Celebrate Cyber Monday with 25% Off IIR and IBC Pharma and Life Sciences Events

Use code CYBER25 for 25% off the current rate TODAY ONLY. For this exclusive savings use code CYBER25 to register today, November 30th for all the below IIR and IBC Life Sciences pharmaceutical and life sciences conferences:

Antibody Engineering & Therapeutics

December 7-10, 2015

San Diego Convention Center

San Diego, CA

Discount code: CYBER25

Download the brochure: http://bit.ly/1MZnpHL

Register: http://bit.ly/1MZnmf3

RIM

Regulatory Information Management Summit

December 14-15, 2015

Ritz Cartlon

Washington DC

Discount code: CYBER25

Download the brochure: http://bit.ly/1lU3rYj

Register: http://bit.ly/1NinS7j

FDA/CMS Summit

December 14-15, 2015

Washington DC

Discount code: CYBER25

View the agenda: http://bit.ly/1lpMvs8

Register: http://bit.ly/1lpMrIN

Drug Delivery Partnerships
January 20-22, 2015

PGA National Resort & Spa

Palm Beach Gardens, FL

Discount code: CYBER25

Download the brochure: http://bit.ly/1QPkxU0

Register: http://bit.ly/1NDAXye

Asia TIDES

February 24-26, 2016

Westin Miyako Kyoto

Kyoto, Japan

Discount code: CYBER25

Download the brochure: http://bit.ly/1lU53S2

Register: http://bit.ly/1IjGIyR

ePharma

February 29-March 2, 2016

Sheraton Times Square

New York, NY

Discount code: CYBER25

Download the brochure: http://bit.ly/1YD9hLV

Register: http://bit.ly/1YD9gaA

BioProcess International Conference & Exposition West

March 14-17, 2016

Oakland Marriott City Center

Oakland, CA

Discount code: CYBER25

View the preliminary agenda: http://bit.ly/1OzE7A6

Register: http://bit.ly/1HzTgSP

TIDES

May 9-12, 2016

Long Beach Convention Center and Entertainment Center

Long Beach, CA

Discount code: CYBER25

Download the brochure: http://bit.ly/1OqjtEp

Register: http://bit.ly/1HzTwkH

We hope to see you at our 2015-16 events!

*All registrations are subject to approval. Discounts cannot be retroactively applied*

Cheers,

The IIR and IBC Life Sciences Teams

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Update on Japan's New Cell Therapy Regulations

By: Leah Kinthaert

At the Cell Therapy BioProcessing Pre-Conference Symposia for the BioProcess International Conference and Exposition, VP of Business Development for RepliCel and cell therapy industry thought leader Lee Buckler updated the audience on Japan's new cell therapy regulations. Buckler was a great person to give insight into these new regulations, because RepliCel is partnered with a Japanese company.

The regulatory environment for cell therapies changed greatly in 2012 when Shinzo Abe was elected prime minister. Last year Abe (who has since then been re-elected) set a plan in action to change the existing regulations and provide $1 billion in stem cell research funding over the next 10 years. This political and economic driven regulatory innovation has created a market push into Japan; Buckler described how his company re-prioritized Japan into their strategy due to this seachange.

Japanese companies are actually getting overt recommendations from their government to go into cell therapies; the government has incentivized companies to locate in Kobe, where the Kobe Biomedical Research Center is located. Buckler stated: "One can't underestimate the power of government to influence corporate decisions. CEOs feel the need to respond to government presence."

Buckler went on to give details about his company RepliCel's research in Japan. RepliCel has partnered with one of the world's top hair care and cosmetics companies, Shiseido. Shiseido has built their own manufacturing facility in Japan, making RepliCel one of just two companies with a cell manufacturing footprint in Japan.

Buckler ended his lecture by asking the audience to ponder this question: "Over the long term, will it (changes in Japanese regulations) have real lasting commercial implications?"

The agenda for the PreConference Symposia on Cell Therapy Bioprocessing on Monday, October 26 can be found here.

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First Ever Biosimilar Approved in Japan

This post on GEN News discusses how Japanese regulatory authorities have approved the first ever biosimilar, and it is Sandoz biosimilar recombinant human growth hormone somatropin. This comes after Japan released guidelines for national regulatory of biosimilars that mimicked the EU's existing process.

The product will be marketed in Japan as Somatropin BS.C. Injection 5mg/10mg. This Sandoz biosimilar was previously approved in the US and Europe in 2006, but only approved in Japan now.

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