The rapidly evolving landscape of advanced therapies, including cell and gene therapies, presents unique challenges for small and mid-sized biotech and pharmaceutical companies.
Navigating the complexities of clinical trials in this space requires more than just technical expertise; it demands a strategic approach to partnership and resource management. In this webinar, the expert speakers will explore the specific hurdles these companies face and how collaboration with specialized service providers can drive success.
Key challenges include managing the intricate regulatory environment, ensuring patient recruitment and retention and handling the logistical complexities of these highly personalized therapies. Smaller organizations often struggle with limited resources, both in terms of personnel and infrastructure, making these trials particularly daunting.
The expert speakers will also discuss how partnering with the right pharmaceutical services provider can help overcome these obstacles. They will delve into strategies for leveraging external expertise to navigate regulatory pathways, optimize trial design and ensure efficient operational execution. The attendees will gain insights into selecting partners who can provide not only technical support but also strategic guidance, helping to reduce risks, accelerate timelines and ultimately bring life-saving therapies to market more effectively.
Register for this webinar today to understand the unique challenges of navigating clinical trials for advanced therapies and learn how strategic partnerships can help achieve successful results.
Speakers
Shaheen Limbada, Chief Operating Officer, WEP Clinical
Shaheen Limbada is a seasoned executive in the CRO and pharmaceutical industry, with over 23 years of experience in drug development, clinical operations, innovation and strategy, pharmacovigilance and post-trial access solutions.
He has worked in large pharma and CRO settings, including AstraZeneca, LEO Pharma, Veristat and Topstone Research. Shaheen is a visionary leader who combines scientific expertise, business acumen and operational excellence to deliver outstanding results for WEP clients and stakeholders. He is passionate about advancing clinical research and improving patient outcomes through innovation, collaboration and patient access.
Message Presenter
Kevin Hennegan, Head of Advanced Therapies, Quantum Regulatory Solutions
Kevin is an Experienced Clinical and Regulatory Affairs professional with a demonstrated history of working in the pharmaceutical, biotech and medical device industries. He is skilled in U.S. Food and Drug Administration (FDA) Interactions, Medical Devices, Life Sciences, and Clinical Trials. Kevin has a strong scientific background with degrees from Colorado State University and the University of Colorado at Boulder and is an advocate for evidence-based policy making and government investment into scientific research.
Message Presenter
Amanda Moore, Vice President of Program Leadership & Clinical Operations, Abeona Therapeutics
Amanda Moore has 20 years of clinical operations and development experience in the biotechnology and pharmaceutical industry with a track record of leading innovation in clinical trials, pioneering operating committee relationships and oversight of global development programs.
Ms. Moore joined Abeona in October 2020, holding positions of increasing responsibility, and most recently served as Senior Director, Head of Program Leadership. Previously, she has served in clinical operations and development roles with Biogen, Reckitt Benckiser, Sage Therapeutics and Intercell. Ms. Moore holds a Master’s degree in Health Science from George Washington University.
Message PresenterWho Should Attend?
This webinar will appeal to professionals in the following fields:
- Clinical development
- Clinical operations
- R&D
- Medical affairs
- Regulatory affairs
What You Will Learn
Attendees will learn about:
- How the right pharmaceutical services provider can help navigate regulatory challenges, optimize trial design and manage operations for advanced therapies
- The complexities of regulatory pathways and how to ensure drug development success by effectively managing these challenges
- Strategies to manage the advanced therapy trials, including supply chain management, patient handling and trial coordination
Xtalks Partner
WEP
At WEP, we are With Every Patient. With this as our guiding principle, we operate as a leading Pharma Services Provider that works with clients to design and execute value-driven clinical development programs. The WEP team are experts at navigating the regulatory complexities and managing the end-to-end operation of a program. Our tailored solutions are built to overcome the unique challenges of trial delivery in oncology, rare diseases and advanced therapies. With deep therapeutic understanding and a commitment to patient-centered drug development, we become an extension of a client’s team to help them unlock the full potential of their promising new molecule.
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