HSG Updates

HSG UPDATES – September 2023

September 2023
MAKING AN IMPACT

  1. CEO’s Insights
  2. New Options for Patients: FDA Approval of Valbenazine
  3. Lowering Research Participation Barriers: vUHDRS® Topline Results
  4. Facilitating HD Research Collaboration: CHDI
  5. Forging More Diversity and Representation in Research: myHDstory® Results
  6. Creating Opportunities for Learning, Engaging, and Connecting: HSG 2023 Annual Meeting
  7. Building a Stronger HSG: ENGAGE-HD + New Members + Process for New Ideas and Projects
  8. Reflections on an Impactful Life: Remembering Christine Hunter
  9. Catalysts for the Future: HSG Education and Training
  10. In the Know

1.   CEO’s Insights

In memory of Christine Hunter, someone who was devoted to making an impact on the Huntington’s disease community with her skills, talent, and heart, we are dedicating this issue of HSG Updates to the theme of impact. While we have had some big wins, we recognize these are some battles won while a war rages on. No one is giving up. In this issue we explore some of the areas in which HSG has recently driven progress, spurred potential, and helped positively impact the acceleration of treatments for HD.

– Shari Kinel, JD

2.   New Options for Patients: FDA Approval of Valbenazine 

We are thrilled with the recent approval of valbenazine for chorea in adults with HD. This approval was based off the positive, highly statistically significant results from the KINECT-HD trial and the ongoing KINECT-HD2 trial led by the HSG and NBI. While this is not the first VMAT2 inhibitor approved for chorea associated with HD, this is still a welcome and important win for those living with or at-risk for HD.

Evaluation of the ENROLL-HD database demonstrates that chorea may be undertreated. The reasons for this finding are multifactorial but this reminds us that we still have work to do in the realm of symptomatic treatment for HD. Chorea is certainly not the only symptom our patients struggle with; however, it is an important symptom that can negatively impact quality of life, functional independence and increase caregiver burden.

A positive trial not only gives our patients another symptomatic treatment option, but also provides opportunities to raise awareness and in doing so, hopefully indirectly improves care and access to HD patients and families. In addition, the availability of multiple treatment options encourages ongoing research and innovation in the field of HD.

We remain optimistic about and focused on an approved disease modifying therapy for HD hopefully sooner rather than later, but in the interim, we hope that additional effective symptomatic treatments can help our HD patients and families throughout their journey.

– Erin Furr Stimming, Study Principal Investigator of KINECT®-HD/HD-2 Studies

3.   Lowering Research Participation Barriers: vUHDRS® Topline Results

The Huntington Study Group (HSG) has revolutionized research methodologies by introducing innovative approaches. Our participant-centric strategies, coupled with advancements in technology, aim to deliver clinical trials to participants, eliminating the need for participants to travel to trial sites. This approach mitigates recruitment and participation barriers, including unforeseen circumstances, geographical constraints, evolving participant preferences, and time constraints. HSG has a longstanding commitment to addressing these challenges, consistently achieving study enrollment and retention objectives while conducting high-quality clinical trials.

In 2010, HSG’s Project AWARE was a comprehensive survey of over 600 individuals and families impacted by Huntington’s disease (HD). This observational study aimed to enhance awareness, willingness, and ability to participate in clinical trials and observational studies, contributing to the design of future trials. HSG has diligently applied the insights gained from Project AWARE to initiatives aimed at facilitating access to research centers and formulating study protocols that incorporate the input of HD patients, thereby enhancing the quality of clinical trials.

In keeping with the HSG’s philosophy of bringing innovative methods to clinical research, the HSG successfully embarked on developing a virtual version of the gold standard assessment tool, the Unified Huntington’s Disease Rating Scale (UHDRS®) developed in 1996 (HSG et al 1996). The results of the virtual Unified Huntington’s Disease Rating Scale (vUHDRS®) showed that virtual implementation of the vUHDRS® was reliable and feasible including assessment of motor, Total Functional Capacity and all other functional sections, cognitive and behavioral sections. The HSG is looking to the vUHDRS® as the next research study tool to assist with the development of hybrid clinical trials combining remote and in-person visits to significantly reduce participant burden and increase research.

