Protein-based drugs are a quickly growing pharmaceutical sector, providing treatments for cancer and autoimmune diseases, among others. Obviously, efficient, accurate lab results are desirable. The goal is the development of compounds that have a stability measured in years.
Though there are many factors that can negatively affect the successful development of protein drugs, it is useful to examine some of the most common. Chief among the factors affecting the stability of protein pharmaceuticals are protein aggregation, deamidation, and oxidation. What are these processes? How could they influence your results? Most importantly, how can you prevent them?
Protein Aggregation
To be used in pharmaceutical drug molecules, proteins are routinely folded via van der Waals attractions as well as hydrophobic attractions. These protein protein interactions cause the amino acid chains in proteins to become attracted to themselves and fold in. Unfortunately, when these folded proteins exist in high concentrations, the same attractions can cause amino acids in neighboring proteins to attach to each other, forming protein aggregates.
Protein aggregation can increase the viscosity of the medications, as well as produce visible particles, making the final product less desirable. However, safety concerns are an even greater concern. Aggregations can result in liquids with unknown concentrations, limiting the amount of the drug that can be administered at any time. Researchers also worry about the human body developing immunity to the proteins or even an autoimmune disease.
Deamidation
Deamidation is a chemical reaction in which proteins lose an amide functional group. Often, unfavorable laboratory conditions cause deamidation, including high temperatures and high pH conditions. Deamidation results in the degradation of the protein because it damages the side chains that contain the amides. It is impossible to make generalizations about the effects of deamidation. Effects on protein activity range from none to decreased activity so effects must be considered on a case-by-case basis.
Deamidation affects the final product primarily because it alters the protein, resulting in a product with unknown properties. The product’s stability is affected, and the degree to which the product is effective is now an unknown. It is important to limit deamidation in the lab.
Oxidation
Protein oxidation is one of the main forms of degradation in protein pharmaceuticals. In oxidation, amino acid residues with high oxygen reactivity are exposed to contaminating oxidizing agents during processing and storage. Light and transition metal ions speed up oxidation, resulting in the further break down of the protein.
By Amy Perry, director of product marketing, OpenText.
Amy Perry
The pace of digital transformation today is increasing rapidly, with more industries jumping on the bandwagon to adopt new technologies which recast workflows. New solutions powered by artificial intelligence and machine learning are enabling machines to handle processes once cumbersome to employees.
In fact, the rate of this shift is so pronounced that according to Deloitte, the average digital transformation budget has increased by 25 percent over the past year, from $11 million to $13.6 million. More than half of mid-sized and large companies are spending more than $10 million on these efforts.
While this is a trend impacting almost every industry, it presents unique challenges to the healthcare sector. One of the most important challenges digital transformation extends to healthcare professionals is in the area of interoperability. As the sheer amount of health-related data, along with the ways to transmit and store this data, continues to increase, the ability of healthcare organizations to juggle the free flow of information between the patient’s care team and the patient is becoming more vital. At the same time, healthcare providers must ensure the highest levels of patient data privacy.
Unsurprisingly, most healthcare providers are preparing for this challenge. According to a new survey of healthcare IT professionals conducted by OpenText in conjunction with IDG Research, 85 to 94 percent of healthcare organizations are either actively investing or are planning to quickly invest in interoperability infrastructure to provide more intelligent and connected healthcare. While this intent is a great starting point, the journey can still be challenging for organizations of every size.
Ensuring a more free flow of information between providers to enhance the patient experience while simultaneously adhering to HIPAA’s privacy mandates may initially seem impossible to many teams. A wider embracement of paperless fax solutions across the industry could provide a data-centric solution which allows organizations to further interoperability goals while also ensuring that patient privacy remains paramount.
Paperless fax gains momentum
The evolution to fax stems from HIPAA guidelines mandating all patient information be securely stored and communicated. Tools such as email lack essential regulatory compliance and must be shelved in favor of other forms of communication, such as secure fax. While paper-based fax has become almost obsolete in other industries, it is still heavily used in healthcare despite causing some roadblocks to efficient communication. Paper-based fax requires a labor-intensive process that results in limited access to patient information at the point of care and slower care coordination between providers. Though these shortcomings are widely recognized among healthcare professionals, nearly half of patient information is still being transmitted by paper-based fax.
Findings from the same survey confirm momentum in paperless fax technologies. According to survey respondents, 50 percent of all medical communications continues to be done via some form of fax, but paperless faxing surpasses paper-based faxing in terms of medical communications volume. Among this, a significant majority of the survey respondents showed favorability to paperless faxing because of its digital integration capabilities.
