13
September

10:00 AM ET

When an Approved Product Becomes an Orphan: Repurposing Strategies in the Orphan Space

Join us to discover:

Considering repurposing your product for a new indication – such as a rare disease? Perhaps you’re aware of an unmet need; pharmacological and pharmaceutical properties suggesting utility in a new indication; or current product utilization outside of the approved indication. All present an opportunity to explore your product in a new market.

Successful product transition is predicated upon integrated services within a “matrix” team addressing relevant concepts, such as regulatory considerations, program and protocol design through to clinical operations, and eventual formulary placement and reimbursement. Join us for a discussion on how to repurpose for your product for orphan designation.

Online Agenda

Why you should attend

The virtual boardroom is limited to 25 participants only. Each participant shall have the opportunity to raise questions and vividly contribute to the discussion.

Meet the Facilitators

The virtual boardroom will be lead by our expert facilitators:

Michael F. Murphy, MD, PhD

Chief Medical and Scientific Officer Worldwide Clinical Trials

Brenda Rolfe, PMP

Executive Director, Project Management Worldwide Clinical Trials

Sean Kennedy, MPH

Real World Evidence Strategy Lead Worldwide Clinical Trials

More about Worldwide Clinical Trials:

More information

Worldwide Clinical Trials is a global, midsize contract research organization (CRO) that provides top-performing bioanalytical 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, and Asia, Worldwide is powered by its more than 3,000 employee experts

For more information, please visit www.worldwide.com or connect with us on Twitter, LinkedIn, Facebook, and Instagram.

Further Information

Interested in attending this virtual roundtable or running your own? Drop us a message today and we will get in touch

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Worldwide Clinical Trials Virtual Boardroom 3rd May 2022

When an Approved Product Becomes an Orphan: Repurposing Strategies in the Orphan Space

Online Agenda

What are the differences in regulatory jurisdictions regarding data for orphan drug or rare pediatric drug designation – is rationale and epidemiology always sufficient?

Are the available nonclinical data from an approved product sufficiently enabling for an orphan indication or is an additional work stream implicated?

What is the strategic role of patient advocacy in both successful development as well as commercialization?

How can you integrate perspectives of multiple diverse stakeholders along the continuum of product repurposing to assure access and approval?

Why you should attend

Meet the Facilitators

Michael F. Murphy, MD, PhD

Brenda Rolfe, PMP

Sean Kennedy, MPH

More about Worldwide Clinical Trials:

Further Information

Select days you wish to attend You can add multiple days

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Select days you wish to attend You can add multiple days

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