The vUHDRS® results were presented at the International Congress of Parkinson’s Disease and Movement Disorders® in Copenhagen, Denmark in August and will be presented at HSG’s annual meeting in Phoenix.

– Samuel Frank, MD, vUHDRS® Study Principal Investigator
– Jody Goldstein, vUHDRS® Study Co-Principal Investigator

4.   Facilitating HD Research Collaboration: CHDI

For 30 years, HSG has been working to improve the lives of people impacted by Huntington’s disease through research, education, and collaboration. By building collaborative relationships and credibility with key HD stakeholders, we are better positioned to understand perspectives and fulfill the needs of research site personnel, sponsors, and people impacted by HD.

In July of this year, we announced that our clinical research organization (CRO), HSG Clinical Research, Inc. (HSGCR), began providing services for CHDI Foundation’s Enroll-HD observational study and clinical research platform in the US and Canada. Enroll-HD is currently the world’s largest observational study for Huntington’s disease families, providing an important resource for HD families, clinicians, researchers, advocates, pharma, and biotech companies.

The melding of the operational and clinical experience and knowledge of CHDI and HSG will enable the teams to mold the next generation of Enroll-HD by enhancing operational efficiency and quality and potentially creating new ways to recruit study participants, collect study data, and ensure data integrity.

Combining the strengths of both organizations allows us to more collaboratively accelerate treatments that make a difference and make a greater impact for the entire HD community. 

– Elise Kayson, HSG VP of Clinical Operations 

If you’re interested in collaborating with HSG, send us a note at info@hsglimited.org

5.   Forging More Diversity and Representation in Research: myHDstory® Results

One of the main goals at HSG is to improve diversity in research by reaching underrepresented populations. We know from the HSG Care Improvement Project surveys and other work that 70% of people with HD do not access specialty care. Because the US is such a large country, and specialty care and research are concentrated in big cities, many groups, particularly those in rural and less populous areas, are not able to join clinical or observational studies.  It can also be burdensome to travel to a site for research visits. Those with fewer economic advantages are therefore underrepresented in many studies.

Most clinical trials are 90% or more Caucasian, but the overall population is much more racially diverse, and HD affects all races and ethnic groups. At HSG, we have several initiatives to make research more accessible and inclusive. This includes the myHDstory® online, direct-to-participant research platform. We recognize that research cannot be representative of the entire HD population if it does not include perspectives from people of all backgrounds.  With the myHDstory® platform, people with HD can participate in an observational study from the comfort of their own home or other private location.

HD presents many challenges to patients and their families. HSG offers online participation through the myHDstory® platform to lessen this burden with respect to research participation. It is our hope that these efforts will make research more representative of the HD population as a whole and help us to understand how people from differing economic and racial/ethnic backgrounds experience HD symptoms.

More studies are currently in the works for the myHDstory® platform, including new PROs, longitudinal capabilities, and reaching even more participants. We hope to have some exciting announcements

– Karen Anderson, MD, Study Principal Investigator of ‘Making HD Voices Heard’

6.   Creating Opportunities for Learning, Engaging, and Connecting:
HSG 2023 Annual Meeting

Among the not-so-hidden benefits of the HSG meeting is the opportunity to meet, re-meet, learn from, and connect with colleagues who share a passion for care of HD families and research in HD. For a young clinician, investigator, or coordinator, this is the best opportunity you will have all year to discuss difficult cases, think about different ways of managing patients, learn about new and upcoming research studies, and share HD-related experiences. You can join a working group, volunteer for a committee, learn from a seasoned investigator how to conduct a study more efficiently, and test out your bright idea on an interested audience. Submit a poster describing your work! New in 2023 is a Saturday training program called ENGAGE-HD, specifically directed towards the HD experts of the future.   

Even if your hair has begun to turn gray, you will still benefit from hearing about the successes and challenges that your colleagues have faced, while inspiring and encouraging the younger attendees. Become an HSG leader! Give a presentation, create a new working group, lead a clinical trial!   

The relationships you develop and nurture at the HSG 2023 meeting will last throughout your professional lifetime—and beyond! 

