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Archive for the ‘Personal Health Applications: Tech Innovations serves HealhCare’ Category

Digital Therapeutics: A threat or opportunity to pharmaceuticals


Reporter and Curator: Dr. Sudipta Saha, Ph.D.

 

Digital Therapeutics (DTx) have been defined by the Digital Therapeutics Alliance (DTA) as “delivering evidence based therapeutic interventions to patients, that are driven by software to prevent, manage or treat a medical disorder or disease”. They might come in the form of a smart phone or computer tablet app, or some form of a cloud-based service connected to a wearable device. DTx tend to fall into three groups. Firstly, developers and mental health researchers have built digital solutions which typically provide a form of software delivered Cognitive-Behaviour Therapies (CBT) that help patients change behaviours and develop coping strategies around their condition. Secondly there are the group of Digital Therapeutics which target lifestyle issues, such as diet, exercise and stress, that are associated with chronic conditions, and work by offering personalized support for goal setting and target achievement. Lastly, DTx can be designed to work in combination with existing medication or treatments, helping patients manage their therapies and focus on ensuring the therapy delivers the best outcomes possible.

 

Pharmaceutical companies are clearly trying to understand what DTx will mean for them. They want to analyze whether it will be a threat or opportunity to their business. For a long time, they have been providing additional support services to patients who take relatively expensive drugs for chronic conditions. A nurse-led service might provide visits and telephone support to diabetics for example who self-inject insulin therapies. But DTx will help broaden the scope of support services because they can be delivered cost-effectively, and importantly have the ability to capture real-world evidence on patient outcomes. They will no-longer be reserved for the most expensive drugs or therapies but could apply to a whole range of common treatments to boost their efficacy. Faced with the arrival of Digital Therapeutics either replacing drugs, or playing an important role alongside therapies, pharmaceutical firms have three options. They can either ignore DTx and focus on developing drug therapies as they have done; they can partner with a growing number of DTx companies to develop software and services complimenting their drugs; or they can start to build their own Digital Therapeutics to work with their products.

 

Digital Therapeutics will have knock-on effects in health industries, which may be as great as the introduction of therapeutic apps and services themselves. Together with connected health monitoring devices, DTx will offer a near constant stream of data about an individuals’ behavior, real world context around factors affecting their treatment in their everyday lives and emotional and physiological data such as blood pressure and blood sugar levels. Analysis of the resulting data will help create support services tailored to each patient. But who stores and analyses this data is an important question. Strong data governance will be paramount to maintaining trust, and the highly regulated pharmaceutical industry may not be best-placed to handle individual patient data. Meanwhile, the health sector (payers and healthcare providers) is becoming more focused on patient outcomes, and payment for value not volume. The future will say whether pharmaceutical firms enhance the effectiveness of drugs with DTx, or in some cases replace drugs with DTx.

 

Digital Therapeutics have the potential to change what the pharmaceutical industry sells: rather than a drug it will sell a package of drugs and digital services. But they will also alter who the industry sells to. Pharmaceutical firms have traditionally marketed drugs to doctors, pharmacists and other health professionals, based on the efficacy of a specific product. Soon it could be paid on the outcome of a bundle of digital therapies, medicines and services with a closer connection to both providers and patients. Apart from a notable few, most pharmaceutical firms have taken a cautious approach towards Digital Therapeutics. Now, it is to be observed that how the pharmaceutical companies use DTx to their benefit as well as for the benefit of the general population.

 

References:

 

https://eloqua.eyeforpharma.com/LP=23674?utm_campaign=EFP%2007MAR19%20EFP%20Database&utm_medium=email&utm_source=Eloqua&elqTrackId=73e21ae550de49ccabbf65fce72faea0&elq=818d76a54d894491b031fa8d1cc8d05c&elqaid=43259&elqat=1&elqCampaignId=24564

 

https://www.s3connectedhealth.com/resources/white-papers/digital-therapeutics-pharmas-threat-or-opportunity/

 

http://www.pharmatimes.com/web_exclusives/digital_therapeutics_will_transform_pharma_and_healthcare_industries_in_2019._heres_how._1273671

 

https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/exploring-the-potential-of-digital-therapeutics

 

https://player.fm/series/digital-health-today-2404448/s9-081-scaling-digital-therapeutics-the-opportunities-and-challenges

 

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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

