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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State of the Cell Therapy Industry 2015: Approvals, Funding and the Future

By: Leah Kinthaert

At the Cell Therapy BioProcessing Pre-Conference Symposia for the BioProcess International Conference and Exposition, the packed room was treated to two "Where are we now in cell therapy" analyses which gave an excellent examination of the current state of the industry, and provided predictions and suggestions for a successful future.

Kirk Trisler, Principal at Dark Horse Consulting, opened the event with an extensive overview of the current landscape in cell therapies, going through cell therapies that have been approved and examining who the players are for cardiology, oncology, neurology, diabetes, and opthamology.

Tisler presented two helpful maps, one showing "Cell Therapy CMO Options in Europe" the other "Cell Therapy CMO Options in the US". The US map showed that the "only options for Phase III" in the US are WuXi, Lonza, PCT (one in CA, one in NJ), UC Davis, Temple, Stanford, City of Hope, and U of Iowa.

Tisler then went through a list of all cell therapies that have been approved. They are: Provenge by Dendrion; Lavir by Fibrocell; Holoclar by Chiesi; Chondrocelect by TiGenix; Carticel by Genzyme/Vericel; and Apligraf, Dermagraft and Ginutiut all by Organogenisis.

Chris Gemmiti, Business Development Lead, Wyss Institute - whose discussion was titled "State of the Industry - From Fund Raising to Partnering to Adoption and Commercial Success" - continued on the track of giving an overview for the current cell therapy space. He said that there has been over three billion dollars in federal funding for regenerative medicine over the last three years. Financing for cell therapy companies in the first half of this year alone is over seven billion dollars, with an additional eight billion in milestone payments.

Gemmiti then went on to talk about the companies who have been funded this year: including Semma, Voyager, Dimension, Unum, Regenxbio, and Audentes. "Look at Semma," he said "(they got) $44 billion in funding and they're not even at the IMD stage."

He continued with more helpful stats:

• There are 580 regenerative medicine companies worldwide
• There are 72 approved products

Gemmiti closed his presentation by cautioning the audience: "Market caps are great but they have to translate to revenue in the real world...Just having approvals and a large market cap doesn't mean commercial success."

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

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BioProcess International Awards: Best Technology Application — Upstream (user or supplier)

The 2014 BioProcess International Awards celebrate and recognize the outstanding people, organizations and technologies that have significantly changed, impacted, and advanced the efficiency of biotherapeutic development and manufacturing process ultimately allowing the industry to deliver better, more effective treatments to a global patient base.  We're accepting nominations through June 27, 2014.   In the weeks leading up to the nomination deadline, we'll be spotlighting many of the award categories here. Visit the webpage to find out more.

Today, we spotlight the award for:

Best Technology Application — Upstream (user or supplier)

Submit your nomination here.

From the point at which a lead candidate enters development, and through its early production and process development stages, it often receives undue “hype” for as-yet unmet promises of success. The winner in this category will offer more than hype: It will have shown through adoption and application of an existing technology or development of its own materials and methods that it is paving the way toward a new approach to process design or a new apparatus that shows well-documented improvement over existing equipment. The winner may, alternatively, be a software program or other automated system that helps reduce contamination as well as product variability; in upstream applications, the winner may be able to document hitherto unreachable titers through application of its own or a supplier’s technology. The possibilities are many and varied, and the award will be given to the nomination that offers the best documentation and justification.

The BioProcess International Awards will be handed out this October at the BioProcess International event in Boston.  If you have any questions, feel free to reach out to Jennifer Pereira.

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BioProcess International presents the Downstream Processing Podcast Series

We are pleased to announce the second series in our 2013 BPI Conference Pre-Event Podcast program. As a reader of this blog, you are granted exclusive access to podcasts recorded by conference keynotes, chair people, session moderators, and speakers who offer their expert perspective and commentary on the scientific trends impacting the bioprocessing industry.

The Downtream Processing Edition previews what you will experience while attending the 2013 BioProcess International Conference & Exhibition taking place at the Hynes Convention Center, Boston MA, September 16-19, 2013.

Download the podcasts.

This month we feature:

• - Audiocast: Downstream Strategies for High-Density Cell Cultures By Dr. Gregory Zarbis-Papastoitsis, Vice President of Process and Manufacturing Sciences at Eleven Biotherapeutics
• - Audiocast: Controlling Process Variability Due to Raw Material Variability By Dave Kolwyck, MS, MBS, Principal Scientist, Amgen
• - Audiocast: Challenges to the Entry of New Biologics into the Market By Joanne T. Beck, Ph.D., Vice President, Process Development, Shire Human Genetic Therapies
• - Audiocast: The BioProcess International Conference & Exhibition: By Barry Walsh and Michael Keenan, Conference Directors, IBC Life Sciences

We also have podcasts featuring our speakers from the Upstream Processing , Manufacturing and Analytical Methods and Instrumentation.

Bioprocess International will take place September 16-19, 2013 in Boston, MA. If you want to know more about these speakers, their presentations and the rest of the program, download the agenda. As a reader of this blog, when you register to join us and mention code BLOG13JP to save 20% off the standard rate!

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