News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Millennial Clinical Laboratory Managers Went Digital with Their Networking at Last Week’s Executive War College

With Millennials soon to make up the majority of the medical laboratory workforce, it’s only natural that digital networking is gaining momentum at events like the Executive War College

Attendees at last week’s Executive War College Conference on Laboratory and Pathology Management in New Orleans will tell you that the mobile app used by participants was on fire.

At any hour during the in-person event in New Orleans, attendees scheduled meetups, participants asked questions to conference organizers, and users discussed important clinical laboratory and anatomic pathology topics. All of those interactions occurred within the Whova meeting application, which served as the Executive War College’s virtual guide.

In many ways, widespread use of the meeting app reflects a younger crowd that lives life on mobile phones. It’s not all that different than the changing face of the clinical lab industry as laboratory veterans retire and new faces come in, said Robert Michel, Founder of the Executive War College (EWC) and Editor-in-Chief of Dark Daily’s sister publication The Dark Report.

“It’s clear from the soaring use of our conference’s meeting app at the Executive War College that a younger generation is changing how business is conducted during and after a lab industry conference,” he observed. “Generation X and Millennials are steadily influencing how people network at live events.”

Michel noted during his keynote at the conference that Millennials will make up 75% of the hospital lab and pathology workforce by 2025, so their digital habits will become the norm at in-person events.

Robert Michel
“It is remarkable that, among the 900 attendees at this year’s event, there were more than 750,000 impressions involving the sponsors and companies supporting this year’s conference,” said Robert Michel (above), Editor-in-Chief of Dark Daily and Founder of the Executive War College. “It shows that these attendees are serious about identifying solutions and vendors who can help them solve the various pain points in their laboratories.” (Photo copyright: Dark Intelligence Group.)

88% of Attendees at Executive War College Used the Event App

Usage numbers aggregated during the EWC conference of people who downloaded and used the meeting app speak for themselves:

  • A large majority of attendees (88%) downloaded the app.
  • Users sent 11,398 messages in the app.
  • There were 136 community board discussions posted.
  • Users created 80 meetups, with 677 people attending those gatherings.
  • There were 764,745 sponsor impressions in the app (in other words, clicks on a sponsor link or attendees navigating to sponsor material).

What the numbers don’t convey is that the conference’s meeting app was also fun to use!

“We love the app,” said Melissa Butterworth, co-founder, Managing Director and President of Advanced Strategic Partners, in a Whova discussion group.   

Butterworth spoke during a special session at the Executive War College. She also took the No. 1 spot on the meeting app’s leaderboard for the event, collecting an impressive 225,900 points. Users gained points for the leaderboard based on activities they completed in the app.

Spirited competition ensued among the leaderboard’s top users, who jockeyed for position as the conference progressed. Plenty of off-topic conversations took place in the app as well, as attendees helped each other navigate New Orleans with tips about restaurants, local cemetery tours, or where to work out.

The leaderboard on the Whova meeting application
The leaderboard on the Whova meeting application (above) at the conclusion of this year’s Executive War College on Laboratory and Pathology Management showed the top point gainers. (Photo copyright: Dark Intelligence Group.)

Clinical Laboratory Sponsors Reached Out to Attendees in New Ways

For sponsors and other vendors visiting the conference, the meeting app provided a different avenue to approach attendees beyond the typical networking that takes place during breaks, cocktail receptions, luncheons, and off-site parties.

For example, some sponsors shared white papers or YouTube videos via the app’s community boards or asked questions about topics of interest. Additionally, sponsors could respond directly to queries from attendees.

“At the Executive War College, there was clearly a sustained exchange between vendors looking to engage business development opportunities and participants who have pain points that need to be addressed and are looking for solutions,” Michel said.

The next Executive War College will return to New Orleans on April 25-26, 2023. Click on this link to access early registration discounts.

