SBIR and STTR Applicants Notice of Upcoming Changes Around Disclosures of Foreign Investments and Affiliations or Relationships Fenwick West LLP JDSupra

TL/DR: For participation in the SBIR and STTR programs, agencies now have a standard set of questions to ask small business concerns about their foreign investments and affiliations. Companies can use the questions to prepare for their disclosures.

The Small Business Administration (SBA) is amending the Policy Directive of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs to harmonize participating agencies’ collection of information about applicants’ foreign investments and affiliations. Participating agencies have been required to collect such disclosures since passing of the SBIR and STTR Extension Act of 2022.

 

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Register to attend a free NIH webinar. Attendees will learn about a new method for administering Transcranial Magnetic Stimulation (TMS). This new method improves both the instrumentation used to deliver TMS treatment, and the treatment’s magnetic pulse pattern; which when applied to an awake rat treatment model, was shown to provide significant improvement over conventional TMS treatment methods.

 

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Continuous manufacturing (CM) is an exciting frontier in drug manufacturing with the capacity to increase process efficiency while reducing costs. Manufacturers are now looking at ways to apply CM to make biologics. Biopharmaceutical continuous manufacturing (BCM) could increase product quality and productivity, enhance the process and product control, and increase flexibility, while also decreasing certain fixed costs associated with facility size and equipment maintenance, thereby reducing the environmental impact. There are barriers to the
widespread adoption of BCM, however

Credit: Rita Elena Serda, Duncan Comprehensive Cancer Center at Baylor College of Medicine, National Cancer Institute, National Institutes of Health
A pseudo-colored scanning electron micrograph shows two T cells (red) attacking a cancer cell (white)

Marios Gavrielatos had never participated in a machine learning competition when he decided to enter the Eric and Wendy Schmidt Center’s Cancer Immunotherapy Data Science Grand Challenge.

Gavrielatos’ friend and colleague, Konstantinos Kyriakidis, asked him to team up in the competition after learning about it from a promotional video on YouTube.

Image: Credit: Rita Elena Serda, Duncan Comprehensive Cancer Center at Baylor College of Medicine, National Cancer Institute, National Institutes of Health A pseudo-colored scanning electron micrograph shows two T cells (red) attacking a cancer cell (white)

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Maryland should see a boost in direct public funding toward manufacturing and lab space later this year as Gov. Wes Moore said he plans to sign a bill that will help build out the state's science and technology industries through a new fund.

Image: Wes Moore spoke about several of his plans to boost Maryland's innovation infrastructure at the TechStars Equitech Demo Day on April 4, 2023. Photo by Matt Hooke/Baltimore Business Journal

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A SELL-OUT crowd is anticipated for the AURP Bio Health Caucus in Boston, planned prior to the BIO International Convention.

Focusing on building research space supporting communities of bio innovations, we invite developers, A/E firms, researchers, economic development reps, VC firms, and bio innovation district managers to attend.

Click here to learn more.

Wes Moore Official Governor Portrait

Maryland should see a boost in direct public funding toward manufacturing and lab space later this year as Gov. Wes Moore said he plans to sign a bill that will help build out the state’s science and technology industries through a new fund.

Prior to his keynote speech at the TechStars Equitech Demo Day this week, Moore said he planned to sign Senate Bill 549, or House Bill 552, “as soon as it’s on my desk,” which would authorize the creation of the “Build Our Future” grant program to fund infrastructure projects in a variety of technological fields.

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Through this Challenge, NIA is seeking researchers and entrepreneurs with a demonstrated need who have innovative ideas for science-driven technologies and products with the potential to increase the diversity of NIA-funded small business research and development. Entrepreneurs from groups underrepresented in health-related sciences are strongly encouraged to apply.

 

Deka

Deka Biosciences (“Deka”), a clinical-stage biotechnology company headquartered at 20271 Goldenrod Lane in Germantown and focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, announced that the first subject has been dosed in a Phase 1 clinical trial of DK210 (EGFR) at NEXT Oncology in Fairfax, Virginia. The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, potential efficacy and evaluate possible biomarkers of response to DK210 (EGFR) in patients with advanced solid cancer(s) who are expressing epidermal growth factor receptors (EGFR) (NCT05704985).

Per the press release: “We are beyond thrilled to begin the clinical trial of DK210 (EGFR), marking our first program to enter clinical development,” said John Mumm, Ph.D., President and CEO of Deka. “Importantly, we anticipate that the results of the study will confirm the clinical safety, pharmacokinetics, exploratory efficacy and correlative biomarker responses to our first DiakineTM, establishing a solid foundation for the expanded use of this treatment in cancer patients.”

