NNPDF Celebrates Monumental Milestone with the First U.S. Approval for ASMD

Jill Beirl

The National Niemann-Pick Disease Foundation joins with patients and families in the U.S. and the entire global Niemann-Pick community in celebrating this historic advance in research: the first-ever U.S. approval of a treatment for ASMD!

For more than 20 years, NNPDF has worked to support patients and families impacted by ASMD (acid sphingomyelinase deficiency) by raising awareness and advocating for research that can lead to life-changing therapies. While we have faced many challenges in the effort to bring new treatment options to patients who desperately need them, today we can see a sign of hope for the ASMD community and for all patients living with Niemann-Pick disease.  

The U.S. Food and Drug Administration (FDA) has announced the approval of Xenpozyme (olipudase alfa) for intravenous infusion in pediatric and adult patients with ASMD. Xenpozyme is an enzyme replacement therapy that has been shown to help reduce sphingomyelin accumulation in the liver, spleen, and lung. The efficacy of Xenpozyme for the treatment of ASMD was demonstrated in a controlled study of 31 patients. Based on results from the study, the FDA was able to conclude that Xenpozyme is effective and that treatment helped to improved lung function and reduced liver and spleen size in patients.

NNPDF would like to take this opportunity to recognize the hard work of many people including regulatory and industry leaders who have made this milestone possible. We applaud Sanofi for their commitment to moving this program forward. We also want to emphasize that this approval would not have been possible without the patients and families who participate in clinical research and who use their voices and stories to raise awareness of the need for treatments and support.

More than anything, this life-changing moment is an example of what we can accomplish when we work together. Hopefully, this will bring new levels of momentum and dedication to promising research moving forward. The Niemann-Pick community is resilient and thanks to the bravery and persistence of patients and families, people living with ASMD in the U.S., Europe and Japan can now have access to an approved treatment.

We are so happy to see this amazing progress and will use this to fuel us on our journey to finding approved treatment options for all people impacted by all types of Niemann-Pick.

Supporting one another. Supporting our community.

Summer 2022 Newsletter

Jill Beirl

APPROVAL!!

Xenpozyme (olipudase alfa) for Treatment of ASMD

We are pleased to share the U.S. Food and Drug Administration (FDA) has approved Xenpozyme™ (olipudase alfa-rpcp) for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients! Xenpozyme is the first therapy indicated specifically for the treatment of ASMD, and is currently the only approved treatment for this disease.

This has been a long road and the ASMD community played a vital and persistent role in bringing this medicine through the trials process and to an approval.  We are incredibly pleased that we now have a first approved medicine in the Niemann-Pick community.

Read Sanofi press release.
Read FDA press release.

Community Update Series presents: Xenpozyme (olipudase alfa) update with Sanofi’s Patient Supports Services

Join us for a community meeting with Sanofi’s Patient Supports Services as they share more information regarding the approval of Xenpozyme treatment of ASMD.

Wednesday, September 7th, 2022
8:00 pm ET
Join Zoom Meeting

Message from the Board Chair

Dear, NNPDF Community,

As the conference came to a close this year, I was reminded of the strength of our community yet again. Our community gathered in-person and virtually during this year’s conference and I could not be prouder of our PERSEVERENCE through all that our community has faced in the past year. Our conference not only symbolized but brought to life the endurance and insurmountable strength of who we are when we are all together. We support each other and support our community. Thank you to all who participated, from our families, our clinicians, researchers, scientists, and sponsors.

Thank you for the incredible moments at our conference, from pointed questions, extraordinary feedback, love shared, siblings uniting, and dance moves like no one was watching. It was an honor hosting the INDPA. Partnership and strategy are at the forefront of everyone’s intentions and execution of initiatives. Thank you to all for the conference, it was not only informative for so many, but collaborative and just downright refreshing to see old friends and new.

The momentum from the conference has continued on in the work that we do. We have collaborated with industry and families to elevate our voices and we will keep our eyes on all that our families face and how we can help. My wish, as I start my tenure as Board Chair, is to continue the trajectory of the foundation with an incredible board and staff. Our voices and our community have come so far and we still have a long way to go, but I have faith that our efforts combined are going to impact the lives of our loved ones now and in the future.

The recordings will be available in the upcoming weeks. We hope that you were able to joyfully connect, meet new families, reconnect with friends, and truly live in this journey knowing that you are supported and loved by us all. We say it often, but it never loses its power, we may not be the family you ever wanted to have, but we are the family that will never leave your side. No matter where you are on this journey, your voice will be heard, you have us to lean on, and we remain founded in our roots. We believe deeply in the future of research that promotes clinical treatments with potential to improve patient quality of life and with intent to ultimately treat and cure all Niemann-Pick disease types.

Warm Regards,


Becky McGuire
NNPDF Board Chair

NNPDF Family Support & Medical Conference

THANK YOU to all that joined us in Orlando and virtually for the 30th Annual Family Support & Medical Conference. We were so happy to meet with you in person! New friendships and connections were made, we learned more about each other, and how we can help one another to grow as a community in the US and abroad.

In the upcoming days we will be sharing links to the LiveStream sessions and photos of the event.

Thank You to our Family Support & Medical Conference Sponsors

NNPDF Award Recipients

We are honored to present our 2022 award recipients! Thank you for the impact you have in the Niemann-Pick community and your chosen career paths. Congratulations!

Endurance Award 2022 - Sousa
Persevere Award
Dr. Ed Schuchman
NNPDF Cora Sterling
Endurance Award
Christopher Sousa
ASMD Scholarship Award 2022 - Visoky
Joele Ruppert & Joseph Colton
ASMD Scholarship
Yasmin Markman
Joele Ruppert & Joseph Colton
ASMD Scholarship
Jack Visoky

NNPDF 2022 Board of Directors

We are honored to present your 2022 NNPDF Board of Directors. NNPDF Board members generously volunteer their time and energy to keep your family support organization moving forward and are essential in the progress of Niemann-Pick Disease awareness. Thank you to each of you for serving in these vitally important roles.

FRONT ROW:  Becky McGuire (Board Chair), Paul Merrigan, Travis Obermeyer, Cara Gilmore, Anthony Leoni, and Kari Lato.  BACK ROW:  Joslyn Crowe (Executive Director), Gail Koujaian, Taylor Sabky, Mary Francis Harmon, Liz Heinze (Vice Chair), Meghann Ferguson (Secretary), and Mike Smith (Treasurer).

NNPDF Welcomes New Board Members

We are proud to welcome the following incoming Board Members to the NNPDF team: Gail Koujaian, Travis Obermeyer, and Taylor Sabky. Learn more about them.

Sabky Taylor SQR 2022

Gail Koujaian
Mother of Alec,
and Hayley (In Memory), NPC

Travis Obermeyer
Father of Austin, ASMD

Taylor Sabky
Mother of Purnell
(In Memory), ASMD

Duke-Margolis Center Webinar

On August 4th, the FDA and Duke Margolis Center for Health Policy held a webinar on Endpoint Considerations to Facilitate Drug Development for Niemann-Pick Type C which discussed key themes from the January 2022 public workshop.   Discussion included a review of challenges, and opportunities for endpoint selections in NPC to support product development.

The recording for this webinar is available here.

This discussion was focused on a longer-term view of drug development including the importance of biomarkers and endpoints in NPC drug development. NNPDF recognizes the importance of these scientific areas and will continue to work in partnership with all NPC community organizations and foundations to assist with biomarker development. Our goal as a national patient organization is to ensure that we simultaneously continue to ensure attention and focus on our investigational therapies currently in development and continue to find paths to move to approved therapies expediently.

It’s not too late to join ASMD Accelerate!

Join ASMD Accelerate to support the ASMD research community and improve care! Thank you to the 15 families who have contributed their child’s de-identified medical data in support of ASMD research. We are 60% of the way to our goal and still enrolling for this incredibly important study. Your help can shape the future of ASMD care.

Signing up for ASMD Accelerate takes less than 10 minutes and PicnicHealth will do the hard work of collecting your child’s records on your behalf. Enroll today by visiting picnichealth.com/asmd-wylder-nation or email [email protected] with any questions.

AllStripes Update

AllStripes recently informed NPC families that with deep regret they will no longer be supporting the NPC Sibling Study. In response to broader economic downturn, AllStripes is reprioritizing its resources so that they may continue to sustainably support rare disease research. Unfortunately, this means that they cannot continue resourcing several studies, including the NPC sibling study.

We (NNDPF, APRMF, Firefly Fund, and NP Canada) have chosen to partner with the International Niemann-Pick Disease Registry (INPDR) moving forward and to continue the NPC sibling study through the INPDR. The INPDR is the Niemann-Pick specific patient registry which is led and governed by the Niemann-Pick community. We are recommending that all NPC families who have shared their loved one’s data with AllStripes have their data transferred to INPDR. This is completely voluntary and each family’s decision is respected. We have worked with AllStripes and the INPDR to ensure that this is a user-friendly and fairly simple process for families.

For information on how to share you loved one’s records with the INPDR, or if you have any questions, please contact us at [email protected].

Virtual Roundtable Discussion of the ACT for ALS Bill

In July 2022 NNPDF held a roundtable discussion on the Accelerating Access to Critical Treatments for ALS ACT, which is designed offer grants and other financial incentives to support expanded access programs in ALS and other rare neurodegenerative diseases. The forum included 15 U.S. organizations focused on rare neurodegenerative diseases.

