• 00:48

    Risk Based Monitoring: New Thinking on Clinical Oversight

    in Science

    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


    Guests:


    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


     


     

  • 01:06

    The HD View with Dr. Lorna Speid

    in Health

    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.  

  • 00:36

    Founder of Wellcoaches, Author, & Wellness Visionary Margaret Moore

    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.


    http://www.wellcoachesschool.com/index.cfm?page=AU_coachmeg


    Organize Your Mind, Organize Your Life a Harvard Health book published by Harlequin

  • 00:31

    Clinical Air Episode #3 Dpharm & Beyond

    in Business

    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.
    Guests:
    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    

  • 00:45

    What Sanofi-Aventis Learned from Its FaceBook Experience & What the Experts Recommend It Do Now

    in Business

    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.

  • 00:19

    Diabetes Co-stars Casting Call Contest

    in Business

    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.

  • 00:46

    Meds first for diabetes? We talk how to first treat diabetes

    in Caregiving

    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 

  • 00:28

    Bridging the EU Pharma-Digital Agency Divide

    in Business

    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.

  • 00:14

    Final Wrap up of US Pro Cycling Challenge

    in Fitness

    Timmy Duggan (Liquigas), Gavin Mannion (Bontrager/Livestrong) and Kiel Reijnen (TT1/Sanofi) join us for the final wrap up of last weeks stage race through Colorado!

  • 00:15

    Over The Top Radio - US Pro Cycling Challenge

    in Fitness

    Timmy Duggan (Liquigas), Gavin Mannion (Bontrager/Livestrong), Kiel Reijnen (Team Type 1/Sanofi) and possibly others join us at 8:30PM Mountain Time to discuss Stage 4 and the upcoming Stage 5.  By the way, happy 21st birthday Gavin!

  • 00:44

    Over The Top Radio - US Pro Cycling Challenge

    in Fitness

    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!

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