Click here to read more via The MoCo Show.

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Join AURP in Boston for a Deep Dive into Building Communities of Biotech Innovation!

June 4th-5th, 2023 | Boston, MA

A SELL-OUT crowd is anticipated for the AURP Bio Health Caucus in Boston, planned prior to the BIO International Convention.

Focusing on building research space supporting communities of bio innovations, we invite developers, A/E firms, researchers, economic development reps, VC firms, and bio innovation district managers to attend.

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Richmond, VA, April 05, 2023 (GLOBE NEWSWIRE) -- Phlow Corp., a U.S.-based public benefit corporation and contract development and manufacturing organization (CDMO), today announced that it has closed a $36 million Series B capital raise as part of its mission to protect America’s medicine cabinet. Since its launch in 2020, Phlow has been working to leverage advanced development and manufacturing processes to re-imagine the domestic production of key starting materials (KSM), active pharmaceutical ingredients (API), and finished pharmaceutical products that are critical to U.S. healthcare.

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GERMANTOWN, Md., April 3, 2023 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced the amendment of its exclusive license agreement with Alaunos Therapeutics, Inc. (Alaunos).

With this amendment, Precigen has the unique ability to utilize the clinically validated UltraCAR-T platform for unencumbered development and commercialization of two proven CAR-T targets, CD19 and B-cell maturation antigen (BCMA). These targets enhance Precigen's UltraCAR-T library approach, which is designed to transform the personalized cell therapy landscape for cancer patients through the development and validation of a library of non-viral plasmids to target various hematological and solid tumor-associated antigens. Enabled by the design and manufacturing advantages of UltraCAR-T, coupled with the capabilities of the UltraPorator® system, Precigen is working to empower cancer centers to deliver personalized, autologous CAR-T treatment with overnight manufacturing for cancer patients. The addition of CD19 and BCMA targets positions Precigen as a front runner in the CAR-T space.

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GERMANTOWN, Md., April 5, 2023 /PRNewswire/ -- Deka Biosciences ("Deka"), a clinical-stage biotechnology company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, announced today that the first subject has been dosed in a Phase 1 clinical trial of DK210 (EGFR) at NEXT Oncology in Fairfax, Virginia. The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, potential efficacy and evaluate possible biomarkers of response to DK210 (EGFR) in patients with advanced solid cancer(s) who are expressing epidermal growth factor receptors (EGFR) (NCT05704985).

"We are beyond thrilled to begin the clinical trial of DK210 (EGFR), marking our first program to enter clinical development," said John Mumm, Ph.D., President and CEO of Deka. "Importantly, we anticipate that the results of the study will confirm the clinical safety, pharmacokinetics, exploratory efficacy and correlative biomarker responses to our first DiakineTM, establishing a solid foundation for the expanded use of this treatment in cancer patients."

Ruchika Nijhara

COLUMBIA, Md. (April 4, 2023) – The Maryland Stem Cell Research Commission announces the appointment of Ruchika Nijhara, Ph.D., MBA, as executive director of the Maryland Stem Cell Research Fund (MSCRF). As executive director, Nijhara oversees all MSCRF activities and seven programs accelerating stem cell research, commercialization and cures.

The Maryland Stem Cell Research Commission (Commission), which oversees the fund, was established as an independent unit within the Maryland Technology Development Corporation (TEDCO). It leads the way in identifying and supporting the most promising stem cell technologies in our region.

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April 3, 2023 - The battle against Cancer has long been a collective effort, with advances in treatment and prevention made possible through the dedicated work of researchers, caregivers, advocates, and the investment of federal, state, and local governments, as well as private investment. Building on the progress made thus far, the National Cancer Plan represents a bold and ambitious framework to end Cancer as we know it. The National Cancer Plan has been developed to coordinate a comprehensive national response to achieving the goals of the Cancer Moonshot initiative, led by President Biden and First Lady Biden, and to deliver better cancer outcomes to all people​.

Image: https://twitter.com/theNCI/status/1642905180596498433/photo/1

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April 3, 2023 - Medcura, Inc., a life science and medical device company based in Riverdale, MD, is experiencing substantial growth in the BioHealth Capital Region. The company has developed a cutting-edge proprietary biosurgical technology demonstrating the rapid arrest of difficult-to-control surgical bleeding. This innovative technology offers the industry-best highly disruptive economics and has been tested in numerous challenging pre-clinical models. In addition to its versatility, the platform can be expanded into highly differentiated product solutions, as seen in Medcura's emerging surgical and recently commercialized consumer product applications. Notably, the company's products have garnered recognition for quickly stopping bleeding using naturally abundant and highly economical ingredients.

