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Posts Tagged ‘clinical trial 2.0’


5:00 – 5:45 PM Early Diagnosis Through Predictive Biomarkers, NonInvasive Testing

Reporter: Stephen J. Williams, Ph.D.

 

Diagnosing cancer early is often the difference between survival and death. Hear from experts regarding the new and emerging technologies that form the next generation of cancer diagnostics.

Moderator: Heather Rose, Director of Licensing, Thomas Jefferson University
Speakers:
Bonnie Anderson, Chairman and CEO, Veracyte @BonnieAndDx
Kevin Hrusovsky, Founder and Chairman, Powering Precision Health @KevinHrusovsky

Bonnie Anderson and Veracyte produces genomic tests for thyroid and other cancer diagnosis.  Kevin Hrusovksy and Precision Health uses peer reviewed evidence based medicine to affect precision medicine decision.

Bonnie: aim to get a truth of diagnosis.  Getting tumor tissue is paramount as well as properly preserved tissue.  They use deep RNA sequencing  and machine learning  in their clinically approved tests.

Kevin: Serial biospace entrepreneur.  Two diseases, cancer and neurologic, have been diseases which have been hardest to get reproducible and validated biomarkers of early disease.  He concentrates on protein biomarkers.

Heather:  FDA has recently approved drugs for early disease intervention.  However the use of biomarkers can go beyond patient stratification in clinical trials.

Kevin: 15 approved drugs for MS but the markers are scans looking for brain atrophy which is too late of an endpoint.  So we need biomarkers of early disease progression.  We can use those early biomarkers of disease progression so pharma can target those early biomarkers and or use those early biomarkers of disease progression  for endpoint

Bonnie: exciting time in the early diagnostics field. She prefers transcriptomics to DNA based methods such as WES or WGS (whole exome or whole genome sequencing).  It was critical to show data on the cost savings imparted by their transcriptomic based thryoid cancer diagnostic test for payers to consider this test eligible for reimbursement.

Kevin: There has been 20 million  CAT scans for  cancer but it is estimated 90% of these scans led to misdiagnosis. Biomarker  development  has revolutionized diagnostics in this disease area.  They have developed a breakthrough panel of ten protein biomarkers in serum which he estimates may replace 5 million mammograms.

All panelists agreed on the importance of regulatory compliance and the focus of new research should be on early detection.  In addition they believe that Dr. Gotlieb’s appointment to the FDA is a positive for the biomarker development field, as Dr. Gotlieb understands the potential and importance of early detection and prevention of disease.  Kevin also felt Dr. Gotlieb understands the importance of incorporating biomarkers as endpoints in clinical trials.  Over 750 phase 1,2, and 3 clinical trials use biomarker endpoints but the pharma companies still need to prove the biomarkers clinical relevance to the FDA.They also agreed it would be helpful to involve advocacy groups in putting more pressure on the healthcare providers and policy makers on this importance of diagnostics as a preventative measure.

In addition, the discovery and use of biomarkers as disease endpoints has led to a resurgence of Alzheimer’s disease drug development by companies which have previously given up on these type of neurodegenerative diseases.

Kevin feels proteomics offers great advantages over DNA-based diagnostics, especially in cancer such as ovarian cancer, where a high degree of specificity for a diagnostic test is required to ascertain if a woman should undergo prophylactic oophorectomy.  He suggests that a new blood-based protein biomarker panel is being developed for early detection of some forms of ovarian cancer.

Please follow on Twitter using the following #hash tags and @pharma_BI

#MCConverge

#cancertreatment

#healthIT

#innovation

#precisionmedicine

#healthcaremodels

#personalizedmedicine

#healthcaredata

And at the following handles:

@pharma_BI

@medcitynews

 

Please see related articles on Live Coverage of Previous Meetings on this Open Access Journal

LIVE – Real Time – 16th Annual Cancer Research Symposium, Koch Institute, Friday, June 16, 9AM – 5PM, Kresge Auditorium, MIT

Real Time Coverage and eProceedings of Presentations on 11/16 – 11/17, 2016, The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

Tweets Impression Analytics, Re-Tweets, Tweets and Likes by @AVIVA1950 and @pharma_BI for 2018 BioIT, Boston, 5/15 – 5/17, 2018

BIO 2018! June 4-7, 2018 at Boston Convention & Exhibition Center

https://pharmaceuticalintelligence.com/press-coverage/

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Live Conference Coverage Medcity Converge 2018 Philadelphia: Clinical Trials and Mega Health Mergers

Reporter: Stephen J. Williams, PhD

1:30 – 2:15 PM Clinical Trials 2.0

The randomized, controlled clinical trial is the gold standard, but it may be time for a new model. How can patient networks and new technology be leveraged to boost clinical trial recruitment and manage clinical trials more efficiently?

Moderator: John Reites, Chief Product Officer, Thread @johnreites
Speakers:
Andrew Chapman M.D., Chief of Cancer Services , Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital
Michelle Longmire, M.D., Founder, Medable @LongmireMD
Sameek Roychowdhury MD, PhD, Medical Oncologist and Researcher, Ohio State University Comprehensive Cancer Center @OSUCCC_James

 

Michele: Medable is creating a digital surrogate biomarker for short term end result for cardiology clinical trials as well as creating a virtual site clinical trial design (independent of geography)

Sameek:  OSU is developing RNASeq tests for oncogenic fusions that are actionable

John: ability to use various technologies to conduct telehealth and tele-trials.  So why are we talking about Clinical Trials 2.0?