A panel of experts provided an overview of the bill including the FDA Action Plan and the Grant Program.

Top findings include:

  • A need to bring representatives from CDER, CBER, and other divisions at the FDA to establish consistency between Centers and form a predictable path for drug development.
  • The option to consider alternatives to placebo trials in ALS.
  • Calls for higher levels of funding.
  • NIH Grant applications are open now for ALS with notification in Sept 2022.

NNPDF will continue to host these forums, our actions for next steps include:

  • A series of quarterly discussions to continue to invite community perspectives on program execution.
  • Updates on the logistics of the FDA Grants Program as they become available.
  • Review of  the benefits of a new alliance  of organizations in rare neurodegenerative diseases to represent community interests with a stronger voice.

NNPDF In Action

Evren Ayik, and Justin and Garrett Hopkin attend Sanofi’s 2022 TORCH Awards in Cambridge, Massachusetts.

Justin Garret 2022 TORCH Awards

Clinical Trial Updates

Clinical trials are currently in progress to study and develop treatments for ASMD and NPC. The NNPDF posts new information regarding clinical trial updates as soon as it is received. Visit our Clinical Trials web page for up to date information on all clinical trials.

Update from Sanofi:  We are pleased to share the U.S. Food and Drug Administration (FDA) has approved Xenpozyme™ (olipudase alfa-rpcp) for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients! Xenpozyme is the first therapy indicated specifically for the treatment of ASMD, and is currently the only approved treatment for this disease.

This has been a long road and the ASMD community played a vital and persistent role in bringing this medicine through the trials process and to an approval.  We are incredibly pleased that we now have a first approved medicine in the Niemann-Pick community.
Read Sanofi press release.
Read FDA press release.
Read Xenpozyme press release.

Update from Sanofi:  European Approval! News from Sanofi on Xenpozyme (olipudase alfa): “Xenpozyme® (olipudase alfa) approved by European Commission as first and only treatment for ASMD”. The European Commission (EC) has approved Xenpozyme® (olipudase alfa) as the first and only enzyme replacement therapy for the treatment of non-Central Nervous System (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD) in pediatric and adult patients with ASMD type A/B or ASMD type B. Read the press release.

Surveys, Studies, & Market Research

Be sure to check out our Surveys & Market Research webpage for current survey and study opportunities in the Niemann-Pick disease space. Participating in surveys and studies is important to the advancement of health options for our Niemann-Pick community members. Contact Laurie Turner at [email protected] for any questions.

Fundraising

Contributions through fundraising by NNPDF members, families and friends are used to provide services and information to individuals and families affected by NPD, as well as supporting research into finding treatments. Please continue to host and support NPD fundraisers. Awareness Events promote awareness to the general public about Niemann-Pick Disease.

If you have recently hosted a fundraising event, send us your photos and we’ll share them and details from your event in upcoming newsletters!

THANK YOU to Stacy Stemmerman, Lane Hemsley, Stacy Tillotta, Vera Stricklin, and Natalie Johnson who recently hosted Facebook Fundraisers for the NNPDF! We truly appreciate your support!

Want to host your own Facebook Fundraiser? It’s easy! Visit facebook.com/fund/NNPDF to get started!

NNPDF Membership

Enrolling, confirming, or updating your membership will ensure we have accurate information for you and your family. This will help us to continue to provide you with important notifications and updates from the NNPDF.

Click here to update or enroll today!


For assistance contact Laurie at [email protected] or call 920-542-4038

Emergency Hardship Program

The NNPDF Emergency Hardship Program continues to offer assistance to qualified NNPDF U.S. member families facing a crisis. Funding includes but is not limited to, specialized medical equipment, durable medical goods, utility bills (heating and cooling, electricity, phone, water and sewer), home and car repairs, and bereavement expenses. Click here for complete details and eligibility information.

Please contact Laurie Turner, Family Services Manager at 920-542-4038 or [email protected] if you have any questions about this program.

            

Supporting one another. Supporting our community.

June 2022 Newsletter

Jill Beirl

Message from the Board Chair

Dear NNPDF Community,

Over the past several months, our NNPDF staff and volunteers have had our eyes on the end of July, hopeful that the world will be in a place where we can all come together safely to meet in person for the 30th Annual NNPDF Family Support & Medical Conference.  Recognizing we all have different levels of comfort with travel and gathering right now, it appears that we are in as good of a place as we could hope for with the meeting only a month away. We are striving to not only make this conference enjoyable and impactful for our entire community but also keep everyone as safe and comfortable as possible. I am deeply appreciative of all those who are working tirelessly to organize this meeting where we can gather, learn, connect, and enjoy. I miss seeing all of you in three dimensions and look forward to catching up in Orlando.

While conference planning has been a key task for the organization over the last few months, the NNPDF remains laser focused on our primary missions of supporting families and advocating for the community. We appreciate your assistance with the feedback many of you have provided through the Community Survey. Your feedback will help us direct services and ensure we remain on course with accomplishing our primary missions 1) advocacy and 2) support for all patients and families throughout their experience with Niemann-Pick Disease. 

Our community continues to persevere as we navigate the trials and tribulations of drug development in the rare disease space. While we have had our share of disappointment and frustration, there is hopeful dialogue and encouraging movement toward needed change in clinical trial design and accepted endpoints.  We hope this evolution will provide the framework for collaborative engagement with industry and regulators to identify disease-modifying therapies through clinical trials that are designed with patients in mind to more clearly identify safe, effective therapies for Niemann Pick.  I’m hopeful that the dialogue from our experts at the conference will continue to move the needle in the right direction.

The conference marks the time of year when we onboard our new board of directors for the NNPDF as other board members complete their terms of service. Our board is a collection of amazing volunteers, and it has been my pleasure to work with them over the last six years to ensure the NNPDF is accomplishing its mission of supporting you. For those of you who attend the conference in person, I invite you to reach out to your NNPDF board members who will be present. They want to hear from you.  Please let them know how we are doing and what we can do to better serve you.

In compliance with our bylaws, it is time for me to step off the board. It has been my honor to help lead the Foundation, and I’m very proud of all that our staff, volunteers, and community have accomplished. Our community has come together to create a stronger national patient organization to meet our needs and amplify our voice to key opinion leaders. While there is always work left to be done, I am supremely confident that we are poised to meet those needs. I look forward to continuing my support of NNPDF as I transition off the board over the next several months and plan to remain involved with several key directives including newborn screening, patient registries, and clinical trial design. The transition in board leadership has literally been years in the making, and I’m thrilled that Becky McGuire will be accepting the role of board chair after serving as vice-chair. She has several years of experience on the board, and her strengths in leadership, communication, and fundraising will be great assets for the Foundation and the community. She has an incredibly talented and caring group of board members around her that will foster the continued growth of the foundation and ensure we meet our mission to serve all of you. I could not be more excited about the direction of the organization based on the leadership and staff we have in place.

Warm Regards,


Justin Hopkin, MD
NNPDF Board Chair

NNPDF Family Support & Medical Conference

in Conjunction with INPDA Biennial Meeting

 

JOINT CONFERENCE DATES:  July 28 – July 31, 2022
NNPDF:  July 28 – 30  |  INPDA:  July 29 – July 31

Wyndham Grand Orlando Resort Bonnet Creek | Orlando, FL

Conference Deadlines

  • Register by June 24th to get your complimentary commemorative conference shirt.
  • Reserve your hotel by June 27th to receive your hotel accommodations at the discounted group rate. Our special group rate is applicable for the dates of July 23 – August 4, based on availability.

Thank You to our conference Sponsors


LAST CALL: NPC Family Advisory Working Groups

NNPDF will host Family Advisory Working Groups on Thursday, July 28, 2022 from 1:00 pm – 4:00 pm EST, prior to the start of our 30th Annual Family Support & Medical Conference.

Family Advisory Working Groups foster communication between Niemann-Pick families and pharmaceutical & research partners to provide guidance on the patient and family experience. Pre-registration is required.

Family Advisory Working Group participants are eligible for
1-night hotel room per family on July 27th (room and tax only)
and up to $350 stipend per participant.

Understanding patient and caregiver perspectives is extremely important to our pharmaceutical industry and research partners working to bring treatments to families. Patients and their families are often the most knowledgeable members of the care team and can offer unique perspectives.

NNPDF Community Survey

We invite you to take part in a brief survey to highlight some of the key issues that are important to members of the Niemann-Pick community. Your responses will help NNPDF develop a better understanding of the issues that are most important to you and your family. Responses will be used to help NNPDF identify the priorities and areas of unmet need in planning for development of new support programs and resources for families at every stage of the Niemann-Pick journey.

In addition to your response, we also invite you to share your thoughts regarding our programs and services and how we can best meet your needs in the months and year ahead. Survey closes on July 4th, 2022.

ASMD Community Survey

As olipudase alfa moves through the regulatory process, we are proactively preparing for the next steps, which include speaking with insurance companies and ensuring reimbursement and coverage for patients across the country.  To help us better understand our ASMD population, can you please take a moment to complete the following brief surveyThis survey will close on Monday, July 11, 2022.

For assistance or any questions, please contact [email protected].

It’s not too late to join ASMD Accelerate!

Just over a year ago, Wylder Nation and NNPDF partnered together to launch ASMD Accelerate to support the ASMD research community. To date, we’ve had 15 contribute their child’s de-identified medical data in support of ASMD research!