– Martha Nance, MD, HSG Executive Membership Committee and Chair of HSG Family Education Committee

If you’re planning to attend this year’s annual meeting, here are a few useful links:

7.   Building a Stronger HSG: ENGAGE-HD + New Members + Process for New Ideas & Projects

ENGAGE-HD
In the realm of scientific progress, one fundamental truth stands out: progress requires people. The pursuit of groundbreaking research is inherently dependent on the collaborative efforts of dedicated individuals. But despite the increasing prevalence of progressive neurodegenerative diseases, the relatively stagnant numbers of medical students opting to specialize in neurology creates a concerning gap. The future of HD research and patient care is at risk. HD is a scientifically fascinating and clinically significant disease that has the potential to attract the intellectual curiosity of the next generation of medical practitioners and researchers. To galvanize this interest and nurture a fascination with HD as a career path, we need to offer HD-specific education created and curated by international experts.

The acronym ENGAGE-HD means to Educate, Nurture, Gather, Acquire knowledge, Grow, and Excite professionals, both experienced and new, about HD. The HSG ENGAGE-HD program is an initiative to attract, foster, and educate new members and researchers and to create educational programs and events exclusively centered on Huntington’s disease for those with an interest in neurology and movement disorders. Through this initiative, we hope to strengthen the impact HSG has on the world of research and treatment. 

Our overarching goal is to orchestrate a transformation: expand the pool of professionals dedicated to the pursuit of movement disorders (particularly HD), bolster the knowledge of people committed to research and treatment of HD, and add meaningfully to the body of HD-related publications. By cultivating the growth of researchers and practitioners passionate about Huntington’s disease, HSG becomes a stronger organization, better poised to enhance patient care and uncover scientific breakthroughs.

– Jee Bang, MD, MPH, HSG Executive Membership Committee and Chair, HSG Provider Education Committee

Over the past few months, HSG’s membership has continued to grow. There are several new faces as well as some people with whom HSG has been working for quite some time and are now official. We welcome all of you to our network and look forward to everything we will accomplish together. You are the future of HSG.

If you are already an HSG member, please login here to ensure all of your information is up to date.

Process for New Ideas and Projects
At HSG, we’re continually impressed by our members and the education, research, and care initiatives you develop. As our network continues to grow and thrive, we want to ensure that we have the proper support in place to help ensure efficiency, effectiveness, and collaborative success. Please take the time to familiarize yourselves with the related policies and processes below, and don’t hesitate to reach out with any questions.

Preliminary Proposal Form
Are you interested in starting an education or care initiative or a research project under HSG? If so, start by filling out our Preliminary Proposal Form. This is a short form intended to provide leadership with high-level details so they can ensure it is in line with HSG’s mission and is feasible from a resource perspective. If your preliminary form is approved, you will be asked to submit a more detailed proposal through either the HSG Education or Care Initiative Formal Proposal Form or the HSG Investigator-Initiated Clinical Research Formal Proposal Form. If your preliminary form is not approved, you will be provided with feedback and suggestions for a one-time resubmission.

Policy for Proposals Utilizing HSG Resources
If you are working on an HSG-approved project and are seeking funding from an external company (i.e., not HSG), please complete the Policy for Proposals Utilizing HSG Resources form prior to contacting any potential funders.

8.   Reflections on an Impactful Life: Remembering Christine Hunter

When we think of dedicated professionals, few names shine as brightly as Christine Hunter’s. With a heavy heart, we reflect on her life, one that left an indelible mark on our hearts and the world of medical research. Christine’s journey was nothing short of extraordinary, and her legacy continues to resonate within the Huntington’s and Parkinson’s Disease and communities.

A Passionate Advocate
Christine’s involvement in the Parkinson’s community was profound. She served as a coordinator representative on the Executive Committee at PSG (Parkinson Study Group) and, beyond retirement, remained actively engaged with the Parkinson’s Foundation and the Michael J. Fox Foundation. Her dedication was unwavering, a testament to her heart of gold and a smile that radiated love and kindness to all fortunate enough to know her.

Karen Williams, from Northwestern, eloquently captured Christine’s essence when she said, “Christine always made time for everyone, especially her fellow coordinators. She served as a mentor (officially and unofficially) to so many people over the years and was always available to lend an ear or give her opinion, she was a wealth of knowledge.”

