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Archive for the ‘Personalized and Precision Medicine & Genomic Research’ Category


Personalized Medicine been Positively affected by FDA Drug Approval Record

Reporter: Aviva Lev-Ari, PhD, RN

FDA to Clear Path for Drugs Aimed at Cancer-Causing Genes

By Anna Edney and Michelle Cortez

June 20, 2017, 10:41 AM EDT June 20, 2017, 3:02 PM EDT

https://www.bloomberg.com/news/articles/2017-06-20/fda-moves-to-clear-path-for-drugs-aimed-at-cancer-causing-genes

 

 

‘Landmark FDA approval bolsters personalized medicine’

PMC – An Op-Ed in STAT News

by Edward Abrahams

June 21, 2017

Our understanding of cancer has been morphing from a tissue-specific disease — think lung cancer or breast cancer — to a disease characterized more by specific genes or biomarkers than by location. A recent FDA decision underscores that transition and further opens the door to personalized medicine.

Two years ago, the director of the FDA’s Office of Hematology and Oncology Products told the Associated Press that there was no precedent for the agency to approve a drug aimed at treating tumors that generate a specific biomarker no matter where the cancer is in the body. Such a drug had long been seen as the epitome of personalized medicine. But with the rapid pace of progress in the field, director Dr. Richard Pazdur said, such an approval could one day be possible.

That day has arrived.

In a milestone decision for personalized medicine, the FDA approved Merck’s pembrolizumab (Keytruda) late last month for the treatment of tumors that express one of two biomarkers regardless of where in the body the tumors are located. The decision marks the first time FDA has approved a cancer drug for an indication based on the expression of specific biomarkers rather than the tumor’s location in the body.

Keytruda is designed to help the immune system recognize and destroy cancer cells by targeting a specific cellular pathway. The FDA notes that the two biomarkers — microsatellite instability-high (MSI-H) and mismatch repair deficient (dMMR) — affect the proper repair of DNA inside cells.

The approval represents an important first for the field of personalized medicine, which anticipates an era in which physicians use molecular tests to classify different forms of cancer based on the biomarkers they express, then choose the right treatment for it. In contrast to standard cancer treatments, which are given to large populations of patients even though only a fraction of them will benefit, Keytruda was approved only for the 4 percent of cancer patients whose tumors exhibit MSI-H or dMMR mutations. That may help the health system save money by focusing resources only on patients who are likely to benefit from Keytruda.

Such “personalized” strategies now dominate the landscape for cancer drug development. Personalized medicines account for nearly 1 of every 4 FDA approvals from 2014 to 2016, and the Tufts Center for the Study of Drug Development estimates that more than 70 percent of cancer drugs now in development are personalized medicines.

While this is encouraging, the U.S. research, regulatory, and reimbursement systems aren’t aligned to stimulate the development of personalized medicines, and may even deter progress.

The Trump administration’s proposal to cut biomedical research spending at the National Institutes of Health by 18 percent in fiscal year 2018, for example, would undermine its ability to fund more studies like the National Cancer Institute’s Molecular Analysis for Therapy Choice (MATCH) trial, which is designed to test targeted therapies across tumor types.

While the regulatory landscape for these targeted medicines is clear, the path to market for the molecular tests that do the targeting is not. That uncertainty continues to stifle investment in the innovative tests that make personalized medicine possible. The result is a clinical environment in which the patients who could benefit from personalized medicines are often never identified because the necessary tests aren’t available to them.

Finally, increasing pressure on pharmaceutical and diagnostic companies to decrease prices without considering their value to individual patients and the health system could also deter investment in innovative solutions that address unmet medical needs, particularly for smaller patient populations.

Confronted with unprecedented opportunities in personalized medicine, policymakers would do well to ensure that our research, regulatory, and reimbursement systems facilitate the development of and access to these promising new therapies. Only then can we ensure that Keytruda’s groundbreaking approval represents the beginning of a new era that promises better health and a more cost-effective health system.

Edward Abrahams, Ph.D., is president of the Personalized Medicine Coalition.

 

 

 

SOURCE

From: <cwells@personalizedmedicinecoalition.org>

Date: Wednesday, June 21, 2017 at 1:38 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: PMC in STAT: “Landmark FDA Approval Bolsters Personalized Medicine”

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The Future of Hospitals – How Medical Care and Technology Work Together to Advance Patient Care 

Curator: Gail S. Thornton, M.A.

