Funding, Deals & Partnerships: BIOLOGICS & MEDICAL DEVICES; BioMed e-Series; Medicine and Life Sciences Scientific Journal – http://PharmaceuticalIntelligence.com
Real Time Coverage @BIOConvention #BIO2019: After Trump’s Drug Pricing Blueprint: What Happens Next? A View from Washington; June 3 2019 1:00 PM Philadelphia PA
Dan Todd is the Principal of Todd Strategy, LLC, a consulting firm founded in 2014 and based in Washington, DC. He provides legislative and regulatory strategic guidance and advocacy for healthcare stakeholders impacted by federal healthcare programs.
Prior to Todd Strategy, Mr. Todd was a Senior Healthcare Counsel for the Republican staff of the Senate Finance Committee, the Committee of jurisdiction for the Medicare and Medicaid programs. His areas of responsibility for the committee included the Medicare Part B and Part D programs, which includes physician, medical device, diagnostic and biopharmaceutical issues.
Before joining the Finance Committee, Mr. Todd spent several years in the biotechnology industry, where he led policy development and government affairs strategy. He also represented his companies’ interests with major trade associations such as PhRMA and BIO before federal and state representatives, as well as with key stakeholders such as physician and patient advocacy organizations.
Dan also served as a Special Assistant in the Office of the Administrator at the Centers for Medicare & Medicaid Services (CMS), the federal agency charged with the operation of the Medicare and Medicaid programs. While at CMS, Dan worked on Medicare Part B and Part D issues during the implementation of the Medicare Modernization Act from 2003 to 2005.
Cost efficiencies were never measured.
Removing drug rebates would cost 180 billion over 10 years. CBO came up with similar estimate. Not sure what Congress will do. It appears they will keep the rebates in.
House Dems are really going after PBMs; anytime the Administration makes a proposal goes right into CBO baseline estimates; negotiations appear to be in very early stages and estimates are up in the air
WH close to meet a budget cap but then broke down in next day; total confusion in DC on budget; healthcare is now held up, especially the REBATE rule; : is a shame as panel agrees cost savings would be huge
they had initiated a study to tie the costs of PartB to international drug prices; meant to get at disparity on international drug prices; they currently are only mulling the international price index; other option is to reform Part B; the proposed models were brought out near 2016 elections so not much done; unified agenda;
most of the response of Congress relatively publicly muted; a flat fee program on biologics will have big effect on how physicians and health systems paid; very cat and mouse game in DC around drug pricing
administration is thinking of a PartB “inflation cap”; committees are looking at it seriously; not a rebate; discussion of tiering of physician payments
Ways and Means Cmmtte: proposing in budget to alleve some stresses on PartB deductable amounts;
PartD: looking at ways to shore it up; insurers 80% taxpayers 20% responsible; insurers think it will increase premiums but others think will reduce catastrophic costs; big part of shift in spending in Part D has been this increase in catastrophic costs
this week they may actually move through committees on this issue; Administration trying to use the budgetary process to drive this bargain; however there will have to be offsets so there may be delays in process
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Stroke is a leading cause of death worldwide and the most common cause of long-term disability amongst adults, more particularly in patients with diabetes mellitus and arterial hypertension. Increasing evidence suggests that disordered physiological variables following acute ischaemic stroke, especially hyperglycaemia, adversely affect outcomes.
Post-stroke hyperglycaemia is common (up to 50% of patients) and may be rather prolonged, regardless of diabetes status. A substantial body of evidence has demonstrated that hyperglycaemia has a deleterious effect upon clinical and morphological stroke outcomes. Therefore, hyperglycaemia represents an attractive physiological target for acute stroke therapies.
However, whether intensive glycaemic manipulation positively influences the fate of ischaemic tissue remains unknown. One major adverse event of management of hyperglycaemia with insulin (either glucose-potassium-insulin infusions or intensive insulin therapy) is the occurrence of hypoglycaemia, which can also induce cerebral damage.
Doctors all over the world have debated whether intensive glucose management, which requires the use of IV insulin to bring blood sugar levels down to 80-130 mg/dL, or standard glucose control using insulin shots, which aims to get glucose below 180 mg/dL, lead to better outcomes after stroke.
A period of hyperglycemia is common, with elevated blood glucose in the periinfarct period consistently linked with poor outcome in patients with and without diabetes. The mechanisms that underlie this deleterious effect of dysglycemia on ischemic neuronal tissue remain to be established, although in vitro research, functional imaging, and animal work have provided clues.
While prompt correction of hyperglycemia can be achieved, trials of acute insulin administration in stroke and other critical care populations have been equivocal. Diabetes mellitus and hyperglycemia per se are associated with poor cerebrovascular health, both in terms of stroke risk and outcome thereafter.
Interventions to control blood sugar are available but evidence of cerebrovascular efficacy are lacking. In diabetes, glycemic control should be part of a global approach to vascular risk while in acute stroke, theoretical data suggest intervention to lower markedly elevated blood glucose may be of benefit, especially if thrombolysis is administered.
Both hypoglycaemia and hyperglycaemia may lead to further brain injury and clinical deterioration; that is the reason these conditions should be avoided after stroke. Yet, when correcting hyperglycaemia, great care should be taken not to switch the patient into hypoglycaemia, and subsequently aggressive insulin administration treatment should be avoided.
Early identification and prompt management of hyperglycaemia, especially in acute ischaemic stroke, is recommended. Although the appropriate level of blood glucose during acute stroke is still debated, a reasonable approach is to keep the patient in a mildly hyperglycaemic state, rather than risking hypoglycaemia, using continuous glucose monitoring.
The primary results from the Stroke Hyperglycemia Insulin Network Effort (SHINE) study, a large, multisite clinical study showed that intensive glucose management did not improve functional outcomes at 90 days after stroke compared to standard glucose therapy. In addition, intense glucose therapy increased the risk of very low blood glucose (hypoglycemia) and required a higher level of care such as increased supervision from nursing staff, compared to standard treatment.
Live Conference Coverage @Medcity Converge 2018 Philadelphia: Oncology Value Based Care and Patient Management
Reporter: Stephen J. Williams, Ph.D.
3:15 – 4:00 PM Breakout: What’s A Good Model for Value-Based Care in Oncology?
How do you implement a value-based care model in oncology? Medicare has created a bundled payment model in oncology and there are lessons to be learned from that and other programs. Listen to two presentations from experts in the field.
Mari: Building strategic partnerships with partners focused on population based health and evidence based outcomes. they provide data analytics and consultative services. Incorporate risk based systems. also looking at ancillary segments because they see cost savings. True Performance is their flagship performance program and 11% lower ED (saving $18 million) rates and 16% lower readmissions ($200 million cost savings). Also launched the Highmark Cancer care Program with Johns Hopkins. They monitor the adherence pathways and if clinician shows good adherence they give reimbursements.
Charles: Integra is a cloud based care platform focused on oncology and urology and allow clinicians to practice value based care. Providers must now focus on total cost including ER visits, end of life and therapies (which is half of total cost in US). The actionable ways to reduce costs is by reducing ER visits. What is working? Data on reimbursements models is very accurate so practices can dig into data and find effieciencies. However most practices do not have the analytics to do this.
care navigation
care path based treatment choices
enhanced patient access and experience
What is not working
data not structured so someone has to do manual curation of records
flawed logic based on plurality of visits but physician doesn’t know who else they saw
target pricing not taking into account high prices of new therapies
lack of timely reporting either by patient or physician
insufficient reimbursements
technology limitations
4:10- 4:55 Breakout: What Patients Want and Need On Their Journey
Cancer patients are living with an existential threat every day. A panel of patients and experts in oncology care management will discuss what’s needed to make the journey for oncology patients a bit more bearable.
sponsored by CEO Council for Growth
Moderator:Amanda Woodworth, M.D., Director of Breast Health, Drexel University College of Medicine Speakers: Kezia Fitzgerald, Chief Innovation Officer & Co-Founder, CareAline® Products, LLC Sara Hayes, Senior Director of Community Development, Health Union @SaraHayes_HU Katrece Nolen, Cancer Survivor and Founder, Find Cancer Help @KatreceNolen John Simpkins, Administrative DirectorService Line Director of the Cancer Center, Children’s Hospital of Philadelphia @ChildrensPhila
Kezia: was a cancer patient as well as her child getting treated at two different places and tough part was coordinating everything including treatments and schedules, working schedules
Katrece: had problem scheduling with oncologists because misdiagnosis and her imaging records were on CD and surgeon could not use the CD
John: the above are a common frustration among patients at a time when they don’t need the confusion. He feels cancer centers need to coordinate these services better
Sara: trying to assist people with this type of coordination is very tough even with all the resources
Kazia: she needed to do all the research on her own because big dichotomy being an adult and a pediatric patient where pediatrics get more information and patient centered care. She felt she felt burdening the physicians if she asked the same questions. How can we get more interaction with primary care physicians and feel comfortable with their interaction?
John: there is this dichotomy especially on wait times for adults is usually longer. We can also improve patient experience with counseling patients
Katrece: Just working with a patient navigator is not enough. The patient needs to take charge of their disease.
Sara: Patient communities can help as sometimes patients learn from other patients.
Amanda: in breast cancer , navigators are common but must take care they are not only people patients see after a while
John: at CHOP they also have a financial navigator. On the adult side there are on call financial navigators. Recent change of the high deductible plans are a major problem. Although new families are starting to become comfortable with the financial navigator
Katrece: guiding your children through your experience is important. It was also important for her to advocate for herself as she had three different sites of cancer care to coordinate and multiple teams to coordinate with each other
Amanda: A common theme seems to be hard trying to find the resources you need. Why is that?
Kazia: Sometimes it is hard to talk about your disease because it can be emotionally draining comforting other people who you told about the disease and they are being empathetic. Sometimes they want to keep their ‘journey’ to themselves
John: A relative kept her disease secret because she didn’t want to burden others…. a common cancer patient concern
Sara: Moderation of a social group is necessary to keep it a safe space and prevent trollers (like in Facebook support groups).