  •  In a national survey, the Fiber Choice® line of chewable prebiotic fiber tablets and gummies, achieved the #1 share of gastroenterologist (GE) recommendations, more than four times greater than that for the nearest branded competitor
  • Fiber Choice contains a well-studied prebiotic fiber that promotes regularity and supports the growth of beneficial microorganisms for general digestive health
  • The convenience, taste and efficacy of Fiber Choice, makes it a GE-endorsed choice toward helping address the “fiber gap” in American diets

 Boca Raton, Fla. – (June 3, 2018) – IM HealthScience® (IMH), innovators of medical foods and dietary supplements, today announced a high-quality and replicated nationwide survey conducted among a representative and projectible sample of U.S. gastroenterologists, which revealed Fiber Choice® as the #1-recommended chewable prebiotic fiber brand.

The results of a ProVoice survey, fielded in May 2018 by IQVIA, showed Fiber Choice as the leader by far. Its share of gastroenterologist endorsements was more than four times greater than that of its nearest branded competitor.

Less than 3 percent of Americans get the recommended minimum amount of fiber, and 97 percent need to increase their fiber intake[1]. Although the recommended daily fiber intake is 25 to 38 grams[2], most Americans only get about half that amount. This “fiber gap” reflects a diet with relatively few high-fiber foods, such as fruits, vegetables, nuts, legumes and whole-grains, and is large enough for the U.S. government to deem it a public health concern for most of the U.S. population.

To help bridge this gap, gastroenterologists recommend fibers including Fiber Choice chewable tablets and gummies. For doctors, it’s a simple, convenient and tasty way to help their patients get the fiber needed for overall good digestive health.

“Dietary fiber is known for keeping our bodies regular,” said Michael Epstein, M.D., FACG, AGAF, a leading gastroenterologist and Chief Medical Advisor of IM HealthScience. “Most importantly, it’s essential that you get enough fiber in your diet. One way to do that is to supplement your daily intake of dietary fiber with natural, prebiotic fiber supplements.”

Inulin, the 100 percent natural prebiotic soluble fiber in Fiber Choice, has been studied extensively and has been shown to support laxation and overall digestive health as well as glycemic control, lowered cholesterol, improved cardiovascular health, weight control and better calcium absorption.

Fiber Choice can be found in the digestive aisle at Walmart, CVS, Target, Rite Aid and many other drug and food retailers.

About ProVoice Survey
ProVoice has the largest sample size of any professional healthcare survey in the U.S., with nearly 60,000 respondents across physicians, nurse practitioners, physician assistants, optometrists, dentists, and hygienists, measuring recommendations across more than 120 over-the-counter categories. Manufacturers use ProVoice for claim substantiation, promotion measurement, and HCP targeting.

IQVIA fielded replicated surveys in April 2018 and May 2018 respectively among U.S. gastroenterologists for IM HealthScience. The ProVoice survey methodology validated the claim at a 95 percent confidence level that “Fiber Choice® is the #1 gastroenterologist-recommended chewable prebiotic fiber supplement.”

About Fiber Choice®

The Fiber Choice® brand of chewables and gummies is made of inulin [pronounced: in-yoo-lin], a natural fiber found in many fruits and vegetables. Inulin works by helping to build healthy, good bacteria in the colon, while keeping food moving through the digestive system. This action has a beneficial and favorable effect in softening stools and improving bowel function.

Research shows that the digestive system does more than digest food; it plays a central role in the immune system. The healthy bacteria that live in the digestive tract promote immune system function, so prebiotic fiber helps nourish the body. Inulin also has secondary benefits, too, of possibly lowering cholesterol, balancing blood chemistry and regulating appetite, which can help reduce calorie intake and play a supporting role in weight management.

The usual adult dosage with Fiber Choice Chewable tablets is two tablets up to three times a day and for Fiber Choice Fiber Gummies is two gummies up to six per day.

About IM HealthScience®

IM HealthScience® (IMH) is the innovator of IBgard and FDgard for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), respectively. In 2017, IMH added Fiber Choice®, a line of prebiotic fibers, to its product line via an acquisition. The sister subsidiary of IMH, Physician’s Seal®, also provides REMfresh®, a well-known continuous release and absorption melatonin (CRA-melatonin™) supplement for sleep. IMH is a privately held company based in Boca Raton, Florida. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing products to address overall health and wellness, including conditions with a high unmet medical need, such as digestive health. The IM HealthScience advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting (SST). For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com,  www.FDgard.comwww.FiberChoice.com, and www.Remfresh.com.

