Stem Cell Clinic

Novel Tafasitamab Combination Finds a Role in Second-line DLBCL Treatment – Targeted Oncology

By Stem Cell Treatment

Targeted OncologyTM: What are the approved treatment options for such a patient in the second-line setting? What disease characteristics would help to determine which regimen should be used?

SVOBODA: Once we would determine that the patient is not a candidate for transplant, the NCCN [National Comprehensive Cancer Network] guidelines [say that] the preferred regimens as of early 2021the next meeting is in September, so well have some other updatesare gemcitabine/oxaliplatin plus or minus rituximab [Rituxan] and polatuzumab vedotin [Polivy] plus or minus bendamustine plus or minus rituximab.1

The regimens [most oncologists are more] familiar with [include] dose-adjusted EPOCH [etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin] if the patient is not a transplant candidate in the second lineIm not sure where that would be, and Im not sure that people would use [this here]and CEOP [cyclophosphamide, etoposide, vincristine, prednisone], which is basically etoposide instead of erythromycin. Some of the other regimens that are mentioned [in the guidelines are] gemcitabine-based regimensthe GDP [gemcitabine, dexamethasone, carboplatin] and gemcitabine/vinorelbine. Rituximab monotherapy in the [older] or very fragile patients [has a] 20% response rate; and tafasitamab [Monjuvi] plus lenalidomide [Revlimid] is now approved for second line for those patients who are not eligible for autologous stem cell transplant [ASCT].

DLBCL is pretty heterogeneous, so we have been trying to always determine [if it is the] germinal center B-cell [GCB] origin or the nongerminal center activated B-cell [ABC] type. And for the nongerminal center type, which [is] CD10 negative, it seems that ibrutinib [Imbruvica] works particularly well, so its sometimes used in these more fragile patients as a monotherapy.

What is different about the novel agent tafasitamab?

Tafasitamab has been approved now for several months in combination with lenalidomide for adult patients with relapsed or refractory DLBCLthis can include the patients with lymphoma that transforms from, lets say, follicular or low-grade lymphoma and who are not eligible for ASCT.2

Tafasitamab is an antibody against CD19. For simplification purposes, you can think of [it as similar to rituximab] which is an anti-CD20 antibody, but this is an anti-CD19 monoclonal antibody. With rituximab or other monoclonal antibodies, the mechanism of action is binding the antibody to CD19-positive B cells, which causes direct cell death but also cell-mediated cytotoxicity and cellular phagocytosis.

Then I think the lenalidomide has synergy, in some ways, and potentiation of activity both in vivo and in vitro, and we know the lenalidomide can activate the T cells and natural killer cells. It can have activity alone, especially in the ABC subtype of DLBCL.

What data support the approval and use of this regimen in this setting?

So again, this is a combination. We know [that as a] single agent, tafasitamab may also have activity. It was fairly low activity in DLBCL, 25% or so, when it was studied as a monotherapy.3 But the interesting thing was that the patients who responded had a very nice, long duration of response [DOR] that lasted for quite some time. The median duration was around 20 months, so those were quite impressive data.

The study that was the basis for the FDA to approve tafasitamab with lenalidomide was a phase 2 study, single arm, open label [L-MIND trial; NCT02399085].4 It included about 80 patients with DLBCL. They were deemed not eligible for ASCT. Primary refractory patients were to be excluded initially, but some of the primary refractory patients got on the study.

Tafasitamab was given as an intravenous infusion, very similar to [rituximab], and its given weekly for the first 3 cycles for the first 3 months, with the asterisk [being] that, for the first cycle, they give the tafasitamab on day 1 and day 4so, Monday and Thursday, then another Monday, and then just on Mondays. For cycles 4 [through] 12, you would give it only twice a month, on day 1 and day 15, and you give the lenalidomide in the typical multiple myeloma dose25 mg per day, 3 weeks on, 1 week off.

This was done for a year for 12 cycles; and patients who had stable disease or better were allowed to continue on with tafasitamab maintenance, just twice a month, until progression. The primary end point was overall response; secondary end points were progression-free survival [PFS], DOR, safety, and biomarker analysis.