Scott Wallask

Related Information:

Keynote Speakers at the Executive War College Describe the Divergent Paths of Clinical Laboratory Testing

COVID-19 Testing Reimbursement Scrutiny is Coming for Clinical Laboratories, Attorneys Predict at Executive War College

Artificial Intelligence in Digital Pathology Developments Lean Toward Practical Tools

Adolescents with Specific Health Conditions Experience Accelerated Aging at Midlife, According to Published Study in New Zealand

Study shows that access to early childhood treatment could have lasting effects and prevent premature adult aging

Researchers in New Zealand have found that people who experienced “daily smoking status, obesity, or a psychological disorder diagnosis” beginning early in life were “biologically older” at midlife than those who did not. The findings suggest that early access to treatments for these health concerns could decrease risk for “accelerated biological aging,” according to the study published in JAMA Pediatrics.

Although these findings do not currently provide a path to a diagnostic test for clinical laboratories, this study is yet another example of how researchers are increasingly using broad swaths of healthcare data to help identify people at risk for certain healthcare conditions.

Such research often presents opportunities for medical laboratories to participate in healthcare Big Data analysis, which in turn helps healthcare providers make precision medicine diagnoses for individual patients.

Study Assessments and Clinical Laboratory Biomarkers

Researchers from the Dunedin Multidisciplinary Health and Development Research Unit (DMHDRU) at University of Otago analyzed the health and behaviors of 910 people (54% men, 46% women) born in Dunedin, New Zealand, between April 1, 1972, and March 31, 1973, through age 45.

The scientists found that participants who had one of three health conditions as an adolescent—obesity, smoking daily, or psychological disorder (anxiety, attention deficit/hyperactivity disorder, depression)—showed advanced signs of aging at age 45 when compared to others without those conditions, CNN reported.

The signs included:

  • Walking 11.2 centimeters per second slower.
  • Brain appears 2.5 years older.
  • Face appears four years older.

At age 11, 13, and 15, the Dunedin Study participants were assessed by pulmonary specialists and others for asthma, cigarette smoking, and obesity, Fox News reported.

Kyle Bourassa, PhD
“There’s a long history of that kind of research in terms of how smoking is damaging at the cellular level but also can result in the kinds of health conditions that we associate with biological aging, like (chronic obstructive pulmonary disease), lung cancer, things like that,” the study’s first author Kyle Bourassa, PhD (above), told CNN. “The hope is if we were to study a cohort now, a much higher proportion of those children and adolescents are actually going to be treated for these things, which will reduce the risk of accelerated aging later in life,” he added. Results of the study may also lead to new clinical laboratory diagnostics. (Photo copyright: Duke University.)

According to an earlier DMHDRU statement, the biomarkers used at this point in the study included:

The researchers also tracked asthma’s effects but concluded it did not contribute to aging, probably due to availability of asthma treatments, the authors wrote in their study published in JAMA Pediatrics, titled, “Association of Treatable Health Conditions During Adolescence with Accelerated Aging at Midlife.”

“Participants who had smoked daily, had obesity, or had a psychological disorder diagnosis during adolescence were biologically older at midlife compared with participants without these conditions. Participants with asthma were not biologically older at midlife compared with those without asthma,” the researchers wrote. These findings led the researchers to certain conclusions about receiving early treatments, CNN reported.

“No participants in this cohort were prescribed stimulants for attention-deficit/hyperactivity disorder, and selective serotonin reuptake inhibitors were not yet in use for adolescent depression and anxiety during the study period. Whereas 81.1% of the adolescents with asthma received some type of treatment, which could have mitigated the implications for biological aging,” the authors wrote in their study.

“Our paper reaffirms that those are important treatments and those kinds of investments younger in the lifespan could net big benefits in terms of both health and the cost of healthcare later on as well,” Kyle Bourassa, PhD, told CNN. Bourassa is the study’s First Author and a clinical psychology researcher and advanced research fellow at the Durham VA Health Care System.

Clinical Laboratories Curate Massive Amounts of Healthcare Data

For pathologists and medical laboratory scientists, the University of Otago study is a reminder that clinical laboratories provide a critical tool to diagnostics professionals: housing, sharing, and analyzing data that contribute to precision medicine diagnoses.

The DMHDRU researchers’ findings also highlight the importance of access to common treatments offered early in life for some people to reduce risk of accelerated aging and disease.