If you are interested in joining ASMD Accelerate and making a difference in the future of ASMD research, we are still enrolling new members.

This research study is a way your child’s journey can contribute to ASMD research without the need for travel, lab testing, or physical record collection coordination. Additionally, if your child’s journey with ASMD has ended this study can help carry on their legacy and contribute to improving the future of ASMD care.

Signing up for ASMD Accelerate takes less than 10 minutes and PicnicHealth will do the hard work of collecting your child’s records on your behalf. Let us know if you have any questions!

Visit picnichealth.com/asmd-wylder-nation or email [email protected] with any questions.

Duke-Margolis Center Update

Endpoint Considerations to Facilitate Drug Development for NPC Workshop Summary

Duke-Margolis Center has shared an update related to the January workshop on Endpoint Considerations to Facilitate Drug Development for NPC. Your contributions prior to and during the workshop helped ensure that patients and families were at the center of the conversation and that the event was informative for all NPC drug development stakeholders. The workshop summary is now available.

A brief webinar along with the FDA will be held on Thursday, August 4, from 3:00-4:00 pm ET to provide an overview of the key themes and future directions shared during the January 2022 workshop and presented in this newly released workshop summary report.

The webinar is intended to be another touchpoint for NPC drug development stakeholders on this important topic. Stakeholders will be able to submit questions about the workshop summary in advance of the webinar using this form, and we will get to as many as we can in the webinar format. Please note that the webinar is not intended to cover any new content beyond the January workshop and the workshop summary.

Workshop Summary
Webinar Registration
Questions Submission Form

Milestones: Willow Hemsley

Oh Willow… the places you will go. For as long as I can remember I have dreaded the thought of this day. Willow started school today, at an actual school, and rode a bus to and from… Mom may have been a crazy person who followed the bus and was there to make sure her first bus ride went ok and that she got settled into her classroom with her new teacher. With Willow getting ready to go to Kindergarten in the Fall we figured it was best to give summer school a test run to see how she does. As you can tell from the picture, she was very excited!
– Krystal Samuelson

If you have a special milestone to share, send it to us at [email protected] and we’ll include it in our newsletter or other communications.

INPDR Poster Presentation on NPC

INPDR recently presented a poster titled “Quality of life in patients with Niemann-Pick disease type C and their carers”. This research study was funded by NNPDF, NPUK, and INPDA. View the poster.

Community News Update

Update from Mandos Health:
Mandos Health has shared the following update with the NNPDF. Read complete update.

Clinical Trial Updates

Clinical trials are currently in progress to study and develop treatments for ASMD and NPC. The NNPDF posts new information regarding clinical trial updates as soon as it is received. Visit our Clinical Trials web page for up to date information on all clinical trials.

Surveys, Studies, & Market Research

Be sure to check out our Surveys & Market Research webpage for current survey and study opportunities in the Niemann-Pick disease space. Participating in surveys and studies is important to the advancement of health options for our Niemann-Pick community members. Current surveys and studies are listed below. Contact Laurie Turner at [email protected] for any questions.

Fundraising

Contributions through fundraising by NNPDF members, families and friends are used to provide services and information to individuals and families affected by NPD, as well as supporting research into finding treatments. Please continue to host and support NPD fundraisers. Awareness Events promote awareness to the general public about Niemann-Pick Disease.

If you have recently hosted a fundraising event, send us your photos and we’ll share them and details from your event in upcoming newsletters!

THANK YOU to the Genesee Regional Bank (GRB) in Rochester, NY and the Vandetta family who recently hosted the “Rock the Bank” fundraiser for NNPDF in a tribute honoring the memory of GRB team member Michael Vandetta and his son, Vinny (ASMD in Memory).  GRB’s own house band, Refer with Caution, brought down the house with a show for the ages. Check out a clip from the event on Facebook at t.ly/Vandetta/FB

THANK YOU to Patricia Steiger, Paul Fonseca and April Thompson who recently hosted Facebook Fundraisers for the NNPDF! We truly appreciate your support!

Want to host your own Facebook Fundraiser? It’s easy! Visit facebook.com/fund/NNPDF to get started!

NNPDF Membership

Enrolling, confirming, or updating your membership will ensure we have accurate information for you and your family. This will help us to continue to provide you with important notifications and updates from the NNPDF.

Click here to update or enroll today!


For assistance contact Laurie at [email protected] or call 920-542-4038

Emergency Hardship Program

The NNPDF Emergency Hardship Program continues to offer assistance to qualified NNPDF U.S. member families facing a crisis. Funding includes but is not limited to, specialized medical equipment, durable medical goods, utility bills (heating and cooling, electricity, phone, water and sewer), home and car repairs, and bereavement expenses. Click here for complete details and eligibility information.

Please contact Laurie Turner, Family Services Manager at 920-542-4038 or [email protected] if you have any questions about this program.

            

Supporting one another. Supporting our community.

In the Spotlight with Pam Andrews

Jill Beirl

Pam Andrews

Mom to Belle & Abby, NPC
Firefly Fund, Co-Founder and Executive Director

Tell us a bit about yourself.
My name is Pam Andrews. I’m a sixth generation Texan and was born in a small town just outside of Austin called Brenham, Texas. You may have heard of it before, as it’s the home of Blue Bell Ice Cream. My parents met when in graduate school at the University of Texas at Austin. My mom had just graduated from law school and the only job she could find after graduation (1972), as a new female attorney in Texas, was working as a secretary in a law firm in Brenham, Texas. I have three sisters (Lisa, Jessica and Leslie) and a brother (Sean, who passed away just seven months ago).  We didn’t stay in Brenham long and moved back to Austin when I was three years old. Growing up in the 70’s and 80’s was a bit idyllic, to be honest. My siblings and I would play outside with neighborhood friends for 6-8 hours at a time on the weekends. Our bicycles got us around and we walked to and from our neighborhood school during the week. My parents worked hard and a lot and my siblings and I looked after each other. I remember using a kitchen stool to make dinner for my sisters. I wasn’t tall enough to see the top of the stove so I would get a step stool and stand on it and make dinner that way. I was probably seven years old. My grandfather (and great grandfather actually) were both doctors in Ft. Worth, Texas and Alpine, Texas. Truth be told, that was really my only exposure to healthcare or the medical profession when I was growing up. Grandaddy made house calls, delivering babies at home and I remember that he pierced kids’ ears in his office. There was the occasional penicillin shot when someone was sick, but otherwise it was delivering babies and piercing ears. My father, later in my 20’s, was diagnosed with and died from Cancer. I definitely came to understand that people get sick. However, if you had told me in 1978 or even 1994 that I would later have two beautiful daughters who would both be diagnosed with a rare genetic neurodegenerative disease, I would have thought that you were certifiable. As a young girl, I would have never fathomed this life.

I live in Austin with my husband, Chris Andrews, our two beautiful daughters, Belle (12yo) and Abby (7yo) and our two miniature poodles, Lady and Lucy. For fun you will find me taking walks in the neighborhood with my dogs or hanging out in our backyard, by the pool with my girls, and spending time with the little family that Chris and I have made. The girls are filled with joy and laughter and they truly enjoy life and enjoy talking with people in their little lives and they laugh hysterically at each other’s wild antics. They love music and singing and being silly little girls. It is my greatest joy in life, and honor really, to be Belle and Abby’s mama. It is what I enjoy the most in life.

When did you receive Belle and Abby’s diagnosis and what led to this?
Belle was diagnosed first after a diagnostic odyssey that spanned several years and included countless appointments with doctors and specialists. Leading up to Belle’s diagnosis what concerned us the most was her tripping and falling, which seemed to be getting worse with each passing day. Belle’s platelets were also always low and her spleen was enlarged. Those were the early signs that kept me tossing and turning at night. And she developed a tremor at about 3yo. For years I was told that she was within the normal range and not to worry. I was a first time mom so I didn’t have a neurotypical child as a reference, but something inside of me kept nudging me to continue pressing for answers. My nieces and nephews and Belle’s friends would come over and I would talk with other moms and no one seemed to have the same types of symptoms that we were seeing.

Finally, we met with a young doctor who was also a mom – she agreed with us that something wasn’t right. Her name is Dr. Amy White and she is now on the BOD of Firefly Fund. Belle was about 4 1/2 at the time and Abby was about 9 months old.  Belle’s diagnosis was eventually made through whole exome sequencing. It was suggested that we test Abby immediately, she was 18 months old at the time and had absolutely no reason to believe that she also had NPC. It was terrifying. As you might imagine, our pain more than doubled with Abby’s diagnosis, just 10 days after Belle.

How did you learn about NNPDF?
We learned about the NNPDF really slowly after diagnosis. Initially, the day of our diagnosis, we were given a Make A Wish form and told to take the girls to Disney World and to enjoy them. The doctor made it clear that there were no approved drugs and nothing that could be done. The only information that was given to us was a one pager on NPC and the Make A Wish form. We left the doctors office and made some calls to immediately take steps to form the Firefly Fund. Initially, we thought we were going to have to figure it all out on our own. Over the course of the next few months we had countless calls with NPC families and researchers and clinicians. We were so relieved to learn from some of those early conversations with members from the NPC Community that there was a patient organization and several mature family-led, patient inspired organizations that had been funding research for over 25 years.  We began to feel the weight of the girls’ diagnosis lift. We realized that we didn’t have to do this by ourselves.

