Current Trends in Cell Therapy
The fattest and the most prestigious conference in clinical oncology (ASCO) could be a turning point for Chinese CAR-T biotech. Yesterday, presentation of preliminary data from CAR-T trial in numerous myeloma by China’s company Nanjing Legend Biotech (Legend), was a bomb! Repercussions of this success could be historic for perception of Chinese CAR-T biotech by “Western world”.
Very first of all, ASCO committee recognized the importance of Legend’s data and accepted their late-breaking abstract. Right after presentation, ASCO issued an instant press release. A hum was rapidly escalated by big media outlets (Reuters, NBC, CBS and others) as well as by coverage of specialized biothech/ medical news journalists (see: EP Vantage, Endpoints, FierceBiotech and STAT).
The data are spectacular – 100% response rate with 74% CR at four months (n=Nineteen). Much anticipated data release from very similar trial, run by US-based bluebird bio, was overshadowed by Chinese Nanjing Legend, introduced in the same day.
Why is it a big deal for Chinese CAR-T biotech? Well, I don’t reminisce so much attention from “western word” to any CAR-T data (and even for any cell therapy data), coming from China, before. China has a lot of CAR-T trials going on and it has published their results (see here, here and here) and introduced on prestigious conference (for example, ASH two thousand sixteen – see here and here). Despite fairly good (comparable to “western world”) results, it had never got covered by western media and biotech analysts. The common perception of data from China among “westerners” was something like “it is unreliable” and “untrusted”. Would Legend’s ASCO success be a game changer for Chinese CAR-T biotech? I hope so. Well, at least now we got to know what city of Nanjing is.
Analysis of published results of clinical trials in regenerative medicine
About two years ago I attempted to analyze published results of regenerative medicine clinical studies. It was very hard and time consuming thing to do, so I’ve ditched my efforts. Recently, I was very blessed to find a examine by Tania Bubela’s group from University of Alberta, published in Stem Cell Reports. This is the very first detailed and the most accomplish explore of published results of clinical trials in the field of regenerative medicine.
The investigate captures all trials, registered in international databases until end of 2012. The authors permitted Two.Five years time lag from registration to beginning of their analysis in mid-2015. Besides cell-based regenerative medicine trials, search criteria also included agents to (1) stimulate stem/ progenitor cells in vivo and (Two) mobilize stem/ progenitor cells for for regenerative purposes. The authors captured many parameters, but the most significant were number of publications (reported results), time to publication from trial completion, completeness (quality) of trial reporting and results of published trials.
To me, the most significant thing from methodology was to learn how to perform comprehensive search for publications of trial results. It was done by the search of three databases: PubMEd, Embase and Google Scholar for –
- trial ID (for example, NCT #);
- investigator names, indicated in registry;
- key words from trial title.
Using this search strategy, the authors identified three hundred fifty seven publications, 74.2% of which linked to trial registration ID.
The examine has a lot of interesting data, which you can use to make graphs for your presentations. Here is one graph I made:
Now, some interesting quotes and my comments.
About publication rate:
Of 1,052 novel trials in our dataset, three hundred ninety three were ended, eighty one were terminated or suspended, twenty two were withdrawn, and the remaining five hundred fifty six were in progress, including trials with unknown status. Of the trials finished, one hundred seventy nine (45.4%) had published results in two hundred five associated publications with English-language abstracts…
For clinical trials of novel stem cell interventions, a publication rate of 45.5% for finished trials is consistent with other studies of publication rates. However, it remains problematic because the stem cell field combines high patient expectations, patient advocacy, strong political support, and therapeutic promise with regulatory concerns over safety and limited evidence of efficacy…
Interestingly, “publicability” does not increase with progression of trials from Phase one to Three/Four. Thus, % of publications in Phase one trials was 27.7%, in Phase two – 27.2% and in Phase Trio/Four – 25%.
On trials results:
Safety was reported by 91.2% of publicly funded and 93.0% of industry-funded trials; a higher proportion of industry-funded than publicly funded trials reported positive efficacy (77.2% versus 67.2%); fewer industry-funded than publicly funded trials reported no efficacy (14.0% versus 22.7%); more publications advocating for further or continuing studies reported on industry-funded compared with publicly funded trials (82.4% versus 75.6%).
