Author: Raymond McBride

San Antonio’s Texas Biomed expanding work

Before the COVID-19 pandemic, Texas Biomedical Research Institute had established itself as a go-to researcher of infectious diseases, along with therapeutics and vaccines to combat them. It was recognized by the federal government, though not necessarily among the top contractors able to take on more government-funded bioscience research.

Since the pandemic began, the independent San Antonio nonprofit has expanded its reputation with government and within the private sector, namely the pharmaceutical industry. And that has widened Texas Biomed’s potential customer and revenue base at a time that it’s undergoing an expansion and modernization plan estimated at more than $300 million.

Texas Biomed, which seeks to increase its staff from 430 to 700 employees in the next decade, is looking to strengthen partnerships with pharmaceutical companies like Pzifer and Regeneron Pharmaceuticals. After being contracted by those two companies to study and develop COVID-19 vaccines and therapeutics, more calls have come from the industry seeking Texas Biomed’s help to streamline the path from research to market.

On ExpressNews.com: Texas Biomed elevated to state’s only prime contractor in U.S. response to pandemic, bioterrorism

With a new financial strategy, the institute is ready to engage with Big Pharma and high-dollar contracts. Its researchers boast access to high-level containment labs and a primate center, confident that they can help pharmaceutical companies move scientific discoveries to preclinical studies and commercial adoption.

Texas Biomed CEO Dr. Larry Schlesinger said Big Pharma has “reduced its investment” in developing new drugs to treat infectious diseases in recent years, to a large extent out of concern that their shelf lives are too short. And the resulting void is where the research institute can play a key role.

“They need a nonprofit to do the hard development work they could then take over and commercialize,” Schlesinger said.

At the same time, Schlesinger believes the nonprofit can grow its basic science research like medical schools or universities that have long histories of working with industry partners.

“Based on the need to really handle infection, we need to have more products,” he said. “We don’t convert our scientists to businessmen. We just help them understand how there’s a very fine line between cutting-edge, basic science discovery and a possible application.”

Diversifying revenue

Texas Biomed reported revenue of $70 million this year, up 38.6 percent from $50.5 million in 2017. It secured $108 million in grants and contracts in 2022, up significantly from $27 million in 2017.

As part of the institute’s expansion plan, it broke ground on a $15 million-plus animal care complex and is ramping up efforts for its new Global Center for Bioscience, which is known as “the future home for multidisciplinary team science,” director of public relations Nicole Foy has said.

Federally funded work won’t be enough to help bring Texas Biomed’s vision to fruition.

“Funding (from the National Institutes of Health) for biomedical research is tight,” Schlesinger said. “When we ask for $1 for an experiment, the NIH pays us $1.98. The 98 cents is the indirect revenue on every dollar to fund the lights and the mortar and the bricks to help the research. That alone is not enough money actually to sustain the expense of science.”

He said the nonprofit aims to diversify its revenue.

His rough idea is to generate 50 percent of Texas Biomed’s revenue from NIH funding, with the rest coming from current government grants and increased private sector contracts from Big Pharma, which would provide indirect funding for research, the expansion of the campus and hiring scientists.

“For institute’s that don’t diversify, they either close or they are in slow decline, because you can’t support the cost of the science,” he said. “I would say diversification is critical.”

Big Pharma is also interested in engaging scientists to work on lucrative biological data projects. Besides studying infectious diseases, scientists might be involved in collecting biological data — a lucrative market. For Texas Biomed, it’s a new practice with the potential to yield tension among scientists.

Schlesinger hopes to find an “aligned strategy” to complete such data projects while keeping scientists on task to research infectious diseases. He doesn’t want to “get into the business of ripping off the scientists to do contract work.”

“We need to resource both properly to avoid that tension,” he said. “We’re growing, and there’s tension that comes with growth. But tension needs to be in right-sizing both sides of the house at the same time, trying to keep a handle on administrative costs so we have the money available to do that science.”

The nonprofit expects to receive more federal funding after being named a prime contractor with the Biomedical Advanced Research and Development Authority.

Since 2015, the nonprofit has received about $46 million through subprime contracts with the authority. The new status puts it in the top ranks of the authority’s limited network and enables it to receive up to $100 million in federal funding over five years. It’s now the only researcher in Texas with the designation.

It will also continue to seek funding from the city of San Antonio, philanthropists and private sector contracts. In 2022, the San Antonio City Council voted to give $10 million in federal COVID-19 relief money to the nonprofit.

Infectious disease a ‘growth area’

Texas Biomed’s revenue from contract research — much of it involving projects that are confidential — jumped 187 percent from 2017 to 2022, the nonprofit reported.

And it expects contract revenue to grow based on the threat of infectious diseases, a threat it considers to be massive, so much so that its executives believe infectious diseases may become the leading cause of death by 2050.

Such projections are based on a groundbreaking report — by the United Nation’s ad hoc Interagency Coordination Group on Antimicrobial Resistance — that estimated drug-resistant diseases could cause 10 million deaths per year by that time, up from about 700,000 today. The U.N. said the economic damage from such a level of deaths could be as “catastrophic” as the global financial crisis of 2008-09 and push millions of people into poverty.

“From a business perspective, this is a growth area,” Schlesinger said.

As COVID-19 has killed millions across the U.S. and the world, the bioscience industry has been rushing to study infectious diseases and bring therapeutics and vaccines to market.

To that end, Schlesinger said Texas Biomed has found created a business model “at the cutting edge of infectious disease research and development model that you’re going to see more of,” Schlesinger said. “The world is demanding more options to treat infection.”

Texas Biomed has existing partnerships with MAPP Biopharmaceuticals in California and the nonprofit Sabin Vaccine Institute in Washington, D.C., involving recent Sudan Ebolavirus vaccines and therapies. It has also re-established existing models for mpox, formerly called monkeypox, to support therapy studies for Regeneron.

“Our business is science,” Cory Hallam, vice president of business development and strategic alliance, said. “Our currency is quality science regardless of who the audience is, whether it’s your collaborators and fellow researchers that are pushing the boundaries and discovery or partners or clients you’re working with to actually do science for them.”

‘Primed’ for the pandemic

Yale-educated oil man Tom Slick founded Texas Biomed in 1941, and he started the nonprofit Southwest Research Institute seven years later.

Ever since, Texas Biomed scientists have primarily worked on independent projects funded by the NIH, part of the U.S. Department of Health and Human Services, Foy said.

They studied diabetes, obesity, cancer and aging. But under the leadership of Schlesinger, who became CEO in 2017, the institute pivoted to focus on researching infectious diseases.

That year, an internal audit found that 70 percent of the institute’s research involved infectious disease, a category that drove about 80 percent of its revenue. Another 10 percent of revenue came from contracts, almost exclusively in high-containment work in Texas Biomed’s biosafety level 4 lab, known as BSL-4.

Texas Biomed is home to the nation’s only privately owned BSL-4 containment lab used to study infectious agents or toxins and life-threatening disease. It also operates 7,500 square feet of BSL-3 labs.

On ExpressNews.com: National group says San Antonio shouldn’t give COVID-19 relief funds to Texas Biomed

Then, in early 2020, amid the coronavirus pandemic’s initial stages, Schlesinger issued funding calls to local donors — including H-E-B, USAA and the McCombs Foundation — to collect nearly $3.5 million for five COVID-19 research projects.

The nonprofit also received a $60,000 grant from the NIH to help it determine which animal — baboon, macaque or marmoset — could produce best test subjects.

The institute’s Southwest National Primate Research Center has more than 2,500 primates, including chimpanzees and about 1,000 baboons — making it the world’s largest colony of baboons for biomedical research. It hasn’t conducted “invasive research” on chimpanzees since 2016, after the NIH announced it would no longer support biomedical research on the endangered species.

Scientists conduct research on primates in the BSL-3 and BSL-4 labs — the same facilities they used to study Ebola, hepatitis C, Zika and SARS, a coronavirus genetically related to the strain that caused COVID-19.

Texas Biomed established partnerships with pharmaceutical giant Pfizer and biotechnology company Regeneron Pharmaceuticals, both based in New York. It also worked with Novavax, a biotechnology firm in Maryland, as well as Gilead, a pharmaceutical company in California.

The institute’s staff gained national recognition for its contributions to researching COVID-19 and for helping the government and Big Pharma get therapeutics and vaccines onto market.

“Being primed helped us when the pandemic hit,” Schlesinger said.

eric.killelea@express-news.net

Transgender patients face discrimination during health care visits

One trans woman recalled a doctor calling her “it.” A nonbinary person was grilled about their use of “they/them” pronouns during an ultrasound. A trans-masculine person moved out of Tennessee, fearing they would lose access to hormone therapy as legislators passed bills restricting gender-affirming care.

