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Enclara Pharmacia Announces the Appointment of Mark Morse as CEO

Enclara Pharmacia, the market leader in comprehensive pharmacy management services to the hospice community, announced today the appointment of Mark Morse as Chief Executive Officer. He will assume day-to-day leadership of Enclara and work in partnership with its current leadership team to help reduce pharmacy costs for hospices, improve patient care, and support caregivers through digital innovation, medication access, clinical care and more.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201014005070/en/

Mark Morse, Chief Executive Officer, Enclara Pharmacia (Photo: Business Wire)

Mark succeeds Andy Horowitz, Enclara founder and CEO, who made plans to move into a strategic advisor role as part of Humana’s acquisition of the pharmacy services provider in February. In the months since, Horowitz has provided direction and leadership throughout the integration process to help bring the two companies together and ensure a smooth transition. He will continue to act as a strategic advisor as part of the Humana-Enclara agreement, and remain involved in the long-term success of the company.

“A key part of our strategic plan, established when Humana agreed to acquire Enclara, was that I would transition into an advisory role when it made the most sense,” Horowitz said. “I believe we have reached a point where it is time for a new leader to execute on the roadmap we have established. I’m really proud of the entire Enclara team and the company we have built together, and I am confident in how Mark will lead Enclara into the future.”

Before joining Enclara, Morse most recently served as Humana’s vice president of Pharmacy Service Operations, overseeing a team of approximately 3,000 associates in 16 domestic and overseas locations. Under his leadership, Humana was named the best in Mail Order Pharmacy Customer Satisfaction in the J.D. Power U.S. 2020 Pharmacy Study, the third consecutive year Humana received this honor. Throughout his over 30-year career, Morse has also led the strategy and operations for many large-scale sales, systems and customer-focused initiatives.

“Andy and his team have built an amazing company, which serves a critical and noble need in the market and for the patients it serves,” Morse said. “I care deeply about advancing both Enclara’s growth and hospices’ capacity to provide quality end-of-life care. My goal is to leverage Humana’s scale and resources to help Enclara deliver timely and cost-effective pharmacy solutions while maintaining what makes Enclara uniquely Enclara.”

Morse’s previous roles at Humana include serving as practice leader for pharmacy benefit management sales, generating an additional $50M in annual revenue. He was also sales director for national and major accounts. Prior to joining Humana in 2001, Morse spent six years with United Healthcare, serving as the business owner for its consumer portal and operations director for health plan and systems migrations. Morse holds a Bachelor of Science in Management Systems from Rensselear Polytechnic Institute, America’s first technological research university.

About Enclara Pharmacia

Enclara Pharmacia is a national full-service PBM and mail order supplier of medications and clinical services developed specifically for the

Regeneron CEO says $450 million contract with U.S. secured 300k doses of antibody drug

Washington — Dr. Leonard Schleifer, the founder and CEO of Regeneron Pharmaceuticals, which developed the antibody cocktail heralded by President Trump, estimated Sunday that a $450 million contract the company won from the federal government over the summer will secure roughly 300,000 doses of the treatment.

“They bought from us several hundred thousand, maybe around 300,000 doses, which they are going to make it for free,” Schleifer said in an interview with “Face the Nation.” “We can’t do this alone. We need the entire industry.”

The Trump administration announced in July it signed a $450 million contract with Regeneron to supply the treatment. But with the number of new coronavirus cases outpacing the doses of the drug available, Schleifer conceded the federal government, together with ethics experts at the Food and Drug Administration, will have to decide who receives the limited supply.

“Coming up with a distribution system where we take what’s limited, and we try and give it to the people who most need it, who would most benefit from it — the vulnerable people, elderly people, people who are at high risk, household contacts perhaps,” he said. “We have to figure out ways to ration this.”

Mr. Trump was given a single dose of Regeneron’s antibody cocktail while he was being treated for COVID-19 and has gone on to praise the treatment, officially known as REGN-COV2, as a “cure” for the virus.

But the treatment has yet to undergo a peer-reviewed drug trial and has only been given to 10 people outside of clinical trials.

Schleifer called Mr. Trump’s case a “case report” and said while it is evidence of how the drug worked, it’s the “weakest evidence that you can get.”

“The real evidence has to come — about how good a drug is and what it will do on average — has to come from these large clinical trials, these randomized clinical trials, which are the gold standard,” he said.

Regeneron applied for an emergency use authorization from the FDA, and if it’s granted, the government has agreed “to making these doses available to the American people at no cost.”

