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The state’s largest hospital system on Friday reported the worst financial loss in its history while fighting the COVID-19 pandemic — but still ended the fiscal year in better shape than expected.
Mass General Brigham, formerly known as Partners HealthCare, lost $351 million on operations in the fiscal year that ended Sept. 30. In 2019, the system recorded a gain of $382 million.
The loss, however, is not as great as projected, thanks in part to an infusion of federal aid and patients returning to hospitals in large numbers after the first COVID surge receded.
“2020 is like no other year,” said Peter Markell, chief financial officer at Mass General Brigham, which includes Massachusetts General Hospital, Brigham and Women’s Hospital, and several community hospitals. “At the end of the day, we came out of this better than we thought we might.”
Total revenue for the year remained relatively stable at about $14 billion.
When the pandemic first hit Massachusetts in March, hospitals across the state suddenly experienced sharp drops in revenue because they canceled so much non-COVID care to respond to the crisis at hand. They also faced new costs related to COVID, including the personal protective equipment needed to keep health care workers safe from infection.
Federal aid helped to make up much of the losses, including $546 million in grant money that went to Mass General Brigham. The nonprofit health system also slashed capital expenses in half, by about $550 million, and temporarily froze employee wages and cut their retirement benefits.
Among the unusual new costs for Mass General Brigham this year was the expense of building a field hospital, Boston Hope, at the Boston Convention and Exhibition Center. The project cost $15 million to $20 million, Markell said, and Mass General Brigham is working to recoup those costs from government agencies.
The second surge of COVID, now underway, could hit hospitals’ bottom lines again, though Markell expects a smaller impact this time. One reason is because hospitals are trying to treat most of the patients who need care for conditions other than COVID even while treating growing numbers of COVID patients. In the spring, hospitals canceled vastly more appointments and procedures in anticipation of the first wave of COVID.
Mass General Brigham hospitals were treating more than 300 COVID patients on Friday, among the more than 1,600 hospitalized across the state.
Steve Walsh, president of the Massachusetts Health & Hospital Association, said hospitals across the state will need more federal aid as they continue battling COVID into the new year.
“The financial toll of COVID-19 has been felt by every hospital and health care organization in the Commonwealth,” he said. “Those challenges will continue during 2021.”
Integration of Mass General Hospital and Brigham Women’s Hospital was accelerated by the COVID-19 pandemic
Reporter: Aviva Lev-Ari, PhD, RN
BASED on
At Mass General Brigham, a sweeping effort to unify hospitals and shed old rivalries
Executives say greater cooperation is necessary to stay relevant in a dynamic and competitive health care industry. But the aggressive push to integrate is stirring tensions and sowing discontent among doctors and hospital leaders.
The work of integration was accelerated by the COVID-19 pandemic. As patients flooded hospitals last spring, Mass General Brigham — not each of its individual hospitals — set pandemic policies, from what kind of personal protective equipment health care providers should wear, to which visitors were allowed inside hospitals, to how employees would be paid if they were out sick with the virus.
During the winter surge of COVID, Mass General Brigham officials closely tracked beds across their system and transferred patients daily from one hospital to another to ensure that no one facility became overwhelmed.
And, in the early months of the pandemic, the company dropped the name Partners, which meant little to patients, and unveiled a new brand to reflect the strength of its greatest assets, MGH and the Brigham.
Officials at the nonprofit health system have instructeddepartment heads across their hospitals to coordinate better, so, for example, if a patient needs surgery at the Brigham but is facing a long wait, they can refer that patient to another site within Mass General Brigham.
Some executives want patients, eventually, to be able to go online and book appointments at any Mass General Brigham facility, as easily as they make reservations for dinner or a hotel.
Walls described it like this: “How do we put things together that make things better and easier for patients, and leave alone things that are better where they are?
“We’re not going to push things together that don’t fit together,” he said.
And yet the aggressive pursuit of “systemness,” as executives call it, is taking a toll. Physicians and hospital leaders are struggling with the loss of control over their institutions and worried that the new era of top-down management threatens to homogenize a group of hospitals with different cultures and identities.
Veteran physicians and leaders have been surprised and upset by the power shift that is stripping them of the ability to make key decisions and unhappy with abrupt changes they feel are occurring with little discussion. Most are uncomfortable sharing their concerns publicly.
“If you’re not on the train, you’re getting run over by the train,” said one former Mass General Brigham executive who requested anonymity in orderto speak openly. “It’s not an environment to invite debate.”
Amid the restructuring, senior executives are departing in droves. They include the CEO of the MGH physicians group, Dr. Timothy Ferris; Brigham and Women’s president Dr. Elizabeth Nabel; chief financial officer of the system, Peter Markell; Cooley Dickinson Hospital president Joanne Marqusee; and president of Spaulding Rehabilitation Network, David Storto.
Some also fear the internal discord could hinder Mass General Brigham’s ability to attract talented leaders.
Top executives acknowledge there is angst — “Change is hard,” Klibanski said — but are pushing ahead.
Dr. Henry Bourne has trained graduate students and postdocs at UCSF for over 40 years. In his iBiology talk, he discusses the imminent need for change in graduate education. With time to degrees getting longer, the biomedical community needs to create experimental graduate programs to find more effective and low cost ways to train future scientists and run successful laboratories. If we don’t start looking for solutions, the future of the biomedical enterprise will grow increasingly unstable.
Henry Bourne is Professor Emeritus and former chair of the Department of Pharmacology at the University of California – San Francisco. His research focused on trimeric G-proteins, G-protein coupled receptors, and the cellular signals responsible for polarity and direction-finding of human leukocytes. He is the author of several books including a memoir, Ambition and Delight, and has written extensively about graduate training and biomedical workforce issues. Now Dr. Bourne’s research focuses on the organization and founding of US biomedical research in the early 20th century.
“Ablation is removal of material from the surface of an object by vaporization, chipping, or other erosive processes.”; WikipediA.
The use of ablative techniques in medicine is known for decades. By the late 90s, the ability to manipulate ablation sources and control their application to area of interest improved to a level that triggered their adaptation to cancer treatment. To date, ablation is still a controversial treatment, yet steadily growing in it’s offerings to very specific cancer patients’ population.
The attractiveness in ablation as a form of cancer treatment is in the promise of minimal invasiveness, focused tissue destruction and better quality of life due to the ability to partially maintain viability of affected organs. The main challenges preventing wider adaptation of ablative treatments are: the inability to noninvasively assess the level of cancerous tissue destruction during treatment; resulting in metastatic recurrence of the disease and the insufficient isolation of the treatment area from its surrounding. This frequently results In addition, post-ablation salvage treatments are much more complicated. Since failed ablative treatment represents a lost opportunity to apply effective treatment to the primary tumor the current trend is to apply such treatments to low-grade cancers.
