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Building Blocks of IO Clinical Trials - Part 1 May 10, 2018

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Building Blocks of IO Trials: This talk will consist of 7 perspectives that identify operational aspects of IO trials, including a patient perspective, site management, 3rd party component, clinical supply chain, a PI perspective, data management and project management. The collaborative talk concludes with a panel discussion and Q&A. This Discussion was presented at the 2018 Immuno-Oncology 360° Meeting.

Endpoints News Industry Report on IO Collaborations and Trends May 09, 2018

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Endpoints News Industry Report on IO Collaborations and Trends In this episode of Pharma Talk Radio, John Carroll, Editor-in-Chief of Endpoints News, reviewed the build up of the immuno-oncology space over the past few years at the IO360° conference that took place February 2018. Mr Carroll discussed the impact the large amount of money and the extraordinary numbers that have been invested in the space, have had on collaborations. He also shed light on the natural limitations and boundaries that are going to impact IO R&D, along with exploring China as an upcoming major player in the IO space. About John Carroll: John Carroll is a biotech analyst with 38 years of prize-winning experience in journalism. For more information visit: https://endpts.com/ This talk was given at Day 2 of Immuno-Oncology 360° meeting in 2018. Save the Date: The 5th annual Immuno-Oncology 360° program will take place February 6-8, 2019 in NYC. For more information visit: http://theconferenceforum.org/conferences/immuno-oncology-360/overview/

CTTI Report - Mobile Clinical Trials Program: Recommendations on Novel Endpoints Apr 30, 2018

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Mobile Podcast Series #2 CTTI Findings are in from their Mobile Clinical Trials Program: Recommendations on Novel Endpoints CTTI's Mobile in Clinical Trials program was launched three years ago to propose recommendations that clarify the pathway for developing novel endpoints for use in clinical trials from data generated using mobile technology. Jennifer Goldsack shares recommendations and insights from their findings on: Developing an internal process for identifying endpointsStrategies for reducing friction throughout the processExecuting the processThe science required to validate an endpointA suite of tools developed in the process to help facilitate implementation The next Mobile in Clinical Trials conference is September 24 in Boston. Mobile is the annual update on not only the latest progress in applying mobile/digital tools to clinical trials, but how and when to do this and for what benefit. Speaker: Jennifer Goldsack, MChem, MA, MBA, CPHQ, Clinical Project Manager, CTTI Producer: Valerie Bowling, Executive Director, Mobile in Clinical Trials

How a Mobile App Can Offer Unique Value in Assessing Patient Reported Outcomes Apr 29, 2018

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Podcast on Mobile in Clinical Trials Series #1 How a Mobile App Can Offer Unique Value in Assessing Patient Reported Outcomes Crescendo Biosciences's CIO, Alex Bangs, reports on how a human-centered design approach was used to create MyRA, an award-winning app for patients living with RA. This podcast comes from the 2017 Mobile in Clinical Trials US event. The next Mobile in Clinical Trials conference is May 15-16 in London and then September 24 in Boston. Mobile is the annual update on not only the latest progress in applying mobile/digital tools to clinical trials, but how and when to do this and for what benefit. Speaker: Alex Bangs, Chief Information Officer, Crescendo Biosciences Producer: Kim Chin, Marketing Director, Mobile in Clinical Trials

Lessons Learned from the Journey of a CMO Leader, Michael Rosenblatt, MD Apr 18, 2018

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The Chief Medical Officer Summit is delighted to present a podcast featuring the Keynote Fireside Chat with Michael Rosenblatt, MD, on Lessons Learned from the Journey of a CMO Leader In this session, Dr Rosenblatt, former Merck CMO, will share his insights on career path decision-making and will compare the experiences and lessons learned from being the CMO on the drug development side versus the biotech investor side of the industry. Moderated by CEO of Evelo Biosciences, Simba Gill, MBA, PhD. Join us at the 6th annual CMO Summit, the largest annual gathering for physicians to exchange best practices in clinical development within the confines of the emerging biotech space. We already have 50 CMOs confirmed to attend. You won't want to miss out on this event. Producer: Valerie Bowling, Executive Director, Chief Medical Officer Summit

Developing a Pathway for Compassionate Use Cases Apr 17, 2018

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The Chief Medical Officer Summit is delighted to share a podcast featuring a presentation prepared by Drs Alison Bateman-House and Arthur Caplan of NYU's Division of Medical Ethics on the topic of: Developing a Pathway for Compassionate Use Cases What should the CMO do when they receive a request?What's the role of the CMO, the FDA and the IRB?Lessons learned from Janssen Case StudyHow do you scale down for a biotech?Potential modelsCan the process be accelerated? Join us at the 6th annual Chief Medical Officer Summit, the largest annual gathering for physicians to exchange best practices in clinical development and R&D within in the confines of the emerging biotech space. We already have 50 CMOs confirmed to attend, and you will not want to miss out on this event. Speaker: Alison Bateman-House, PhD, MPH,Assistant Professor, Division of Medical Ethics,NYU Producer: Valerie Bowling, Executive Director, Chief Medical Officer Summit

