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Ask Dr. Kevin: Clinical Trials are the Foundation for Scientific Innovation

NNPA NEWSWIRE — As you may have heard, my team at Pfizer recently experienced a significant disappointment. Our phase 3 trial for rivipansel, a potential treatment for the debilitating vaso-occlusive crises (VOCs) endured by virtually every person with sickle cell disease (SCD), did not meet its study endpoints. Both professionally and personally, this news was hard to hear, especially knowing that people with SCD have such limited treatment options available to them. However, even though the study didn’t turn out as we had hoped, the good news is that the rivipansel program greatly advanced our understanding of SCD and VOCs, which will be important for future SCD research programs and drug development.

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Dr. Kevin Williams is the Chief Medical Officer (CMO) for Pfizer Rare Disease. In this role, he leads a Medical Affairs organization of approximately 150 medical colleagues around the globe supporting Pfizer’s efforts and portfolio in Rare Disease.

By Dr. Kevin Williams, Chief Medical Officer for Rare Disease at Pfizer

The “Ask Dr. Kevin” series is brought to you by Pfizer Rare Disease in collaboration with the National Newspaper Publishers Association (NNPA) to increase understanding of sickle cell disease.

Dr. Kevin Williams is the Chief Medical Officer for Rare Disease at Pfizer where he leads a Medical Affairs organization of approximately 150 medical colleagues around the globe. He pursued medicine after being inspired by his father’s work as a general practitioner in his hometown of Baton Rouge, Louisiana. Dr. Kevin is passionate about raising awareness and increasing understanding of rare diseases, such as sickle cell disease, in the African American community.

As you may have heard, my team at Pfizer recently experienced a significant disappointment. Our phase 3 trial for rivipansel, a potential treatment for the debilitating vaso-occlusive crises (VOCs) endured by virtually every person with sickle cell disease (SCD), did not meet its study endpoints. Both professionally and personally, this news was hard to hear, especially knowing that people with SCD have such limited treatment options available to them. However, even though the study didn’t turn out as we had hoped, the good news is that the rivipansel program greatly advanced our understanding of SCD and VOCs, which will be important for future SCD research programs and drug development.

As I’ve written about before, SCD is the most common inherited blood disorder, and it disproportionately affects people of African descent[i]. VOCs, one of the most common complications of SCD, are marked by extreme pain resulting from sickle-shaped red blood cells clumping together in the bloodstream[ii]. The standard of care for patients experiencing these pain crises has remained largely unchanged since the first report of SCD in 1910, and is restricted mostly to treating disease symptoms, like the use of opioids for pain management. Just last month, Novartis was granted FDA approval for a treatment to reduce the frequency of VOCs experienced by patients; however, there still stands a greater need for therapies that target the root cause of these painful episodes.

The clinical trial for rivipansel may have come to an end; however, the one thing that working in SCD and collaborating with the NNPA and SCD-focused patient groups over the last several years has taught me is that this community is strong. Their strength inspires me and my team every day and fuels our passion for our work in advancing the scientific research of rare diseases like SCD.

In this article, I’d like to share a little more about the importance of innovation in rare diseases and answer some common questions about the role clinical trials play as the foundation for moving medical innovation forward.

Why are clinical trials important?

Cutting-edge research and clinical trials are key to making an impact for patients and are essential to the development of new treatments. These studies also deepen our understanding of diseases, especially rare diseases, such as SCD, where few advances have been made. For rare diseases in particular, only 5% of diseases have an FDA-approved treatment[iii], so there is a lot of work to be done in this area.

At their core, clinical trials are designed to produce high-quality data that will translate into a better understanding of the treatments that work best for certain diseases and people. Given their crucial role in medical science, clinical trials are highly regulated and conducted using high-quality scientific and ethical standards to ensure the safety of participating patients.

Are there potential challenges associated with clinical trials?

The biggest challenge is that a clinical trial may fail, even after decades of research aimed at uncovering a treatment breakthrough. While no one likes to hear a clinical trial didn’t meet its goals, especially people in need of new treatment options, researchers are unfortunately unable to anticipate the end results of these studies in advance.