Transgender Americans often face subtle discrimination, outright hostility and ill-informed medical professionals in their interactions with the health-care system, according to a poll by The Washington Post and KFF, a nonprofit focused on national health issues.

Challenges arise during routine medical visits as well as when transgender people seek hormone therapy and other forms of gender-affirming care.

Nearly half (47 percent) of trans adults say the health-care providers they have come in contact with know “not too much” or “nothing at all” about providing health care to trans people. Just 10 percent say the health-care providers they have come in contact with know “a lot” about caring for trans people. About 4 in 10 (37 percent) trans adults say it is “somewhat” or “very” difficult to find a health-care provider who treats them with dignity and respect; while about a quarter (24 percent) of cisgender adults say the same. Just over half (53 percent) of trans adults say it is easy to find health care they can afford, less than the 63 percent of cisgender adults who say the same.

Activists say a welcoming health-care system would include affordable access to gender-affirming care from counseling to surgery. Good care also includes professionals treating transgender people with respect, using their preferred pronouns and not being quick to blame hormone treatment for unrelated medical problems.

About 3 in 10 trans adults say they have had to teach a doctor or other health-care provider about trans people so they could get appropriate care, had a doctor or other health-care provider refuse to acknowledge their preferred gender identity and instead refer to their sex assigned at birth, or been asked unnecessary or invasive questions about their gender identity unrelated to the medical reason for their visit. About 1 in 6 trans adults say they have had a doctor or other health-care provider refuse to provide them with gender-affirming care, such as hormone treatments.

The Post-KFF poll is the largest nongovernmental survey of U.S. trans adults to rely on random sampling methods. It builds on a body of research that has often demonstrated poor access to health care for transgender people but with limited data.

“LGBTQ+ people experience high levels of stigma and discrimination and victimization that persists across the lifetime, and this new work amplifies that,” said Lindsey Dawson, director of LGBTQ Health Policy at KFF.

“To have your gender affirmed and to be in an inclusive environment where you have to be quite vulnerable about gender identity can be quite meaningful,” Dawson said. “To have negative experiences might dissuade somebody from accessing health care in the future.”

As Republican state lawmakers mobilize to restrict access to gender-affirming care for children — and in some cases, adults — the poll offers a reminder of the basic struggles transgender adults face in medical environments.

The poll finds trans people’s ease of access to health-care providers who treat them with dignity and respect is not significantly different in states that former president Donald Trump won compared with states President Biden won. The survey also finds that trans adults in urban areas are more likely to report having to educate health-care professionals (38 percent) than those in suburban/rural areas (23 percent) — challenging perceptions that more liberal areas are havens for tolerance and inclusivity.

In follow-up interviews, five transgender and nonbinary Americans who responded to the poll elaborated on their experiences:

Corey Brooks (they/them)

25, Pittsburgh

Even the name of the place Corey Brooks frequented for routine medical care — Magee-Womens Hospital — felt alienating.

Patients donned pink gowns. Cutouts of pink bras were plastered on the walls. A sign urged patients to “fight like a girl.”

“Things like that are just incredibly disorienting for someone going into those spaces who is always being reminded, hey, this wasn’t designed for you,” Brooks said. “You’re not really sure if you should disclose to these people that you’re trans or not.”

Brooks identifies as nonbinary and transgender, but as someone who was assigned female at birth, they share similar health needs as cisgender women for gynecologic care and screenings for chest health as they age.

Brooks was used to uncomfortable visits to the doctor, based on their college experiences when university health services staff peppered them with questions about birth control and sexual activity, assuming they were a cisgender heterosexual woman. They wrote their senior thesis on health access issues for transgender people and avoided the doctor for a few years after graduation.

The worst experience came while undergoing an ultrasound on their chest at the women’s hospital in Pittsburgh. The doctor paused and stared at Brooks’s medical file, spotting a note that they use they/them pronouns.

“What does that even mean?” Brooks recalled the doctor asking in a tone dripping with hostility rather than curiosity.

“As a trans person, that’s unfortunately not uncommon where you’re expected to provide all of this education for your providers,” Brooks said. “You wouldn’t expect a patient who is diagnosed with diabetes to have to educate their doctor on what diabetes is.”

Suzanne Rathburn (she/her)

70, Weed, Calif.

In the 1980s, a psychiatrist pushed his chair away from his desk and abruptly ended a meeting after Suzanne Rathburn explained she was trans. In 2012, a Veterans Affairs doctor referred to her as “it.”

In hundreds of medical visits over decades of navigating gender-affirming care and a rare genetic disease, Rathburn said she’s only had a few doctors she considers “good.”

As she began her transition in the 1980s after leaving the Air Force, Rathburn turned to the library to learn more about gender dysphoria and to find a therapist. She received a vaginoplasty. At the Oakland VA where she underwent hormone therapy, Rathburn said just one of the doctors treated her with respect, while others were dismissive of her medical needs or made negative comments about her gender identity — despite being in the LGBT-friendly San Francisco Bay Area.

Fed up after repeated indignities, Rathburn filed a discrimination complaint against another VA hospital that declined to perform a Pap test after several years of her requests. She said the VA eventually referred her to a doctor outside the system, and her complaint remained unresolved.

It wasn’t until she moved to rural Weed near the Oregon border in 2011 at age 59 that Rathburn experienced some of the best medical care of her life. A medical practice she visited near Medford, Ore., changed its intake forms when she pointed out gender questions were binary. A doctor in the nearby town of Mount Shasta, Calif., treated her trans identity as no big deal and spent time researching her genetic disease. Her therapist, also in Mount Shasta, specializes in supporting trans patients.

“I don’t have to explain it to her,” Rathburn said. “We talked about stuff I haven’t talked about with other therapists or to the psychiatrists I’ve had over 20 years.”

Hans Dirkmaat (they/he)

29, Longmont, Colo.

Hans Dirkmaat knew the nurse practitioner was ill-suited to care for transgender people when they had to explain what top surgery was.

During the primary-care visit, the provider marveled at why someone would want to remove their breasts. She asked, “When are you going to get a penis?”

Another medical professional in the room mouthed, “I’m sorry.”

Dirkmaat, who identifies as trans-masculine and nonbinary, didn’t have many choices for medical care that were in their insurance provider network when they lived in Nashville. They hoped the provider would have been more sensitive because she had mentioned having a lesbian daughter during their first appointment.

But tolerance for gay people does not mean a medical provider is attuned to the health-care needs of trans people. Transgender people weigh the risks and benefits of different aspects of gender-affirming medical care, and most have not received hormone therapy or transition-related surgeries.

Dirkmaat was wary of taking testosterone because of a heightened risk of cardiovascular complications. Their mother had died of heart disease at 41.

But that same nurse practitioner declined to prescribe medication to treat their high cholesterol because it could create pregnancy complications. The fact that Dirkmaat is married to a cisgender woman and has no plans to have children did not sway the provider. She said she would only authorize the pills if Dirkmaat were to undergo testosterone treatment.

“It’s very frustrating,” Dirkmaat said. “Like I can’t make decisions for me.”

The climate for transgender people in Nashville was starting to feel more unsafe, they said. The clinic specializing in transgender care where they received chest masculinization surgery became a magnet for right-wing protests, forcing the clinic to close on some days to protect patients. They drew more disgusted looks on the streets.

Tennessee GOP lawmakers joined the vanguard of a national movement to restrict care for transgender people, passing legislation to ban gender-affirming care for minors. Activists fear care for adults is next, noting legislation introduced to prohibit the state Medicaid program from working with insurers that cover gender-affirming care.

As Dirkmaat weighed whether to take hormones, they feared such therapy could be banned next.

So they moved to a suburb of Boulder, Colo., where a doctor who specializes in hormone therapy and its effects on the cardiovascular system is just an hour drive away.

Ezekiel Scott (he/they)

31, Columbus, Ohio

When Ezekiel Scott left Minnesota to attend college in Ohio last year, he brought six months’ worth of hormone medication just in case he ran into trouble resuming care. It wasn’t enough.

Administrators at Ohio State University assured Scott, who identifies as transgender and nonbinary, that hormone therapy would be covered under student health insurance. But first he needed to reestablish care with a doctor — and that proved to be a challenge.

He didn’t want to go to just any doctor, but one familiar with treating transgender patients. He had had negative experiences with doctors who were quick to blame the hormone therapy for mundane medical conditions, including one who suggested ending it to address a rash on his arm.