This information is for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professional. You should not use this information for diagnosing a health problem or disease. The company will strive to keep information current and consistent but may not be able to do so at any specific time. Generally, the most current information can be found on www.fiberchoice.com. Individual results may vary.

SOURCE/REFERENCES

[1] Greger, Michael, M.D., FACLM. (2015, September 29). Where Do You Get Your Fiber? [Blog post]. Retrieved from https://nutritionfacts.org/2015/09/29/where-do-you-get-your-fiber/

[2] Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, DC: The National Academies Press. https://doi.org/10.17226/10490.

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

2018

Benefits of fiber in diet

https://pharmaceuticalintelligence.com/2018/03/14/benefits-of-fiber-in-diet/

2016

Nutrition & Aging: Dr. Simin Meydani appointed Vice Provost for Research @Tufts University

https://pharmaceuticalintelligence.com/2016/08/01/nutrition-aging-dr-simin-meydani-appointed-vice-provost-for-research-tufts-university/

2015

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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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President Carter’s Status

Author: Larry H. Bernstein, MD, FCAP

 

 

Most Experts Not Surprised by Carter’s Status 

But early response does not mean ‘cure’

http://www.medpagetoday.com/HematologyOncology/SkinCancer/55076

 

http://clf1.medpagetoday.com/media/images/55xxx/55076.jpg

by Charles Bankhead
Staff Writer, MedPage Today

 

Former President Jimmy Carter’s announcement that he is free of metastatic melanoma surprised many people but, not most melanoma specialists contacted by MedPage Today.

With the evolution of modern radiation therapy techniques and targeted drugs, more patients with metastatic melanoma achieve complete and partial remissions, including remission of small brain metastases like the ones identified during the evaluation and initial treatment of Carter. However, the experts — none of whom have direct knowledge of Carter’s treatment or medical records — cautioned that early remission offers no assurance that the former president is out of the woods.

“If I had a patient of my own with four small brain mets undergoing [stereotactic radiation therapy], I would tell them that I fully expected the radiation to take care of those four lesions,” said Vernon K. Sondak, MD, of Moffitt Cancer Center in Tampa. “The fact that President Carter reports that it has done just that is not a surprise to me at all.

“I would also tell my patient that the focused radiation only treats the known cancer in the brain, and that if other small areas of cancer are present, they will likely eventually grow large enough to need radiation or other treatment as well, and that periodic brain scans will be required to monitor for this possibility.”

Carter also is being treated with the immune checkpoint inhibitor pembrolizumab (Keytruda), which is known to stimulate immune cells that then migrate to tumor sites to eradicate the lesions, noted Anna Pavlick, DO, of NYU Langone Medical Center in New York City.

“Melanoma is no longer a death sentence, and we are really changing what happens to patients,” said Pavlick. “It really is amazing.”

Carter’s melanoma story began to emerge in early August when he had surgery to remove what was described as “a small mass” from his liver. Following the surgery, Carter announced that his doctors had discovered four small melanoma lesions in his brain, confirming a suspicion the specialists had shared with him at the time of the surgery.

Carter subsequently underwent focused radiation therapy to eradicate the brain lesions and initiated a 12-week course of treatment with pembrolizumab. The radiation therapy-targeted therapy combination was a logical option for Carter, given observations that the PD-L1 inhibitor has synergy with radiation, noted Stergios Moschos, MD, of the University of North Carolina Lineberger Comprehensive Cancer Center at Chapel Hill.

“I have seen this in other patients with metastatic melanoma,” said Gary K. Schwartz, MD, of Columbia University Medical Center in New York City. “It is remarkable but absolutely possible within the realm of immunotherapy today.”

Although Carter’s announcement is undeniably good news, the optimism should be tempered by a long-term perspective, suggested Nagla Abdel Karim, MD, PhD, of the University of Cincinnati Medical Center.

“We do have similar stories; however, we would be careful to call it a ‘complete remission’ and ‘disease control’ and not a ‘cure,’ so far,” said Karim. “We would resume therapy and follow-up any autoimmune side effects. Most important is the quality of life, which he seems to enjoy, and we are very happy with that.”

Darrell S. Rigel, MD, also of NYU Langone Medical Center, represented the lone dissenter among specialists who responded to MedPage Today‘s request for comments.

“I’m happy for him, but it’s very unusual, especially in older men, who usually have a worse prognosis,” said Rigel. “He is on a new drug that may have a little more promise, but there is no definitive cure at this point.”

