Tag: Angi Robinson

Consulting

BIO International: Discover the Latest in Innovative Rare Disease Trial Design

DURHAM, N.C., June 5, 2019 — Premier Research is sponsoring the Orphan & Rare Disease session track at this year’s BIO International Convention, June 3-6 in Philadelphia. Our own Angi Robinson, vice president for clinical development services in rare diseases and pediatrics, will participate in the panel discussion Rare Finds: Innovative Clinical Trial Design for...

Rare Disease and Pediatrics Expert to Address WODC Europe November 7

DURHAM, N.C., October 30, 2018 — Angi Robinson, Executive Director for Rare Disease and Pediatrics at Premier Research, will discuss clinical development strategies for genetic rare disease research November 7 at the World Orphan Drug Congress in Barcelona. Ms. Robinson’s presentation, starting at 2:20 p.m., will examine management of confirmatory testing and specialty labs, the...

Planning Rare Disease Studies: Our Top Expert to Address WODC

DURHAM, N.C., APRIL 23, 2018 — Premier Research’s top rare disease and pediatrics expert will discuss clinical trial planning at the World Orphan Drug Congress in Oxon Hill, Maryland. Angi Robinson, Executive Director, Strategic Development, Rare Disease & Pediatrics, will present Early Development Planning for Orphan Drugs: Tasks, Timelines, and Takeaways on Thursday, April 26,...

Clinical Research: Phase 1 - Phase 4

Registry and Natural History Studies: Vital, Contrasting Roles in Clinical Research

Both registry studies and natural history studies play important roles in rare disease research. Understanding the differences between the two types of studies and how they can be used to inform clinical development can help sponsors plan for success. Sound drug development requires a comprehensive understanding of the disease being treated. To design reliable clinical...

Medical and Regulatory Affairs

What’s Ahead in Orphan Drugs? Attend Our June 1 Webinar

DURHAM, N.C., May 31, 2016 — Treatment of rare indications is turning a promising corner as regulators and lawmakers boost incentives and guidance in these areas of unmet medical need. Three experts from Premier Research will look at financial aid, expedited reviews, and other avenues available to orphan drug developers in a webinar on Wednesday, June...

Patient and Stakeholder Engagement

Premier Research’s New Pediatric Survey Reveals Challenge in Identifying Sufficient Clinical Patients

A new survey of clinical trial decision makers commissioned by Premier Research reports that identifying an adequate number of children suitable to be patients is far and away the single greatest challenge in conducting a pediatric clinical trial. The Premier Research survey also revealed a surprising lack of awareness among clinical trial sponsors that, as part of the Safety and Innovation Act (FDASIA), FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet specific criteria.

Patient and Stakeholder Engagement

Premier Research’s New Survey of Rare Diseases, Orphan Drugs Highlights Regulatory Challenges

A new survey of clinical trial decision makers commissioned by Premier Research reports that nearly two-thirds (64%) of respondents said that among the most difficult factors in recruiting for a rare disease or orphan drug clinical trial was not only finding patients to join and remain in trials, but identifying and setting up investigative sites for studies.

Premier Research Experts to Share Rare Disease Insights at World Orphan Drug Congress

Premier Research will present a speaker and host two roundtable sessions at the World Orphan Drug Congress, April 22-24 in Washington, DC. The Philadelphia-based contract research organization is a platinum sponsor of the fifth annual event, a top meeting place for biopharma, biotechs, government, patient groups, and others.

Achieving Uncommon Success in Rare and Ultra-Rare Disease Studies Webinar

Premier Research and Alexion Pharmaceuticals will co-present a webinar on achieving uncommon success in rare and ultra-rare disease studies on Wednesday, March 11, at 11am EDT (NA) / 3pm GMT (UK) / 4pm CET (EU-Central).

Consulting

Premier Research Experts Led Pediatric Session at ACRP 2012

Premier Research participated at the ACRP 2012 Global Conference, April 16-18 in Houston, Texas. Dr. Charlene Sanders, M.D., Vice President, Global Regulatory Affairs & Pediatric Strategic Consulting and Angi Robinson, Executive Director, Clinical Trials Management led a session entitled “Successful Pediatric Studies: Key Study Design and Site Selection Considerations.”