Patients Were Her Priority
Throughout her illustrious career, Christine never lost sight of her patients. Whether speaking at support groups, volunteering at Tourette’s camps, or offering one-on-one support to patients and their families, she embodied the true spirit of compassionate healthcare. ZsaZsa Brown, also from Northwestern, aptly noted, “She was an advocate for the HD community as well as a great role model for us Coordinators. She will truly be missed!” 

A Remarkable Leader and Friend
Joseph Jankovic, MD, a close colleague and friend, beautifully encapsulated Christine’s remarkable contributions. He described her as “a beacon of hope for countless patients with Parkinson’s disease, Huntington’s disease, Tourette syndrome, and many other movement disorders.” Christine’s dedication went beyond borders, as she volunteered on medical missions in underserved areas and touched lives worldwide.

In a poignant personal note, Dr. Jankovic shared, “Christine was my most trusting professional partner, advisor, and confidant as well as a close friend. Because of her unique combination of warm empathy and inspiring enforcer of discipline, I often referred to her as a hybrid between Mother Theresa and General Patton.”

Christine’s sudden and tragic passing on July 26, 2023, during a family vacation in Branson, Missouri, has left a void in our lives and the broader medical community. She is survived by her loving husband, two sons, and four sisters.

As we reflect on Christine’s impactful life, let us honor her memory by carrying forward her passion for our work and striving to make our patients’ lives better. Her kindness, generosity, and wisdom will continue to inspire us and future generations, ensuring her legacy lives on.

9.   Catalysts for the Future: HSG Education and Training

Preparing investigators and coordinators for clinical trial conduct is at the core of the HSG Site Readiness Training Program. The HSG training and development programs serve as a catalyst to ensure ample support and clear guidance to all HSG members. For years, our Site Readiness Training Program (formerly known as “Member Education”) has served as the foundation for advancing clinical trial knowledge and developing what we refer to as “Tiger Teams” – an elite set of sites that can rapidly deploy a clinical study.

Our training programs include a comprehensive collection of tools and resources that enables HSG members to execute clinical trials in rapid time to provide consistent, timely, high-quality data. Providing education and training on innovative assessment tools, new methodologies, and changes in established techniques are key to preparing the next generation of researchers, clinical trial success, and ultimately our ability to make an impact for the HD community.

– Samuel Frank, MD, Co-Chair of HSG Executive Membership Committee

– Jody Goldstein, HSG Director of Clinical Operations

10.   IN THE KNOW

Grant Opportunity
The Hereditary Disease Foundation provides Postdoctoral Fellowships and Grants to researchers around the world to advance the discovery and development of treatments for Huntington’s disease and other brain disorders. They began accepting Letters of Intent for Postdoctoral Fellowships and Grants on September 15, 2023 with a due date of November 1, 2023. Click here to learn more.

Upcoming Events
Help4HD International Symposium – October 13-14 in San Diego, CA
If you’re attending this meeting and would like to connect with HSG’s Director of Clinical Operations, Jody Goldstein, send us a note at info@hsglimited.org.

European Huntington’s Association Conference – October 19-22 in Belgium

Quick Links
HSG Website
HD Trial Finder – US & Canada
HD Trial Finder – Europe
clinicaltrials.gov

If you would like to write an article for the HSG Updates newsletter or have your meeting or event featured, contact kristin.keyes@hsglimited.org 

We’re Back! HSG 2022 ANNUAL MEETING Returns to In-Person

July 2022

Start Booking Your Travel Now – HSG 2022 ANNUAL MEETING Returns to In-Person!

Special Sessions –
by invitation only
(Wednesday & Thursday Morning)

HSG EXPO &
General Sessions
(Thursday Evening & Friday)

FAMILY DAY
Symposium
(Saturday)

HSG is hosting this year’s ANNUAL MEETING in-person at the Grand Hyatt Tampa Bay in sunny Tampa, Florida on November 3-5, 2022.

Learn About the Latest HD Research
Clinical Trial Updates
Workshops
Networking
Inspirational Speakers!

Online registration is now open!

