On April 28 and 29, the FDA held a public workshop on Wound Healing. It was organized by Dr. Dev Verma in the FDA’s Division of Dermatology and Dentistry at the Center for Drug Evaluation and Research. Dr. Verma has actually practiced in a wound center and the insightful list of topics, speakers and panel discussions reflected his deep understanding of the field and its challenges.

On Day 1 I spoke in the morning about one of my favorite topics, the “Nameless” wounds (and whether we can even GIVE wounds names in a meaningful way). On Day 2, I spoke in the morning on Patient Registries and Real World Evidence, and in the afternoon, with Marcia Nusgart, Executive Director of the Alliance of Wound Care Stakeholders on an Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds.

I am also proud and grateful to some of my patients who courageously participated. THANK YOU for helping to represent the patient experience of chronic wounds to the FDA so that they understand what problems we need to solve from the patient’s perspective.

Because it was a public meeting, links to the video recordings are available to the public. Eventually the FDA will generate a document to synthesize what they learned, but in the meantime, everyone has access to this incredible 2 day workshop for free. These links do not expire and do not require a passcode.

• Day 1 recording
• Day 2 recording

Here’s the FDA Wound Healing Workshop AGENDA:

DAY 1: Thursday 4/28/22

MORNING SESSION 1: Pathways to Product (drug/device/biologic/combination) Development; FDA speakers

OBJECTIVES:

• State the purpose of the 2-day workshop, what groups are represented, and the conference goals/objectives (what we hope to accomplish).
• Outline the landscape of product development for non-healing chronic wounds, highlighting current challenges and momentum provided by the OND Wound Healing Science Strategies Pilot program.
• Identify each FDA Center’s role in product development.
• Describe current standards for development as influenced by the Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds — Developing Products for Treatment, June 2006.• Outline and identify current products on the market for chronic non-healing wounds.

TIMELINE:

• 09:00 – 09:05 am: Intro comments (Kendall Marcus, MD)09:05 – 09:15 am: OND Science Strategies overview (FDA identified barriers to product development) (Dev Verma, MD)
• 09:15 – 09:25: CDER representative (pathways/types of products reviewed/approved) (Gary Chiang, MD, MPH)
• 09:25 – 09:35 am: CDRH representative (pathways /types of products reviewed/approved) (Allan Guan, PhD)
• 09:35 – 09:45 am: CBER representative (pathways /types of products reviewed/approved) (Rosa Sherafat-Kazemzadeh, MD)
• 09:45 – 09:55 am: FDA guidance / current standards for product development (Clarifying the purpose of 2006 wound healing guidance, emphasizing that it a set of recommendations and is not set in stone and that product development is collaborative) (Jennifer Bai, MD)
• 09:55 – 10:05 am: Break

MORNING SESSION 2: Understanding non-healing chronic wounds (Setting the Stage)

OBJECTIVES:

• Describe the basic physiologic process and principles of normal wound healing from acute wounding to closure, including re-epithelialization and remodeling over time [identify proper terminology to describe wounds].
• Identify the factors that disrupt normal wound healing and lead to chronic wounds.• Understand that chronic wounds are complex and multi-factorial wounds.
• Describe the most common non-healing chronic wounds (DFU, arterial/venous wounds, pressure wounds, “nameless” wounds), currently available treatments, and identify current standards of care for each.
• Identify gaps in current treatment of chronic non-healing wounds [Explore what new products would be helpful/are needed to heal specific non-healing chronic wounds (DFU, arterial/venous wounds, pressure wounds, “nameless” wounds)].

TIMELINE:

• 10:05 – 10:10 am: Intro comments (Dev Verma, MD)
• 10:10 – 10:20 am: Wound healing stages; How acute and chronic wounds differ (Kenneth Fan, MD)10:20 – 10:30 am: Diabetic foot wounds (Paul Kim, DPM, MS)
• 10:30 – 10:40 am: Arterial and venous chronic wounds (Lisa Gould, MD, PhD)
• 10:40 – 10:50 am: Pressure wounds (Aimee Garcia, MD)
• 10:50 – 11:00 am: Un-Categorized/ “Nameless” non-healing wounds (e.g: surgical wounds) (Caroline Fife, MD)
• 11:00 – 11: 05 am: Break
• 11:05 – 11:45 am: Panel discussion (FDA moderator Dr. Dev Verma, Dr. Kenneth Fan, Dr. Paul Kim, Dr. Lisa Gould, Dr. Aimee Garcia, Dr. Caroline Fife, Dr. Sharon Gerecht [non-clinical/research perspective], Dr. Marjana Tomic-Canic [non-clinical/research perspective], Dr. Christopher Attinger)
• 11:45 – 12:30 pm: Lunch break

AFTERNOON SESSION 1:

OBJECTIVES:

• Hear perspectives from patients, caregivers, and other patient representatives to reflect upon their comprehension of their wound (why it exists) and how it affects their QOL
• Understand what changes in signs or symptoms are clinically meaningful to them; and learn about their experiences with clinical trials of wound healing products and the current approaches to treating chronic, nonhealing wounds.

TIMELINE:

• 12:30 – 2:30 PM Patient Voice Session (led by FDA Patient Focused Drug Development Team)
• 2:30 – 2:40: Break

AFTERNOON SESSION 2: Intro to clinical trial issues.

OBJECTIVES:

• Identify strategic, operational, and tactical challenges to implementation of successful clinical trials for non-healing chronic wounds (which will be expanded upon in Day 2).

