Phase I Studies in Patient Populations: De-risking Clinical Development by Obtaining Key Patient Data Earlier

Life Sciences, Clinical Trials, Patient Recruitment & Retention, Drug Discovery & Development,
  • Thursday, June 25, 2020 | 9am EDT (NA) / 2pm BST (UK) / 3pm CEST (EU-Central)
  • 60 min

In this webinar, members of Simbec-Orion’s specialist early phase Project Management team will discuss how they tackled a range of challenges to successfully execute a variety of Phase I clinical studies in patient populations.

Attendees will learn how different regulatory and operational strategies were employed to optimise trial efficiency, minimise regulatory review timeframes and maximise recruitment efforts of early phase patient studies. These will be demonstrated via a number of case studies including:

  • A First-into-Human study combining healthy volunteer and rare disease patient population parts within the same protocol
  • A human pharmacology study involving patients with neurodegenerative disease
  • A gamma-scintigraphy imaging/inhaled drug lung distribution study in patients with moderate and severe chronic obstructive pulmonary disease (COPD)

Speakers

Nadine Aawar, Director Project Management, Simbec-Orion

Nadine Aawar is experienced in developing, implementing and managing phase I bioavailability/PK studies and investigator – led phase II and phase III multi-centre publicly and commercially-sponsored trials in different study populations and settings (children and young people, infections, dental, GP Practices, secondary and primary care). Nadine obtained a PhD in Clinical Pharmacy from Cardiff University and also holds an MPharm.

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Laura Llewellyn, Project Director, Simbec-Orion

Laura Llewellyn joined Simbec-Orion in November 2018. Laura has extensive experience in the development, implementation and execution of multi-center clinical trials. Following completion of her PhD at the University of Oxford, Laura joined the Cancer Research UK Clinical Trials Unit at the University of Birmingham where she managed a team of clinical research professionals to deliver early phase trials sponsored by both academic and commercial organizations. During this time, Laura undertook a postgraduate diploma in Clinical Oncology. In addition, Laura holds an MSc in Biomedical Science and a BSc in Biology.

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Laura Galligan, Project Manager, Simbec-Orion

Laura Galligan joined Simbec-Orion in September 2017 from the Welsh Ambulance Service where she has supported the growth of pre-hospital research in Wales and facilitated the conduct of numerous trials for cardiac arrest, stroke, transient ischaemic attacks and hip fractures. Laura has over 3 years of research experience within the National Health Service (NHS) that has included a role of Clinical Trials Coordinator for the Aneurin Bevan University Health Board. This role required Laura to coordinate and facilitate commercial and non-commercial trials across a number of specialities including oncology, respiratory, surgical and emergency care. Laura uses her NHS experience to support the growth of patient trials at Simbec-Orion.

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Who Should Attend?

Drug developers with assets in pre-clinical development – aiming to go into early phase I/II research in the next 12 – 18 months

Director level in the following job titles:

  • Clinical development
  • Clinical operations
  • Procurement
  • Translational medicine
  • Clinical pharmacology

 

What You Will Learn

  • Regulatory strategies to minimize review timeframes and maximize recruitment efforts
  • The importance of operational excellence to increase trial efficiency

Xtalks Partner

Simbec-Orion

Simbec-Orion is a  full service international CRO focused on oncology, rare disease and healthy volunteer studies. We offer our clients a full spectrum of drug development services from first-in-human Phase I clinical studies through to pivotal Phase III studies and Phase IV post marketing studies. We have expertise in all drug types, dosage forms and delivery mechanisms. Established in 1976, our experience and expertise enables us to become a true ally on your drug development journey.

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