No surprises here. I was very nosey to learn anything about trials failure rate in from phase-to-phase. According to table two from the examine, positive outcomes of Phase one and 1/Two were reported in 125/167 (74.8%) publications, of Phase two and Two/Three in 59/93 (63.4%), of three and Trio/Four in Trio/12 (25%). However, difference was insignificant:
No trial characteristic had a significant overall effect on the publication of positive results, albeit phase III and phase III/IV trials were less likely to report positive results than phase I and phase I/II trials (odds ratio [OR] 0.11; p < 0.004).
It seem to me that “positive outcome” was “as reported” in publications, but not assessed by Bubela’s group. 63.4% of success rate in Phase two looks too high to me. Two years ago, I was attempting to assess trials outcome myself, since many reports, which contained mixed (some end points were met some were not) or incomplete results, were introduced as “positive” by authors in publications. That’s why, I think, these numbers are overestimated. Also, these numbers do not permit us to calculate “failure rate” precisely, since all “incomplete/ mixed/ inconclusive/ failed” could fall under “other than positive”. According to Bubela’s examine, trial status has significant effect of the completeness of reporting (I understood that completeness of reporting was worse with progression of trial phase).
On publication bias:
Our result of 67.3% publications reporting positive outcomes is concerning when combined with the early stage of most, and incomplete status of many, novel stem cell clinical trials.
On “unproven stem cell therapies”:
We identified forty eight clinical trials with registration numbers on both ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) from known clinics in North America, Eastern Europe, and Asia that suggest unproven stem cell therapies (Table S1). Trials of adipose-derived stem cells or umbilical cord mesenchymal stem cells predominated for a range of conditions in both adult and pediatric participants. Most were recruiting or “enrolling by invitation.” None reported results.
This kind of analysis was performed for the very first time. The visible question here is how did authors identify clinics with “unproven stem cell therapies” in databases? The explanation is in methods:
…we searched our dataset for the names of clinics that provide unproven stem cell therapies identified from the stem cell tourism literature (Li et al., 2014, Master et al., 2014, Master and Resnik, 2011, Levine, 2010, Lau et al., 2008, Turner and Knoepfler, 2016, Goldring et al., 2011, von Tigerstrom, 2008, Sipp and Turner, 2012, Ogbogu et al., 2013)…
It is very very interesting to observe how datasets like Knoepfler/ Turner on “stem cell clinics” became a reference for the other analytical studies.
Overall, this probe provides very unique and useful information for all of us in the field. I’d very recommend you to read it and utilize their data in your work. It will be significant to proceed to track publications and trial results after two thousand twelve and see how data will evolve over time. Because we cannot calculate “trials failure rate” precisely, based on data from this examine, it will be significant to perform such analysis in the future.
Historical analysis of cell-based therapeutic products marketed and approved worldwide
2017 marks twenty years since the very first regulatory approval of cell-based therapeutic product on a market. In one thousand nine hundred ninety seven Carticel (manufactured by Genzyme Corp.) was approved by FDA for US market. One year before Carticel approval, two cell-based products were launched and marketed for the very first time in Europe (Italy) – Laserskin and Hyalograft by Fidia Advanced Biopolymers. I was nosey to learn about other approved and marketed cell-based products worldwide in the last twenty years. I also wished to learn what happen to the very first products, marketed 15-20 years ago. It took me almost a year to investigate this topic, collecting bits of information from public sources and conferences. Today, I’m sharing some of my data analysis.
I searched published literature, company press releases, mass media coverage, books (via Google books), patents, presentations from conferences and meetings, information from regulatory agencies. Also, I’ve learned some unique information from numerous conferences and from private communications.
- the product must contain alive cells and used for therapeutic purpose;
- the product must be marketed and/ or approved by regulatory agency;
- cord blood products for homologous use, obtained BLA as FDA requirement in US;
- traceable public information is available.
- absence of traceable public information when and where product was marketed;
- tissues for transplantation without brand name (not a product);
- More than three thousand therapeutic products marketed in Japan, as Specific Processed Cellular Products under the Act on the Safety of regenerative Medicine (ASRM) – Class III Regenerative Medicine products (not regulated under the PMDA). In this case, individual institutions (hospitals) submit a “Plan to Provide Regenerative Medicine” and seek for approval from Japanese Ministry of Health, Labour and Welfare (MHLW). Information about three ASRM products was publicly available and searchable. These three products were included in the dataset as an exception.