 

 

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Lifelong Contraceptive Device for Men: Mechanical Switch to Control Fertility on Wish

Reporter and Curator: Dr. Sudipta Saha, Ph.D.

There aren’t many options for long-term birth control for men. The most common kinds of male contraception include

  • condoms,
  • withdrawal / pulling out,
  • outercourse, and
  • vasectomy.

But, other than vasectomy none of the processes are fully secured, comfortable and user friendly. Another solution may be

  • RISUG (Reversible Inhibition of Sperm Under Guidance, or Vasalgel)

which is said to last for ten years and no birth control pill for men is available till date.

VIEW VIDEO

http://www.mdtmag.com/blog/2016/01/implanted-sperm-switch-turns-mens-fertility-and?et_cid=5050638&et_rid=461755519&type=cta

Recently a German inventor, Clemens Bimek, developed a novel, reversible, hormone free, uncomplicated and lifelong contraceptive device for controlling male fertility. His invention is named as Bimek SLV, which is basically a valve that stops the flow of sperm through the vas deferens with the literal flip of a mechanical switch inside the scortum, rendering its user temporarily sterile. Toggled through the skin of the scrotum, the device stays closed for three months to prevent accidental switching. Moreover, the switch can’t open on its own. The tiny valves are less than an inch long and weigh is less than a tenth of an ounce. They are surgically implanted on the vas deferens, the ducts which carry sperm from the testicles, through a simple half-hour operation.

The valves are made of PEEK OPTIMA, a medical-grade polymer that has long been employed as a material for implants. The device is patented back in 2000 and is scheduled to undergo clinical trials at the beginning of this year. The inventor claims that Bimek SLV’s efficacy is similar to that of vasectomy, it does not impact the ability to gain and maintain an erection and ejaculation will be normal devoid of the sperm cells. The valve’s design enables sperm to exit the side of the vas deferens when it’s closed without any semen blockage. Leaked sperm cells will be broken down by the immune system. The switch to stop sperm flow can be kept working for three months or 30 ejaculations. After switching on the sperm flow the inventor suggested consulting urologist to ensure that all the blocked sperms are cleared off the device. The recovery time after switching on the sperm flow is only one day, according to Bimek SLV. However, men are encouraged to wait one week before resuming sexual activities.

Before the patented technology can be brought to market, it must undergo a rigorous series of clinical trials. Bimek and his business partners are currently looking for men interested in testing the device. If the clinical trials are successful then this will be the first invention of its kind that gives men the ability to control their fertility and obviously this method will be preferred over vasectomy.

 

References:

 

https://www.bimek.com/this-is-how-the-bimek-slv-works/

 

http://www.mdtmag.com/blog/2016/01/implanted-sperm-switch-turns-mens-fertility-and?et_cid=5050638&et_rid=461755519&type=cta

 

http://www.telegraph.co.uk/news/worldnews/europe/germany/12083673/German-carpenter-invents-on-off-contraception-switch-for-sperm.html

 

http://www.discovery.com/dscovrd/tech/you-can-now-turn-off-your-sperm-flow-with-the-flip-of-a-switch/

 

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Occupational Therapy

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

Definition of Occupational Therapy

Occupational therapy is a client-centred health profession concerned with promoting health and well being through occupation. The primary goal of occupational therapy is to enable people to participate in the activities of everyday life. Occupational therapists achieve this outcome by working with people and communities to enhance their ability to engage in the occupations they want to, need to, or are expected to do, or by modifying the occupation or the environment to better support their occupational engagement.(WFOT 2012)

Read the Statement on Occupational Therapy

In occupational therapy, occupations refer to the everyday activities that people do as individuals, in families and with communities to occupy time and bring meaning and purpose to life. Occupations include things people need to, want to and are expected to do.