Kazia: most group members will get together and force those trollers out of the group
Katrece: alot of anxiety after treatment ends, patient feels like being dropped on the floor like they don’t get support after treatment. If there were survivorship navigators might be helpful
Amanda: for breast cancer they do a Survivor Care Package but just a paper packet, patients do appreciate it but a human coordinator would be a great idea
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#MCConverge
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Please see related articles on Live Coverage of Previous Meetings on this Open Access Journal
A Rich Tradition of Patient-Focused Care — Richmond University Medical Center, New York’s Leader in Health Care and Medical Education
Author: 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
Richmond University Medical Center (www.RUMSCI.org), an affiliate of The Mount Sinai Hospital and the Icahn School of Medicine, is a 470+ bed health care facility and teaching institution in Staten Island, New York. The hospital is a leader in the areas of acute, medical and surgical care, including emergency care, surgery, minimally invasive laparoscopic and robotic surgery, gastroenterology, cardiology, pediatrics, podiatry, endocrinology, urology, oncology, orthopedics, neonatal intensive care and maternal health. RUMC earned The Joint Commission’s Gold Seal of Approval® for quality and patient safety.
RUMC is a designated Level 1 Trauma Center, a Level 2 Pediatric Trauma Center, a Level 3 Neonatal Intensive Care Unit (NICU), which is the highest level attainable, and a designated Stroke Center, receiving top national recognition from the American Heart Association/American Stroke Association. Their state-of-the-art Cardiac Catheterization Lab has Percutaneous Coronary Intervention (PCI) capabilities, for elective and emergent procedures in coronary angioplasty that treats obstructive coronary artery disease, including unstable angina, acute myocardial infarction (MI), and multi-vessel coronary artery disease (CAD).
RUMC maintains a Wound Care/Hyperbaric Center and a Sleep Disorder Center on-site at its main campus. The facility also offers behavioral health services, encompassing both inpatient and outpatient services for children, adolescents and adults, including emergent inpatient and mobile outreach units. RUMC is the only facility that offers inpatient psychiatric services for adolescents in the community.
In April 2016, RUMC announced its intent to merge with Staten Island Mental Health Society in order to expand its footprint in Staten Island and integrate behavioral health services alongside primary care. As part of New York’s Medicaid reforms, funding is available to incentivize providers to integrate treatment for addiction, mental health issues and developmental disabilities with medical services.
With over 2,500 employees, RUMC is one of the largest employers on Staten Island, New York.
Image SOURCE: Photographs courtesy of Richmond University Medical Center, Staten Island, New York. Interior and exterior photographs of the hospital.
Below is my interview with President and Chief Executive Officer Daniel J. Messina, Ph.D., FACHE, LNHA, which occurred in September, 2016.
What has been your greatest achievement?
Dr. Messina: Professionally, my greatest achievement is my current responsibility – to be President and Chief Executive Officer of one of the greatest hospitals with a strong, solid foundation and rich history. I was born in this hospital and raised on Staten Island, so to me, there is no greater gift than to be part of a transformative organization and have the ability to advance the quality of health care on Staten Island.
My parents taught me the value of responsibility and motivation and instilled in me the drive and tenacity to be the best person I could be – for my employees and for my family. I am a highly competitive person, who is goal-oriented, hands-on and inspired by teamwork. I rarely sit behind my desk as I believe my place is alongside my team in making things happen.
As a personal goal, I recently climbed the 20,000-foot Mount Kilimanjaro in Tanzania. It was the experience of a lifetime. I could not have completed this challenge without the support of the guides and porters who helped me and my group along the way. For me, it was a challenge in proving to myself that I could be out of my comfort zone. My group and I hiked hours and hours each day, dodging rocks and scrambling along rock walls with the goal of reaching the summit. In many ways, it takes a village to climb the mountain, relying on each other in the group to get you to the next level.
In many ways, that is how I see my professional day at the hospital, working with a strong team of dedicated medical staff and employees who are focused on one goal, which is to continue our hard work, continue to improve care and continue to move forward to advance life and health care.
The mission of Richmond University Medical Center, an affiliate of The Mount Sinai Hospital and Mount Sinai School of Medicine, serves the ethnically diverse community of Staten Island, New York, by providing patients with a range of services.
How has your collaboration with the Mount Sinai network helped to expand health care delivery and services for patients of Staten Island, New York?
Dr. Messina: Being able to serve our patients year after year continues to be a top priority, so we are constantly improving upon our rich history of 100 years of exceptional patient-focused care given by our medical and surgical health care professionals as well as innovative technologies and programs created by our award-winning hospital team. We have committed medical specialists, passionate employee staff, exceptional Board of Trustees, supportive elected government officials – all who in their own way contributes to providing the highest level of patient care to the more than 500,000 residents of Staten Island, New York.
As a member of the Mount Sinai Health network, we have found ways to work collaboratively with our academic partner to ensure that our patients’ health care needs not only are fully met but also exceeded. This alliance will facilitate the development of a new, Comprehensive Breast and Women’s Healthcare Center. We have leveraged our Breast and Women’s Health Center with our RUMC general surgeons in conjunction with breast imaging, fellowship-trained physicians from Mount Sinai’s Icahn School of Medicine. The physicians who are granted this renowned fellowship interact with our patients and become an active participant in multidisciplinary breast conferences and resident and medical student education. For patients, this means that they have access to the best minds and latest research, therapies and treatment regimens throughout our network.
What makes Richmond University Medical Center and its specialty areas stand out from other hospitals?
Dr. Messina: We bring the highest level of advanced medicine to our patients. For more than 100 years, we have built a rich history of delivering patient-focused care that is unique. Our organization is recognized as a family organization with strong community spirit and family values. We are proud to be a high-technology/high-touch organization of caring professionals that go above and beyond the standard of health care. Our strengths lie in the areas of acute, medical and surgical care, including emergency care, surgery, minimally invasive laparoscopic and robotic surgery, gastroenterology, cardiology, pediatrics, podiatry, endocrinology, urology, oncology, orthopedics, neonatal intensive care and maternal health.
Each year, we embark upon a comprehensive, robust strategic planning process that involves our senior leadership team, clinical chairs, Board of Trustees as well as our medical and surgical staff and hospital employees that looks out three to five years in the future to determine what is best for the patient. We are each committed in our own way to quality patient care and building an even stronger organization.
Some of our achievements are noteworthy:
As a New York City Department of Emergency Services designated Level 1 Trauma Center and Level 2 Pediatric Trauma Center, the only Trauma Center dually verified in New York City, we rely on sophisticated equipment so our medical and surgical specialists are prepared to treat severe conditions within minutes.
Our Neonatal Intensive Care Unit (NICU) is a designated Level 3 facility, the highest level attainable. The unit delivers 3,000 babies annually and it was recognized as having the lowest mortality rate in the metropolitan area and a survival rate of 99 percent, that exceeds national benchmarks. Our specialists in our pediatric ambulatory services department treat over 10,000 patients annually and our children’s urgent care area records over 23,000 visits annually.
Our state-of-the-art, 38,000-square-foot Emergency Department (ED), which will be replaced by an expanded facility and projected to open in 2018, will provide for more focused care, operational efficiency and flexibility for our staff and patient. We also will be better integrated and connected to the entire hospital campus.
Originally designed to serve 22,000 patients each year, the ED is expected to accommodate an increased volume of patients, which is estimated at 70,000 and give our medical specialists the tools they need to provide the best in care for this volume of patients. In a new patient and family-centered space with 49 treatment positions, the new ED will be connected to the existing hospital, close to surgical services, the radiology department and lab services.
Equally as important, the hospital has been strong in the face of natural disasters, especially Hurricane Sandy which occurred a few years ago, and the new ED is being designed with storm resilient and redundant design to minimize impact from severe weather conditions.
In fact, the New York City Council and the Staten Island Borough President have set aside a combined $13.5 million for this $60+ million project and believe in the transformative impact that it will have on emergency care on Staten Island. These local officials believe that Staten Island residents deserve quality, readily accessible health care.
Heroin addiction is an epidemic on Staten Island, so we have a number of programs in place at RUMC’s Silberstein Center to provide outpatient treatment, rehabilitation and clinics, along with group therapy sessions, Alcoholics Anonymous meetings and individual therapy sessions.
Our new primary care/walk-in facility in the heart of Staten Island borough is operational and there are no appointments required. Patients can visit with one of three physicians or a nurse practitioner. This off-site facility is not located in the hospital complex and is an expansion of our services outside of the hospital walls.
We also maintain a Wound Care Center, Pain Management Center and a Sleep Disorder Center at our facility. In fact, we are the only local facility that offers inpatient psychiatric services for adolescents and we are expanding our capacity to meet the needs of the community.
RUMC has been awarded a top designation jointly by the American Heart Association and the American Stroke Association. What does that mean to the hospital?
Dr. Messina: This designation makes us proud as the recipient of the American Heart Association/American Stroke Association’s Quality Achievement Award for six consecutive years and its first Elite Plus recognition. This means that we have achieved 85 percent or higher adherence in indicators for two or more consecutive 12-month periods to improve quality of patient care and outcomes for stroke patients.
Our cardiac catheterization lab with Percutaneous Coronary Intervention (PCI) capabilities – the newest facility of its kind on Staten Island — now treats semi-urgent and elective coronary procedures.
For patients, this means that we have a commitment to ensure that stroke patients receive the most appropriate treatment according to nationally recognized, research-based guidelines based on the latest scientific evidence. With a stroke, when time is lost, brain is lost, and this award demonstrates our commitment to ensuring patients receive care based on evidenced-based guidelines. We are dedicated to continually improving the quality of stroke care and this recognition helps us achieve that goal.