Seventy-six percent of respondents either agreed or strongly agreed with the statement that they are happy with their current paperless faxing method because it’s integrated with their electronic medical record (EMR), back-end system, or other applications. By integrating digital faxing with EMR, document management systems, and clinical applications, a paperless fax solution becomes the most connected device in an organization, optimizing patient information exchange, reducing costs, and increasing productivity.
The catalyst for future patient information exchange
In addition, a favorable attribute to paperless faxing is that it provides a much more secure form of patient information exchange and surpasses the requirements of HIPAA’s Protected Health Information privacy rule. As new interoperability tools based on standards for the secure transmission of patient records are considered across many healthcare organizations, health providers can leverage their existing paperless fax solution to transition to modern, secure, and interoperable exchanges of patient documentation that are integrated across systems and applications.
Ultimately, the study’s findings show technology has reversed the death knell many initially thought had struck the fax industry. In fact, instead of being a siloed or time-consuming way to share information, new paperless fax technologies are helping eliminate these inefficiencies by shortening the time it takes to get patient information to the right provider and facilitating faster access to critical information at the point of care. Implementing a cloud-based delivery system is an attractive step as organizations move to the adoption of digital transformation. Healthcare providers must modernize legacy systems and embrace these new technologies to stay at the forefront of the industry and meet patients’ growing expectations.
By Drew Ivan, EVP of product and strategy of Rhapsody.
Drew Ivan
It was generally recognized by 2009 that the health care industry was long overdue when it came to adopting electronic systems for storing patient data. At the time, hospital adoption of electronic health record (EHR) systems was at about 10 percent while electronic record keeping was commonplace in most other industries. EHR technology was widely available, yet doctors and hospitals were still using paper charts.
The HITECH Act of 2009 was part of a broader stimulus package that financially nudged hospitals and eligible professionals to adopt and use EHRs. The meaningful use incentive program began a national, decade-long project to adopt, implement, and optimize EHR software. The program was a huge success, judged by the most obvious metric, EHR adoption. Today, nearly 100 percent of hospitals are using electronic health records. This means that records are safe from physical damage, far easier to analyze and report on, and – in theory at least – easier to transfer from one provider to another.
However, when viewed through the lens of return on investment, the success is less impressive. The federal government has spent $36 billion to encourage providers to adopt EHR systems but the industry has spent far more than that to procure, implement and optimize the software. Yet, hospitals are seeing reduced productivity, doctors face a huge documentation burden, and interoperability remains an unsolved problem. The first two problems are the consequence of workflow changes brought on by the EHR systems, but interoperability roadblocks ought to have been eliminated by implementing EHR systems, so why is it still so difficult to transfer records from one provider to another, or from a provider to the patient?
Health IT experts generally consider three categories of obstacles to interoperability:
Business disincentives: allowing medical records to move to a different provider makes it easier for patients themselves to move to another provider, and helping customers switch health care providers is contraindicated by usual business practices (even though HIPAA states that patients are entitled to receive copies of their medical records and may direct copies of their records to be sent elsewhere.)
Technical challenges: Meaningful use set a fairly low bar for cross-organizational data exchange requirements, and it did little to ensure that EHR systems could understand data sent from another system. Although these problems are largely resolved today, there is still the impression that “interoperability is a hard technical problem”.
Network effects: point-to-point connections between providers are impractical, but the network approach also has its drawbacks. The assortment of HIEs and national interoperability initiatives is huge and confusing, and it’s not obvious which network(s) an organization should join.
There may have been an assumption that when medical records moved from paper to electronic format they would immediately become more interoperable, but by 2016, the level of interoperability was far below what patients and regulators expected. As a result, the 21st Century Cures Act of 2016 was passed by Congress and signed into law by the outgoing Obama administration. The law’s scope included a number of health care priorities, including a patch for the interoperability gap left by Meaningful Use. Cures explicitly forbids providers, technology vendors, and other organizations from engaging in “information blocking” practices.
Earlier in 2019, the Office of the National Coordinator for Health IT (ONC) issued a notice of proposed rulemaking (NPRM) that defined exactly what is (and what is not) meant by “information blocking.” Once adopted, the expectation will be that a patient’s medical records will move according to the patient’s preferences. Patients will be able to direct their data to other providers and easily obtain copies of their data in electronic format.
Inanovate, Inc., a life science company specializing in the development of blood tests for cancer and autoimmune diseases, has secured an initial closing of $3.1million on a Series C financing round.
