News From

The Kith Collective

Announcing A Global Alliance of Organizations Serving Two Rare Brain Diseases

Advacing research and education on Progressive Supranuclear Palsy (PSP) and Corticobasal Degeneration (CBD)

April 27, 2020

Today leaders of 12 non-governmental organizations (NGO’s) focused on providing advocacy, support, and information for patients, families, and caregivers suffering from the rare neurological diseases Progressive Supranuclear Palsy (PSP) and Corticobasal Degeneration (CBD) announced formation of a global alliance, PROMOTUS. Kith Collective founder Kim McCleary facilitated the June 2019 meeting of these global leaders to help them identify shared goals and potential benefits of joining efforts. She presented learnings from global alliances for other conditions and helped prioritize action steps that led up to the April 2020 announcement.

Understanding the ​Lived Experience of Eczema

Announcing the "Voice of the Patient" Report from the Eczema Patient-Focused Drug Development Meeting

March 18, 2020

​For the first time ever, adults and children living with eczema and their family members shared riveting descriptions of symptom burdens, challenges managing the disease, and treatment expectations with U.S. Food and Drug Administration (FDA) regulators, drug developers, and researchers. This comprehensive, full-color report shares testimony, data, and photos from the 160 in-person participants, 1,508 respondents to the companion survey, and thousands of virtual attendees participating via webcast. The More Than Skin Deep survey is one of the largest surveys of the eczema community to date.

Taking Stock of PFDD: Envisioning a Vibrant Future for Patient-Focused Drug Development

Article published in FDLI's Update Magazine

February 24, 2020

PFDDworks, a collaborative forum convened by the Kith Collective and Faegre Drinker for patient advocacy leaders to share learnings and advance understanding of patient-focused medical product development, authored an article published in the Food and Drug Law Institute (FDLI) Update Magazine. This article examines the impacts of PFDD and makes recommendations for the future of the initiative. 

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New year, new math at the Kith Collective

January 06, 2020

The dawn of each new year often brings growth, and here at the Kith Collective, we are ringing in 2020 by growing our team! Samantha Mayberry joins the Kith Collective as Director of Client Services where she will support client work and project management. Sam and Kim formerly worked together at FasterCures where Sam was the mastermind behind programming for the annual Partnering for Cures events and played a key role in defining and delivering the Patients Count program. More recently, Sam led patient education, engagement, and advocacy at the National Osteoporosis Foundation. Get to know more about her on our About page or reach out at sam@kithcollective.com

New Patient-Focused Drug Development Initiative for Eczema Features Largest Coalition of Organizations Yet

Kith Collective provides communications, survey, and outreach support

August 01, 2019

The Kith Collective is honored to be working with a joint initiative of five nonprofit organizations to bring the voices of individuals and families living with eczema to inform medical product development and regulation. The “More Than Skin Deep” initiative will collect and share patient and caregiver experiences as they relate to impacts on daily life, symptom management, and treatment expectations through an online survey and a Sept. 23, 2019, meeting with FDA officials. We will be writing the "voice of the patient" report to distill meeting dialogue and survey responses as an evergreen resource for the FDA, life science companies, researchers, the patient community, and the public. 

Expanding Patient-Focused Medical Product Development to Leverage Caregivers' Insights

New report from the National Alliance for Caregiving and the LEAD Coalition

May 29, 2019

"Paving the Path for Family-Centered Design: A National Report on Family Caregiver Roles in Medical Product Development," explores the vital roles that family caregivers can play in shaping biomedical research and development, regulatory decision-making, and healthcare delivery. This first-of-its-kind report, authored by Kith Collective founder, Kim McCleary, addresses opportunities to incorporate the critical knowledge of caregivers in developing pharmaceutical products, biologic therapies, diagnostics, and medical devices.

"Paving the Path" provides recommendations for leveraging caregivers’ enormous reservoir of information and observations about the conditions their care recipients experience and associated health outcomes. The report was developed with clear recognition that people living with various health conditions along with their friends and family members are essential partners in the delivery of health care. 

Pink Sheet Reports on DBSA's "Well Beyond Blue" Meeting

Nov. 16, 2018 externally led patient focused medical product development meeting makes news

December 10, 2018

"The Nov. 16 PFDD meeting [was] a structured way to make sure there is a fresh record of the patient voice during the ongoing review of new treatment approaches. The Depression and Bipolar Support Alliance worked with the Milken Institute in August and September to conduct a patient survey in anticipation of the meeting. During the PFDD meeting, patients aired grievances about the “throw things against the wall” approach to selecting treatments, as well as the side effects that accompany them."

Supporting Wellness Survey Reported in STAT

Lived experience perspectives on desired outcomes, research priorities

October 24, 2018

STAT reporter Megan Thielking shines a light on the first peer-designed survey to elicit the perspectives of people living with depression on two important topics: how they define wellness and their priorities for research. Results from 5,600 survey responses collected to-date were shared at the Milken Institute's Future of Health Summit. 