Donna Marie Pocius

Related Information:

Association of Treatable Health Conditions During Adolescence with Accelerated Aging at Midlife

Having Certain Health Conditions in Adolescence May Be Linked with Faster Aging in Adulthood, Study Says

Aging Faster in Adulthood Linked to Health Conditions in Adolescence

After Winning Conviction of Theranos Founder Elizabeth Holmes, Prosecutors Follow Similar Script at Ex-COO Ramesh Balwani’s Fraud Trial

Defense attorneys attempted to describe Balwani as simply an investor in Theranos, but prosecutors used the defendant’s own text messages to debunk that claim

Clinical laboratory directors and pathologists following the criminal fraud trial of ex-Theranos President and COO Ramesh “Sunny” Balwani may be experiencing a case of déjà vu as the former executive of the now-defunct blood-testing company has his day in court.

Even as Balwani’s defense team attempted to distance their client from the company’s day-to-day decision-making activities, prosecutors followed an almost identical script from the previous fraud trial of Theranos founder Elizabeth Holmes conducted earlier this year. That trial led to her conviction on four counts of defrauding investors.

As was the case in the Holmes trial, text messages between the two Theranos top executives (Balwani and Holmes) are again center stage in the San Jose, Calif., courtroom of U.S. District Judge Edward Davila.

Balwani Texts Reveal an ‘Unhappy’ Man Under Pressure

Balwani, 56, worked alongside Holmes at Theranos from 2009 to 2016. He purchased $5 million in stock in the company and helped finance the startup by underwriting a $13 million loan. Like Holmes, Balwani faces a dozen counts of fraud and conspiracy to commit wire fraud.

Jurors in the Balwani trial were shown a collection of private text messages between Balwani and Holmes—who also was his girlfriend at the time—that shed light on their business and personal relationships.

“I am responsible for everything at Theranos,” Balwani wrote in a text exchange with Holmes, NBC Bay Area reported. “I worked six years day and night to help you … sad about where we are,” he wrote.

“I am very unhappy because my work sucks,” Balwani told Holmes in another text. NBC Bay Area also reported on other text messages that discussed meeting new investors, meeting revenue goals, and potentially buying a corporate plane.

Ramesh “Sunny” Balwani
Just like former Theranos CEO/founder Elizabeth Holmes, former Theranos president/COO Ramesh “Sunny” Balwani (above) faces a dozen counts of fraud and conspiracy to commit wire fraud. Clinical laboratory directors will be particularly interested in the outcome of these trails since the responsibility of CLIA-laboratory directors to report anomalies in medical laboratory testing played a key part in defense testimony. (Photo copyright: The Guardian.)

Defense Counterattacks with Expert Testimony

Balwani’s defense team launched a counterattack the following day when witness Constance Cullen, PhD, a former immunologist at Schering-Plough, stated on cross examination that she dealt only with Holmes and never met Balwani or other Theranos executives, NBC Bay Area reported.

During Holmes’ trial, Cullen testified that Holmes had used the Schering-Plough logo without authorization on studies presented to potential investors which aimed to validate Theranos’ blood-testing technology.

Balwani’s defense team previously described him as a Theranos “shareholder” in an effort to distance him from executive decisions that allegedly misled Theranos investors about the startup’s revenues and accuracy of the company’s “revolutionary” Edison blood-testing device, which Theranos claimed could perform hundreds of clinical laboratory tests using a finger-prick of blood.

According to additional NBC Bay Area coverage of the trial, a former Walgreens executive testified he worked closely with Balwani during the drugstore chain’s failed multiyear partnership with Theranos, which included a $50 million investment to bring in-store medical laboratory testing to its pharmacies.

“As a person who was an investor and essentially serving as the chief operations officer, Sunny Balwani absolutely was intimately involved in the Walgreens relationship and all the relationships Theranos had,” chief legal analyst for Esquire Digital and editor of Today’s Esquire, Aron Solomon, JD, told NBC Bay Area in a video interview.

NBC Bay Area reported that prosecutors introduced text messages between Balwani and Holmes in which Balwani admitted he did not inform Walgreens that third-party equipment—not the Theranos Edison device—was being used for much of the actual clinical laboratory testing done in Walgreens stores.