Studies have shown that hospitals that consistently follow these quality improvement measures can reduce length of stay and 30-day readmission rates and reduce disparities in care. To qualify for the Elite Plus recognition, we met quality measures developed to reduce the time between the patient’s arrival at the hospital and treatment with the clot-buster tissue plasminogen activator, or tPA, the only drug approved by the U.S. Food and Drug Administration to treat ischemic stroke. If given intravenously in the first three hours after the start of stroke symptoms, tPA has been shown to significantly reduce the effects of stroke and lessen the chance of permanent disability. We earned the award by meeting specific quality achievement measures for the diagnosis and treatment of stroke patients at a set level for a designated period.
According to the American Heart Association/American Stroke Association, stroke is the number five cause of death and a leading cause of adult disability in the United States. On average, someone suffers a stroke every 40 seconds; someone dies of a stroke every four minutes; and 795,000 people suffer a new or recurrent stroke each year.
The values of Richmond University Medical Center are summarized in the acronym, WE CARE (Welcoming Energized Compassion Advocacy Respect Excellence). How is this part of your day-to-day life?
Dr. Messina: For more than 100 years, Richmond University Medical Center has
been building a rich history of exceptional patient-focused care for the residents of Staten Island. Each year, we carry that tradition forward by our medically innovative and patient-focused care and services we offer. It is the passion, creativity and caring of everyone who is part of our ‘hospital team’ that moves the organization to new heights.
The chart below summarizes our credo, the values that guide us every day and help us focus on the care and well-being of the people who come through our doors.
We are welcoming and gracious toward each other, and toward all who come to receive our services.
Personnel are energized for quality, creativity, commitment and teamwork.
Compassion is the way we share deep concern and care toward each person.
Advocacy is our activity that promotes the rights and responsibilities of patients, families and staff, in the hospital setting and in the community.
We show respect by recognizing the basic dignity of every person in all our interactions and in the formulation of policies and procedures.
Excellence is our way of demonstrating that we can always be more and always be better.
The Richmond University Medical Center Board is comprised of distinguished leaders of the Staten Island community who are committed to the success of the hospital and to the health of Staten Islanders.
How is this local approach revolutionizing health care for the Staten Island community?
Dr. Messina: The members of our distinguished Board of Trustees, who represent a cross-section of business professionals and community leaders, continue our goal of meeting the needs of our patients and our hospital.
Our Board remains committed to providing solutions for our patients to challenging healthcare issues they face every day and to making a difference in the lives of patients by providing the latest thinking and technology solutions. Our Board Chairperson Kathryn K. Rooney, Esq., and Vice Chairperson Ronald A. Purpora, as well as the other Board members, and even our elected government officials, have a strong connection to Staten Island and we believe it truly ‘takes a village’ to make this organization flourish.
Each year, our Board of Trustees is presented with new opportunities and possibilities for growth and development. That is why their top priority for this past year was approving the construction of a state-of-the-art Emergency Department (ED) as this undertaking will serve both the patients and staff equally. In order to serve the residents of Staten Island properly, the new ED will accommodate an increased number of patients and our medical staff will receive the tools and technology to provide the best in care for our patients.
This past year, we were provided with a $1.5 million gift from the Staten Island Foundation that will go toward the hospital’s capital campaign to construct the new $60 million Emergency Department. We decided to name the RUMC’s Allan Weissglass Pavilion Center for Ambulatory Care, in honor of our long-time community and business leader, who is a founding Board member and Board of Trustees member. Allan Weissglass devoted his time, energy and talent to the success of this hospital over many years.
We are positioning our organization for the future and we continuously build on our strengths, being responsive to the needs of the community. In the past, we saw the patient was the only ‘customer’ of the hospital. Today, that perception is evolving and our ‘customers’ are many. With the help and support of donors, local foundations, volunteers, staff, and the community, local government officials, we are building a bright future for Richmond University Medical Center.
What is RUMC’s commitment to graduate medical education?
Dr. Messina: Our six Graduate Medical Education (GME) programs in Internal Medicine, Obstetrics and Gynecology, Pediatrics, Psychiatry, and Diagnostic Radiology and Podiatry, signify our commitment to teaching as a cornerstone of our philosophy. Our medical staff are seen as role models for our medical residents and provide quality training, medical education and research capabilities. Our existing medical staff functions as supervising physicians and gives medical residents exposure to specific responsibilities and patient care, as well as scholarly opportunities. One interesting fact is that the doctors we train come back to help treat our patients by using their knowledge and experience to work in our community.
You mentioned that ‘outreach in the community’ as a key factor in the success of the hospital’s mission to enhance the quality of life for residents of Staten Island. What types of activities are under way?
Dr. Messina: Our lifesaving work takes many forms. We are constantly finding new and different ways to engage with our community – to raise awareness and educate on a number of diseases and conditions, and, hopefully move toward better health care. We believe that our patients need to see us outside of a clinical environment, which strengthens our relationship.
For example, over the past year:
We sponsored an annual health and wellness expo with the Staten Island Economic Development Corporation that was attended by over 2,000 people to equip the community with knowledge about their health and the local health services available to them.
We pioneered an organ donor enrollment day by welcoming 59 visitors and guests who can potentially donate their organs to save lives.
We partnered with the New York City Department of Transportation and our own Trauma team to demonstrate and educate the community on car seat safety.
Our Dermatologist team took part in the Borough President’s “Back to the Beach” festival by performing skin screenings and distributing sunscreen and information on skin cancer.
Our Obstetrics and Gynecology team hosted a baby expo to talk with new mothers and mothers-to-be about services available at the hospital.
Our Diabetologist team partnered with the YMCA on a 16-week partnership to curb the diabetes epidemic on Staten Island through information talks and health screenings.
We were even present at last year’s Staten Island Yankees home opening baseball game to throw out the first pitch and conduct a blood drive while distributing wellness information.
Since roughly one third of the residents on Staten Island are enrolled in Medicaid or Medicare, what steps are you taking to improve the delivery of treatment for them?
Dr. Messina: We started several initiatives last year that were funded by the federal and state governments to look at the way care is delivered to patients who are enrolled in Medicare and Medicaid. So far, we’ve reduced costs by $3.75 million and realized $1.8 million in shared savings that are re-invested in key hospital programs.
As you know, Medicare and Medicaid are two different government-run programs that were created in 1965 in response to the inability of older and low-income Americans to buy private health insurance. They were part of our government’s social commitment to meeting individual health care needs. Medicare is a federal program that provides health coverage if you are 65 or older or have a severe disability, no matter your income, while Medicaid is a state and federal program that provides health coverage if you have a very low income.
We’ve set up our own Richmond Quality Accountable Care Organization (ACO), that comprises 30 providers serving 7,500 Medicare patients. This innovative program is accountable for the quality, cost and overall care provided to people on Medicare and who are enrolled in the traditional fee-for-service program. One program that is ongoing is one that we’ve partnered with the Visiting Nurse Service of Staten Island to prevent hospital readmissions and to identify hospitalized patients who would benefit from a higher level of care and home care services.
Another program that is under way for our Medicaid patients is teaching our staff to prevent hospital readmissions by creating an accurate list of medications that a patient takes and comparing that list against physician’s admission, transfer and discharge orders to ensure that the correct medication plan is in place.
We believe that we are transforming the underlying systems with a focus on delivering quality care and hopefully better outcomes for patients.
RUMC recently announced a merger with Staten Island Mental Health Society (SIMHS) to integrate SIMHS’ broad range of behavioral health programs into the hospital’s existing medical and behavioral program throughout Staten Island. What does this merger bring to the community?
Dr. Messina: We believe that the proposed merger between RUMC and the Staten Island Mental Health Society (SIMHS) will provide a strengthened, comprehensive network of behavioral health services across Staten Island.
This partnership will bring together two Staten Island institutions, with a combined 230 years of service to the borough, and create one strong and vibrant organization dedicated to meeting the health needs of the diverse community.
Merging the range of community-based behavioral health services provided by SIMHS with the solid foundation of primary care services provided by RUMC will create a seamless range of behavioral and medical services for our residents. We are in the unique position to transform and enhance the services of these two vital health care providers. The SIMHS will keep its name and become a division of the hospital. The merger is expected to close during calendar year 2017.
Image SOURCE: Photograph of President and Chief Executive Officer Daniel J. Messina, Ph.D., FACHE, LNHA, courtesy of Richmond University Medical Center, Staten Island, New York.
Daniel J. Messina, Ph.D., FACHE, LNHA President & Chief Executive Officer
Daniel Messina, Ph.D., FACHE, LNHA, became President and Chief Executive Officer of Richmond University Medical Center (RUMC) – an affiliate of The Mount Sinai Hospital and Mount Sinai School of Medicine – in April 2014.
Dr. Messina, a life-long resident of Staten Island, is a seasoned executive with nearly 30 years of healthcare leadership expertise. For the previous 13 years, he served as the System Chief Operating Officer of CentraState Healthcare System in Freehold, New Jersey, where his responsibilities included all System Operations for the Medical Center, Assisted Living Facility, Skilled Nursing and Rehabilitation Center and Continuing Care Retirement Community. While in this role, Dr. Messina developed additional growth strategies that include a new Cancer Center, a Proton Therapy Center, Radio-Surgery, a new Infusion Center and programs in Robotics, Minimally Invasive Surgery, Bariatric and Neurosurgery. Other accomplishments include a new state-of-the-art 26-bed Critical Care Unit, a 49-bed Emergency Department, and the development of an 180,000 sq. ft. Ambulatory Campus and Wellness Center anchored by a 35,000 sq. ft. Medical Fitness Center. Additionally, Dr. Messina developed the Linda E. Cardinale MS Center – one of the largest and most comprehensive MS Centers in the tristate area – leading to a fundraising event that has generated over $2 million.
