Learn How to Develop a Transparent and Consistent Corporate Policy for Early Patient Access
Sponsored by: Clinigen Group plc
- Patient Access
- Early Access
- Expanded Access
- Compassionate Use
Date: 17 November
Time: 3PM London/10AM New York
The BMS experience
Patients are better informed than ever about novel treatments and as shown by the number of high-profile patient-driven campaigns we have recently seen, calling companies to open up access to medication ahead of commercial launch. Regulators are increasingly scrutinising early access to medicines and considering (see the draft Cures Act in the US) mandating companies to make their access policies public. Are you and your company ready to respond to this changing environment? Do you have an ethical, compliant and fair policy in place to manage requests for access to your investigational products?
With an unrivalled level of experience, Clinigen Consulting helps pharmaceutical companies navigate the complexities of providing access to unlicensed and unavailable medicines around the world.
In this webinar, Sue Hannah (BMS) and Romina Oxborough (Clinigen), will present on their experience in developing a Policy for Early Patient Access and examples of the benefit for BMS and for their patients.
Don’t miss the opportunity to learn about Early Access Policy Development in this free webinar – register now!
Director, Clinigen Consulting
Romina joined Idis in 2012 and spent over two years in programme management. She then moved to head the newly created Medical Operations department with responsibility for the Drug Safety, Medical Information and Medical Data Management teams. Romina is currently the Director of Clinigen Consulting where she heads an international team of consultants and data experts specialising in unlicensed medicines. Romina is responsible for developing new strategic services to support the corporate objectives and global expansion of the Clinigen Group.
Romina holds a PhD and an MBA and has co-authored a number of international peer-reviewed publications and several conference abstracts and presentations.
Director, Global Clinical Operations, Bristol-Myers Squibb
Sue has been with Bristol-Myers Squibb for 25 years and has worked in Data Management, Clinical Operations, Continuous Improvement and Documentation. The majority of her career has been spent in clinical operations managing Phase III projects and managing Protocol and Study Managers. Most recently, Sue has led the clinical operations for Early Patient Access. She has led the initiation, management and closure of large named patient and cohort programs for multiple compounds. In addition she is the tri-chair of the Early Patient Access Council.
Prior to joining BMS, Sue worked as a Clinical Research Associate. She is trained as both a Dietitian and Registered Nurse and has a Masters in Management.
Sue is passionate about helping others and is energized by the knowledge that the contributions of her team are helping others.
Key Learning Objectives
- Gain understanding on the need for a corporate policy on Early/Expanded Access
- Get practical tips on how to develop a policy
- Learn from the first-hand experiences of a top 10 global Pharma company
- Head of Medical Affairs
- Chief Medical Officer
- Head of Clinical Development
- Head of Safety
- Head of Regulatory
- Chief Compliance Officer
- Medical Director