Well Beyond Blue PFMPD Meeting Announced

Depression & Bipolar Support Alliance engages Kith Collective for support with outreach

September 26, 2018

In the 60 years that have passed since the first antidepressant medication was approved by the FDA, there have been significant advances in the scientific understanding of depression and better recognition of the challenges faced by many who live with this condition. Yet, treatment options that support individual definitions of wellness remain elusive for many. To address this need, the Depression and Bipolar Support Alliance (DBSA) has launched the “Well Beyond Blue” initiative to empower people living with depression to have a voice in the development of new treatment options. The November 16 meetings provides a platform to share their wellness preferences directly with decision makers, including regulators, life science industry innovators, researchers, and others.

First-of-its-kind Survey of Depression & Bipolar Yields New Insights

The Kith Collective guided peer-led survey development in unique collaboration

September 10, 2018

The Milken Institute Center for Strategic Philanthropy and the Depression & Bipolar Support Alliance have teamed up to elevate the voices of people living with depression and bipolar in research and therapy development. As part of these efforts, they fielded a first-of-its-kind "Supporting Wellness" survey in August 2018. By September 7, the survey garnered more than 3,000 responses from across the country, including family members or caregivers of those with a diagnosis of depression or bipolar. A press release issued by the Milken Institute reports interim results. 

First-ever Patient-Focused Medical Product Development Meeting Report Issued

Kith Collective provides end-to-end strategic counsel, program management, data analysis & reporting for AWAKE Sleep Apnea Initiative

September 05, 2018

"Raising Voices for Progress in Treatment and Care" is based on first-person accounts conveyed at the June 8, 2018 AWAKE Sleep Apnea patient-focused medical product development meeting attended by 465 people (in person and by live webcast) and a Patient & Caregiver Survey that attracted responses from 5,630 adults of all ages from around the country.

Parent Project Muscular Dystrophy Breaks New Ground with Compass Meeting

The Kith Collective was there to document it

July 09, 2018

PPMD developed a novel meeting format utilizing the FDA’s “Patient-Focused Drug Development Workshop” framework while also broadening the discussion scope to include stakeholders from other federal agencies, payers, the biopharmaceutical industry, and patient advocacy coalition partners. This expanded format allowed PPMD to build upon the Duchenne community’s work with the Duchenne guidance, patient preference studies, and formalized data collection. “The Duchenne Patient-Focused Compass” meeting was comprised of panels of Duchenne community members (patients and caregivers) to explore ‘living with Duchenne’, clinical trial and therapeutic experiences, and access to approved therapies, across the Duchenne spectrum. The report, authored by Kim McCleary, documents the compelling testimony, the community's unmet needs, and patient-focused policy agenda to advance care and cures.

Biogen Hosts Roundtable to Gather Input on Patient-Focused Drug Development

Planning, prep & moderating provided by Kith Collective

May 14, 2018

In conjunction with events marking the company's 40th anniversary, Biogen executives met with seven progressive patient advocacy leaders to strengthen their approach to integrating patient perspectives earlier and more consistently throughout the R&D process and across the lifecycle of innovative medicines.

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Collective Signs of Progress in Patient-Centricity

September 30, 2019

FDA Issues Draft Guidance on Methods to Identify What Is Important to Patients

In the second of a series of four methodological patient-focused drug development (PFDD) guidance documents, FDA presents a range of methods and established best research practices to identify what is important to patients with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient's disease. 

September 24, 2019

FDA Issues Draft Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations

In this guidance document, FDA's CDRH highlights the benefits of engaging with patient advisors early in the medical device development process and addresses  common questions and misconceptions about collecting and submitting to FDA patient engagement information. 

October 15, 2018

FDA Workshop Will Inform Guidance on Patient-Centered Measures

FDA will host a two-day public workshop to discuss: 1) methods to develop and identify what is most important to patients and caregivers with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient’s disease; and 2) best practices for selecting, developing or modifying fit-for-purpose Clinical Outcome Assessments (COAs) to measure the patient experience in clinical trials.

 

This workshop will inform development of patient-focused drug development guidance as required by Section 3002 of the 21st Century Cures Act of 2016, and as part of commitments made by FDA under PDUFA VI.

October 02, 2018

DIA to Host Workshop on Patient Engagement Metrics

This 2-day conference in Washington, D.C. is designed to help build abilities to measure the effectiveness of patient-centric efforts, with a focus on developing and implementing measures assess engagement effectiveness. Speakers will present case examples of how they have measured the impact of engagement at multiple stages throughout the product's lifecycle, as well as how data is used to advance patient engagement programs and initiatives.

August 22, 2018

FasterCures launches PFDD Meeting Tracker

The FDA's Patient-Focused Drug Development initiative has spurred more than 40 condition-specific meetings, with 26 hosted by the agency and a growing number sponsored by non-profit organizations with FDA in listening mode. To augment FDA's list, FasterCures has created a collated list of past and future PFDD meetings and resources they have generated. 

June 12, 2018

FDA Issues Draft Guidance to Better Incorporate Patient Voice in Drug Development

The first of a series of four methodological patient-focused drug development (PFDD) guidance documents, FDA outlines how patients, researchers, medical product developers and others can collect and submit patient experience data and other relevant information from patients and caregivers to inform medical product development and regulatory decision making.

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