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Medical College of Wisconsin CEO on science, academic medicine during COVID

Dr. John Raymond Sr. has served as president and CEO of the Milwaukee-based Medical College of Wisconsin since July 2010. It’s the nation’s third-largest private medical school, and its more than 1,600 faculty physicians constitute one of the largest medical groups in a state where COVID-19 cases have surged in recent weeks. Raymond talked with Assistant Managing Editor David May about lessons learned during the pandemic and priorities for the months ahead. The following is an edited transcript.

MH: Can you talk about Wisconsin’s COVID-19 caseload? It’s recently been one of the nation’s hot spots for surges in new cases.

Raymond: Like many parts of the Midwest, Wisconsin is experiencing rapid community spread of COVID-19, especially in the north central and northeastern regions of the state. In addition to a surge of new cases, the positivity rates and the reproductive numbers and measures of contagiousness are very unfavorable. So this indicates a large and growing burden of disease. Data posted (on Sept. 30) by the Wisconsin Department of Health Services showed that every county of the state had either a high or very high burden of disease. And more than half of the counties had a trajectory that was unfavorable.

And this has also been exacerbated by the need to quarantine healthcare staff, who either have active infections or who have confirmed exposure. In many cases, especially in rural parts of states, the staff is the bottleneck. You can create surge capacity for ventilators, ICU beds and hospital beds, but if you don’t have enough staff to take care of the patients, that’s a real problem.

MH: Initial reporting was that the universities were a part the problem, but what about the rural areas? Is there a general theory about what’s happening?

Raymond: We had well over 100,000 students, returning to school; most of the universities in Wisconsin had some form of in-person classroom activity that began in early September and late August. So for the first week in September, when the surge really was beginning to be apparent in Wisconsin, most of the cases were associated with young people in the 18-24 range. There was a very, very significant spike in cases. What was interesting though, is the spike wasn’t limited just to counties that had a large university; we were seeing community spread in addition to the return of thousands of students. And we believe that was in part due to long-term (pandemic) fatigue, some skepticism about the utility of wearing a masks and a lot of gatherings and relaxation of social distancing around the Labor Day holidays.

MH: Given all that’s transpired, what have your doctors and affiliated hospitals learned during this pandemic?

Raymond: Like other parts of the country, we now know much better how to triage and provide supportive care for patients with COVID-19. And there are some moderately effective therapeutics that we can strategically deploy to help us. Just the level of comfort in taking care of novel coronavirus has increased significantly.

We’ve been

Facing Disaster After Disaster, the American Red Cross C.E.O. Stays Optimistic

It helped me in my career. There were 50 women and 1,900 men. I had a great education there, but what it really also taught me was what it felt like to be the only woman in the room. I don’t remember taking any classes where there were other women. So you learn how to hold your own, because you have no choice.

What did you learn from the corporate world that you’ve been able to apply to your work at the Red Cross?

What is really profoundly different at a nonprofit is that you really have to not only lead with your head, you have to lead with your heart. If you explain the changes you are making through the lens of the mission, people will do anything for you. But they need to know, and understand, how their actions are going to impact the mission.

At AT&T I’d tell people to calm down. “It’s only telecommunications,” I’d say. “We’re not saving lives here. Let’s not panic.” I always was unflappable at Fidelity. “We’re just managing money here,” I’d say. “We’re not saving lives here.” That schtick does not work at the American Red Cross.

But you had to make some painful cuts when you took over.

Part of the reason we had a deficit is there was a lot of duplication. When I walked in the door, there were 720 different chapters, and each chapter had a C.E.O., a local board, their own marketing, their own email platform, their own finances, their own bank accounts, their own treasury, their own purchasing. I had 69 different contracts for T-shirts. So a lot of it was just consolidation and turning to a classic headquarters model. The first year we were able to save $15 million just by managing our purchasing function.

I didn’t hear a lot of complaints about taking all that back-office stuff and centralizing it. We withheld merit increases for a year, and I didn’t hear a peep. We had to do layoffs and I didn’t even hear much squawking about that.

How has the pandemic impacted your ability to operate?

We’re delivering our mission exactly as we should, but the way we’re doing service delivery is different. The first place where we saw the impact of this was in our biomedical organization, which provides 40 percent of the nation’s blood supply. It was kind of stunning how fast that occurred. We watched blood drives start to get canceled rapidly. Schools were closed, businesses were closed. But the team stood up new blood drives in sports arenas and parking lots.

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Gilead Drug Shows Promising Results In Treating COVID, Ready For Distribution Says CEO

KEY POINTS

  • Gilead’s coronavirus treatment redemsivir was found to reduce recovery time in patients by several days
  • Redemsivir and other drug treatments could serve as stopgap measures until a proper vaccine is ready and approved
  • The Trump administration and Congress re-entered negotiations about a stimulus package to help a U.S. economy hit hard by the pandemic

Final results from Gilead Sciences’ latest remdesivir trial showed the antiviral drug was effective in treating coronavirus patients and cutting recovery time by at least a week.