2018 Chief Medical Officer Summit Podcast Overview in a Nutshell Apr 17, 2018

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This podcasts gives you an overview on what to expect for the 2018 Chief Medical Officer Summit in a nutshell. The concept of the CMO Summit came from MPM Capital’s Dr Elizabeth Stoner, who told us that there is a deep need for a Summit that is designed for CMOs and heads of R&D in the emerging biotech space, specifically, where we can cover all the key issues affecting R&D decisions together with business development issues. The program takes place on May 7th and 8th at the Omni Parker House in Boston and we already have over 50 CMOs committed to attending. The program is co-chaired by Julie Krop, MD, CMO, EVP, Clinical Development & Regulatory Affairs, AMAG Pharmaceuticals, Inc, and Jim Roach, MD, FACP, FCCP, CMO, Pulmatrix. The 6th Annual Chief Medical Officer Summit is produced by the Conference Forum. The Conference Forum is life science industry research firm that carefully and meticulously presents strategic level programming. As with all Conference Forum events, you can expect prominent networking. To learn more about the event, visit www.theconferenceforum.org. Be sure to use code TEML for a 10% discount. Thanks for listening.

Clinical Research as a Care Option, 2nd annual - 3 min Podcast Overview Mar 04, 2018

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In this three minute podcast, you get an overview of one of the hottest topics we are covering in a full day 2nd annual event on Clinical Research as a Care Option. (CRAACO). Making clinical trials a care option is arguably the greatest challenge we can collaborate on in bringing patients closer to clinical trials. CRAACO takes place on April 11th at the Boston Marriott Cambridge. We look at how to integrate clinical research into the overall continuum of patient care and ask, how do we make clinical research a care option? The program is co-chaired by Jeff James CEO, Wilmington Health and Katherine Vandebelt, Chief Ecosystem Officer at Reify Health. The 2nd annual CRAACO event is produced by the Conference Forum. The Conference Forum is life science industry research firm with veteran researchers, who carefully and meticulously present strategic level programming. As with all Conference Forum events, you can expect networking activities and prominent networking. To learn more about CRAACO, visit www.theconferenceforum.org. Be sure to use code TEML for a 10% discount. Thanks for listening.

What to Expect at Clinical Trial Collaborations 2018 – 5 min Podcast Mar 04, 2018

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This podcast gives you a five minute overview of the 3rd annual Clinical Trial Collaborations conference, otherwise known as CTC. CTC is a strategic level event focused on arguably the most important change in transforming drug development: How and who we collaborate with to drive better clinical trial outcomes? CTC is ideal for people working in clinical trial operations, who are involved with external relationships or need to be involved with external relationships and want to see examples of strategic and creative solutions to successful collaborations and who we need to be collaborating with next? The program takes place on April 9th – 11th at the Boston Marriott Cambridge and is divided into three parts, one on each day of the event. Part I deals with new advancements in clinical trial collaborations, current examples to challenge us, and progress. Part II focuses on strategic collaborations, virtual trials and next generation monitoring. Part III addresses how do we bring clinical research closer to patients and vice versa. CTC is co-chaired by Ken Getz, Director of Sponsored Research, Tufts CSDD, Murray Abramson, MD, VP, Clinical Operations, Biogen, Jeff James, CEO, Wilmington Health and Katherine Vandebelt, Chief Ecosystem Officer, Reify Health. Use code TEML for 10% off and for more information visit, www.theconferenceforum.org.

Mobile in Clinical Trials Europe New for 2018 - 4 min Podcast Overview Mar 01, 2018

Show notes

The Mobile in Clinical Trials conference comes to Europe for the first time on May 15th and 16th at the Millennium Gloucester Hotel in London. If you work or want to work with mobile and digital technologies to make clinical trials more efficient and reduce patient burden, we highly recommend this conference for you. Using our past four years of experience in the US, we are able to combine the best examples of mobile and digital optimization in clinical trials from the US with examples from the UK and other parts of Europe. Mobile in Clinical Trials Europe is chaired by Pfizer’sDr Daniel Karlin with a pharma speaking faculty of who’s who in leading mobile in clinical trials. VIP Guests include Verily Life Sciences’Dr Tushar Parlikar on how Verily’s studywatch is tackling scalability of wearables in clinical trials and Vodafone’s Dr Nuria Oliver, who gives a visionary keynote to address data-driven decision making. Mobile in Clinical Trials Europe is produced by the Conference Forum. The Conference Forum is life science industry research firm with veteran researchers, who carefully and meticulously present high quality programming. As with all Conference Forum events, you can expect networking activities and prominent networking. To learn more, visit www.theconferenceforum.org. Be sure to use code TEML for a 10% discount. Thanks for listening.

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