Cell Therapy's Got Talent Technology Showcase - A Call for Cell Therapy Manufacturing Technology Presentations

in collaboration with:

In an effort to showcase the latest technologies driving the production of cell therapies, the Cell Therapy Group and Informa Life Sciences are proud to announce the introduction of the "Technology Showcase" session and award to be held in conjunction with Informa's Cell Therapy Manufacturing conference to be held 30 November to 1 December 2011 in Brussels Belgium.

Having held the same conference last year in London, Informa is committed to building on the success of last year's event by continuing to create a meaningful European forum for the issues related to the clinical and particularly commercial-scale production of cell-based therapies.

The Technology Showcase session, taking place on the main agenda, will feature 6 x 10 minute presentations from innovative companies developing cutting-edge technologies in the field of cell therapy manufacturing, and is particularly relevant to SME and academic groups with limited marketing resources.

All presentations will be reviewed by the Scientific Advisory Board with the winner announced at the end of the session. Exposure on BioProcess International's website is also included.

Technologies we'd like to promote include:

• Manufacturing systems including bioreactor technologies
• Cell harvest/collection technologies
• Cell storage/logistics technologies
• Clinical cell delivery and/or other point-of-care technologies
• Automation technologies
• Cell separation system
• Cell process devices
• Innovative reagents, scaffolds, matrices, and other “ancillary” tools
• Technologies to close currently open systems
• Suspension-based production systems
• Disposable technologies

How to apply:

To apply to present companies must submit an abstract (<300 words) to daniel.barry@informa.com and lbuckler@celltherapygroup.com outlining the product or service to be presented and why it is a critical technology related to cell therapy manufacturing.

The deadline for applications is SEPTEMBER 15 2011 - Priority given to early submissions

The cost of taking part in the Technology Showcase is £2,700 which includes the following benefits:

• 1 x 2-day conference pass (normal price £1,599)
• 10-minute podium presentation within main conference room
• 1 poster display in the Exhibition Hall
• Marketing - company logo displayed on website and event guide
• Exposure in BPI Magazine

Terms and conditions:

To be eligible the product or service to be presented must be:

• On the market for no less than 2 years or expected to be on the market no later than Q4 2012
• Appropriate for, applicable to, and compliant with clinical-grade manufacturing requirements (technologies only available for research use will not be considered)

Plus...

• The company must have no more than 15 employees
• The company has been running for no more than 5 years, and
• The company generates annual revenue of no more than $5m

For further information please contact: daniel.barry@informa.com or lbuckler@celltherapygroup.com

In vivo cell trafficking just took a leap forward

Today Celsense, Inc. and the University of Pittsburgh Cancer Center announced that the FDA has authorized the use of the Cell Sense imaging reagent for use in a phase I clinical trial of a dendritic cell caccine to treat colorectal cancer patients.

This is the first FDA authorization of the use of Cell Sense in patients. Cell Sense is a novel perfluorocarbon tracer agent used to safely and efficiently label cells ex vivo without the use of transfection agents. Labeled cells are then transplanted into the patient enabling researchers and clinicians to non-invasively track the administration and migration of therapeutic cells using MRI. Applications include tracking cells in immunotherapy or regenerative medicine as well as the diagnosis of inflammatory sites by tracking selected populations of immune cells.

Cell Sense has been studied extensively in preclinical testing with many different human cell types including human cells in animals. For instance, in 2009 a paper was published in Informa's Cytotherapy, in which Celsense’s novel perfluorocarbon tracer agent (product “Cell Sense”) was used to label human DCs ex vivo for the purpose of tracking the cells in vivo post-transplant by 19F MRI. The paper provided an assessment of the technology and demonstrated that human DCs were effectively labeled without significant impact on cell viability, phenotype or function. Furthermore, the labeled dendritic cells were clearly detected in vivo by 19F MRI in a model system, with the labeled cells being shown to migrate selectively towards draining lymph node regions within 18 hours after transplant.

Many investigators looking at various ways to label cells to enable in vivo imaging have expressed concern that the FDA would delay the regulatory progress of their therapeutic candidates if an imaging modality was introduced.

This concern is based on numerous reports of MRI contrast reagents, such as the commonly investigated USPIO (ultrasmall superparamagnet iron oxide), deleteriously affecting the cells (see recent paper in Cell Transplantation).

"We believe that the authorization of this IND will alleviate such concerns and lower the barriers for adoption. The agency’s tangible support for bringing new technologies to bear in the translation of cell-based therapeutics is very encouraging,” s Charlie O'Hanlon, President and CEO of Celsense.