The 81 patients who were enrolled [had a] median age of 72, the majority had stage III or IV disease [75%], and the median [number of] prior lines of therapy was 2. They did sneak in some primary refractory patients, about 19%; those were the patients who didnt respond to their frontline [therapy]. There were also a few patients who had prior stem cell transplant. When you look at the GCB versus non-GCB [subtype], the majority were patients who were difficult to determine [67%], but it looked [like for patients for whom] we have the data, more had the non- GCB than the GCB [subtype]. The data [we have show that] the older the patients get, the more likely they are [to have] the non-GCB subtype.

What did the study findings show?

Response was pretty excellent for this situation. Again, this is in patients who are progressing after R-CHOP and are not candidates for transplant. There was a 43% complete response [CR] rate. I like the updated data from the 2-year follow-up, where the median DOR is 34 months. Thats pretty good3 years.5 There was partial response in 14 patients, or 17%; stable disease, 15%; progressive disease, 16%; not evaluable, 10%. The disease control rate was 74%. The Kaplan-Meier curves [for] DOR after 24 months of follow-up [show] pretty long durations, especially in the CR group, and so it looks like a good agent in that setting.

When you look at PFS rate at 1 year, its 50%. Median overall survival, which I think is quite important for this type of population, is 74% at 12 months and 18 months, 64%.4 With 2 years of follow-up, the median PFS was 16.2 months [and the] median overall survival was 31.6 months for all the patients.5

What was the safety profile like for the combination regimen?

The most common adverse events [AEs] were hematologic. I think that [the AEs are] not very different from the lenalidomide monotherapy. Im not sure whether there is a great mechanical or physiologic reason why the cytopenias, other than lymphopenia, would be clearly affected by the CD19 antibody. There were no deaths and no grade 5 hematologic or nonhematologic toxicities on the L-MIND study. There were definitely neutropenias, thrombocytopenias, but the numbers were fairly low.

There were a few episodes of neutropenic fever; there was 1 patient with agranulocytosis. Im not familiar with exactly what happened, but like with any treatment, you have to watch blood counts quite closely. Overall, the numbers look very good in terms of the AEs.

[For the] nonhematologic AEs, rashes we see with lenalidomide; diarrhea; fatiguedifficult to attribute to one or the otherbut overall, it was a well-tolerated [regimen].

In these older patients, the serious AEs that were found to be treatment related by investigator were about 19% of the patients15 out of 81. The serious AEs would [include] any hospitalization, for example, or longer [emergency department] visit, over 24 hours. These types of things happen over a year of active lymphoma. Twelve percent discontinued the combination due to AEs. So even though there were treatment-emergent AEs leading to death, that was defined by protocol. None were considered related to the study treatment, but they occurred during the treatment with this regimen. Im not sure exactly what details, but 4 patients out of the 81 died while on the study.

The combination had many more AEs than the tafasitamab alone, which is understandable because the combination has lenalidomide, [which] can cause cytopenias, anemia, and all of these other issues that we discussed already. For the tafasitamab monotherapy, there have been some cases of cytopenias, but its hard to know whether its just carried over, to some extent, from the lenalidomide. You could think, like with [rituximab] maintenance, whether you could have some increased infections. There were 2 cases of febrile neutropenia, but overall [it was] well tolerated.

References:

1. NCCN. Clinical Practice Guidelines in Oncology. B-cell lymphomas, version 3.2021. Accessed May 12, 2021. https://bit.ly/3geoS5N

2. FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma. FDA. Updated August 3, 2020. Accessed May 12, 2021. https://bit.ly/3bodb9v

3. Jurczak W, Zinzani PL, Hess G, et al. A phase IIa, open-label, multicenter study of single-agent tafasitamab (MOR208), an Fc-optimized anti-CD19 antibody, in patients with relapsed or refractory B-cell non-Hodgkins lymphoma: long-term follow-up, final analysis. Blood. 2019;134(suppl 1):4078. doi:10.1182/blood-2019-124297

4. Salles G, Duell J, Gonzlez Barca E, et al. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020;21(7):978-988. doi:10.1016/S1470-2045(20)30225-4