However, even though we can’t be sure of the results, it’s still critical for this research to happen to bring new treatment advances to those in need. Did you know that for every approved medicine, there are countless others that don’t pass through the grueling clinical trial and regulatory processes? A recent report found that the likelihood of drugs moving from clinical phase to approval is only 9.6%[iv]. Moreover, even if an investigational therapy is backed by promising data, it can take around 12 years or longer for it to gain approval.

Another challenge can be enrollment of volunteers to participate in clinical trials. Historically, recruitment obstacles have been a barrier in SCD research. However, a poll conducted, as a part of Pfizer and the NNPA’s collaboration, found that a majority of respondents had positive or neutral attitudes toward SCD clinical trials, and furthermore, they indicated a willingness to participate in them if provided the appropriate information. These results are encouraging and suggest people are becoming more inclined to participate in clinical trials for hard-to-treat diseases like SCD.

What have you learned about clinical trials during your time at Pfizer?

Pfizer strives to accelerate the development and delivery of groundbreaking medicines and the dedication, talent and resources that support our clinical trials can’t be captured in a few words. However, as I’ve said earlier, advancing research and conducting clinical trials comes with the unfortunate reality of not always being successful.

The news that our trial for rivipansel didn’t achieve its goals was disappointing, especially for the SCD community who is eagerly awaiting new therapies for VOCs. That said, we are channeling this loss into renewed energy and making it our purpose to learn from it. We are in the process of reviewing the trial data closely to ensure our findings can help inform and shape future SCD programs.

Regardless of the outcomes, I want to stress again that more trials in the rare disease space, particularly for SCD, are desperately needed. I am confident in saying our steadfast commitment to this community will continue, as we work tirelessly to look for new ways to continue advancing care.

About Dr. Kevin Williams

Dr. Kevin Williams is the Chief Medical Officer (CMO) for Pfizer Rare Disease. In this role, he leads a Medical Affairs organization of approximately 150 medical colleagues around the globe supporting Pfizer’s efforts and portfolio in Rare Disease. Dr. Kevin joined Pfizer in January 2004 as a Director of Regional Medical & Research Specialist working in the HIV disease area. After moving into a Team Leader position in July 2005, he served in various leadership roles during his career at Pfizer. Dr. Kevin moved into his current Rare Disease CMO position in May 2016.

Dr. Kevin received his medical degree from the UCLA School of Medicine and is board certified in Internal Medicine. Following a 2-year fellowship in Health Services Research at UCLA and a brief academic career as an Instructor of Medicine at the UCLA School of Medicine, he spent 8 years in private practice caring for HIV-positive patients while maintaining an academic appointment at the UCLA School of Medicine as an Assistant Clinical Professor of Medicine. In addition to his medical degree, Dr. Kevin has a Master’s in Public Health from the UCLA School of Public Health and a Juris Doctorate from Harvard Law School.  

Keep up to date on Pfizer’s Rare Disease efforts by visiting our page here. You can also follow Pfizer on Facebook and Twitter.

[i] Serjeant GR. One hundred years of sickle cell disease. Br J Haematol. 2010;151(5):425-429.

[ii] American Family Physician. “Approach to the Vaso-occlusive Crisis in Adults with Sickle Cell Disease.” https://www.aafp.org/afp/2000/0301/p1349.html.

[iii] Global Genes. “Rare Disease: Facts and Statistics.” https://globalgenes.org/rare-diseases-facts-statistics/

[iv] Biotechnology Innovation Organization (BIO). “Clinical Development Success Rates 2006-2015.” https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf.

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Black Artists in America, Installation Three Wraps at the Dixon Gallery and Gardens

TRI-STATE DEFENDER — With 50+ paintings, sculptures and assemblages, the exhibit features artists like Varnette Honeywood from Los Angeles, whose pieces appeared in Bill Coby’s private collection (before they were auctioned off) and on “The Cosby Show.” Also included are works by Alonzo Davis, another Los Angeles artist who opened one of the first galleries there where Black Artists could exhibit. 