Gilead’s CEO said, given the positive results, the company was ready for mass production and distribution of the drug.

As of Friday, Johns Hopkins said the U.S. has over 7.6 million confirmed cases of coronavirus and 212,805 reported deaths from it. The latest trial was conducted for nearly a month and involved over 1,062 patients hospitalized for coronavirus. Half of the patients were given remdesivir while the other half were given placebo as part of the randomized, double-blind trial. Trial sites were located in the U.S., United Kingdom, Denmark, Mexico, Japan, Germany, Greece, Korea, Spain, and Singapore.

Average recovery time for people given remdesivir was found to be shortened by five days. While overall data showed the drug was not significant in reducing mortality, it appeared effective in lowering the mortality rate among patients on oxygen.

“Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with COVID-19 and had evidence of lower respiratory tract infection,” the final report in the New England Journal of Medicine said.

Gilead CEO Daniel O’Day said the company was pleased with the results and ready for distribution, if and when the drug is approved.

“These results are meaningful,” O’Day told CNBC. “They’ll definitely help patients around the world who have the misfortune of entering the hospital to get better, and I’m really pleased to say that we have ample supply.”

Former Food and Drug Administration Commissioner Dr. Scott Gottlieb said while remdesivir, alone, is likely not enough to treat coronavirus, this data is a good sign in battling the pandemic.

“I think combined with the antibody drugs, which should be coming onto the market soon based on the data that we’ve seen, this is a pretty effective treatment regime in advance of a vaccine,” Gottlieb told CNBC.

While a drug like remdesivir, or the antibody treatment developed by Eli Lilly, serve as a stopgap means of addressing coronavirus, a vaccine will still be needed to serve as a long-term answer. The hope is that a vaccine will be approved and ready for distribution by the end of December, with timetables having life get back to some degree of normalcy by summer 2021.

Some of the vaccines furthest along include:

  • Moderna and the National Institute of Health’s mRNA vaccine, currently in Phase 3 trials
  • China’s CanSino Biologics and Russia’s Gamaleya Research Institute have vaccines in limited approval, though experts warned these were likely rushed and could still be harmful
  • AstraZeneca and the

AccuRisk Solutions Welcomes David Przesiek as New CEO to Tactical Risk Solutions

AccuRisk Solutions LLC, a nationally recognized leader in innovative insurance solutions, continues to strategically invest in the company’s growth with the addition of David Przesiek as CEO of Tactical Risk Solutions.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201008006010/en/

Dave Przesiek, President of Tactical Risk Solutions (Photo: Business Wire)

David Przesiek is a 25-year veteran of the health insurance industry. Formerly a Senior Vice President and Chief Sales Officer for Fallon Community Health, Przesiek was responsible for all product lines including commercial sales and government programs as well as market research, business and product development and UltraBenefits, Inc., and Group Insurance Service Center, Inc. (GISC), Fallon’s third-party administrators. In his role at Fallon, he oversaw the introduction of limited networks, a transparency tool called SmartShopper, a comprehensive wellness program called the Healthy Health Plan and helped kicked off a strategic initiative aimed at improving the customer experience for Fallon Health.

“We are thrilled that David is on the AccuRisk team. David will be responsible for developing and executing the strategy of Tactical Risk Solutions as we look to launch products to meet the benefit needs of employers across the country,” said AccuRisk CEO Daniel Boisvert. “His experience and reputation will help us elevate Tactical Risk Solutions to a new level of success, and we are looking forward to see David unleash the potential of the captive model and create a profitable and sustainable company.”

“I’m thrilled to join AccuRisk during this exciting period of company growth. AccuRisk is known for their innovative solutions and I’m looking forward to being part of such an established market leader,” said Przesiek. “I’m passionate about driving innovation in health care for employers and brokers and improving the member’s experience. With AccuRisk, this can actually be accomplished.”

About AccuRisk Solutions LLC

AccuRisk Solutions LLC is a Chicago-based Managing General Underwriter focused on providing its producers with innovative insurance products and outstanding customer service. The AccuRisk executive management team is composed of proven leaders within the industry who are driven to provide better results for clients. AccuRisk partners with leading insurance carriers and healthcare visionaries to provide a comprehensive array of healthcare and employee benefit solutions. Their objective is to assist producers in providing their employer clients with unique and cost-effective solutions. Visit www.accurisksolutions.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201008006010/en/

Contacts

David Przesiek
DPrzesiek@accurisksolutions.com

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Trump’s use of Regeneron treatment creates ‘tough situation’: CEO

President Donald Trump’s use of Regeneron’s experimental coronavirus treatment creates “a very tough situation” for the drugmaker since it hasn’t been cleared for broader use, CEO Dr. Leonard Schleifer told CNBC on Monday.

