BreakThru SCI

I received the following email from this group called BreakThru SCI. They shared some information that is useful to the broader SCI community. I am not affiliated with this group, just thought it might be useful. Please feel free to share this:

Dear [Redacted],

Thank you for your interest in joining the BreakThru SCI mission. I appreciate your comment about wanting to get NVG-291 approved.  We couldn’t agree more.  At BreakThru SCI, our entire focus in on ensuring promising therapies get into the hands of people with SCI, as soon as possible. But it is not an easy journey, and we cannot accomplish this alone.  We need your involvement and that of your friends and family.  We really need you to reach out to your Senatorial health staffers in California and ask them to attend our upcoming congressional briefing event.

More likely than not, like you, our family never expected to be part of the spinal cord injury community. Everything changed when our son Clay sustained a cervical spinal cord injury in 2022. Early on, we learned something that inspired the creation of BreakThru SCI: while there are still no FDA-approved drug therapies for spinal cord injury, promising treatments are advancing through clinical development. Our son was fortunate enough to participate in the NervGen  NVG-291 clinical trial, and we believe people living with SCI deserve every opportunity to benefit from promising therapies, like NVG-291, as quickly as possible.

But that won't happen for years if our community remains silent.

We need policymakers and regulators to hear directly from people living with SCI, their families, caregivers, and advocates. That's why we're asking for your help.

Our goal is simple: fill the room with congressional health staff who can help elevate SCI as a priority, and help accelerate SCI drug development.

Action #1 - Contact Your California  Senators: https://www.senate.gov/senators/senators-contact.htm 

• Once you locate your California senator, fill out your personal information.  In the ‘message' section, write a note saying that you need your senator's health staffer to attend this incredibly important congressional briefing. copy and paste our congressional briefing invitation(see below) and ask them to RSVP and attend.  Share your story and that it’s critical they attend:

(Copy and paste this invitation). 

Subject: Congressional Briefing: Accelerating Breakthrough Spinal Cord Injury Innovation

Dear Congressional Health Staff and Stakeholders,

You are invited to attend a Congressional Staff Briefing on spinal cord injury (SCI), emerging restorative therapies, and the patient perspectives helping shape the future of SCI treatment.

At a pivotal moment in the field, this discussion will bring together regulatory, policy and scientific experts, as well as SCI clinical trial participants to explore emerging therapies, patient-centered innovation, and the opportunities and challenges shaping the future of SCI treatment.

The briefing will include remarks from Janet Woodcock, M.D., former Acting Commissioner of the U.S. Food and Drug Administration (FDA) and former Director of the FDA's Center for Drug Evaluation and Research (CDER). Dr. Woodcock will share perspectives on patient-focused drug development, regulatory innovation, and the importance of understanding meaningful benefit to communities of of significant unmet need.

The briefing will feature scientific perspectives from Geoffrey T. Manley, M.D., Ph.D., Chief of Neurosurgery at Zuckerberg San Francisco General Hospital and Professor and Vice Chairman of Neurosurgery at the University of California, San Francisco (UCSF). An internationally recognized leader in neurotrauma research, Dr. Manley has dedicated his career to advancing the understanding and treatment of traumatic brain injury and spinal cord injury.

The briefing will be moderated by Gavin Proffitt, former Healthcare Policy Advisor to U.S. Senator Ron Johnson (R-Wis.) and current Federal Government Affairs Director in the biopharmaceutical industry. Drawing on both his public policy experience and a deeply personal connection to spinal cord injury, Gavin will share perspectives on patient advocacy and the importance of ensuring the SCI community is heard by policymakers.

• Day: Thursday, September 17
• Time: 12:30 PM EST
• Room: Dirksen Senate Office Building, Room G11, Washington DC
• Lunch: Lunch will be served

RSVP appreciated, but not required, to assist with room capacity and catering.
RSVP HERE .

Sincerely,

The BreakThru SCI Team
Suzy, Jeb, Henry, and Clay Scherb

Please Visit www.BreakThruSCI.com 

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Action #2: Help Us Reach 1,000 Participants for the FDA PFDD Meeting

On September 29, the FDA will host its virtual Patient-Focused Drug Development (PFDD) Meeting on Spinal Cord Injury.  https://www.scipfdd.org/

This is one of the most important opportunities our community has to share directly with the FDA what meaningful recovery looks like and why SCI remains an area of significant unmet need.The FDA will use the personal stories and voices of SCI community who attend this virtual meeting, for potentially approving future spinal cord injury drugs. September 29th virtual meeting is our opportunity to share our voice.  I will be recorded in the meeting and sharing Clay’s experience from the NervGen trial.  

Our goal is to have 1,000 participants attend this PFDD virtual meeting.

Please register and encourage your family, friends, caregivers, clinicians, and advocates to register as well.

Register for the PFDD Meeting: https://www.scipfdd.org/

Action #3: Share This Email

Please forward this message to others in the SCI community and beyond.

If you know someone with a connection to a senator, member of Congress, governor, or other policymaker, we would love to hear from you. Personal connections can help open doors and amplify our message.

This Is Just the Beginning

The Congressional Briefing and PFDD  FDA meeting are important milestones, but they are only the beginning.

We are building a movement to ensure that people living with SCI have a voice in the decisions that shape the future of treatment. We hope you'll stay engaged, participate in future advocacy opportunities, and help us grow this community.

Together, we can make sure the SCI community is heard.

With gratitude,

Suzy Scherb
Executive Director
www.BreakThruSCI.com