Co-Editor: The VOICES of Patients, Hospital CEOs, HealthCare Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures

 

Gap Medics (https://www.gapmedics.com/blog/), the world’s leading provider of hospital work experience placements for high school and university students, recently released their “Futuristic Hospitals” infographic. The infographic reviews a collection of top hospitals in the world based on several key factors:

  • overall patient care,
  • innovative medical and technological excellence,
  • efforts toward sustainability,
  • environmental stewardship, and
  • social responsibility, as well as
  • other innovative health care features

to help advance the field of medicine and, ultimately, patient care.

Futuristic Hospitals Infographic

Image SOURCE: Infographic of Futuristic Hospitals courtesy of Evolved Digital and Gap Medics. Reprinted here with Permission from the Source.

 

“Many leading hospital facilities are now rolling out significant improvements and changes that couldn’t have been envisioned 10 years ago,” said Ian McIntosh, Director, Evolved Digital (http://evolveddigital.co.uk/), a U.K.-based digital marketing company specializing in search engine optimization and content marketing, whose team created the infographic for Gap Medics.

Science and innovation are working together to help convey higher expectations for quality medical and health care and advancements in the hospital experience for health care providers, patients and their families.

Particularly, the infographic analyzed prominent hospitals around the world so patients and their families can learn about the latest advances and efforts in patient care and hospital and medical technology.

In this infographic, we investigated the most cutting-edge hospital facilities in the world, where best-in-class technology and innovative medical care are making a difference in providing a quality experience all over the world.

“Gap Medics creates programs offered to thousands of students from Europe, Asia and the United States so they have the opportunity to gain insights into the work of doctors, nurses, physician assistants, midwives and dentists before the students begin their clinical training,” said Dave Brown, Director, Gap Medics, a U.K.-based company that provides hospital work experience between 1-8 weeks to students 16 years of age and older.

This one-in-a-lifetime opportunity helps students better understand their chosen career path, develop as people, and strengthen their university application process.

 

REFERENCE/SOURCE

http://evolveddigital.co.uk/

https://www.gapmedics.com/blog/2017/03/27/futuristic-hospitals/

Other related articles published in this Open Access Online Scientific Journal include the following:

 

“Sudden Cardiac Death,” SudD is in Ferrer inCode’s Suite of Cardiovascular Genetic Tests to be Commercialized in the US

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/02/10/sudden-cardiac-death-sudd-is-in-ferrer-incodes-suite-of-cardiovascular-genetic-tests-to-be-commercialized-in-the-us/

 

Hybrid Cath Lab/OR Suite’s da Vinci Surgical Robot of Intuitive Surgical gets FDA Warning Letter on Robot Track Record

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/19/hybrid-cath-labor-suites-da-vinci-surgical-robot-of-intuitive-surgical-gets-fda-warning-letter-on-robot-track-record/

 

3D Cardiovascular Theater – Hybrid Cath Lab/OR Suite, Hybrid Surgery, Complications Post PCI and Repeat Sternotomy

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/19/3d-cardiovascular-theater-hybrid-cath-labor-suite-hybrid-surgery-complications-post-pci-and-repeat-sternotomy/

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Pharmacotyping Pancreatic Cancer Patients in the Future: Two Approaches – ORGANOIDS by David Tuveson and Hans Clevers and/or MICRODOSING Devices by Robert Langer

Curator: Aviva Lev-Ari, PhD, RN

 

This curation provides the resources for edification on Pharmacotyping Pancreatic Cancer Patients in the Future

 

  • Professor Hans Clevers at Clevers Group, Hubrecht University

https://www.hubrecht.eu/onderzoekers/clevers-group/

  • Prof. Robert Langer, MIT

http://web.mit.edu/langerlab/langer.html

Langer’s articles on Drug Delivery

https://scholar.google.com/scholar?q=Langer+on+Drug+Delivery&hl=en&as_sdt=0&as_vis=1&oi=scholart&sa=X&ved=0ahUKEwixsd2w88TTAhVG4iYKHRaIAvEQgQMIJDAA

organoids, which I know you’re pretty involved in with Hans Clevers. What are your plans for organoids of pancreatic cancer?