In “Theranos Loses Its Biggest Revenue Source as Walgreens Ends Partnership and Shuts Down Blood-Collections for Clinical Laboratory Tests,” Dark Daily reported on Walgreens’ decision to sever its relationship with Theranos after federal regulators cited serious deficiencies at the Theranos lab in Newark, Calif., which led to the blood company voiding or revising thousands of blood test results delivered by its Edison device over a two-year period.

Prosecutors Claim Balwani, Holmes Worked ‘Together’ to Defraud Investors

Earlier in April, government lawyers responded to claims from Holmes’ defense team that Judge Davila should set aside the convictions in Holmes’ fraud case because evidence at trial did not support a guilty verdict, Fortune reported.

The prosecutors countered in a court filing that the “overwhelming weight of the evidence admitted at trial supports the jury’s conviction” of conspiracy to commit wire fraud and fraud on Theranos investors.

Prosecutors maintained the Holmes trial was “replete with examples” of Holmes and Balwani “working together and conspiring to effectuate a scheme to defraud investors.” The two “were constantly in communication via email, text message, and in-person meetings” about the company’s laboratories, financials, patient blood-testing, and relationships with Walgreens, investors, and visits by regulators, the Fortune article noted.

Holmes was convicted on January 3, 2022, on three counts of wire fraud and one count of conspiracy to commit wire fraud. Her sentencing date is September 26. She faces up to 20 years in prison but remains free on bond while awaiting sentencing. Balwani’s trial is ongoing.

Clinical laboratory managers and pathologists following the Theranos saga with interest should expect more revelations in the weeks to come. Balwani’s trial, which began in March, is expected to last at least three months.

Andrea Downing Peck

Related Information:

Texts Between Theranos Founder Elizabeth Holmes and Ex-COO Sunny Balwani Show Their Dynamic in a New Light

Prosecutors Highlight Theranos Machines in Trial Against Sunny Balwani

Jurors See New Text Messages Between Sunny Balwani and Elizabeth Holmes

Testimony Continues in Balwani-Theranos Fraud Trial

What the Elizabeth Holmes Verdict Means for the Future of Startup Culture

Leader or Follower? Defense Team Tries to Distance Former COO from Theranos

Elizabeth Holmes Prosecutors Push Back on Her Bid for New Trial

Video: Prosecutors Highlight Theranos Machines in Trial Against Sunny Balwani

Testimony Continues in Balwani-Theranos Fraud Trial

Theranos Loses Its Biggest Revenue Source as Walgreens Ends Partnership and Shuts Down Blood-Collections for Clinical Laboratory Tests

Artificial Intelligence in Digital Pathology Developments Lean Toward Practical Tools

Patient care gaps can be addressed by machine learning algorithms, Labcorp vice president explains

Is there hype for artificial intelligence (AI)? As it turns out, yes, there is. Keynote speakers acknowledged as much at the 2022 Executive War College Conference on Laboratory and Pathology Management. Nevertheless, leading clinical laboratory companies are taking real steps with the technology that showcase AI developments in digital pathology and patient care.

Labcorp, the commercial laboratory giant headquartered in Burlington, N.C., has billions of diagnostic test results archived. It takes samplings of those results and runs them through a machine learning algorithm that compares the data against a condition of interest, such as chronic kidney disease (CKD). Machine learning is a subdiscipline of AI.

Based on patterns it identifies, the machine learning algorithm can predict future test results for CKD based on patients’ testing histories, explained Stan Letovsky, PhD, Vice President for AI, Data Sciences, and Bioinformatics at Labcorp. Labcorp has found the accuracy of those predictions to be better than 90%, he added.

In “Keynote Speakers at the Executive War College Describe the Divergent Paths of Clinical Laboratory Testing as New Players Offer Point-of-Care Tests and More Consumers Want Access to Home Tests,” Robert Michel, Editor-in-Chief of Dark Daily, reported on how AI in digital pathology was one of several “powerful economic forces [that] are about to be unleashed on the traditional market for clinical laboratory testing.”

Labcorp also has created an AI-powered dashboard that—once layered over an electronic health record (EHR) system—allows physicians to configure views of an individual patient’s existing health data and add a predictive view based on the machine learning results.

For anatomic pathologists, this type of setup can quickly bring a trove of data into their hands, allowing them to be more efficient with patient diagnoses. The long-term implications of using this technology are significant for pathology groups’ bottom line.