Nevertheless, the attractiveness of treating cancer in a focused way that preserves the long-term quality of life continuously feeds the development efforts and investments related to introduction of new and improved ablative treatments giving the hope that sometime in the future focused ablative treatment will reach its full potential.
Primary or metastatic osseous and soft tissue lesions can be treated by ablation techniques.
Methods
These techniques are classified into chemical ablation (including ethanol or acetic acid injection) and thermal ablation (including laser, radiofrequency, microwave, cryoablation, radiofrequency ionisation and MR-guided HIFU). Ablation can be performed either alone or in combination with surgical or other percutaneous techniques.
Results
In most cases, ablation provides curative treatment for benign lesions and malignant lesions up to 3 cm. Furthermore, it can be a palliative treatment providing pain reduction and local control of the disease, diminishing the tumor burden and mass effect on organs. Ablation may result in bone weakening; therefore, whenever stabilization is undermined, bone augmentation should follow ablation depending on the lesion size and location.
Conclusion
Thermal ablation of bone and soft tissues demonstrates high success and relatively low complication rates. However, the most common complication is the iatrogenic thermal damage of surrounding sensitive structures. Nervous structures are very sensitive to extremely high and low temperatures with resultant transient or permanent neurological damage. Thermal damage can cause normal bone osteonecrosis in the lesion’s periphery, surrounding muscular atrophy and scarring, and skin burns. Successful thermal ablation requires a sufficient ablation volume and thermal protection of the surrounding vulnerable structures.
Teaching points
• Percutaneous ablations constitute a safe and efficacious therapy for treatment of osteoid osteoma.
• Ablation techniques can treat painful malignant MSK lesions and provide local tumor control.
• Thermal ablation of bone and soft tissues demonstrates high success and low complication rates.
• Nerves, cartilage and skin are sensitive to extremely high and low temperatures.
• Successful thermal ablation occasionally requires thermal protection of the surrounding structures.
For the purpose of this chapter we picked up three techniques:
Radiofrequency ablation
Straight or expandable percutaneously placed electrodes deliver a high-frequency alternating current, which causes ionic agitation with resultant frictional heat (temperatures of 60–100 ˚C) that produces protein denaturation and coagulation necrosis [8]. Concerning active protective techniques, all kinds of gas dissection can be performed. Hydrodissection is performed with dextrose 5 % (acts as an insulator as opposed to normal saline, which acts as a conductor). All kinds of skin cooling, thermal and neural monitoring can be performed.
Microwave ablation
Straight percutaneously placed antennae deliver electromagnetic microwaves (915 or 2,450 MHz) with resultant frictional heat (temperatures of 60–100 ˚C) that produces protein denaturation and coagulation necrosis [8]. Concerning active protective techniques, all kinds of gas dissection can be performed, whilst hydrodissection is usually avoided (MWA is based on agitation of water molecules for energy transmission). All kinds of skin cooling, thermal and neural monitoring can be performed.
Percutaneous ablation of malignant metastatic lesions is performed under imaging guidance, extended local sterility measures and antibiotic prophylaxis. Whenever the ablation zone is expected to extend up to 1 cm close to critical structures (e.g. the nerve root, skin, etc.), all the necessary thermal protection techniques should be applied (Fig. 3).
a Painful soft tissue mass infiltrating the left T10 posterior rib. b A microwave antenna is percutaneously inserted inside the mass. Due to the proximity to the skin a sterile glove filled with cold water is placed over the skin. c CT axial scan 3 months …
Irreversible Electroporation (IRE)
Each cell membrane point has a local transmembrane voltage that determines a dynamic phenomenon called electroporation (reversible or irreversible) [16]. Electroporation is manifested by specific transmembrane voltage thresholds related to a given pulse duration and shape. Thus, a threshold for an electronic field magnitude is defined and only cells with higher electric field magnitudes than this threshold are electroporated. IRE produces persistent nano-sized membrane pores compromising the viability of cells [16]. On the other hand, collagen and other supporting structures remain unaffected. The IRE generator produces direct current (25–45 A) electric pulses of high voltage (1,500–3,000 V).
Lastly we wish to highlight a method that is mostly used on patients diagnosed at intermediate or advanced clinical stages of Hepatocellular Carcinoma (HCC); transarterial chemoembolization (TACE)
“Transcatheter arterial chemoembolization (also called transarterial chemoembolization or TACE) is a minimally invasive procedure performed in interventional radiology to restrict a tumor’s blood supply. Small embolic particles coated with chemotherapeutic agents are injected selectively into an artery directly supplying a tumor. TACE derives its beneficial effect by two primary mechanisms. Most tumors within the liver are supplied by the proper hepatic artery, so arterial embolization preferentially interrupts the tumor’s blood supply and stalls growth until neovascularization. Secondly, focused administration of chemotherapy allows for delivery of a higher dose to the tissue while simultaneously reducing systemic exposure, which is typically the dose limiting factor. This effect is potentiated by the fact that the chemotherapeutic drug is not washed out from the tumor vascular bed by blood flow after embolization. Effectively, this results in a higher concentration of drug to be in contact with the tumor for a longer period of time.Park et al. conceptualized carcinogenesis of HCC as a multistep process involving parenchymal arterialization, sinusoidal capillarization, and development of unpaired arteries (a vital component of tumor angiogenesis). All these events lead to a gradual shift in tumor blood supply from portal to arterial circulation. This concept has been validated using dynamic imaging modalities by various investigators. Sigurdson et al. demonstrated that when an agent was infused via the hepatic artery, intratumoral concentrations were ten times greater compared to when agents were administered through the portal vein. Hence, arterial treatment targets the tumor while normal liver is relatively spared. Embolization induces ischemic necrosis of tumor causing a failure of the transmembrane pump, resulting in a greater absorption of agents by the tumor cells. Tissue concentration of agents within the tumor is greater than 40 times that of the surrounding normal liver.”; WikipediA
To compare the overall survival of patients with hepatocellular carcinoma (HCC) who were treated with lipiodol-based conventional transarterial chemoembolization (cTACE) with that of patients treated with drug-eluting bead transarterial chemoembolization (DEB-TACE).
Methods
By an electronic search of our radiology information system, we identified 674 patients that received TACE between November 2002 and July 2013. A total of 520 patients received cTACE, and 154 received DEB-TACE. In total, 424 patients were excluded for the following reasons: tumor type other than HCC (n = 91), liver transplantation after TACE (n = 119), lack of histological grading (n = 58), incomplete laboratory values (n = 15), other reasons (e.g., previous systemic chemotherapy) (n = 114), or were lost to follow-up (n = 27). Therefore, 250 patients were finally included for comparative analysis (n = 174 cTACE; n = 76 DEB-TACE).