5. Salles G, Duell J, Gonzlez Barca E, et al. Primary analysis results of the single arm phase II study of MOR208 plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (L-MIND). Abstract presented at: 15th International Conference on Malignant Lymphoma; June 18-23, 2019; Lugano, Switzerland. Accessed April 15, 2021. https://bit.ly/3wZgJIt

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Novel Tafasitamab Combination Finds a Role in Second-line DLBCL Treatment - Targeted Oncology

Global Nerve Repair and Regeneration Devices Market to Reach $11. 8 Billion by 2026 – GlobeNewswire

By Stem Cell Treatment

New York, June 23, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Nerve Repair and Regeneration Devices Industry" - https://www.reportlinker.com/p05957490/?utm_source=GNW The rapid rise in the incidence of nerve injuries worldwide, increasing prevalence of various neurological disorders, especially in the expanding elderly population, and development of advanced technology-based nerve repair and regeneration products are fueling growth in the global market. The constant increase in incidence of nerve injuries is leading to high demand for nerve repair and regeneration products. The growing incidence of chronic nervous system disorders such as Parkinson`s and Alzheimer`s disease is also driving demand for nerve repair and regeneration procedures and devices. There is also increased funding for clinical trials aimed at development of effective and safe therapies for treatment of various neurological disorders. Initiatives such as stem cells in umbilical blood infusion for cerebral palsy; and the use of Polyethylene glycol (PEG) drug for promoting axonal fusion technique for repairing peripheral nerve injuries are favoring market growth.

- Amid the COVID-19 crisis, the global market for Nerve Repair and Regeneration Devices estimated at US$6.6 Billion in the year 2020, is projected to reach a revised size of US$11.8 Billion by 2026, growing at a CAGR of 10% over the analysis period. Neurostimulation & Neuromodulation Devices, one of the segments analyzed in the report, is projected to grow at a 9.7% CAGR to reach US$10.9 Billion by the end of the analysis period. After a thorough analysis of the business implications of the pandemic and its induced economic crisis, growth in the Biomaterials segment is readjusted to a revised 11.7% CAGR for the next 7-year period. This segment currently accounts for a 13.8% share of the global Nerve Repair and Regeneration Devices market. The neurostimulation and neuromodulation devices segment growth will be fueled by rising incidence of peripheral nerve injuries, development of technologically advanced products and favorable reimbursement scenario. Within the segment, internal neurostimulation and neuromodulation devices category is being driven due to the devices` ability to lower occurrence of post-surgical complications and reducing duration of hospitalization. Biomaterials segment is expected to witness high growth, driven by broadening application range, increased availability of government funding for innovations, and development of advanced products.

The U.S. Market is Estimated at $2.2 Billion in 2021, While China is Forecast to Reach $1.8 Billion by 2026

- The Nerve Repair and Regeneration Devices market in the U.S. is estimated at US$2.2 Billion in the year 2021. The country currently accounts for a 30.45% share in the global market. China, the world`s second largest economy, is forecast to reach an estimated market size of US$1.8 Billion in the year 2026 trailing a CAGR of 13% through the analysis period. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 7.7% and 8.8% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 9.2% CAGR while Rest of European market (as defined in the study) will reach US$2 Billion by the end of the analysis period. Increasing incidence of neurological diseases and expanding geriatric population, increasing spending on healthcare sector, positive reimbursement framework and presence of several leading industry players are fueling growth in the North America region. Asia-Pacific is poised to grow at a robust pace, driven by sizeable patient pool, favorable healthcare initiatives and high unmet healthcare needs. The Asia-Pacific market is expected to gain from notable surge in aging population, increasing awareness regarding neurological disorders, and rising incidence of cancer and osteoporosis. Select Competitors (Total 61 Featured)

Read the full report: https://www.reportlinker.com/p05957490/?utm_source=GNW

CONTENTS

I. METHODOLOGY

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW Impact of Covid-19 and a Looming Global Recession 2020 Marked as a Year of Disruption & Transformation EXHIBIT 1: World Economic Growth Projections (Real GDP, Annual % Change) for 2019 to 2022 Global Nerve Repair & Regeneration Market Buckles under COVID- 19 Strain Covid-19 Patients in Prone Position Suffering Nerve Damage Bodes Well for Market Growth Nerve Repair and Regeneration Market Set for a Robust Growth Neurostimulation & Neuromodulation Devices Hold Commanding Slot in Nerve Repair & Regeneration Market Biomaterials to Exhibit Rapid Growth Nerve Repair and Regeneration Market by Application US and Europe Dominate the Market Asia-Pacific and other Emerging Regions Display Impressive Growth Potential Recent Market Activity

