Clasp Therapeutics Doses First Patient in Phase 1 Clinical Trial With a First-in-Class T-Cell Engager Designed to Target Cancer Cells With Absolute Specificity

CAMBRIDGE, Mass. & ROCKVILLE, Md.--(BUSINESS WIRE)--Clasp Therapeutics, a biotechnology company bringing unparalleled precision to immuno-oncology using next-generation T-cell engagers (TCEs), today announced dosing of the initial patient in the GUARDIAN-101 phase 1 trial of CLSP-1025, the first tumor-specific TCE to enter clinical development. CLSP-1025 exclusively targets cancer cells expressing the p53R175H mutation, a mutation associated with a wide range of solid tumors, including colorectal, pancreatic, lung, gastric, esophageal, gynecological, and prostate cancers.

In this timely episode of BioTalk, returning guest Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News, joins host Rich Bendis to explore how sweeping changes in U.S. regulatory policy, workforce dynamics, and economic pressures are affecting the biotech industry in real time.

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Alex breaks down the potential consequences of FDA workforce cuts, particularly for small and mid-sized biotechs that depend on regulatory guidance, and offers perspective on how HHS and NIH budget proposals could reshape the national innovation infrastructure. The conversation covers everything from the impact of tariffs on manufacturing and supply chains to the slowing pace of M&A activity and venture capital investment trends. Alex also shares his insights on IPO strategy shifts, and whether the current biotech environment is poised for a rebound—or a broader realignment with global competitors. This is a must-listen episode for anyone navigating the uncertain waters of biotech in 2025.

April 28, 2025 | This email address is being protected from spambots. You need JavaScript enabled to view it. - A new collaboration bringing entrepreneurs and investors together with physician-scientists, surgeons, and medical technologists promises to launch the Baltimore region as a major national hub for new biomedical ventures and start-up companies. The initiative, called the “Innovation Alliance,” leverages the region's national and international leadership in biomedical research and technology to attract venture capital, foster startups, drive economic growth, and ultimately bring to market new treatments, cures, and technologies that will directly improve lives.  

This transformative device advances safety and efficiency in drug preparation, underscoring the startup's journey from solo founder to FDA-cleared innovator.

FREDERICK, Md., April 25, 2025 /PRNewswire/ -- Carr Tech Corp, a Maryland-based medical device startup founded by pharmacist-turned-entrepreneur Sue Carr, proudly announces that the company has received FDA 510(k) Class II clearance for its flagship product, FROG (Filter Removal of Glass), an all-in-one filter needle designed to enhance safety and efficiency in medication preparation and administration.

"I am humbly grateful and happy to announce that we officially received FDA 510(k) Class II approval of FROG," said Carr. "This milestone is not just a win for Carr Tech—it's a win for every healthcare worker who's ever struggled with cumbersome drug prep protocols and every patient who deserves safer medication handling."

FROG is the first and only all-in-one filter needle that eliminates multiple steps from the current multi-component method of drawing medication from glass ampoules. Traditional procedures often involve using separate filter and non-filter needles to prevent the risk of glass particle contamination—a process that is time-consuming, costly, and prone to error. FROG's innovative design consolidates these steps, reducing procedural risk, streamlining workflow, and enhancing patient safety. 

Read more ...

Collaboration will deliver innovative AI-powered pathology tools and quality control enhancements to accelerate clinical trials and biomarker discovery

BOSTON and FREDERICK, Md., April 25, 2025 /PRNewswire/ --Precision for Medicine, a leading provider of next generation drug development research and services, and PathAI, a global leader in digital pathology, today announced a strategic collaboration to partner on developing novel AI-based technologies and to integrate PathAI's advanced digital pathology and analysis capabilities across Precision for Medicine's clinical trial and biospecimen operations.

This collaboration includes use of several PathAI technologies and establishes an agreement to offer novel tools and analytical services that address emerging needs in biomarker discovery, spatial biology, and tissue-based clinical research. Through this collaboration PathAI's tools and services will help augment Precision for Medicine's proprietary pipeline providing biopharma clients with access to imaging workflows offered through Precision for Medicine's integrated laboratory and clinical trial services.