Results
There were no significant differences between the two groups regarding sex, overall status (Barcelona Clinic Liver Cancer classification), liver function (Child-Pugh), portal invasion, tumor load, or tumor grading (all p > 0.05). The mean number of treatment sessions was 4 ± 3.1 in the cTACE group versus 2.9 ± 1.8 in the DEB-TACE group (p = 0.01). Median survival was 409 days (95 % CI: 321–488 days) in the cTACE group, compared with 369 days (95 % CI: 310–589 days) in the DEB-TACE group (p = 0.76). In the subgroup of Child A patients, the survival was 602 days (484–792 days) for cTACE versus 627 days (364–788 days) for DEB-TACE (p = 0.39). In Child B/C patients, the survival was considerably lower: 223 days (165–315 days) for cTACE versus 226 days (114–335 days) for DEB-TACE (p = 0.53).
Conclusion
The present study showed no significant difference in overall survival between cTACE and DEB-TACE in patients with HCC. However, the significantly lower number of treatments needed in the DEB-TACE group makes it a more appealing treatment option than cTACE for appropriately selected patients with unresectable HCC.
Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting
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:
I came across a few recent articles on the subject of US Patent Office guidance on patentability as well as on Supreme Court ruling on claims. I filed several patents on clinical laboratory methods early in my career upon the recommendation of my brother-in-law, now deceased. Years later, after both brother-in-law and patent attorney are no longer alive, I look back and ask what I have learned over $100,000 later, with many trips to the USPTO, opportunities not taken, and a one year provisional patent behind me.
My conclusion is
(1) that patents are for the protection of the innovator, who might realize legal protection, but the cost and the time investment can well exceed the cost of startup and building a small startup enterprize, that would be the next step.
(2) The other thing to consider is the capability of the lawyer or firm that represents you. A patent that is well done can be expected to take 5-7 years to go through with due diligence. I would not expect it to be done well by a university with many other competing demands. I might be wrong in this respect, as the climate has changed, and research universities have sprouted engines for change. Experienced and productive faculty are encouraged or allowed to form their own such entities.
(3) The emergence of Big Data, computational biology, and very large data warehouses for data use and integration has changed the landscape. The resources required for an individual to pursue research along these lines is quite beyond an individuals sole capacity to successfully pursue without outside funding. In addition, the changed designated requirement of first to publish has muddied the water.
Of course, one can propose without anything published in the public domain. That makes it possible for corporate entities to file thousands of patents, whether there is actual validation or not at the time of filing. It would be a quite trying experience for anyone to pursue in the USPTO without some litigation over ownership of patent rights. At this stage of of technology development, I have come to realize that the organization of research, peer review, and archiving of data is still at a stage where some of the best systems avalailable for storing and accessing data still comes considerably short of what is needed for the most complex tasks, even though improvements have come at an exponential pace.
I shall not comment on the contested views held by physicists, chemists, biologists, and economists over the completeness of guiding theories strongly held. Only history will tell. Beliefs can hold a strong sway, and have many times held us back.
I am not an expert on legal matters, but it is incomprehensible to me that issues concerning technology innovation can be adjudicated in the Supreme Court, as has occurred in recent years. I have postgraduate degrees in Medicine, Developmental Anatomy, and post-medical training in pathology and laboratory medicine, as well as experience in analytical and research biochemistry. It is beyond the competencies expected for these type of cases to come before the Supreme Court, or even to the Federal District Courts, as we see with increasing frequency, as this has occurred with respect to the development and application of the human genome.
I’m not sure that the developments can be resolved for the public good without a more full development of an open-access system of publishing. Now I present some recent publication about, or published by the USPTO.
DR ANTHONY MELVIN CRASTO
Dr. Melvin Castro – Organic Chemistry and New Drug Development
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USPTO Guidance On Patentable Subject Matter: Impediment to Biotech Innovation
Joanna T. Brougher, David A. FazzolareJ Commercial Biotechnology 2014 20(3):Brougher
jcbiotech-patents
Abstract In June 2013, the U.S. Supreme Court issued a unanimous decision upending more than three decades worth of established patent practice when it ruled that isolated gene sequences are no longer patentable subject matter under 35 U.S.C. Section 101.While many practitioners in the field believed that the USPTO would interpret the decision narrowly, the USPTO actually expanded the scope of the decision when it issued its guidelines for determining whether an invention satisfies Section 101.
The guidelines were met with intense backlash with many arguing that they unnecessarily expanded the scope of the Supreme Court cases in a way that could unduly restrict the scope of patentable subject matter, weaken the U.S. patent system, and create a disincentive to innovation. By undermining patentable subject matter in this way, the guidelines may end up harming not only the companies that patent medical innovations, but also the patients who need medical care. This article examines the guidelines and their impact on various technologies.
35 U.S.C. Section 101 states “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
” Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 566 U.S. ___ (2012)
Association for Molecular Pathology et al., v. Myriad Genetics, Inc., 569 U.S. ___ (2013).
Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95, 103 (C.C.S.D.N.Y. 1911)
USPTO. Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products.
A 2013 Supreme Court decision that barred human gene patents is scrambling patenting policies.
PHOTO: MLADEN ANTONOV/AFP/GETTY IMAGES
A year after the U.S. Supreme Court issued a landmark ruling that human genes cannot be patented, the biotech industry is struggling to adapt to a landscape in which inventions derived from nature are increasingly hard to patent. It is also pushing back against follow-on policies proposed by the U.S. Patent and Trademark Office (USPTO) to guide examiners deciding whether an invention is too close to a natural product to deserve patent protection. Those policies reach far beyond what the high court intended, biotech representatives say.
“Everything we took for granted a few years ago is now changing, and it’s generating a bit of a scramble,” says patent attorney Damian Kotsis of Harness Dickey in Troy, Michigan, one of more than 15,000 people who gathered here last week for the Biotechnology Industry Organization’s (BIO’s) International Convention.
At the meeting, attorneys and executives fretted over the fate of patent applications for inventions involving naturally occurring products—including chemical compounds, antibodies, seeds, and vaccines—and traded stories of recent, unexpected rejections by USPTO. Industry leaders warned that the uncertainty could chill efforts to commercialize scientific discoveries made at universities and companies. Some plan to appeal the rejections in federal court.
USPTO officials, meanwhile, implored attendees to send them suggestions on how to clarify and improve its new policies on patenting natural products, and even announced that they were extending the deadline for public comment by a month. “Each and every one of you in this room has a moral duty … to provide written comments to the PTO,” patent lawyer and former USPTO Deputy Director Teresa Stanek Rea told one audience.
At the heart of the shake-up are two Supreme Court decisions: the ruling last year in Association for Molecular Pathology v. Myriad Genetics Inc. that human genes cannot be patented because they occur naturally (Science, 21 June 2013, p. 1387); and the 2012 Mayo v. Prometheus decision, which invalidated a patent on a method of measuring blood metabolites to determine drug doses because it relied on a “law of nature” (Science, 12 July 2013, p. 137).
