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
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
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 |
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 |
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 |
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 |
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
- Shanda H. Blackmon, M.D., M.P.H., F.A.C.S.
- Steven Chmura
- Frank C. Detterbeck, M.D.
- Qiuwei Feng Speakers
- John Handy
- David Harpole
- Puneeth Iyengar, MD, PhD
- Fabien Maldonado
- Tony Mok
- Michael Offin
- Robert Olson MD FRCPC MSc
- Stephen Solomon
- Robert Suh, M.D.
- Alda Tam
- Nataliya Uboha
- Eric Vallières, MD FRCSC
- Momen M. Wahidi, MD, MBA
- Bradford Wood
- Jonathan Yang
- Lonny Yarmus
- Kazuhiro Yasufuku MD, PhD, FRCSC
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: CDRH-OPEQ-StrategicInitiatives@fda.hhs.gov