“That’s the first thing we’re going to try? Not like, I don’t know, a skin cream?” Scott said.

The hormones were essential to feeling comfortable in his own skin and affirming his gender identity, but the treatment was cast as cosmetic and unnecessary. “It’s like being told to stop having your own face,” he said.

It took four months to get an appointment at a university health clinic. After obtaining authorization to receive testosterone, a national shortage of the intramuscular injections further delayed his access to treatment as he exhausted his previous supply.

For several months, he had to ration weekly hormone injections that helped him develop facial hair and a deeper voice in line with his gender identity. And because he had had his ovaries removed, the absence of natural hormones risked his heart health.

His depression and anxiety grew worse, and he experienced suicidal ideations. Medication management for ADHD, once balanced with the hormone therapy, became complicated. He experienced hot flashes, an apparent result of early menopause caused by hormones not coming in properly.

Months later, he found a walk-in clinic recommended by a nonbinary friend. He got hormones that same day, eight months after he moved. His mental health improved, he could focus in school again, and the hot flashes ended.

“All of it is back in balance,” Scott said.

Richael Faithful (they/them)

37, Washington, D.C.

Richael Faithful is no stranger to cringeworthy moments during visits to the doctor.

Staff at some offices would misgender them. The first dermatologist they saw appeared nervous and avoided eye contact after Faithful disclosed being trans. One lung specialist they saw for breathing issues who seemed well-meaning shared a story about knowing “a transgender.”

“Once folks have bad experiences, it’s really hard to trust the health-care system again,” said Faithful, a D.C. resident who identifies as nonbinary and trans-masculine. “But I do want other trans folks and other cis folks to know there are good providers out there providing high-quality care.”

Faithful does not identify as a woman but is not transitioning to be a man either. For them, gender-affirming care means presenting more masculine to the world.

Faithful considers themselves part of the top 1 percent in being able to access gender-affirming care because they have the financial means and emotional support network to do so.

Faithful sought hormone therapy through a nurse practitioner at a medical concierge service with a reputation for being trans friendly and where membership costs $300 a year. They pay $265 every month and a half for hormones. They were able to travel with their partner to Florida for two weeks to undergo chest reconstruction surgery from a well-known plastic surgeon who does not accept health insurance and charges $15,000, paid in advance.

The staff at another dermatology practice where Faithful received acne treatment used the correct pronouns and showed a nuanced understanding of the relationship between hormone treatment and acne.

Faithful said they could afford these services as a consultant for social justice organizations who receives health insurance through their partner’s plan — while other Black transgender people living in the poorest parts of the city struggle to access basic gender-affirming care.

“My stress level is just kind of lower because I notice I’m not navigating even seemingly small things that just are distracting or annoying when they continue to happen,” Faithful said.

Scott Clement and Emily Guskin contributed to this report.

President Biden Announces Key Appointments to Boards and Commissions

WASHINGTON – Today, President Biden announced his intent to appoint members of the President’s Council on Sports, Fitness, & Nutrition. The President’s Council on Sports, Fitness, & Nutrition is a federal advisory committee that aims to promote healthy, accessible eating and physical activity for all Americans, regardless of background or ability. President Biden issued Executive Order 14048, renewing the President’s Council on Sports, Fitness, & Nutrition, which allows for continued promotion of the National Youth Sports Strategy and provides for the work of the Council to include a focus on expanding national awareness of the importance of mental health as it pertains to physical fitness and nutrition.

In 2022, President Biden appointed José Andrés and Elena Delle Donne to serve as Co-Chairs of the President’s Council on Sports, Fitness, & Nutrition.

President Biden announced his intent to appoint the following individuals to serve as members of the Council:

  • Maribel Campos Rivera
  • Tamika Catchings
  • Ayesha Curry
  • Stephen Curry
  • Jon Feinman
  • Tina Flournoy
  • Jose Garces
  • J. Nadine Gracia
  • Meg Ham
  • Kahina Haynes
  • Ryan Howard
  • Martin E. Ingelsby
  • Barbie Izquierdo
  • Ben Jacobs
  • Chloe Kim
  • Chaunte Lowe
  • Viviana Martinez-Bianchi
  • Elana Meyers Taylor
  • Dariush Mozaffarian
  • Kim Ng
  • Allison O’Toole
  • Oluwaferanmi Oyedeji Okanlami
  • Laura Ricketts
  • Stefany Shaheen
  • Billy Shore
  • Michael Solomonov
  • Melissa Stockwell

Maribel Campos Rivera

Dr. Maribel Campos Rivera is a Physician scientist, Board-Certified in Pediatrics, Neonatal and Perinatal Medicine and Obesity Medicine, with degrees in Health Care Administration and Clinical Research. She is a Robert Wood Johnson Interdisciplinary Research Leaders Alumni with over 20 years of experience implementing diverse research designs. As Professor of the University of Puerto Rico Medical Sciences Campus she has mentored trainees at different stages of training and backgrounds, providing them the opportunity to meet their community and be better equipped to address the social determinants of health. Her research work focuses on the effects of fetal and early childhood exposures on health across the lifespan. Her trajectory includes community action projects fostering a culture of health through system alignment, science education, and interdisciplinary care. Her team specializes in collaborating with community-based and professional organizations towards the development and implementation of evidence-based solutions that are place-based and community informed. Her role within the Voices for Healthy Kids community supported by the American Heart Association is just one example of their contributions towards health equity. She is the founder and Director of the Center for Community Outreach for Health Across the Lifespan and member of the Board of Directors of the Puerto Rico College of Physicians and Surgeons as President of the Research and Technological Development Institute. Her commitment to improve the rate of adoption of healthy lifestyles fueled her transition from NICU Medical Director to Founder of Emerge, a public benefit corporation dedicated to family-based holistic healthcare.

Tamika Catchings

One of the most decorated athletes of all time, Tamika Catchings has left an indelible mark at every level of the game. Catchings is a four-time Olympic gold medalist, ten-time WNBA All-Star, five-time Defensive Player of the Year, and a WNBA Champion. She helped lead the Indiana Fever to a league-record 12 consecutive playoff appearances and was 2011 league MVP and 2012 Finals MVP, leading the Fever to their first WNBA Championship. Catchings retired as the leading rebounder in WNBA history and second in all-time scoring.

In 2004, she launched the Catch the Stars Foundation, which empowers youth by providing goal setting programs that promote fitness, literacy, and youth development. In addition to the Foundation, Catchings operates the cozy Tea’s Me Café on the north side of downtown Indianapolis, and continues her engagement with basketball, serving as an ESPN/SEC Network Analyst. Catchings is the author of an autobiographical story, Catch A Star: Shining through Adversity to Become a Champion, sharing her story of overcoming hearing loss, separation from family, high expectations, and the pain of debilitating physical injuries. Catchings was routinely acknowledged for her sportsmanship and has received numerous accolades for her dedicated efforts on behalf of varied social causes, including the ESPN Sports Humanitarian of the Year, the WNBA’s Dawn Staley Community Leadership Award, the WNBA’s Kim Perrot Sportsmanship Award, and the Pathfinder Award by the Indiana Sports Corporation, honoring those who improve the lives of America’s youth.

Ayesha Curry

Ayesha Curry is a renowned restauranteur, chef, two-time New York Times bestselling author, producer, host, entrepreneur, and was featured on the prestigious Forbes “30 Under 30” list. Her accessible approach to cooking has made her one of the most sought-after experts in food and lifestyle. Ayesha is the Founder and CEO of Sweet July, her burgeoning lifestyle brand with a focus to uplift an inclusive and eclectic array of creators through the products sold and stories shared. In 2019 Ayesha launched Sweet July, a quarterly lifestyle magazine that covers a range of topics such as wellness, fashion, fitness, beauty, entrepreneurism, and food. Following the launch of the magazine, Ayesha opened a brick-and-mortar Sweet July storefront and café in Oakland, California and its accompanying website, featuring thoughtfully-created products alongside other carefully selected items from Black-owned and female-founded companies. In 2020, Ayesha launched Sweet July Productions, which focuses on creating content centered around food, family, faith, and female empowerment. Most recently, Ayesha served as Host and Executive Producer of HBO Max’s “About Last Night.” In 2022, Ayesha announced Sweet July Books in partnership with Zando. Sweet July Books will acquire fiction and nonfiction work, with a focus on diverse authors and women’s stories. Ayesha, along with her husband Stephen, is the co-founder of Eat. Learn. Play., an organization dedicated to unleashing the potential of every child and making a positive impact for generations to come.