Myriad and Mayo are already having a noticeable impact on patent decisions, according to a study released here. It examined about 1000 patent applications that included claims linked to natural products or laws of nature that USPTO reviewed between April 2011 and March 2014. Overall, examiners rejected about 40%; Myriad was the basis for rejecting about 23% of the applications, and Mayo about 35%, with some overlap, the authors concluded. That rejection rate would have been in the single digits just 5 years ago, asserted Hans Sauer, BIO’s intellectual property counsel, at a press conference. (There are no historical numbers for comparison.) The study was conducted by the news service Bloomberg BNA and the law firm Robins, Kaplan, Miller & Ciseri in Minneapolis, Minnesota.
USPTO is extending the decisions far beyond diagnostics and DNA?
The numbers suggest USPTO is extending the decisions far beyond diagnostics and DNA, attorneys say. Harness Dickey’s Kotsis, for example, says a client recently tried to patent a plant extract with therapeutic properties; it was different from anything in nature, Kotsis argued, because the inventor had altered the relative concentrations of key compounds to enhance its effect. Nope, decided USPTO, too close to nature.
In March, USPTO released draft guidance designed to help its examiners decide such questions, setting out 12 factors for them to weigh. For example, if an examiner deems a product “markedly different in structure” from anything in nature, that counts in its favor. But if it has a “high level of generality,” it gets dinged.
The draft has drawn extensive criticism. “I don’t think I’ve ever seen anything as complicated as this,” says Kevin Bastian, a patent attorney at Kilpatrick Townsend & Stockton in San Francisco, California. “I just can’t believe that this will be the standard.”
USPTO officials appear eager to fine-tune the draft guidance, but patent experts fear the Supreme Court decisions have made it hard to draw clear lines. “The Myriad decision is hopelessly contradictory and completely incoherent,” says Dan Burk, a law professor at the University of California, Irvine. “We know you can’t patent genetic sequences,” he adds, but “we don’t really know why.”
Get creative in using Draft Guidelines!
For now, Kostis says, applicants will have to get creative to reduce the chance of rejection. Rather than claim protection for a plant extract itself, for instance, an inventor could instead patent the steps for using it to treat patients. Other biotech attorneys may try to narrow their patent claims. But there’s a downside to that strategy, they note: Narrower patents can be harder to protect from infringement, making them less attractive to investors. Others plan to wait out the storm, predicting USPTO will ultimately rethink its guidance and ease the way for new patents.
Public comment period extended
USPTO has extended the deadline for public comment to 31 July, with no schedule for issuing final language. Regardless of the outcome, however, Stanek Rea warned a crowd of riled-up attorneys that, in the world of biopatents, “the easy days are gone.”
Manual of Patent Examining Procedure (MPEP)Ninth Edition, March 2014
The USPTO continues to offer an online discussion tool for commenting on selected chapters of the Manual. To participate in the discussion and to contribute your ideas go to: http://uspto-mpep.ideascale.com.
Manual of Patent Examining Procedure (MPEP)Ninth Edition, March 2014
The USPTO continues to offer an online discussion tool for commenting on selected chapters of the Manual. To participate in the discussion and to contribute your ideas go to:http://uspto-mpep.ideascale.com.
The documents updated in the Ninth Edition of the MPEP, dated March 2014, include changes that became effective in November 2013 or earlier.
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After more than 5 years and two draft versions, the final version of the Guidance for
Industry (GfI) – “Electronic Source Data in Clinical Investigations” was published in
September 2013. This new FDA Guidance defines the FDA’s expectations for sponsors,
CROs, investigators and other persons involved in the capture, review and retention of
electronic source data generated in the context of FDA-regulated clinical trials.In an
effort to encourage the modernization and increased efficiency of processes in clinical
trials, the FDA clearly supports the capture of electronic source data and emphasizes
the agency’s intention to support activities aimed at ensuring the reliability, quality,
integrity and traceability of this source data, from its electronic source to the electronic
submission of the data in the context of an authorization procedure. The Guidance
addresses aspects as data capture, data review and record retention. When the
computerized systems used in clinical trials are described, the FDA recommends
that the description not only focus on the intended use of the system, but also on
data protection measures and the flow of data across system components and
interfaces. In practice, the pharmaceutical industry needs to meet significant
requirements regarding organisation, planning, specification and verification of
computerized systems in the field of clinical trials. The FDA also mentions in the
Guidance that it does not intend to apply 21 CFR Part 11 to electronic health records
(EHR). Author: Oliver Herrmann Q-Infiity Source: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM328691.pdf Webinar: https://collaboration.fda.gov/p89r92dh8wc
The Bioscience Crowdfunding Environment: Will Crowdfunding be the Bigger, New VC
Reporter: Stephen J. Williams, Ph.D.
Pharmaceutical Consulting Consortium International Inc. (PCCI) recently presented their 7th annual Roundtable “CROWDFUNDING FOR LIFE SCIENCES: A BRIDGE OVER TROUBLED WATERS?”, a panel discussion on how this new funding mechanism applies to early stage life science companies and changes the funding landscape.
A major provision in the recently passed JOBS Act resulted in Securities & Exchange Commission (SEC) rule changes revolutionizing the way companies can raise capital, with some figures in the range of $11 trillion dollars. Companies, startups, and entrepreneurs can, in a manner, now go directly to the individual investor and raise capital. This method is generally referred to as CROWDFUNDING.
As explained by Mark Roderick, moderator for the meeting, there are two main types of approved crowdfunding:
Donation-based Crowdfunding – Popularized by the crowdfunding platform Kickstarter, this method of raising capital can accept small donations from anyone for an idea/project to be completed. The donor may either get a free token of appreciation or access to enjoy the fruits of the project, for example, a watching a movie funded by the donor. Some scientific researchers have used Kickstarter as a method to fund their research.
Investor-based Crowdfunding– This type of crowdfunding involves the actual transfer of securities, and investors must qualify according to rules set by the SEC and go thru brokers, or portals, like the bioscience and healthcare internet portal Poliwogg.
Investor-based crowdfundingwas discussed at the meeting. There are five different mechanisms with this type of funding: Title II (Rule 506c), Title II, Title IV, Existing Regulation A, and Rule 504. The main focus of the meeting was on Title II as, according to Mr. Roderick, involves the mechanism most suited for biotech startups, while rules for Title III still need to be finalized.
Title II crowdfunding requires that “accredited” or “qualified” investors (those who make at least $200,000/year or net worth $1 million US) go through licensed dealer internet nodes (or Portals) like Poliwog. The Portal will have lists of startups they deem legitimate which investors can choose from. For instance the Epilepsy Foundation uses Poliwog to fund certain projects.