While there have been approved uses of imaging reagents (e.g., Feridex, etc) with cell therapies in other countries (e.g. Isreal), I believe this may be the first FDA-sanctioned use of a particle-based imaging label with a cell-based therapy. Other approaches to cellular imaging include nuclear imaging reagents and genetically modifying cells with reporter genes such as those provided by CellSight Technologies.

Imaging labels are capable of providing investigators with data demonstrating where the cells go, at what volumes, and for how long they stay at the target location.

The industry has been keen to see these kinds of technologies clinically employed but different cell-based labels have created their own technical, clinical, and/or regulatory hurdles. I'm hopeful that Celsense and others like them are now ushering us into a new era where we will eventually be able to use various technologies to monitor and collect valuable data concerning cells after they have been administered as a therapy to a patients.

Additional resources on the topic of imaging for cell therapies:

CIRM recently hosted a webinar - "CIRM/RMC Webinar: Imaging Technology for Cellular Therapies. One of the speakers, Dr. Shahriar Yaghoubi from CellSight Technologies, provides an overview of cell therapy imaging with emphasis on PET. Click hear for the archived playback.

A very interesting article posted today on Harvard's StemBook website. "In-vivo Stem Cell Imaging - Regulatory Challenges and Advances". Nice overview intel from J. Bulte and a snapshot into E. Wirth's (of Geron) perspective re: stem cell imaging.

A new book from CRC Press edited by Dara Kraitchman and Joe Wu will be out soon. It gathers together different methods for comparison. The issue will remain the sensitivity of the methods to track few cells. "Stem Cell Labeling for Delivery and Tracking Using Non-Invasive Imaging".

MRI contrast agents can change stem cell proliferation

There s also a very informative discussion thread on the topic in the Cell Therapy Industry group on LinkedIn.

Cell Therapy Conferences

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For those of you have been asking, we've now created what we hope is the most comprehensive and current listing of conferences in cell therapy and regenerative medicine. Check it out here and let us know if you believe any should be added.

Cell Therapies: Commercializing a New Class of Biopharmaceuticals

Over the past six months I have been honored and pleased to have seen and been part of an increasing focus and attention being paid to the unique manufacturing and bioproduction issues related to cell therapy.

Certainly it is the Cell Therapy Group's view, that this is both timely and much-needed as more cell therapies reach later-stage. Issues related to larger scale production and lowering the costs associated with it will be critical to successful commercialization of these products. It is encouraging to see both content-providers and and companies involved in potentially bringing solutions to these issues now bringing their focused energies to this sector.

This focus has come from a number of different sources including conferences focused solely on the topic, companies engaging stakeholders in identifying potential bottlenecks they might be positioned to solve, more conference sessions dedicated to these issues, and now a commitment by one of the leading publications in bioprocessing to engage both the cell therapy industry and the traditional bioprocessing community in stepping up the level of two-way education, dialog, and problem-solving that will be critical to commercializing these products.

In March/April 2011, watch for a special issue of BioProcess International entitled "Cell Therapies: Commercializing a New Class of Biopharmaceuticals".

BioProcess International is a publishing leader of cutting edge technologies, improved processes and breakthrough sciences. With this cell therapy focused issue, in partnership with ISCT and others, BPI is launching what we hope will be a regular supplement and increased focus on the unique bioproduction issues related to cell-based therapies.

BioProcess International aims to accomplish three main objectives with this supplement:

• Educate the bioprocess and cell therapy market (suppliers and end-users) on the similarities and differences between the two processes;
• Educate and encourage the investor community to keep increasing their interest and investment;
• Expedite the commercialization process.

Distribution will include:

• BPI's 30,010 qualified readers;
• Delegates attending ISCT's 2011 Annual Meeting (included in all delegate bags)
• Delegates attending ESACT 2011 (Chair drop at the Cell Therapy Plenary Session)
• INTERPHEX 2011 Cell Therapy Roundtable (VIP Invitations, 200 attendees, produced by BPI)
• BIO 2011 International Convention (BioProcess Theatre - Cell Therapy track)

If you are interested in advertising, click here for more info.

While the content for this issue is now being finalized, it you are interested in contributing something to BPI, we are looking for more cell therapy related content. As the cell therapy representative on BPI's advisory board I would be happy to champion it through submission.

Cheers.

--Lee

The LinkedIn Cell Therapy Industry Group - 1,000 members strong

As some of you may know, much of my recent social media energy has been spent on LinkedIn rather than blogging. This was not a conscious decision but I will admit to finding the immediacy and interconnectivity of the LinkedIn/Twitter combo to be more seductive of my limited time than the more laborious and seemingly more unidirectional facets of blogging. I'm still working on a return to more diligent and regular blogging - we'll see how that goes.

