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In September 2012, TransCelerate Biopharma launched with the aim of simplifying and accelerating the delivery of innovative medicines to patients. What progress has really been made and what are the realistic goals for 2015? In our 2015 kick off radio show, Clinical Air Episode #13, host Craig Lipset, Head of Clinical Innovation, R&D, Pfizer talks with Dalvir Gill, PhD, CEO of Transcelerate and Andy Lee, MD, SVP, Head of Global Clinical Trial Operations at Merck. In this frank discussion, we learn:
What’s working well and changes for 2015?
Is Tanscelerate performing better or differently from other collaborations?
How have engagements with outside organizations advanced? Where do gaps remain?
How are new areas selected and scope defined?
Thoughts on implementing new ideas
New role for CROs
What deliverables does Tanscelerate anticipate for 2015?
In Clinical Air Episode #12, Craig Lipset, Head of Clinical Innovation, R&D, Pfizer talks with Marc Sluijs, Director Life Science Business Development at Oracle Health Sciences.
Marc shares his thoughts on the digital health space and where technology is heading in clinical trials. In this informal discussion, Craig and Marc also cover how digital technologies can better serve patients as well as tips on keeping tabs on this rapidly moving space and what can disrupt pharma?
Head of Clinical Innovation, R&D
Director Life Science Business Development
Oracle Health Sciences
The Conference Forum
Dr. Suzana Flores is a clinical psychologist, Amazon best selling author of Facehooked: How Facebook Affects Our Emotions, Relationships, and Lives. (Reputation Books). As a national social-media expert and commentator, Dr. Flores has appeared on national and international newscasts, podcasts, radio and talk shows including Al Jazeera - The Stream, "Leiberman Live" on The Howard Stern Show, WCIU Channel - "The U," National Public Radio (NPR), "Just Jenny" Sirius XM Channel, WGN Radio Chicago, The ManCow Show, Univision Television News, Charlotte News WSOC-TV, WLTH 1370AM Radio, "LIVE! with The Love Dr." Deanna Lorraine, The Ron Kelly Show, Sound Off with E.V.E, and radio broadcasts out of Germany, U.K. and Canada. Dr. Flores has been quoted in The Chicago Tribune, The Huffington Post, ABC.com, CBS.com, Esquire.com, Everyday Health Magazine, Mashable.com, Dame Magazine, The Nation Magazine, SheKnows.com, Vegas Seven Magazine, New Parent Magazine, Hispanic Health & Beauty Magazine, La Raza Newspaper, Newlyweds.com, Upwave.com, Mujeres Sin Censura, and Moms.me. In her hometown of Chicago, Dr. Flores has earned a Masters in Counseling from Loyola University and a Doctorate degree in clinical psychology from Argosy University - Illinois School of Professional Psychology. Her new book, FACEHOOKED, is an exploration of the psychological effect of Facebook, and social-media networks, on the way we think, communicate, interact and understand ourselves and others. Over the past three years Dr. Flores has studied the Facebook phenomenon extensively, interviewing people from across the globe on their experiences with social-media addiction, and how social-media has affected their sense of self, social interactions, sense of privacy, need for validation, relationships, along with their emotional responses to stress encountered online, cyber-bullying, and emotional manipulators.
A1-hour discussion of the role both clinical aCGH and exome sequencing play in the optimization of genetic diagnosis. The purpose of this webinar is to discuss the unique roles of microarray and diagnostic exome sequencing in the clinical diagnostic process, while also examining benefits, limitations, and detection rates of these tests.
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
In Clinical Air episode # 8, host Craig Lipset, Head of Clinical Innovation, R&D, Pfizer hosts a show discussing investigators as partners in clinical research. Guests include:
Christine Pierre, President, Society of Clinical Research
Jacalyn Kent, Director, Clinical Development Information & Optimization, Eli Lilly
Key topics include:
Misunderstandings around Remote Based Monitoring
Training and communication challenges for remote site managers
What are the real cost savings around RBM...are we just shifting costs?