The NNPDF was in the middle of a transition when we were diagnosed. They were looking for a new leader and for a Board Chair. I think we first met Joslyn and Justin in 2018 and that is when we really began to get to know and work with the NNPDF.  It was through the newborn screening work that Firefly Fund does that I began to really understand the significance and importance of a national patient organization in a rare disease community. The NPC Community’s interactions with the healthcare stakeholders like the medical profession, with regulators, with public health officials, with drug developers and companies, all rely on a healthy patient organization. The work that the NNPDF does is vital to the overall success of the NPC Community.

Why is newborn screening important to the Niemann Pick community and what difference can it make in the future?
Newborn Screening is a public health service that reaches 4 million babies born in the United States each year. The newborn screening program ensures that all babies are screened for certain serious life-limiting conditions at birth, and for those babies with the conditions, it allows doctors to start treatment before some of the harmful effects happen. Newborn screening is performed soon after the birth of your baby, and in most cases, while you are still in the hospital. Specific protocols for newborn screening follow up vary from state to state, as does the list of conditions screened for.  

It is my opinion that newborn screening is the single most important public health program that exists worldwide. As Belle and Abby’s mom, I understand first hand the horror of watching your child slip through your fingers while searching for answers.  The diagnostic odyssey that NPC families are forced to travel is barbaric and unnecessary in 2022. Newborn screening will provide families with information about the health status of their newborn, which will allow for early intervention. We know, and there is consensus among NPC expert clinicians, that early intervention in the NPC patient improves health outcomes. Chris and I live this reality every single day in our home as we watch the trajectory of our two daughters’ lives go in two completely different directions due to the fact that one was diagnosed before any visible signs or symptoms of the disease and one was not.  

Shortly after our diagnosis, Chris and I sought out the counsel of someone who has become our dear friend and mentor, Dr. Philip Reilly. At the time in 2016, I’d just finished his book, Orphan: The Quest to Save Children with Rare Genetic Disorders and I wanted to hear his perspective regarding where he thought there were unmet needs in the NPC Community. Dr. Reilly was the first person to encourage us to focus on newborn screening for the NPC community. He wisely explained to us, from the perspective of a venture capitalist mixed with his experience as a clinical geneticist (he has a law degree, as well), that if NPC patients can be identified at birth then what will happen as a result is that NPC patients will have plenty of treatments in no time. He explained that newborn screening for NPC would accelerate the drug development process because we would be helping “them” to help us. 

In addition to finding our patients early, newborn screening is important to the NPC Community because it will help researchers and clinicians better understand the incidence and prevalence of the disease. And data collected through newborn screening pilot studies, such as ScreenPlus in New York, will help us better understand the heterogeneity of the disease and how the variability in onset of NPC patients impacts families and the public health system. Through newborn screening, we are essentially introducing a whole new disease to the medical community – doctors, hospitals, payors, drug companies, regulators, labs, and the list goes on.  We’ve all witnessed over the past two years the havoc that a new disease state can wreck on the healthcare system and for teeny tiny, ultra rare disease groups like NPC, the onus is on the NPC Community to demonstrate that we are ready to be in the public health service referred to around the world as newborn screening.  

The process is long and arduous. There is zero room for errors. We can not misdiagnose newborns. We have to demonstrate that our short and long term clinical follow up protocols improve health outcomes for those patients identified at birth. Once we are able to identify our patients early, before any visible signs or symptoms of the disease, we will see improved clinical trial outcomes, which will lead to therapeutic approvals and maybe even therapeutic options for our loved ones.  

How can families get involved with newborn screening efforts?
I think the most important thing that families can do is to look for ways to advocate for newborn screening for NPC at home. Every state health department has a newborn screening advisory committees and in all 50 states there are rare disease parents on those committees. I sit on the Newborn Screening Advisory Committee in Texas. As I mentioned earlier, newborn screening lists vary from state to state.  Ultimately, we will need NPC to be added to every single state newborn screening list. Right now, through ScreenPlus, the NPC Community is collecting evidence necessary to be added to these lists. Once we are added to the RUSP, which I believe can happen within the next 3-4 years, we will need to immediately turn our attention to the states. Anything that parents can do to ensure that NPC is “in line” for inclusion on the various state lists would be helpful. We will add this to the agenda for one of our upcoming working group calls. Please let people know that they can reach out to me if they are interested in joining.

Another thing that NPC families can do from home is sign up for the AllStripes sibling study where data is being collected and analyzed for health outcomes for siblings diagnosed at different points of disease progression. The evidence collected through the study will provide data to the newborn screening advisory committee that will decide if NPC meets the criteria for early intervention. It is really important that families sign up for this study and it can be done from the comfort of your home computer by clicking here.

What advice would you share with newly diagnosed families?
Don’t forget to breathe. Focus on the things that bring you joy rather than on the things that you can’t change or control. Don’t be afraid to pick up the phone and reach out to other families. Ask a lot of questions. If someone is upset with you for asking too many questions, ask more questions. You are not alone and you don’t have to travel this rare journey alone, if you don’t want to. Reach out to families that have traveled the road before you and allow them to share their experience, strength and hope with you. The NPC Community is resilient and strong and committed to moving NPC into a new and different public health paradigm. None of us can do this alone and thank goodness we don’t have to.

What are your hopes for the future for your girls and for the Niemann-Pick community?
Gosh, everyday my focus and hope for my girls is that they are happy and that they know with every fiber of who they are that they are loved and cherished and absolutely adored. I hope and pray that they know that their life has purpose and meaning far beyond their NPC diagnosis. I hope they never let their NPC diagnosis define who they are. I hope they laugh often and that they rest easy knowing that Chris and I will be there beside them on this journey every step of the way. I believe that in Belle and Abby’s lifetime we will be able to render NPC a chronic disease. We have the tools necessary to do this in the NPC Community now and I believe that if we all work together, we can accomplish this goal. I was talking to another NPC mom just yesterday and we agreed that finding a drug cocktail to render NPC a chronic disease seems like an easy feat compared to the education and awareness that is necessary for stakeholders to move NPC into the healthcare system. The good news is that we don’t have to do it all in one day, but rather one day at a time we need to keep putting one foot in front of the other and doing the important work that we’ve been called to do in honor of those who came before us, for our loved ones and for those yet to be born with an NPC diagnosis in their future.   

I believe that the NPC Community should feel proud of all that has been accomplished in the past 25 years. I look forward to seeing what transpires over the next 25 years.

Supporting one another. Supporting our community.

May 2022 Newsletter

Jill Beirl

NNPDF Family Support & Medical Conference

in Conjunction with INPDA Biennial Meeting

 

JOINT CONFERENCE DATES:  July 28 – August 1, 2022
NNPDF:  July 28 – 30  |  INPDA:  July 29 – August 1

Wyndham Grand Orlando Resort Bonnet Creek | Orlando, Florida

Conference Deadlines

  • Conference Registration by June 24th to receive your complimentary 2022 Family Conference shirt
  • Hotel Reservations by June 27th to receive the NNPDF hotel group rate
  • Online Registration by July 22nd on site registration will be available

DEADLINES APPROACHING!

NNPDF Cora Sterling Endurance Award

Do you know a great young person who shines for Niemann-Pick awareness? NNPDF is seeking nominations for the NNPDF Cora Sterling Endurance Award. This award is presented annually at the NNPDF Family Support & Medical Conference to a young person (under age 25) who shines in raising awareness of Niemann‐Pick disease in the community. Nomination deadline is May 31st.

NNPDF Research Fellowship Applications

NNPDF is accepting Research Fellowship Applications. The Peter G. Pentchev Niemann-Pick Type C Research Fellowship and the Edward H. Schuchman ASMD Research Fellowship are 1-year awards intended for early-stage researchers. These awards support young scientists in pursuit of independent hypotheses and encourage scholarly development about Niemann-Pick Disease.

Niemann-Pick Disease research is one of the pillars of our mission and we are proud that since 1993, NNPDF has funded 52 grants and 20 fellowships totaling over $4,000,000. Many former grantees and fellows have remained active contributors in the Niemann-Pick Disease space. Contact [email protected] with questions. Application deadline is June 1st.

INPDA - ASMD Webinar Recording Available

We are pleased to share the collaborative webinar recording entitled The impacts of olipudase alfa on pediatric patients with ASMD and their families: Results of an international survey. The webinar was hosted by the INPDA, INPDR, NNPDF, and NPUK.

Thank you to those that joined us, and to our featured speakers; Sandy Cowie, President, International Niemann-Pick Disease Alliance (INPDA), Conan Donnelly, CEO, International Niemann-Pick Disease Registry (INPDR), and Justin Hopkin, Chair, National Niemann-Pick Disease Foundation (NNPDF).

Watch the recording.
View the slideshow presentation.

Join ASMD Accelerate, Help Change the Future of ASMD Care

Just over a year ago, Wylder Nation, NNPDF, and PicnicHealth launched ASMD Accelerate to help support the ASMD research community. Thank you so much to the 15 families who have contributed their child’s de-identified medical data in support of ASMD research! Every child’s story can make a difference for the future of ASMD care.

If you are interested in joining ASMD Accelerate and making a difference in the future of ASMD research, we are still enrolling new members! This research study is a way your child’s journey can contribute to ASMD research without the need for travel, lab testing, or physical record collection coordination. Additionally, if your child’s journey with ASMD has ended this study can help carry on their legacy and contribute to improving the future of ASMD care.