Stephen Curry

Stephen Curry’s on and off court legacy is underscored by transformation and innovation. Widely regarded as the greatest shooter in NBA history, Stephen is point guard for the Golden State Warriors where his 14-year career is marked by many firsts. He was the first person to be named Most Valuable Player by unanimous vote in NBA history, the first player to hit 100 3-pointers in the NBA Finals, one of a select few to win MVP awards two years in a row, remains the all-time leading scorer in Golden State Warriors history, and recently surpassed former record-holder Ray Allen for most 3-pointers made in NBA history. He holds nine NBA All-Star selections and four NBA Championships. An emerging figure in the Bay Area, the athlete’s endeavors tout a number of innovative and progressive consumer, entertainment, and non-profit entities. He is the CEO of SC30 Inc. (SC30), a purpose-driven company that focuses on the athlete’s off-court endeavors spanning brand partnerships, media, investments, and philanthropy. In 2020, he launched Curry Brand, a purpose-driven legacy brand powered by Under Armour, with a mission to open doors for underrepresented youth and increase access for sports across the country. In 2019, Stephen and Ayesha Curry launched Eat. Learn. Play. Foundation, an organization dedicated to unlocking the amazing potential of every child by fighting to end childhood hunger, ensuring students have access to a quality education, and providing safe places for all children to play and be active. Stephen co-founded Unanimous Media in 2018, with a goal to elevate diverse voices and shine a light on compelling narratives focused on family, sports, and faith-based content for all platforms. Additionally, he founded UNDERRATED, an inspiring lifestyle brand committed to providing equity, access, and opportunity to underrepresented communities.

Jon Feinman

Jon Feinman founded InnerCity Weightlifting (ICW) in 2010, building upon his experience in AmeriCorps and as a personal trainer. As CEO, he is focused on aligning the vision, strategy, culture, and growth of ICW to flip power dynamics, bridge social capital, and amplify the voice and agency of people at ICW. Over his 13 years at ICW, the company evolved from a weight training program, to a workforce development track, to a social justice organization. What started as a gym is now a community where people belong, together. Where people are valued as equals, and people with lived experience are listened to as the experts. It is a person-centric organization, where goals are determined by and driven by each individual. Rather than doing something “for” someone, ICW partners with and alongside each person to assist in empowering personal success.

Feinman received his MBA from Babson College in 2010 where he launched ICW. For his work, Feinman has received awards from the Boston Celtics, Year Up, Good Sports, Bostinno, and Babson College. In 2014 he was named one of the Ten Outstanding Young Leaders by the Greater Boston Chamber of Commerce, and in 2015 received the Ernst and Young New England Entrepreneur of the Year for Social Entrepreneurship. ICW has been featured on ESPN, CBS, NESN, and in the Boston Globe, Wall Street Journal, Fast Company, and NPR.

Tina Flournoy

Tina Flournoy was born and raised in Savannah, Georgia. She and her family – grandmother, mother, father, and four brothers – were all true sports fans. For Flournoy, it is a passion that has endured throughout a career in government, labor, and politics. She has experienced firsthand the power sports has to bring people and communities together and to help young people become confident, healthy, and focused. Flournoy served as Chief of Staff to Vice President Kamala Harris. Prior to joining the Vice President’s staff, she served as Chief of Staff to former President Bill Clinton. In that role she worked with the 42nd President to manage all of his activities with the Clinton Presidential Center in Little Rock, the Clinton Foundation, his multiple television, digital, and written engagements and all other business, political, and personal interests. Throughout this period, President Clinton’s office worked with numerous strategic partners in the U.S. and around the globe to develop and implement projects to create economic opportunity, improve public health, and inspire lasting civic engagement.

Previously, Flournoy oversaw public policy and political strategy for the American Federation of Teachers (AFT) in the office of the international union’s President. Specifically, she was responsible for political mobilization, government relations, human rights, and community development. She was also the liaison to elected officials, civic organizations, nonprofits, businesses, and advocacy groups for AFT. Flournoy clerked for The Honorable Julia Cooper Mack of the District of Columbia Court of Appeals. Additionally, she served as Chief Counsel in both the White House Office of Presidential Personnel and in the 1992 Presidential Transition Office. She was Counsel for the Democratic National Committee and General Counsel for the 1992 Democratic National Convention. She received her Juris Doctorate from Georgetown University School of Law and her Bachelor of Arts from Georgetown University.

Jose Garces

Iron Chef, father, husband, James Beard Award-winner, entrepreneur, and food innovator, Chef Jose Garces is known as a leading culinary authority of Spanish and Latin-American food. From the Spanish tapas at Amada, his first restaurant, to the rotating tasting menus at Volvér at the Kimmel Cultural Campus, Garces continually pushes the boundaries of culinary excellence. While he maintains his successful career owning and operating full-service restaurants, Garces is also looking toward the future, with an increased focus on bringing restaurant-quality experiences to the homes and businesses of culinary enthusiasts in new and interesting ways. From enhanced home delivery options and virtual online cooking demos, to live online cooking classes, Garces is excited to connect with both fans of his work on television, as well as the home cook who’d like to experience “chef life” in their own kitchen.

As a child of immigrants and a leader in the diverse and inclusive hospitality industry, the wellbeing of his community in Philadelphia has always been dear to Garces’ heart. To help provide ongoing and actionable assistance to the immigrant community, Garces co-founded The Garces Foundation in 2011. The Garces Foundation provides services, including community health days, English language skills classes that target the restaurant industry, and most recently, an increased focus on procuring and providing food supplies to the food insecure. Garces is the author of two cookbooks, Latin Evolution and The Latin Road Home.

J. Nadine Gracia

Dr. J. Nadine Gracia is the President and CEO of Trust for America’s Health, a nonprofit, nonpartisan public health policy, research, and advocacy organization that promotes optimal health for every person and community and makes the prevention of illness and injury a national priority. She is a national health equity leader with extensive leadership in federal government, the nonprofit sector, academia, and professional associations. Gracia served in the Obama-Biden Administration as the Deputy Assistant Secretary for Minority Health and Director of the Office of Minority Health at the U.S. Department of Health and Human Services (HHS). In that capacity, she directed departmental policies and programs to end health disparities, advance health equity, and provided executive leadership on administration priorities including the Affordable Care Act and My Brother’s Keeper. Previously, she served as Chief Medical Officer in the HHS Office of the Assistant Secretary for Health, where her portfolio included adolescent health, emergency preparedness, environmental health and climate change, global health, and the White House Council on Women and Girls. Prior to that role, she was appointed as a White House Fellow at HHS and worked in the Office of the First Lady on the development of the Let’s Move! initiative to solve childhood obesity. Passionate about service and leadership development, she is active in many professional and civic organizations.

Meg Ham

As President of Food Lion, Meg Ham leads 82,000 associates who are dedicated to providing fresh, healthy, and affordable food to approximately ten million customers each week across ten Southeastern and Mid-Atlantic states. During her more than 30-year tenure at Ahold Delhaize USA, parent company of Food Lion, Ham has served in executive leadership roles in both retail operations and merchandising functions at Food Lion and its sister banner, Hannaford, and at the helm of Bottom Dollar Food, the company’s former discount banner. Ham has built her career as a food retailer, focused on the value of service to customers and associates. Being part of the community a company serves is a driving force for Ham. Since 2014, Food Lion Feeds, the company’s hunger-relief platform, has donated more than one billion meals to food-insecure neighbors across Food Lion’s ten-state operating footprint.

Ham has been recognized locally and nationally for her contributions to Food Lion and the grocery industry. She was named a 2022 Most Admired CEO by the Charlotte Business Journal and received the 2015 Top Women in Grocery Trailblazer Award. She holds a B.S. in Business Management and Marketing from Cornell University, where she also served as the captain of the swimming and diving team.

Kahina Haynes

Kahina Haynes, Executive Director of The Dance Institute of Washington since 2016, is a passionate arts activist and the visionary architect behind one of Washington, D.C.’s leading models for advancing equity in community health, development, and achievement outcomes. Utilizing an innovative and holistic systems approach, The Dance Institute of Washington uses it platforms to educate, create, and advance practices to address longstanding disparities in the dance industry. Following the untimely passing of the Institute’s Founder Fabian Barnes, Haynes led a strategic revitalization of the organization which saw a breadth of new radical program designs, the award of a groundbreaking federal funding appropriation of $1 million from the U.S. Congress, and a multi-year facilities renovation to outfit the flagship site to expand on its 44,000 family reach.

