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Since the FDA and EMA published their current thinking on clinical oversight and risk-based monitoring (RBM) strategies, the topic has received a magnitude of attention, commanding column inches, webinar discussions and industry conferences. With so much discussion going on, it is unsurprising that many sponsors are feeling out in the cold when it comes to identifying how to practically implement RBM strategies within study designs. As data quality matters most in determining study success and ensuring patient safety, the latest recommendations have created growing demand for solutions that simplify the transition to risk-based techniques.
In this program, our guests discuss how emerging technologies and Central Statistical Monitoring (CSM) now present more practical means of implementing successful RBM strategies. Both Sanofi and Novartis will provide a large pharma perspective on making the move to RBM.
Host: Valerie Bowling, Executive Director, The Conference Forum
Marc Buyse, Founder, International Drug Development Institute & CluePoints
Eric Genevois-Marlin, VP, Biostatistics & Programming, Sanofi
Thomas Haag, Data Integrity Process Expert, eClinical Quality Assurance, Novartis Pharmaceuticals
We are very pleased to have Dr. Speid with us tonight. Lorna Speid, PhD, is a pharmacist. She works in the pharmaceutical industry as a regulatory affairs and drug development consultant. She has a practice in the development of new treatments for rare diseases.
After working for Sanofi Winthrop in the United Kingdom, Ciba Geigy at headquarters in Switzerland, and Novartis in Switzerland, she moved to the United States. She worked for three small companies in the United States, and now runs her own consulting practice. Dr. Speid sat on an important NIH Committee for the development of new treatments for rare diseases. She is the founder of a non-profit called Rare Diseases Patients First! This organization is planning to provide education to patients around the world that have a rare disease, about the clinical trial process. This will be done free of charge. We will provide more information about these educational internet-based meetings, as soon as they are ready to be rolled out later this year. Dr. Speid advises on the development of new treatments for rare diseases.
Dr. Speid saw a need to provide information to patients about clinical trials that would allow them to be empowered enough to ask the right questions before entering clinical trials, and while in clinical trials. She wrote the book Clinical Trials: What Patients and Healthy Volunteers Need to Know, to accomplish this. It was published by Oxford University Press in 2010.
in Self Help
Margaret Moore, MBA (aka Coach Meg) is a 17-year veteran of the biotechnology industry in the UK, Canada, US, and France. She served in executive roles at three companies which later joined Sanofi, and served as CEO and COO of two early stage biotech companies.
In 2000, Margaret shifted from high tech medicine to coaching in healthcare and wellness, and founded Wellcoaches Corporation - strategic partner of the American College of Sports Medicine, now a standard-bearer for professional coaches in healthcare and wellness. The Wellcoaches School of Coaching has trained more than 7,500 health and wellness coaches in 47 countries.
Margaret is co-founder (with Carol Kauffman) and co-director of the Institute of Coaching at McLean Hospital, an affiliate of Harvard Medical School, and co- course director of the annual Coaching in Leadership & Healthcare conference offered by Harvard Medical School. Margaret's collaboration with Edward Phillips, MD, to create a Harvard Medical School CME program to teach physicians basic coaching skills, led to the launch of the Institute of Lifestyle Medicine now based at Joslin Diabetes Center, of which Margaret is an advisor. She is a co-founder and co-leader of the National Consortium for Credentialing Health & Wellness Coaches (www.ncchwc.org) which is developing national standards and certification of health and wellness coaches.
Organize Your Mind, Organize Your Life a Harvard Health book published by Harlequin
A panel of executives from leading pharma and the venture capital community at the DPharm Disruptive Innovations conference recently awarded the 2013 Disruptive Innovator of the Year title to Medidata Solutions and Spaulding Clinical Research. They won for their collaboration on a novel study evaluating the impact of mobile and cloud-based technology on patient engagement for improved health outcomes in the diabetes community.
Host Craig Lipset, Head of Clinical Innovation, R&D at Pfizer speaks with Dr. Andrew Lee of Sanofi on key takeaways from the 2013 DPharm conference along with the CEOs of the winning companies to learn more about their collaboration.
Andrew Lee, MD, SVP, Deputy Head of Clinical Sciences & Operations, Sanofi
Glen De Vries, President of Medidata Solutions
Randy Spaulding, Founder and CEO of Spaulding Clinical Research
A conversation with Dennis Urbaniak, VP U.S. Diabetes at sanofi-aventis, about the recent activity on S-A's VOICES corporate Facebook page. We'll discuss the lessons learned and hear advice from independent experts. Urbaniak is willing to answer questions and consider advice from listeners.
Sanofi US to Develop Documentary Featuring Real Patients and Their Stories
A conversation with Bruce Braughton, Vice President, Insulin Franchise for Sanofi U.S. about the "Diabetes Co-stars Casting Call" contest and the use of real patients and their stories in promotional documentaries.
The debate rages on, how to treate diabetes why Drs dont do enough to educate before giving meds, do they always needs meds, and what steps should be taken before meds are given and much more. if you have been recently diagonsed this is a great show for you. Hosted by Charles Mattocks, Celebrity chef from such shows as CNN and Dr Oz talks with Dr Brad Eilerman
Co host by Martina
Brad currently works as a clinical endocrinologist at the St. Elizabeth Regional Diabetes Center in the Greater Cincinnati area. Brad is currently on the speaker’s board of Sanofi, Novo Nordisk, Glaxo Smith Klein, BMS, Amylin, Merck, BI, and Abbott Pharmaceuticals. He is sub-Investigator in clinical trials for Sanofi, Amylin, and Orexigen. He developed insulin dosing software as co-founder of Endometrix LLC and is currently in the process of launching a product with a major pharmaceutical company. For more info visit http://thediabeticyoufilm.com or http://thediabeticyou.com
What EU Pharma Marketers Need from Digital Agencies
Guest Saidat Amirkhanova, former Digital Communications Director at sanofi-aventis, discusses the relationship EU pharmaceutical marketers and digital agencies from the perspective of someone with many years of experience on the inside of the industry and who is now working on the outside.
Join us for Stage 3 insights from Timmy Duggan (Liquigas), Gavin Mannion (Bontrager/Livestrong), Kiel Reijnen (Team Type 1/Sanofi) and possibly even one or two more guests! Crested Butte, CO to Aspen, CO - this one is a beast and we can't wait to hear what these racers have to say about it!
Pro Cyclist Kiel Reijnen (Team Type 1-Sanofi) joins us to discuss his podium finish at last weekend's USPRO Cycling Championships!
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