Organoids are a really terrific model of a patient’s tumour that you generate from tissue that is either removed at the time of surgery or when they get a small needle biopsy. Culturing the tissue and observing an outgrowth of it is usually successful and when you have the cells, you can perform molecular diagnostics of any type. With a patient-derived organoid, you can sequence the exome and the RNA, and you can perform drug testing, which I call ‘pharmacotyping’, where you’re evaluating compounds that by themselves or in combination show potency against the cells. A major goal of our lab is to work towards being able to use organoids to choose therapies that will work for an individual patient – personalized medicine.

Organoids could be made moot by implantable microdevices for drug delivery into tumors, developed by Bob Langer. These devices are the size of a pencil lead and contain reservoirs that release microdoses of different drugs; the device can be injected into the tumor to deliver drugs, and can then be carefully dissected out and analyzed to gain insight into the sensitivity of cancer cells to different anticancer agents. Bob and I are kind of engaged in a friendly contest to see whether organoids or microdosing devices are going to come out on top. I suspect that both approaches will be important for pharmacotyping cancer patients in the future.

From the science side, we use organoids to discover things about pancreatic cancer. They’re great models, probably the best that I know of to rapidly discover new things about cancer because you can grow normal tissue as well as malignant tissue. So, from the same patient you can do a comparison easily to find out what’s different in the tumor. Organoids are crazy interesting, and when I see other people in the pancreatic cancer field I tell them, you should stop what you’re doing and work on these because it’s the faster way of studying this disease.

SOURCE

Other related articles on Pancreatic Cancer and Drug Delivery published in this Open Access Online Scientific Journal include the following:

 

Pancreatic Cancer: Articles of Note @PharmaceuticalIntelligence.com

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/05/26/pancreatic-cancer-articles-of-note-pharmaceuticalintelligence-com/

Keyword Search: “Pancreatic Cancer” – 275 Article Titles

https://pharmaceuticalintelligence.wordpress.com/wp-admin/edit.php?s=Pancreatic+Cancer&post_status=all&post_type=post&action=-1&m=0&cat=0&paged=1&action2=-1

Keyword Search: Drug Delivery: 542 Articles Titles

https://pharmaceuticalintelligence.wordpress.com/wp-admin/edit.php?s=Drug+Delivery&post_status=all&post_type=post&action=-1&m=0&cat=0&paged=1&action2=-1

Keyword Search: Personalized Medicine: 597 Article Titles

https://pharmaceuticalintelligence.wordpress.com/wp-admin/edit.php?s=Personalized+Medicine&post_status=all&post_type=post&action=-1&m=0&cat=0&paged=1&action2=-1

  • Cancer Biology & Genomics for Disease Diagnosis, on Amazon since 8/11/2015

http://www.amazon.com/dp/B013RVYR2K

 

 

VOLUME TWO WILL BE AVAILABLE ON AMAZON.COM ON MAY 1, 2017

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Forthcoming e-Book on Amazon.com

The VOICES of Patients, HealthCare Providers, Care Givers and Families: Personal Experience with Critical Care and Invasive Medical Procedures

2017 

 

Author, Curator and Editor

Larry H Bernstein, MD, FCAP

Chief Scientific Officer

Leaders in Pharmaceutical Business Intelligence, Northampton, MA

Larry.bernstein@gmail.com

and

Contributing Editor and Author

Gail S. Thornton, PhD(c)

Leaders in Pharmaceutical Business Intelligence, New Jersey

gailsthornton@yahoo.com

Aviva Lev-Ari, PhD, RN

Editor-in-Chief BioMed e-Series of e-Books

Leaders in Pharmaceutical Business Intelligence, Boston

avivalev-ari@alum.berkeley.edu

BioMedical e-Books e-Series:

Cardiovascular, Genomics, Cancer, BioMed, Patient-centered Medicine

https://pharmaceuticalintelligence.com/biomed-e-books/

Abbreviated electronic Table of Contents (eTOCs)