UMD I Corps Upcoming Cohort Dates

The regional UMD I-Corps Customer Discovery Workshops introduce teams and individuals with innovations to the concepts of business models and customer discovery.

UMD offers several live (over Zoom), instructor-led I-Corps workshops each year. You may only join these cohorts with instructor approval upon completing the I-Corps Prerequisite, a self-paced, online course.

 

Venable LLP Expands with Venable Blue About Venable LLP

Venable LLP today introduced Venable Blue, a legal and consulting service that helps clients protect their reputation and manage risk online. The service helps companies build, operationalize, and deploy integrated programs and systems, and manage escalations in all areas of business, including regulatory, compliance, content, child safety, human rights, and privacy online. Venable Blue extends and complements the robust offerings of Venable’s Technology and Innovation practice in data privacy, cybersecurity, and autonomous and connected mobility.

 

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How will protein engineering unleash a new era of therapeutic possibilities for BioHealth and the BioHealth Capital Region? Join us on this episode of BioTalk with Rich Bendis as Rich chats with Dr. Luis Alvarez, Founder & CEO of Theradaptive, who is at the forefront of protein engineering technology. Learn about Theradaptive’s ingenious approach to overcoming the challenges of naturally occurring proteins, elevating the efficacy and safety of therapeutics through precision-targeted delivery, and mitigating off-target side effects. From spinal fusion and orthopedics to soft tissue repair and targeted chemotherapeutics, Theradaptive’s breakthrough technology is set to transform the lives of millions grappling with debilitating conditions linked to loss of tissue function. Be part of the conversation that’s unlocking a world of untapped potential in the convergence of protein engineering and therapeutic discovery. Listen now here or via your favorite podcasting platforms:

A graduate of West Point, Dr. Luis Alvarez served in the U.S. Army for 20 years. Following a combat tour and seeing fellow servicemembers forced to undergo delayed amputations due to tissue damage, he was motivated to pursue a Ph.D. in biological engineering at MIT, where he was a Hertz Foundation Fellow. Dr. Alvarez founded Theradaptive following his time in the Army, using what he learned from his research to create a platform that can now deliver biologics in a highly targeted way. Previously, he was the founding deputy director of the U.S. Department of Defense’s Regenerative Medicine Program Office as well as lead for the DoD’s $720 million nerve agent pharmaceutical countermeasures program. As CEO and co-founder, Dr. Alvarez has seen the Theradaptive team grow from two to 32 people. The FDA granted the company three breakthrough designations for various spine indications, accelerating the process of reaching approval.

Click here for the transcript

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BLACKSBURG, Va. (March 28, 2023) – The Virginia Tech Corporate Research Center (VTCRC) announced today that three companies have been selected to join Johnson & Johnson Innovation – JLABS (JLABS). Under a collaboration between VTCRC and Johnson & Johnson Innovation, LLC, established to support innovators in the Blacksburg-Roanoke region with the aim to accelerate emerging biotech and life science startups, the selected companies will have full access to JLABS programming, resources, and mentorship from experts across The Johnson & Johnson Family of Companies virtually.

Acomhal Research, Qentoros, and The Tiny Cargo Company will benefit from the JLABS global life science network and industry connections, along with access privileges to the JLABS @ Washington, DC site, while keeping their businesses located in the region.

Tomatoes were among the plants tested for sound by Tel Aviv University researchers. (David Besa, CC BY 2.0, Wikimedia Commons)

It has been known for some time that plants communicate with one another, but Israeli scientists now say they’ve identified “words,” and have found that different species speak in different “languages,” according to a groundbreaking new study published Thursday in the prestigious scientific journal Cell.

Scientists already know that plants communicate in a variety of ways when they are stressed. They might change physically (by wilting or changing leaf color), become bitter to the taste (to deter herbivores), or emit smells (volatile organic compounds) to tell other members of the family that they are under attack, for example by insects.

Image: Tomatoes were among the plants tested for sound by Tel Aviv University researchers. (David Besa, CC BY 2.0, Wikimedia Commons)

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By Tom Still

MADISON, Wis. -- Society has been here many times before. A little more than 200 years ago, a group of English textile workers called the Luddites took to destroying mill machinery -- not because they were inherently anti-technology -- but mainly to protest labor conditions at the time. The movement faded in a few years and the textile industry continued down an inevitable road to automation.

