trials in all therapeutic categories and age groups. CRN centrally manages an extensive network of over 10,000 traveling nurses and homecare pharmacists and over 5,000 mobile phlebotomists. Services are available 365 days a year:

  • Study drug storage, compounding, dispensing, delivery
  • Study drug administration (IV, SQ, oral)
  • Blood draws and processing (safety labs, serial pK draws)
  • Patient assessments and education
  • Study documentation

CRN services are particularly beneficial for long-term studies or studies with frequent visits where patients are unreliable, unable, or unwilling to travel to the investigator’s site for drug administration, blood draws or assessments.

CRN is a diversity company and has been exceeding expectations for over 12 years.
http://www.clinicalresource.net/



ABOUT OUR SPEAKERS:
- Lisa A. Ward, MPH Clinical Research Manager, Genzyme Corporation

Lisa A.Ward, MPH is currently employed by Genzyme Corporation in Cambridge, MA as a Manager, Clinical Operations and has functioned as the Clinical Project Manager for the pivotal study for Myozyme in the late onset Pompe population for the past 2 years. Lisa has served in many clinical roles at two CROs, ClinTrials, Inc and Quintiles, Inc. where she spent 10 years working her way up from Clinical Project Assistant to Manager of Clinical Operations. Lisa earned a masters degree in public health with a concentration in nutrition.


- Gail Adinamis , President, CEO, Clinical Resource Network, Inc.

Gail Adinamis is president and CEO of Clinical Resource Network, Inc. (CRN), a diversity company specializing in the provision of in-home nursing and pharmacy services to facilitate clinical trials in North America.

Ms. Adinamis has over 25 years of comprehensive phase I-IV clinical trials experience including over 12 years of global clinical trials management at Abbott Laboratories and Astellas Pharma US. She also established the clinical trials divisions for three national homecare companies and served as president of those wholly-owned subsidiaries.

Ms. Adinamis is a member of the Women’s President Organization, the DIA and ACRP. She has been recognized by numerous Who’s Who organizations and has been an invited speaker at several industry conferences.



 
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