For historical analysis I was attempting to capture the earliest available data. Some early approvals and self-launches happened before defining regulatory framework for cell/ tissue products. So, some cell-based products were approved as devices. The following data were captured: name of the product, name of the manufacturer, year of approval and/ or when it was launched on the market, where it was marketed, name of regulatory agency (if it was approved), indication, cell type, traceable switches (off market, manufacturer went for bankruptcy…). The entire dataset is available on Cell Trials Data.
(1) As of March 2017, I was able to identify ninety marketed cell-based products. There were mentions of few products, without traceable information of when it was launched (for example, Cartogen in Australia). 61% (55/90) of marketed products were approved by regulatory agencies; 12% (11/90) were self-launched with manufacturing license, issued by governmental agency; 27% (24/90) were self-launched without information about manufacturing license.
How to cite this figure: Bersenev, Alexey (2017): Self-launched versus approved cell-based products, marketed worldwide. figshare. https://doi.org/Ten.6084/m9.figshare.4829452
(Two) Most of cell-based products were marketed for three major groups of indications: skin defects (31%), cartilage repair (24%) and oncology (19%).
By the time of writing this post, at least twelve products (13%) were off market. This number is underestimated, since there was no public information available about current status of many products, marketed earlier. At least five manufacturers went to bankruptcy, some were acquired or outlicensed products to other companies.
(Three) Since 1997, there were fifty eight regulatory approvals of fifty five cell-based products by thirteen different jurisdictions. Three products were approved by more than one jurisdiction (Provenge, Prochymal and MACI).
How to cite this figure: Bersenev, Alexey (2017): Regulatory approvals of cell-based therapeutic products by jurisdiction. figshare. https://doi.org/Ten.6084/m9.figshare.4829182.v1
(Four) Historical trend for approvals is leisurely going up with some volatility. Number of approvals per year was ranging from zero to 8.
How to cite this figure: Bersenev, Alexey (2017): Historical trend in regulatory approvals of cell-based therapeutic products worldwide. figshare.
How to cite this post:
Bersenev Alexey. Historical analysis of cell-based therapeutic products marketed and approved worldwide. CellTrials blog. April 7, 2017. Available: http://celltrials.info/2017/04/07/marketed-approved
PS: I’d like to thank Colin Lee Novick for clarifying information about regulation in Japan.
CAR cell therapy trials in China
Many of you know that China is very active in CAR cell therapy field. However, it is not effortless to track this activity. I made an attempt to analyze CAR cell trials data from China, using All CAR-T Trials dataset from Cell Trials Data. Here are some of my findings. Until 2010, all CAR cell […]
Number of CAR cell therapy trials worldwide
CAR (Chimeric Antigen Receptor)-based cell clinical trials is one of the best areas in cell therapy right now. Today, I’d like to share with you a trend for total number of CAR cell trials, registered worldwide. Importantly, I made figures available for free download on FigShare. You can get it in high resolution and use […]
Cell therapy trials data
Dear readers, as you know I have been collecting cell therapy clinical trials data for several years now. I posted some snapshots, based on my own raw data analysis as “annual reports“. However, I have not collective or suggested raw data before. I’m blessed to tell you that now everyone can get raw data and […]
Cell Therapy two thousand sixteen – Year in Review (part Two)
This is the 2nd part of my overview of the most significant events in cell therapy in 2016. CRISPR-modified cells go clinical This year, for the very first time, CRISPR gene-edited cells were used in human. Chinese oncologists from Sichuan University used CRISPR editing method to knockout PD-1 gene on autologous T-cells of the patient with […]
Cell Therapy two thousand sixteen – Year in Review (part 1)
In the last day of two thousand sixteen I’d like to look at back and overview the most interesting events (in my opinion) and trends of the year. I’m going to split this overview for two parts without any particular order. Results of pivotal CAR-T cell trials Two major commercial developers of CD19 CAR-T cell therapies – […]
What does the Cures Act mean for regulation of cell therapy in US
Fresh law, called “21st Century Cures Act”, has been signed this week in US. This is phat legislation, which covers fresh developments and initiatives, aimed to improve healthcare system. Few sections of the Cures Act specifically dedicated to regenerative medicine. These sections were proposed by industry lobby organization Alliance of Regenerative Medicine (ARM) as the […]
Presentation: CELL THERAPY – Definitions, Classifications and Trends
Here is my talk that I gave on August fifteen this year during annual BioProcessing Summit in Boston. Cell Therapy – Definitions and Classifications from nanog Link Transcript: Two. Cell therapy is mostly experimental field right now. So, one of the best ways to track activities in this field is to look at number of […]
Cell Trials
Current Trends in Cell Therapy
The fattest and the most prestigious conference in clinical oncology (ASCO) could be a turning point for Chinese CAR-T biotech. Yesterday, presentation of preliminary data from CAR-T trial in numerous myeloma by China’s company Nanjing Legend Biotech (Legend), was a bomb! Repercussions of this success could be historic for perception of Chinese CAR-T biotech by “Western world”.