Dr. Messina received his B.S. in Health Science/Respiratory Therapy from Long Island University Brooklyn, and earned his M.P.A. in Healthcare Administration from LIU Post. He obtained his Ph.D. in Health Sciences and Leadership at Seton Hall University where he currently serves as an adjunct professor in the School of Health and Allied Sciences. He is active in the American College of Health Care Executives, is board certified in healthcare management as an ACHE Fellow, and recently completed a three-year term as Regent for New Jersey.
Dr. Messina serves as trustee on the National Multiple Sclerosis Society, the New Jersey Metro Chapter, and the Alumni Board of Trustees at Seton Hall University. He is a Board member of the VNA Health Group of New Jersey and a member of the Policy Development Committee of the New Jersey Hospital Association. Dr. Messina has been honored by various organizations for his service to the community, including Seton Hall University with the “Many Are One” award, the American College of Healthcare Executives with Senior, Early and Distinguished Service Awards, New Jersey Women Against MS, CentraState Auxiliary, and the Staten Island CYO.
Editor’s note:
We would like to thank William Smith, director of Public Relations, Richmond University Medical Center, for the help and support he provided during this interview.
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Achievement Beyond Regulatory Approval – Design for Commercial Success
Stephen J. Williams, Ph.D.: Reporter
The Mid-Atlantic group Life Sciences Collaborative, a select group of industry veterans and executives from the pharmaceutical, biotechnology, and medical device sectors whose mission is to increase the success of emerging life sciences businesses in the Mid-Atlantic region through networking, education, training and mentorship, met Tuesday March 3, 2015 at the University of the Sciences in Philadelphia (USP) to discuss post-approval regulatory issues and concerns such as designing strong patent protection, developing strategies for insurance reimbursement, and securing financing for any stage of a business.
The meeting was divided into three panel discussions and keynote speech:
Panel 1: Design for Market Protection– Intellectual Property Strategy Planning
Panel 2: Design for Market Success– Commercial Strategy Planning
Panel 3: Design for Investment– Financing Each Stage
Keynote Speaker: Robert Radie, President & CEO Egalet Corporation
Below are Notes from each PANEL Discussion:
For more information about the Life Sciences Collaborative SEE
Panel 1: Design for Market Protection; Intellectual Property Strategy Planning
Take-home Message: Developing a very strong Intellectual Property (IP) portfolio and strategy for a startup is CRITICALLY IMPORTANT for its long-term success. Potential investors, partners, and acquirers will focus on the strength of a startup’s IP so important to take advantage of the legal services available. Do your DUE DIGILENCE.
Panelists:
John F. Ritter, J.D.., MBA; Director Office Tech. Licensing Princeton University
Panel Moderator: Dipanjan “DJ” Nag, PhD, MBA, CLP, RTTP; President CEO IP Shaktl, LLC
Notes:
Dr. Nag:
Sometimes IP can be a double edged sword; e.g. Herbert Boyer with Paul Berg and Stanley Cohen credited with developing recombinant technology but they did not keep the IP strict and opened the door for a biotech revolution (see nice review from Chemical Heritage Foundation).
Naked patent licenses are most profitable when try to sell IP
John Ritter: Mr. Ritter gave Princeton University’s perspective on developing and promoting a university-based IP portfolio.
30-40% of Princeton’s IP portfolio is related to life sciences
Universities will prefer to seek provisional patent status as a quicker process and allows for publication
Princeton will work closely with investigators to walk them through process – Very Important to have support system in place INCLUDING helping investigators and early startups establish a STRONG startup MANAGEMENT TEAM, and making important introductions to and DEVELOPING RELATIONSHIOPS with investors, angels
Good to cast a wide net when looking at early development partners like pharma
Good example of university which takes active role in developing startups is University of Pennsylvania’s Penn UPstart program.
Last 2 years many universities filing patents for startups as a micro-entity
Comment from attendee: Universities are not using enough of their endowments for purpose of startups. Princeton only using $500,00 for accelerator program.
Cozette McAvoy: Mrs. McAvoy talked about monetizing your IP from an industry perspective
Industry now is looking at “indirect monetization” of their and others IP portfolio. Indirect monetization refers to unlocking the “indirect value” of intellectual property; for example research tools, processes, which may or may not be related to a tangible product.
Good to make a contractual bundle of IP – “days of the $million check is gone”
Big companies like big pharma looks to PR (press relation) buzz surrounding new technology, products SO IMPORTANT FOR STARTUP TO FOCUS ON YOUR PR
Ryan O’Donnell: talked about how life science IP has changed especially due to America Invests Act
Need to develop a GLOBAL IP strategy so whether drug or device can market in multiple countries
Diagnostics and genes not patentable now – Major shift in patent strategy
Companies like Unified Patents can protect you against the patent trolls – if patent threatened by patent troll (patent assertion entity) will file a petition with the USPTO (US Patent Office) requesting institution of inter partes review (IPR); this may cost $40,000 BUT WELL WORTH the money –BE PROACTIVE about your patents and IP
Panel 2: Design for Market Success; Commercial Strategy Planning
Take-home Message: Commercial strategy development is defined market facing data, reimbursement strategies and commercial planning that inform labeling requirements, clinical study designs, healthcare economic outcomes and pricing targets. Clarity from payers is extremely important to develop any market strategy. Develop this strategy early and seek advice from payers.
Panelists:
David Blaszczak; Founder, Precipio Health Strategies
Terri Bernacchi, PharmD, MBA; Founder & President Cambria Health Advisory Professionals
Paul Firuta; President US Commercial Operations, NPS Pharma
Panel Moderator: Matt Cabrey; Executive Director, Select Greater Philadelphia
Notes:
David Blaszczak:
Commercial payers are bundling payment: most important to get clarity from these payers
Payers are using clinical trials to alter marketing (labeling) so IMPORTANT to BUILD LABEL in early clinical trial phases (phase I or II)
When in early phases of small company best now to team or partner with a Medicare or PBM (pharmacy benefit manager) and payers to help develop and spot tier1 and tier 2 companies in their area
Terri Bernacchi:
Building relationship with the payer is very important but firms like hers will also look to patients and advocacy groups to see how they respond to a given therapy and decrease the price risk by bundling
Value-based contracting with manufacturers can save patient and payer $$
As most PBMs formularies are 80% generics goal is how to make money off of generics
Patent extension would have greatest impact on price, value
Paul Firuta:
NPS Pharma developing a pharmacy benefit program for orphan diseases
How you pay depends on mix of Medicare, private payers now
Most important change which could affect price is change in compliance regulations
Panel 3: Design for Investment; Financing Each Stage
Take-home Message: VC is a personal relationship so spend time making those relationships. Do your preparation on your value and your market. Look to non-VC avenues: they are out there.
Panelists:
Ting Pau Oei; Managing Director, Easton Capital (NYC)
Manya Deehr; CEO & Founder, Pediva Therapeutics
Sanjoy Dutta, PhD; Assistant VP, Translational Devel. & Intl. Res., Juvenile Diabetes Research Foundation
In 2000 his experience finding 1st capital was what are your assets; now has changed to value
Notes:
Ting Pau Oei:
Your very 1st capital is all about VALUE– so plan where you add value
Venture Capital is a PERSONAL RELATIONSHIP
1) you need the management team, 2) be able to communicate effectively (Powerpoint, elevator pitch, business plan) and #1 and #2 will get you important 2nd Venture Capital meeting; VC’s don’t decide anything in 1st meeting
VC’s don’t normally do a good job of premarket valuation or premarket due diligence but know post market valuation well
Best advice: show some phase 2 milestones and VC will knock on your door
Manya Deehr:
Investment is more niche oriented so find your niche investors
Define your product first and then match the investors
Biggest failure she has experienced: companies that go out too early looking for capital
Dr. Dutta: funding from a non-profit patient advocacy group perspective
Your First Capital: find alliances which can help you get out of “valley of death”
Develop a targeted product and patient treatment profile
Non-profit groups ask three questions:
1) what is the value to patients (non-profits want to partner)
2) what is your timeline (we can wait longer than VC; for example Cystic Fibrosis Foundation waited long time but got great returns for their patients with Kalydeco™)
3) when can we see return
Long-term market projections are the knowledge gaps that startups have (the landscape) and startups don’t have all the competitive intelligence
Have a plan B every step of the way
Other posts on this site related to Philadelphia Biotech, Startup Funding, Payer Issues, and Intellectual Property Issues include:
Peer-reviewed journals retracted 110 papers over the last 2 years. Nature reports the grim details in “Publishing: the peer review scam”.
When a handful of authors were caught reviewing their own
papers, it exposed weaknesses in modern publishing systems.
Editors are trying to plug the holes.
The Hill reports that the FDA may lift its ban on blood donations from gay men. The American Red Cross has voiced its support for lifting of the ban.
Advisers for the Food and Drug Administration (FDA) will meet this week to decide whether gay men should be allowed to donate blood, the agency’s biggest step yet toward changing the 30-year-old policy.
If the FDA accepts the recommendation, it would roll back a policy that has been under strong pressure from LGBT advocates and some members of Congress for more than four years.
“We’ve got the ball rolling. I feel like this is a tide-turning vote,” said Ryan James Yezak, an LGBT activist who founded the National Gay Blood Drive and will speak at the meeting. “There’s been a lot of feet dragging and I think they’re realizing it now.”
Groups such as the American Red Cross and America’s Blood Centers also voiced support of the policy change this month, calling the ban “medically and scientifically unwarranted.”
The FDA will use the group’s recommendation to decide whether to change the policy.
“Following deliberations taking into consideration the available evidence, the FDA will issue revised guidance, if appropriate,” FDA spokeswoman Jennifer Rodriguez wrote in a statement.
This reporter has more than 20 years of Blood Bank experience. The factor in favor of the recommendation is that the HIV 1/2 and other testing is accurate enough to leave the question of donor lifestyle irrelevant. However, it remains to be seen whether the testing turnaround time is sufficient to prevent the release of units that may be contaminated prior to transfusion, which is problematic for platelets, that have short expirations. In all cases of donor infection, regardless of whether units are released, a finding leads to not releasing the product or to recall.