Real time data and how this should affect sites and payments
Reducing burdens to the sites
Investigator turn over rate, making sites sustainable
How a patient experiences a clinical trial is changing. Access, ease, efficiencey, safety and better quality data collection are the target goals. This episode features some of the emerging technologies together with a discussion on the opportunities and challenges to include patient access, recruitment and retention. Predictions for 2014 are shared by our guests.
Craig H. Lipset, MBA
Head of Clinical Innovation, Worldwide Research and Development, Pfizer Inc.
Tomasz Sablinski, MD, PhD
Founder & CEO, Transparency Life Sciences
Senior Director, Product Development, Innovation Lead, Genentech, A Member of the Roche Group, United States
Join host, Craig Lipset, Head of Clinical Innovation, R&D, Pfizer lead a discussion on Investing in the future of clinical research.
Todd Pietri, Co-Founder, Milestone Ventures
Jeremy Sohn, Managing Director, MPM Capital
VC views on:
Disruption in the clinical trial space
Finding opportunities (incubators and accelerators)
Good sources of deal flows
Investing in technology or people?
Beyond the pill
Craig, Todd and Jeremy will also be speaking at Mobile@Dpharm on September 10th at the Farimont Copley Plaza hotel in Boston. This event helps drug developers get their arms around the mobile/digital clinical trial landscape and figure out:
How mobile is innovating clinical trials
What parts of clinical trials mobile/digital technology is currently impacting
How mobile technology is making clinical trials cheaper, easier and more accurate
How mobile/digital is increasing the efficacy of drugs
What the true value is to clinical trials
There is an opportunity to participate in creating a clinical trial app. Mobile@Dpharm will also be of interest to investors and app developers. Following this one day event is DPharm: Disruptive Innovations to Advance Clinical Trials. For more information, visit www.theconferenceforum.org or call 646 350 2580.
in Self Help
Kelly Tonelli is a clinical psychologist working in private practice with patients who are experiencing life transitions, many of whom are teenage girls. She happily relocated from Michigan to Southern California to attend Pepperdine University and fell in love with the sunshine (snow is cold). She’s been fortunate to have spent time working and learning at Children’s Hospital of Los Angeles (CHLA) before going into private practice. She divides her time between her practice, writing, spending time with her husband, and driving her daughter to dance class.
Allison Risha, RN, BSN, OCN, a nursing program coordinator from the Levine Cancer Institute in Charlotte, North Carolina, joins Mike and Joyce to talk about the current state of clinical trials for genitourinary cancers.
Ms. Risha has worked in many aspects of cancer treatment, and is currently a planner and organizer of programs for staff members and patients.
Please join us, and bring your own questions about clinical trials, what they offer beyond standard treatments, and what to think about when considering participation in a clinical trial.
Join host, Craig H. Lipset, Head of Clinical Innovation, R&D, Pfizer lead a discussion on what it really means to partner with patients in clinical trials.
Jeri Burtchell, Founder, Partners in Research
Regina Holliday, Artist and Medical Advocate
For more information on Jeri's new launch, visit: Healthivibe.com and for Regina walking gallary, google Regina Holliday, walking gallary.
For more information on the topic of Patients as Partners, visit www.theconferenceforum.org. The Conference Forum presented a program in March 2014 fully dedicated to understanding the journey a patient takes in clinical trials. Also take a look at Disruptive Innovations to Advance Clinical Trials scheduled for September 11-12, 2014 in Boston. This event addresses significant innovation to help improve a patients experience in a clinical trial.
This show is part of the Leukemia & Lymphoma Society Patient Education Series.
Our special guest is Dr. Christopher Yasenchak from Compass Oncology in Portland, Oregon. Dr. Yasenchak received his M.D. from Pennsylvania State University. He continued his training at the Mayo Clinic College of Medicine and is board certified in hematology, medical oncology and internal medicine. His clinical focus is multiple myeloma, lymphoma, stem cell transplantation, gastrointestinal malignancies and clinical trials.
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