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Stem cell research hits inflection point a year after NY halts funding

Posted on 09.02.2022


The state’s decision last year to halt funding for stem cell research has forced local scientists to hit pause on work that could spur new treatments for cardiovascular disease, sickle cell anemia and much more. As state lawmakers negotiate the budget for the upcoming fiscal year, researchers are calling for them to reinstate the program.

Lawmakers canceled the $600 million New York State Stem Cell Science program in the spring of 2021 as part of the state budget. Now the researchers who had relied for years on NYSTEM funding have exhausted the money, and their work has ground to a halt just as their promising new therapies become ready for clinical trials.

“We have the ability to, with some new funding, get these clinical trials up off the ground that have stalled,” said Jonathan Teyan, the chief operating officer of the Associated Medical Schools of New York, a Midtown-based consortium. “We are at an inflection point.”

Stem cells have the power to develop into almost any kind of cell in the body, which makes them a powerful tool for scientists to better understand how health issues emerge and how to treat them.

Weill Cornell Medicine researcher Todd Evans was part of a NYSTEM-funded collaboration with Memorial Sloan Kettering that was investigating a potential cure for sickle cell anemia using stem cells.

Evans said the funding enabled them to conduct enough basic science research to advance the new therapy into clinical trials, but cancellation of the NYSTEM program forced them to put the work on hold while they search for new funding sources.

Another of his projects was investigating the use of stem cells to repair heart damage in cardiovascular disease.

“Clinical trials are really expensive,” Evans said. “Certainly we won’t give up, but it’s really a shame.”

Since its inception in 2007, the NYSTEM program has awarded about $400 million to 372 projects spanning 37 New York institutions, according to its website. The awards generated $481 million in additional support from other funding sources and supported more than 750 jobs statewide.

Asked about the rationale for the cancelation, Freeman Klopott, a spokesman for the state Division of the Budget, told Crain’s last year that the state expected stem cell research would continue within academic and private research communities “rather than the Department of Health, which is focused on its core mission of delivering direct services and achieving positive health outcomes for all New Yorkers.”

NYSTEM-funded researchers are hunting for funding opportunities with the National Institutes of Health, pharmaceutical companies and private philanthropy, but they said the process could take months—or even years. In the meantime, they risk losing talented scientists who were working on the projects they already started.

Dr. Erika Bach, an associate professor in the Department of Biochemistry and Molecular Pharmacology at New York University’s Grossman School of Medicine, said she had to fire two of her lab’s five researchers once her NYSTEM funding ran out.

Bach’s lab had been examining how stem cells behave when they are healthy and what causes them to malfunction. She said the findings could inform future innovations to combat aging or to regenerate organs using a patient’s own cells.

Bach is pursuing federal grant opportunities to continue the work, but she said the National Institutes of Health could take six to 18 months just to give her a definitive rejection. That puts researchers like herself at a disadvantage with researchers in states such as California that have robust funding programs for stem cell research.

The Associated Medical Schools of New York, which represents the state’s 17 public and private medical schools, is pushing Gov. Kathy Hochul and state lawmakers to restore state funding for stem cell research in the fiscal 2023 budget, at a cost of $44.8 million per year.

Otherwise, Weill Cornell’s Evans said, the state risks a “brain drain” to California and other states that fund this research, which will then reap the economic benefits of the new jobs and companies that result. Evans said he has already lost one of his top junior faculty members to a California university since the NYSTEM funding dried up.

“Those people have to move on, so you lose the talent and the staff to drive the program,” he said. “That’s where you lose the momentum.” —Maya Kaufman

 

Pfizer forecasts record 2022 revenue after $37B in vaccine sales last year


Pfizer closed out 2021 with nearly $37 billion in sales of its Covid-19 vaccine, which buoyed 95% revenue growth for the full year, according to financial results released Tuesday.

The Midtown East drugmaker reported $25 billion in income, after adjustments, on more than $81 billion in revenue for the year. Diluted earnings reached $4.42 per share after adjustments, up 96% from the prior year.

Its vaccine with BioNTech accounted for nearly half the year’s revenue. Eliquis, Pfizer’s blood-clotting medication with Bristol Myers Squib, was the next bestselling product with nearly $6 billion in direct sales and alliances revenues for the year.

Paxlovid, Pfizer’s oral treatment for Covid, generated $76 million in U.S. sales after it won emergency-use authorization from the federal government in late December.

During the last three months of 2021, Pfizer notched $24 billion in total revenue, a 105% year-over-year-increase. The Covid vaccine comprised $12.5 billion of that. The company reported $6.2 billion in income for the quarter after adjustments, up 156% year over year.

But Pfizer’s share price dipped after its fourth-quarter results and 2022 forecast for sales of the Covid vaccine and pill missed Wall Street estimates.

The drugmaker projected full-year revenues of $98 billion to $102 billion including $32 billion from its Covid vaccine and $22 billion from its Covid pill.