Over $1 million awarded to 7 university projects 

COLUMBIA, Md., (April 24, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced the next round of Maryland Innovation Initiative (MII)’s Technology Assessment awards, marking a significant milestone in promoting the commercialization of groundbreaking research from Maryland's prestigious academic research institutions. The Technology Assessment award is a nine-month project that builds on strong preliminary data that demonstrates the technology’s utility for specific commercial applications beyond basic research.  

“The Technology Assessment phase of our program provides non-dilutive funding to advance technologies with commercial potential,” said Abi Kulshreshtha, MII’s executive director. “In this award cycle, the Maryland Innovation Initiative staff and technical reviewers selected seven projects from a competitive pool of applicants, which altogether received grants totaling more than $1 million to advance innovations ranging from new cancer therapeutics to inclusive AI-driven education technology solutions.”

The U.S. biomedical innovation system is world-leading, built by a century of federal investment that peaked last year at $50 billion. That foundation has been thrown into uncertainty by shifts in policy under the second Trump Administration aimed to reduce spend, shift research priorities, and divest from universities. While these changes have appeared to many to come on suddenly, they reflect long-growing concerns with the U.S. scientific system—initiated by issues with trust and reproducibility, barriers to accessing knowledge, and structural limitations on creative risk-taking.

The scientific community is actively seeking additional funders to step in and fill the anticipated funding gap, which may be as big as $20B annually. New pledges are starting to be made. At the state level, California is advancing a bill to fund general scientific research and Texas is advancing a bill to fund Alzheimer’s research. Both of these states have a history of scientific funding, including through the California Institute for Regenerative Medicine and the Texas Cancer Prevention and Research Institute of Texas (CPRIT). Corporate pledges are also happening—Recursion Pharmaceuticals has funded a pre-seed accelerator designed to close gaps in SBIR funding—and groups outside of the US are launching opportunities for funding or training that are aimed at US-based scientists. Other potential sources of funding include philanthropies, family offices, regional governments, private investors, disease foundations, and crowd-funding. If contributions from these groups rise to meet the anticipated $20B funding gap, the system will shift fundamentally—from one organized around a central funder to one sustained by a kaleidoscope of funders. This transition will open-up new and interesting opportunities.

From low-rate loan options to a tech-advanced platform, the National Institutes of Health Federal Credit Union offers compassionate, personalized banking services that save time and money for its members, who predominantly reside in the Washington, D.C., metro area.

Since 1940, the National Institutes of Health Federal Credit Union (NIHFCU) has primarily served the employees and contractors of the National Institutes of Health (NIH) and others simi- larly employed in the biomedical and health care industries. Its extensive experience in these communities positions the credit union to best serve the unique needs of this popula- tion, with branches both in surrounding areas and on NIH campuses. The credit union offers tailored loan programs such as special medical school lines of credit for soon-to-be medical practitioners, student loan refinancing options for current medical practitioners, and unique borrowing options for NIH international fel- lows. Today, NIHFCU makes membership available to virtually anyone, whether they work in or outside of the health care or bio-medical fields.

Swiss MedTech leader taps renowned pediatric innovation expert to serve as Chief Strategy and Innovation Officer and Head of Pediatrics

BERN, SWITZERLAND / ACCESS Newswire / April 23, 2025 / Compremium AG, a pioneering Swiss medical technology company, announced today the appointment of Kolaleh Eskandanian, PhD, MBA, as Chief Strategy and Innovation Officer and Head of its newly formed Division of Pediatrics and Special Populations.

Dr. Eskandanian, a global leader in pediatric innovation, joins Compremium from Children's National Hospital in Washington, D.C., where she most recently served as Vice President and Chief Innovation Officer, Executive Director of the Sheikh Zayed Institute for Pediatric Surgical Innovation, and founding executive of Innovation Ventures. Her appointment marks a strategic milestone in Compremium's expansion into pediatric and special populations, reinforcing its commitment to developing precision diagnostics and next-generation health technologies for patients worldwide.