Please visit https://huntingtonstudygroup.org/hsg-2022/ for additional details and registration links. Here is what to expect this year – View HSG 2022 Agenda

Book Flights ASAP as flight costs are increasing.

Please contact Kristin Strazdins at Kristin@hsglimited.org for any questions regarding meeting logistics or travel and lodging.

HSG UPDATES: vUHDRS® Study Update

July 2022

The Unified Huntington’s Disease Rating Scale (UHDRS®) was established to routinely assess motor, cognitive, behavioral and function in Huntington disease (HD) in a standardized fashion in 1996. Since that time we have evolved. We have computers in our pocket and the Internet was invented as a great tool. We have developed and tested many interventions since that time, but all research studies rely on assessments completed in person. The pandemic and other life events highlighted the need to assess patients and research participants remotely.

The virtual UHDRS® (vUHDRS®) study, funded and sponsored by the Huntington Study Group (HSG) will determine the reliability of administering all sections of the UHDRS® virtually compared to in-person for clinical care and clinical trial use. The vUHDRS® study may assist with the development of hybrid trials thereby reducing participant burden. In addition, consistent TeleVisit use of the vUHDRS® could enhance clinical care.

The study will be conducted at about 15 HSG sites in the United States. The study is about to start. We will be looking for about 60 participants who have motor manifest HD so that we can assess their symptoms in person and through a TeleVisit.

HSG UPDATES: myHDstory™ Pilot Study Celebrates Major Milestone

July 2022

The HSG is excited to share that the pilot study, Making HD Voices Heard, on the new online research platform, myHDstory™, has reached its first enrollment milestone!  

“The HSG is beyond thrilled by the level of participation in this first-of-its-kind study. We are extremely grateful to all the Making HD Voices Heard participants,” said Dr. Karen Anderson, Professor of Psychiatry and Neurology at Georgetown University Medical Center and Principal Investigator of the Making HD Voices Heard study. “We hope the feasibility data and patient reports collected from this pilot will inform future direct-to-participant (DTP) research.  It is our goal to engage larger segments of the Huntington disease (HD) population, family members, and caregivers, improving HD care and treatments.”

The HSG collaborated with technology companies Grey Matter Technologies, Inc. and Neurotargeting, LLC to make this novel online research study accessible for qualifying United States residents to access. The myHDstory™ platform is intended to capture longitudinal data on Huntington disease from the patient perspective, giving voice to consenting adults to report what they feel, experience, and how they function with Huntington disease. This research platform is a significant opportunity for the HSG to serve the HD community because myHDstory™ enables collection of data directly from patients, in their own words, about their experiences living with HD, without in person study visits.
 
“We would like to thank the Griffin Foundation, NJ Cure HD, Ira Shoulson, Elise Kayson-Rubin, and Richard Rubin for their support of myHDstory™,” said Shari Kinel, Chief Executive Officer of the Huntington Study Group. “The HSG would also like to extend our appreciation to advocacy groups that helped raise awareness of the pilot study, including Help 4 HD, Huntington’s Disease Youth Organization (HDYO), HD Reach, and Huntington’s Disease Society of America (HDSA).”

For more information about myHDstory™, visit https://huntingtonstudygroup.org/myhdstory/

HSG UPDATES: Seeking Self-Nominations for Upcoming EMC Investigator & Coordinator Election

July 2022

Dear HSG Investigator and Coordinator Members,

Thank you for participating in the election of the Co-Chairs of the HSG Executive Membership Committee. There are additional opportunities still available, and your participation is once again requested!

As announced at the HSG town hall meetings back in January and February, after the EMC Co-Chairs election, there is to be an election for the following two positions on the Executive Membership Committee:

  • One (1) HSG CREDENTIALED INVESTIGATOR, who has been credentialed for at least five (5) years and participated in at least one (1) HSG clinical trial.
  • One (1) HSG CREDENTIALED COORDINATOR, who has been credentialed for at least five (5) years and participated in at least one (1) HSG clinical trial.

These individuals will join the other members on the Executive Membership Committee and serve in by aiding the nonprofit arm of the HSG to achieve in its mission driven goals.

The self-nomination form for HSG Credentialed Investigators and Coordinators to run for the open positions on the Executive Membership Committee is now open.