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By Candace A. Gray | Tri-State Defender

The tulips gleefully greet those who enter the gates at the Dixon Gallery & Gardens on an almost spring day. More than 650,000 bulbs of various hues are currently on display. And they are truly breathtaking.

Inside the gallery, and equally as breathtaking, is the “Black Artists in America, From the Bicentennial to September 11” exhibit, which runs through Sunday, March 29. This is the third installment of a three-part series that started years ago and illustrates part of the Black experience through visual arts in the 20th century.

“This story picks up where part two left off,’’ said Kevin Sharp, the Linda W. and S. Herbert Rhea director for the Dixon. “This era is when we really start to see the emergence of these important Black artists’ agency and freedom shine through. They start to say and express what they want to, and it was a really beautiful time.”

With 50+ paintings, sculptures and assemblages, the exhibit features artists like Varnette Honeywood from Los Angeles, whose pieces appeared in Bill Coby’s private collection (before they were auctioned off) and on “The Cosby Show.” Also included are works by Alonzo Davis, another Los Angeles artist who opened one of the first galleries there where Black Artists could exhibit.

“Though [Davis] was from LA, he actually lived in Memphis for a decade,” said Sharp. “He was a dean at Memphis College of Art, and later opened the first gallery in New York owned and operated by black curators.”

Another featured artist is former NFL player, Ernie Barnes. His work is distinctive. Where have you seen one of his most popular paintings, Sugar Shack? On the end scene and credits of the hit show “Good Times.” His piece Saturday Night, Durham, North Carolina, 1974 is in this collection.

Memphis native James Little’s “The War Baby: The Triptych” is among more than 50 works featured in “Black Artists in America, From the Bicentennial to September 11” at the Dixon Gallery & Gardens, the final installment of a three-part series highlighting the impact and evolution of Black artists through 2011.

Memphis native James Little’s “The War Baby: The Triptych” is among more than 50 works featured in “Black Artists in America, From the Bicentennial to September 11” at the Dixon Gallery & Gardens, the final installment of a three-part series highlighting the impact and evolution of Black artists through 2011.

The exhibit features other artists with Memphis ties, including abstract painter James Little, who was raised in a segregated Memphis and attended Memphis Academy of Art (before it was Memphis College of Art). He later moved to New York, became a teacher and an internationally acclaimed fixture in the art world in 2022 when he was named a Whitney Biennial selected artist at the Whitney Museum of American Art in New York.

Other artists like Romare Bearden, who had a Southern experience but lived up North, were featured in all three installments.

“During this period of time, he was a major figure,” said Sharp. “He wrote one of the first books on the history of African American art during a time when there were more Black academics, art teachers, more Black everything!”

Speaking of Black educators, Sharp said the head curator behind this tri-part series and Dixon’s partner in the arts is Earnestine Jenkins, Ph.D., an art history professor at the University of Memphis, who also earned a Master of Arts degree from Memphis State University (now UofM).  “We began working with Dr. Jenkins in 2018,” he said.

Sharp explained that it takes a team of curators, registrars, counterparts at other museums, and more, about three years to assemble an exhibit like this. It came together quite seamlessly, he added. Each room conjured up more jaw-dropping “wows” than the one before it. Each piece worked with the others to tell the story of Black people and their collective experience during this time period.

One of the last artists about whom Sharp shared information was Bettye Saar, who will turn 100 years old this year. She’s been working in Los Angeles for 80 years and is finally getting her due. Her medium is collages or assemblages, and an incredible work of hers is on display. She’s married to an artist and has two daughters, also artists.

The exhibit catalogue bears some of these artists’ stories, among other scholarly information.

The exhibit, presented by the Joe Orgill Family Fund for Exhibitions, is culturally and colorfully rich. It is a must see and admission to the Dixon is free.

Visit https://www.dixon.org/ to learn more.