Part One: Perceptions of Care

Chapter 1

1.1    Personal Tale of JL’s Whole Genome Sequencing
1.2    Live Notes from @AACR’s #cbi16 Meeting on Precision 
1.3    Live Notes from @AACR’s #cbi16 Meeting on Precision 
1.4    Supportive Treatments: Hold the Mind Strong During Cancer
1.5    Finding My Voice: A Laryngectomee’s Story
 

Chapter 2

2.1     Delivery of Care – See Live links in the body of the e-Book, below

2.2  Hospital CEO:  A New Standard in Health Care – Farrer Park 
2.3  Drug Discovery for Cancer Cure:  Value for Patients – Turning 
2.4  Hospital CEO: A Rich Tradition of Patient-Focused Care 
2.5  Hospital CEO:  University Children’s Hospital Zurich 

2.6 Hospital CEO: Swiss Paraplegic Centre, Nottwil, Switzerland – A World-Class Clinic for Spinal Cord Injuries

Part Two: The Voice of Cancer Survivors

Chapter 3

3.1    Cancer Companion Diagnostics

3.2    lncRNAs in Human Cancers
3.3    Liquid Biopsy Assay May Predict Drug Resistance
3.4    Pharmacogenomic Biomarkers for Personalized Cancer 
 

Chapter 4

4.1 Personalized Medicine: Cancer Cell Biology and Minimally Invasive Surgery (MIS)

4.2    Cardiotoxicity and Cardiomyopathy Related to Drugs Adverse 
 

Chapter 5

5.1       Thyroid Cancer

5.1.1    Experience with Thyroid Cancer
5.1.2    Cancer Signaling Pathways and Tumor Progression
5.2      Brain Surgery
5.2.1   A Cousin’s Experience with a Pituitary Acromegaly
5.2.2    Loss of Normal Growth Regulation
5.2.3    Glioma, Glioblastoma and Neurooncology
5.3       Breast Cancer
5.3.1    Faces of Breast Cancer – Find Your Story, Join the Conversation
5.3.2    An Emotional and Thoughtful Decision Over BRAC1 and Surgery
5.4       Ovarian Cancer
5.4.1    A Curated History of the Science Behind the Ovarian Cancer
5.4.2    Good and Bad News Reported for Ovarian Cancer Therapy
5.4.3    Almudena’s Story:  A Life of Hope, Rejuvenation and Strength
5.5       Hematological Malignancies
5.5.1    Hematological Malignancy Diagnostics
5.5.2    Hematological Cancer Classification
5.5.3    Chemotherapy in AML
5.5.4    Update on Chronic Myeloid Leukemia
5.5.5    Rituximab for a variety of B-cell malignancies
5.5.6    T cell-mediated immune responses & signaling pathways 
5.5.7    Gene expression and adaptive immune resistance mechanism
5.5.8    Sunitinib brings Adult Acute Lymphoblastic Leukemia (ALL) to R
5.5.9    Management of Follicular Lymphoma
5.5.10   Gene Expression and Adaptive Immune Resistance Mechanisms 
5.6       Other Types of Cancer
5.6.1    Lung Cancer Therapy
5.6.2    Non-small Cell Lung Cancer drugs
5.6.3    Colon Cancer
5.6.4    GERD and esophageal adenocarcinoma
5.6.5    Melanoma
5.6.6   Adenocarcinoma of the Duodenum – Nathalie’s Story: A Health 
5.7     Organ Transplantation
5.7.1     Marcela’s Story: A Liver Transplant Gives the Gift of Life 
 

Chapter 6

6.1   Nutrition: Articles of Note @PharmaceuticalIntelligence.com
6.2   Epigenetics, Environment and Cancer: Articles of Note 
6.3   The relationship of stress hypermetabolism to essential 
6.4   Cancer Drug-Resistance Mechanism
6.5   Biochemistry and Dysmetabolism of Aging and Serious Illness
6.6   Experience of and Alleviation of Pain
 

Chapter 7

7.1   Metabolomics: its applications in food and nutrition research
7.2   Neutraceuticals

Part Three: The Voice of Open Heart Surgery Survivors

Chapter 8
8.1   A Patient’s Perspective: On Open Heart Surgery
8.2   Triple-bypass operation at age 69 – Ralph’s Story
8.3   A Fantastic Vessel-Clearing Innovation on The vessel-clearing 

 

