Drug Development in NMIBC from Scientific, Regulatory, Clinician, and Patient Perspectives (2021)

March 4, 2021 to March 6, 2021

Johns Hopkins Greenberg Bladder Cancer Institute and American Urological Association Translational Research Collaboration

The fourth annual bladder cancer translational research meeting, co-sponsored by the American Urological Association and the Johns Hopkins Greenberg Bladder Cancer Institute, will be a three-day, virtual workshop focused on the science and treatment of non-muscle-invasive bladder cancer.

Non-muscle-invasive bladder cancer (NMIBC) represents the most common clinical disease state at diagnosis of bladder cancer. Given the often chronic nature of the illness and need for frequent cystoscopic monitoring, NMIBC has been considered among the most expensive malignancies to care for in the United States. Arguably the most effective immunotherapy developed for the treatment of cancer to date, BCG, has been a standard of care of the treatment of NMIBC for decades. However, the disease is replete with clinical and scientific dilemmas. There have been major shortages of BCG, leading clinicians and patients to consider other treatment modalities. Optimal treatment protocols for patients with disease that progresses despite standard intravesical treatment strategies are not well defined. The heterogeneity of the disease leads to major uncertainties regarding when to employ a potentially curative but life-altering treatment strategy, radical cystectomy.

The meeting will provide a critical overview of the various treatment modalities for non-muscle-invasive bladder and upper urinary tract cancer, key aspects to non-clinical and clinical drug development in this disease, and emerging knowledge regarding the genomic immunobiologic underpinnings of treatment response and resistance. This information will help practitioners make informed decisions about the treatment of various disease states of non-muscle-invasive bladder cancer, and help researchers identify current gaps in knowledge that could be addressed through research to further optimize the treatment of this disease.

Program Planning Committee

  • Matthew Galsky, MD (Co-Chair), Icahn School of Medicine At Mount Sinai
  • Yair Lotan, MD (Co-Chair), UT Southwestern Medical Center at Dallas
  • Phillip Abbosh, MD, PhD, Fox Chase Cancer Center
  • Brian Baumann, MD, Washington University School of Medicine in St. Louis
  • Peter Black, MD, University of British Columbia and Vancouver Prostate Centre
  • Stephen A. Boorjian, MD, Mayo Clinic
  • Jason Efstathiou, MD, PhD, Massachusetts General Hospital
  • Bishoy Faltas, MD, Weill Cornell Medicine
  • Christopher Hoimes, DO, PhD, Duke University
  • Elizabeth Plimack, MD, MS, Fox Chase Cancer Center
  • Sarah P. Psutka, MD, MSc, University of Washington
  • John Sfakianos, MD, Icahn School of Medicine At Mount Sinai
  • Robert Svatek, MD, UT Health San Antonio

 

Registration Fees

The registration deadline is February 25, 2021.

CategoryAUA MemberNon-Member
MD/Urologist$160$200
PhD Research Scientist$160$200
Resident, Fellow, Trainee, or StudentFree$60
Industry Representatives$360 - Please call AUA Customer Service at 1-800-908-9414 to register by phone.*
* Industry representatives who register online will be unable to pay the registration fee in full, and will therefore be unable to attend the meeting. AUA Customer Service will reach out to individuals who register online and appear to be employed by industry for rate clarification.

Target Audience

  • Urologic oncologists
  • Medical oncologists
  • Radiation oncologists
  • Translational researchers
  • Patient advocates
  • Medical professional employed by industry

Learning Objectives

After completing this activity, participants will be able to:

  1. Describe the state of the science in treatment of non-muscle-invasive bladder cancer.
  2. Discuss the key aspects to clinical trial design in the BCG-naïve and BCG-unresponsive clinical disease states of non-muscle-invasive bladder cancer.
  3. Describe the relevant clinical, genomic, and immunobiologic variables associated with patient outcomes after for non-muscle-invasive bladder cancer.
  4. Explain patient perspectives on the treatment options for non-muscle-invasive bladder cancer.
Course summary
Available credit: 
  • 10.75 AMA PRA Category 1 Credit™
  • 10.75 Non-Physician Participation
Course opens: 
12/01/2020
Course expires: 
03/06/2021
Event starts: 
03/04/2021 - 3:00pm
Event ends: 
03/06/2021 - 4:00pm
Price:
$200.00
Rating: 
0

*Draft agenda subject to change

Thursday, March 4, 2021 (All Times in EDT)

3:00 PMWelcome, Opening Remarks

Matthew Galsky, MD
Icahn School of Medicine At Mount Sinai

 

Yair Lotan, MD
UT Southwestern Medical Center at Dallas

 

David McConkey, PhD
Johns Hopkins University School of Medicine

 

Aria F. Olumi, MD
Beth Israel Deaconess Medical Center and Harvard Medical School

 

Carolyn J.M. Best, PhD
American Urological Association

3:10 PMBladder Cancer Advocacy Network (BCAN) Patient PanelBCAN Patient Panel
4:10 PMPANEL: Clinical Development of Therapies for NMIBC: What is Success?