Very first of all, ASCO committee recognized the importance of Legend’s data and accepted their late-breaking abstract. Right after presentation, ASCO issued an instantaneous press release. A hum was rapidly escalated by big media outlets (Reuters, NBC, CBS and others) as well as by coverage of specialized biothech/ medical news journalists (see: EP Vantage, Endpoints, FierceBiotech and STAT).
The data are spectacular – 100% response rate with 74% CR at four months (n=Nineteen). Much anticipated data release from very similar trial, run by US-based bluebird bio, was overshadowed by Chinese Nanjing Legend, introduced in the same day.
Why is it a big deal for Chinese CAR-T biotech? Well, I don’t recall so much attention from “western word” to any CAR-T data (and even for any cell therapy data), coming from China, before. China has a lot of CAR-T trials going on and it has published their results (see here, here and here) and introduced on prestigious conference (for example, ASH two thousand sixteen – see here and here). Despite fairly good (comparable to “western world”) results, it had never got covered by western media and biotech analysts. The common perception of data from China among “westerners” was something like “it is unreliable” and “untrusted”. Would Legend’s ASCO success be a game changer for Chinese CAR-T biotech? I hope so. Well, at least now we got to know what city of Nanjing is.
Analysis of published results of clinical trials in regenerative medicine
About two years ago I attempted to analyze published results of regenerative medicine clinical studies. It was very hard and time consuming thing to do, so I’ve ditched my efforts. Recently, I was very glad to find a examine by Tania Bubela’s group from University of Alberta, published in Stem Cell Reports. This is the very first detailed and the most finish probe of published results of clinical trials in the field of regenerative medicine.
The examine captures all trials, registered in international databases until end of 2012. The authors permitted Two.Five years time lag from registration to beginning of their analysis in mid-2015. Besides cell-based regenerative medicine trials, search criteria also included agents to (1) stimulate stem/ progenitor cells in vivo and (Two) mobilize stem/ progenitor cells for for regenerative purposes. The authors captured many parameters, but the most significant were number of publications (reported results), time to publication from trial completion, completeness (quality) of trial reporting and results of published trials.
To me, the most significant thing from methodology was to learn how to perform comprehensive search for publications of trial results. It was done by the search of three databases: PubMEd, Embase and Google Scholar for –
- trial ID (for example, NCT #);
- investigator names, indicated in registry;
- key words from trial title.
Using this search strategy, the authors identified three hundred fifty seven publications, 74.2% of which linked to trial registration ID.
The investigate has a lot of interesting data, which you can use to make graphs for your presentations. Here is one graph I made:
Now, some interesting quotes and my comments.
About publication rate:
Of 1,052 novel trials in our dataset, three hundred ninety three were ended, eighty one were terminated or suspended, twenty two were withdrawn, and the remaining five hundred fifty six were in progress, including trials with unknown status. Of the trials finished, one hundred seventy nine (45.4%) had published results in two hundred five associated publications with English-language abstracts…
For clinical trials of novel stem cell interventions, a publication rate of 45.5% for ended trials is consistent with other studies of publication rates. However, it remains problematic because the stem cell field combines high patient expectations, patient advocacy, strong political support, and therapeutic promise with regulatory concerns over safety and limited evidence of efficacy…
Interestingly, “publicability” does not increase with progression of trials from Phase one to Three/Four. Thus, % of publications in Phase one trials was 27.7%, in Phase two – 27.2% and in Phase Trio/Four – 25%.
On trials results:
Safety was reported by 91.2% of publicly funded and 93.0% of industry-funded trials; a higher proportion of industry-funded than publicly funded trials reported positive efficacy (77.2% versus 67.2%); fewer industry-funded than publicly funded trials reported no efficacy (14.0% versus 22.7%); more publications advocating for further or continuing studies reported on industry-funded compared with publicly funded trials (82.4% versus 75.6%).