The panelists discussed matters including:
How crowdfunding is different than other mechanisms like venture capital
What are the regulations and financial responsibilities for both biotech and crowdfunder
Liabilities
Due-diligence issues
The panelists included:
Mark Roderick, moderator. Mark is an attorney at Flaster/Greenberg PC (@CrowdfundAttny on Twitter) and has developed great experience and expertise in the details of crowdfunding. He maintains a Crowdfunding blog www.crowdfundattny.com, which contains information and links about the JOBS Act and crowdfunding.
Recent estimates place Title II Crowdfunding capacity to $1 Trillion.
Venture Capital (VC) had estimated only $5 Billion bio-investment in 2013.
Where does the rest go?
Mr. Skerret noted that bioangels can only take you so far but thinks that crowdfunding may fill this “valley of death”.
Liabilities
Crowdfunding is SELLING SECURITIESso there is liability, disclosure and nondisclosure issues.
Title II contains 580 pages of regulations and SEC needs a licensed intermediary.
Due-Diligence
Barbara Schiberg also noted that with VCs or bioangels groups you also get s support network, basically their rolodex of contacts and KOL’s and experts. With Crowdfunding like Poliwog they just handle linking investors with entrepreneur. Any contact is done through social media and the crowd.
BioAdvance hires experts – may take months to years to get expert opinion
Poliwog only has responsibility to investor to make sure company is legitimate. They don’t do extensive due diligence like bioangels. Most crowdfunding do not have extensive networks of professionals.
To obtain a video recording of this meeting and get more information please go to PCCI’s web site at http://www.rxpcci.com/meetings.htm.
Other posts on this site related to FUNDING and Bio Investing include:
Information Security and Privacy in Healthcare is part of the 2nd Annual Medical Informatics World, April 28-29, 2014, World Trade Center, Boston, MA
Reporter: Aviva Lev-Ari, PhD
Concurrent Tracks
Provider-Payer-Pharma Cross-Industry Data Collaboration
Coordinated Patient Care Engagement and Empowerment
Population Health Management and Quality Improvement
Information Security and Privacy in Healthcare
Dinner Workshop
Advancing the Use of EHR/EMR for Clinical Research and Drug Development
About the Conference
Cambridge Healthtech Institute and Bio-IT World’s Second Annual Medical Informatics World builds upon last year’s successful inaugural launch by delivering timely programming focused on the cross-industry connections and innovative solutions needed to take biomedical research and healthcare delivery to the next level.
The 2014 meeting will bring together more than 300 senior level executives and industry leaders from each side of the discussion – providers, payers and pharma – in the fields of healthcare, biomedical sciences, health informatics, and IT. Over two days of insightful discussions and engaging presentations, leading experts will share emerging trends and solutions in population health management, payer-provider-pharma data collaborations, optimizing patient care and engagement, leveraging mobile technologies, sustaining innovation within the rapidly changing care delivery models, enhancing clinical decision support, controlling costs and improving quality, and maintaining security-privacy in healthcare. Led by key decision makers and senior executives at the forefront of healthcare information technology, the conference is a must-attend for all involved in this evolving industry.
Co-located with CHI’s flagship Bio-IT World Expo, a premier event showcasing the myriad applications of IT and informatics to the life sciences enterprise, Medical Informatics World completes the week of scientific content by bridging the healthcare and life science worlds. As Bio-IT World Expo attracts more than 2,500 delegates from dozens of countries as well as more than 130 exhibiting companies, networking opportunities abound at the two events.
KEY NOTES
John Halamka, M.D., MS, CIO, Beth Israel Deaconess Medical Center Bryan Sivak, CTO & EIR, U.S. Department of Health and Human Services Roy Beveridge, M.D., Senior Vice President and CMO, Humana Mark Davies, M.D., Executive Medical Director, Health & Social Care Information Centre, National Health Service Sachin Jain, M.D., MBA, Vice President and Chief Medical Information & Innovation Officer, Merck & Co. Jacob Reider, M.D., Acting Principle Deputy National Coordinator, Office of the National Coordinator for Health Information Technology (ONC), U.S. Department of Health and Human Services
REAL CHALLENGES OF UNAUTHORIZED DISCLOSURE OF PHI Patient Privacy and Security: What Recent Benchmarks of Healthcare Providers Revealed Larry Ponemon, Chairman and Founder, Ponemon Institute Fair Information Practice for Cyber ID Adrian Gropper, M.D., CTO, Patient Privacy Rights Should I Trust You With My Patient’s Data? Rick Moore, CIO, National Committee for Quality Assurance (NCQA)
HITECH REGULATIONS AND THE FUTURE OF TRANSPARENCY A Practical Look at the HITECH Proposed Regulations and Federal Information Transparency Policies: The Payer Perspective Marilyn Zigmund Luke, Senior Counsel and Compliance Officer, America’s Health Insurance Plans (AHIP) Just Added! Omnibus HIPAA Rulemaking and a New Era of Privacy and Security: Don’t be an Ostrich Lassaad Fridhi, Information Privacy & Security Officer, Commonwealth Care Alliance
PUTTING HEALTHCARE DATA IN THE CLOUD Can PHI and the Cloud Coexist? Paul Connelly, Vice President, CISO, Hospital Corporation of America (HCA) Just Added! U Mass Medical College-NIH Case Study: A Privacy Solution for Sharing and Analyzing Healthcare Data Luvai Motiwalla, Ph.D., Professor, Operations and Information Systems (OIS), Manning School of Business, U Mass Lowell
BYOD: BALANCING PRIVACY, SECURITY AND FLEXIBILITY BYOD: Job Security for Privacy and Information Security Professionals Marti Arvin, Chief Compliance Officer, David Geffen School of Medicine, UCLA Health System
BYOD: BRING YOUR OWN DEVICE OR BRING YOUR OWN DISASTER? Mobile Security and BYOD in a Large Hospital System Jennings Aske, CISO, Partners HealthCare System Just Added! A Modern CISO’s Role is More than Tech: Achieving the Elusive Balance Between Information Security and Human Factors SumitSehgal, Chief Information Security & Privacy Officer, Boston Medical Center Can a Company with More than Two Million Employees Successfully Implement BYOD? Anthony Martin, Senior Associate General Counsel, Privacy & Information Security, Walmart
OVERCOMING THE INTEROPERABILITY-PRIVACY STANDOFF “Mind the Gap”: Lessons from London on Using Information to Improve English Healthcare Samantha Meikle, Director, London Connect Overcoming the Interoperability-Privacy Standoff Peter Madras, M.D., Senior Staff, Lahey Health and Hospitals; Founder, Medical Record Bank
KEYNOTE SESSION: CONNECTING PATIENTS, PROVIDERS, AND PAYERS Health Delivery Reform and the Future of Health IT-Enabled Quality Improvement Jacob Reider, M.D., Acting Principle Deputy National Coordinator, Office of the National Coordinator for Health Information Technology (ONC), U.S. Department of Health and Human Services Healthcare IT Innovations that are Connecting Patients, Providers, and Payers John Halamka, M.D., MS, CIO, Beth Israel Deaconess Medical Center Three Patients: How Health Information Technology Will Enable the Pharmaceutical Industry to Improve Patient Care Sachin Jain, M.D., MBA, Vice President and Chief Medical Information & Innovation Officer, Merck & Co. Keynote Panel: Deploying Information Technology to Enable Innovation within the Future State of Care Susan Dentzer, Senior Policy Adviser, Robert Wood Johnson Foundation
KEYNOTE SESSION: TRANSFORMING GOVERNMENT & HEALTHCARE THROUGH INNOVATION Startup Mentality: Transforming Government & Health Bryan Sivak, Chief Technology Officer & EIR, U.S. Department of Health and Human Services Humana’s Approach to Medicare Advantage Roy Beveridge, M.D., Senior Vice President and Chief Medical Officer, Humana The English Patient, a Story of NHS Informatics Mark Davies, M.D., Executive Medical Director, Health & Social Care Information Centre, National Health Service Keynote Panel: What are the Remaining Policy and Technology Barriers to Information Sharing with Patients? Daniel Sands, M.D., MPH, Assistant Clinical Professor, Harvard Medical School; Co-Founder, Society for Participatory Medicine To learn more, view the brochure or visit MedicalInformaticsWorld.com/Information-Security-Privacy.
