Rare Cancers: Special Considerations for Complex Clinical Studies

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Drug Discovery & Development,
  • Tuesday, November 17, 2020 | 11am EST (NA) / 4pm GMT (UK) / 5pm CET (EU-Central)
  • 60 min

All clinical trials face challenges, but for rare disease trials, there are additional and unique challenges. Recruiting patients with the accurate rare disease diagnosis is a significant hurdle, followed by the challenges of addressing the difficulty and strain of these diseases on the patients themselves throughout the course of the study. With many rare diseases being genetic in nature, outcomes and decisions weigh heavily on the patient families.

For rare oncology trials, it becomes even more complex, from recruiting patients with specific biomarkers and genetic characteristics to navigating complex logistics and timing with individualized therapies and addressing evolving trial designs. A high number of study sites are required to enroll a very small number of patients. Statistical significance may be limited as well, so analysis may hinge on individual patients and historical comparison. Additionally, working with regulatory authorities throughout the process is critical.

Join Deb Kientop, Vice President, Strategic Development, Oncology, Dr. Marie Bonneterre, Vice President, Medical Affairs, Oncology and Rachael Young, Director, Feasibility on Tuesday, November 17 at 11:00 am EST as they tackle these challenges in this live webinar.

Speakers

http://Deb%20Kientop,%20Synteract

Deb Kientop, Vice President, Strategic Development, Oncology, Synteract

Deb Kientop, MBA brings over 25 years of experience in oncology drug development, starting in the cancer research labs at the University of Wisconsin, and moving into business development, medical affairs and clinical development roles within pharma and CRO. Her career has included thought leader engagement, product lifecycle planning, strategy development and execution for proposals and bid defenses, and corporate strategy and alliance management. Through her work with oncology investigators and patient advocacy organizations, she has been able to incorporate insights into patient-centric development strategies. Kientop is also a published author and cancer patient advocate.

Prior to joining Synteract, Kientop was the Vice President of Life Sciences at Inteliquet, a healthcare technology company. Previously, she held senior director strategy positions at two large CROs, as well as numerous biopharmaceutical organizations including MedImmune, MGI Pharma and Eisai.

Kientop holds a Bachelor of Science in Pharmacology and Toxicology and a Master of Business Administration from the University of Wisconsin.

Message Presenter
http://Dr.%20Marie%20Bonneterre,%20Synteract

Marie Bonneterre, Vice President, Medical Affairs, Oncology, Synteract

Dr. Marie-Edith A. Bonneterre is board-certified in Medical Oncology. She was trained at the Paris Diderot and Paris Sud Universities and also holds a University Degree in Bioethics and a master’s degree in Marketing and Management from the HEC Business School.

Dr. Bonneterre brings a mixture of experience, focusing on clinical development in both pharmaceutical and hospital settings. Recently as an independent advisor, she was Head of Strategic Development with Pharma Mar S.A. in Madrid, Spain until 2017. She acquired CRO experience through her role as Senior Medical Director of Global Drug Development for a large CRO from 2011 to 2014. She also served as Global Medical Director in Oncology and Hematology at Genzyme Corporation in Oncology-Hematology global development, and prior to that with Novartis and Sanofi.

In the academic setting, Dr. Bonneterre created and directed the Clinical Research Unit of the Oscar Lambret Cancer Centre, the Comprehensive Cancer Centre of Northern France for over eight years. As a full-time clinician and head of this unit, she was in charge of organizing and coordinating the clinical research of the institution on a national and international basis.

Dr. Bonneterre was elected a member of the French departmental Board of Physicians and was also for many years, an expert for the French Drug Agency in the Drug Usage & Advertisement Control Commission and the Clinical Trials Commission. She has contributed to 166 scientific presentations and publications, to the direction of 33 graduation assays or thesis and is a full member of main scientific organizations such as ASCO, AACR, ASH and ESMO.

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http://Rachael_Young_Synteract

Rachael Young, Director, Feasibility, Synteract

Rachael is an experienced feasibility strategist with over eight years of industry experience focused on the development of complex, data-driven feasibility strategies to support robust clinical trial planning. She works in a cross-therapeutic team supporting all stages of feasibility from early pre-award study planning through to site identification, selection and initiation. With expertise across multiple therapeutic areas

Rachael is able to analyze wide data sets to inform evidence-based and data-driven decision making ensuring effective strategies are implemented bespoke to the clinical program. Her passion lies in rare and orphan drug development, whereby understanding a multitude of unique factors is critical to overcoming study obstacles and ultimately ensuring patients gain access to these life changing trials.

Message Presenter

Who Should Attend?

This webinar will appeal to VPs, Directors, Managers, Department Heads, Scientists and Researchers working in areas of Rare Cancer drug development, including:

  • Clinical Affairs
  • Clinical R&D
  • Clinical Research
  • Clinical Pharmacology
  • Clinical Operations
  • Project Management
  • Regulatory Affairs
  • Medical Affairs

What You Will Learn

Panelists will explore:

  • An overview of past and current rare oncology development
  • Medical considerations when creating a protocol
  • How to find the right patients and investigators
  • What the future of rare oncology looks like

After the webinar, participants will have a stronger strategy for tackling rare oncology studies to support a patient-first approach while running an efficient, effective, on-time trial.

Xtalks Partner

Synteract

With employees across 21 countries, Synteract is an innovative, full-service CRO supporting biopharma companies across all phases of drug development to help bring new medicines to market. Synteract has conducted 4,000 studies on six continents and in more than 60 countries, working with more than 26,000 investigative sites and 750,000 patients. Greater than 245 of its 4,000 studies have been in pediatric populations. In addition to pediatrics clinical trials, Synteract offers a notable depth of therapeutic expertise in dermatology, neurodegenerative, oncology and immunotherapy, and rare/orphan disease studies.

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