No surprises here. I was very nosey to learn anything about trials failure rate in from phase-to-phase. According to table two from the explore, positive outcomes of Phase one and 1/Two were reported in 125/167 (74.8%) publications, of Phase two and Two/Trio in 59/93 (63.4%), of three and Three/Four in Three/12 (25%). However, difference was insignificant:
No trial characteristic had a significant overall effect on the publication of positive results, albeit phase III and phase III/IV trials were less likely to report positive results than phase I and phase I/II trials (odds ratio [OR] 0.11; p < 0.004).
It seem to me that “positive outcome” was “as reported” in publications, but not assessed by Bubela’s group. 63.4% of success rate in Phase two looks too high to me. Two years ago, I was attempting to assess trials outcome myself, since many reports, which contained mixed (some end points were met some were not) or incomplete results, were introduced as “positive” by authors in publications. That’s why, I think, these numbers are overestimated. Also, these numbers do not permit us to calculate “failure rate” precisely, since all “incomplete/ mixed/ inconclusive/ failed” could fall under “other than positive”. According to Bubela’s investigate, trial status has significant effect of the completeness of reporting (I understood that completeness of reporting was worse with progression of trial phase).
On publication bias:
Our result of 67.3% publications reporting positive outcomes is concerning when combined with the early stage of most, and incomplete status of many, novel stem cell clinical trials.
On “unproven stem cell therapies”:
We identified forty eight clinical trials with registration numbers on both ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) from known clinics in North America, Eastern Europe, and Asia that suggest unproven stem cell therapies (Table S1). Trials of adipose-derived stem cells or umbilical cord mesenchymal stem cells predominated for a range of conditions in both adult and pediatric participants. Most were recruiting or “enrolling by invitation.” None reported results.
This kind of analysis was performed for the very first time. The visible question here is how did authors identify clinics with “unproven stem cell therapies” in databases? The explanation is in methods:
…we searched our dataset for the names of clinics that provide unproven stem cell therapies identified from the stem cell tourism literature (Li et al., 2014, Master et al., 2014, Master and Resnik, 2011, Levine, 2010, Lau et al., 2008, Turner and Knoepfler, 2016, Goldring et al., 2011, von Tigerstrom, 2008, Sipp and Turner, 2012, Ogbogu et al., 2013)…
It is very very interesting to observe how datasets like Knoepfler/ Turner on “stem cell clinics” became a reference for the other analytical studies.
Overall, this explore provides very unique and useful information for all of us in the field. I’d very recommend you to read it and utilize their data in your work. It will be significant to proceed to track publications and trial results after two thousand twelve and see how data will evolve over time. Because we cannot calculate “trials failure rate” precisely, based on data from this examine, it will be significant to perform such analysis in the future.
Historical analysis of cell-based therapeutic products marketed and approved worldwide
2017 marks twenty years since the very first regulatory approval of cell-based therapeutic product on a market. In one thousand nine hundred ninety seven Carticel (manufactured by Genzyme Corp.) was approved by FDA for US market. One year before Carticel approval, two cell-based products were launched and marketed for the very first time in Europe (Italy) – Laserskin and Hyalograft by Fidia Advanced Biopolymers. I was nosey to learn about other approved and marketed cell-based products worldwide in the last twenty years. I also desired to learn what happen to the very first products, marketed 15-20 years ago. It took me almost a year to investigate this topic, collecting bits of information from public sources and conferences. Today, I’m sharing some of my data analysis.
I searched published literature, company press releases, mass media coverage, books (via Google books), patents, presentations from conferences and meetings, information from regulatory agencies. Also, I’ve learned some unique information from numerous conferences and from private communications.
- the product must contain alive cells and used for therapeutic purpose;
- the product must be marketed and/ or approved by regulatory agency;
- cord blood products for homologous use, obtained BLA as FDA requirement in US;
- traceable public information is available.
- absence of traceable public information when and where product was marketed;
- tissues for transplantation without brand name (not a product);
- More than three thousand therapeutic products marketed in Japan, as Specific Processed Cellular Products under the Act on the Safety of regenerative Medicine (ASRM) – Class III Regenerative Medicine products (not regulated under the PMDA). In this case, individual institutions (hospitals) submit a “Plan to Provide Regenerative Medicine” and seek for approval from Japanese Ministry of Health, Labour and Welfare (MHLW). Information about three ASRM products was publicly available and searchable. These three products were included in the dataset as an exception.