Stan Letovsky, PhD
Stan Letovsky, PhD (above), Vice President for AI, Data Sciences, and Bioinformatics at Labcorp, discussed AI developments in digital pathology during his keynote address at the 2022 Executive War College in New Orleans. “The best thing as a community that we can do for patients and their physicians with AI is to identify care gaps early on,” he said, adding, “If pathologists want to grow and improve their revenue, they have to be more productive.” (Photo copyright: Dark Intelligence Group). 

Mayo Clinic Plans to Digitize 25 Million Glass Slides

In other AI developments, Mayo Clinic in Rochester, Minn., has started a project to digitally scan 25 million tissue samples on glass slides—some more than 100 years old. As part of the initiative, Mayo wants to digitize five million of those slides within three years and put them on the cloud, said pathologist and physician scientist Jason Hipp, MD, PhD, Chair of Computational Pathology and AI at Mayo Clinic.

“We want to be a hub within Mayo Clinic for digital pathology,” Hipp told Executive War College attendees during his keynote address.

Hipp views his team as the bridge between pathologists and the data science engineers who develop AI algorithms. Both sides must collaborate to move AI forward, he commented, yet most clinical laboratories and pathology groups have not yet developed those relationships.

“We want to embed both sides,” Hipp added. “We need the data scientists working with the pathologists side by side. That practical part is missing today.”

The future medical laboratory at Mayo Clinic will feature an intersection of pathology, computer technology, and patient data. Cloud storage is a big part of that vision.

“AI requires storage and lots of data to be practical,” Hipp said. 

Scott Wallask

Related Information:

Keynote Speakers at the Executive War College Describe the Divergent Paths of Clinical Laboratory Testing

COVID-19 Testing Reimbursement Scrutiny is Coming for Clinical Laboratories, Attorneys Predict at Executive War College

What is Machine Learning?

Data Scientist Overview

Keynote Speakers at the Executive War College Describe the Divergent Paths of Clinical Laboratory Testing as New Players Offer Point-of-Care Tests and More Consumers Want Access to Home Tests

27th annual meeting of medical laboratory and pathology managers delivers insights on the path ahead for diagnostics, ranging from the supply chain shortage and the ‘Great Resignation’ to advances in artificial intelligence and whole genome sequencing in service of precision medicine

Divergent paths of diagnostic testing are among the central topics being discussed at the 27th annual Executive War College on Laboratory and Pathology Management happening this week in New Orleans.

What’s coming as healthcare providers move to post-COVID-19 pandemic workflows will be of keen interest to clinical laboratory leaders attending this critical event. Several new and dynamic market changes are reshaping the development of, ordering, and reimbursement for medical laboratory tests. They include:

  • Millennials as change agents in how care is accessed and delivered.
  • New buyers of large volumes of clinical lab tests, such as retail pharmacies.
  • How clinical laboratories can earn new sources of revenue while supporting precision medicine.

Clinical Labs Should Prepare for the ‘Coming Roller Coaster Ride’

Robert L. Michel, Editor-in-Chief of Dark Daily’s sister publication, The Dark Report, and Founder of the Executive War College, described the “coming roller coaster ride” for the pathology and clinical laboratory industries.

Amid the usual operational issues labs deal with (e.g., workforce shortages, supply chain disruptions, regulatory pressures), he noted the emergence of new and powerful forces pulling clinical laboratories and pathology groups in all directions.

“One primary factor is how Millennials will use healthcare differently than Gen Xers and Baby Boomers,” Michel noted. “Similarly, Millennials will make up 75% of the pathologists and the lab workforce by 2025.

“Another major force for change will be new buyers of clinical laboratory tests,” he continued. “For example, expect to see national retail pharmacy chains build thousands of primary care clinics in their retail pharmacies. These clinics will need lab tests and will become major buyers of near-patient analyzers and lab tests.

“A third interesting factor is that a new class of in vitro diagnostics (IVD) manufacturers are developing analyzers and test systems that use minimal amounts of specimens and return answers in minutes. Primary care clinics in retail pharmacies will be interested in buying these lab testing solutions,” Michel concluded.