2. FOCUS ON SELECT PLAYERS

3. MARKET TRENDS & DRIVERS High Incidence of Neurological Disorders: A Key Market Driver EXHIBIT 2: Annual Incidence of Adult-Onset Neurologic Disorders in the US Effects of COVID-19 on the Nervous System Sheds Focus on Neuromodulation Applications Increasing Cases of Peripheral Nerve Injuries Drive the Nerve Repair and Regeneration Market Growing Number of Vehicular Accidents Drive the Peripheral Nerve injuries Repair Market Rising Geriatric Population and Subsequent Growth in Prevalence of Neurological Disorders EXHIBIT 3: Global Population Statistics for the 65+ Age Group in Million by Geographic Region for the Years 2019, 2025, 2035 and 2050 Growing Incidence of Neurodegenerative Diseases Propels the Market for Deep Brain Stimulation Devices EXHIBIT 4: Global Alzheimers Prevalence by Age Group EXHIBIT 5: Diagnosed Prevalence Cases of Parkinson?s Disease Across Select Countries EXHIBIT 6: Global DBS Market by Leading Player (2020E): Market Share Breakdown of Revenues for Medtronic, Boston Scientific, and Abbott Select Available Deep Brain Stimulation Devices Available in the Market Intensified Research Activity Across Various Neural Disciplines Induces Additional Optimism Stem Cell Therapy: A Promising Avenue for Nerve Repair and Regeneration Increasing Cases of Epilepsy Drives the Demand for Vagus Nerve Stimulation Devices EXHIBIT 7: Epilepsy Incidence by Type (2019): Percentage Share Breakdown for Idiopathic and Symptomatic Epilepsy EXHIBIT 8: Symptomatic Epilepsy Incidence by Type (2019): Percentage Share Breakdown of Congenital, Degenerative, Infective, Neoplastic, Trauma, and Vascular Epilepsy Spinal Cord Injuries Propel the Demand for Spinal Cord Stimulation Devices Recent Developments in Spinal Cord Injury Treatment Biomaterials (Nerve Conduits and Nerve Wraps) to Witness Rapid Growth New Biomaterials Pave the Way for Innovative Neurodegeneration Therapies Role of Nerve Conduits in the Treatment of Peripheral Nerve Injury Innovative Nerve Conduits from Stryker TENS (Transcutaneous electrical nerve stimulation devices) Market Witnesses Rapid Growth Non-Invasiveness of TMS (Transcranial Magnetic Stimulation) Propelling the adoption of TMS devices Nerve Grafts for Bridging Larger Nerve Gaps Role of Nerve Grafting in Treatment of Peripheral Nerve Injuries FDA-approved Nerve Tubes for Peripheral Nerve Repair

4. GLOBAL MARKET PERSPECTIVE Table 1: World Current & Future Analysis for Nerve Repair and Regeneration Devices by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2020 through 2027 and % CAGR

Table 2: World Historic Review for Nerve Repair and Regeneration Devices by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 3: World 15-Year Perspective for Nerve Repair and Regeneration Devices by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets for Years 2012, 2020 & 2027

Table 4: World Current & Future Analysis for Neurostimulation & Neuromodulation Devices by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2020 through 2027 and % CAGR

Table 5: World Historic Review for Neurostimulation & Neuromodulation Devices by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 6: World 15-Year Perspective for Neurostimulation & Neuromodulation Devices by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

Table 7: World Current & Future Analysis for Biomaterials by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2020 through 2027 and % CAGR

Table 8: World Historic Review for Biomaterials by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 9: World 15-Year Perspective for Biomaterials by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

Table 10: World Current & Future Analysis for Neurostimulation & Neuromodulation Surgeries by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2020 through 2027 and % CAGR