In any event, today's blog entry is ironically about the very thing which has replaced my blogging in many ways for the interim: the LinkedIn Cell Therapy Industry Group which I founded in July 2008 (about the same time as I launched this blog).

Primarily due to the outstanding participation of great members, the group has turned out to be what I had hoped would be and I believe has become a fairly valuable resource for those in or interested in the cell therapy industry.

The group grew exponentially throughout 2010 and we are proud today to announce our 1,000th member. Without his knowledge, Luc Gervais today became the 1,000th member of the LinkedIn Cell Therapy Industry Group.

Luc Gervais lists himself on LinkedIn as a "Technologist Entrepreneur" but is also a Researcher at IBM Research, Zurich Research Laboratory in addition to being a researcher at the University Hospital Basel.

He was recently involved in the development of IBM's novel, microfluidic "lab on a chip" technology that uses capillary action to create a potential one-step diagnostic tool, and which could ultimately test for a wide range of diseases and viruses. The chip requires only a small drop of blood, which it draws through tiny channels within the device. The blood reacts with different disease markers to provide accurate diagnoses in about 15 minutes.

Luc represents what I believe is one of the most exciting signs of development in and maturation of the cell therapy industry. Luc's career has included being a Game Developer at Unlikely Games, a Computational Chemistry Developer at Boehringer Ingelheim Pharmaceuticals, and a Quality Assurance Specialist at Steltor. On LinkedIn, he lists "regenerative medicine" as one of his interests.

People with the kind of experience Luc possesses are bringing a world of scientific, technical, and commercial expertise to regenerative medicine and cell therapy from outside the sector. This promises to revolutionize the way we think about, develop, and apply our technologies.

Luc and others like him who are exploding into the regenerative medicine and cell therapy field bring with them the potential for interdisciplinary exploration, the opportunity to draw from lessons already learned in other sectors, and the chance to view our field not just in terms of the incredible potential for new therapeutics which cell therapy represents but how that fits into the broader world in which cell therapy is growing up. A world that includes phenomenal advancements in personalized medicine, diagnostics, theranostics, biomarkers, bioinformatics, the ability to access and interpret personal genomics data, etc.

I have yet to speak to Luc (this was all posted from publicly available information) but I'm hoping to bring you an interview of him shortly not because being the 1,000th member of the LinkedIn Cell Therapy Industry Group is deserving of any particular attention (and certainly will not rank in his list of accomplishments I'm sure) but because I'm curious about what Luc represents.

Stay tuned....

--Lee

Careers in cell therapy & regenerative medicine

As you will see just below, this post falls under the category of a thinly veiled and somewhat shameless plug which I hope you'll tolerate if I'm transparent about it upfront and I add what may be a little useful commentary along the way.

I won't have to convince "regular" readers of this "irregular" blog that regenerative medicine is one of the fastest growing life science sectors.

Given the pace of the industry's growth, the amount of public money being "invested" in the sector, and the general enthusiasm that the science generates, it is no surprise that is increasingly an area of interest for those seeking a new career path.

One commonly held misconception is that career opportunities in the sector are limited largely to those in early-stage research.

While it is true that the industry is still in the nascent stages of commercial development compared to other more mature segments in the broader biopharmaceutical industry, careers in regenerative medicine span the full research and commercial spectrum from pre-clinical to clinical research in both academic and corporate settings, manufacturing, regulatory, quality, operations, logistics, finance, business development, marketing, sales, communications, and executive management.

As has been discussed here in the past, most analysts agree that in 2008 the industry passed the $1 billion mark in annual revenue generated from sale of approved therapeutic products falling under the regenerative medicine category (see here for more in-depth analysis).

Furthermore, most large multinational life science companies are now investing heavily into the sector on the promise that it will revolutionize healthcare in the coming decades.

I believe the 2008 decision by Pfizer to create a substantial new Regenerative Medicine division will be seen as a seminal turning point in corporate perspectives on the industry. Since that point most life sciences have begun investing in regenerative medicine strategies and the trend has even leaked outside of life science to companies such as Google Ventures which has informally identified regenerative medicine as one of their primary areas of interest when looking at companies in which to invest.

Most major universities have now created both academic and research programs dedicated to the emerging field of regenerative medicine such that there is a new class of graduates now emerging in both scientific and commercial disciplines with regenerative medicine as a primary focus.

However, one of the difficulties with finding a career in regenerative medicine is that it is comprised of what has heretofore been fairly discrete disciplines of stem cell biology, pharmaceutical sciences, biotechnology, tissue engineering, stem cell transplantation, device technologies, cell therapies, etc.

