Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapies

Life Sciences, Clinical Trials, Drug Discovery & Development,
  • Wednesday, May 25, 2022

Monogenic diseases have found much promise in the clinical development of cell and gene therapies. In recent years, these therapeutics have advanced to utilize more successful vectors, and many patients are seeing cell or gene therapy treatments for their disease entering clinical trials. For all the progress and hope these therapeutics have brought in recent years, they first faced decades of unexpected challenges and program-ending obstacles. The few approved advanced therapies and the many programs which have gone through development offer valuable insight for use in directing future programs.

Stay abreast of these rapidly changing advanced therapies and the post-pandemic pressures they face by attending this webinar. Our speakers will cover:

  • Current trends in cell and gene therapy research
  • Pandemic-induced pressures and challenges to advancement
  • Pain points for developers and program development
  • Navigation of clinical holds
  • Site activation trends and challenges
  • Patient competition strategies
  • Rare disease cell and gene therapies

Speakers

http://Dana%20Durst,%20Worldwide%20Clinical%20Trials

Dana Durst, Senior Director, Site Activation and Regulatory Therapeutic Lead, Oncology, Worldwide Clinical Trials

Ms. Durst has more than 15 years of clinical research experience. She began her career in research as a Project Assistant in 2006 and developed within this role before moving into a site budget associate role. Since 2012 she has been involved in Global Study Start Up operations and management.

Ms. Durst has broad therapeutic area experience including oncology, gene therapy, dermatology, ophthalmology, and cardiovascular studies ranging from Phase I-IV. Ms. Durst has overseen all aspects of startup as well as maintenance activities in a variety of countries worldwide in both early and late phase trials and with both small and large clients.

Ms. Durst has a bachelor’s degree in communications from the University of North Carolina at Wilmington. She is remotely located in Wilmington, North Carolina, USA.

Message Presenter
http://Chris%20Jenkins,%20CBS

Chris Jenkins, PHD, MPH, RBP, CHMM, Principal Partner & Chief Gene Therapy Biosafety Officer, CBS

Dr. Jenkins has more than 16 years of experience in the fields of biological safety, gene therapy, corporate development, human protections, and biosafety compliance in academic, private research institute and clinical settings. He has experience overseeing a broad range of entity research compliance and has served as IRB and IBC Chair at over 1200 convened meetings, including at Saint Louis University, The Scripps Research Institute, the University of Missouri, WIRB-Copernicus-Group IRB, and the University of Texas at Austin. Dr. Jenkins conducted masters and doctorate studies in Public Health, with a focus on Biosecurity through the Saint Louis University School for Public Health and Social Justice. He is frequently consulted for workshops, webinars, presentations, and has a number of articles in print and review.

Message Presenter
http://Derek%20Ansel,%20Worldwide%20Clinical%20Trials

Derek Ansel, MS, CCRA, Senior Director, Therapeutic Strategy Lead, Rare Diseases, Worldwide Clinical Trials

Mr. Ansel has worked in clinical research for more than ten years with a focus almost exclusively in rare and pediatric diseases, including non-malignant hematology, autoimmune diseases, metabolic disorders, movement disorders, and other genetic conditions. At Worldwide, he leads and supports corporate initiatives within rare and pediatric diseases and maintains relationships with over 45 patient-focused advocacy organizations.

Mr. Ansel is a non-affiliated member of the IRB at Thomas Jefferson University in Philadelphia, PA. He holds a master’s degree in pharmacology and toxicology from Michigan State University and is pursuing a master’s degree in Genetic Counseling from Bay Path University.

Message Presenter

Cathy Purvis, MBA, Site Activation Manager, Worldwide Clinical Trials

Ms. Cathy Purvis has over 5 years of clinical research experience across all phases and many therapeutic areas including oncology, neurology, gastroenterology, women’s health, pediatrics, orthopedics, and cardiovascular studies. Within oncology, she has been involved in multiple gene therapy trials. She has been involved in all aspects of study start-up as well as maintenance activities all the way up to NDA submission. Although most of her experience lies in the US, she has worked on projects in a number of countries worldwide.

Ms. Purvis has bachelor’s degrees in business administration and international studies as well as a master’s in business administration from the University of North Carolina at Wilmington.

Message Presenter

Who Should Attend?

This webinar will appeal to Vice Presidents, Directors, Managers, Department Heads, Scientists and Researchers working within:

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

What You Will Learn

Attendees will learn about:

  • Current trends in cell and gene therapy research
  • Pandemic-induced pressures and challenges to advancement
  • Pain points for developers and program development
  • Navigation of clinical holds
  • Site activation trends and challenges
  • Patient competition strategies
  • Rare disease cell and gene therapies

Xtalks Partner

Worldwide

Worldwide Clinical Trials is a global, midsize contract research organization (CRO) that provides top-performing preclinical and Phase I-IV clinical development services to the biotechnology and pharmaceutical industries.

Founded in 1986 by physicians committed to advancing medical science, our full-service clinical experience ranges from early phase and bioanalytical sciences through late phase studies, post approval, and real-world evidence. Major therapeutic areas of focus include cardiovascular, metabolic, neuroscience, oncology, and rare diseases. Operating in 60+ countries with offices in North and South America, Eastern and Western Europe, Russia, and Asia, Worldwide is powered by its more than 2,800 employee experts.

For more information, please visit www.worldwide.com.

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