Moderator: Yair Lotan, MD
UT Southwestern Medical Center at Dallas

 

Seth Lerner, MD
Baylor College of Medicine

 

Noah Hahn, MD
Johns Hopkins University School of Medicine

 

Brian Baumann, MD
Washington University School of Medicine in St. Louis

 

Elaine Chang, MD
U.S. Food and Drug Administration

5:10 PMDiscussion, Q&A 
5:30 PMBreak 
5:45 PMSESSION ONE: Drug Development for BCG-naïve NMIBC

Moderator: John Sfakianos, MD
Icahn School of Medicine At Mount Sinai

5:50 PMModel Systems to Facilitate Development of Therapies for NMIBC

Phillip Abbosh, MD, PhD
Fox Chase Cancer Center

6:10 PMWhat Novel Therapies Can Compete (or Combine) with BCG in BCG-naïve NMIBC?

Robert Svatek, MD
UT Health San Antonio

6:30 PMRegulatory Considerations in the BCG-Naïve NMIBC Setting

Chana Weinstock, MD
U.S. Food and Drug Administration and Baltimore VA Medical Center

6:50 PMDiscussion, Q&A 
7:10 PMClosing Remarks 
7:15 PMAdjourn 

Friday, March 5, 2021 (All Times in EDT)

3:00 PMOpening Remarks, Recap from Previous Day, and Goal Setting

Matthew Galsky, MD
Icahn School of Medicine At Mount Sinai

 

Yair Lotan, MD
UT Southwestern Medical Center at Dallas

3:10 PMSESSION TWO: Clinical Dilemmas in Management of NMIBC

Moderator: Sarah Psutka, MD, MSc
University of Washington School of Medicine

3:15 PMTrial Design Considerations for Intermediate Risk NMIBC

Trinity Bivalacqua, MD, PhD
Johns Hopkins University School of Medicine

3:35 PMWhat is Natural History (HGT1, CIS, HG Ta)? Novel Therapies Versus Cystectomy

Angie Smith, MD, MS
University of North Carolina School of Medicine

3:55 PMSequential Therapy in BCG Unresponsive Disease

Sima Porten, MD, MPH
University of California, San Francisco

4:15 PMDiscussion, Q&A 
4:35 PMBreak 
4:50 PMKeynote: The Science of Combination Therapy

Adam Palmer, PhD
University of North Carolina School of Medicine

5:20 PMDiscussion, Q&A 
5:30 PMKeynote: Racial Disparities in Cancer Clinical Trials

Otis Webb Brawley, MD
Johns Hopkins University School of Medicine

6:00 PMDiscussion, Q&A 
6:10 PMClosing Remarks 
6:15 PMAdjourn 

Saturday, March 6, 2021 (All Times in EDT)

12:00 PMOpening Remarks, Recap from Previous Day, and Goal Setting

Matthew Galsky, MD
Icahn School of Medicine At Mount Sinai

 

Yair Lotan, MD
UT Southwestern Medical Center at Dallas

12:10 PMSESSION THREE: Risk Stratification of NMIBC Through Genomics and Immunobiology

Moderator: Peter Black, MD
University of British Columbia

12:15 PMPredicting Response to BCG

Max Kates, MD
Johns Hopkins University School of Medicine

12:35 PMCan We Identify Patients Who Should Undergo Immediate Cystectomy?

Joaquim Bellmunt, MD, PhD
Beth Israel Deaconess Medical Center and Harvard Medical School

12:55 PMThe Role of Radiology and Radiomics in Staging and Risk Stratification of NMIBC

Manjiri Dighe, MD, MBBS
University of Washington Medical Center

1:15 PMUnderstanding the Microenvironment of NMIBC and Possible Future Immune Targets

Amir Horowitz, PhD
Icahn School of Medicine at Mount Sinai

1:35 PMDiscussion and Q&A 
1:55 PMBreak 
2:10 PMSESSION FOUR: Treatment of Non-Muscle-Invasive Urothelial Cancer of the Upper Tract

Moderator: Jonathan Coleman, MD
Weill Cornell Medicine

2:15 PMMultimodal Therapy for Upper Tract Disease

Surena Matin, MD
University of Texas MD Anderson Cancer Center

2:35 PMSpecial Considerations for UTUC and Lynch Syndrome

Jennifer Taylor, MD, MPH
Baylor College of Medicine

2:55 PMGenomics of UTUC

Bishoy Faltas, MD
Weill Cornell Medicine

3:15 PMThe Role of Neoadjuvant Therapy and Node Dissection for UTUC

Vitaly Margulis, MD
UT Southwestern Medical Center

3:35 PMDiscussion, Q&A 
3:55 PMClosing Remarks 
4:00 PMAdjourn Meeting 

Faculty disclosures will be posted here prior to the start of the course. AUA Office of Education Staff has nothing to disclose.

