Thanks to scientific advances and resource investment, the cell and gene therapy pipeline continues to expand. Current research infrastructure, however, cannot support the increased clinical development. The use of exploratory endpoints is growing, and often, small patient populations are difficult to identify, alongside challenges with recruiting diverse patient populations. Meanwhile, sites are understaffed and overwhelmed.
To support sponsors and their partners to innovate in this growing, but uncertain space Parexel presents New Medicines, Novel Insights which is their perspective on speeding life-changing medicines to market. With a focus on cell and gene therapies, the second report in the series launches in mid-May and explores factors that are critical to therapy development success, accounting for the market and operational landscape in 2023.
In this webinar, the speakers explore one of the topical clinical development perspectives contained within the report, the challenges and opportunities of moving trials into the community. Get practical guidance and actionable insight for addressing the complexity of study start-up and execution outside the traditional cell and gene therapy sites.
Join this webinar to learn how moving cell and gene therapy trials from overloaded research centers to communities can increase diversity, expand patient access and relieve site fatigue. Hear perspectives from site and project leadership experts and Clinical Biosafety Services, all working together to expand into community-based settings.
Speakers
(Moderator) Alberto Grignolo, PhD, Corporate Vice President, Corporate Strategy & Thought Leadership, Parexel
Alberto Grignolo has over 40 years of experience as a regulatory and drug development professional and corporate executive, including 30 years as a consultant to pharmaceutical and biotechnology companies. Alberto is a past chairman of the board of the Regulatory Affairs Professionals Society (RAPS), a Fellow of the Drug Information Association (DIA) and the Editor-in-Chief of DIA Global Forum.
Message Presenter
Chris Jenkins, PhD, MPH, Principal Partner & Chief Gene Therapy Biosafety Officer, Clinical Biosafety Services
Dr. Chris Jenkins, PhD, MPH, is the CEO, Founder and Principal Partner of Sabai Global + Subsidiaries of Clinical Biosafety Services IBC, Castle IRB and Shield Consulting. He has worked 15+ years in the fields of pharmaceuticals, biological safety, gene therapy/gene transfer, corporate development, human research protections and biosafety compliance fields in academic, private research institutes and clinical settings. He has experience overseeing a broad range of entity research compliance chairing IBCs and IRBs at over 1500 convened meetings.
Message Presenter
Kathy Scott, Associate Director, Site Alliances, Parexel
Kathy Scott has 35 years of clinical development experience spanning roles within pharmaceutical companies, a Site Management Organization, a Regulatory Science Consultant Company and full-service Clinical Research Organizations.
In her current role, Kathy is dedicated to applying her in-depth knowledge of clinical trial processes to engage and develop long-term strategic relationships with the most experienced research and healthcare institutions and serves as a central point of contact for her partnering sites to deliver clinical trial efficiencies and support across all their Parexel trials.
Message Presenter
Shannon Macquarrie, Senior Vice President, Project Leadership, Parexel
Shannon Macquarrie has 20+ years’ experience within clinical trials in both CDMO and CRO organizations. Her focus is effective project, program and operations management and partnership with clients to ensure successful delivery. In her current role at Parexel, as Senior Vice President for Project Leadership, Shannon partners with clients with trials across therapeutic areas to optimize the delivery of their projects.
Message PresenterWho Should Attend?
- Clinical Operations
- Cell and Gene Therapy Programs
- Commercial
- Diversity, Equity and Inclusion
- Executive/C-level
- Health Economic and Outcomes Research
- Investigators
- Market Access
- Medical Affairs
- Patient Recruitment and Retention
- Rare Disease Programs
- Sites
What You Will Learn
Attendees will gain insights into:
- The importance of cross-industry engagement, alignment and communication to drive a community-based model forward
- How clinical trial sponsors and their partners can manage risk and create value through site diversification
- Practical advice for engaging new sites and investigators
- Considerations for study start-up and execution
Xtalks Partner
Parexel
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com and follow us on LinkedIn, Twitter, Facebook and Instagram.
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