Day 2 :
Tamera Norton Smith has twenty-six years of experience investigating and auditing severe GCP noncompliance. She began her career in GCP and GMP environments in 1990 with the USFDA's Atlanta and Buffalo Districts. Her passion for FDA's mission led her to found her own business in 1999 to audit independently and teach responsible research conduct and ethical research practices. She founded Norton Audits in 1999. It was founded on the sole principle that research participants and patients should be safe and protected while vital and effective products are investigated with complete and accurate results and outcomes
A keynote address to cover specific advancements in clinical research in recent history. Explore the impact of personalized medicine. Suprising top advancements are coming from unique and smaller sources. In the world of big companies examine how individual scientists and academic centers are making strides in cancer treatment and cures. Reflect on the global need for sharing critical results for advancing medical treatments.
The Center for Information and Study on Clinical Research Participation, USA
Jill has worked in the non-profit sector for over 20 years. She is the Senior Director, Patient Engagement at The Center for Information and Study on Clinical Research Participation (CISCRP). In this role, she oversees a team dedicated to helping sponsor companies provide lay language summaries to study volunteers. She also manages the planning, creation, and execution of CISCRP education and outreach programs; development and fundraising; marketing and public relations; and business development. She is passionate about providing education to the public so they can make an informed decision as to whether clinical research is right for them. Working at CISCRP affords her the opportunity to engage patients in the continuum of the clinical research process; whether it’s providing education when they are in a physician’s office or receiving a lay summary after they have given the gift of participation by participating in a study.
There is a critical unmet need to raise public and patient awareness about the importance of clinical research participation. Studies show that public awareness and knowledge about clinical research is poor, particularly among children and young adults — our future study volunteers. CISCRP, a 14-year-old non-profit organization dedicated to educating patients and the public, has been developing a science museum exhibit custom tailored to raise clinical research literacy among this special community. Science museums receive more foot traffic each year than do sporting events and theme park attractions combined. And museums are widely regarded as one of the most effective ways to educate children and their families. This session explores CISCRP's science museum exhibit concepts-in-development, their rationale, as well as a national roll-out plan.
Thomas E Serena is the Founder and Medical Director of Serena Group™, a family of wound, hyperbaric and research companies. He completed his residency in Surgery at the Hershey Medical Center. To date he has opened and operates wound care centers across the United Sates and globally. He has been the Lead or Principal Investigator in over 100 clinical trials and is recognized internationally as an expert in the field of Wound Healing. He has more than 100 published papers and has given more than 1000 invited lectures throughout the world. He has been a Member of the Board of Directors of the Wound Healing Society and served two terms on the Board of the Association for the Advancement of Wound Care (AAWC) and is at present the President-Elect. He has also been Vice-President of the American College of Hyperbaric Medicine and President of the American Professional Wound Care Association.
Clinical research has been an essential component of SerenaGroup’s® Center-of-Excellence model for wound and hyperbaric centers. We are one of the world’s leaders in clinical research in wound healing and hyperbaric medicine. In recent years, we realized that a comprehensive research program must include translational research. In 2015 SerenaGroup Innovation™ opened a laboratory at Northeastern Ohio Medical School to conduct preclinical and bench studies in wound healing. We also partnered with several university preclinical research groups. An unexpected shift in the mindset of our PhDs and clinical investigators occurred in a relatively short period of time: information began to flow from the lab into the clinic and back again. At our conferences, clinicians expressed a desire for new therapies and improved treatments. The research team focused on these unsolved problems. The result has been improved treatment algorithms, a better understanding of the science behind existing treatment modalities and most importantly, innovation. The research team has filed numerous patents as a result of these efforts. Clearly, a translational culture improves patient care and drives innovation.