By Drew Hansen - Assistant Managing Editor - April 23, 2025 - Richmond pharmaceutical ingredient company Phlow Corp. said Tuesday it has expanded its laboratories at the Virginia Biotechnology Research Park and doubled in size to more than 90 scientists and skilled professionals.

The public benefit corporation said it has expanded its labs by acquiring additional analytical capabilities, including advanced spectroscopy tools to analyze chemical composition and develop and validate analytical methods from its scientists.

Phlow said the new capabilities allow it to streamline its processes and will open it up for more collaboration.

COLUMBIA, Md., April 23, 2025 — Welldoc^®, a digital health leader revolutionizing cardiometabolic care, announced today that it was Certified™ by Great Place to Work® for the fourth year in a row. This prestigious award recognizes companies with exceptional workplace cultures based solely on employee feedback. An impressive 94 percent of employees said Welldoc is a great place to work, exceeding the U.S. average by 37 points.

Great Place to Work is the global authority on workplace culture, employee experience and leadership behaviors proven to deliver market-leading revenue, employee retention and increased innovation. The Great Place to Work Certification is based on results of the Trust Index™ survey administered by the Great Place to Work Institute, which assesses employee satisfaction in key areas, including credibility, respect, fairness and camaraderie.

Richmond, Virginia, April 22, 2025 (GLOBE NEWSWIRE) -- Phlow Corp., a leading pharmaceutical contract development and manufacturing organization (CDMO) in America, announced today a significant expansion in its analytical capabilities, use of artificial intelligence (AI), workforce, and domestic infrastructure. Marking a period of exceptional growth and momentum, Phlow has more than doubled in size and now employs over 90+ highly skilled scientists and professionals dedicated to building a resilient, high-quality pharmaceutical supply chain on U.S. Soil.

Driven by its strategic purpose to create the future of how medicines are made by helping brilliant minds bring medicines to life through advanced development and manufacturing in America, Phlow has expanded its state-of-the-art laboratories in the Virginia Biotechnology Research Park in Richmond, Virginia. The expansion includes acquiring additional analytical capabilities, including advanced spectroscopy tools and high-resolution, high-mass accuracy mass spectrometry, adjacent to its existing process research and development lab, enabling Phlow’s talented team of scientists to develop and validate analytical methods. This enhancement allows Phlow to streamline processes and foster greater collaboration, ultimately reinforcing our commitment to delivering innovative solutions and high-quality products. Phlow’s expanded laboratory space now offers comprehensive analytical services, including industry-leading analytical solutions for drug assays, impurity characterization and control, purity analysis, and process optimization for cutting-edge technologies such as continuous flow chemistry.

This blog is part of a series on the geographic concentration of pharmaceutical manufacturing. This blog focuses on the manufacturing of active pharmaceutical ingredients (API). For a discussion on finished dose manufacturing, see here .

Historically, U.S. pharmaceutical tariffs have been based on the country where the pharmaceutical API was made.¹ Using USP’s Medicine Supply Map, we analyzed the geographic concentration of U.S. prescription API manufacturing, by volume. 

GAITHERSBURG, Md. & OAKLAND, Calif.--(BUSINESS WIRE)--GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced its plans to acquire Fabric Genomics, a pioneer in AI-powered genomic interpretation. The transaction enables GeneDx’s leadership in the next phase of genomic medicine: decentralized testing with centralized intelligence.

“Healthcare is at an inflection point where integrating genomic insights into standard care is becoming essential – both for better clinical outcomes and for saving the healthcare system valuable dollars. To achieve this, we must evolve and provide adaptable solutions so this information can be used more proactively and without geographic constraints. Adding Fabric Genomics and their talented team moves us closer to that future, enabling our partners to deliver groundbreaking genomic insights to patients across the globe,” said Katherine Stueland, President and CEO of GeneDx.

Since 1940, the NIH Health Federal Credit Union (NIHFCU) has been providing affordable loans and banking solutions to the local biomedical and healthcare communities, including NIH’s civilian workforce and contractors and a lengthy list of other industry employers and organizations in the DMV.