Prior to her Executive Director role, Haynes worked in organizational development and process evaluation and strategy for a number of philanthropies and multi-laterals including the United Nations (Bureau for Development Policy at UNDP), the Annie E. Casey Foundation, the U.S. Department of Health & Human Services, SafeKids Worldwide, the World Bank Group, and the U.S. Department of State. Haynes was recently recognized by the National Black Voices for Black Justice Fund as a 2022 awardee for work in addressing structural and systemic racism, and is also the recipient of the David Bradt Non-profit Leadership Award (2021). She holds a B.A. from Princeton University with a Minor in African American Studies and a concentration in Dance, as well as an MSC from Oxford University in Evidence-based Social Intervention.

Ryan Howard

Ryan Howard was born November 19, 1979 in St. Louis, Missouri. He is a former Major League Baseball player who spent most of his career as a first baseman for the Philadelphia Phillies. Howard made history in Major League Baseball when he became the fastest player to reach 100 and 200 homeruns. Known for his power, and a 58 home run season, Howard is a member of the 50 home run club. To top off numerous baseball accolades, Howard helped bring the 2008 World Series Championship to Philadelphia.

Throughout his baseball career and currently, Howard dedicates his time off the field to numerous philanthropic endeavors. Since retiring from Major League Baseball, Howard has become an entrepreneur. He spent time with ESPN as an analyst for Baseball Tonight and co-authored six children’s books, published by Scholastic. Howard enjoys spending time with his wife and four kids. In the past few years, Howard has found his way back to the baseball field, as a coach to his daughter’s softball team. In his spare time, Howard enjoys playing golf.

Martin E. Ingelsby

Martin E. Ingelsby is currently the head basketball coach at the University of Delaware and just finished his seventh season leading the Blue Hens. His tenure in Newark is highlighted by Delaware winning the 2022 CAA Men’s Basketball Tournament and advancing to the NCAA Tournament for the first time in eight years. He is a graduate of the University of Notre Dame and was a captain and three-year starter on the Men’s Basketball team from 1997-2001. After graduation, he spent 13 years on Mike Brey’s coaching staff at Notre Dame helping the Irish to eight NCAA Tournament appearances and back-to-back Elite 8’s in 2015 and 2016. Ingelsby and his wife Colleen have four children, Will, Kate, Jack, and Ben, and reside in Wilmington, Delaware.

Barbie Izquierdo

Barbie Izquierdo is the Director of Advocacy, Neighbors Engagement at Feeding America, and founder of Community Driven Consulting LLC. For more than a decade, Izquierdo has dedicated her life to fighting the exploitation of people with lived experience who have been affected by public policy. She has served as a global, bilingual spokesperson, speaking at the White House under the Obama-Biden administration on behalf of Witnesses to Hunger and has been featured in outlets like the Associated Press, CNN, the Washington Post, BBC World News, and People Magazine, as well as in conferences, podcasts, and more. As an Afro-Latina born and raised in North Philadelphia, Izquierdo felt the impacts of food insecurity and other social justice issues firsthand and is now an advocate, organizer, and consultant providing technical support regarding the engagement and inclusion of people with lived experience. In 2022, she was awarded the 2022 Citizen Award by Global Citizen, which celebrates remarkable changemakers who are taking exceptional actions to end extreme poverty now. Izquierdo understands the power of storytelling and has used her lived experience and advocacy journey as a catalyst for policy change. She was featured in the call-to-action documentary “A Place at the Table,” highlighting the implications U.S. hunger has on the economic, social, and cultural wellbeing of the country and the solutions required to solve it once and for all. Izquierdo’s mission is to help bring dignity and equity into the frameworks used by non-profit organizations and government entities.

Ben Jacobs

Ben Jacobs, a tribal member of the Osage Nation of northeast Oklahoma, is co-founder of Tocabe: An American Indian Eatery and Tocabe Indigenous Marketplace based in Denver, Colorado. Tocabe restaurant first opened its doors in December 2008, adding a second location in 2015 and food truck in 2016. In 2021, with his business partner, Jacobs helped launch Tocabe Indigenous Marketplace. Tocabe’s marketplace is an online resource helping further advance the Native food system and develop a Native specific supply chain. The marketplace is designed as a multifaceted concept supporting both the Native and Indigenous food system while maintaining economic growth for underrepresented and economically disadvantaged communities.

For over a decade on a national level, Jacobs has worked with the U.S. Department of Agriculture and Food Distribution Program on Indian Reservations (FDPIR). While advocating for feeding Native peoples, his work with FDPIR has included traveling to tribal communities supporting how best to incorporate local and traditional ingredients in collaboration with commodity ingredients to support better individual health and nutrition. Within Colorado, Jacobs is in his second term as a member of the Minority Business Office Advisory Council appointed by Governor Jared Polis (D-CO). He is also a board member of the Rocky Mountain Indian Chamber of Commerce.

Chloe Kim

The 2022 Winter Olympics cemented Chloe Kim as the female face of both snowboarding and action sports when she became the first female in history to win back-to-back Olympic Gold Medals in halfpipe snowboarding. After being accepted to Princeton University, Kim took the 2019-20 season off from competing to focus on her education. Returning in January 2021 after a 20-month hiatus from snowboarding competition, Kim continued her dominance of the sport, winning all four women’s superpipe events in the 2020-21 season including her sixth X Games gold medal and her second World Championship.

Kim has had just as much success off the mountain as she’s had on it. She has been featured on Forbes 30 under 30 list, TIME’s 100 list, and TIME’s 30 Most Influential Teens list (three years in a row), as well as the cover of Time Magazine, Shape Magazine, Sports Illustrated, Sports Illustrated Kids, and ESPN Magazine. She also had an appearance in a Maroon 5 video and the Charlie’s Angels reboot. Additionally, Kim has taken home five ESPY Awards, was honored with the “Daring to Disrupt” award at the 2022 Glamour Women of the Year Awards, has received three Nickelodeon Kids Choice Sports Awards and two Laureus World Sports Awards, and has been recognized for her positive impact in the Asian American community. Kim, whose parents emigrated from Korea, now lives in Los Angeles.

Chaunte Lowe

Chaunte Lowe is an Olympic high jumper who competed in four Olympic Games, making her fourth team as a mother of three. The 12-time U.S. National Champion has earned permanent places in three separate Halls of Fame. Lowe touched the nation’s heart when she trained for her fifth Olympic Games while undergoing chemotherapy and a double mastectomy to advocate for breast cancer awareness. Her accolades include winning an Olympic bronze medal in the 2008 Olympic Games and three medals at the World Championship of gold, silver, and bronze. Now retired after dedicating over 20 years to professional sports, Lowe commits her time to inspiring audiences through professional speaking, serving as a spokesperson for several organizations committed to doing good in the community, and advocating health and wellness in the fight against breast cancer. She is an accomplished motivational speaker and children’s book author, engaging audiences worldwide with her dynamic storytelling on resilience, leadership, teamwork, overcoming obstacles, and sharing her journey as an Olympian and breast cancer thriver.

Viviana Martinez-Bianchi

Viviana Martinez-Bianchi, MD, FAAFP is a family doctor, associate professor, and Director for Health Equity at Duke University’s Department of Family Medicine and Community Health. She is co-founder and Co-Director of LATIN-19, the Latinx Advocacy Team and Interdisciplinary Network for COVID-19, a multi-sector group addressing Hispanic health during the COVID-19 pandemic and beyond. At the state level, Governor Roy Cooper (D-NC) appointed her in July 2020 to the Andrea Harris Social, Economic, Environmental, and Health Equity Task Force, and she served as a Latinx Health advisor for the North Carolina Department of Health and Human Services during the pandemic response. Nationally, she chaired the Health Equity Team for Family Medicine for America’s Health. Internationally, Martinez-Bianchi was an Executive Member-at-Large of the World Organization of Family Doctors and its liaison to the World Health Organization from 2016 to 2021. Martinez-Bianchi has been the recipient of many awards, including the 2021 Marian Bishop Leadership Award by the Society of Teachers of Family Medicine Foundation, North Carolina’s 2021 Family Physician of the Year by the North Carolina Academy of Family Physicians, and the 2022 Foundation for Health Leadership and Innovation Community Achievement award.

Martinez-Bianchi sees patients at the Duke Family Medicine Center in Durham, North Carolina, and newborn health rounds at Duke Regional Hospital. Her work includes the full spectrum of ambulatory family medicine with an emphasis on prevention, chronic disease management, women’s health, prenatal care, addressing social determinants of health, and promoting an understanding of health equity.