The president, who announced Friday that he and first lady Melania Trump tested positive for the coronavirus, was given an 8 gram dose of Regeneron’s monoclonal antibody treatment, his doctors said.

The company said it provided the drug to the president in response to a “compassionate use” request from Trump’s doctors, which allows for expanded access to experimental drugs for “immediately life-threatening” illnesses, according to the Food and Drug Administration. It allows patients to access an investigational drug outside of clinical trials in lieu of adequate other treatments.

That means that while the president’s doctors were confident enough of the drug’s benefit to administer it to Trump, the treatment remains unavailable to most Americans.

“We have tried to take a principled approach until there is a broader authorization,” Schleifer told CNBC’s Meg Tirrell on “Squawk Box.” “Asking somebody like the president to go into a clinical trial just wasn’t practical.”

Until the FDA takes a look at all the available data on the benefits and risk of the drug for Covid-19 patients, patients who want to receive the treatment should enroll in a clinical trial, Schleifer said. He added that patients in clinical trials are closely monitored so that researchers can understand how the drug affects the disease, but at least a third of patients will receive a placebo.

“Giving it to [Trump] or to others who might not be able or don’t qualify for clinical trials is the right use of compassionate use. That’s for small numbers of people, for these exceptions,” he said. “We want everybody to be potentially able to benefit. We understand we don’t make that decision. This is a decision the FDA has to make.”

Schleifer added that he thinks the treatment meets “a lot of” the FDA’s standards for an emergency authorization. But he said the company needs to continue to collect data in controlled clinical trials to better understand the treatment. But as trials continue, the virus continues to infect more than 40,000 people every day across the U.S.

“This is all very complicated because it’s real lives at stake” he said. “If it’s my loved one or your loved one, … yes, we want to give this if we can help them. Of course, we want to get definitive evidence, so it’s a tough act to balance.”

Shares of the company were up more than 5% in early trading Monday.

Some analysts have speculated that the use of Regeneron’s antibody cocktail to treat the president is a tacit endorsement of the drug and could signal a swift approval by the FDA. Schleifer, however, tried to assure the public in the CNBC interview that the FDA has its own standards for authorization and the White House does not play a role. 

The class of drug has long been used to

Pfizer CEO pushes back against Trump claim on vaccine timing

The head of Pfizer, one of the drugmakers racing to develop a coronavirus vaccine, told employees he was disappointed that its work was politicized during this week’s presidential debate and tried to reassure U.S. staff that the company won’t bend to pressure to move more quickly.

Chief Executive Officer Albert Bourla told the employees Thursday that the company is “moving at the speed of science,” rather than under any political timing, according to a staff letter obtained by The Associated Press.

“The only pressure we feel — and it weighs heavy — are the billions of people, millions of businesses and hundreds of government officials that are depending on us,” Bourla wrote.


Despite top U.S. federal health officials repeatedly stating that a vaccine is unlikely to be available widely until 2021, President Donald Trump has insisted that a vaccine will be ready before Election Day.

During Tuesday’s debate with former Vice President Joe Biden, Trump said he had talked with the companies whose experimental vaccines are furthest along in testing.

“I’ve spoken to Pfizer, I’ve spoken to all of the people that you have to speak to, Moderna, Johnson & Johnson, and others. They can go faster than that by a lot,” Trump claimed. “It’s become very political.”

Pfizer has said that it expects to have data from its ongoing late-stage test by October that could show whether the vaccine is safe and effective. In his letter to employees, Bourla wrote that the company hopes to have “a hundred million doses delivered by the end of the year.”

Those doses could not be distributed until the Food and Drug Administration reviews Pfizer’s data and decides whether to issue what’s called an emergency use authorization. That would allow distribution of the vaccine on a limited basis, with initial shots expected to go to medical and other frontline workers, nursing homes and people most at risk of catching or becoming seriously ill from the virus.

Moderna’s chief executive, Stéphane Bancel, told the UK’s Financial Times on Wednesday that Moderna would not be ready to seek emergency use authorization from the FDA for its vaccine candidate before Nov. 25 at the earliest.

Johnson & Johnson just started the late-stage and final patient study of its vaccine last week.

And AstraZeneca, which has a candidate in late-stage trials around the world, has its U.S. study on hold while the FDA reviews a possible safety problem.

Bourla and top executives of eight other companies developing COVID-19 vaccines and treatments pledged in early September not to seek even emergency use authorization, let alone a full approval of their products, until they were proven safe and effective.

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Johnson reported from Fairless Hills, Pennsylvania. Lemire reported from Washington.

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Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma

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