Democrats made a strategic mistake by passing the Affordable Care Act, Sen. Charles Schumer (N.Y.), the third-ranking member of the Senate Democratic leadership, said Tuesday.
Schumer says Democrats “blew the opportunity the American people gave them” in the 2008 elections, a Democratic landslide, by focusing on healthcare reform instead of legislation to boost the middle class.
“After passing the stimulus, Democrats should have continued to propose middle class-oriented programs and built on the partial success of the stimulus,” he said in a speech at the National Press Club.
He said the plight of uninsured Americans caused by “unfair insurance company practices” needed to be addressed, but it wasn’t the change that people wanted when they elected Barack Obama as president.
“Americans were crying out for an end to the recession, for better wages and more jobs; not for changes in their healthcare,” he said.
This reader finds the observation by Senator Schumer very perceptive, regardless of whether the observation in hindsight might have had a different political outcome. It has been noted that President Obama had a lot on his plate. Moreover, we have not seen such a poor record of legislation in my lifetime. There are underlying issues of worldview of elected officials that also contribute to the events.
THE PEER-REVIEW SCAM
BY CAT FERGUSON, ADAM MARCUS AND IVAN ORANSKY
N AT U R E | 2 7 N O V 2 0 1 4; VO L 5 1 5 : 480-82.
Most journal editors know how much effort it takes to persuade busy researchers to review a paper. That is why the editor of The Journal of Enzyme Inhibition and Medicinal Chemistry was puzzled by the reviews for manuscripts by one author — Hyung-In Moon, a medicinal-plant researcher then at Dongguk University in Gyeongju, South Korea.
The reviews themselves were not remarkable: mostly favourable, with some suggestions about how to improve the papers. What was unusual was how quickly they were completed — often within 24 hours. The turnaround was a little too fast, and Claudiu Supuran, the journal’s editor-in-chief, started to become suspicious.
In 2012, he confronted Moon, who readily admitted that the reviews had come in so quickly because he had written many of them himself. The deception had not been hard to set up. Supuran’s journal and several others published by Informa Healthcare in London
invite authors to suggest potential reviewers for their papers. So Moon provided names, sometimes of real scientists and sometimes pseudonyms, often with bogus e-mail addresses that would go directly to him or his colleagues. His confession led to the retraction of 28 papers by several Informa journals, and the resignation of an editor.
Moon’s was not an isolated case. In the past 2 years, journals have been forced to retract more than 110 papers in at least 6 instances of peer-review.
PEER-REVIEW RING
Moon’s case is by no means the most spectacular instance of peer-review rigging in recent years. That honour goes to a case that came to light in May 2013, when Ali Nayfeh, then editor-in-chief of the Journal of Vibration and Control, received some troubling news. An author who had submitted a paper to the journal told Nayfeh that he had received e-mails about it from two people claiming to be reviewers. Reviewers do not normally have direct contact with authors, and — strangely — the e-mails came from generic-looking Gmail accounts rather than from the professional institutional accounts that many academics use (see ‘Red flags in review’).
Nayfeh alerted SAGE, the company in Thousand Oaks, California, that publishes the journal. The editors there e-mailed both the Gmail addresses provided by the tipster, and the institutional addresses of the authors whose names had been used, asking for proof of identity and a list of their publications.ew rigging. What all these cases had in common was that researchers exploited vulnerabilities in the publishers’ computerized systems to dupe editors into accepting manuscripts, often by doing their own reviews. The cases involved publishing behemoths Elsevier, Springer, Taylor & Francis, SAGE and Wiley, as well as Informa, at least one of the systems — could make researchers vulnerable to even more serious identity theft. “For a piece of software that’s used by hundreds of thousands of academics worldwide, it really is appalling,” says Mark Dingemanse, a linguist at the Max Planck Institute for Psycholinguistics in Nijmegen, the Netherlands, who has used some of these programs to publish and review papers.
A 14-month investigation that came to involve about 20 people from SAGE’s editorial, legal and production departments. It showed that the Gmail addresses were each linked to accounts with Thomson Reuters’ ScholarOne, a publication-management system used by SAGE and several other publishers, including Informa. Editors were able to track every paper that the person or people behind these accounts had allegedly written or reviewed, says SAGE spokesperson Camille Gamboa. They also checked the wording of reviews, the details of author-nominated reviewers, reference lists and the turnaround time for reviews (in some cases, only a few minutes). This helped the investigators to ferret out further suspicious-looking accounts; they eventually found 130.
SAGE investigators came to realize that authors were both reviewing and citing each other at an anomalous rate. Eventually, 60 articles were found to have evidence of peer-review tampering, involvement in the citation ring or both. “Due to the serious nature of the findings, we wanted to ensure we had researched all avenues as carefully as possible before contacting any of the authors and reviewers,” says Gamboa. When the dust had settled, it turned out that there was one author in the centre of the ring: Peter Chen, an engineer then at the National Pingtung University of Education (NPUE) in Taiwan, who was a co-author on practically all of the papers in question.
PASSWORD LOOPHOLE
Moon and Chen both exploited a feature of ScholarOne’s automated processes. When a reviewer is invited to read a paper, he or she is sent an e-mail with login information. If that communication goes to a fake e-mail account, the recipient can sign into the system under whatever name was initially submitted, with no additional identity verification. Jasper Simons, vice-president of product and market strategy for Thomson Reuters in Charlottesville, Virginia, says that ScholarOne is a respected peer-review system and that it is the responsibility of journals and their editorial teams to invite properly qualified reviewers for their papers.
ScholarOne is not the only publishing system with vulnerabilities. Editorial Manager, built by Aries Systems in North Andover, Massachusetts, is used by many societies and publishers, including Springer and PLOS. The American Association for the Advancement of Science in Washington DC uses a system developed in-house for its journals Science, Science Translational Medicine and Science Signaling, but its open-access offering, Science Advances, uses Editorial Manager. Elsevier, based in Amsterdam, uses a branded version of the same product, called the Elsevier Editorial System.
Usually, editors in the United States and Europe know the scientific community in those regions well enough to catch potential conflicts of interest between authors and reviewers. But Lindsay says that Western editors can find this harder with authors from Asia — “where often none of us knows the suggested reviewers”. In these cases, the journal insists on at least one independent reviewer, identified and invited by the editors.
The Changing Economics of Cancer Medicine: Causes for the Vanishing of Independent Oncology Groups in the US
Reporter: Aviva Lev-Ari, PhD, RN
Private Oncologists Being Forced Out, Leaving Patients to Face Higher Bills
Photo
Dr. Peter Eisenberg, left, said people with less money were treated differently by doctors.Credit Preston Gannaway for The New York Times
When Dr. Jeffery Ward, a cancer specialist, and his partners sold their private practice to the Swedish Medical Center in Seattle, the hospital built them a new office suite 50 yards from the old place. The practice was bigger, but Dr. Ward saw the same patients and provided chemotherapyjust like before. On the surface, nothing had changed but the setting.
But there was one big difference. Treatments suddenly cost more, with higher co-payments for patients and higher bills for insurers. Because of quirks in the payment system, patients and their insurers pay hospitals and their doctors about twice what they pay independent oncologists for administering cancer treatments.
There also was a hidden difference — the money made from the drugs themselves. Cancer patients and their insurers buy chemotherapy drugs from their medical providers. Swedish Medical Center, like many other others, participates in a federal program that lets it purchase these drugs for about half what private practice doctors pay, greatly increasing profits.
Oncologists like Dr. Ward say the reason they are being forced to sell or close their practices is because insurers have severely reduced payments to them and because the drugs they buy and sell to patients are now so expensive. Payments had gotten so low, Dr. Ward said, that they only way he and his partners could have stayed independent was to work for free. When he sold his practice, Dr. Ward said, “The hospital was a refuge, not the culprit.”
When a doctor is affiliated with a hospital, though, patients end up paying, out of pocket, an average $134 more per dose for the most commonly used cancer drugs, according to a report by IMS Health, a health care information company. And, the report notes, many cancer patients receive multiple drugs.
“Say there was a Costco that had very good things at reasonable prices,” said Dr. Barry Brooks, a Dallas oncologist in private practice. “Then a Neiman Marcus comes in and changes the sign on the door and starts billing twice as much for the same things.” That, he said, is what is happening in oncology.
The situation is part of the unusual world of cancer medicine, where payment systems are unique and drive not just the price of care but what drugs patients may get and where they are treated. It raises questions about whether independent doctors, squeezed by finances, might be swayed to use drugs that give them greater profits or treat poorer patients differently than those who are better insured.
But one thing is clear: The private practice oncologist is becoming a vanishing breed, driven away by the changing economics of cancer medicine.
Practices are making the move across the nation. Reporting on the nation’s 1,447 independent oncology practices, the Community Oncology Alliance, an advocacy group for independent practices, said that since 2008, 544 were purchased by or entered contractual relationships with hospitals, another 313 closed and 395 reported they were in tough financial straits. In western Washington, just one independent oncology group is left.
Christian Downs, executive director of the Association of Community Cancer Centers, said that although there are no good data yet, he expected the Affordable Care Act was accelerating the trend. Many people bought inadequate insurance for the expensive cancer care they require. Community doctors have to buy the drugs ahead of time, placing a burden on them when patients cannot pay. The act also requires documentation of efficiencies in medical care which can be expensive for doctors in private practice to provide. And it encourages the consolidation of medical practices.
The American Hospital Association cites advantages for patients being treated by hospital doctors. “The hassle factor is reduced,” said Erik Rasmussen, the association’s vice president of legislative affairs. Patients can have scans, like CT and M.R.I., use a pharmacy and get lab tests all in one place instead of going from facility to facility, he said.
And, he added, there is a reason hospitals get higher fees for their services — it compensates them for staying open 24 hours and caring for uninsured and underinsured patients.
