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Plus! Choose from two comprehensive pre-conference workshops:
A: Oncology Imaging Endpoint Assessment | B: Surrogate Endpoints and Accelerated Drug Approval Pathways
C O N F E R E N C E P R E V I E W *
Life Sciences *This is preliminary conference information. Topics, agenda and speaker names are subject to change without notice.
November 2-3, 2015  Philadelphia, PA
Validate Endpoints, Interpret QOL Scores and Incorporate Patient Preferences
to Satisfy Regulatory Requirements for Reliability and Validity
Oncology Endpoints &
QOL Assessments
Who Should Attend
You will benefit from attending this event if you are a manager, associate director, director
or vice president from a biotech, pharmaceutical, medical device company or academic
research institute with responsibilities or involvement in the following areas:
Oncology Heads  Program Leads  Medical Affairs  HEOR  PRO
Clinical Research/Outcomes  Data Management/Statistics
This conference will also benefit consultants, CROs, imaging and technology
vendors working with the above audience.
Although the FDA has long-time considered OS as the gold standard for oncology endpoints, there has been a
push for the inclusion of patient preferences and benefit-risk assessments, leading to the acceptance of surrogate
endpoints based on QOL measures.
CBIs Oncology Endpoints and QOL Assessments provides insight into the rapidly changing field of oncology
clinical trials including case studies and perspectives surrounding endpoint selection, QOL interpretation and the
development of PRO measures to ensure validity and integrity of the trial to support regulatory approval.
Benchmark against leading oncology thought-leaders:
A Great Place to Meet Your Market!
Take advantage of the best opportunity to
meet potential clients face-to-face. Build
relationships while demonstrating thought
leadership and sharing expertise. For more
information on how to position your
company as a sponsor or exhibitor, contact:
Taylor Biggers
339-298-2108 | taylor.biggers@cbinet.com
Understand patient needs when designing clinical trials and assessing oncology endpoints in terms of disease,
treatment and impact of therapy
Develop patient reported outcome tools to identify benefit-risk assessments of treatments
Create strategies to validate endpoints without subjecting the immune system to toxicities in
immuno-oncology clinical trials
Obtain PRO label claims in oncology trials by creating system indexes
	 Ira Klein,
Medical Director,
Aetna
	 Scott Megaffin,
President,
Churchill
Pharmaceuticals, LLC
	 David Cella, Ph.D.,
Director,
Patient-Centered
Outcomes,
Institute of Public
Health for Medicine
	 Pablo Lapuerta, M.D.,
Executive Vice President
and Chief Medical
Officer, Lexicon
Pharmaceuticals
Featured Speakers:

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PC15013_ConferencePreview

  • 1. Plus! Choose from two comprehensive pre-conference workshops: A: Oncology Imaging Endpoint Assessment | B: Surrogate Endpoints and Accelerated Drug Approval Pathways C O N F E R E N C E P R E V I E W * Life Sciences *This is preliminary conference information. Topics, agenda and speaker names are subject to change without notice. November 2-3, 2015 Philadelphia, PA Validate Endpoints, Interpret QOL Scores and Incorporate Patient Preferences to Satisfy Regulatory Requirements for Reliability and Validity Oncology Endpoints & QOL Assessments Who Should Attend You will benefit from attending this event if you are a manager, associate director, director or vice president from a biotech, pharmaceutical, medical device company or academic research institute with responsibilities or involvement in the following areas: Oncology Heads Program Leads Medical Affairs HEOR PRO Clinical Research/Outcomes Data Management/Statistics This conference will also benefit consultants, CROs, imaging and technology vendors working with the above audience. Although the FDA has long-time considered OS as the gold standard for oncology endpoints, there has been a push for the inclusion of patient preferences and benefit-risk assessments, leading to the acceptance of surrogate endpoints based on QOL measures. CBIs Oncology Endpoints and QOL Assessments provides insight into the rapidly changing field of oncology clinical trials including case studies and perspectives surrounding endpoint selection, QOL interpretation and the development of PRO measures to ensure validity and integrity of the trial to support regulatory approval. Benchmark against leading oncology thought-leaders: A Great Place to Meet Your Market! Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while demonstrating thought leadership and sharing expertise. For more information on how to position your company as a sponsor or exhibitor, contact: Taylor Biggers 339-298-2108 | taylor.biggers@cbinet.com Understand patient needs when designing clinical trials and assessing oncology endpoints in terms of disease, treatment and impact of therapy Develop patient reported outcome tools to identify benefit-risk assessments of treatments Create strategies to validate endpoints without subjecting the immune system to toxicities in immuno-oncology clinical trials Obtain PRO label claims in oncology trials by creating system indexes Ira Klein, Medical Director, Aetna Scott Megaffin, President, Churchill Pharmaceuticals, LLC David Cella, Ph.D., Director, Patient-Centered Outcomes, Institute of Public Health for Medicine Pablo Lapuerta, M.D., Executive Vice President and Chief Medical Officer, Lexicon Pharmaceuticals Featured Speakers: