The expiration of patents and other intellectual property rights for originator biologics over the next decade opens up opportunities for biosimilars to enter the market and increase competition. Despite the challenges associated with the development of biosimilar drugs, many drug manufacturers are entering the race to develop biosimilars especially for blockbuster mAbs creating acute demand for investigators and patients.
With increased clinical trial activity through Phase III, the ability to recruit patients into these important studies becomes a key stepping stone to Biosimilar commercial success.
Join our speaker for an in-depth look at the challenges and solutions in conducting biosimilar trials.
Speaker
Rodeina Challand B.Sc., Executive Director, Biosimilars Development, Scientific Affairs, PRA
Rodeina Challand has 25 years of experience in healthcare, cancer research, and the Pharmaceutical industry across a wide range of roles. As director of clinical projects at Hospira Inc., her responsibilities included creating clinical development strategies for biosimilars and serving as head of clinical operations in Europe. For over 10 years, she directed the conduct of Phase I-IV clinical trials, including large pivotal biosimilar multi-national, multi-center trials and several post-authorization safety studies for biosimilars. She was the lead in the development of Hospira’s first biosimilar, Hospira GCSF, from lab to clinic.
Ms. Challand has experience in all aspects of biosimilar development including study design and regulatory agency discussions (Europe, US, Japan, Australia, Singapore, and South Korea) and has worked on six biosimilar molecules. She was also the company’s representative in several EMA consultations with regard to the development of the EMA Biosimilar Guidelines and was a member of the European BioPharmaceutical Group, which is a sector of the European Generic Association.
More recently in her role in PRA, Ms. Challand has worked on 7 Biosimilar programmes in various capacity including consulting, strategy, feasibility, IMP management and study delivery. She has also represented PRA as a speaker in several International Biosimilar conferences across the Globe.
Message PresenterWho Should Attend?
- Heads of Research & Development
- Directors of Clinical Operations
- Program & Clinical Study Managers
- VPs of Clinical Development
- Therapeutic Area Leaders
- Chief Medical Officers
- Chief Scientific Officers
From pharmaceutical and biotechnology companies worldwide
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PRA
As a leading CRO, PRA is transforming clinical trials through our people, innovation and operational transparency. We combine therapeutic and operational expertise with local knowledge to serve clients across all phases of drug development. With 40 drug approvals to date, PRA has an impressive therapeutic background that encompasses a variety of compounds, ranging from niche treatments to blockbuster drugs and biosimilars.
During the last five years, PRA has conducted biosimilars clinical trials in a number of therapeutic areas including endocrinology, genitourinary, hematology, infectious diseases, immunology and neurology.
PRA offers comprehensive, cross-functional support for your biosimilar development programs including consultation, regulatory, early development services, bioanalytical, study conduct, and license application.
In addition to our experience with biosimilar development programs, PRA has substantial experience working on studies involving other biological drugs.
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