————————————————————————
Information Security and Privacy in Healthcare is part of the Second Annual Medical Informatics World, to be held April 28-29, 2014 at the World Trade Center in Boston, MA. The event builds upon last year’s successful inaugural launch by delivering timely programming focused on the cross-industry connections and innovative solutions needed to take biomedical research and healthcare delivery to the next level. The 2014 meeting will bring together more than 300 senior level executives and industry leaders from each side of the discussion – providers, payers and pharma – in the fields of healthcare, biomedical sciences, health informatics, and IT. Medical Informatics World Conference Tracks Provider-Payer-Pharma Cross-Industry Data Collaboration Coordinated Patient Care, Engagement and Empowerment Population Health Management and Quality Improvement Information Security and Privacy in Healthcare Also Available On-Site, A Dinner Workshop Advancing the Use of EHR/EMR for Clinical Research and Drug Development: A Platform that Reuses EHRs across Hospitals to Support Clinical Research supported by Sustainability Measures* (Details) > Download the full program. > For the latest speaker additions and presentation updates, visit MedicalInformaticsWorld.com. > Register now to join 300+ colleagues! > Learn more about sponsorship and exhibit opportunities.
SOURCE
From: Medical Informatics World 2014 <jaimeh@healthtech.com> Date: Wed, 26 Mar 2014 11:59:00 -0400 To: <avivalev-ari@alum.berkeley.edu> Subject: Just Added! NIH Health Privacy Case Study, Balancing Security & Human Factors, Omnibus HIPAA Rulemaking
“Sudden Cardiac Death,” SudD is in Ferrer inCode’s Suite of Cardiovascular Genetic Tests to be Commercialized in the US
Curator: Aviva Lev-Ari, PhD, RN
Uncertainty around reimbursement for targeted NGS tests is faced by Molecular Diagnostic and Genomics Services companies
VIEW VIDEO
Democratization of Genomic Medicine: Michael Bolick @ TEDxTalks
Ferrer inCode’s Suite of Cardiovascular Genetic Tests included the following tests:
SudD inCode (Sudden Cardiac Death)
Cardio inCode,
Thrombo inCode, and
Nutri inCode
Selah Genomics, Ferrer inCode to Offer NGS-based Cardiovascular Test in US
2014/02/06
Selah Genomics, a Greenville, S.C.-based molecular diagnostic and genomics services company, has partnered with Spanish pharmaceutical company Ferrer inCode to commercialize Ferrer inCode’s suite of cardiovascular genetic tests in the US.
Selah will first validate Ferrer’s next-generation sequencing-based test for sudden cardiac death, SudD inCode, on Illumina’s MiSeq system to run out of its CLIA-certified laboratory.
Meantime, Selah plans to validate three other Ferrer inCode PCR-based cardiovascular tests — Cardio inCode, Thrombo inCode, and Nutri inCode — in its own lab using PCR, but may eventually combine the tests into one comprehensive panel to run on an NGS system, Selah CEO Michael Bolick told Clinical Sequencing News.
Selah already offers its PrecisionPath targeted Cancer Test in collaboration with the Greenville Health System’s Institute for Translational Oncology Research. All consenting cancer patients at ITOR receive the PrecisionPath test, which runs on Life Technologies’ Ion Torrent PGM and uses the Ion AmpliSeq technology.
Currently, Selah receives between 10 and 20 samples per week for PrecisionPath, and it plans to roll the test out nationwide later this year.
Bolick said that the company is also developing Hepatitis C and HIV assays for the MiSeq, and that the firm will likely purchase Illumina’s MiSeqDx, which recently received clearance from the US Food and Drug Administration.
Selah also collaborates with pharmaceutical companies to develop companion diagnostic tests. Bolick anticipates that the firm will use the MiSeqDx for those tests since they will “ultimately need [pre-market approval].” Having an FDA-cleared platform on which to develop the tests will be helpful in gaining a PMA designation, he said.
Selah also offers Exome Sequencing Services on the Ion Proton for research use only. In addition, it has a
Pacific Biosciences RS II and
Roche’s 454 GS FLX in house.
Bolick said that the company is currently using the PacBio machine for discovery work in infectious disease.
Ferrer inCode’s SudD inCode Test
currently assesses 55 genes related to structural heart problems that cause sudden cardiac arrest, Robert Jenkins, who manages Ferrer inCode’s UK and Americas groups, told CSN. However, the company is planning to
expand the test to 104 genes and also to include
genes related to conductive myopathy,
sudden infant death, and
aneurysms.
While the test sequences the entire genes, only well-known causative variants are reported, Jenkins said. However, the firm has been collecting all the sequenced variants, so it could potentially add content to the test if enough evidence is gathered to validate any of those variants as clinically significant.
Ferrer inCode currently runs SudD inCode on the MiSeq as an LDT, which is how Selah will validate and market the test in the US.
Jenkins said that for now, Ferrer plans to keep the Cardio, Nutri, and Thrombo inCode tests PCR-based.
Cardio inCode looks at around 125 variants involved in genetic risk for cardiac disease.
When it is used with traditional markers such as
lipid profiling, an individual’s
smoking and drinking habits, and
body mass index,
Jenkins said the genetic test helps to reclassify around 20 percent to 25 percent of individuals deemed in the intermediate risk category as either high or low risk.
