Agenda now available for IBC’s Cell Therapy Bioprocessing & Commercialization meeting

 

The full agenda is now available for IBC's Cell Therapy Bioprocessing & Commercialization meeting, coming to Alexandria, VA on September 30 - October 2, 2015. Start planning your team's trip today to attend the leading forum for cell therapy developers and end users to collectively share ideas, solutions and lessons learned to help you:

• Applying genome editing and other disruptive technologies 
• Developing scalable and transferable manufacturing processes 
• Biopreservation, cold chain management and patient delivery 
• Develop a successful and sustainable business model 
• Advance next generation cancer immunotherapies 
• Foster partnerships and outsource strategies for R&D and manufacturing 
• Implement strategies for pricing, reimbursement, and adoption 
• Negotiate the regulatory pathway to approval 

 Download the complete agenda.

Register now with the code XB15188BLOG and save $100 off the current rate - Register by June 19 and lock in a $550 savings*, click here to register.

If you have any questions about the event, please reach out to Ksenia Newton at knewton@iirusa.com

"Process innovations in cell therapy are happening at an extremely rapid rate and IBC is the best place to keep up with technology and people in the field.” - Jon Rowley, Ph.D., RoosterBio Inc.

“The content and networking opportunities are first class. This is a must attend for anyone involved in cell therapy and gene therapy.” - Robert Speziale, Vice President, Invetech Inc. 

*Discount is valid for new registrations only and cannot be combined with any other offer.

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FDA Establishes New "Purple Book" for Biosimilars

It may not make the New York Times’ Best Seller List, but the release of the FDA’s new book is certainly noteworthy.  The FDA today announced that they’ve published their first ever edition of the “Purple Book”, a list of licensed biological products and interchangeable biosimilars. 

The organization’s new list will serve a similar role to that of its counterpart in the pharmaceutical industry, the Orange Book, and will look to answer questions around the substitutability of products.  Many have voiced concerns over the extent to which biologics and biosimilars will be used interchangeably.  Although aimed to replicate the biologics they’re designed after, biosimilars are not identical to those drugs and therefore are not necessarily perfect substitutes in all cases.

The FDA has indicated that they will use a four part scale to categorize the interchangeability: 

•       •  Not similar
•       •  Similar
•       •  Highly similar
•       •  Highly similar with a fingerprint-like similarity

The book is broken up into two sections—biologic products regulated by the Center for Drug Evaluation and Research (CDER) and those regulated by the Center for Biologics Evaluation and Research (CBER). Among the information included in these lists is the date a biologic was licensed, the product name, the proprietary name and the BLA number. 

As we begin to see biosimilar applications roll in, we may see this list build out rather quickly over the next few years. 

You can find the announcement from the FDA here.

We’ll have more on the latest developments in the biosimilars market at the 15^thAnnual Business of Biosimilars meeting. Join us October 20-22 in Boston, MA. Download the agenda to see what’s on tap.

                                                                                                     

SAVE $100.  Register here and use code XP1986BLOG.

Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
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