The investment, led by South Dakota Equity Partners, Mr. T. Denny Sanford, and Sanford Frontiers, a corporate affiliate of Sanford Health, will help speed the development of Inanovate’s breast cancer blood test, which aims to identify false positives from screening mammograms and reduce costly, stressful, and unnecessary follow-up imaging.
The test is part of a larger plan from Inanovate, which also includes a second test that aims to monitor the progress of breast cancer patients through therapy and beyond, and identify a recurrence event in its earliest stage, when it may be more effectively treated and cured.
“We are excited to have secured investment that will allow our company to implement our development plan through the next 18 months,” Inanovate CEO David Ure said. “We’re pleased to have partnered with investors who share our vision for improving cancer diagnosis and treatment through technology innovation. Our partners bring both expertise and passion to our investment team as we align to the needs and goals of one of the leading hospital networks in the country.”
The most recent investment builds on a strong year for Inanovate, which included a $2 million Phase 2 SBIR grant from the National Cancer Institute, along with a licensing and collaboration agreement with Sanford Health that provides access to intellectual property relating to a set of breast cancer biomarkers, in addition to patient recruitment and sample access for Inanovate’s trials.
Kim Patrick
“Improving breast cancer care is an important goal of ours,” said Kim Patrick, chief business development officer for Sanford Health. “This protein-screening technology aims to improve the diagnosis of breast cancer and its recurrence.”
The Inanovate blood tests work by detecting antibodies in a patient’s blood that have been associated with breast cancer. Because the antibodies circulate in the blood, a simple blood draw can be evaluated to discover if the disease might be present. To analyze this blood draw, Inanovate uses their patented biomarker analysis platform: The BioID-800. The machine is compact, fully automated, fits on a bench top and uses disposable test cartridges.
“This is a highly sensitive but low-cost instrument that can recognize the presence of multiple different biomarkers from a small sample of blood in one low cost easy to use test,” Ure said.
For the third year in a row, Christiana Care Health System has earned the Most Wired designation from the College of Healthcare Information Management Executives, recognizing healthcare organizations that exemplify best practices through their adoption, implementation and use of information technology.
Christiana Care is the only healthcare organization in Delaware and one of only 5 percent of U.S. hospitals to receive this designation.
The recognition is the result of years of strategic planning with a focus on how technology can break down barriers to access and coordinate high-value care. For example, Christiana Care has introduced Health Records on iPhone, which brings together hospitals, outpatient services and the existing Apple Health app to make it easy for patients to see their available medical records from multiple providers whenever they choose.
Randall Gaboriault
“Technology touches every single interaction we have with our patients, and it creates an efficient way for us to connect with our neighbors and deliver the world’s best care, powered by a foundation of technology and empathy,” said Randall Gaboriault, MS, chief information officer and senior vice president of Innovation and strategic development at Christiana Care.
Christiana Care’s place on the forefront of IT trends and best practices is the result of both a long-term investment in culture and a reimagining of IT processes, creating an environment in which good ideas can rapidly progress from concept to impact.
Lynne McCone
“Our Clinical and IT teams have developed and persistently iterate a model of shared thinking, shared learning and shared working to deliver projects that expand our capabilities to serve our neighbors in ways we had hardly imagined a few years earlier,” said Lynne McCone, vice president of IT application services for Christiana Care.
Christiana Care’s use of transformational technologies to improve patient care includes:
Video monitoring to help protect hospital patients from falls.
Telemedicine advancements, including video visits.
Direct access by patients to the physician notes in their electronic health record, and the ability to contribute to their record through an online patient portal.
Online express check-in at Christiana Care’s six Medical Aid Units.
Christiana Care’s Patient Portal, already recognized as a secure way for patients to stay informed about their health records, now offers patients a chance to enter their problems, allergies, medications, immunizations and surgical history. Upon physician review, these data flow directly into their electronic health record. Anyone who’s ever forgotten to mention a health issue to their doctor or nurse can appreciate the value of a convenient way to add to their record, thereby informing their care team.
Amid the latest security breaches at well-known companies like Facebook and Marriott, cybersecurity has never been at the forefront of conversation more than it is today. No other industry knows the dangers of information vulnerability better than the healthcare sector, where confidential patient data is stored and shared across often obsolete systems on a regular basis. Although advancements in technology are allowing hospitals and clinics to digitally transform their networks, maintaining a high degree of security continues to be a challenge, which is why it’s important for organizations to carefully evaluate their current processes and decide which networking models to implement for the future.