Elana Meyers Taylor

Elana Meyers Taylor is the most decorated Black athlete in Winter Olympic history, winning five Olympic medals in four Olympic Games for Team USA in the sport of bobsled. She graduated from the George Washington University with a Bachelor’s in exercise science and a Master’s in sports management, where she was a five-time team captain and MVP for the softball team. Additionally, she was an Academic All-American and then went on to earn an MBA in finance from the Keller Graduate School. In 2019, Meyers Taylor served as president of the Women’s Sports Foundation. She currently serves on the Board of Directors for the U.S. Olympic and Paralympic Committee, the Board of Trustees for the Women’s Sports Foundation, and the Georgia Council for Developmental Disabilities. She is married to Nic Taylor and mother to Nico (3 years) and Noah (3 months).

Dariush Mozaffarian

Dr. Dariush Mozaffarian is a cardiologist, Jean Mayer Professor at the Friedman School of Nutrition Science and Policy at Tufts University, Professor of Medicine at Tufts School of Medicine, and an attending physician at Tufts Medical Center. His work aims to create the science and translation for a food system that is nutritious, equitable, and sustainable. Mozaffarian has authored more than 500 scientific publications on dietary priorities for obesity, diabetes, and cardiovascular diseases, and on evidence-based policy approaches and innovations to reduce diet-related diseases and improve health equity in the U.S. and globally. Some of his areas of interest include healthy diet patterns, nutritional biomarkers, Food is Medicine interventions in healthcare, nutrition innovation and entrepreneurship, and food policy. He is one of the top cited researchers in medicine globally, he has served in numerous advisory roles, and his work has been featured in an array of media outlets. Mozaffarian received his B.S. in biological sciences from Stanford University, M.D. from Columbia University, and Doctorate in Public Health from Harvard University, and additional clinical training in internal medicine at Stanford University and in cardiology at the University of Washington. He is married, has three children, and actively trains as a Fourth Degree Black Belt in Taekwondo.

Kim Ng

Kim Ng is the highest-ranking woman in baseball operations among the 30 MLB teams and was the first woman hired to the General Manager position by any of the professional men’s sports teams in the North American Major Leagues. Ng owns nearly 35 years in Major League Baseball, including a combined 21 years of previous experience in the front offices for the Chicago White Sox, New York Yankees, and Los Angeles Dodgers. She has been an integral part of eight postseason appearances, including six League Championship series and three World Championships with the Yankees.

Ng graduated from the University of Chicago, where she played softball and earned a degree in Public Policy. She has appeared on Forbes’ list of the Most Influential Minorities in Sports, Forbes’ list of the Most Influential Women in Sports, Adweek’s Most Powerful Women in Sports, included as one of InStyle Magazine’s Badass 50 Women, and included among the South Florida Business Journal’s Power Leaders. She also serves on the Anti-Defamation League’s Sports Leadership Council. In 2021, she was recognized as the Best Hire in Sports by the Sports Business Journal, the Trailblazer of the Year by Baseball America, a Game Changer by the Asia Society, and received the Billie Jean King Leadership Award from the Women’s Sports Foundation as well as the Lou Gehrig Sports Award from the ALS Association of Greater New York. Ng also took part in the 2021 Presidential Inauguration as part of the Celebrating America event.

Allison O’Toole

Allison O’Toole is the proud CEO of Second Harvest Heartland, a regional food bank that’s changing the way hunger is addressed in America. Located in the heart of the Twin Cities, Second Harvest Heartland serves 59 counties in Minnesota and Western Wisconsin through partnerships with 1,500 food shelf and program partners. Committed to ending racial and geographic inequities in who is hungry, Second Harvest Heartland has introduced freshly prepared, culturally connected meals and farm partnerships to feed more people. Last year, Second Harvest Heartland distributed 113 million meals to 813,000 people.

O’Toole’s current role is the culmination of three decades working at the intersection of health and community service to help organizations, programs, and people thrive. She is credited with overhauling Minnesota’s insurance exchange program as part of the Affordable Care Act, where she oversaw a rebuild of the organization’s operations, customer service, and outreach programs, resulting in three years of record-breaking enrollment. O’Toole also served as a leader at United States of Care and a Minneapolis-based public affairs firm, and as State Director for Senator Amy Klobuchar (D-MN). Early in her career, O’Toole dedicated a decade to criminal justice as a prosecutor in the Twin Cities. O’Toole received her Bachelor of Arts in Political Science and Art History from Franklin and Marshall College in Lancaster, Pennsylvania, her Juris Doctor from Mitchell Hamline School of Law in St. Paul, Minnesota, and an honorary Doctor of Humane Letters from Franklin and Marshall College. She serves on the board of directors at UCare and the board of trustees at Breck School. O’Toole loves art, local food, and Prince.

Oluwaferanmi Oyedeji Okanlami

Dr. Oluwaferanmi Okanlami (aka “Dr. O”) is an Assistant Professor of Family Medicine, Physical Medicine & Rehabilitation, and Urology at Michigan Medicine, an Adjunct Assistant Professor of Orthopaedic Surgery at UCLA, and the Director of Student Accessibility and Accommodation Services at the University of Michigan, where he oversees Services for Students with Disabilities, two Testing Accommodation Centers, and the Adaptive Sports & Fitness Program. As a former academic All-American student-athlete at Stanford, he is no stranger to the importance of sports, fitness, and nutrition. However, after experiencing a spinal cord injury during his orthopaedic surgery residency at Yale, he began to see life “from the other side of the stethoscope,” realizing how inaccessible our world is for individuals living with disabilities. He now navigates the world as a proud wheelchair user and has a catch phrase – “Disabusing Disability” – hoping to demonstrate that DISability doesn’t mean INability. He is invited to speak regularly about topics related to diversity, equity, accessibility, and inclusion, including, but not limited to, creating a health system that is accessible to and inclusive of both patients and providers with disabilities, and providing reasonable and appropriate accommodations for students with disabilities in higher education. He is passionate about adaptive sports and fitness, striving to provide equitable access to physical fitness and inclusive recreational and competitive sports for all.

Laura Ricketts

Laura Ricketts is an entrepreneur, community advocate, and co-owner of the Chicago Cubs Major League Baseball Club. She is on the Cubs Board of Directors and is Chair of the Board of Chicago Cubs Charities, where she leads the organization’s philanthropy, sports-based youth development, and academic programming. She is the first openly LGBTQ woman to co-own an MLB franchise. Ricketts is also Co-Founder and Director of Beyond Barriers, an innovative career fitness platform designed to transform professional women into future-ready leaders and help companies unlock potential at scale by improving performance, increasing retention and diversity, and promoting engagement. Prior to her work with the Chicago Cubs and Beyond Barriers, Ricketts co-founded Ecotravel LLC, a digital ecotourism hub dedicated to educating travelers and promoting global ecotourism. She also practiced corporate and securities law at the Chicago law firm Schiff Hardin LLP.

Ricketts’ advocacy work is largely focused on increasing the empowerment, engagement, and representation of the queer and intersectional women’s communities. She is Co-Founder and Board Chair of LPAC and serves on the Obama Foundation Inclusion Council as well as the Board of Advisors for Opportunity Education. She is a past member of the Board of Trustees for the John F. Kennedy Center for the Performing Arts, and has served on the Board of Directors of EMILY’s List, Lambda Legal, and Housing Opportunities for Women. Ricketts earned a B.A. in Philosophy from the University of Chicago and a J.D. from the University of Michigan Law School.

Stefany Shaheen

Stefany Shaheen is an advocate, entrepreneur, and business leader. She co-founded and is currently President of Good Measures. Harnessing the power of food as medicine, the company was awarded a suite of patents by the U.S Patent Office and Shaheen is a named inventor. She was inspired to launch Good Measures following her eldest daughter’s diagnosis with Type 1 diabetes and has dedicated herself to making life better for people living with chronic conditions. Shaheen authored a New York Times bestseller, Elle & Coach, about this experience, which also led her to serve on the Board of Trustees for Joslin Diabetes Center, the world’s preeminent diabetes research, clinical care, and education organization. Shaheen served on the Portsmouth, New Hampshire City Council and is currently Chair of the Police Commission. Governor John Lynch (D-NH) appointed her to serve, and she became Chair of the State’s Commission on the Status of Women. A graduate of MIT’s Sloan School of Management and Harvard’s Kennedy School of Government, Shaheen was also a Division I Scholarship Athlete. Shaheen and her husband live in Portsmouth, New Hampshire where they raised four children, and she had the distinct pleasure of coaching one as part of the Portsmouth High School Girls Varsity Volleyball Team.