Visit picnichealth.com/asmd-wylder-nation or email [email protected] with any questions.

Join ASMD Accelerate.

Pfrieger's Digest

NNPDF is pleased to share the latest edition of Pfrieger’s Digest, written by Frank Pfrieger, PhD of Niemann-Pick Selbsthiifegruppe (Germany). This publication provides a summary of research advances based on selected peer-reviewed publications in scientific journals. Read the latest issue.

Transport NPC

Cyclo Therapeutics’ May newsletter is live and shares a new column with you called “Powerful Patient Advocates.” This month features an interview with Barbara Lazarus. Read the newsletter.

Clinical Trial Update

Clinical trials are currently in progress to study and develop treatments for ASMD and NPC. The NNPDF posts new information regarding clinical trial updates as soon as it is received. Visit our Clinical Trials web page for up to date information on all clinical trials.

Update from Orphazyme: Orphazyme announces update on in-court restructuring proceedings. NNPDF has received the following press release which speaks to the progress the team has made in finding a potential path forward for arimoclomol. Read the press release.

Community News Update

Update from Orphazyme:
Orphazyme to sell to KemPharm, Inc.: NNPDF has received the following news from Orphazyme: Orphazyme A/S under In-Court-Restructuring to sell substantially all of its assets and business activities to KemPharm, Inc.
Read Orphazyme press release.
Read KemPharm press release.

We will continue to keep you informed as more information is available. If you have any questions, please contact Joslyn Crowe, NNPDF Executive Director, at [email protected].

Update from Cyclo Therapeutics:
Cyclo Therapeutics has shared the following letter to the NPC community. Read the letter.

Surveys, Studies & Market Research

Be sure to check out our Surveys & Market Research webpage for current survey and study opportunities in the Niemann-Pick disease space. Participating in surveys and studies is important to the advancement of health options for our Niemann-Pick community members. Current surveys and studies are listed below. Contact Laurie Turner at [email protected] for any questions.

Fundraising

Contributions through fundraising by NNPDF members, families and friends are used to provide services and information to individuals and families affected by NPD, as well as supporting research into finding treatments. Please continue to host and support NPD fundraisers. Awareness Events promote awareness to the general public about Niemann-Pick Disease.

If you have recently hosted a fundraising event, send us your photos and we’ll share them and details from your event in upcoming newsletters!

THANK YOU to Claudia Rae and Allison Reiter who recently hosted Facebook Fundraisers for the NNPDF! We truly appreciate your support!

Want to host your own Facebook Fundraiser? It’s easy! Visit facebook.com/fund/NNPDF to get started!

NNPDF Membership

Enrolling, confirming, or updating your membership will ensure we have accurate information for you and your family. This will help us to continue to provide you with important notifications and updates from the NNPDF.

Click here to update or enroll today!


For assistance contact Laurie at [email protected] or call 920-542-4038

Emergency Hardship Program

The NNPDF Emergency Hardship Program continues to offer assistance to qualified NNPDF U.S. member families facing a crisis. Funding includes but is not limited to, specialized medical equipment, durable medical goods, utility bills (heating and cooling, electricity, phone, water and sewer), home and car repairs, and bereavement expenses. Click here for complete details and eligibility information.

Please contact Laurie Turner, Family Services Manager at 920-542-4038 or [email protected] if you have any questions about this program.

            

Supporting one another. Supporting our community.

Message from NNPDF on arimoclomol

Jill Beirl

Dear NPC Community Members,

This week, Orphazyme announced that they have reached an agreement with US-based pharma company KemPharm to acquire arimoclomol, the investigational drug candidate that Orphazyme had in development for the treatment of Niemann-Pick disease type C (NPC), which is schedule to officially to occur on June 1, 2022. Under the terms of the agreement, arimoclomol will continue to be available to patients through existing early access programs. KemPharm also intends to continue to pursue the approval of arimoclomol with both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

We are also pleased to learn that KemPharm intends to retain the majority of Orphazyme’s remaining employees, who have learned a lot about the community through our partnership over the past several years.

We look forward to this next phase in our partnership and learning more about KemPharm and their plans to continue the development program for arimoclomol. The company has previously focused on development of novel treatments for rare central nervous system (CNS) diseases and has experience bringing other treatments to market through regulatory approval. The company also has previous experience with FDA approvals following an initial CRL (complete response letter).

As many are aware, the NPC community has faced a long road in the effort to make an approved treatment available to patients in the U.S. The decision by KemPharm to advance the development program for arimoclomol highlights the continued urgent need for us to work with industry, regulators and other stakeholders to continue this essential work. Though we still have a long way to go, we are encouraged by this news and look forward to working with the KemPharm team in the months ahead.

NNPDF leadership is meeting with KemPharm in the next few days and they have been invited to share an update at our upcoming 30th Anniversary Family Support & Medical conference.

For further details about the acquisition, see the press releases below:
Orphazyme press release
KemPharm press release

Sincerely,


Joslyn Crowe, MSW, MA
NNPDF Executive Director

Supporting one another. Supporting our community.

April 2022 Newsletter

Jill Beirl

Message from the Executive Director

Dear NNPDF Community,

Excitement is building for our 30th anniversary Family Support & Medical Conference! From July 28th – 30th, we’ll once again gather IN-PERSON (!!) in Orlando to share, learn, support, and be together as a Niemann-Pick community. We’ve seen over the past two years that virtual conferences are possible, and effective, but nothing can replicate the essence and importance of being together in real life.

Among all the many challenges and changes introduced by the COVID pandemic, some seem likely to linger, possibly for years. In the Niemann-Pick disease community, as in many other rare disease communities, it will be essential for us to continually monitor these changes to assess how they might affect patients, caregivers, families and others. And one of these challenges – scheduling events where patients and families can meet in person – is high on the list of factors we must consider in this new world in which we are now living.

Meeting in person has potential benefits in any sort of social or business setting. It is easier to share information (without Zoom fatigue) and have side conversations. It is also just more fun. But it has a special meaning in the Niemann-Pick community. Many will remember a time when it was difficult for patients and families with rare diseases to even find each other. There are so many stories of families who lived with NPD for years before they had a chance to meet someone who really understood what they were experiencing. And when they were eventually able to connect in person, the experience was often transformational. Suddenly there was a stronger sense of community. There was support – even if it was just words of encouragement – from someone who really “gets it” about living with a disease. 

As Liz Heinze, mom to Katie, Tyler, and Faith, all of whom passed from NPC, and daughter Serina who is an active leader of the Niemann-Pick sibling community, explains “the first conference was a game changer not only for my husband and I to meet other parents, but for our children to meet other kids with the same illness.  And, most helpful for our healthy daughter to make friends with other siblings. The friendships we make at the in-person conferences are more precious than gold. We look forward to seeing our Niemann-Pick family each year.”

In an effort to provide support for individuals and families affected by Niemann-Pick disease, the NNPDF has for many years made opportunities to bring patients and families together a top priority, and our Annual Family Conference has been the largest gathering of people living with Niemann-Pick disease in the US. For 30 years, we have watched as children have met and played with other children, parents shared hugs and coping strategies, and families were able to interact together with medical experts. This year, we also highlighted resources related to health and wellness, including insights into emerging trends like 2024년 코리아카지노사이트에서 추천하는 사이트, which emphasize the importance of community engagement in improving quality of life. The Conference got bigger every year because families experienced firsthand the benefits of meeting in person, and they wanted more.

And then COVID came. We rapidly had to find new models to foster connection. Zoom was the default, the goal was to make sure we did not lose the sense of community that joining together brings to so many families. It sufficed in this unique pandemic situation. There was no need to travel – or even dress up—and programs allowed people to easily drop in for shorter or longer periods depending on their schedules. But most people agreed that meeting in person – the ability for one-to-one conversations, spontaneous exchanges, and sharing meals – is the best way to build and strengthen the NPD community. Virtual connection worked, but the essence and importance of in-person connection was lost.

Fast forward to our new world. Some families are eager and ready to jump back to in-person gatherings and some are still hesitant. We are working to figure out the best options when it comes to staying connected, including hybrid models like our virtual conference option.

As we consider all these factors, NNPDF keeps its goal on allowing our families to stay connected and positioned to provide the levels of support and engagement that our families need.

In many ways, nothing is better than being able to meet in person – even just once a year or once in a while. Our conference promises to be dynamic and interactive, it will strengthen community ties and give participants value – in terms of emotional support, learning opportunities, and chances to connect with others. As we plan for the future, NNPDF will continue to work to make sure that we bring you the very best opportunities for friends and families to join together to help us plan for a better future for everyone affected by Niemann-Pick disease. I look forward to seeing you there.

Best wishes,


Joslyn Crowe, MSW, MA
NNPDF Executive Director

NNPDF Family Support & Medical Conference

in Conjunction with INPDA Biennial Meeting

Register by May 16 for Early Bird discounted rate!

JOINT CONFERENCE DATES:  July 28 – August 1, 2022
NNPDF:  July 28 – 30  |  INPDA:  July 29 – August 1

Wyndham Grand Orlando Resort Bonnet Creek | Orlando, Florida

DEADLINES APPROACHING!

NNPDF Family Advisory Working Groups

The NNPDF will host Family Advisory Working Groups on Thursday, July 28, 2022 from 1:00 pm – 4:00 pm EST at the Wyndham Grand Hotel in Orlando prior to the start of our Family Support & Medical Conference. Pre-registration is required.