Why legacy-oriented architectures can’t defend against cyberattacks
Today, many medical providers have networks built on legacy-oriented architectures that run a broad range of enterprise applications. While legacy EHR systems have performed positively in protecting patient records, legacy networks have not historically protected patient information flowing across a variety of applications used by staff and providers.
Legacy networks, which primarily offer only border protection, do not adequately protect the enterprise applications and data existing outside of a medical records system. This type of environment is vulnerable to cyber hacks. Think back to the numerous cyberattacks on credit card information in the last few years, including Equifax’s data loss. As internal applications are not protected to the same extent as EMRs, networks built on legacy technologies are not designed to defend against users on cloud applications or internal vendors, patients and customers/business partners that may occasionally gain access.
The rise in zero-trust, session-based networking
In today’s digital landscape, modern healthcare networks must utilize zero-trust models to truly secure sensitive data. Session-based networking models are designed to use an exclusive two-way exchange of information between two specific endpoints. This type of model is context-aware and scalable across network boundaries, making the design more secure than overlay networks of the past. In addition, zero-trust networks are rooted in the principle of “never trust, always verify,” and work to treat internal and external access the same. They are designed to address lateral threat movement within the network by managing access enforcement based on user, data and location. But even as modern healthcare networks adopt these new models for enhanced security, challenges still remain.
Challenge #1: Packet-level authentication
A common challenge for legacy-oriented architectures is ensuring that all data within the network is automatically encrypted. Zero-trust models, on the other hand, require authentication for every packet in a provider’s network. These models have a unique ability to thwart malicious intents directly from the network layer. This next-generation feature secures networking while simultaneously increasing performance by using standard compute utility infrastructure (no different than servers) to replace proprietary and legacy networking devices.
Challenge #2: Maintenance and updates
Updating modern networks requires continuous work, and the healthcare industry is struggling to maintain network access rights. As IoT-connected devices continue to permeate the industry, it is becoming necessary to secure these new access points on a daily basis. In fact, by 2020, 40 percent of IoT technology will be health-related, making up a $117 billion market. As modern waiting rooms are flooded with patients opting to kill time on their mobile devices rather than flipping through magazines, sensitive information is increasingly at risk of being accessed on these networks.
Challenge #3: The cultural mindset within organizations
The implementation of a modern network model impacts the entire healthcare organization. Since deploying network security can involve team members from all levels within the organization, it is crucial that all members are educated and aware of security and policy advancements. Unfortunately, according to an AT&T Cyber Security Insights report, roughly 78 percent of all employees fail to comply with their organization’s security policies and procedures. Creating a sense of personal responsibility and motivation to adhere to security policies within an organization can make all the difference in the fight to protect confidential data. Moreover, since zero-trust networks require cloud-based infrastructures, selecting the right partnership with a secure vendor can prove difficult.
While cutting-edge technology presents an array of opportunity for the healthcare industry, which has infamously been slow to adopt system changes, it also poses unique challenges for network security that healthcare organizations will need to work to surpass in the coming years.
By Christopher Maiona, M.D., SFHM, chief medical officer, PatientKeeper, Inc.
Christopher Maiona, M.D.
The news on physician burnout lately has been mixed. A 2018 Massachusetts Medical Society/Harvard report received considerable attention – it proclaimed physician burnout has become a crisis, widespread in the medical profession, driven by rapid changes in health care and physicians’ professional environment. Yet last month a study published in Mayo Clinic Proceedings found that physician burnout actually declined more than 10 percentage points from 2014 to 2017, though the rate for doctors was still considerably higher than for U.S. workers at large. And just last week, an American Academy of Family Physicians survey reported that 71 percent of practicing physicians are happy, albeit frustrated by the extent to which administrative and clerical tasks have become part of their daily work.
What to make of all this seemingly contradictory data?
When I began practicing as a hospitalist in the 1990s, the administrative burden on physicians was much less than today, owing in part to the regulations and routine processes of the day and the typical patient caseload. Back then I saw 12 patients per day. With that caseload, you could break even on billing while still having plenty of time to interact with patients and colleagues. While it would not be feasible to return to that volume today, the point is that the hospital afforded a much more professionally rewarding environment. There was time to discuss interesting cases with colleagues. There was time to revisit patients and dig deeper into their records. You had time to sit at a patient’s bedside and hold their hand. The pace today does not afford this opportunity, much to the dissatisfaction of physicians. The resulting isolation from patients and peers is a contributing factor to the burnout seen among physicians.