ACCREDITATION:

The American Urological Association (AUA) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION:

The American Urological Association designates this live activity for a maximum of 10.75 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

OTHER LEARNERS:

The AUA is not accredited to offer credit to participants who are not MDs or DOs. However, the AUA will issue documentation of participation that states that the activity was certified for AMA PRA Category 1 Credit™.

EVIDENCE BASED CONTENT:

It is the policy of the AUA to ensure that the content contained in this CME activity is valid, fair, balanced, scientifically rigorous, and free of commercial bias.

AUA DISCLOSURE POLICY:

All persons in a position to control the content of an educational activity (i.e., activity planners, presenters, authors) are required to disclose to the provider any relevant financial relationships with any commercial interest. The AUA must determine if the individual’s relationships may influence the educational content and resolve any conflicts of interest prior to the commencement of the educational activity. The intent of this disclosure is not to prevent individuals with relevant financial relationships from participating, but rather to provide learners information with which they can make their own judgments.

RESOLUTION OF IDENTIFIED CONFLICT OF INTEREST:

All disclosures will be reviewed by the program/course directors or editors for identification of conflicts of interest. Peer reviewers, working with the program directors and/or editors, will document the mechanism(s) for management and resolution of the conflict of interest and final approval of the activity will be documented prior to implementation. Any of the mechanisms below can/will be used to resolve conflict of interest:

  • Peer review for valid, evidence-based content of all materials associated with an educational activity by the course/program director, editor, and/or Education Conflict of Interest Review Work Group or its subgroup.
  • Limit content to evidence with no recommendations
  • Introduction of a debate format with an unbiased moderator (point-counterpoint)
  • Inclusion of moderated panel discussion
  • Publication of a parallel or rebuttal article for an article that is felt to be biased
  • Limit equipment representatives to providing logistics and operation support only in procedural demonstrations
  • Divestiture of the relationship by faculty

OFF-LABEL OR UNAPPROVED USE OF DRUGS OR DEVICES:

The audience is advised that this continuing medical education activity may contain reference(s) to off-label or unapproved uses of drugs or devices. Please consult the prescribing information for full disclosure of approved uses.


AUA PARTICIPANT INFORMATION & POLICIES

DISCLAIMER: 

The opinions and recommendations expressed by faculty, authors and other experts whose input is included in this program are their own and do not necessarily represent the viewpoint of the AUA.

CONSENT TO USE OF PHOTOGRAPHIC IMAGES: 

Attendance at or participation in AUA meetings and other activities constitutes an agreement by the registrant to AUA's use and distribution (both now and in the future) of the attendee's image or voice in photographs and electronic reproductions of such meetings and activities.

AUDIO, VIDEO AND PHOTOGRAPHIC EQUIPMENT: 

The use of audio, video and other photographic recording equipment by attendees is prohibited inside AUA meeting rooms.

REPRODUCTION PERMISSION: 

Reproduction of written materials developed for this AUA course is prohibited without the written permission from individual authors and the American Urological Association.

SPECIAL ASSISTANCE/DIETARY NEEDS:

The AUA complies with the Americans with Disabilities Act §12112(a). If any participant is in need of special assistance or has any dietary restrictions, please see the registration desk.

Available Credit

  • 10.75 AMA PRA Category 1 Credit™
  • 10.75 Non-Physician Participation

Price

Price:
$200.00
Please login or register to take this course.

Registration Fees

The registration deadline is February 25, 2021.

CategoryAUA MemberNon-Member
MD/Urologist$160$200
PhD Research Scientist$160$200
Resident, Fellow, Trainee, or StudentFree$60
Industry Representatives$360 - Please call AUA Customer Service at 1-800-908-9414 to register by phone.*
* Industry representatives who register online will be unable to pay the registration fee in full, and will therefore be unable to attend the meeting. AUA Customer Service will reach out to individuals who register online and appear to be employed by industry for rate clarification.

Cancellation requests must be made in writing prior to March 2, 2021. Requests may be made via email to customerservice@auanet.org or fax to 410-689-3912. Please call 1-800-908-9414 or email registration@AUAnet.org with any questions related to registration.