For doctors in private practice, providing chemotherapy to uninsured and Medicaid patients is a money loser. As a result, many, including Dr. Ward before he sold his practice, end up sending those patients to nearby hospitals for chemotherapy while keeping them as patients for office visits.
“We hate doing it, I can’t tell you how much we hate doing it,” said Dr. Brooks, the Texas oncologist. “But I tell them, ‘It will cost me $200 to give you this medication in my office, so I am going to ask you to go to the hospital as an outpatient for infusions.’ ”
Dr. Peter Eisenberg, in private practice in Marin County in Northern California, said: “The disgrace is that we have to treat people differently depending on how much money they’ve got. That we do diminishes me.”
Hospitals may be less personal and less efficient, said Dr. Richard Schilsky, chief medical officer at the American Society of Clinical Oncology. Many private practice oncology offices, he said, “Run on time, they are efficient, you get in, you get out, as opposed to academic medical centers where they may be an hour and a half behind.”
Dr. Ward and others in private practice said they tried for years to make a go of it but were finally defeated by what he described as “a series of cuts in oncology reimbursement under the guise of reform to which private practice is most vulnerable.”
Lower reimbursements have two effects. One is on overhead. Unlike other doctors, oncologists stock their own drugs, maintaining a sort of mini-pharmacy. If a patient gets too sick to receive a drug or dies, the doctor takes the loss. That used to be acceptable because insurers paid doctors at least twice the wholesale price of drugs. Now doctors are reimbursed for the average cost of the drug plus 4.3 percent, there are more and more drugs to stock, and drugs cost more.
“The overhead is enormous,” Dr. Schilsky said. “This is one of the reasons why many oncologists are becoming hospital-based.”
The second — and bigger — effect is less profit from selling drugs to patients. For years, chemotherapy drugs provided a comfortable income. Those days are gone, doctors say.
The finances are very different in hospitals, with their
higher reimbursement rates for administering drugs,
discounts for buying large quantities, and
a special federal program that about 30 percent of hospitals qualify for.
The program, to compensate research hospitals and hospitals serving poor people,
lets hospitals buy chemotherapy drugs for all outpatients at about a 50 percent discount.
In addition, Dr. Schilsky notes, cancer patients at hospitals use other services, like radiation therapy, imaging and surgery.
“A cancer patient is going to generate a lot of revenue for a hospital,” Dr. Schilsky said.
Health care economists say they have little data on how the costs and profits from selling chemotherapy drugs are affecting patient care. Doctors are constantly reminded, though, of how much they can make if they buy more of a company’s drug.
Celgene, for example, in a recent email about its drug Abraxane, told one doctor who had bought 50 vials that he could get a rebate of $647.51 by buying 68 vials. If he bought 175 vials he’d get $1,831.93
This hidden profit possibility troubles Dr. Peter B. Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center.
“When you walk into a doctor’s office you don’t know that in most cancer scenarios there are a range of therapeutic choices,” Dr. Bach said. “Unless the doctor presents options, you assume there aren’t any.”
While individual oncologists deny choosing treatments that provide them with the greatest profit, Dr. Kanti Rai, a cancer specialist at North Shore-Long Island Jewish Cancer Center, said it would be foolish to believe financial considerations never influence doctors’ choices of drugs.
“Sometimes hidden in such choices — and many times not so hidden — are considerations of what also might be financially more profitable,” he said.
A version of this article appears in print on November 24, 2014, on page A13 of the New York edition with the headline: Private Oncologists Being Forced Out, Leaving Patients to Face Higher Bills.
There are two recent articles that are, if not interesting, possibly important in the direction of cellular regulation, adaptation, and decline. One deals with apoptosis, or cell death, which is synchronized with recovery of membrane and protein breakdown for reuse in synthesis and maintenance. The other is a new perspective to Alzhemier’s Disease, for which there is no effective pharmacotherapy. In both cases, the stresses of the cell are critical to the responce to the environment. This is not just about the classical transcriptomics story. This is a perfect followup to the just posted research on the regulatory role of a small RNA that is related to, but distinct from silencing RNA, and also the revelations about lncRNA.
Protein Helps Cells Adapt—or Die
Scientists show how cell stress both prevents and promotes cell suicide in a study that’s equally divisive.
By Ruth Williams | July 3, 2014
A cellular stress pathway called the unfolded-protein-response (UPR) both activates and degrades death receptor 5 protein (DR5), which can promote or prevent cell suicide, according to a paper published in Science today (July 3). The theory is that initial stress blocks cell suicide, or apoptosis, to give the cell a chance to adapt, but that if the stress persists, it eventually triggers apoptosis.
“This work has made the most beautiful simplification of all this big complex mess. Basically, they identified and pinpointed the specific protein involved in the switching decision and explain how the decision is made,” said Alexei Korennykh, a professor of molecular biology at Princeton University, who was not involved in the work.
But Randal Kaufman of the Sanford-Burnham Medical Research Institute in La Jolla, California, was not impressed. He questioned the physiological relevance of the experiments supporting the authors’ main conclusions about this key cellular process.
Protein folding in a cell takes place largely in the endoplasmic reticulum (ER), but if the process goes awry, unfolded proteins accumulate, stressing the ER. This triggers the UPR, which shuts down translation, degrades unfolded proteins, and increases production of protein-folding machinery. If ER stress is not resolved, however, the UPR can also induce apoptosis.
Two main factors control the UPR—IRE1a and PERK. IRE1a promotes cell survival by activating the transcription factor XBP1, which drives expression of cell-survival genes. PERK, on the other hand, activates a transcription factor called CHOP, which in turn drives expression of the proapoptotic factor DR5.
Peter Walter of the University of California, San Francisco, and his colleagues have now confirmed that CHOP activates DR5, showing that it is a cell-autonomous process. But they have also found that IRE1a suppresses DR5, directly degrading its mRNA through a process called regulated IRE1a-dependent degradation (RIDD). Inhibition of IRE1a in a human cancer cell line undergoing ER stress both prevented DR5 mRNA decay and increased apoptosis.
However, in an e-mail to The Scientist, Kaufman expressed concern that “the significance of RIDD has not been demonstrated in a physiologically-relevant context.”
Walter insisted that the evidence for RIDD’s existence is “crystal clear.” His only concession was that “the effects aren’t 100 percent,” he said, because “RIDD degrades mRNA by a few-fold,” making it difficult to measure.
This RIDD debate aside, the researchers have also sparked a rumpus with their finding that IRE1a expression switches off just 24 hours after ER stress initiation, leaving PERK to drive the cell toward apoptosis. “We and others have evidence that suggests another model,” said Scott Oakes, a professor of pathology at the University of California, San Francisco, “which is that both PERK and IRE1a under high stress will send out death signals.”
Whether IRE1a promotes or inhibits apoptosis under extreme stress “is controversial,” said Ira Tabas, a professor at Columbia University in New York City. But it’s essential that scientists figure it out. Cell death from ER stress is a pathological process in many major diseases, Tabas said, and there are IRE1a inhibitors in pharmaceutical development. “It is very important because under high stress you have two different views here,” said Oakes. “One is that you want to keep IRE1a on, the other is that you want to shut it off.”
Because ER stress is central to many diseases, “a lot of people are passionate about it,” said Tabas, explaining the polemic views. “Who’s right? . . . I think it depends on the context in which the experiments are done—one pathway may be important in some settings, and another pathway may be important in different settings,” he suggested. What might help to resolve the issues, he said, will be “in vivo causation studies using actual disease models.”
Researchers will continue to debate. So, said Walter, “we’ll have to see what holds-up five years from now.”
M. Lu et al., “Opposing unfolded-protein-response signals converge on death receptor 5 to control apoptosis,” Science, 345:98-101, 2014.
It is one of the big scientific mysteries of Alzheimer’s disease: Why do some people whose brains accumulate the plaques and tangles so strongly associated with Alzheimer’s not develop the disease?
Now, a series of studies by Harvard scientists suggests a possible answer, one that could lead to new treatments if confirmed by other research.
The memory and thinking problems of Alzheimer’s disease and other dementias, which affect an estimated seven million Americans, may be related to a failure in the brain’s stress response system, the new research suggests. If this system is working well, it can protect the brain from abnormal Alzheimer’s proteins; if it gets derailed, critical areas of the brain start degenerating.
“This is an extremely important study,” said Li-Huei Tsai, director of the Picower Institute for Learning and Memory at the Massachusetts Institute of Technology, who was not involved in the research but wrote a commentary accompanying the study. “This is the first study that is really starting to provide a plausible pathway to explain why some people are more vulnerable to Alzheimer’s than other people.”
An image of tau tangles in the brain, often a hallmark of Alzheimer’s disease.
The research, published on Wednesday in the journal Nature, focuses on a protein previously thought to act mostly in the brains of developing fetuses. The scientists found that the protein also appears to protect neurons in healthy older people from aging-related stresses. But in people with Alzheimer’s and other dementias, the protein is sharply depleted in key brain regions.
Experts said if other scientists could replicate and expand upon the findings, the role of the protein, called REST, could spur development of new drugs for dementia, which has so far been virtually impossible to treat. But they cautioned that much more needed to be determined, including whether the decline of REST was a cause, or an effect, of brain deterioration, and whether it was specific enough to neurological diseases that it could lead to effective therapies.
“You’re going to see a lot of papers now following up on it,” said Dr. Eric M. Reiman, executive director of the Banner Alzheimer’s Institute in Phoenix, who was not involved in the study. “While it’s a preliminary finding, it raises an avenue that hasn’t been considered before. And if this provides a handle on which to understand normal brain aging, that will be great, too.”
REST, a regulator that switches off certain genes, is primarily known to keep fetal neurons in an immature state until they develop to perform brain functions, said Dr. Bruce A. Yankner, a professor of genetics at Harvard Medical School and the lead author of the new study. By the time babies are born, REST becomes inactive, he said, except in some areas outside the brain like the colon, where it seems to suppress cancer.
