Key Considerations for the Development and Marketing of Biosimilar Products
Sep 9 2014 8:30AM - Sep 10 2014 4:30PM | DIA
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509
The rapid rise in the number of biologic products, and their ever expanding health authority-approved treatment indications, make biopharmaceuticals the most rapidly growing medicinal product segment for chronic disease therapy populations. Extensive use of biologics products have become mainstay treatment for diseases including cancer, diabetes, rheumatoid arthritis and multiple sclerosis. Patent expirations for these novel biopharmaceuticals now allow opportunity for development of follow-on products.
These follow-on biologics have garnered great interest for their cost-effective benefits in patient care as well as development opportunities for sponsors who see a new revenue stream. However, the pathway to commercialization is complicated by regulatory challenges, manufacturing hurdles as well as challenges in understanding the needed data requirements to establish a viable safe and effective product compared to the originator.
This comprehensive, high-level training program will provide a hands-on learning experience to those seeking to understand how a follow-on biologic or candidate biosimilar product is developed, regulated and registered for global commercialization. Information will also be provided on remaining issues yet to be resolved that may further complicate successful integration of biosimilars into common therapeutic practice.
Course Level: Intermediate
What You Will Learn
- Understanding the “similar but not identical” paradigm
- The current global regulatory environment
- Components of strategic biosimilar development
- CMC/Quality requirements
- Need for preclinical evaluation
- Clinical efficacy study requirements
- Comparative PK/PD exercise
- Challenges to development and market entry
Who Should Attend
Professionals who work in the areas of:
- Quality and Manufacturing
- Regulatory Affairs
- Clinical Research, Development
- Medical Affairs
- Business and Marketing
- Emerging Markets
At the conclusion of this course participants should be able to:
- Recognize key terminology associated with global biosimilar development
- Describe the current regulatory pathway from various health authorities
- Apply the current regulations and guidelines to establish product similarity
- Identify the strategic development steps to complete biosimilar development
- Recognize current challenges to development and commercialization of biosimilars in established as well as emerging markets
Group Discounts Available! Register 3 and Get the 4th FREE!
Hotel & Travel
Training Course Location
DIA Worldwide Headquarters
800 Enterprise Road, Suite 101
Horsham, PA 19044
Please keep monitoring the website for more hotel information as contracts are being finalized at this time.
Toll Free 1.888.257.6457
Monday-Friday 8:30AM-8:00PM ET
Agenda Details and Event Logistics
Colleen Buckley, Event Planner
Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102, (703) 506-3275.
As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer 1.4 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.
DIA’s Certificate Program Statement
These programs are part of DIA’s Certificate Program and are awarded the following:
• Clinical Research Certificate Program: 8 Elective Units
• Regulatory Affairs Certificate Program: 8 Elective Units
For more information go to www.diahome.org/certificateprograms
|Key Considerations for the Development and Marketi
It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.
Statement of Credit:
If you would like to receive a statement of credit, you must attend the course, sign-in at the DIA registration desk each day of the course, and complete the on-line credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on two weeks after the last day of the course.
To view DIA’s grievance policy, please visit the CE page on the DIA website at www.diahome.org/CE
- Charitable Nonprofit/Academia Member
- Member Government
- Member Standard
- Member Standard (As of 08/20/2014)
- Charitable Nonprofit/Academia Nonmember
- NonMember Government
- NonMember Standard
Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already discounted fees for government or charitable nonprofit/academia.
To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.