Fun Facts: An original James Little design lives in the flooring of the basketball court at Tom Lee Park, and he makes and mixes his own paint colors.

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Grief, Advocacy, and Education: A Counselor Reflects on Black Maternal Health

SAN DIEGO VOICE & VIEWPOINT — Last month healthcare leaders, birth workers, and community members gathered to honor the legacy of Charleston native Dr. Janell Green Smith, a nurse-midwife and doctor of nursing practice who died in January from childbirth complications. She had participated in more than 300 births and specialized in helping Black women give birth safely.  

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By Jennifer Porter Gore | Word-In-Black | San Diego Voice and Viewpoint

In 2024, the number of U.S. mothers who died as a result of pregnancy or childbirth dropped compared to 2023. But while slightly fewer Black mothers died that year, they still had three times the mortality rate of white women.

South Carolina’s rates of maternal deaths outpaced even the national rates. In fact, the state’s overall rate of maternal deaths between 2019 and 2023 was higher than all but eight states and the District of Columbia.

Last month healthcare leaders, birth workers, and community members gathered to honor the legacy of Charleston native Dr. Janell Green Smith, a nurse-midwife and doctor of nursing practice who died in January from childbirth complications. She had participated in more than 300 births and specialized in helping Black women give birth safely.

Her death shocked the community and her colleagues who are determined to address concerns about Black maternal health. The event also covered the importance of protecting mental health during grief and of men’s role in solving the maternal health crisis.

As both a therapist and a father, Lawrence Lovell, a licensed professional counselor and founder of Breakthrough Solutions, discussed ways the event’s attendees could process their grief over Green Smith’s death. He also shared ways male partners can advocate for women’s maternal health during pregnancy and childbirth.

Lovell spoke not just as a therapist but also as a father whose own family had briefly crossed paths with Green Smith. The event, he said, emerged organically from a moment of collective mourning.

Despite the grief, “it was still, like, a really beautiful event, a much-needed event, and it almost felt like we were all giving each other a collective family hug,” says Lovell.

His connection to Green Smith, Lovell says, was brief but meaningful during his wife’s pregnancy with their second child. Green Smith was practicing at the same birthing center where they had their child. She began practicing in Greenville a short time later.Even that short connection carried significance for Lovell, given the small number of Black maternal health professionals.

Lovell did not initially plan to become a mental health practitioner; he chose the career path after graduating from college, when someone suggested he consider psychology. His interest deepened when he noticed how few Black men work in mental health.

“Being Black man and playing football in college, there weren’t a lot of people that look like me talking about mental health,” says Lovell. “[I wanted] to give people that look like me an opportunity to work with someone that looks like them.”

Working with Expectant and New Parents

Lovell often counsels couples preparing for parenthood by, helping partners understand what a successful pregnancy, childbirth, and postpartum recovery look like. That often means helping women manage postpartum depression.

As a man, Lovell says, it’s “humbling” that a woman “just trusts me enough to work with me through their pregnancy or their postpartum recovery.”

In his work, Lovell has noticed how few men understand pregnancy before they experience it with their partner. Because early pregnancy symptoms are often invisible, he says, men may underestimate how much support a mom-to-be actually needs.

“Sometimes they may not realize they don’t know much about pregnancy and what to expect in those three trimesters,” Lovell says. “I tell a lot of the men that just because you can’t see [she’s pregnant] doesn’t mean that she won’t appreciate your intense support in that first trimester.”

Education about pregnancy and postpartum recovery, he says, can change how men support their partners.

Teaching Advocacy in the Delivery Room

Another major focus of Lovell’s counseling is preparing men to advocate for mothers during labor.

“Helping men understand what pregnancy looks like: what delivery is going to look like, and what are the realistic expectations that I should have of myself in postpartum,” he says.

Lovell encourages partners to be honest about their expectations for what will happen during delivery. He helps them prepare for the big day by discussing the birth plan and knowing how to quickly recognize problems. Clear communication, he says, prevents misunderstandings.