Table 11: World Historic Review for Neurostimulation & Neuromodulation Surgeries by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 12: World 15-Year Perspective for Neurostimulation & Neuromodulation Surgeries by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

Table 13: World Current & Future Analysis for Neurorrhaphy by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2020 through 2027 and % CAGR

Table 14: World Historic Review for Neurorrhaphy by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 15: World 15-Year Perspective for Neurorrhaphy by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

Table 16: World Current & Future Analysis for Nerve Grafting by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2020 through 2027 and % CAGR

Table 17: World Historic Review for Nerve Grafting by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 18: World 15-Year Perspective for Nerve Grafting by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

Table 19: World Current & Future Analysis for Stem Cell Therapy by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2020 through 2027 and % CAGR

Table 20: World Historic Review for Stem Cell Therapy by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 21: World 15-Year Perspective for Stem Cell Therapy by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

Table 22: World Current & Future Analysis for Hospitals & Clinics by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2020 through 2027 and % CAGR

Table 23: World Historic Review for Hospitals & Clinics by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 24: World 15-Year Perspective for Hospitals & Clinics by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

Table 25: World Current & Future Analysis for Ambulatory Surgery Centers by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2020 through 2027 and % CAGR

Table 26: World Historic Review for Ambulatory Surgery Centers by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 27: World 15-Year Perspective for Ambulatory Surgery Centers by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

III. MARKET ANALYSIS

UNITED STATES Table 28: USA Current & Future Analysis for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 29: USA Historic Review for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 30: USA 15-Year Perspective for Nerve Repair and Regeneration Devices by Product - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Devices and Biomaterials for the Years 2012, 2020 & 2027

Table 31: USA Current & Future Analysis for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 32: USA Historic Review for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 33: USA 15-Year Perspective for Nerve Repair and Regeneration Devices by Application - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy for the Years 2012, 2020 & 2027

Table 34: USA Current & Future Analysis for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 35: USA Historic Review for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 36: USA 15-Year Perspective for Nerve Repair and Regeneration Devices by End-Use - Percentage Breakdown of Value Sales for Hospitals & Clinics and Ambulatory Surgery Centers for the Years 2012, 2020 & 2027

CANADA Table 37: Canada Current & Future Analysis for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 38: Canada Historic Review for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 39: Canada 15-Year Perspective for Nerve Repair and Regeneration Devices by Product - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Devices and Biomaterials for the Years 2012, 2020 & 2027

Table 40: Canada Current & Future Analysis for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 41: Canada Historic Review for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 42: Canada 15-Year Perspective for Nerve Repair and Regeneration Devices by Application - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy for the Years 2012, 2020 & 2027

Table 43: Canada Current & Future Analysis for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 44: Canada Historic Review for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 45: Canada 15-Year Perspective for Nerve Repair and Regeneration Devices by End-Use - Percentage Breakdown of Value Sales for Hospitals & Clinics and Ambulatory Surgery Centers for the Years 2012, 2020 & 2027

JAPAN Table 46: Japan Current & Future Analysis for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 47: Japan Historic Review for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 48: Japan 15-Year Perspective for Nerve Repair and Regeneration Devices by Product - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Devices and Biomaterials for the Years 2012, 2020 & 2027

Table 49: Japan Current & Future Analysis for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 50: Japan Historic Review for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 51: Japan 15-Year Perspective for Nerve Repair and Regeneration Devices by Application - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy for the Years 2012, 2020 & 2027

Table 52: Japan Current & Future Analysis for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 53: Japan Historic Review for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 54: Japan 15-Year Perspective for Nerve Repair and Regeneration Devices by End-Use - Percentage Breakdown of Value Sales for Hospitals & Clinics and Ambulatory Surgery Centers for the Years 2012, 2020 & 2027

CHINA Table 55: China Current & Future Analysis for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 56: China Historic Review for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 57: China 15-Year Perspective for Nerve Repair and Regeneration Devices by Product - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Devices and Biomaterials for the Years 2012, 2020 & 2027

Table 58: China Current & Future Analysis for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 59: China Historic Review for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 60: China 15-Year Perspective for Nerve Repair and Regeneration Devices by Application - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy for the Years 2012, 2020 & 2027