VIEWS – All time for HEALTH CARE PROVIDER INSTITUTIONS –

LIVE Interviews by Gail Thornton

 

TITLE

URL

# Views

on 4/12/2017

Swiss Paraplegic Centre, Nottwil, Switzerland – A World-Class Clinic for Spinal Cord Injuries

# Views

on 4/12/2017

60

 

https://pharmaceuticalintelligence.com/2017/03/23/swiss-paraplegic-centre-nottwil-switzerland-a-world-class-clinic-for-spinal-cord-injuries/

 

60
University Children’s Hospital Zurich (Universitäts-Kinderspital Zürich), Switzerland – A Prominent Center of Pediatric Research and Medicine

# Views

on 4/12/2017

84

 

https://pharmaceuticalintelligence.com/2016/12/21/university-childrens-hospital-zurich-universitats-kinderspital-zurich-switzerland-a-prominent-center-of-pediatric-research-and-medicine/

 

84
A Rich Tradition of Patient-Focused Care — Richmond University Medical Center, New York’s Leader in Health Care and Medical Education

# Views

on 4/12/2017

 139

 

https://pharmaceuticalintelligence.com/2016/10/17/a-rich-tradition-of-patient-focused-care-richmond-university-medical-center-new-yorks-leader-in-health-care-and-medical-education/

 

139
Value for Patients – Turning Advances in Science: A Case Study of a Leading Global Pharmaceutical Company – Astellas Pharma Inc.

# Views

on 4/12/2017

329

 

https://pharmaceuticalintelligence.com/2016/08/24/value-for-patients-turning-advances-in-science-a-case-study-of-a-leading-global-pharmaceutical-company-astellas-pharma-inc/

 

329
A New Standard in Health Care – Farrer Park Hospital, Singapore’s First Fully Integrated Healthcare/Hospitality Complex

# Views

on 4/12/2017

670

https://pharmaceuticalintelligence.com/2016/06/22/a-new-standard-in-health-care-farrer-park-hospital-singapores-first-fully-integrated-healthcarehospitality-complex/

 

670

VIEWS – All time for Patient Experience

LIVE Interviews by Gail Thornton

 

TITLE

URL # Views
WEGO Health Awards Competition Focuses on Patients

 

# Views

on 4/12/2017

17

https://pharmaceuticalintelligence.com/2016/09/13/wego-health-awards-competition-focuses-on-patients/

 

17
Almudena’s Story: A Life of Hope, Rejuvenation and Strength

 

# Views

on 4/12/2017

109

https://pharmaceuticalintelligence.com/2016/08/10/almudenas-story-a-life-of-hope-rejuvenation-and-strength/

 

109
Nathalie’s Story: A Health Journey With A Happy Ending

 

# Views

on 4/12/2017

300

https://pharmaceuticalintelligence.com/2016/07/30/nathalies-story-a-health-journey-with-a-happy-ending/

 

300
Ralph’s Story: An Entertainer at Heart

# Views

on 4/12/2017

143

 

https://pharmaceuticalintelligence.com/2016/07/30/ralphs-story-an-entertainer-at-heart/

 

143
Marcela’s Story: A Liver Transplant Gives the Gift of Life

 

# Views

on 4/12/2017

48

https://pharmaceuticalintelligence.com/2016/07/23/marcelas-story-a-liver-transplant-gives-the-gift-of-life/

 

48
The Role of Big Data in Medicine

 

# Views

on 4/12/2017

55

https://pharmaceuticalintelligence.com/2016/05/16/the-role-of-big-data-in-medicine/

 

55
A Revolutionary, Personalized Approach in Brain Tumor Research

 

# Views

on 4/12/2017

46

https://pharmaceuticalintelligence.com/2016/04/11/a-revolutionary-personalized-approach-in-brain-tumor-research/

 

46

 

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The 13th Annual Personalized Medicine Conference: “From Concept to the Clinic”, November 14 – 16, 2017, Joseph B. Martin Conference Center, Harvard Medical School, 77 Avenue Louis Pasteur, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

The 13th Annual Personalized Medicine Conference will blend an exploration of all the issues facing personalized medicine with practical insights from both clinical experts and patients on how to move evolving concepts into the clinic. Among other topics, the program will cover value frameworks and pharmaceutical pricing, the implications of gene therapy and gene editing, the Trump administration’s perspectives on personalized medicine, and the role of big data.