Andrew: We are not meeting many patients needs.  The provider also have a workload that prevents from the efficient running of a clinical trial.

Michele:  Personalized medicine: what is the framework how we conduct clinical trials in this new paradigm?

Sameek: How do we find those rare patients outside of a health network?  A fragmented health system is hurting patient recruitment efforts.

Wout: The Christmas Tree paradigm: collecting data points based on previous studies may lead to unnecessary criteria for patient recruitment

Sameek:  OSU has a cancer network (Orion) that has 95% success rate of recruitment.  Over Orion network sequencing performed at $10,000 per patient, cost reimbursed through network.  Network helps pharma companies find patients and patients to find drugs

Wout: reaching out to different stakeholders

John: what he sees in 2.0 is use of tech.  They took 12 clinic business but they integrated these sites and was able to benefit patient experience… this helped in recruitment into trials.  Now after a patient is recruited, how 2.0 model works?

Sameek:  since we work with pharma companies, what if we bring in patients from all over the US.  how do we continue to take care of them?

Andrew: utilizing a technology is critically important for tele-health to work and for tele-clinical trials to work

Michele:  the utilization of tele-health by patients is rather low.

Wout:  We are looking for insights into the data.  So we are concentrated on collecting the data and not decision trees.

John: What is a barrier to driving Clinical Trial 2.0?

Andrew: The complexity is a barrier to the patient.  Need to show the simplicity of this.  Need to match trials within a system.

Saleem: Data sharing incentives might not be there or the value not recognized by all players.  And it is hard to figure out how to share the data in the most efficient way.

Wout: Key issue when think locally and act globally but healthcare is the inverse of this as there are so many stakeholders but that adoption by all stakeholders take time

Michele: accessibility of healthcare data by patients is revolutionary.  The medical training in US does not train doctors in communicating a value of a trial

John: we are in a value-driven economy.  You have to give alot to get something in this economy. Final comments?

Saleem: we need fundamental research on the validity of clinical trials 2.0.

Wout:  Use tools to mine manually but don’t do everything manually, not underlying tasks

Andrew: Show value to patient

2:20-3:00 PM CONVERGEnce on Steroids: Why Comcast and Independence Blue Cross?

This year has seen a great deal of convergence in health care.  One of the most innovative collaborations announced was that of Cable and Media giant Comcast Corporation and health plan Independence Blue Cross.  This fireside chat will explore what the joint venture is all about, the backstory of how this unlikely partnership came to be, and what it might mean for our industry.

sponsored by Independence Blue Cross @IBX 

Moderator: Tom Olenzak, Managing Director Strategic Innovation Portfolio, Independence Blue Cross @IBX
Speakers:
Marc Siry, VP, Strategic Development, Comcast
Michael Vennera, SVP, Chief Information Officer, Independence Blue Cross

Comcast and Independence Blue Cross Blue Shield are teaming together to form an independent health firm to bring various players in healthcare onto a platform to give people a clear path to manage their healthcare.  Its not just about a payer and information system but an ecosystem within Philadelphia and over the nation.

Michael:  About 2015 at a health innovation conference they came together to produce a demo on how they envision the future of healthcare.

Marc: When we think of a customer we think of the household. So we thought about aggregating services to people in health.  How do people interact with their healthcare system?

What are the risks for bringing this vision to reality?

Michael: Key to experience is how to connect consumer to caregiver.

How do we aggregate the data, and present it in a way to consumer where it is actionable?

How do we help the patient to know where to go next?

Marc: Concept of ubiquity, not just the app, nor asking the provider to ask patient to download the app and use it but use our platform to expand it over all forms of media. They did a study with an insurer with metabolic syndrome and people’s viewing habits.  So when you can combine the expertise of IBX and the scale of a Comcast platform you can provide great amount of usable data.

Michael: Analytics will be a prime importance of the venture.

Tom:  We look at lots of companies that try to pitch technologies but they dont understand healthcare is a human problem not a tech problem.  What have you learned?

Marc: Adoption rate of new tech by doctors is very low as they are very busy.  Understanding the clinicians workflow is important and how to not disrupt their workflow was humbling for us.

Michael:  The speed at which big tech companies can integrate and innovate new technologies is very rapid, something we did not understand.  We want to get this off the ground locally but want to take this solution national and globally.

Marc:  We are not in competition with local startups but we are looking to work with them to build scale and operability so startups need to show how they can scale up.  This joint venture is designed to look at these ideas.  However this will take a while before we open up the ecosystem until we can see how they would add value. There are also challenges with small companies working with large organizations.

 

Please follow on Twitter using the following #hashtags and @pharma_BI

#MCConverge

#cancertreatment

#healthIT

#innovation

#precisionmedicine

#healthcaremodels

#personalizedmedicine

#healthcaredata

And at the following handles:

@pharma_BI

@medcitynews

 

Please see related articles on Live Coverage of Previous Meetings on this Open Access Journal

LIVE – Real Time – 16th Annual Cancer Research Symposium, Koch Institute, Friday, June 16, 9AM – 5PM, Kresge Auditorium, MIT

Real Time Coverage and eProceedings of Presentations on 11/16 – 11/17, 2016, The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

Tweets Impression Analytics, Re-Tweets, Tweets and Likes by @AVIVA1950 and @pharma_BI for 2018 BioIT, Boston, 5/15 – 5/17, 2018

BIO 2018! June 4-7, 2018 at Boston Convention & Exhibition Center

https://pharmaceuticalintelligence.com/press-coverage/

 

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