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admin 15.03.2015

The Life Sciences Report: Gil, you serve on numerous boards, and you are the former chairman of the Alliance for Regenerative Medicine (ARM). Gil Van Bokkelen: The National Center for Regenerative Medicine, which is based in Ohio, is not a lobbying organization. When the effort was first initiated more than a decade ago, we recognized that concerted cooperation and joint effort was needed to address some of the bottlenecks that impede translational activity.
TLSR: If we compare cell technologies to small molecules, which represent a 7,000a€“10,000-year-old industry, or to antibodies, still brand new as a 20-year old industry, where do regenerative medicine and cell technologies fall on the timeline of development? GVB: I see a lot of parallels, as your question suggests, in terms of what is going on in cell therapy now and what was going on a few years ago in the field of therapeutic antibody development. In terms of the timeline, I would say that the cell therapy industry is where the field of antibodies was when it emerged from the dark, and the real value creation began. The field of antibodies started to take off when researchers began to make humanized forms of antibodies that were much more reflective of what the body needs, and could have a dramatic, therapeutic effect. GVB: I believe, over the next three to five years, we are going to see enormous growth and progress in treatments that will deliver on the promise of cell therapy, and these will do a lot of good for patients. TLSR: You seem to be making the case for regenerative therapy not building new tissues with stem cells as building blocks, but rather utilizing a paracrine-signaling effect, for lack of a better term, where the cells react dynamically with the patient. But I do believe, to answer your question, that the paracrine effects of stem cells, meaning their ability to express factors directly in response to significant tissue damage and resulting inflammation, has emerged over the past decade as a major component of the therapeutic effectiveness of cell-based therapies.
But, as you also noted, there are emerging specialties in the sectora€”for instance, companies developing 3-D printer systems for tissue engineering and other applications. The field of regenerative medicine is giving birth to not just companies focused on developing the cell therapy, but also to a whole interrelated group of companies and industries that are leveraging their respective strengths, expertise and capabilities to move the field forward.
GVB: I see room for both autologous therapies and allogeneic (same species donor-derived) therapies.
TLSR: My impression is that the allogeneic or allograft therapies are going to offer a better margin for the developer because they can be taken off the shelf, while autologous cells have to be harvested and processed individually and then administered back to the patient.
GVB: There are some challenges that apply to autologous therapies that truly scalable allogeneic therapies can overcome. But that being said, I also think there will be opportunity for autologous-based therapy that can address areas of unmet medical need. TLSR: Gil, do you foresee patients being routinely treated with stem cell therapies, such as patients who have had strokes, patients who have had spinal injuries, and patients undergoing coronary artery bypass surgeries who simultaneously receive cells delivered to ischemic myocardial tissues? TLSR: It is difficult for a small company to enter many different specialties of medicine on its own. GVB: We now have more than 30 years of experience in the biotechnology industry, and we can see many different instances of that. Streetwise Reports LLC does not guarantee the accuracy or thoroughness of the information reported. Streetwise Reports LLC receives a fee from companies that are listed on the home page in the In This Issue section. Regenerative Medicine is a field of research and clinical application that focuses on the process of replacing or producing normal functioning cells, organs or tissue. These treatments are being utilized successfully across a wide array of medical specialties, including: Neurology, Ophthalmology, Plastic Surgery, Rehabilitation Medicine, Urology, Orthopedics, Endocrinology and Dermatology to name a few. In PRP Therapy, a patient’s own blood is drawn and spun down to our body’s most potent healing factors.
With Stem Cell Therapy, a patient’s healthy, pre-developed cells are isolated, concentrated and introduced into the damaged organ or tissue. Cytokine Therapy focuses on isolating the gene for a specific growth factor or anti-inflammatory protein. We hope this post is helpful for anyone who is thinking of taking advantage of the medical progress being made in the area of regenerative medicine. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. This is an excellent presentation on companies and products that are making their mark on the Regenerative Medicine Market.
Annette Jones, president and CEO of Alliston Memorial Hospital stated that they are thrilled to have recruited such a successful orthopaedic surgeon as the community had an urgent need of orthopaedic services. Doctor Syndie Singer stated that she is thrilled for the opportunity to offer local patients care close to their homes. Singer is a doctor who specialized at the University of Toronto and completed a one-year fellowship at St. You’re also current chairman of the board of governors of the National Center for Regenerative Medicine (NCRM). It is a collection of institutions focused on translational research in regenerative medicine. You can imagine that the field of cell therapy and regenerative medicine had some unique complexities associated with it, including conducting preclinical studies where investigators used human cells and evaluated their safety and efficacy in animal models, as well as actual clinical application of various types of therapies in human patient populations.