The dialogue at the conference shapes the community’s agenda and guides the Coalition’s work. Anyone with an interest in the field is welcome to participate.

 

SOURCE

From: <pmc@personalizedmedicinecoalition.org>

Date: Monday, March 13, 2017 at 10:19 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: The 13th Annual PM Conference: “From Concept to the Clinic”

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Precision Medicine Market size worth $87.7BIL by 2023

 Article Publication Request by

Jui Kate | SEO Analyst

Global Market Insights

E-mail: jui.k@gminsights.com | Web: www.gminsights.com 

Published Date: July 25, 2016   Author: Global Market Insights, Inc.

Precision Medicine Market size is expected to reach USD 87.79 billion by 2023; as per a new research report by Global Market Insights, Inc.
Increasing demand for personalized medicine specifically in cancer treatments and advancements in new healthcare technologies will drive precision global medicine market size. Favorable government regulations and standards will help sustain revenue growth.
The individualized diagnosis approach has dramatically improved owing to large-scale biologic database development, efficient methods for patient characterization, and computational tools to analyze large data sets. Emphasizing the need for public health database, The White House dedicated USD 55 million for creation of its largest database ‘Precision Medicine Initiative’ (PMI).

 

 Request Sample Buy NowInquiry Before Buying

 

Recent research advances have helped expand benefits to various aspects of healthcare by enabling better understanding of disease mechanisms, assessment of disease risks and prediction of optimal therapy. A large number of investments in diagnostic research will further accelerate the shift from treatment to preventive medicine in healthcare.
Gene sequencing market size was over USD 8 billion in 2015. Post announcement of the PMI, FDA has recently issued draft guidelines on next generation sequencing-based tests to develop a new kind of healthcare that takes into account individual differences in people’s genes, environments and lifestyles.
Browse key industry insights spread across 94 pages with 85 market data tables & 62 figures & charts from the report, “Precision Medicine Market Size By Technology (Big Data Analytics, Gene Sequencing, Drug Discovery, Bioinformatics, Companion Diagnostics), By Application (Oncology, CNS, Immunology, Respiratory), Industry Analysis Report, Regional Outlook (U.S., Canada, Germany, UK, France, Scandinavia, Italy, Japan, China, India, Singapore, Mexico, Brazil, South Africa, UAE, Qatar, Saudi Arabia), Application Potential, Price Trends, Competitive Market Share & Forecast, 2016 – 2023” in detail along with the table of contents:

https://www.gminsights.com/industry-analysis/precision-medicine-market
Key insights from the report include:

  • Drug discovery technology contributed over USD 9 billion to the global precision medicine market size in 2015, and is estimated to expand at 8.3% CAGR from 2016 to 2023. NGS and other such technologies will open new opportunities for industry participants. Regulation of NGS based test development will help create regulatory processes for genetic test development and application.
  • The global companion diagnostics market is predicted to reach USD 17 billion by 2023. It plays a significant role in development of targeted drugs, thus speeding up the move towards more precise and individualized pharmacotherapy.
  • Oncology application was over 30% of the precision medicine market share in 2015. There have been significant developments taken place across the globe in the area of breast cancer and other related cancers. Predictive biomarkers in lung cancer therapy targets receptors such as c-ros oncogene 1 receptor tyrosine kinase (ROS1), Epidermal Growth Factor Receptor (EGFR), Immune Checkpoints, and Anaplastic Lymphoma Kinase (ALK).
  • U.S. precision medicine market share accounted for over 65% of the North American revenue in 2015, and is anticipated to continue witnessing growth due to increased government initiatives. For instance, The President’s budget in 2016 has allocated USD 130 million to the NIH for development of a national research cohort of a million voluntary U.S. participants, and the data is linked to EHR for easy access to academic scientists and physicians.
  • China contributed 25% to the Asia Pacific precision medicine market size in 2015, mainly due to considerable government initiatives supporting growth in the region. Pfizer, Novartis, Covance, Medtronics, Qiagen, Quest Diagnostics, Roche Holding, Teva Pharmaceuticals, and Biocrates Life Sciences are some notable industry participants.