The credit union industry has flourished for well over a century (1909 to be exact) with its “people helping people” philosophy to financial services. Today, while the NIHFCU has expanded its member eligibility requirements beyond the NIH and its affiliates, the recent Reduction in Force (RIF) activities of the federal government will have consequences for many of its members and their families. As NIHFCU has done many times throughout its history (the most recent being the COVID-19 pandemic), it has risen to the occasion to provide for its members who are experiencing direct financial hardship due to the RIF and to live up to the credit union industry’s “people helping people” values.  

The event, presented by the Maryland Stem Cell Research Fund (MSCRF) and the Maryland Department of Commerce’s Office of Life Science, will spotlight the latest advancements in stem cell research and regenerative medicine technology. Attendees will have the opportunity to listen to elevator pitches from MSCRF's portfolio companies, each showcasing their unique value proposition to a panel of investors. Additionally, the Showcase will include poster presentations highlighting promising technologies, fostering engagement and dialogue.

FREDERICK, Md., April 15, 2025 /PRNewswire/ -- Nikon CeLL innovation Co., Ltd. (NCLi), a subsidiary of Nikon Corporation has entered into a strategic licensing agreement with RoosterBio, Inc. (RoosterBio), a leading stem cell technology company in the US.

This agreement provides the Japanese biopharma industry with an end-to-end solution for development and manufacturing of human mesenchymal stem cells (MSC) and extracellular vesicle (EV) therapeutics. Drug developers can leverage RoosterBio's technology platform to accelerate the development of their advanced therapies with NCLi, and then seamlessly transition to clinical manufacturing within NCLi's GCTP*1/GMP*2 facility designed specifically for cell therapies.

A new hub for biotech and medical device startups is on the horizon. The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is preparing to open the doors to HJF Innovation Labs in North Bethesda, Maryland, with occupancy beginning Fall 2025.

This first-of-its-kind incubator is tailored to support the development of dual-use medical technologies—those that serve both military and civilian needs. From navigating the complexities of military medical product development to accessing HJF’s expansive research infrastructure and stakeholder network, startups will gain the tools they need to scale innovation and bring critical solutions to market.

Maintaining biotechnology superiority is essential to the U.S. economy and national security, and it must be supported with strategic federal funding that leans into America’s strengths by encouraging private investment, according to a three-year-long Congressional study.

“From more productive seeds and targeted cancer therapies to the possibility of genetically enhanced soldiers, biotechnology’s reach extends far beyond the laboratory,” says the report from the National Security Commission on Emerging Biotechnology (NSCEB), released April 8. “Falling further behind would signal a global power shift toward China and create an array of new strategic challenges for the U.S. government.”

COLUMBIA, Md., (April 14, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $25,000 Pre-Seed Rural Business Innovation Initiative (RBII) investment in Neuros Biotechnology, Inc. TEDCO’s RBII was designed to enhance technology commercialization and provide technical and business assistance to small and early-stage companies based in rural Maryland.

The Maryland Department of Commerce, in collaboration with the University of Maryland, College Park, is hosting the AI for Smart Manufacturing Productivity Forum on Tuesday, May 13, from 1:00 PM to 6:00 PM at A. James Clark Hall.

This half-day event brings together experts, industry leaders, and policymakers to explore how artificial intelligence can transform manufacturing productivity, especially for small and medium-sized enterprises. Highlights include a keynote from Dr. Jay Lee, Director of the Industrial AI Center, and panel discussions featuring leaders from IBM, Hardwire, Fraunhofer USA, and more.

BioHealth Innovation, Inc. (BHI) was proud to join innovators, resource partners, and public officials at the first-ever BioConnect event—a new platform designed to foster collaboration across Montgomery County’s life sciences community. Held at the University of Maryland Institute for Health Computing (UM-IHC) in North Bethesda, the event was co-hosted by Montgomery County, MCEDC, and UM-IHC, and marks the start of a recurring series aimed at deepening connections between startups, investors, and regional stakeholders.