“We are issuing guidance for the coming year which, if achieved, would represent the highest level of annual revenues and adjusted diluted EPS in Pfizer’s long history,” Frank D’Amelio, Pfizer’s outgoing chief financial officer and executive vice president, said in a statement, using the acronym for earnings per share.

CEO Albert Bourla told investors on Tuesday that Paxlovid sales could still end up “way bigger than what we have right now.”

Pfizer stock closed at $51.70 per share Tuesday. —M.K.

 

St. Mary’s Healthcare System for Children gets $20M donation


St. Mary’s Healthcare System for Children received a $20 million donation from philanthropist Cindy Johnson, it announced Monday.

The post-acute pediatric hospital, which is located in Bay Terrace, Queens, said the donation will ensure its financial stability and provide funding for remote services and at-home care, among other new programs.

St. Mary’s was forced to close in March 2020 during the onset of the pandemic and shut down some of its programs, notably its Medical Day Healthcare Program, which provided clinical and rehabilitative care to children and young adults dealing with chronic conditions.

The $20 million gift from Jonson is expected to go far, hospital leadership said.

“It’s a transformative gift, frankly,” President and CEO Dr. Edwin Simpser said. “Managed well it can last a very long time. Our goal is that it will serve our health care system for many years to come.”

Simpser said $1 million of the gift is already set to go toward a new program in home care.

“We’re going to provide new technology to literally change the paradigm for home care monitoring for really sick kids,” Simpser said. “Nothing else has been designated now, only that million [dollars].”

The hospital has a $150 million budget and serves 3,000 children per year.

“A gift of this size, and the different types of programs it will help develop, over time it will serve thousands of children,” Simpser said. “We’re talking about some of the sickest kids in the New York metropolitan area.”

Johnson co-chairs the St. Mary’s board of directors. She and her husband, Tod Johnson, opened the Cindy and Tod Johnson Center for Pediatric Feeding Disorders at the hospital.

St. Mary’s provides care to children and young adults with special needs and life-threatening conditions, including long-term care and post-acute injury care. It was founded in 1870. —Brian Pascus

 

FiDi startup providing tech for remote clinical trials raises $45M


Koneksa, a Financial District startup that specializes in digital biomarker tracking for clinical trials, has raised $45 million in a Series C funding round.

AyurMaya, an affiliated fund of Matrix Capital Management, led the round with participation from such investors as Takeda Ventures, the investment arm of the pharmaceutical company. Merck and Novartis also have invested in the startup.

Founded in 2013, Koneksa’s software platform uses algorithms to monitor patient data—digital biomarkers—remotely and in real-time. It collects such data from a mix of devices, including home spirometers and consumer wearables, such as the Apple Watch.

The hope is to more efficiently and safely bring medicine to market, by making clinical trials easier for the people participating and the researchers monitoring the results.

“Covid-19, the rise of remote monitoring and virtual clinical trials created the circumstances for rapid adoption and success of digital biomarkers,” Dr. John Wagner, chief medical officer of Koneksa, said in a statement.

Wagner’s hiring was announced with the funding news on Monday. Wagner, formerly chief medical officer at Cygnal Therapeutics, is the first to hold the title at Koneksa.

Koneksa had raised $25.6 million in two deals prior to this latest investment.

Last year was a record-setting one for investment into local health care startups, with New York-based companies raising $9 billion total. —Ryan Deffenbaugh

 

AT A GLANCE


WHO’S NEWS: Ruben Diaz Jr. has been appointed senior vice president of strategic initiatives at Montefiore Medicine, the health system announced Tuesday. Diaz most recently served as Bronx borough president.

Thea Gallagher has joined the department of psychiatry at NYU Langone Health as assistant professor and coordinator of digital mental health, outcomes and wellness, the system said Tuesday. Gallagher joins from the Perelman School of Medicine at the University of Pennsylvania.

CANCER FUNDRAISER: The Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai raised over $2.5 million during its 11th annual online benefit at the end of 2021, the health system said Tuesday. It will use the funds for research and clinical trials, cold cap technology to prevent hair loss during chemotherapy and personalized wellness services for patients.

MULTIPLE SCLEROSIS: The National Multiple Sclerosis Society has been awarded a $750,000 grant from Bristol Myers Squibb to increase health care access for medically underserved multiple sclerosis patients in New York City, it announced Tuesday. The award is among nearly $8 million in health equity grants that the New Jersey pharmaceutical company is distributing to 24 nonprofits across the U.S.

VIRTUAL CARE: Empire BlueCross and Empire BlueCross BlueShield in New York today have launched virtual primary care services for eligible members enrolled in its commercial health plans, the insurer announced Tuesday. Members of Empire’s fully insured plans and select large group administrative services clients will have access to a 24/7 medical text chat for urgent care, video visits for preventive health care and other primary care services through Anthem’s Sydney Health app.

CONTACT US: Have a tip about news happening in the local health care industry? Want to provide feedback about our coverage? Contact the Health Pulse team at [email protected]



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