“Why should a fetal gene be coming on in an aging brain?” he wondered. He hypothesized that it was because in aging, as in birth, brains encounter great stress, threatening neurons that cannot regenerate if harmed.
His team discovered that REST appears to switch off genes that promote cell death, protecting neurons from normal aging processes like energy decrease, inflammation and oxidative stress.
Analyzing brains from brain banks and dementia studies, the researchers found that brains of young adults ages 20 to 35 contained little REST, while healthy adults between the ages of 73 and 106 had plenty. REST levels grew the older people got, so long as they did not develop dementia, suggesting that REST is related to longevity.
But in people with Alzheimer’s, mild cognitive impairment, frontotemporal dementia and Lewy body dementia, the brain areas affected by these diseases contained much less REST than healthy brains.
This was true only in people who actually had memory and thinking problems. People who remained cognitively healthy, but whose brains had the same accumulation of amyloid plaques and tau tangles as people with Alzheimer’s, had three times more REST than those suffering Alzheimer’s symptoms. About a third of people who have such plaques will not develop Alzheimer’s symptoms, studies show.
REST levels dropped as symptoms worsened, so people with mild cognitive impairment had more REST than Alzheimer’s patients. And only key brain regions were affected. In Alzheimer’s, REST steeply declined in the prefrontal cortex and hippocampus, areas critical to learning, memory and planning. Other areas of the brain not involved in Alzheimer’s showed no REST drop-off.
It is not yet possible to analyze REST levels in the brains of living people, and several Alzheimer’s experts said that fact limited what the new research could prove.
John Hardy, an Alzheimer’s researcher at University College London, cautioned in an email that information from post-mortem brains could not prove that a decline in REST caused dementia because death might produce unrelated damage to brain cells.
To investigate further, the team conducted what both Dr. Tsai and Dr. Reiman called a “tour de force” of research, examining REST in mice, roundworms and cells in the lab.
“We wanted to make sure the story was right,” Dr. Yankner said. “It was difficult to believe at first, to be honest with you.”
Especially persuasive was that mice genetically engineered to lack REST lost neurons as they aged in brain areas afflicted in Alzheimer’s.
Dr. Yankner said REST appeared to work by traveling to a neuron’s nucleus when the brain was stressed. In dementia, though, REST somehow gets diverted, traveling with toxic dementia-related proteins to another part of the neuron where it is eventually destroyed.
Experts said the research, while intriguing, left many unanswered questions. Bradley Wise of the National Institute on Aging’s neuroscience division, which helped finance the studies, said REST’s role needed further clarification. “I don’t think you can really say if it’s a cause of Alzheimer’s or a consequence of Alzheimer’s” yet, he said.
Dr. Samuel E. Gandy, an Alzheimer’s researcher at Mount Sinai Medical Center, wondered if REST figured only in neurodegenerative diseases or in other diseases, too, which could make it difficult to use REST to develop specific treatments or diagnostic tests for dementia.
“My ambivalence is, is this really a way that advances our understanding of the disease or does this just tell us this is even more complicated than we thought?” he said.
Dr. Yankner’s team is looking at REST in other neurological diseases, like Parkinson’s. He also has thoughts about a potential treatment, lithium, which he said appears to stimulate REST function, and is considered relatively safe.
But he and other experts said it was too early. “I would hesitate to start rushing into lithium treatment” unless rigorous studies showed that it could forestall dementia, said Dr. John C. Morris, an Alzheimer’s researcher at Washington University in St. Louis.
Still, Dr. Morris said, the REST research the team conducted so far is “very well done, and certainly helps support this idea that we’ve all tried to understand about why Alzheimer’s is age-associated and why, while amyloid is necessary for the development of Alzheimer’s disease, it certainly is not sufficient.”
He added, “There have to be some other processes and triggers that result in Alzheimer’s.”
Correction: March 19, 2014
Because of an editing error, an earlier version of this article misstated the gender of Dr. Li-Huei Tsai. Dr. Tsai is a woman.
This article is concerned only with updating the importance of key nutrients for maintenance of health. Nutritional losses are associated with memory loss, impaired immunity, and loss of lean body mass.
Low levels of omega-3 fatty acids may cause memory problems
ST. PAUL, Minn. – A diet lacking in omega-3 fatty acids, nutrients commonly found in fish, may cause your brain to age faster and lose some of its memory and thinking abilities, according to a study published in the February 28, 2012, print issue of Neurology®, the medical journal of the American Academy of Neurology. Omega-3 fatty acids include the nutrients called docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA).
salmon dinner
“People with lower blood levels of omega-3 fatty acids had lower brain volumes that were equivalent to about two years of structural brain aging,” said study author Zaldy S. Tan, MD, MPH, of the Easton Center for Alzheimer’s Disease Research and the Division of Geriatrics, University of California at Los Angeles.
For the study, 1,575 people with an average age of 67 and free of dementia underwent MRI brain scans. They were also given tests that measured mental function, body mass and the omega-3 fatty acid levels in their red blood cells.
The researchers found that people whose DHA levels were among the bottom 25 percent of the participants had lower brain volume compared to people who had higher DHA levels. Similarly, participants with levels of all omega-3 fatty acids in the bottom 25 percent also scored lower on tests of visual memory and executive function, such as problem solving and multi-tasking and abstract thinking.
ABSTRACT In patients with chronic kidney disease (CKD), loss of cellular proteins increases the risks of morbidity and mortality. Persistence of muscle protein catabolism in CKD results in striking losses of muscle proteins as whole-body protein turnover is great; even small but persistent imbalances between protein synthesis and degradation cause substantial protein loss. No reliable methods to prevent CKD-induced muscle wasting currently exist, but mechanisms that control cellular protein turnover have been identified, suggesting that therapeutic strategies will be developed to suppress or block protein loss. Catabolic pathways that cause protein wasting include activation of the ubiquitin-proteasome system (UPS), caspase-3, lysosomes and myostatin (a negative regulator of skeletal muscle growth). These pathways can be initiated by complications associated with CKD, such as metabolic acidosis, defective insulin signalling, inflammation, increased angiotensin II levels, abnormal appetite regulation and impaired microRNA responses. Inflammation stimulates cellular signalling pathways that activate myostatin, which accelerates UPS-mediated catabolism. Blocking this pathway can prevent loss of muscle proteins. Myostatin inhibition could yield new therapeutic directions for blocking muscle protein wasting in CKD or disorders associated with its complications.
We’re Fishing the Oceans Dry. It’s Time to Reconsider Fish Farms.
Food and Agriculture Organization of the United Nations -State of World Fisheries and Aquaculture 2014
Aquaculture has gotten much greener, with American innovators leading the way.
When I meet Kenny Belov mid-morning at San Francisco’s Fisherman’s Wharf, the boats that would normally be out at sea chasing salmon sit tethered to their docks. The steady breeze coursing through the bay belies choppier conditions farther out—so rough that the local fishermen threw in the towel for the fifth morning in a row. Belov scans the horizon as he explains this, feet away from the warehouse of his sustainable seafood company, TwoXSea. Because his business hinges on what local fishermen can bring in, he’s used to coping with wild fish shortages.
If we continue to fish at the current pace, some scientists predict we’ll be facing oceans devoid of edible marine creatures by 2050.
But unlike these fishermen, Belov has a stash of treasure in his warehouse, as he soon shows me: a golf-cart-size container of plump trout, their glossy bodies still taut from rigor mortis. The night before, Belov drove north to Humboldt to help “chill kill” the fish by submerging them live into barrels of slushy ice water. Belov can count on shipments of these McFarland Springs trout every week—because he helped grow them himself on a farm.
For many consumers, aquaculture lost its appeal after unappetizing news spread about commercial fish farms—like fish feed’s pressure on wild resources, overflowing waste, toxic buildup in the water, and displacement of natural species. But consider this: Our appetite for seafood continues to rise. Globally, we’ve hungered for 3.2 percent more seafood every year for the last five decades, double the rate of our population. Yet more than four-fifths of the world’s wild fisheries are overexploited or fully exploited (yielding the most fish possible with no expected room for growth). Only 3 percent of stocks are considered underexploited—meaning they have any significant room for expansion. If we continue to fish at the current pace, some scientists predict we’ll be facing oceans devoid of edible marine creatures by 2050.
Aquaculture could come to the rescue. The Food and Agriculture Organization of the United Nations predicts that farmed fish will soon surpass wild-caught; by 2030, aquaculture may produce more than 60 percent of fish we consume as food.
Food and Agriculture Organization of the United Nations “State of World Fisheries and Aquaculture” 2014 report
One of the most pressing concerns about aquaculture, though, is that many farmed fish are raised on a diet of 15 million tons a year of smaller bait fish—species like anchovies and menhaden. These bait—also known as forage fish—are ground up and converted into a substance called fishmeal. It takes roughly five pounds of them to produce one pound of farmed salmon. Bait fish are also used for nonfood products like pet food, makeup, farm animal feed, and fish oil supplements.
Forage fish are a “finite resource that’s been fully utilized.”
It may appear as though the ocean enjoys endless schools of these tiny fish, but they too have been mismanaged, and their populations are prone to collapse. They’re a “finite resource that’s been fully utilized,” says Mike Rust of NOAA’s fisheries arm. Which is disturbing, considering that researchers like those at Oceana argue that forage fish may play an outsize role in maintaining the ocean’s ecological balance, including by contributing to the abundance of bigger predatory fish.
And that’s where Belov’s trout come in: Though he swears no one can taste the difference, his fish are vegetarians. That means those five pounds of forage fish can rest easy at sea. It also means that the trout don’t consume some of the other rendered animal proteins in normal fishmeal pellets: bone meal, feather meal, blood meal, and chicken byproducts.