For historical analysis I was attempting to capture the earliest available data. Some early approvals and self-launches happened before defining regulatory framework for cell/ tissue products. So, some cell-based products were approved as devices. The following data were captured: name of the product, name of the manufacturer, year of approval and/ or when it was launched on the market, where it was marketed, name of regulatory agency (if it was approved), indication, cell type, traceable switches (off market, manufacturer went for bankruptcy…). The entire dataset is available on Cell Trials Data.
(1) As of March 2017, I was able to identify ninety marketed cell-based products. There were mentions of few products, without traceable information of when it was launched (for example, Cartogen in Australia). 61% (55/90) of marketed products were approved by regulatory agencies; 12% (11/90) were self-launched with manufacturing license, issued by governmental agency; 27% (24/90) were self-launched without information about manufacturing license.
How to cite this figure: Bersenev, Alexey (2017): Self-launched versus approved cell-based products, marketed worldwide. figshare. https://doi.org/Ten.6084/m9.figshare.4829452
(Two) Most of cell-based products were marketed for three major groups of indications: skin defects (31%), cartilage repair (24%) and oncology (19%).
By the time of writing this post, at least twelve products (13%) were off market. This number is underestimated, since there was no public information available about current status of many products, marketed earlier. At least five manufacturers went to bankruptcy, some were acquired or outlicensed products to other companies.
(Three) Since 1997, there were fifty eight regulatory approvals of fifty five cell-based products by thirteen different jurisdictions. Three products were approved by more than one jurisdiction (Provenge, Prochymal and MACI).
How to cite this figure: Bersenev, Alexey (2017): Regulatory approvals of cell-based therapeutic products by jurisdiction. figshare. https://doi.org/Ten.6084/m9.figshare.4829182.v1
(Four) Historical trend for approvals is leisurely going up with some volatility. Number of approvals per year was ranging from zero to 8.
How to cite this figure: Bersenev, Alexey (2017): Historical trend in regulatory approvals of cell-based therapeutic products worldwide. figshare.
How to cite this post:
Bersenev Alexey. Historical analysis of cell-based therapeutic products marketed and approved worldwide. CellTrials blog. April 7, 2017. Available: http://celltrials.info/2017/04/07/marketed-approved
PS: I’d like to thank Colin Lee Novick for clarifying information about regulation in Japan.
CAR cell therapy trials in China
Many of you know that China is very active in CAR cell therapy field. However, it is not effortless to track this activity. I made an attempt to analyze CAR cell trials data from China, using All CAR-T Trials dataset from Cell Trials Data. Here are some of my findings. Until 2010, all CAR cell […]
Number of CAR cell therapy trials worldwide
CAR (Chimeric Antigen Receptor)-based cell clinical trials is one of the best areas in cell therapy right now. Today, I’d like to share with you a trend for total number of CAR cell trials, registered worldwide. Importantly, I made figures available for free download on FigShare. You can get it in high resolution and use […]
Cell therapy trials data
Dear readers, as you know I have been collecting cell therapy clinical trials data for several years now. I posted some snapshots, based on my own raw data analysis as “annual reports“. However, I have not collective or suggested raw data before. I’m blessed to tell you that now everyone can get raw data and […]
Cell Therapy two thousand sixteen – Year in Review (part Two)
This is the 2nd part of my overview of the most significant events in cell therapy in 2016. CRISPR-modified cells go clinical This year, for the very first time, CRISPR gene-edited cells were used in human. Chinese oncologists from Sichuan University used CRISPR editing method to knockout PD-1 gene on autologous T-cells of the patient with […]
Cell Therapy two thousand sixteen – Year in Review (part 1)
In the last day of two thousand sixteen I’d like to look at back and overview the most interesting events (in my opinion) and trends of the year. I’m going to split this overview for two parts without any particular order. Results of pivotal CAR-T cell trials Two major commercial developers of CD19 CAR-T cell therapies – […]
What does the Cures Act mean for regulation of cell therapy in US
Fresh law, called “21st Century Cures Act”, has been signed this week in US. This is fat legislation, which covers fresh developments and initiatives, aimed to improve healthcare system. Few sections of the Cures Act specifically dedicated to regenerative medicine. These sections were proposed by industry lobby organization Alliance of Regenerative Medicine (ARM) as the […]
Presentation: CELL THERAPY – Definitions, Classifications and Trends
Here is my talk that I gave on August fifteen this year during annual BioProcessing Summit in Boston. Cell Therapy – Definitions and Classifications from nanog Link Transcript: Two. Cell therapy is mostly experimental field right now. So, one of the best ways to track activities in this field is to look at number of […]