Family Advisory Working Groups will provide Industry partners the opportunity to connect privately with a group of 6-10 NPC or ASMD patients and/or immediate family members for a 3-hour session. Groups are limited to 2 adult participants per family, living in the U.S.

Participants are eligible for a $350 stipend per participant and 1-night hotel (night of July 27th) included per family. Application deadline is May 16th.

Family Conference Scholarships

NNPDF Family Conference Scholarship assistance is available to help NNPDF families (living in the U.S.) offset the cost of attending the 2022 NNPDF Family Support and Medical Conference. Scholarships are limited to the immediate family members of an individual with NPD.

The NNPDF Family Conference Scholarship will provide up to three (3) nights hotel (room and tax only*) to eligible applicants. Application deadline is May 16th.

Joele Ruppert & Joseph Colton ASMD Scholarship

NNPDF is accepting applications for the Joele Ruppert and Joseph Colton ASMD Scholarship created in honor of the lives of these two cherished children (both diagnosed with ASMD) and their parents.

This scholarship provides one-time funding of $500.00 to individuals diagnosed with ASMD for studies in post-secondary (high school) degrees, including two-year colleges, four-year colleges, vocational schools, and other post-secondary institutions.

Read complete story and learn more about this scholarship opportunity. Application deadline is May 16th.

NNPDF Cora Sterling Endurance Award

Do you know a great young person who shines for Niemann-Pick awareness? NNPDF is seeking nominations for the NNPDF Cora Sterling Endurance Award. This award is presented annually at the NNPDF Family Support & Medical Conference to a young person (under age 25) who shines in raising awareness of Niemann‐Pick disease in the community. Nomination deadline is May 31st.

NNPDF Research Fellowship Applications

NNPDF is accepting Research Fellowship Applications. The Peter G. Pentchev Niemann-Pick Type C Research Fellowship and the Edward H. Schuchman ASMD Research Fellowship are 1-year awards intended for early-stage researchers. These awards support young scientists in pursuit of independent hypotheses and encourage scholarly development about Niemann-Pick Disease.

Niemann-Pick Disease research is one of the pillars of our mission and we are proud that since 1993, NNPDF has funded 52 grants and 20 fellowships totaling over $4,000,000. Many former grantees and fellows have remained active contributors in the Niemann-Pick Disease space. Contact [email protected] with questions. Application deadline is June 1st.

INPDA - ASMD Survey Webinar

Join the INPDA on Thursday, May 12, 2022 at 1:00pm EST for a webinar where they will be sharing The impacts of olipudase alfa on paediatric patients with ASMD and their families: Results of an international survey.

Register here in advance for this webinar. After registering, you will receive a confirmation email containing information about joining the webinar.

Community Update Webinar Series with Sanofi - Recording

Thank you to all who joined us for the Community Update Webinar Series with Sanofi. Michael Clavadetscher and Kate Tighe of Sanofi discussed Regular Monitoring for Early Symptom Management and ASMD resources available through the Sanofi team. Watch the recording.

Pam Andrews

Mom to Belle & Abby, NPC
Firefly Fund, Co-Founder and Executive Director

Tell us a bit about yourself.
My name is Pam Andrews. I’m a sixth generation Texan and was born in a small town just outside of Austin called Brenham, Texas. You may have heard of it before, as it’s the home of Blue Bell Ice Cream. My parents met when in graduate school at the University of Texas at Austin. My mom had just graduated from law school and the only job she could find after graduation (1972), as a new female attorney in Texas, was working as a secretary in a law firm in Brenham, Texas. I have three sisters (Lisa, Jessica and Leslie) and a brother (Sean, who passed away just seven months ago).  We didn’t stay in Brenham long and moved back to Austin when I was three years old. Growing up in the 70’s and 80’s was a bit idyllic, to be honest. My siblings and I would play outside with neighborhood friends for 6-8 hours at a time on the weekends. Our bicycles got us around and we walked to and from our neighborhood school during the week. My parents worked hard and a lot and my siblings and I looked after each other. I remember using a kitchen stool to make dinner for my sisters. I wasn’t tall enough to see the top of the stove so I would get a step stool and stand on it and make dinner that way. I was probably seven years old. My grandfather (and great grandfather actually) were both doctors in Ft. Worth, Texas and Alpine, Texas. Truth be told, that was really my only exposure to healthcare or the medical profession when I was growing up. Grandaddy made house calls, delivering babies at home and I remember that he pierced kids’ ears in his office. There was the occasional penicillin shot when someone was sick, but otherwise it was delivering babies and piercing ears. My father, later in my 20’s, was diagnosed with and died from Cancer. I definitely came to understand that people get sick. However, if you had told me in 1978 or even 1994 that I would later have two beautiful daughters who would both be diagnosed with a rare genetic neurodegenerative disease, I would have thought that you were certifiable. As a young girl, I would have never fathomed this life.

I live in Austin with my husband, Chris Andrews, our two beautiful daughters, Belle (12yo) and Abby (7yo) and our two miniature poodles, Lady and Lucy. For fun you will find me taking walks in the neighborhood with my dogs or hanging out in our backyard, by the pool with my girls, and spending time with the little family that Chris and I have made. The girls are filled with joy and laughter and they truly enjoy life and enjoy talking with people in their little lives and they laugh hysterically at each other’s wild antics. They love music and singing and being silly little girls. It is my greatest joy in life, and honor really, to be Belle and Abby’s mama. It is what I enjoy the most in life.

When did you receive Belle and Abby’s diagnosis and what led to this?
Belle was diagnosed first after a diagnostic odyssey that spanned several years and included countless appointments with doctors and specialists. Leading up to Belle’s diagnosis what concerned us the most was her tripping and falling, which seemed to be getting worse with each passing day. Belle’s platelets were also always low and her spleen was enlarged. Those were the early signs that kept me tossing and turning at night. And she developed a tremor at about 3yo. For years I was told that she was within the normal range and not to worry. I was a first time mom so I didn’t have a neurotypical child as a reference, but something inside of me kept nudging me to continue pressing for answers. My nieces and nephews and Belle’s friends would come over and I would talk with other moms and no one seemed to have the same types of symptoms that we were seeing.

Finally, we met with a young doctor who was also a mom – she agreed with us that something wasn’t right. Her name is Dr. Amy White and she is now on the BOD of Firefly Fund. Belle was about 4 1/2 at the time and Abby was about 9 months old.  Belle’s diagnosis was eventually made through whole exome sequencing. It was suggested that we test Abby immediately, she was 18 months old at the time and had absolutely no reason to believe that she also had NPC. It was terrifying. As you might imagine, our pain more than doubled with Abby’s diagnosis, just 10 days after Belle.

How did you learn about NNPDF?
We learned about the NNPDF really slowly after diagnosis. Initially, the day of our diagnosis, we were given a Make A Wish form and told to take the girls to Disney World and to enjoy them. The doctor made it clear that there were no approved drugs and nothing that could be done. The only information that was given to us was a one pager on NPC and the Make A Wish form. We left the doctors office and made some calls to immediately take steps to form the Firefly Fund. Initially, we thought we were going to have to figure it all out on our own. Over the course of the next few months we had countless calls with NPC families and researchers and clinicians. We were so relieved to learn from some of those early conversations with members from the NPC Community that there was a patient organization and several mature family-led, patient inspired organizations that had been funding research for over 25 years.  We began to feel the weight of the girls’ diagnosis lift. We realized that we didn’t have to do this by ourselves.

The NNPDF was in the middle of a transition when we were diagnosed. They were looking for a new leader and for a Board Chair. I think we first met Joslyn and Justin in 2018 and that is when we really began to get to know and work with the NNPDF.  It was through the newborn screening work that Firefly Fund does that I began to really understand the significance and importance of a national patient organization in a rare disease community. The NPC Community’s interactions with the healthcare stakeholders like the medical profession, with regulators, with public health officials, with drug developers and companies, all rely on a healthy patient organization. The work that the NNPDF does is vital to the overall success of the NPC Community.

Why is newborn screening important to the Niemann Pick community and what difference can it make in the future?
Newborn Screening is a public health service that reaches 4 million babies born in the United States each year. The newborn screening program ensures that all babies are screened for certain serious life-limiting conditions at birth, and for those babies with the conditions, it allows doctors to start treatment before some of the harmful effects happen. Newborn screening is performed soon after the birth of your baby, and in most cases, while you are still in the hospital. Specific protocols for newborn screening follow up vary from state to state, as does the list of conditions screened for.  

It is my opinion that newborn screening is the single most important public health program that exists worldwide. As Belle and Abby’s mom, I understand first hand the horror of watching your child slip through your fingers while searching for answers.  The diagnostic odyssey that NPC families are forced to travel is barbaric and unnecessary in 2022. Newborn screening will provide families with information about the health status of their newborn, which will allow for early intervention. We know, and there is consensus among NPC expert clinicians, that early intervention in the NPC patient improves health outcomes. Chris and I live this reality every single day in our home as we watch the trajectory of our two daughters’ lives go in two completely different directions due to the fact that one was diagnosed before any visible signs or symptoms of the disease and one was not.  