Furthermore, most recruiters and online job sites have very little experience or focus on the industry making recruiting difficult for positions in regenerative medicine companies or departments. The task is further complicated by the fact that the candidate pool is small and diversely spread over a multitude of disciplines, centers, and a multitude of small companies.

Finally there are only now emerging industry publications, organizations, online communities, and websites that truly represent the broad spectrum of regenerative medicine and that can be used as central resources for recruiting.

All this is why my partners and I saw the need for an online recruiting tool that really focused on regenerative medicine in a way that would support the industry's maturation. What we wanted to bring was a very simple solution that would create as much value as possible for those looking to recruit the right talent into their regenerative medicine efforts. This was the genesis behind RegenerativeMedicineJobs.com.

(here comes the shameless part....)

About RMJ

At RegenerativeMedicineJobs.com, we believe the growth trajectory of this industry requires a specialized, online recruiting system – one that is more than just a website for posting jobs but also plugged into the large and diverse network of associations, publications, and social media that serves this industry.

RegenerativeMedicineJobs.com is a specialized online job board focused on recruiting for positions in the rapidly growing field of regenerative medicine. The site is simple to use and focused in scope. But this is more than just another website.

RMJ has developed a sophisticated system designed to leverage our extensive network in RM to ensure every post gets maximum attention and attracts the best candidates.

Traffic is pulled to the site and job postings are pushed to a targeted audience by focused social media and marketing campaigns. This is the latest way to recruit for any position in a regenerative medicine department, division, or company. This is regenerative medicine recruiting with a focus.

RegenerativeMedicineJobs.com (RMJ) is a collaboration between CTG Consulting, Co. and Pencilneck Software, Co. The personnel behind this collaboration created Cell Therapy News, Cell Therapy Blog, the LinkedIn Cell Therapy Industry Group, and have produced over a dozen organizational or event-based websites in the cell therapy, stem cell, and regenerative medicine space.

The site has been designed to be simple and intuitive with only one goal in mind: to be the best online tool for recruiting personnel into positions in the regenerative medicine industry.

We don't offer resume posting, career advice, assistance building your CV, hand holding, shoulders to cry on, or job postings outside of regenmed. We believe in the value of specialization.

The site is a listing of regenerative medicine jobs (period). All types of jobs for all types of organizations but only regenmed job (period).

We have only one rule: the jobs posted must be for a position within the regenerative medicine space. We define regenerative medicine as anything involving cell therapy, stem cells as therapies or tools for discovery or toxicity testing, or non-cell based programs/products (e.g., small molecules, biologics, devices, etc) used to replace or regenerate cells, tissues, or organs to restore, repair, or establish normal function.

The site has a topical niche with no regional focus or bias. This is meant to be a global tool equally useful for a company or university in Poland, Taiwan, Brazil, the United States, etc.

The site is also meant to be useful for recruiting any positions scientific or commercial, business or technical, executive or laborer.

*

We hope you find it useful.

We hope it contributes to the industry's growth and maturation.

We hope you will provide us feedback on what we're doing well and what we can do better.

FDA files injunction again Regenerative Sciences citing Regenexx violates regulations

For those of you who follow this blog, you'll imagine my surprise to wake up the morning to the following announcement from the FDA:

_____________________________________________________________

FDA NEWS RELEASE

For Immediate Release: August 6, 2010

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product

Violations of current good manufacturing practice and labeling requirements cited

The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to bear the “Rx only” symbol.

The company’s cultured cell product is derived from a patient’s bone marrow or fluid surrounding the patient’s joints (synovial fluid). The cells are grown, processed, and mixed with drug products outside the body before being injected back into the patient.

Regenerative Sciences’ cultured cell product is not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication.

“FDA recognizes the importance of the development of novel and promising new therapies,” said Karen Midthun, M.D., acting director of FDA’s Center for Biologics Evaluation and Research. “However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public’s health at risk.”

The complaint for the injunction was filed Aug. 6, 2010, by the Justice Department on behalf of the FDA in the U.S. District Court for the District of Columbia, against Regenerative Sciences and three of its employees, Christopher J. Centeno, M.D., John R. Schultz, M.D., and Michelle R. Cheever. The injunction would permanently prevent the company and cited individuals from adulterating and misbranding the cultured cell product while the product, or one or more of its components, is held for sale after shipment in interstate commerce.

Regenerative Sciences has agreed to cease production of the cultured cell product while the case is pending.

The FDA warned Regenerative Sciences about its cGMP violations as recently as June 2010. The company failed to make sufficient corrections, and the conduct of the individuals cited in the complaint demonstrates refusal to comply with the law.