Impact of Genomics on Cancer Diagnosis and Treatment:
Open Drug Policy Forum

June 10, 2013 / 9:00am - 3:00pm
Case Western Reserve University / Wolstein Research Building Auditorium

Overview

A revolution in cancer care is emerging and will become mainstream over the next few years. We now have the ability to analyze the genetic changes in each person's tumor—so-called precision or personalized cancer care. However, this often leads to a conundrum. The drug selected based on the genetic mutation may not have been approved for that type of tumor. While a physician can prescribe the drug, insurance and Medicare may not pay for it. Right now the complexity of these issues is disruptive to normal reimbursement policy.

In this forum we will discuss the following:

Patients have begun to ask for genetic tests and now face the prospect of expecting access to drugs that cannot be reimbursed through insurance carriers. The ways that physicians at cancer centers are evaluating these issues will be described. We will ask the FDA to help us understand the review process for genetic tests, and will educate the public about the complexity of the process and the incredible potential for this new therapeutic approach. Legislation may be needed to change the way drugs are reimbursed based on individualized genetic testing. Now is the time to have the discussion about the approaches that could be taken.

We have assembled cancer experts from six Midwest cancer centers within 150 miles of Cleveland - Roswell Park Cancer Institute, University of Pittsburgh Cancer Institute, University of Michigan Comprehensive Cancer Center, The Ohio State University Comprehensive Cancer Center, Karmanos Cancer Institute, and Case Comprehensive Cancer Center. We also invited the FDA, and pharmaceutical and insurance company representatives to participate in this dynamic discussion.

Comprehensive Cancer Center Participation

Hosted by the Case Comprehensive Cancer Center in partnership with Karmanos Cancer Institute, The Ohio State University Comprehensive Cancer Center, Roswell Park Cancer Institute, University of Michigan Comprehensive Cancer Center, and University of Pittsburgh Cancer Institute.

Agenda

9:00am Registration and Breakfast
9:30am Welcome and Introduction Stanton L. Gerson, MD
9:40am Keynote Address: How Genomics May Transform Cancer Care Arul M. Chinnaiyan, MD, PhD
10:00am Break
10:05am How to Validate Genomic Based Decision Making in Cancer Moderator: Sanford D. Markowitz, MD, PhD
Panel Members: Roy A. Jensen, MD; Carl Morrison, DVM, MD; Robert J. Penny, MD, PhD; Michael A. Tainsky, PhD
10:50am Challenges for the FDA and CMS: Drug Approval and Reimbursement for Off-label Drug Use for Cancer Genetic Alterations Moderator: Richard L. Schilsky, MD
Panel Members: James H. Doroshow, MD; Martine J. George, MD, MSc; Elizabeth A. Mansfield, PhD; Neal J. Meropol, MD; Anthony J. Murgo, MD, MS; Jeffrey C. Roche, MD, MPH
11:35am Implications for Public Policy-Discussion with Congressional Representatives and NCI/FDA Moderator: Donald L. Trump, MD
Panel Members: James H. Doroshow, MD; Stanton L. Gerson, MD; Elizabeth A. Mansfield, PhD; Antony J. Murgo, MD, MS; Richard L. Schilsky, MD; Mikkael A. Sekeres, MD, MS
12:30pm Lunch / Networking
1:15pm Genomics and Drug Reimbursement: White Paper from the Cleveland Forum 2013 Moderator: Stanton L. Gerson, MD
Panel Members: Brian J. Bolwell, MD; Richard L. Schilsky, MD; Donald L. Trump, MD; Max S. Wicha, MD
2:00pm Implementing Proper Use of Genomic Tests to Select Therapeutics Moderator: Lyndsay N. Harris, MD
Panel Members: Gerold Bepler, MD, PhD; James H. Doroshow, MD, Candace S. Johnson, PhD; James J. Lee, MD, PhD; Patricia M. LoRusso, DO; Michelle L. McGowan, PhD
2:45pm Wrap Up / Next Steps
2:55pm Food for Travel

Registration

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Directions

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Directions to Case Western Reserve University

From the east via Interstate 90 exit at Martin Luther King Jr. Boulevard, proceed south for about a mile to the East 105th traffic light; cross East 105th and bear right through the traffic circle, continuing along Martin Luther King Jr. Boulevard to Euclid Avenue. Turn left onto Euclid and proceed to parking (see below).

From the east via Interstate 80 (Ohio Turnpike - From Eastern Ohio and Pennsylvania), remain on the Turnpike until you reach exit 187. Exit there and proceed north on Interstate 480, which merges with Interstate 271. Exit I-271 at Cedar Road and follow it westbound toward Cleveland. Where Cedar starts down a steep hill and lane-switching lights are hanging overhead, look for a sign identifying Case Western Reserve University at the corner of Murray Hill Road (the first light near the bottom of the hill). Turn right onto Murray Hill, bear left at the traffic light, and turn left at the three-way stop on the other side of the bridge. You will be on Adelbert Road near the center of campus. Proceed to parking (see below).

From the west via the Ohio Turnpike (Interstate 80), exit at Exit 142 and follow Interstate 90 east. Shortly after passing the downtown exits, exit at Martin Luther King Jr. Boulevard. Proceed south for about a mile to the East 105th traffic light; cross East 105th and bear right through the traffic circle, continuing along Martin Luther King Jr. Boulevard to Euclid Avenue. Turn left onto Euclid and proceed to parking (see below).

From the south via Interstate 71 or Interstate 77, proceed north until I-71 (or I-77) merges with Interstate 90. Take I-90 east then exit at Martin Luther King Jr. Boulevard. Proceed south for about a mile to the East 105th traffic light; cross East 105th and bear right through the traffic circle, continuing along Martin Luther King Jr. Boulevard to Euclid Avenue. Turn left onto Euclid and proceed to parking (see below).

Alternate route through downtown Cleveland: Any of the above directions can be altered if desired by taking route 90 into downtown Cleveland and exiting on Chester Avenue. Head east on Chester to Euclid (just past E. 105th st). Turn left onto Euclid and proceed to parking (see below).

Parking

Parking for the Wolstein Research Building is available in three locations. Please bring your ticket with you for validation.

Veale Parking Garage
From Euclid Avenue, head south on Adelbert Road. Follow Adelbert Road and turn right into the Veale Parking Garage immediately past One-to-One Fitness. To walk to the Wolstein Research Building, walk toward Circle Drive. Then turn left on Cornell Road and head north. The Wolstein Building will be on your right hand side.

UH Drive garage
From Euclid Avenue, cars will enter the new garage off UH Drive. To get to the Wolstein Building, walk to Euclid. Take a right at Euclid and head east toward Cornell Road. At Cornell road, take a right and head south. The Wolstein Building will be on your left hand side.

Rainbow Babies and Children's Hospital Garage
From Euclid Avenue, head south on Adelbert Road. Follow Adelbert Road and turn left into the Rainbow Babies and Children's Hospital Garage across from One-to-One Fitness. To walk to the Wolstein Research Building, please take a left out of the garage and walk toward Circle Drive. Then turn left on Cornell Road and head north. The Wolstein Building will be on your right hand side.

Overnight Accommodations

Courtyard by Marriott
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216.791.5678
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Glidden House
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866.812.4537
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Contact Us

For More Information

Gillian Todd
Web and Communications Coordinator
Case Comprehensive Cancer Center
216.844.8317
gillian.irwin@case.edu

Media Contact

Christine Somosi
Director of Marketing and Communications
Case Comprehensive Cancer Center and National Center for Regenerative Medicine
216.368.6287
christine.somosi@case.edu