Robert L. Michel
Robert L. Michel (above), Editor-in-Chief of The Dark Report and Founder of the Executive War College, has studied and worked with leaders of clinical laboratories and pathology groups for more than four decades. During his keynote address, he predicted that powerful economic forces are about to be unleashed on the traditional market for clinical laboratory testing. Those forces include the use of artificial intelligence (AI) in digital pathology, primary care in retail pharmacies, and increased focus on precision medicine. (Photo copyright: The Dark Intelligence Group.)

Peer-to-Peer Learning Opportunities

With approximately 90 presenters scheduled, clinical laboratory leaders from such prestigious institutions as Johns Hopkins Hospital, Mayo Clinic, United Indian Health Services, and more will facilitate peer-to-peer learnings throughout the conference.

In addition, industry executives scheduled to deliver keynotes include Jon Harol, Lighthouse Lab Services Founder and President; Stan Letovsky, PhD, Vice President for AI, Data Sciences and Bioinformatics as well as other executives from Labcorp; and Curtiss McNair II, Vice President and General Manager of Laboratory Services at American Oncology Network.

In addition, several sessions and panel Q/A discussions will cover critical legal and regulatory issues and payer challenges facing the industry.

New Technologies, Workflows, Analytics

The 2022 Executive War College master classes, breakouts, panel discussions, and benefactor sessions will highlight several significant themes:

  • Lab data analytics and utilization. Sessions this year are heavily weighted toward data analytics, aggregation, and utilization. Look for case studies demonstrating the value of lab data, and where and how data has become actionable and monetized. As Dark Daily previously reported, useful data structures have been difficult to achieve for clinical laboratories; however, the case studies featured during this week’s conference will demonstrate signs of progress and highlight lessons learned.
  • Automation. Several case studies are planned that focus on expansion and modernization using laboratory automation. From Butler Health System, an independent hospital system in western Pa., Robert Patterson, MD, Medical Director of Pathology, Laboratory Medicine, and Laboratory Outreach, will detail steps Butler took that enabled its labs to better compete with other area health systems and national reference laboratories. Likewise, Eric Parnell, System Supervisor of Microbiology for Bronson Healthcare in southern Mich., will discuss his lab’s transition to and implementation of total laboratory automation.
  • Genetic testing and next-generation sequencing (NGS). Quickly becoming the foundational disruptor technology on which many new and powerful clinical laboratory tests and procedures are based, genomic testing has now become accessible and affordable. Many clinical laboratories and pathology groups are using molecular diagnostics testing to deliver clinical value to referring physicians.

Other sessions include:

  • Launching and scaling clinical NGS testing in a clinical environment (featuring a project at Rady Children’s Hospital in San Diego).
  • How labs and payers can work together to achieve better outcomes and health equity using genomic testing.
  • Effective ways to repurpose PCR and other genetic test instruments to build specimen volume and increase lab revenue.

Paths Forward for Clinical Labs and Pathology Groups

Another important topic being discussed at the 2022 Executive War College is how to position clinical laboratories and pathology groups for the next phase of modern healthcare.

Legal experts and consultants from McDonald Hopkins LLC, Advanced Strategic Partners, Pathology Practice Advisors, and ECG Management Consultants, among others, will answer questions on:

  • Attracting capital for clinical labs and pathology groups.
  • Emerging concepts in growth strategies.
  • Business valuation factors.
  • Unexpected disruptions during sales closings.

These are just a few highlights of the informative sessions and expert speakers scheduled during this week’s 27th annual Executive War College in New Orleans. Look for more coverage in Dark Daily during the days ahead and in upcoming editions of our sister publication The Dark Report.

Full details about the 2022 Executive War College can be found by clicking on this link. (Or copy/paste this URL into your web browser: http://www.executivewarcollege.com.)

Speakers, session topics, and the conference agenda can be viewed by clicking on this link. (Or copy/paste this URL into your web browser: https://executivewarcollege.darkintelligencegroup.com/executive-war-college-agenda-2022.)

—Liz Carey

Related Information:

Executive War College on Lab and Pathology Management

Executive War College: Efficient Data Structure Can Bring in More Reimbursement Dollars and Allow Clinical Laboratories to Sell Aggregated Information

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