Billy Shore

Billy Shore is the founder and executive chair of Share Our Strength, which through campaigns like No Kid Hungry and Cooking Matters, has reduced childhood hunger across the United States. Before founding Share Our Strength, Shore served on the senatorial and presidential campaign staffs for former Senator Gary Hart (D-CO) and as Chief of Staff to former Senator Robert Kerrey (D-NE). In 2014, congressional leaders appointed him to the National Commission on Hunger, a group tasked with finding innovative ways to end hunger and improve nutrition in America. In addition to his work with Share Our Strength, Shore is a leading voice in the national conversation on hunger and poverty. He is the author of four books focused on social change, including The Cathedral Within and The Light of Conscience. He also hosts Add Passion and Stir, a podcast that brings together high-profile chefs and change-makers to talk about the central role food plays in social justice. A native of Pittsburgh, Pennsylvania, Shore earned a Bachelor of Arts at the University of Pennsylvania and his law degree from George Washington University in Washington, DC. U.S. News and World Report named him one of America’s Best Leaders.

Michael Solomonov

Mike Solomonov is a beloved champion of Israel’s extraordinarily diverse culinary landscape, and the chef widely recognized for bringing Israeli cuisine to diners across the U.S. and around the world. He is co-owner of CookNSolo Restaurants with hospitality entrepreneur Steve Cook, and Chef of the trailblazing restaurant Zahav which has put the rich melting pot of Israeli cuisine at the forefront of dining in America today. Solomonov is the co-author of three cookbooks, and the recipient of the following James Beard awards: 2011 “Best Chef, Mid-Atlantic”, 2016 “Best International Cookbook” and “Book of the Year” for his and Steve Cook’s best-selling Zahav: A World of Israeli Cooking, and the 2017 “Outstanding Chef.” In May of 2019, Zahav was awarded “Outstanding Restaurant” by the James Beard Foundation, making Zahav the first Israeli-American restaurant to be awarded this great honor. In addition to his work at Zahav, Solomonov co-owns Philadelphia’s Federal Donuts, Dizengoff, Abe Fisher, Goldie, K’Far, Merkaz, and Laser Wolf as well as Lilah, an event venue bringing together 15 years of culinary and hospitality wizardry. In 2022, CookNSolo expanded to Brooklyn with much acclaim, bringing grill house sensation Laser Wolf, as well as Israeli bakery and café K’Far, to The Hoxton hotel in Williamsburg. Outside of the restaurants, you can often find Mike with Steve at Pho 75 in South Philly, working out the kinks in their Israeli village.

Melissa Stockwell

Melissa Stockwell was the first female American Soldier to lose a limb in Operation Iraqi Freedom. Her vehicle was hit by a roadside bomb on April 13, 2004, resulting in the loss of her left leg, above the knee. She was honored with a Purple Heart and a Bronze Star for her service. Four years later she represented the USA again, this time as a member of the U.S. Paralympic Swim Team where she was the first Iraq War veteran to qualify for the Paralympic Games. She would return to the Paralympic Games twice more, in 2016 and 2020, this time in triathlon. She has remained one of the world’s most elite Para-triathletes, winning three World Championship titles and the 2016 Paralympic Bronze Medalist. She is both a World Record-holding marathon runner and an Ironman.

Away from the field of play, in 2011 she co-founded the non-profit organization Dare2tri Paratriathlon club, which serves youth and adults with physical disabilities along with injured service members. Dare2tri provides adaptive equipment, training, coaching, and support in triathlon. In 2019, Stockwell and her husband, Brian Tolsma, opened the doors to Tolsma Stockwell Prosthetics, providing state of the art, custom-made orthotics and prosthetics to the amputee community, including some of the top adaptive athletes in the world. Stockwell is one of the most critically acclaimed inspirational speakers in the country, and the author of The Power of Choice. Stockwell is the proud mother of Dallas (2014) and Mille (2017) and lives with her family near the U.S. Olympic & Paralympic Training Center in Colorado Springs, Colorado.

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e-IFU requirements translated for implantable medical devices

e-IFU requirements translated for implantable medical devices

At least for those manufacturers that struggled for a long time printing Instructions for Use (IFU’s) without seeing the benefit. Manufacturers of devices such as medical device software, medical devices fitted with a built-in system visually able to display the IFU visually, fixed installed medical devices and implantable and active implantable medical devices.

But what is expected from the manufacturer to comply with this regulation and the medical device regulation (EU) 2017/745?

What do they mean by accessories?

Who is defined as a professional user?

Clarifying these questions is essential for manufacturers who want to stay on the right side of the rules.

Regulation 2021/2226 highlights

The regulation 2021/2226 specifies which medical devices an e-IFU is approved to be the sole IFU – meaning no paper IFU is required. The goal is to decrease the environmental burden and reduce costs linked to paper IFU’s. It also aims to retain and improve levels of safety, with users still able to receive a paper IFU upon request.

Article 3 is the most interesting. It specifies which devices can benefit from the paper IFU exemption.

Implantable and active implantable medical devices and their accessories (cfr. MDR) are covered. But only under the following conditions:

  • Devices and accessories are used by professionals
  • The use by other persons is not reasonably foreseeable

An e-IFU is only allowed if the risk assessment covers elements including knowledge and experience, the environment in which the device is used and protection against tampering.

Medical device regulation (EU) 2017/745 highlights

What is the link with the MDR?

The MDR is the umbrella under which regulation 2021/2226 falls. It gives the manufacturer detailed explanations on the different definitions. In addition, it provides insights on the elements needed in the IFU and e-IFU (MDR, annex I, chapter III).

Those definitions are as follows:

‘Instructions for use’ means the information provided by the manufacturer to inform the user of a device’s intended purpose, proper use and of any precautions to be taken;

“Implantable device” means any device – including a partially or wholly absorbed one – intended either for introduction into the human body or for replacement of an epithelial surface or the surface of the eye. An implantable device is introduced via clinical intervention and remains in place after the procedure. Devices that are partially introduced by clinical intervention and remain in place for a month or more also meet the definition.”

‘Active device’ means any device the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. However, devices that transmit energy or substances between an active device and the patient without any significant change do not meet the definition. Software is also deemed to be an active device.

An accessory for a medical device is defined in relation to true medical devices: it must be used together with one or more medical devices to enable their use, in accordance with their intended purpose. It may also specifically and directly assist the medical functionality of the medical device in terms of its intended purpose.

For many manufacturers though, the definition of ‘accessory for a medical device’ causes much confusion for a number of important reasons.

First of all, not every instrument that is used during an implant surgery is automatically an accessory. It must enable or assist the device in its intended purpose. For example, a trial model, used during surgery, in order for the surgeon to check whether or not the proposed implant will fit inside the body. This model is used prior to placing the implant itself, for sterility reasons. Although this model is a medical device, and briefly an invasive one, it does not enable or assist the implant itself.

Tools used during the surgery such as saws, drills and guides to position the screws are another example. Although used in assisting the surgery, they do not enable or assist the implant in its intended purpose.

However, the screws used to place the implant do not have any other function aside from enabling the implant to stay in its place – and are therefore an accessory for an implant. It is the intended purpose of the screws that means they are defined as accessories for an implant, or a medical device on its own. This definition and the explanation of it must be clearly defined in a definition statement or classification rationale, as part of the technical documentation.

Dental implants have many accessories such as rings, caps, housings.

Clear examples, which the MDCG notes, are accessories for cochlear implants.

Accessories to active implantable devices, with or without contact to the heart, are another example, whether or not they are implantable:

· torque wrench for pulse generators and cardioverter defibrillators

· cables for programmer / pacing system analyser

· magnets for pulse generators and cardioverter generators

· programmers to control an implantable device

· implantable pacemaker leads

If it is clear that your device is an accessory for a medical device, it must also comply with the whole of the MDR in the same way as a medical device. This means it also needs full technical documentation – including an IFU. The manufacturer should have a clear definition statement, including a classification rationale, to clearly identify why it is an accessory for a medical device.

Additionally, the manufacturer should have a written rationale if they are opting purely for an e-IFU. It is important to note that a rationale on its own is insufficient; a thorough risk analysis on the use of an e-IFU and lack of paper IFU is required.

Conclusion

Even though the new regulation on e-IFU is clear, it is not always clear for manufacturers if their device meets the definitions. The medical device regulation sheds some light on the definitions, but it is up to the manufacturer to make sure their devices meet these definitions. It is a requirement to have a rationale on the definition of medical device and accessory for a medical device.

So making sure that the device meets the correct definition is the first step forward. The second step is to rationalise the exemption for having a mandatory paper IFU.

Qarad is an expert in e-IFU. And for regulatory related questions, QbD has a team of regulatory experts to guide you through the regulations. Download the whitepaper on this page to find out more.