The history of technology reveals many such examples of innovation being met with suspicion and worries that mankind would lose its moral compass. From Gutenberg’s printing press to the dawn of the computer age, people have fretted that new ways and machines would erode the ability of people to discern good from bad while dangerously accelerating change.

Marji Graf
The Greater Rockville Chamber of Commerce’s Chief Executive Officer, Marji Graf, serves on Rockville Economic Development, Inc’s (REDI) Board of Directors. REDI congratulates GRCC on their recognition, and is grateful for the continued involvement and guidance of Ms. Graf.
 

Annapolis, Md., Apr. 3, 2023 – The Maryland Association of Chamber of Commerce Executives (MACCE) named Greater Rockville Chamber President and CEO Marji Graf its 2023 Maryland Chamber Executive of the Year.

Marji is an exceptional leader and was selected as MACCE’s 2023 Chamber Executive of the Year because of her many notable accomplishments on behalf of the Greater Rockville Chamber of Commerce,” said Bill Chambers, MACCE President. Marji helped the Greater Rockville Chamber, and its members deal with the many challenges of the pandemic, while still focusing on their program of work and making a difference for her members and her community.

Among the numerous accomplishments noted in Marji’s nomination, standout achievements included diversifying and expanding her chamber’s programming, increasing its fiscal stability, and developing new, innovative responses to attracting and retaining members. “She is a dedicated
leader with a positive attitude and innovative spirit. Her commitment to the Chamber’s success was evidenced by adding new events, advocating for local businesses, and leading an effort to develop and implement valuesbased dues in 2022,” stated Laura Nash, Board Chair of the Greater Rockville Chamber and Relationship Manager and Vice President of West Financial Services.

An active member of MACCE, Marji is currently serving in her second year on MACCE’s Executive Board as Treasurer. Previous to moving to Maryland five years ago, Marji was a chamber leader in New England where she served as President of the Vermont Association of Chamber of Commerce Executives and President of the New England Association of Chamber of Commerce Executives.”

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$600,000 invested into 3 new ventures and $1.6Million awarded to 12 project grants

COLUMBIA, Md. (March 29, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent round of funding through the Maryland Innovation Initiative (MII).

Established in 2012, the MII program was created as a partnership between the State of Maryland and five Maryland academic research institutions: Johns Hopkins University; Morgan State University; University of Maryland, Baltimore; University of Maryland, Baltimore County; and University of Maryland, College Park. The program’s mission is to accelerate and support the commercialization of promising technologies from bench to market through investments in innovation, entrepreneurship and venture creation. 

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When husband and wife Zairen Sun Ph.D. ’98 and Beibei Li Ph.D. ’98 arrived in College Park from China in 1992, they had little understanding of their new country or its traditions or practices. What they did have was a mentor at the University of Maryland who knew what it was like to be an immigrant to the U.S.—and who could empathize with the process of adjusting to a very different way of doing things.

 

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  • NARCAN® Naloxone HCl Nasal Spray 4 mg is currently the first and only prescription strength naloxone nasal spray to receive over-the-counter status in the U.S., which is a critical step toward broadening access
  • Expected over-the-counter availability is anticipated by late summer of this year

GAITHERSBURG, Md., March 29, 2023 (GLOBE NEWSWIRE) -- Today, Emergent BioSolutions Inc. (NYSE: EBS) announced that the U.S. Food and Drug Administration (FDA) has approved NARCAN® Naloxone HCl Nasal Spray 4 mg as an over-the-counter (OTC) emergency treatment of opioid overdose. This decision comes at a time when approximately every eight minutes, a person dies from an opioid overdose and research shows the epidemic is escalating in the U.S. with the rise in synthetic opioids. By offering NARCAN® Nasal Spray as an OTC treatment, anyone will be able to access it without a prescription, which is an important step in the fight to reduce the number of opioid overdose deaths occurring each day.

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MARCH 28, 2023 - GAITHERSBURG, Md., (BUSINESS WIRE) -- Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced it received $35 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd. The investment will be used to advance and accelerate lead candidate JK07, including the planned initiation of the first Phase 2 study in HFrEF, the continuation of the ongoing Phase 1b clinical trial in heart failure with preserved ejection fraction (HFpEF), and the launch of the Company’s first neurology clinical trial with JK07. The financing will also support the ongoing Phase 1/2 trial of JK08 in solid tumors and advance JK06, a pre-clinical biparatopic antibody-drug conjugate, into an initial Phase 1/2 study.