Submit your self-nomination here – https://hsg.memberclicks.net/emc-inv-coord-self-nomination-2022

Be a part of the next generation of the Huntington Study Group and consider nominating yourself by August 31, 2022.

Sincerely,

Sandra Kostyk & Sam Frank
Co-Chairs, HSG Executive Membership Committee

HSG UPDATES: Current Clinical Trials – KINECT-HD2 and PROOF-HD

—–

July 2022

KINECT-HD2 is being conducted by Neurocrine Biosciences, Inc. (“Sponsor”) in partnership with the Huntington Study Group (HSG). KINECT-HD2 is an open-label, multi-center study with sites across the US and Canada and aims to investigate the long-term safety and tolerability, as well as the maintenance of effect of valbenazine for the treatment of chorea associated with HD. Participation in this study will last up to approximately 162 weeks, including up to 4 weeks (28 days) of screening, up to 156 weeks of treatment (about 39 months or approximately 3 years), and a final study visit 2 weeks (14 days) after stopping study drug. The entire study consists of up to approximately 22 study visits. The enrollment goal is to reach approximately 150 participants. KINECT-HD2 was recently amended to include participants on stable background treatment of antipsychotic medication, and is currently open to enrollment.

We are incredibly grateful to all the study participants, study sites, referring sites, Sponsor and study teams for their continued dedication to the study.

If you know of any potential participants, please contact Jody Goldstein by phone (760-845-2105) or email (jody.goldstein@hsglimited.org).

For further information about Neurocrine Biosciences, Inc. and Valbenazine click on links below.

May 12, 2022
Neurocrine Biosciences Receives Orphan Drug Designation for Valbenazine as a Treatment for Chorea Associated with Huntington Disease

April 1, 2022 Press release (KINECT-HD)
Neurocrine Biosciences Presents Phase 3 Data for KINECT-HD Study Evaluating Valbenazine for Chorea Associated with Huntington Disease at AAN 2022

PROOF-HD is a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington), is sponsored by Prilenia Therapeutics and led by the Huntington Study Group in collaboration with TFS, Clinical Trials Coordination Center (U Rochester), and several partner providers. The study is being conducted at 59 sites in North American and Europe, and enrollment was completed in October, 2021. Participant retention has been excellent with approximately 95% of enrolled participants remaining in the study. All active participants have reached the halfway point in the main (double-blind) portion of the study. A number of participants have completed the main study and have rolled over into the Open Label Extension (OLE). The next major milestones include the main study database lock planned for Q1 2023.

The global study team is excited to meet in person at upcoming meetings – the PROOF-HD European and North American Investigators and Coordinators will be meeting at the upcoming EHDN 2022 and HSG 2022 meetings in September and November, respectively.

On behalf of Prilenia and the study team, we are grateful for the collaborative effort of the PROOF-HD study sites, and most importantly, the dedication and commitment of all study participants and their families.

HSG UPDATES: HSG Executive Membership Committee Elected Co-Chairs Begin in New Role

July 2022

On May 12, 2022, Sandra Kostyk (Ohio State) and Sam Frank (Beth Israel Deaconess Medical Center) were elected to serve as Co-Chairs of the Executive Membership Committee (EMC) of the nonprofit Huntington Study Group LTD (HSG). We are pleased to now officially welcome Sandra and Sam into their new role as of July 1, 2022.

This is an exciting and evolving time for the organization. While the HSG launched a wholly-owned for-profit entity in HSG Clinical Research, Inc. (HSGCR) dedicated exclusively to clinical research operations, the nonprofit will continue to rely on our membership to drive its mission driven focus. That mission includes providing premier educational content in Huntington disease (CME4HD™), ongoing training for HSG members (HSG Member Ed), credentialing researchers for clinical trials, and leading innovations in HD research through efforts like the vUHDRS®.

“In their role as Co-Chairs of the EMC, Sandra and Sam will spearhead initiatives to further enhance our core mission as a nonprofit,” said Shari Kinel, CEO of the Huntington Study Group. “We look forward to their collaborative leadership with our members and staff to ensure the HSG continues to make a difference for the entire HD community.”