The parallels continue, as there was much excitement about antibodies in the early days, when researchers thought they could use mouse cells to produce antibodies that could be used in human patients to cure cancer or some other disease. In fact, if you look at some of the most successful therapies on the market today, a meaningful number are therapeutic antibodies.
We are showing tremendous progress with various forms of cell therapy versus a decade ago, but that hasn’t yet fully translated into the type of clinical experience and results that most of us have been anticipating for a long time.
Right now, the field of cell therapy generates roughly $1 billion ($1B) in revenue annually. A decade ago, researchers thought that we would simply use cells to replace what has already been lost.


Administering cells can be a dynamic, druglike event, where the cells don’t permanently engraft but are around for days to weeks to help with tissue repair and healing, then clear the body as would a drug or traditional biologic. This has been proven on autopsy by determination that an engrafted donor neuron was of a different genotype than that of the recipient patient. There is a lot of work to do between early-stage development and actually showing that a therapy works, and then getting the therapy into patients in a scalable and reproducible way. Isn’t it hard to expect investors to shoulder the burden of developing the first therapies in a brand new industry where development can take decades?
One of the things I always explain to investors is that stem cell therapy development is a marathon. There are many services and tools needed, such as instrumentation, to administer cells to patients.
There are many different companies involved in regenerative medicine and, as you correctly noted, there are subsectors and distinct industry segments that have arisen to develop solutions for some of the challenges. Can current good manufacturing practice (cGMP) be developed in an efficient way so that payers can afford the therapies and developers can make a decent bottom line? In the long run, those technologies that are the most scalable, the most standardized and that work the best are going to have the greatest impact. I think that’s why more interest from some of the bigger companies is focused on the allogeneic therapies. In fact, I see evidence that some of those things are going to happen in the next few years. Do you see the small cell technology company as the hub, feeding many different therapies to different large pharmas for many different disease indications? But we also know that the bigger companies, the global companies, have capabilities and expertise in areas that smaller companies don’t.
The smaller companies are doing high-risk research and, of course, some projects are going to pan out and some won’t. But I think the smaller companies have historically embraced that risk and then turned that gamble into medical reality. Van Bokkelen co-founded Athersys in October 1995 and has served as CEO and director since then. Sign up for our free e-newsletter, and you’ll learn when new articles have been published. Mack conducted this interview for The Life Sciences Report and provides services to The Life Sciences Report as an employee or as an independent contractor. Streetwise Reports does not accept stock in exchange for its services or as sponsorship payment. I personally or my family am paid by the following companies mentioned in this interview: Athersys Inc. Streetwise Reports does not make editorial comments or change experts’ statements without their consent.
Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. There are three general types of regenerative medicine that are available to people who suffer from the most common cause of chronic knee pain. There has been significant progress and success under laboratory conditions and with direct patient applications. These growth and anti-inflammatory factors are introduced into the damaged or failing tissue.
These cells then differentiate into healthy functioning cells to improve function of the effected area. For your education, the Reflex Clinic will be posting an ongoing series of blogs focused on these exciting new treatment therapies. Syndie Singer has signed on as a fulltime orthopaedic surgeon at the Stevenson Memorial Hospital and she will be holding her first clinics this week. Put simply, these institutions, like the Cleveland Clinic, University Hospitals Case Western Reserve University, Ohio State University and member affiliates including Athersys Inc. Both large and small companies, and a couple of large pharmas, were among the founding group of membersa€”Pfizer Inc. However, now we have a growing number of programs in mid- and late-stage clinical development that cut across a broad range of therapeutic areas. We see more product approvals, and that’s basically because there are a limited number of them. In fact, there is an enormous amount of evidence suggesting that different cell therapy approaches can express factors that promote healing and tissue repair, and enhance patient recovery in very powerful ways. I am not saying that cell therapy can’t have a profound role in helping to replace damaged or injured tissue.
Then there is the potential to actually augment, replace or regenerate certain types of tissue. Other big companies have declared their commitments to the space and made meaningful investments. I’ve seen a lot of signs over the past yeara€”and going back even earliera€”that a certain segment of the investment community is beginning to see the potential and recognize what the upside is, and that it may not be that far off. It’s going to be based on clinical data and tangible partnerships, which are what I think will be the biggest drivers. There are also adjunctive areas, such as processing, management, handling and testing of cells. Based on what we know how to do today with cGMP product manufacturing, the answer to your question is clearly that we can deliver.


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Streetwise Reports LLC hereby grants an unrestricted license to use or disseminate this copyrighted material (i) only in whole (and always including this disclaimer), but (ii) never in part. In this interview with The Life Sciences Report, Van Bokkelen explores the past, present and future of the cell therapy and regenerative medicine industry, and outlines the investment possibilities in small companies on the sector’s cutting edge.
