Virtual

Event Title

Virtual Public Workshop – Study Design Considerations for Transbronchoscopic Thermal Ablation Devices for the Treatment of Oligometastases to the Lung

April 5 - 6, 2022

Date:: April 5 - 6, 2022
Time:: 11:00 AM - 5:00 PM ET

The Food and Drug Administration (FDA) is announcing a virtual public workshop entitled "Study Design Considerations for Transbronchoscopic Thermal Ablation (TTA) Devices for the Treatment of Oligometastases to the Lung (OML)." The purpose of the workshop is to provide a forum for stakeholders, including clinicians and professional societies, patients, and manufacturers to share information to develop appropriate regulatory review approaches to ensure the safety and effectiveness of this novel local therapy for the treatment of OML.

BACKGROUND

Earlier diagnosis and improved treatment of primary tumors across various anatomical sites has led to the increased need for clinical management strategies for patients presenting with OML. Current treatments include systemic drug therapy, surgical metastasectomy, stereotactic body radiation therapy (SBRT), or CT-guided percutaneous thermal ablation. Recently, the transbronchoscopic approach for catheter delivery of thermal ablation to lung oligometastases has been proposed as a less invasive treatment that may be associated with lower morbidity. However, there is currently a lack of consensus on the role of local therapy in the management of OML and how the safety and effectiveness of new local therapies such as TTA should be evaluated. This public workshop will cover definitions of disease, identification of appropriate patient populations for TTA, and key study design considerations including the most appropriate safety and effectiveness endpoints, control arms, duration of followup, and the role of surrogate endpoints (e.g. local control) in the evaluation of device effectiveness. The workshop will also include a session to obtain patient perspectives on the challenges they experience with OML and what is important to them when considering the benefits and risks of a novel local device therapy.

Date
Webcast workshop link
Preliminary Agenda
Biosketches
Registration
Comments
Contact

DATE

This workshop will be held on April 5, 2022, 11:00 am – 4:05 pm and April 6, 2022, 11:00 am - 5:00 pm (ET) by webcast only.

WEBCAST

The virtual public workshop will be a live webcast and the link will be provided in your confirmation email if you registered. The link for archived webcast will be posted to this webpage for viewing after the public workshop.

Webcast - Day 1: https://fda.yorkcast.com/webcast/Play/6d27f5880b2e4df58598b057349965af1d
Webcast - Day 2: https://fda.yorkcast.com/webcast/Play/46a79e0552264d2185c95b3375cc88141d

PRELIMINARY AGENDA

This agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.