BHI’s Executives-in-Residence Luis Gutiérrez, and Jennifer Butler attended the event alongside Montgomery County Councilmembers Andrew Friedson and Natali Fani-Gonzalez, offering an opportunity to express appreciation for the County’s continued support of the BHI EIR program and broader innovation infrastructure.

On April 8, 2025, the Maryland MedTech Summit convened nearly 370 leaders from across the medical technology ecosystem at the University of Maryland, College Park, spotlighting the depth and diversity of the region’s growing MedTech community. Held at the Stamp Student Union as the flagship event of the inaugural Maryland MedTech Week, the summit offered a full day of programming, networking, and insights into the future of device innovation. This was the 2nd Annual Maryland MedTech Summit, and the Inaugural Maryland MedTech Week, which also featured investor-focused events hosted by Ecphora Capital, The LaunchPort, and the two-day MedTech Innovator East Coast Road Tour.

BioHealth Innovation, Inc. (BHI) was proud to serve as a sponsor of this year’s summit and sent a strong delegation of Entrepreneurs-in-Residence (EIRs), including Luis Gutiérrez, Albine Martin, Jon Kay, Ray Blanchard, and John Sullivan, all of whom provide strategic commercialization support to MedTech startups and early-stage companies across the BioHealth Capital Region and beyond.

by Kate Andrews - Mark T. Esser, vice president for vaccines and immune therapies at pharmaceutical giant AstraZeneca, will be the inaugural chief scientific officer and leader of the Paul and Diane Manning Institute of Biotechnology at the University of Virginia, U.Va. announced Thursday.

Esser, who will join U.Va. May 1, earned a Ph.D. in microbiology in 1998 from U.Va.’s medical school, and has worked in translational medicine at AstraZeneca, MedImmune (which was acquired by AstraZeneca) and Merck. He was involved with development of Evusheld, a medicine that helped prevent and treat COVID-19; infection and cancer vaccine programs; human papillomavirus vaccines; and a monoclonal antibody that helps prevent RSV in infants.

The $350 million Manning Institute, launched in 2023 with a $100 million donation from Albemarle County investors Paul and Diane Manning, is a hub for biotech research, development and manufacturing at U.Va., which is building a 350,000-square-foot structure in Fontaine Research Park in Charlottesville that’s expected to open by late 2026 or early 2027, according to Paul Manning. A member of the university’s board of visitors, Manning founded PBM Products, an infant formula and baby food business, which he sold to Perrigo for an estimated $808 million in 2010. He then started PBM Capital, a private equity firm that invests in pharmaceutical and life sciences startups.

By Alex Keown - Tammi Thomas is a proponent of agape love, a selfless form of unconditional love that puts the needs of others first. Agape love is not static; it requires demonstrative action, something that drives Thomas in both her personal and professional lives.

“This is the kind of love where you see humanity before you see their differences,” she says.

This mindset is critically important for Thomas, who serves as Chief Development and Marketing Officer at TEDCO (Maryland Technology Development Corporation) headquartered in Columbia. TEDCO supports early-stage technology and life sciences companies in Maryland through resources, connections, and funding opportunities that allow businesses to grow.

In her role, Thomas leads the overall strategic direction, execution, and management of the organization’s marketing and fundraising strategies. Through careful crafting and shaping of TEDCO’s strong brand identity, Thomas says entrepreneurs across the state have learned that the organization is a reliable source for venture capital investments – within the top 20 investors in the Mid-Atlantic region, according to Pitchbook. The constant stitching and storytelling Thomas directs continues to promote scaling and stickiness that brings diverse stakeholders together in a collaborative way.

WASHINGTON, D.C., April 08, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced the signing of a Patent License Agreement with Yale School of Medicine and Yale School of Public Health to jointly advance the development and commercialization of tafenoquine for the treatment and prevention of babesiosis.