Thrombo inCode Test
is an approximately 20-variant thrombosis test for individuals that have had a thrombotic event or who have had a history of unsuccessful pregnancies. Often, the cause of thrombosis can go unexplained via testing from serological workups, Jenkins said.
Nutri inCode Test
is a nutrigenomics test that looks at around 90 SNPs. In combination with lifestyle factors, it helps individuals develop a tailored genetics-based plan to reduce obesity, Jenkins said.
Bolick said that while Selah will validate and develop each of these tests individually out of its laboratory, it is also deciding whether to combine the tests into one next-gen sequencing-based test.
Jeremy Stuart, Selah’s VP of genomic services, told CSN that one option would be to incorporate the individual SNPs assessed in the Thrombo, Cardio, and Nutri tests into the SudD test.
Bolick said that the company is now in discussions with third party payors about reimbursement for the tests and is readying a regional pilot program to offer the sequencing-based cardiovascular test as part of a corporate wellness program. The pilot will help Selah figure out a pricing structure and will also demonstrate a “return on investment to the corporation, by allowing for better determination of risk of heart disease,” Bolick said.
Currently, Selah’s other NGS test, PrecisionPath, is being paid for by ITOR. However, Bolick said that initial conversations with third party payors about launching the assay outside of the Greenville Health System have been positive.
Reimbursement success will play a role in determining how the company expands beyond its current tests. For instance, while Selah is interested in moving into
clinical exome sequencing,
Stuart said that right now there is a “lot of uncertainty around reimbursement for targeted NGS tests, let alone exome sequencing.” Selah will first “establish reimbursement for those and then may expand into what’s possible for exome sequencing,” Stuart said. But currently, the exome market is research use only.
SELAH GENOMICS: HARNESS THE POWER OF PRECISION FOR MORE PERSONALIZED TREATMENT
Selah Genomics is a clinical diagnostic specialist supporting healthcare providers and the pharmaceutical industry with advanced molecular and genomic diagnostic services. Selah’s services add value to early stage drug development, clinical trials and regulatory processes in the pharmaceutical industry and helps clinicians and healthcare providers treat and monitor patients, thereby improving patient outcomes.
With the Power of Precision, Selah Genomics provides the best in molecular diagnostic testing, assay validation and genomic profiling that all leads to one common goal: to provide better outcomes for patients.
Michael Bolick, CEO
Michael is a serial entrepreneur with 25 years of experience in the life science and healthcare industries. Most recently, he led a management buyout of Lab21 Ltd’s US-based operations to form Selah Genomics Inc. Prior to co-founding Selah Genomics, Michael served as President of Lab21 Inc which was formed following Lab21 Ltd’s acquisition of his prior company, Selah Technologies LLC. He founded Selah Technologies LLC to commercialize nanotechnologies licensed from Clemson University. Selah focused these nanotechnologies to enable doctors to see cancer during surgery. Prior to founding Selah Technologies, Michael’s career included roles of increasing responsibility in the pharmaceutical sector.
Michael is a Fellow in the Liberty Fellowship Class of 2011. Liberty Fellowship is a program designed specifically for emerging state leaders to reinforce values necessary to lead an exemplary life both personally and professionally. Michael serves as Immediate Past Chair of SCBIO, South Carolina’s Life Sciences Industry Association. Michael earned his bachelor’s degree in Chemical Engineering from North Carolina State University.
Selah Genomics specializes in supporting healthcare providers and the pharmaceutical industry with advanced molecular and genomic diagnostic services.
Selah Genomics provides a suite of services focused on support of molecular biomarker discovery, assay validation and prospective/retrospective clinical trial testing in support of companion diagnostic development and commercialization.
THE FAST-TRACK TO DISCOVERY AND CLINICAL UTILIZATION
Selah Genomics provides a suite of services focused on support of molecular biomarker discovery, assay validation and prospective/retrospective clinical trial testing in support of companion diagnostic development and commercialization. Selah operates NGS platforms from Life Technologies, Illumina, Roche and PacBio as well as an array of real time PCR and other supporting instrumentation systems. We help you select the best platform for each Project in support of your particular goals. Our prime focus – to help fast-track the clinical utilization and commercialization of your biomarker.
Selah enjoys a key corporate relationship with the Greenville Health System’s (GHS) Institute of Translational Oncology Research (ITOR) conducting multiple clinical trials and identification of new oncology biomarkers.
GHS is the 13th largest public hospital in the United States and ITOR has the largest Phase 1 clinical trial program in South Carolina, including a track record of 16 first-in-human trials. The close relationship with ITOR is an enormous asset for Selah. Not only does it allow Selah to provide state-of-the-art molecular diagnostics support for ITOR clinical studies but it leads to first-hand daily interaction with cancer physicians. This interaction stimulates early identification and development of new biomarker panels.
Selah’s Clinical Genomics Center at ITOR is physically located within GHS & ITOR. In addition, Selah operates a Clinical Genomics Center at Innovista on the campus of the University of South Carolina.
Curation, HealthCare System in the US, and Calcium Signaling Effects on Cardiac Contraction, Heart Failure, and Atrial Fibrillation, and the Relationship of Calcium Release at the Myoneural Junction to Beta Adrenergic Release
Curator and e-book Contributor: Larry H. Bernstein, MD, FCAP
Curator and BioMedicine e-Series Editor-in-Chief: Aviva Lev Ari, PhD, RN
This portion summarises what we have covered and is now familiar to the reader. There are three related topics, and an extension of this embraces other volumes and chapters before and after this reading. This approach to the document has advantages over the multiple authored textbooks that are and have been pervasive as a result of the traditional publication technology. It has been stated by the founder of ScoopIt, that amount of time involved is considerably less than required for the original publications used, but the organization and construction is a separate creative process. In these curations we amassed on average five articles in one curation, to which, two or three curators contributed their views. There were surprises, and there were unfulfilled answers along the way. The greatest problem that is being envisioned is the building a vision that bridges and unmasks the hidden “dark matter” between the now declared “OMICS”, to get a more real perspective on what is conjecture and what is actionable. This is in some respects unavoidable because the genome is an alphabet that is matched to the mino acid sequences of proteins, which themselves are three dimensional drivers of sequences of metabolic reactions that can be altered by the accumulation of substrates in critical placements, and in addition, the proteome has functional proteins whose activity is a regulatory function and not easily identified. In the end, we have to have a practical conception, recognizing the breadth of evolutionary change, and make sense of what we have, while searching for more.
We introduced the content as follows:
1. We introduce the concept of curation in the digital context, and it’s application to medicine and related scientific discovery.
Topics were chosen were used to illustrate this process in the form of a pattern, which is mostly curation, but is significantly creative, as it emerges in the context of this e-book.