The investigators dealing with these types of studies have to be aware of the complexities. Investigators became aware of the fact that if they used a mouse-derived antibody in a human patient, it might elicit an immune response, or what researchers refer to as a HAMA (human anti-mouse antibody) response. And, perhaps even more to the point, we have seen a few cell therapies progress all the way through the clinical development process: They are on the market and doing good for patients who really need help. But frankly, I think this number is going to grow substantially, and as it does I believe we are going to see rapid and explosive growth. We are already seeing some pretty exciting examples of that, which could benefit patients who are suffering from spinal cord injury.
These are an incredibly powerful set of capabilities that, frankly, you could never reasonably expect to achieve using traditional, pharmaceutical-based approaches in most areas. What you’ve seen over the past several years, in particular, is more evidence that this is a legitimate area of opportunity that big companies are interested in.
On the regenerative side there would be the creation of tissue, such as tubes and organs, with ink jet-style or three-dimensional (3-D) printers. In fact, there are already companies doing ita€”Shire’s FDA-approved regenerative medicine therapy, Dermagraft, acquired through Advanced BioHealing, and Organogenesis with its state-of-the-art GMP manufacturing capabilities for Apligraf, its FDA-approved product for diabetic foot ulcers and venous leg ulcers, and its more recently approved Gintuit product for oral tissue regeneration.
If you look at the complexity of healing with a condition like spinal cord injury, or with some of the other conditions you’ve mentioned, they are definitely not the easiest indications to go after.
If smaller companies are developing innovative new therapies that address substantial areas of need, that have substantial clinical and value-generation potential, they are producing exactly what the bigger companies want as they look to refresh and rebuild their pipelines. Leading disease foundations and patient groups were also among the founders, as were some clinical institutionsa€”the Cleveland Clinic, again, was involved from the very beginning, as well as the Juvenile Diabetes Research Foundation. Cell therapy is more complex, because cells can do multiple things in parallel that act in concert to enhance healing and repair. An example would be a product like Apligraf, which has been developed by Organogenesis Inc. More therapies will be validated and move forward through the regulatory pathway, get approval, get reimbursement and ultimately reach patients.
They actually accomplish some amazing things, such as interacting with the body and regulating other cell types by expressing multiple different factors.
Many investors tend to shy away from the things that they perceive as unproven or risky until that point when the data becomes overwhelming.
My question is, does each cell technology company have to develop its own platforms and systems for these necessary steps, or are there other industries popping up around cell technologies? Aastrom’s autologous therapy can make a difference in the clinical outcomes for these patients, using their own cells. They may take time, but in cardiovascular disease, stroke and other neurological conditions, and a broad range of other areas, I absolutely see cell therapy making a difference.
He is also chairman of the board of governors for the National Center for Regenerative Medicine, and serves on a number of other boards, including the Biotechnology Industry Organization’s ECS board of directors (from 2001 to 2004, and from 2008 to present), the McGowan Institute for Regenerative Medicine and the Regenerative Medicine Foundation. For the time being, major joint surgeries like hip and knee replacement and serious trauma surgeries will not be offered. Originally founded in 2003 as the Center for Stem Cell and Regenerative Medicine with a substantial grant from the state of Ohio, the organization was designated the NCRM in 2005 by Congress. In contrast to the broader biotechnology industry, which is well represented by the Biotechnology Industry Organization (BIO), where I have served on the board for a number of years, and the pharmaceutical industry (which is represented by the Pharmaceutical Research and Manufac turers of America [PhRMA]), when the cell therapy and regenerative medicine industry started up, nobody directly represented us or oversaw how we interacted with the U.S. And yet finally it broke through and was able to show that a drug that basically had been written off by everyone else as a disaster, thalidomide, could provide meaningful benefit to patients being treated for certain types of cancer. He received a doctorate in genetics from Stanford University and bachelor’s degrees in economics and molecular biology from the University of California at Berkeley. I had the opportunity to review the interview for accuracy as of the date of the interview and am responsible for the content of the interview. Food and Drug Administration (FDA) and other regulators and parts of the federal government. If the company successfully extends that work with additional trials, then investors and patients could see pretty exciting things come to fruition. We’ve experienced some of those ourselves at Athersys, but I have seen some pretty amazing things happen too. Other products or therapies have been developed that are providing relief and help to patients in orthopedic indications and a growing number of other settings.
The best approaches will be embraced by patients and clinicians alike because traditional therapies and interventions have utterly failed in many areas where cell therapies are poised to have an impact.




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