TIMELINE:

• 2:40 – 2:45: Intro comments (FDA representative Dr. Joy Mejia)
• 2:45 – 3:05 pm: Overview of clinical trial issues for chronic wounds (Robert Kirsner, MD, PhD)
• 3:05 – 3:15 pm: Industry perspective on product development for chronic wounds (Dr. Robert Bearden; Smith+Nephew)
• 3:15 – 3:30 pm: Q+A end of day (FDA moderator Dr. Kendall Marcus)

DAY 2: Friday 4/29/22

MORNING SESSION 1: Mechanism of therapeutic action and pathophysiology of wound healing (speakers will focus on both the pathophysiology and gaps in product development)

OBJECTIVES:

• Describe current areas of research in wound healing.
• Explore how current research in wound healing may be applied for innovative product development.

TIMELINE:

• 09:00 – 09:05 am: FDA Intro comments (Felisa [Sally] Lewis, MD)
• 09:05 – 09:20 am: Overview of dynamic reciprocity, and Wound Healing: Innovations and Challenges (Ira Herman, PhD)
• 09:20 – 09:30 am: The role of the wound microbiome in wound healing (Robert Kirsner, MD, PhD)
• 09:30 – 09:50 am: Mechanotransduction in wound healing, and barriers to innovative product development (Geoffrey Gurtner, MD)
• 09:50 – 10:30 am: Panel discussion (FDA moderator Dr. Felisa [Sally] Lewis, Dr. Ira Herman, Dr. Robert Kirsner, Dr. Geoffrey Gurtner, Dr. Sharon Gerecht [engineered bioscaffolds perspective], Dr. Teresa Jones [biomarkers perspective], Dr. Marjana Tomic-Canic [translational research perspective]), Dr. Chandan Sen [biomarkers and translational research perspective])
• 10:30 – 10:40 am: Break

MORNING SESSION 2: Clinical trial issues including execution feasibility (barriers to enrollment e.g: inclusion/exclusion criteria), patient registries, Real World Evidence

OBJECTIVES:

• Elaborate on roadblocks to implementation of successful clinical trials for non-healing chronic wounds.
• Discuss possible solutions to overcoming challenges [identified on Day 1] to implementation of successful clinical trials.
• Explore how to design clinical trials based on real world data and risk stratification.
• Discuss/Propose a baseline standard protocol for wound healing clinical trials.

TIMELINE:

• 10:40 – 10:45 am: Intro comments (Joy Mejia, MD)
• 10:45 – 11:05 am: Defining complete wound closure, and comparative effectiveness trials (Lisa Gould, MD, PhD)
• 11:05 – 11:15 am: Applicability of Wound care RCTS to general wound care populations (Marissa Carter, PhD)
• 11.15 – 11:35 am: Patient registries and RWE (Caroline Fife, MD)
• 11:35 – 11: 40 am: Break
• 11: 40 – 12:20 pm: Panel discussion (FDA moderator Dr. Joy Mejia, FDA statistician Dr. Kathleen Fritsch, Dr. Marissa Carter, Dr. Caroline Fife, Dr. Jaideep Banerjee [Smith+Nephew], Dr. Ron Silverman [3M], Dr. Thomas Serena, Mr. Nico O’Kuinghttons [Huma], Mr. Joseph Rolley [Industry consultant perspective, JTR Business Consulting LLC])
• 12:20 – 1:05 pm: Lunch break

AFTERNOON SESSION 1: Endpoints and clinical outcome assessments.

OBJECTIVES:

• Recognize the importance of COAs that are context relevant for patients with non-healing chronic wounds.
• Discuss possible COAs [e.g. surrogate endpoints] as alternatives/primary endpoints to current guidance (complete wound closure).
• Identify the process of how to develop fit-for-purpose patient reported outcomes (PROs) and Clinician Reported Outcomes (ClinROs).

TIMELINE:

• 1:05 – 1:10 pm: Intro Comments (Dev Verma, MD)
• 1:10 – 1:20 pm: FDA Division of Clinical Outcome assessment (DCOA) overview (Mira Patel, PhD)
• 1:20 – 1:30 pm: Endpoints and Wound Care Collaborative Community (Vickie Driver, DPM)
• 1:30 – 1:40 pm: WOUND-Q (Andrea Pusic, MD; Anne Klassen, PhD)
• 1:40 – 2:20 pm: Panel discussion (FDA DCOA co-moderators Dr. Selena Daniels and Dr. Mira Patel, FDA statistician Dr. Kathleen Fritsch, Dr. Vickie Driver, Dr. Andrea Pusic, Dr. Anne Klassen)
• 2:20 – 2:30 pm: Break

AFTERNOON SESSION 2: CMS and Industry Perspective.

OBJECTIVES:

• Discuss current acceptable evidence for coverage decisions related to wound care devices, drugs, and biologics.
• Identify improved processes to provide patients access to the devices and drugs necessary for non-healing chronic wounds.

TIMELINE:

• 2:30 – 2:40 pm: CMS perspective on wound healing (including discussion of what CMS takes into consideration for local coverage and national coverage determinations) (James Rollins, MD)
• 2:40 – 2:50 pm: An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds (Marcia Nusgart, R.Ph. and Caroline Fife, MD)
• 2:50 – 3:20 pm: Panel discussion (FDA moderator, Dr. James Rollins, Ms. Marcia Nusgart, Dr. Caroline Fife, Dr. Sunil Lalla [Industry consultant perspective], Mr. Joseph Rolley [Industry consultant perspective, JTR Business Consulting LLC], Mr. Mark Olmstead[Smith+Nephew], Ms. Amy Law [3M]), Mr. John Ferros [Organogenesis])

Lessons Learned

OBJECTIVES:

• Summarize key take-aways from 2-day conference.
• Identify next steps (e.g.: summary report).

TIMELINE:

• 3: 20 – 3:30 pm: FDA closing comments/next steps (Kendall Marcus, MD)

The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.