Time	Title	Role	Participant	Specialty	Institution
DAY 1: April 5, 2022
11:00 A.M.	Introduction	Director, OHT1	Malvina Eydelman, MD	Food and Drug Administration
11:05 A.M.	FDA Welcome	Director, OPEQ	William Maisel, MD	Food and Drug Administration
11:10 A.M.	FDA Medical Device Regulation	Assistant Director, Respiratory Devices Team	Brandon Blakely, PhD	Biomedical Engineer	Food and Drug Administration
11:10 A.M.	A Regulatory Perspective on Trial Design and Endpoints for Drugs and Biologics	Clinical Team Lead, Thoracic and Head and Neck Malignancies	Nicole Drezner, MD	Medical Oncologist	Food and Drug Administration
11:30 A.M.	Professional Society Statements
12:30 P.M.	Manufacturer Statementsc
1 P.M.	LUNCH BREAK
1:30 P.M.	Session 1: Oligometastasis to the Lung Overview	Speaker	Anthony Conley, MD	Medical Oncologist	University of Texas MD Anderson Cancer Center
1:30 P.M.	Session 1: Oligometastasis to the Lung Overview	Speaker	Puneeth Iyengar, MD, PhD	Radiation Oncologist	UT Southwestern Medical Center
2:00 P.M.	Panel 1: Parameters defining OML	Panelist	Anthony Conley, MD	Medical Oncologist	University of Texas MD Anderson Cancer Center,
		Panelist	Ross Camidge, MD, PhD	Medical Oncologist	UCHealth Lung Cancer Clinic - Anschutz Medical Campus
		Panelist	David Harpole, MD	Thoracic Surgeon	Duke Health
		Panelist	Eric Vallieres, MD	Thoracic Surgeon	Swedish Hospital
		Panelist	Puneeth Iyengar , MD, PhD	Radiation Oncologist	UT Southwestern Medical Center
		Panelist	Brian Kavanagh, MD, MPH/MSPH	Radiation Oncologist	University of Colorado Cancer Center - Anschutz Medical Campus
		Moderator	Michael Offin, MD	Medical Oncologist	Memorial Sloan Kettering Cancer Center
3:00 P.M.	The Patient Perspective	Moderator	Tracy Gray, MBA, RN, MS and Christopher Eger, MD	Food and Drug Administration
4:00 P.M.	FDA Closing Remarks for Day 1	Medical Officer	Eric Mann, MD, PhD	Food and Drug Administration
4:05 P.M.	Adjourn for Day 1
DAY 2: April 6, 2022
11:00 A.M.	FDA Opening Remarks	Division Director	James J. Lee, PhD	Food and Drug Administration
11:05 A.M.	Session 2: Suitability of local treatments of OML and its dependence on histology and other parameters	Speaker	John Handy, MD	Thoracic Surgeon	Providence Portland Medical Center
11:05 A.M.		Speaker	Quynh-Nhu Nguyen, MD	Radiation Oncologist	University of Texas MD Anderson Cancer Center
11:35 A.M.	Panel 2: Defining an appropriate patient population and goals of local treatment for TTA	Panelist	Juneko Grilley-Olson, MD	Medical Oncologist	Duke Health
		Panelist	John Handy, MD	Thoracic Surgeon	Providence Portland Medical Center
		Panelist	Frank Detterbeck, MD, FACS, FCCP	Thoracic Surgeon	Yale Cancer Center
		Panelist	Steven Chmura , MD, PhD	Radiation Oncologist	University of Chicago
		Panelist	Quynh-Nhu Nguyen, MD	Radiation Oncologist	University of Texas MD Anderson Cancer Center
		Panelist	Josephine Louella Feliciano, MD	Medical Oncologist	Johns Hopkins Medicine
		Moderator	Jonathan Yang, MD, PhD	Radiation Oncologist	Memorial Sloan Kettering Cancer Center
12:35 P.M.	LUNCH BREAK
1:00 P.M.	Session 3: Overview of prior/ongoing study designs for evaluating the safety and effectiveness of local therapies for OML	Speaker	Daniel Gomez, MD, MBA	Radiation Oncologist	Memorial Sloan Kettering Cancer Center
		Speaker	Tom Treasure, MD MS FRCS FRCP	Thoracic Surgeon	University College London, UK
		Speaker	Ross Camidge, MD, PhD	Medical Oncologist	UCHealth Lung Cancer Clinic - Anschutz Medical Campus
1:45 P.M.	Panel 3: Clinical Trial Design for TTA Devices for OML	Panelist	Nataliya Uboha, MD, PhD	Medical Oncologist	University of Wisconsin School of Medicine and Public Health
		Panelist	Tony Mok, MD, FRCPC, FASCO	Medical Oncologist	The Chinese University of Hong Kong
		Panelist	Tom Treasure, MD, MS, FRCS, FRCP	Thoracic Surgeon	University College London, UK
		Panelist	Shanda Blackmon, MD, MPH, FACS	Thoracic Surgeon	Mayo Clinic
		Panelist	Daniel Gomez, MD, MBA	Radiation Oncologist	Memorial Sloan Kettering Cancer Center
		Panelist	Robert Olson, BSc MD FRCPC MSc	Radiation Oncologist	University of Northern British Columbia
		Moderator	Raphael Bueno, MD	Thoracic Surgeon	Brigham and Women's Hospital
2:45 P.M.	BREAK
3:00 P.M.	Session 4: Appropriate Safety Profiles for TTA	Speaker	Alda Tam, MD, MBA, FRCPC, FSIR	Interventional Radiologist	University of Texas MD Anderson Cancer Center
3:00 P.M.	Session 4: Appropriate Safety Profiles for TTA	Speaker	Lonny Yarmus, DO	Interventional Pulmonologist	Johns Hopkins Medicine
3:30 P.M.	Panel 4: Safety Evaluations for TTA in the treatment of OML	Panelist	Shanda Blackmon, MD, MPH, FACS	Thoracic Surgeon	Mayo Clinic
		Panelist	Robert Olson, BSc MD FRCPC MSc	Radiation Oncologist	University of Northern British Columbia
		Panelist	Lonny Yarmus, DO	Interventional Pulmonologist	Johns Hopkins Medicine
		Panelist	Momen Wahidi, MD, MBA	Interventional Pulmonologist	Duke Health
		Panelist	Alda Tam MD, MBA, FRCPC, FSIR	Interventional Radiologist	University of Texas MD Anderson Cancer Center
		Panelist	Brad Wood, MD	Interventional Radiologist	NIH Clinical Center
		Moderator	Robert Suh, MD	Interventional Radiologist	UCLA
4:30 P.M.	Moderator Summaries from each Panel
4:50 P.M.	FDA Concluding Remarks	Director OHT1	Malvina Eydelman, MD	Food and Drug Administration
5:00 P.M.	Adjourn Workshop

BIOSKETCHES

REGISTRATION

Registration is closed as of April 4, 2022.

SUBMIT COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. FDA-2021-N-1312 by May 6, 2022.

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received.

The resulting discussions from the workshop and comments received in the docket will be taken into consideration.

Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at http://www.regulations.gov.

CONTACT

For questions regarding workshop content please contact:

Jeanne Oxley, MBA
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Email: [email protected]