Belov and McFarland Springs’ owner David McFarland were inspired to switch to vegetarian feed in part by Rick Barrows, a USDA researcher. About six years ago, recounts Barrows, several USDA studies confirmed that fish rely on nutrients—vitamins, minerals, fatty acids, and protein—rather than fishmeal or fish oil, to thrive. If those nutrients could be found in other products, including purely plant-based substances, then aquaculture might not be so dependent on feeding fish other smaller fish.
Barrows and team began to test about 50 potential materials a year, and now have a database of 140 that anyone can browse through online. Belov was one of their first commercial partners. The plant-based food fed to McFarland Springs’ trout consists of a hearty blend of marine algae, freshwater micro algae, vitamins, minerals, flax, flax oil, corn, and nut waste. The resulting complete protein means the trout’s omega 3s are high and their omega 6s are low—a ratio that’s said to enhance anti-inflammatory properties. And “they don’t have the concentration of heavy metals that come from the bait fish,” Belov says. I took one of his rosy fillets home and turned it into trout lox; find the recipe here.
McFarland Springs manages the trout’s waste by funneling it out into a natural sagebrush pasture where it composts the soil.
Belov’s fish feed includes California nuts that are too broken or disfigured to be sold.
Barrows thinks region-specific material for this type of feed offers the most potential. For instance, his team learned that around 5 percent of California nuts can’t be sold because they’re broken or disfigured. They realized they could repurpose excess nut parts for the trout feed; the nut bits helped round out the complete protein. Lately, Barrows has become especially excited about turning barley surplus from the beer industry—which comes at a cheap price in Montana, where he’s based—into a feed-grade concentrate for trout feed.
“You can get just as much growth rate out of fishmeal-free feeds as fishmeal,” says Barrows. And his lab has proven as much with eight different fish species: cobia, Florida pompano, coho salmon, Atlantic salmon, walleye, yellowtail, and White seabass.
But the price difference still stands in the way for many fish farmers. Belov pays slightly more than $1/pound for his plant-based feed, whereas fishmeal pellets average around $0.71/pound. He sells his trout for $6.95/pound, about a dollar more than conventional. But he’s well positioned in the affluent Bay Area, and he usually sells out of his McFarland Springs trout well before the end of each week. As innovation continues in the realm of plant-based feeds, he’s hopeful, along with Barrows, that the price of the pellets will continue to drop.
Here in the United States, we consume plenty of farmed fish already, but only 5 percent of it is sourced domestically. “If we didn’t import so much farmed seafood,” implored Four Fish author Paul Greenberg in a recent New York Times op-ed, “we might develop a viable, sustainable aquaculture sector of our own.” It doesn’t just boil down to economics: The locations we generally export from, like China and South Asia, don’t have near the stringent environmental and health regulations as the US. “Growing more seafood at home would help with trade deficit, but also we could control the safety more,” says Barrows.
Though our current aquaculture sector is relatively tiny, US farmers are in a better position to innovate, because we have a sophisticated animal nutrition research center and feed sector, says NOAA’s Rust. “We’re the leading technical country in the world on feed.”
Belov wasn’t always open to aquaculture, and he still feels that fish—such as some salmon—with healthy wild fisheries attached to them should never be farmed. That way, environmentally responsible fishermen can stay in business. His long-term strategy for sustainable seafood? Draw from the “amazing [wild] fisheries that exist, and then you backfill with intelligent aquaculture, and yes, you can feed the planet with sustainable marine products.” Which may take more work, but as he puts it, “We depleted the ocean. It wasn’t anybody else’s fault. So it’s our job to fix it.”
Introduction to Translational Medicine (TM) – Part 1: Translational Medicine
Author and Curator: Larry H Bernstein, MD, FCAP
and
Curator: Aviva Lev-Ari, PhD, RN
This document in the Series A: Cardiovascular Diseases e-Series Volume 4: Translational and Regenerative Medicine, is a measure of the postgenomic and proteomic advances in the laboratory to the practice of clinical medicine. The Chapters are preceded by several videos by prominent figures in the emergence of this transformative change. When I was a medical student, a large body of the current language and technology that has extended the practice of medicine did not exist, but a new foundation, predicated on the principles of modern medical education set forth by Abraham Flexner, was sprouting. The highlights of this evolution were:
Requirement for premedical education in biology, organic chemistry, physics, and genetics.
Medical education included two years of basic science education in anatomy, physiology, pharmacology, and pathology prior to introduction into the clinical course sequence of the last two years.
Post medical graduate education was an internship year followed by residency in pediatrics, OBGyn, internal medicine, general surgery, psychiatry, neurology, neurosurgery, pathology, radiology, and anesthesiology, emergency medicine.
Academic teaching centers were developing subspecialty centers in ophthalmology, ENT and head and neck surgery, cardiology and cardiothoracic surgery, and hematology, hematology/oncology, and neurology.
The expansion of postgraduate medical programs included significant postgraduate funding for programs by the National Institutes of Health, and the NIH had faculty development support in a system of peer-reviewed research grant programs in medical and allied sciences.
The period after the late 1980s saw a rapid expansion of research in genomics and drug development to treat emerging threats of infectious diseases as US had a large worldwide involvement after the end of the Vietnam War, and drug resistance was increasingly encountered (malaria, tick borne diseases, salmonellosis, pseudomonas aeruginosa, staphylococcus aureus, etc.).
Moreover, the post-millenium found a large, dwindling population of veterans who had served in WWII and Vietnam, and cardiovascular, musculoskeletal, dementias, and cancer were now more common. The Human Genome Project was undertaken to realign the existing knowledge of gene structure and genetic regulation with the needs for drug development, which was languishing in development failures due to unexpected toxicities.
A substantial disconnect existed between diagnostics and pharmaceutical development, which had been over-reliant on modification of known organic structures to increase potency and reduce toxicity. This was about to change with changes in medical curricula, changes in residency programs and physicians cross-training in disciplines, and the emergence of bio-pharma, based on the emerging knowledge of the cell function, and at the same time, the medical profession was developing an evidence-base for therapeutics, and more pressure was placed on informed decision-making.
The great improvement in proteomics came from GCLC/MS-MS and is described in the video interview with Dr. Gyorgy Marko-Varga, Sweden, in video 1 of 3 (Advancing Translational Medicine). This is a discussion that is focused on functional proteomics role in future diagnostics and therapy, involving a greater degree of accuracy in mass spectrometry (MS) than can be obtained by antibody-ligand binding, and is illustrated below, the last emphasizing the importance of information technology and predictive analytics
Thermo ScientificImmunoassays and LC–MS/MS have emerged as the two main approaches for quantifying peptides and proteins in biological samples. ELISA kits are available for quantification, but inherently lack the discriminative power to resolve isoforms and PTMs.
To address this issue we have developed and applied a mass spectrometry immunoassay–selected reaction monitoring (Thermo Scientific™ MSIA™ SRM technology) research method to quantify PCSK9 (and PTMs), a key player in the regulation of circulating low density lipoprotein cholesterol (LDL-C).
A Day in the (Future) Life of a Predictive Analytics Scientist
A look into a normal day in the near future, where predictive analytics is everywhere, incorporated in everything from household appliances to wearable computing devices.
During the test drive (of an automobile), the extreme acceleration makes your heart beat so fast that your personal health data sensor triggers an alarm. The health data sensor is integrated into the strap of your wrist watch. This data is transferred to your health insurance company, so you say a prayer that their data scientists are clever enough to exclude these abnormal values from your otherwise impressive health data. Based on such data, your health insurance company’s consulting unit regularly gives you advice about diet, exercise, and sleep. You have followed their advice in the past, and your performance has increased, which automatically reduced your insurance premiums. Win-win, you think to yourself, as you park the car, and decide to buy it.
In the clinical presentation at Harlan Krumholtz’ Yale Symposium, Prof. Robert Califf, Director of the Duke University Translational medicine Clinical Research Institute, defines translational medicine as effective translation of science to clinical medicine in two segments:
Adherence to current standards
Improving the enterprise by translating knowledge
He says that discrepancies between outcomes and medical science will bridge a gap in translation by traversing two parallel systems.
Physician-health organization
Personalized medicine
He emphasizes that the new basis for physician standards will be legitimized in the following:
An interesting sidebar to the scientific medical advances is the huge shift in pressure on an insurance system that has coexisted with a public system in Medicare and Medicaid, initially introduced by the health insurance industry for worker benefits (Kaiser, IBM, Rockefeller), and we are undertaking a formidable change in the ACA.
The current reality is that actuarially, the twin system that has existed was unsustainable in the long term because it is necessary to have a very large pool of the population to spread the costs, and in addition, the cost of pharmaceutical development has driven consolidation in the industry, and has relied on the successes from public and privately funded research.
I shall digress for a moment and insert a video history of DNA, that hits the high points very well, and is quite explanatory of the genomic revolution in medical science, biology, infectious disease and microbial antibiotic resistance, virology, stem cell biology, and the undeniability of evolution.
As I have noted above, genomics is necessary, but not sufficient. The story began as replication of the genetic code, which accounted for variation, but the accounting for regulation of the cell and for metabolic processes was, and remains in the domain of an essential library of proteins. Moreover, the functional activity of proteins, at least but not only if they are catalytic, shows structural variants that is characterized by small differences in some amino acids that allow for separation by net charge and have an effect on protein-protein and other interactions.
Protein chemistry is so different from DNA chemistry that it is quite safe to consider that DNA in the nucleotide sequence does no more than establish the order of amino acids in proteins. On the other hand, proteins that we know so little about their function and regulation, do everything that matters including to set what and when to read something in the DNA.
Jose Eduardo de Salles Roselino
Chapters 2, 3, and 4 sequentially examine:
The causes and etiologies of cardiovascular diseases
The diagnosis, prognosis and risks determined by – biomarkers in serum, circulating cells, and solid tissue by contrast radiography
Treatment of cardiovascular diseases by translation of science from bench to bedside, including interventional cardiology and surgical repair
These are systematically examined within a framework of:
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