On April 1st, Georgetown University celebrated a landmark moment in its growing innovation ecosystem with a full-day dedicated to advancing research, entrepreneurship, and industry collaboration. Hosted by Georgetown’s Office of Technology Commercialization (OTC) in partnership with Georgetown Entrepreneurship, the day’s programming highlighted the university’s commitment to translating bold ideas into real-world solutions.

The day began with the Innovation Awards Luncheon, where outstanding inventors were recognized for their contributions to scientific advancement and commercialization. The Crystal Awards, in particular, honored researchers who are successfully bridging the gap between discovery and application, turning transformative research into real-world impact.

GAITHERSBURG, Md.--(BUSINESS WIRE)--GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced the commercial expansion into Inborn Errors of Immunity (IEI), a group of nearly 500 genetic disorders that impair immune function2, increasing susceptibility to infections, autoimmunity, and inflammatory conditions. The strategic expansion reinforces GeneDx’s mission to improve patient outcomes by providing exome and genome testing solutions for an ever-growing number of patients, now including those with inherited immunological conditions.

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that Great Place to Work® and Fortune magazine recognized the company as one of the Fortune 100 Best Companies to Work For® in 2025. United Therapeutics ranked number 73 out of the 100 companies across the nation included in the list.

“We are honored to be recognized by Fortune as one of the 100 Best Companies to Work For,” said Michael Benkowitz, President & Chief Operating Officer of United Therapeutics. “This reflects a key management objective that United Therapeutics be a destination employer, where Unitherians can have their best career while fulfilling our mission to help very sick patients through the development of novel therapeutics and progress toward an unlimited supply of transplantable organs.”

This summer, your business can tap into Maryland’s top graduate business talent and get rewarded for it. The Maximizing Maryland Graduate Internship Program, run by the Center for Global Business (CGB) at the Robert H. Smith School of Business, offers companies a $1,500 reimbursement per intern hired—while connecting you with highly skilled students trained in global marketing, supply chain, finance, and business strategy.

ASHBURN, Va., April 02, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late clinical stage, specialty pharmaceutical company focused on the development and commercialization of therapeutic products that treat rare and orphan diseases, today announces additional highly positive clinical data from its ongoing Investigator Pediatric Netherton Syndrome (NS) study. After 6 weeks of continued whole body application of QRX003, the subject’s skin remains almost completely healed demonstrating the durability of ongoing daily treatment with the product. In addition, the patient has continued to have no requirement for previously necessary medications such as antibiotics, antivirals, antihistamines and glucocorticoids. Importantly, with the patient’s pruritus or itch almost completely eliminated, she continues to experience zero nightly sleep disturbances without the need for any sedating medication, marking the first continuous period of uninterrupted sleep in the patient’s life. No adverse events have been reported to date after 6 weeks of whole body treatment with QRX003.

POTOMAC, MD / ACCESS Newswire / April 1, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the expansion of its Phase 2 clinical trial, CALMA, evaluating IGC-AD1 for the treatment of agitation in Alzheimer's dementia, to MIND Institute at Miami Jewish Health in Miami, Florida. This addition further advances the company's efforts to accelerate the trial's completion and builds on promising interim data suggesting the potential of IGC-AD1 to improve patient outcomes.

Miami Jewish Health specializes in healthcare and living options for seniors, providing services for more than 85 years and hosting cutting-edge Alzheimer's disease clinical trials. The organization is dedicated to advancing research and innovative treatments for neurocognitive disorders, improving care for individuals living with Alzheimer's and related conditions.

WASHINGTON, March 31, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Bysanti™ (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the efficacy and safety of Bysanti™.

U.S. tariffs on imports could increase the cost of biotechnology operations, threatening innovation that helps patients, according to a survey of biotech firms by the Biotechnology Innovation Organization (BIO).

Nearly 90% of U.S. biotech companies rely on imported components for at least half of their Food and Drug Administration (FDA)-approved products, and they say tariffs would hurt their business, the survey of BIO member companies found.

“This survey demonstrates the far-reaching and potentially damaging impacts of the proposed tariffs on our biotechnology industry, on biomedical research and on patients,” said BIO President & CEO John F. Crowley.