Experts reveal how the pressure of a healthy lifestyle could be having the opposite effect

Over the past few years wellness trends have grown in popularity – from yoga and meditation to gut-friendly foods. 

And while being invested in looking after our physical and mental health is a good thing, experts have questioned if the fixation and constant bombardment on self-improvement actually making us happy. 

Life coach and NLP practitioner Rob Brennan told FEMAIL: ‘The trend of wanting more, wanting to be happier, wanting to look perfect and to have the perfect life, is ironically creating deep rooted unhappiness and discontent.’ 

And from cutting out food groups to eat ‘cleanly’ to tucking into protein bars, experts said there are a number of different ways following wellness trends could be damaging your body.

Here FEMAIL reveals the four trends not to follow…

Experts reveal how the pressure of a healthy lifestyle could be having the opposite effect

Life coach and NLP practitioner Rob Brennan, from London, told FEMAIL the four different wellness trends which could actually be damaging your health – including eating protein bars (stock image)  

1. ‘POSITIVE MENTAL ATTITUDE’…CAN BE TOXIC  

According to Rob, a positivity overload, as in pretending everything is ok when it isn’t and trying to ignore life’s ups and downs, can actually have a negative impact on our mental healthy. 

This the expert coins as ‘toxic positivity’, which he said has come from ‘hijacking of good mental health advice and suggestions by the uninformed influencers’ as well as magazines, the media and celebrities.  

While ‘good vibes only please’ or ‘I choose to surround myself with positive people only as I don’t want to be dragged down’ sound like positive principles, they force us to ignore sadness or pain because it’s unsettling.  

He uses the example of telling people it’s okay not to be okay while wearing a new ‘good vibes only’ hoody to illustrate how this can send people mixed messages and put people off discussing difficult matters.

He said: ‘Life is not all good vibes at all, it’s hard, complicated, tiring and has ups and downs all the way from start to finish; pretending it’s all good vibes and silencing ourselves and others with toxic positivity leads to unhappiness, anxiety and pain.

‘I think I’ll get a hoody made “good vibes only” on the front then “toxic positivity – making people feed bad for feeling sad” on the back, I think it’ll sell well once people get it.’

No one is positive all the time it’s not normal to be so, everyone has trials and struggles and this should be normalised. 

The life coach explained that everyone struggles sometimes but when people feel on the outside or not normal because they are sad, they don’t necessarily get the help that they need. 

Rob said: ‘Whilst society and social media remains riddled with toxic positivity, the clear message to those who aren’t okay is that it is very much not okay and that no one wants to hear about it if you aren’t.’ 

2. INSTA-INSPO… ISN’T REALISTIC  

Unpacking wellness further, Rob described how many people can feel inadequate when confronted with images of what ‘wellness’ and ‘happiness’ looks like.  

He said: ‘These images are simply unattainable to the vast majority and they are created in entirely false situations where reality is a distant consideration.’ 

‘It can take hours to create the right the shot, whether it be the perfect plate of food or position on a yoga mat, when in reality some people may not have the time to engage in a full yoga session first thing or the money to buy in the ‘best health foods’.  

What people don’t see is the deleted shots that weren’t right or what they look like unfiltered, or what they eat 90 per cent of the time. 

Rob wants to remind people that wellness ‘is not associated with actual happiness and health but with the perception of it, and these two things are very different.’

He warns that sharing pictures of ‘healthy lifestyle’, whether it be food, exercise, or taking time for yourself are heading towards toxic territory because it isn’t the norm and often unattainable for most people juggling busy lifestyles, and so they may only ever feel sad and inadequate when they try to incorporate wellness into their lifestyle. 

It’s not just the pressure of leading an active, healthy lifestyle that can be detrimental to overall wellness but nutrition can also have a negative impact.  

3. ‘CLEAN EATING’…COULD BE DEPRIVING YOUR BODY OF NUTRIENTS

Jordan Storey, a nutritionist and personal trainer, explained: ‘Wellness trend “clean eating” – bland chicken and broccoli type training diet focusing on food as fuel can shift our perception of eating as one of life’s pleasures towards seeing it as a chore or with guilt.’ 

Jordan, who was a former bodybuilding, explained how he has trailed many diets within his 15 years of experience. 

He explained: ‘People tend to fall out of love with food easily and even create a negative feeling towards the food they eat, which can impact their mental wellbeing.’ 

Jordan revealed that people may be missing out on the vital vitamins that their bodies need if they are following wellness trends. 

In addition, by eating what you think you are supposed to eat takes the fun out of food.  

He said: ‘My quote “Add love back into your food” simply meaning you should enjoy the foods you are cooking and eating, and not only will your body thank you for it but your whole mindset will change too.’

4. HIGH PROTEIN SNACKS…ARE PACKED FULL OF SUGAR 

In addition, wellness food trends such as ‘high protein snacks’ are all over social media. 

These can include high protein yoghurts, puddings and drinks claiming to be packed with protein and low calorie. 

However Jordan described how they are usually high in sugar and so will spike insulin levels. 

In addition, the protein content they use doesn’t always come from a full complete protein source such as milk protein. 

He said: ‘Can I also just note once you spike your insulin levels they do have to come back down which then they will crash leaving you wanting even more sugar to help stable your blood sugars. 

‘I am not saying to avoid these totally as that wouldn’t be a healthy lifestyle.

‘I do believe in the 80/20 lifestyle rule…however if you do crave something sweet you might as well just enjoy your favourite chocolate bar than go for these. 

‘The high protein is definitely used in the title to make you buy these products. 

‘A burger from McDonalds is much higher in protein than these puddings but they do not claim its a high protein burger.’

Healthy meal delivery company in Tampa grows

TAMPA, Fla. — ReBuilt Meals was born in the kitchen area of an Ybor Metropolis dwelling 7 decades ago and has grown into a multi-amount output facility in Tampa which ships foods to a lot more than a dozen states, according to CEO and Pres. Brandon Assaf.

What You Need To Know

  •  ReBuilt Meals has 30 pick-up spots within 100 miles of Tampa

  • Weekly subscription services delivers keto, plant, effectiveness and way of living strategy meals

  •  Owner Brandon Assaf explained the firm grew from a household kitchen area to a multi-degree facility in 7 a long time

  • The company’s main benefit is to ‘keep up the very good vibes’

“As the trend keeps likely, we’ve by now outgrown our new facility,” he stated. “A new creating is on the horizon.”

ReBuilt Foods offers fresh new, wellness-acutely aware, chef ready meals for supply or pickup. Assaf stated what sets his corporation aside from the competition is the assortment of meals presented weekly and free pickup locations at gyms or nutritional supplement stores.

“We have about 30 locations that we deliver our foods to,” he explained. “Those are identified as our select-up spots in 100 miles of Tampa.”

The fresh macro-based mostly meals arrive thoroughly cooked, have in no way been frozen and can be heated up in a microwave. Assaf said the parts have been very carefully measured and prospects can track their meals.

“If you’re hoping to eliminate pounds, get ready for a opposition, or just wanting to get pleasure from healthy foods throughout your way of life,” he stated. “You can observe and truly feel confident that the meals are what they say they are on the label.”

The company’s weekly membership support presents keto, plant, overall performance and lifestyle approach foods.

Personalized trainer Rafael Jimenez, 47, explained he purchases about 20 meals for each week. At 1st, he had them shipped to his dwelling in Lutz, but afterwards switched to buying them at a diet centre to conserve on shipping and delivery expenditures.

“Knowing that I can occur property and just pop just one of these in the microwave for two to three minutes,” he reported. “I’ll even now hit my numbers without having obtaining to devote a ton of time executing meal prep and all the things.”

Assaf mentioned his company is environmentally helpful and employs Go-Green packaging.

“We’re incredibly mindful in the types of plastics that we use,” he said. “These trays are manufactured with the the very least amount of money of squandered plastic in the complete sector.”

The company’s main value is ‘keep up the good vibes.’ Assaf explained they give absent no cost foods to several charity corporations.

“We’ve donated our time at Feeding Tampa Bay,” he claimed. “We’ve donated 1000’s and thousands of meals to distinct results in and distinct folks in need.”

Assaf reported he acquired the strategy for the enterprise when he commenced cooking healthier meals at residence and his friends preferred some way too.

“Started just to make foods for ourselves and then as that food generation commenced,” he stated. “Some buddies claimed, ‘Hey, if you are cooking now and portioning these foods, then do it for me.’”

ReBuilt Meals will ship to a residence wherever within two times of floor shipping and delivery from Florida, in accordance to Assaf.