He regularly trains men to ask their partners detailed questions about their expectations during and after pregnancy. Advocacy in medical settings can be especially important and requires attention to details the mother may not be able to address.

“It’s always important to fine-tune things and truly understand what helps your partner feel most supported,” Lovell says. “Instead of guessing, you should ask.”

Lovell recalls a moment during the birth of his first child when he had to take that role.

During the delivery, “I felt like something wasn’t as sanitary as I’d like it to be,” he says. “I asked, ‘Hey, can you switch those out? Can you change your gloves?’”

Lovell has a succinct but powerful message he regularly shares with clients’ families, and he shared it with attendees at last month’s event.

“Just to believe women,” he says. “I’ve worked with different couples, and sometimes I’m not really sure that there’s enough empathy from the men.”

That includes how women express pain.

“If a woman says, ‘my pain is at a nine,’ just because how you would express yourself at a nine is different than how she’s expressing herself at [that level] doesn’t mean you shouldn’t believe her,” he says.

Empathy, he says, can change outcomes far beyond the delivery room.

“We’ve got to believe women when they’re talking about their experiences and their feelings and their pain,” he says. “I think there’s a lot that we can prevent if we empathize better.”

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Future of Florida’s Black History Museum in Limbo

JACKSONVILLE FREE PRESS — A proposal sponsored by Tom Leek, a Republican from Ormond Beach, has now passed the Senate in back-to-back legislative sessions. But the House version, filed by Kiyan Michael, a Jacksonville Republican, did not receive final approval in either year, effectively stalling the effort.

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Jacksonville Free Press

Plans to establish a long-awaited Black history museum in Florida are once again on hold after legislation needed to advance the project failed to clear the state House for a second consecutive year, despite repeated approval in the Senate.

A proposal sponsored by Tom Leek, a Republican from Ormond Beach, has now passed the Senate in back-to-back legislative sessions. But the House version, filed by Kiyan Michael, a Jacksonville Republican, did not receive final approval in either year, effectively stalling the effort.

Under Florida law, identical or similar bills must pass both chambers before heading to the governor’s desk. Without House approval, the legislation has been unable to move forward, leaving the project in limbo. Long journey, contested location.

The proposed museum, formally known as the Florida Museum of Black History, has been years in the making, with lawmakers and community leaders framing it as a long-overdue institution to preserve and showcase the state’s African American heritage .A central point of contention has been the museum’s location. St. Augustine — widely recognized as the nation’s oldest city and a site deeply tied to both slavery and early Black history — emerged as the leading contender. Supporters argue the city’s historical significance makes it a natural home for the museum. However, competing interests and regional considerations have fueled debate, slowing consensus among lawmakers.

While the Senate-backed measure has consistently advanced, the lack of alignment in the House has underscored ongoing divisions about how and where the project should take shape.

The holdup in the Florida House appears to be less about opposition to the museum itself and more about a combination of procedural bottlenecks, unresolved structural issues, and lingering disagreements over how the project should be formalized and governed.

Despite the legislative setbacks, Republican Gov. Ron DeSantis has publicly voiced support for the museum. Speaking last month during the unveiling of a statue of abolitionist Frederick Douglass in St. Augustine, DeSantis said the project would move forward “one way or another,” signaling an intent to see the museum built regardless of legislative hurdles.

The anticipated museum has already cleared several hurdles. St. Johns County signed an agreement last year with Florida Memorial University to use the land that once housed its campus last year’s legislative session netted $1 million in funding for St. Johns County to work on planning and design for the museum. However, its anticipated that a million $3 million is needed.

Still, without statutory approval to finalize key components — including governance, funding mechanisms and site selection — the project remains largely conceptual.
With the House bill failing again, the timeline for the museum’s development is unclear. Lawmakers could revisit the proposal in the next legislative session, but any further delays risk pushing the project back several more years. Advocates warn that continued inaction could stall momentum for a museum many see as critical to telling a fuller, more accurate story of Florida’s past. For now, the effort remains paused — caught between political support at the top and legislative gridlock within the Capitol.

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