Shortly after our diagnosis, Chris and I sought out the counsel of someone who has become our dear friend and mentor, Dr. Philip Reilly. At the time in 2016, I’d just finished his book, Orphan: The Quest to Save Children with Rare Genetic Disorders and I wanted to hear his perspective regarding where he thought there were unmet needs in the NPC Community. Dr. Reilly was the first person to encourage us to focus on newborn screening for the NPC community. He wisely explained to us, from the perspective of a venture capitalist mixed with his experience as a clinical geneticist (he has a law degree, as well), that if NPC patients can be identified at birth then what will happen as a result is that NPC patients will have plenty of treatments in no time. He explained that newborn screening for NPC would accelerate the drug development process because we would be helping “them” to help us. 

In addition to finding our patients early, newborn screening is important to the NPC Community because it will help researchers and clinicians better understand the incidence and prevalence of the disease. And data collected through newborn screening pilot studies, such as ScreenPlus in New York, will help us better understand the heterogeneity of the disease and how the variability in onset of NPC patients impacts families and the public health system. Through newborn screening, we are essentially introducing a whole new disease to the medical community – doctors, hospitals, payors, drug companies, regulators, labs, and the list goes on.  We’ve all witnessed over the past two years the havoc that a new disease state can wreck on the healthcare system and for teeny tiny, ultra rare disease groups like NPC, the onus is on the NPC Community to demonstrate that we are ready to be in the public health service referred to around the world as newborn screening.  

The process is long and arduous. There is zero room for errors. We can not misdiagnose newborns. We have to demonstrate that our short and long term clinical follow up protocols improve health outcomes for those patients identified at birth. Once we are able to identify our patients early, before any visible signs or symptoms of the disease, we will see improved clinical trial outcomes, which will lead to therapeutic approvals and maybe even therapeutic options for our loved ones.  

How can families get involved with newborn screening efforts?
I think the most important thing that families can do is to look for ways to advocate for newborn screening for NPC at home. Every state health department has a newborn screening advisory committees and in all 50 states there are rare disease parents on those committees. I sit on the Newborn Screening Advisory Committee in Texas. As I mentioned earlier, newborn screening lists vary from state to state.  Ultimately, we will need NPC to be added to every single state newborn screening list. Right now, through ScreenPlus, the NPC Community is collecting evidence necessary to be added to these lists. Once we are added to the RUSP, which I believe can happen within the next 3-4 years, we will need to immediately turn our attention to the states. Anything that parents can do to ensure that NPC is “in line” for inclusion on the various state lists would be helpful. We will add this to the agenda for one of our upcoming working group calls. Please let people know that they can reach out to me if they are interested in joining.

Another thing that NPC families can do from home is sign up for the AllStripes sibling study where data is being collected and analyzed for health outcomes for siblings diagnosed at different points of disease progression. The evidence collected through the study will provide data to the newborn screening advisory committee that will decide if NPC meets the criteria for early intervention. It is really important that families sign up for this study and it can be done from the comfort of your home computer by clicking here.

What advice would you share with newly diagnosed families?
Don’t forget to breathe. Focus on the things that bring you joy rather than on the things that you can’t change or control. Don’t be afraid to pick up the phone and reach out to other families. Ask a lot of questions. If someone is upset with you for asking too many questions, ask more questions. You are not alone and you don’t have to travel this rare journey alone, if you don’t want to. Reach out to families that have traveled the road before you and allow them to share their experience, strength and hope with you. The NPC Community is resilient and strong and committed to moving NPC into a new and different public health paradigm. None of us can do this alone and thank goodness we don’t have to.

What are your hopes for the future for your girls and for the Niemann-Pick community?
Gosh, everyday my focus and hope for my girls is that they are happy and that they know with every fiber of who they are that they are loved and cherished and absolutely adored. I hope and pray that they know that their life has purpose and meaning far beyond their NPC diagnosis. I hope they never let their NPC diagnosis define who they are. I hope they laugh often and that they rest easy knowing that Chris and I will be there beside them on this journey every step of the way. I believe that in Belle and Abby’s lifetime we will be able to render NPC a chronic disease. We have the tools necessary to do this in the NPC Community now and I believe that if we all work together, we can accomplish this goal. I was talking to another NPC mom just yesterday and we agreed that finding a drug cocktail to render NPC a chronic disease seems like an easy feat compared to the education and awareness that is necessary for stakeholders to move NPC into the healthcare system. The good news is that we don’t have to do it all in one day, but rather one day at a time we need to keep putting one foot in front of the other and doing the important work that we’ve been called to do in honor of those who came before us, for our loved ones and for those yet to be born with an NPC diagnosis in their future.   

I believe that the NPC Community should feel proud of all that has been accomplished in the past 25 years. I look forward to seeing what transpires over the next 25 years.

NPC Spotlight Web Resource

Cyclo Therapeutics’s NPCSpotlight.com is a web resource dedicated to Niemann-Pick type C. This website includes helpful information and resources for NPC patients and families, as well as information and updates on their TransportNPC clinical trial. Check out the NPC Community page to read shared journeys from JP Honsinger and Dee & Dan Reynolds.

Adult Onset Niemann-Pick type C (NPC)

Symptoms of Niemann-Pick disease type C (NPC) can vary widely. In many cases symptoms first appear early in life. However, for a subset of patients who have adolescent/adult-onset NPC, symptoms might not appear until much later. In efforts to help patients and caregivers manage NPC and access the support they need; it is important to understand some key issues related to adult-onset NPC. 

Symptoms
In infancy and childhood, NPC most often presents through physical symptoms such as yellowing of the skin or enlarged liver or spleen. In adult-onset NPC, however, many patients first experience neurological symptoms. These symptoms can lead to difficulties with coordination such as walking, eating, and talking and difficulties looking in a vertical direction. In many cases, people living with adult-onset NPC are first considered to have a mental health condition such as schizophrenia or manic-depressive or bipolar disorders. The differences in symptoms between children and adults can make adult-onset NPC very difficult to diagnose; many patients seek medical care for years before receiving an accurate diagnosis. By raising greater awareness of the symptoms of adult-onset NPC, we can help more patients and families to access the appropriate care they need as quickly as possible.

Support
While living with a rare disease can be difficult for anyone, people and families of adults living with NPC can face severe challenges that affect their emotional and mental well-being. Before symptoms appear, many people living with adult-onset NPC appear relatively healthy and are able to take part in daily activities including exercise, socializing, working and caring for their families. The onset of symptoms, however, can mean that patients decline and lose the ability to work and care for themselves or their families. Symptoms can also lead to emotional challenges and feelings of confusion and frustration. In developing a care program, it is often essential to help patients take steps to manage both their physical and emotional symptoms.

In providing support, it can often be helpful for patients and caregivers to hear from other individuals and families affected by adult-onset NPC. NNPDF board member Cara Gilmore was diagnosed with adult-onset NPC in September of 2019 and is involved in many different efforts to help patients connect to share information. She has participated in media interviews and works with physicians and advocacy groups across the country to help raise awareness. To learn more about her story or to connect with Cara, please visit the resources below.  

NNPDF Resources
NNPDF is dedicated to supporting all people who are living with NPC. We are committed to building broader awareness of adult-onset NPC in both the medical community and among the public. By doing so, we can help more people obtain an accurate diagnosis sooner and then help them get the treatment and support they need. If you or someone you know has started experiencing symptoms, we have a range of resources that can help, including information to help you find a doctor as well as options for financial support. If you have been recently diagnosed with adult-onset NPC, there are also many wonderful individuals and families who work with NNPDF to share advice and support as you navigate this journey.

Our annual Family and Medical Conference is a perfect opportunity to meet with other patients and families who understand the challenges of living with adult-onset NPC and who can share helpful information or just be there to listen. For more information on our conference, please visit this link. At NNPDF we are also continuously working to support research that can lead to new treatment options for people impacted by NPC at any age and we are continually working to expand the resources and services we have to help. For information visit our website or contact us directly at [email protected]. We are here to help.

Newborn Screening Update

Community Activities and Research to Add Niemann-Pick Disease to Newborn Screening Lists Continues

Niemann Pick Type C
Community Activities and Research to add NPC to Newborn Screening lists at the state and federal level in the United States continues to advance in 2022. Please find a summary of these activities below. Additionally, the International Niemann-Pick Disease Alliance has launched a newborn screening initiative with the goal of building an international road map for ensuring that NPC is added to newborn screening lists around the world, where applicable.

  • ScreenPlus is underway in New York with active recruitment at one NY hospital and an additional eight NY hospitals set to begin recruitment as early as this summer. The three major goals of the pilot study are (1) define the analytic and clinical validity of multi-tiered screening assays for 14 disorders, including NPC; (2) determine disease incidence in an ethnically diverse population; and (3) assess the impact of early diagnosis and treatment on health outcomes through the use of longitudinally collected clinical, biomarker, radiographic, and biochemical data. The addition of the remaining hospitals in NY will be an important step towards screening the volume of patients needed for inclusion on newborn screening lists. The ScreenPlus team is working tirelessly to ramp-up, despite the continuing limitations posed by COVID19.  You can learn more about ScreenPlus here.
  • All Stripes is conducting a study of siblings diagnosed with NPC comparing outcomes for siblings diagnosed at different stages of disease progression and intervention. NPC families in the U.S., Canada and the U.K. are welcome to join the AllStripes program to stay updated and be part of future projects. AllStripes does the work to collect your records and make them accessible in your secure account, at no cost. The goal of the study is to have at least 80 NPC patients participating and to date 64 families have enrolled. If you haven’t already, please take a moment to join the AllStripes study here and contribute to this NPC research project without leaving home.
  • Clinical Roundtable NPC clinical experts working to align on key issues such as timing for treatment initiation; measuring disease progression, and the role and value of natural history data. Members of the Clinical Roundtable, led by Drs. Berry-Kravis and Patterson, are working on an update to NPC clinical guidelines that will focus on the importance of early diagnosis and intervention in Niemann-Pick Type C.  