Global Market Insights has segmented the precision medicine industry on the basis of technology, application, and region:

  • Precision Medicine Market Technology Analysis (Revenue, USD Million; 2013 – 2023)
    • Big data analytics
    • Gene Sequencing
    • Drug discovery
    • Bio Informatics
    • Companion Diagnostics
  • Precision Medicine Market Application Analysis (Revenue, USD Million; 2013 – 2023)
    • Oncology
    • CNS
    • Immunology
    • Respiratory
  • Precision Medicine Market Regional Analysis (Revenue, USD Million; 2013 – 2023)
    • North America
      • U.S.
      • Canada
    • Europe
      • UK
      • Germany
      • France
      • Italy
      • Scandinavia
    • Asia Pacific
      • China
      • Japan
      • India
      • Singapore
    • Latin America
      • Mexico
      • Brazil
    • MEA
      • South Africa
      • Saudi Arabia
      • Qatar
      • UAE

SOURCE

From: Jui Kate <jui.k@gminsights.com>

Date: Friday, February 17, 2017 at 6:35 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Article Publication Request

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Personalized Medicine Meeting – Discussion on FDA Regulation with Outgoing FDA Commissioner, Pharma and Investors

Reporter: Aviva Lev-Ari, PhD, RN

The agency has long felt that the current oversight provided by the Centers for Medicare & Medicaid Services under CLIA has critical gaps and is putting patients at risk. However, for more than two decades, the lab industry has aggressively fought against FDA regulation by threatening legal action and lobbying Congress. Despite industry objections, the FDA two years ago pushed ahead a draft guidance outlining a risk-based oversight plan for LDTs. However, following the November elections, the agency said it would hold off on finalizing those plans in order to consider input from other groups and await further input from the new administration.

Then, a week before Donald Trump was sworn into office, the agency released a discussion paper outlining a revised regulatory framework for LDTs based on more than 300 comments to its draft guidance, a public workshop, and meetings with stakeholders. The paper allowed the agency, without issuing enforceable regulations, to publicly respond to the lab industry’s concerns about burdensome requirements, demonstrate that it had listened to critics of the draft plan, and lay out the rationale, once again, for why FDA needed to step in to look at aspects of test development that CMS doesn’t.

“I think the community better take this really seriously,” Califf said discussing LDT regulation at the PMWC. While on the one hand regulation shouldn’t stifle innovation, he noted that doctors can’t be left to figure out which test they should order. “We’ve got to come up with some middle ground, so regardless of where you are in the US you can get a reproducible laboratory result,” he said, especially when patients’ treatment decisions depend on those results. “I think that’s upcoming work for this year,” Califf added.

Some industry observers have noted that in a crowded immunotherapy market, the availability of multiple PD-L1 tests, the availabilty of FDA approved kits and unapproved LDTs that seemingly gauge the same analyte, and the companion versus complementary diagnostic categories, are actually confusing physicians. This has led to some to suggest that drugmakers work with regulators to advance one test.

Additional Sources

  • New Complementary Dx Category Provides Regulatory Flexibility, but Poses Real WorldChallenges

GenomeWeb , 2016

  • At CDx Harmonization Meeting, Drugmakers Take First Step Toward Exploring Test Differences

GenomeWeb , 2015

  • In Approving Opdivo With Dakos Complementary Test, FDA Advances Rx Personalization Option

GenomeWeb , 2015

  • In 2016, Personalized Medicine Saw More CDx Deals, Flexible FDA, No LDT Guidance

GenomeWeb , 2017

  • Agilents Dako Lands FDA Approval for Lung Cancer Complementary Dx

GenomeWeb , 2015

  • In 2015, Precision Medicine Options Grew; FDA, Labs Still at Odds; Payment Remained Mostly Elusive

GenomeWeb , 2015

Outgoing FDA Commissioner, Pharma, Investors Discuss Regulation at Personalized Medicine Meeting

Jan 24, 2017 | Turna Ray

SOURCE

https://www.genomeweb.com/molecular-diagnostics/outgoing-fda-commissioner-pharma-investors-discuss-regulation-personalized?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Daily%20News:%20NSF,%20USDA%20Award%20Microbiome%20Research%20Grants%20-%2001/24/2017%2004:15:00%20PM

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