The new HSG EMC Co-Chairs will begin their term with an orientation to the overall governance structure of the organization, working toward nominating candidates for open EMC positions and filling open HSG subcommittee positions.

Meet the HSG Clinical Research, Inc. (HSGCR) Management Team – The HSG’s CRO

July 2022

HSG Clinical Research, Inc. (HSGCR) was established as a wholly owned for-profit subsidiary of the Huntington Study Group, LTD (HSG) to focus exclusively on delivery the best project management and core operations for clinical research in Huntington disease. Overseeing key roles in leading the HSGCR are some familiar faces with long time service on behalf of the HSG.

Continuing in key realigned operational roles as full-time employees of the organization are:

Shari Kinel – Chief Executive Officer

Shari joined the HSG in 2009 and led the formation of the HSG as a standalone not-for-profit 501(c) organization as well as the formation of HSG Clinical Research, Inc – a for-profit wholly owned subsidiary of the HSG. She oversees the overall operations and leads planning and implementation of strategic initiatives. Shari is involved in helping conduct HD clinical trials including the pivotal trial that resulted in the second FDA-approved drug for HD. Since joining HSG, Shari has served on HD clinical trial steering committees, HD trial project teams and has worked with many HD organizations and partners on special programs. Shari is an attorney who started her career at the government in Washington, DC and then transitioned to financial services until she found her passion working towards finding treatments for people affected by HD.

Anne Van Dusen – Chief Operating Officer

While assisting in nearly all aspects of HSG operations and mission driven programs, with the inception of HSGCR, Anne assumed the role of Chief Operating Officer and lends organizational oversight to both the the HSG and HSGCR to ensure efficiency, efficacy and compliance in all business aspects of the organization. Anne has been a valued member of the HSG for over 5 years, with a expansive background in Finance, Compliance and Quality within the Heathcare Industry for 20+ years.

Michael Lentine – Chief Financial Office

Mike has over a decade of experience in Finance and Research Administration. In his current role, he provides financial oversight for the Huntington Study Group (HSG). He develops budgets, negotiates contracts, oversees accounting operations, and plays a role in driving forward the HSG’s strategic plan. Mike holds an MBA from the University of Rochester’s Simon School of Business.

Joining HSGCR in new roles for the organization are the following:

Andrew Feigin – Chief Medical Officer (CMO)

Prior to the incorporation of HSGCR as its wholly-owned subsidiary, Andy served in many capacities for the HSG, including most recently as the elected Chair of the HSG. He has been involved in HD clinical research since his participation in the Venezuela Collaborative Research Study beginning in 1993, and his independent research has focused on the development of novel imaging biomarkers for use as outcome measures in HD clinical trials. Andy has served in many roles for multicenter HD clinical trials including as principal investigator (SIGNAL, PROOF-HD), co-PI (LEGATO-HD), medical monitor, DSMB member and Chair, steering committee member, as well as serving as a site PI on numerous HD clinical trials. Now, as CMO, his primary role will be to provide leadership and direction for HSGCR’s pipeline of clinical development programs and clinical trials in HD and other rare diseases.

Elise Kayson – Vice President, Clinical Operations

Elise has been actively involved in the HSG in various roles since its inception, and recently joined HSGCR as a full-time employee. This follows the conclusion of her role serving with Andrew Feigin, MD as elected Co-Chair of the Huntington Study Group. Elise has more than two decades of clinical research experience in HD and other rare disorders across both pharmaceutical industry and academia. In her role as VP of Clinical Operations, Elise will provide clinical trial design strategic guidance and leadership and oversight for the execution of all phases of clinical trials ensuring they are completed in a timely manner, to budget and regulatory standards. She will ensure the efficiency, effectiveness, and quality of HSGCR’s operational aspects of development programs and project management for all clinical trials within HSGCR.

Christopher Ross – Senior Director of Scientific Affairs

While leading the HSG Scientific Advisory Council, driving the panel discussions of the popular Innovators Forum at the HSG Annual Meeting, and developing Scientific Advisory Boards and other scientific advice for sponsors, Chris’s role as Chief Scientific Officer has been aligned under HSGCR on the leadership team. He will continue working to support the scientific and clinical trial growth strategies of HSGCR and also continue with scientific advice for other HSG activities.