Then there’s the technology component. EHRs are widely regarded as a significant cause of physician stress and a distraction from patient care. For example, when hospitals installed computerized order entry (CPOE), it eliminated the order clerk and created an additional job for the physician. The evolution of the clinical note is another example of unintended clinical burden, with roots in the evolution of medical practice and the emergence of EHRs.
Take a step back and consider what the original purpose of a physician’s note was: to advance patient care. The note would be updated on a visit-to-visit basis by the same physician or perhaps another physician in the same group covering a weekend. Then shift-based medicine came into play, and the note became a vital mechanism to facilitate care transitions. Then, as malpractice suits became more commonplace, lawyers began requiring physician documentation to support their legal case. From there, we saw the note transform from a clinical and legal document to a billing document and a check for RAC audits.
Given these trends, the pressure on provider organizations (and physicians individually) to document extensively and bill correctly for every service performed has grown over time. Concurrently, the practice of regularly reconciling clinical notes and charges also has grown in importance, both to identify missing charges (for revenue enhancement) and to identify missing notes (for compliance). In order that this process doesn’t become another straw on a physician’s administrative back, many organizations prefer to automate charge-note reconciliation within the revenue cycle management workflow.
For a variety of compelling business reasons, not limited to concerns about physician burnout, healthcare systems must attend to their physician experience with the same level of care and intention as their patient experience. Here are three ways that improving physician experience can help to bolster a hospital’s bottom line:
By Abhinav Shashank, co-founder and CEO, Innovaccer.
Abhinav Shashank
U.S. healthcare is nowhere near what technology made us dream of a decade back. Healthcare technology was meant to act as a means of reducing costs, eliminating burnout, and making care delivery patient-centric. Cut to today, where a broken leg can cost a patient as much as $7,500, seven out of 10 physicians do not recommend their profession to anyone, and we rank poorly among other developed countries in terms of the number of preventable deaths.
Why did technology fail?
While disruptive technology solutions did flood healthcare in the last couple of decades, many of them required physicians to go the extra mile to comprehend those sophisticated systems. Today, physicians are still crunching large data files day in and day out, nurses are doubling up as technical executives, and patients are perplexed by the fact that their providers hardly have time for them.
It’s time for technology to care
If a technology solution is not assisting organizations in improving care quality, reducing costs, and optimizing utilization levels, then its very relevancy is questionable. Healthcare organizations need technologies that can help them actuate their data, realize their strategic goals, and bring patients closer to their providers.
Health IT solutions should make the lives of providers easier. Any health IT solution that puts an additional burden on providers is unjustified and unacceptable. Providers are not data analysts, and expecting them to train tirelessly to understand an IT system and spend a couple of hours each day navigating through complex interfaces can drastically reduce physician-provider time and pave the way for physician burnout.
In with ultimate integration. We need to bring together EHRs, PHMs, payer claims and HIEs and put it all in the palm of the providers’ hands. Whether it’s quality management or data management, it should be simple.
In with relevant insights right at the point of care. Providers are tired of wading through complicated EHRs and excel sheets. What we need now is to seize the nanosecond and realize truly automated care delivery that helps boost the clinical outcomes.
In with 100 percent transparency and bi-directional interoperability. Healthcare providers are often forced to access bits and pieces of electronic healthcare analytics and referrals on disparate applications. Physicians need to capture real-time care gaps, coding opportunities, patient education opportunities, and more; the only problem is that they don’t know how exactly to accomplish this. Providers should be able to capture the gaps in patient care right when they need to and enhance the patient experience of care.
In with true patient-centric care. Healthcare is not just providing episodic care to patients, it is about building relationships with them. In a world where the quality of care directly influences the financial success of an organization, providers should look forward to aligning the needs of their patients to their treatment procedures.
Healthcare of the 2020s needs reliable data activation platforms
“If you can’t explain it simply, you don’t understand it well enough.” — Albert Einstein
Buzzwords like innovation, intelligence, and analytics make sense in today’s time; however, unless the user experience is seamless, the charisma of back-end development does little good for healthcare professionals.
We’re moving into an age of intelligence, and in this age, successful organizations do one thing right- they know the worth of their data. This is the same thing that we need to do in healthcare. Organizations have to switch from a makeshift approach to engage patients and find a concrete strategy that is suited to their advantage, but this needs to be done with the support of data.
Protein-based drugs are a quickly growing pharmaceutical sector, providing treatments for cancer and autoimmune diseases, among others. Obviously, efficient, accurate lab results are desirable. The goal is the development of compounds that have a stability measured in years.
Inanovate, Inc
For the third year in a row, Christiana Care Health System has earned the 