Definition of Occupational Therapy Practice for the AOTA Model Practice Act

http://www.aota.org/-/media/Corporate/Files/Advocacy/State/Resources/PracticeAct/Model%20Definition%20of%20OT%20Practice%20%20Adopted%2041411.ashx

The practice of occupational therapy means the therapeutic use of occupations, including everyday life activities with individuals, groups, populations, or organizations to support participation, performance, and function in roles and situations in home, school, workplace, community, and other settings. Occupational therapy services are provided for habilitation, rehabilitation, and the promotion of health and wellness to those who have or are at risk for developing an illness, injury, disease, disorder, condition, impairment, disability, activity limitation, or participation restriction. Occupational therapy addresses the physical, cognitive, psychosocial, sensory-perceptual, and other aspects of performance in a variety of contexts and environments to support engagement in occupations that affect physical and mental health, well-being, and quality of life. The practice of occupational therapy includes:

A. Evaluation of factors affecting activities of daily living (ADL), instrumental activities of daily living (IADL), rest and sleep, education, work, play, leisure, and social participation, including:

1. Client factors, including body functions (such as neuromusculoskeletal, sensory-perceptual, visual, mental, cognitive, and pain factors) and body structures (such as cardiovascular, digestive, nervous, integumentary, genitourinary systems, and structures related to movement), values, beliefs, and spirituality.

2. Habits, routines, roles, rituals, and behavior patterns.

3. Physical and social environments, cultural, personal, temporal, and virtual contexts and activity demands that affect performance.

4. Performance skills, including motor and praxis, sensory-perceptual, emotional regulation, cognitive, communication and social skills.

B. Methods or approaches selected to direct the process of interventions such as:

1. Establishment, remediation, or restoration of a skill or ability that has not yet developed, is impaired, or is in decline.

2. Compensation, modification, or adaptation of activity or environment to enhance performance, or to prevent injuries, disorders, or other conditions.

3. Retention and enhancement of skills or abilities without which performance in everyday life activities would decline.

4. Promotion of health and wellness, including the use of self-management strategies, to enable or enhance performance in everyday life activities.

5. Prevention of barriers to performance and participation, including injury and disability prevention.

C. Interventions and procedures to promote or enhance safety and performance in activities of daily living (ADL), instrumental activities of daily living (IADL), rest and sleep, education, work, play, leisure, and social participation, including:

1. Therapeutic use of occupations, exercises, and activities.

2. Training in self-care, self-management, health management and maintenance, home management, community/work reintegration, and school activities and work performance.

3. Development, remediation, or compensation of neuromusculoskeletal, sensory-perceptual, visual, mental, and cognitive functions, pain tolerance and management, and behavioral skills.

4. Therapeutic use of self, including one’s personality, insights, perceptions, and judgments, as part of the therapeutic process.

5. Education and training of individuals, including family members, caregivers, groups, populations, and others.

6. Care coordination, case management, and transition services.

7. Consultative services to groups, programs, organizations, or communities.

8. Modification of environments (home, work, school, or community) and adaptation of processes, including the application of ergonomic principles.

9. Assessment, design, fabrication, application, fitting, and training in seating and positioning, assistive technology, adaptive devices, and orthotic devices, and training in the use of prosthetic devices.

10. Assessment, recommendation, and training in techniques to enhance functional mobility, including management of wheelchairs and other mobility devices.

11. Low vision rehabilitation.

12. Driver rehabilitation and community mobility.

13. Management of feeding, eating, and swallowing to enable eating and feeding performance.

14. Application of physical agent modalities, and use of a range of specific therapeutic procedures (such as wound care management; interventions to enhance sensory-perceptual, and cognitive processing; and manual therapy) to enhance performance skills.

15. Facilitating the occupational performance of groups, populations, or organizations through the modification of environments and the adaptation of processes.

Adopted by the Representative Assembly 4/14/11 (Agenda A13, Charge 18)

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Biomarker Development


Biomarker Development

Curator: Larry H. Bernstein, MD, FCAP

 

 

NBDA’s Biomarker R&D Modules

http://nbdabiomarkers.org/

“collaboratively creating the NBDA Standards* required for end-to-end, evidence – based biomarker development to advance precision (personalized) medicine”

http://nbdabiomarkers.org/sites/all/themes/nbda/images/nbda_logo.jpg

http://nbdabiomarkers.org/about/what-we-do/pipeline-overview/assay-development

 

Successful biomarkers should move systematically and seamlessly through specific R&D “modules” – from early discovery to clinical validation. NBDA’s end-to-end systems approach is based on working with experts from all affected multi-sector stakeholder communities to build an in-depth understanding of the existing barriers in each of these “modules” to support decision making at each juncture.  Following extensive “due diligence” the NBDA works with all stakeholders to assemble and/or create the enabling standards (guidelines, best practices, SOPs) needed to support clinically relevant and robust biomarker development.