Alternative solutions in Treatment of Heart Failure (HF), medical devices, biomarkers and agent efficacy is handled all in one chapter.
PCI for valves vs Open heart Valve replacement
PDA and Complications of Surgery — only curation could create the picture of this unique combination of debate, as exemplified of Endarterectomy (CEA) vs Stenting the Carotid Artery (CAS), ischemic leg, renal artery stenosis.
2. The etiology, or causes, of cardiovascular diseases consist of mechanistic explanations for dysfunction relating to the heart or vascular system. Every one of a long list of abnormalities has a path that explains the deviation from normal. With the completion of the analysis of the human genome, in principle all of the genetic basis for function and dysfunction are delineated. While all genes are identified, and the genes code for all the gene products that constitute body functions, there remains more unknown than known.
3. Human genome, and in combination with improved imaging methods, genomics offers great promise in changing the course of disease and aging.
4. If we tie together Part 1 and Part 2, there is ample room for considering clinical outcomes based on individual and organizational factors for best performance. This can really only be realized with considerable improvement in information infrastructure, which has miles to go.
Curation
Curation is an active filtering of the web’s and peer reviewed literature found by such means – immense amount of relevant and irrelevant content. As a result content may be disruptive. However, in doing good curation, one does more than simply assign value by presentation of creative work in any category. Great curators comment and share experience across content, authors and themes.
Great curators may see patterns others don’t, or may challenge or debate complex and apparently conflicting points of view. Answers to specifically focused questions comes from the hard work of many in laboratory settings creatively establishing answers to definitive questions, each a part of the larger knowledge-base of reference. There are those rare “Einstein’s” who imagine a whole universe, unlike the three blindmen of the Sufi tale. One held the tail, the other the trunk, the other the ear, and they all said this is an elephant!
In my reading, I learn that the optimal ratio of curation to creation may be as high as 90% curation to 10% creation. Creating content is expensive. Curation, by comparison, is much less expensive. The same source says “Scoop.it is my content marketing testing “sandbox”. In sharing, he says that comments provide the framework for what and how content is shared.
Healthcare and Affordable Care Act
We enter year 2014 with the Affordable Care Act off to a slow start because of the implementation of the internet signup requiring a major repair, which is, unfortunately, as expected for such as complex job across the US, and with many states unwilling to participate. But several states – California, Connecticut, and Kentucky – had very effective state designed signups, separate from the federal system. There has been a very large rush and an extension to sign up. There are many features that we can take note of:
1. The healthcare system needed changes because we have the most costly system, are endowed with advanced technology, and we have inexcusable outcomes in several domains of care, including, infant mortality, and prenatal care – but not in cardiology.
2. These changes that are notable are:
The disparities in outcome are magnified by a large disparity in highest to lowest income bracket.
This is also reflected in educational status, and which plays out in childhood school lunches, and is also affected by larger class size and cutbacks in school programs.
This is not helped by a large paralysis in the two party political system and the three legs of government unable to deal with work and distraction.
Unemployment is high, and the banking and home construction, home buying, and rental are in realignment, but interest rates are problematic.
3. The medical care system is affected by the issues above, but the complexity is not to be discounted.
The medical schools are unable at this time to provide the influx of new physicians needed, so we depend on a major influx of physicians from other countries
The technology for laboratories, proteomic and genomic as well as applied medical research is rejuvenating the practice in cardiology more rapidly than any other field.
In fields that are imaging related the life cycle of instruments is shorter than the actual lifetime use of the instruments, which introduces a shortening of ROI.
Hospitals are consolidating into large consortia in order to maintain a more viable system for referral of specialty cases, and also is centralizing all terms of business related to billing.
There is reduction in independent physician practices that are being incorporated into the hospital enterprise with Part B billing under the Physician Organization – as in Partners in Greater Boston, with the exception of “concierge” medical practices.
There is consolidation of specialty laboratory services within state, with only the most specialized testing going out of state (Quest, LabCorp, etc.)
Medicaid is expanded substantially under the new ACA.
The federal government as provider of services is reducing the number of contractors for – medical devices, diabetes self-testing, etc.
The current rearrangements seeks to provide a balance between capital expenses and fixed labor costs that it can control, reduce variable costs (reagents, pharmaceutical), and to take in more patients with less delay and better performance – defined by outside agencies.
Cardiology, Genomics, and calcium ion signaling and ion-channels in cardiomyocyte function in health and disease – including heart failure, rhythm abnormalities, and the myoneural release of neurotransmitter at the vesicle junction.
This portion is outlined as follows:
2.1 Human Genome: Congenital Etiological Sources of Cardiovascular Disease
2.2 The Role of Calcium in Health and Disease
2.3 Vasculature and Myocardium: Diagnosing the Conditions of Disease
Genomics & Genetics of Cardiovascular Disease Diagnoses
disruption of Ca2+ homeostasis cardiac & vascular smooth muscle
synaptotagmin as Ca2+ sensor & vesicles
atherosclerosis & ion channels
It is increasingly clear that there are mutations that underlie many human diseases, and this is true of the cardiovascular system. The mutations are mistakes in the insertion of a purine nucleotide, which may or may not have any consequence. This is why the associations that are being discovered in research require careful validation, and even require demonstration in “models” before pursuing the design of pharmacological “target therapy”. The genomics in cardiovascular disease involves very serious congenital disorders that are asserted early in life, but the effects of and development of atherosclerosis involving large and medium size arteries has a slow progression and is not dominated by genomic expression. This is characterized by loss of arterial elasticity. In addition there is the development of heart failure, which involves the cardiomyocyte specifically. The emergence of regenerative medical interventions, based on pleuripotent inducible stem cell therapy is developing rapidly as an intervention in this sector.
Finally, it is incumbent on me to call attention to the huge contribution that research on calcium (Ca2+) signaling has made toward the understanding of cardiac contraction and to the maintenance of the heart rhythm. The heart is a syncytium, different than skeletal and smooth muscle, and the innervation is by the vagus nerve, which has terminal endings at vesicles which discharge at the myocyte junction. The heart specifically has calmodulin kinase CaMK II, and it has been established that calmodulin is involved in the calcium spark that triggers contraction. That is only part of the story. Ion transport occurs into or out of the cell, the latter termed exostosis. Exostosis involves CaMK II and pyruvate kinase (PKC), and they have independent roles. This also involves K+-Na+-ATPase. The cytoskeleton is also discussed, but the role of aquaporin in water transport appears elsewhere, as the transport of water between cells. When we consider the Gibbs-Donnan equilibrium, which precedes the current work by a century, we recall that there is an essential balance between extracellular Na+ + Ca2+ and the intracellular K+ + Mg2+, and this has been superceded by an incompletely defined relationship between ions that are cytoplasmic and those that are mitochondrial. The glass is half full!
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