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Leiden, the Netherlands , March 28, 2023 / B3C newswire / -- MIMETAS, a global leader in human disease modeling announces that it has entered into a strategic partnership with Astellas Pharma Inc., a global pharmaceutical company. The partnership comprises utilizing MIMETAS’ comprehensive tumor models to support the next generation of immuno-oncological therapies.

Vishal and Rich

Ready to explore the frontiers of cancer therapeutics? Discover how AUM Biosciences, with a key presence in Montgomery County, Maryland, in the BioHealth Capital Region, is revolutionizing the development of innovative oncology medicines and transforming the fight against cancer resistance. Join us on this episode of BioTalk with Rich Bendis as we chat with Vishal Doshi, Chairman & CEO of AUM Biosciences, a visionary leader in the biotech industry. Tune in to the conversation that's sparking new hope in the battle against cancer.

Listen now via your favorite podcast platforms: Apple - https://apple.co/42LvH4A Google - https://bit.ly/40yTOBC Spotify - https://spoti.fi/40F2NkV Amazon Music - https://amzn.to/40hFz4L TuneIn - https://bit.ly/42Gpfff YouTube - https://bit.ly/3TMIuji

Macrogenics

ROCKVILLE, MD, March 22, 2023 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today reported that following the U.S. Food and Drug Administration's (FDA) approval of Incyte's Biologics License Application (BLA) for ZYNYZ™ (retifanlimab-dlwr), the Company will receive a $15 million milestone payment from Incyte. ZYNYZ, a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), was previously developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017.

BioBuzz FITCI Partnership

MARYLAND, March 23, 2023 — BioBuzz, the media outlet of Workforce Genetics, and the Frederick Innovative Technology Center, Inc. (FITCI) have announced a strategic partnership to fuel industry growth in the BioHealth Capital Region and growth for both parties.

FITCI CEO Kathie Callahan Brady says she is excited to move forward. “We both focus on the biotech space, but the perspective is different. It is exactly the type of collaboration we want to infuse into our new EDGE@321 entrepreneurial innovation center opening later this year, bridging competencies and markets to strengthen the whole community.”

Image: https://biobuzz.io

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There has been a smoldering fire on the geopolitical stage that, if we continue to ignore, we risk allowing it to spread and burn its surrounding environment. I’m referring to the convergence of multiple technology revolutions with the high-stakes competition between the United States and a rising authoritarian competitor in China.

 

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Event provides forum for researchers to learn more about ARPA-H’s Open Broad Agency Announcement

ARPA-H has opened its first Agency-wide Open BAA, seeking funding proposals for research aiming to improve health outcomes across patient populations, communities, diseases, and health conditions.

On April 4, ARPA-H will host a Proposers’ Day for interested parties to learn more about the application process for the Open BAA and ask questions. Register for the event. (Registration closes 5 p.m. ET on Monday, March 3)

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MARYLAND, March 23, 2023 — BioBuzz, the media outlet of Workforce Genetics, and the Frederick Innovative Technology Center, Inc. (FITCI) have announced a strategic partnership to fuel industry growth in the BioHealth Capital Region and growth for both parties.

FITCI CEO Kathie Callahan Brady says she is excited to move forward. “We both focus on the biotech space, but the perspective is different. It is exactly the type of collaboration we want to infuse into our new EDGE@321 entrepreneurial innovation center opening later this year, bridging competencies and markets to strengthen the whole community.”

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Riley-Brown will succeed Kurt Newman, M.D., who has served in role for over 11 years

March 23, 2023

The Children’s National Board of Directors announced today that Michelle Riley-Brown, MHA, FACHE, has been named as the new president and chief executive officer (CEO) of Children’s National Hospital. On July 1, Riley-Brown will succeed Kurt Newman, M.D., who is retiring after 11 years as president and CEO.

Riley-Brown is an accomplished executive with over 20 years of experience leading and supporting children’s healthcare. She is currently an executive vice president at Texas Children’s Hospital at the Texas Medical Center in Houston, where she serves concurrently as the president of two hospitals in the system while leading the construction and staffing of a third. She also leads system-level operations, strategic planning, physician practice acquisition, quality performance, clinical operations, fund development, marketing, brand management and public relations for the nation’s largest pediatric and women’s healthcare organization.