Community members will hear updates from researchers related to these important newborn screening activities and advancements for Niemann-Pick Disease at the upcoming 2022 Michael, Marcia and Christa Parseghian Scientific Conference in Tucson, Arizona, May 21-24, the National Niemann-Pick Disease Foundation Annual Family and Medical Conference in Orlando, Florida, July 28-30, and the International Niemann-Pick Disease Alliance Annual Meeting in Orlando, Florida, July 29-August 1.

Fundraising

Contributions through fundraising by NNPDF members, families and friends are used to provide services and information to individuals and families affected by NPD, as well as supporting research into finding treatments. Please continue to host and support NPD fundraisers. Awareness Events promote awareness to the general public about Niemann-Pick Disease.

If you have recently hosted a fundraising event, send us your photos and we’ll share them and details from your event in upcoming newsletters!

THANK YOU to Kim O’Riley Lucht, Dani Ganter, and Alyssa Gallegos who recently hosted Facebook Fundraisers for the NNPDF! We truly appreciate your support!

Want to host your own Facebook Fundraiser? It’s easy! Visit facebook.com/fund/NNPDF to get started!

Surveys, Studies & Market Research

Be sure to check out our Surveys & Market Research webpage for current survey and study opportunities in the Niemann-Pick disease space. Participating in surveys and studies is important to the advancement of health options for our Niemann-Pick community members. Current surveys and studies are listed below. Contact Laurie Turner at [email protected] for any questions.

Duke-Margolis NPC Public Workshop Update

A public workshop was previously held by Duke-Margolis Center for Health Policy, sponsored by the FDA. This virtual public workshop allowed participants the opportunity to discuss clinical endpoints relevant to NPC clinical trials and innovative strategies to support therapeutic development for patients with NPC.

Following this workshop, NNPDF submitted a letter and supporting materials to the FDA and Duke Margolis Center for Health Policy in response to the docket.  We are currently awaiting the Summary Document from this workshop which we will share widely once it is available.

Clinical Trial Updates

Clinical trials are currently in progress to study and develop treatments for ASMD and NPC. The NNPDF posts new information regarding clinical trial updates as soon as it is received. Visit our Clinical Trials web page for up to date information on all clinical trials.

NNPDF Membership

Enrolling, confirming, or updating your membership will ensure we have accurate information for you and your family. This will help us to continue to provide you with important notifications and updates from the NNPDF.

Click here to update or enroll today!


For assistance contact Laurie at [email protected] or call 920-542-4038

Emergency Hardship Program

The NNPDF Emergency Hardship Program continues to offer assistance to qualified NNPDF U.S. member families facing a crisis. Funding includes but is not limited to, specialized medical equipment, durable medical goods, utility bills (heating and cooling, electricity, phone, water and sewer), home and car repairs, and bereavement expenses. Click here for complete details and eligibility information.

Please contact Laurie Turner, Family Services Manager at 920-542-4038 or [email protected] if you have any questions about this program.

            

Supporting one another. Supporting our community.

Adult Onset Niemann-Pick type C (NPC)

Jill Beirl

Symptoms of Niemann-Pick disease type C (NPC) can vary widely. In many cases symptoms first appear early in life. However, for a subset of patients who have adolescent/adult-onset NPC, symptoms might not appear until much later. In efforts to help patients and caregivers manage NPC and access the support they need; it is important to understand some key issues related to adult-onset NPC. 

Symptoms
In infancy and childhood, NPC most often presents through physical symptoms such as yellowing of the skin or enlarged liver or spleen. In adult-onset NPC, however, many patients first experience neurological symptoms. These symptoms can lead to difficulties with coordination such as walking, eating, and talking and difficulties looking in a vertical direction. In many cases, people living with adult-onset NPC are first considered to have a mental health condition such as schizophrenia or manic-depressive or bipolar disorders. The differences in symptoms between children and adults can make adult-onset NPC very difficult to diagnose; many patients seek medical care for years before receiving an accurate diagnosis. By raising greater awareness of the symptoms of adult-onset NPC, we can help more patients and families to access the appropriate care they need as quickly as possible.

Support
While living with a rare disease can be difficult for anyone, people and families of adults living with NPC can face severe challenges that affect their emotional and mental well-being. Before symptoms appear, many people living with adult-onset NPC appear relatively healthy and are able to take part in daily activities including exercise, socializing, working and caring for their families. The onset of symptoms, however, can mean that patients decline and lose the ability to work and care for themselves or their families. Symptoms can also lead to emotional challenges and feelings of confusion and frustration. In developing a care program, it is often essential to help patients take steps to manage both their physical and emotional symptoms.

In providing support, it can often be helpful for patients and caregivers to hear from other individuals and families affected by adult-onset NPC. NNPDF board member Cara Gilmore was diagnosed with adult-onset NPC in September of 2019 and is involved in many different efforts to help patients connect to share information. She has participated in media interviews and works with physicians and advocacy groups across the country to help raise awareness. To learn more about her story or to connect with Cara, please visit the resources below.  

NNPDF Resources
NNPDF is dedicated to supporting all people who are living with NPC. We are committed to building broader awareness of adult-onset NPC in both the medical community and among the public. By doing so, we can help more people obtain an accurate diagnosis sooner and then help them get the treatment and support they need. If you or someone you know has started experiencing symptoms, we have a range of resources that can help, including information to help you find a doctor as well as options for financial support. If you have been recently diagnosed with adult-onset NPC, there are also many wonderful individuals and families who work with NNPDF to share advice and support as you navigate this journey.

Our annual Family and Medical Conference is a perfect opportunity to meet with other patients and families who understand the challenges of living with adult-onset NPC and who can share helpful information or just be there to listen. For more information on our conference, please visit this link. At NNPDF we are also continuously working to support research that can lead to new treatment options for people impacted by NPC at any age and we are continually working to expand the resources and services we have to help. For information visit our website or contact us directly at [email protected]. We are here to help.

Supporting one another. Supporting our community.

In the Spotlight with JP De Douza

Jill Beirl

MARCH 2022

João Paulo De Souza

Sr. Program Manager, AllStripes

Tell us a bit about yourself, such as where do you live and what do you enjoy doing?
My name is João Paulo – I know, it’s a bit of a tongue twister, but most people call me JP. I’m a Bay Area native who returned after living in San Luis Obispo, California. From an early age, I knew I wanted to help people. After graduating from the University of California, Berkeley, most of my work has been in a variety of clinical and biotech settings: from creating treatment plans for children with varying developmental disorders to using AI for blood diagnostics.

These days, I’m a Sr. Program Manager at AllStripes, where our mission is to unlock new treatments for people affected by rare disease. I’m fortunate to work alongside many dedicated and talented individuals working toward the same mission, and seeing amazing work being done for communities like NPC. During my free time, I take advantage of the many hikes and parks the Bay Area has to offer with my best friend Samson, my 4-year-old Goldendoodle. I love to experience different cultures through travel, and of course, using my taste buds.

What caused you to get involved in the Niemann-Pick community?
The NPC Sibling Study was one of the first projects I started helping with when I joined the team here at AllStripes. Since then, I’ve had the privilege of working closely with NNPDF, Firefly Fund, Niemann-Pick Canada, and the Ara Parseghian Medical Research Fund. Our work has allowed me to connect with members of the community and hear such unique and powerful stories, which continue to drive me each and every day.

How does the NPC Sibling Study support early NPC intervention?
The intent of the Sibling Study is to provide evidence to support the inclusion of NPC in newborn screening (NBS) programs. Achieving this will allow physicians to diagnose babies with NPC early, which will allow for early intervention. Early intervention may increase the effectiveness of treatments and improve quality of life. Getting NPC added to newborn screening panels would be a huge accomplishment and success for the community!

Why are sibling pairs needed for this research?
In short, the Sibling Study is attempting to show the effects of early intervention. How will this research project do this? When two siblings have the same diagnosis and one sibling had intervention earlier than the other, researchers can determine whether intervening early leads to slower symptom onset and/or decreased severity of symptoms.

Why is data from families whose loved ones have passed important to the study?
While there’s currently no cure for NPC, there have been advancements in treating it. Some of these advancements are recent enough that, in some cases, people who have died from NPC did not have the chance to be treated with disease-specific therapies. Comparing medical records from deceased patients to medical records from living patients can help provide evidence that early diagnosis and intervention makes a real difference. This means the records of loved ones who have passed away from NPC are especially helpful for researchers trying to build evidence for adding NPC to newborn screening.

What are your hopes for the future of the Niemann-Pick community?
My hope is that our work with the NPC community can support the addition of NPC to newborn screening panels. Beyond that, our goal is to unlock new treatments for the NPC community. There are many like me who are working toward this goal, and the Sibling Study is just the first study we hope to work on for the NPC community.

How can families get involved?
To join other patients and families on AllStripes go to allstripes.com/npc.

If anyone has any questions about the study of AllStripes, please feel free to email [email protected].

Supporting one another. Supporting our community.