Precision Medicine: A Medical Miracle or Ethical Nightmare?
The Precision Medicine presentation will explore the concept of precision medicine and how it impacts the conduct of oncology clinical trials, regulatory guidance, subject recruitment, and the protection of human subjects participating in research. Learn to recognize the therapeutic misconception and how it impacts patient, caregiver and investigator/physician in the decision-making process. We will debate the concept of “hope” and “autonomy” and how it impacts patient/caregiver decisions regarding clinical trials when research subject is facing a life-threatening disease.Date(s): Nov 6 2014, 05:00 PM to 07:00 PM
Location: CareFusion Corporation
Precision medicine and patient centricity are here to stay. As regulatory affairs professionals you have seen the shift from therapies that are broad based, non-specific to therapies that target a receptor, metabolic pathway, or gene. You can have your own gene sequenced for less than $1000 and in the future you will be able to obtain a ‘molecular signature’ – information that pertains only to you. Imagine that you have just been diagnosed with late stage cancer and are trying to decide between standard of care and clinical trials. Does having a therapy just for you provide you with more ‘hope’ for a cure? Is your physician/investigator the individual you trust the most? What impact will targeted therapies have on clinical trial design? How will regulatory agencies respond to these new potential therapies? During this presentation you will explore the concept of precision medicine and how it impacts the conduct of oncology clinical trials, regulatory guidance, subject recruitment, and the protection of human subjects participating in research. Learn to recognize the therapeutic misconception and how it impacts patient, caregiver and investigator/physician in the decision-making process. We will debate the concept of “hope” and “autonomy” and how it impacts patient/caregiver decisions regarding clinical trials when research subject is facing a life-threatening disease.
Speaker
Linda Strause, Ph.D.
Strategic Clinical Consultants
Speaker Biography:
Dr. Strause is the Principal and Founder of Strategic Clinical Consultants. She brings over 25 years of expertise in global clinical operations and clinical development, with emphasis in oncology, critical care, and ethical considerations for subjects with life-threatening disease. In addition, Dr. Strause serves as Vice President, Clinical Operations for Leading Biosciences, Inc. where she sees all aspects for the shock program including a phase 2 septic shock and phase 2 cardiovascular shock trials. She was most recently the Executive Director and Head, Clinical Operations for Vical Incorporated where she was responsible for the conduct of all infectious disease programs and all aspects of a phase 3 clinical trial in malignant melanoma conducted at over 100 sites in 15 countries. Dr. Strause has held executive management positions at biotechnology companies, site management and healthcare research organization; and at a global CRO. She has managed all activities of a global study launch including but not limited to site qualification and selection, all investigational site contracts, budgets, payments, regulatory documents and strategic planning. Dr. Strause consults for the biotechnology industry on clinical development and operation strategies and is considered an expert in oncology programs including phase 1 through 3 studies as well as clinical development programs dealing with challenging enrollment and patient care issues.
Agenda
5:00 – 6:00 PM, Registration, Open Networking & Snacks
6:00 – 7:00 PM, Program Presentation
Contact
jodysuro@hotmail.com
Travel Information
Directions to CareFusion:
Address: 3750 Torrey View Ct. San Diego 92121Coming from the North
I-5 South toward San Diego
Exit toward Carmel Mountain Rd
Left onto Carmel Mountain Rd
Left onto Torrey View Court
Facility is on the right
Coming from the South
I-5 North toward Del Mar
Merge onto I-5 local Bypass
Take Carmel Mountain Rd exit (32)
Turn right onto Carmel Mountain Rd
Turn left onto Torrey View Court
Facility is on the right
Cancellation Policy
There will be no refunds for cancellations.