Mission: Collaboratively creating the NBDA Standards* required for end-to-end, evidence – based biomarker development to advance precision (personalized) medicine.
NBDA Standards include but are not limited to: “official existing standards”, guidelines, principles, standard operating procedures (SOP), and best practices.

https://vimeo.com/83266065

 

“The NBDA’s vision is not to just relegate the current biomarker development processes to history, but also to serve as a working example of what convergence of purpose, scientific knowledge and collaboration can accomplish.”

NBDA Workshop VII – “COLLABORATIVELY BUILDING A FOUNDATION FOR FDA BIOMARKER QUALIFICATION”
NBDA Workshop VII   December 14-15, 2015   Washington Court Hotel, Washington, DC

The upcoming meeting was preceded by an NBDA workshop held on December 1-2, 2014, “The Promising but Elusive Surrogate Endpoint:  What Will It Take?” where we explored in-depth with FDA leadership and experts in the field the current status and future vison for achieving success in surrogate endpoint development.  Through panels and workgroups, the attendees extended their efforts to pursue the FDA’s biomarker qualification pathway through the creation of sequential contexts of use models to support qualification of drug development tools – and ultimately surrogate endpoints.

Although the biomarker (drug development tools) qualification pathway (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentTools…) represents an opportunity to increase the value of predictive biomarkers, animal models, and clinical outcomes across the drug (and biologics) development continuum, there are myriad challenges.  In that regard, the lack of evidentiary standards to support contexts of use-specific biomarkers emerged from the prior NBDA workshop as the major barrier to achieving the promise of biomarker qualification.  It also became clear that overall, the communities do not understand the biomarker qualification process; nor do they fully appreciate that it is up to the stakeholders in the field (academia, non-profit foundations, pharmaceutical and biotechnology companies, and patient advocate organizations) to develop these evidentiary standards.

This NBDA workshop will feature a unique approach to address these problems.  Over the past two years, the NBDA has worked with experts in selected disease areas to develop specific case studies that feature a systematic approach to identifying the evidentiary standards needed for sequential contexts of use for specific biomarkers to drive biomarker qualification.   These constructs, and accompanying whitepapers are now the focus of collaborative discussions with FDA experts.

The upcoming meeting will feature in-depth panel discussions of 3-4 of these cases, including the case leader, additional technical contributors, and a number of FDA experts.  Each of the panels will analyze their respective case for strengths and weaknesses – including suggestions for making the biomarker qualification path for the specific biomarker more transparent and efficient. In addition, the discussions will highlight the problem of poor reproducibility of biomarker discovery results, and its impact on the qualification process.

 

Health Care in the Digital Age

Mobile, big data, the Internet of Things and social media are leading a revolution that is transforming opportunities in health care and research. Extraordinary advancements in mobile technology and connectivity have provided the foundation needed to dramatically change the way health care is practiced today and research is done tomorrow. While we are still in the early innings of using mobile technology in the delivery of health care, evidence supporting its potential to impact the delivery of better health care, lower costs and improve patient outcomes is apparent. Mobile technology for health care, or mHealth, can empower doctors to more effectively engage their patients and provide secure information on demand, anytime and anywhere. Patients demand safety, speed and security from their providers. What are the technologies that are allowing this transformation to take place?

 

https://youtu.be/WeXEa2cL3oA    Monday, April 27, 2015  Milken Institute

Moderator


Michael Milken, Chairman, Milken Institute

 

Speakers


Anna Barker, Fellow, FasterCures, a Center of the Milken Institute; Professor and Director, Transformative Healthcare Networks, and Co-Director, Complex Adaptive Systems Network, Arizona State University
Atul Butte, Director, Institute of Computational Health Sciences, University of California, San Francisco
John Chen, Executive Chairman and CEO, BlackBerry
Victor Dzau, President, Institute of Medicine, National Academy of Sciences; Chancellor Emeritus, Duke University
Patrick Soon-Shiong, Chairman and CEO, NantWorks, LLC

 

Mobile, big data, the Internet of Things and social media are leading a revolution that is transforming opportunities in health care and research. Extraordinary advancements in mobile technology and connectivity have provided the foundation needed to dramatically change the way health care is practiced today and research is done tomorrow. While we are still in the early innings of using mobile technology in the delivery of health care, evidence supporting its potential to impact the delivery of better health care, lower costs and improve patient outcomes is apparent. Mobile technology for health care, or mHealth, can empower doctors to more effectively engage their patients and provide secure information on demand, anytime and anywhere. Patients demand safety, speed and security from their providers. What are the technologies that are allowing this transformation to take place?

 

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