Table 61: China Current & Future Analysis for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 62: China Historic Review for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 63: China 15-Year Perspective for Nerve Repair and Regeneration Devices by End-Use - Percentage Breakdown of Value Sales for Hospitals & Clinics and Ambulatory Surgery Centers for the Years 2012, 2020 & 2027

EUROPE Table 64: Europe Current & Future Analysis for Nerve Repair and Regeneration Devices by Geographic Region - France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2020 through 2027 and % CAGR

Table 65: Europe Historic Review for Nerve Repair and Regeneration Devices by Geographic Region - France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 66: Europe 15-Year Perspective for Nerve Repair and Regeneration Devices by Geographic Region - Percentage Breakdown of Value Sales for France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets for Years 2012, 2020 & 2027

Table 67: Europe Current & Future Analysis for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 68: Europe Historic Review for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 69: Europe 15-Year Perspective for Nerve Repair and Regeneration Devices by Product - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Devices and Biomaterials for the Years 2012, 2020 & 2027

Table 70: Europe Current & Future Analysis for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 71: Europe Historic Review for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 72: Europe 15-Year Perspective for Nerve Repair and Regeneration Devices by Application - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy for the Years 2012, 2020 & 2027

Table 73: Europe Current & Future Analysis for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 74: Europe Historic Review for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 75: Europe 15-Year Perspective for Nerve Repair and Regeneration Devices by End-Use - Percentage Breakdown of Value Sales for Hospitals & Clinics and Ambulatory Surgery Centers for the Years 2012, 2020 & 2027

FRANCE Table 76: France Current & Future Analysis for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 77: France Historic Review for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 78: France 15-Year Perspective for Nerve Repair and Regeneration Devices by Product - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Devices and Biomaterials for the Years 2012, 2020 & 2027

Table 79: France Current & Future Analysis for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 80: France Historic Review for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 81: France 15-Year Perspective for Nerve Repair and Regeneration Devices by Application - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy for the Years 2012, 2020 & 2027

Table 82: France Current & Future Analysis for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 83: France Historic Review for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 84: France 15-Year Perspective for Nerve Repair and Regeneration Devices by End-Use - Percentage Breakdown of Value Sales for Hospitals & Clinics and Ambulatory Surgery Centers for the Years 2012, 2020 & 2027

GERMANY Table 85: Germany Current & Future Analysis for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Table 86: Germany Historic Review for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2012 through 2019 and % CAGR

Table 87: Germany 15-Year Perspective for Nerve Repair and Regeneration Devices by Product - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Devices and Biomaterials for the Years 2012, 2020 & 2027

Table 88: Germany Current & Future Analysis for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy - Independent Analysis of Annual Sales in US$ Thousand for the Years 2020 through 2027 and % CAGR

Link:
Global Nerve Repair and Regeneration Devices Market to Reach $11. 8 Billion by 2026 - GlobeNewswire

The growing global "infodemic" around stem cell therapies – Axios

By Stell Cell Research

An industry centered around unproven stem cell therapies is flourishing due to misinformation.

Why it matters: Stem cells offer a tantalizing potential to address a large number of diseases, like Parkinson's, ALS, cancers and bodily injuries. But only a small number of therapies have been found safe and effective through clinical trials, while misinformation continues to proliferate.

The latest: The Pew Charitable Trusts issued a brief in early June that describes a rising number of reported adverse events.

Background: Clinics with unregulated stem cell products or therapies began emerging in the early 2000s all over the world, "taking advantage of the media hype around stem cells and patients hope and desperation," says Mohamed Abou-el-Enein, executive director of the Joint USC/CHLA Cell Therapy Program at USC's Keck School of Medicine.

Regulatory agencies like the FDA need to crack down on these misinformation campaigns, several experts say.

What they're saying: Turner says in that period the FDA contacted about 400 businesses to warn of noncompliance and issued several warning letters, but adds that was "probably of very little consequence. ... A one-year period could be justified, but three years is basically like a security guard walking away from the post, and you can guess what's going to happen."

The big picture: This is a global threat as well, Master and Abou-el-Enein say. In a recent perspective in the journal Stem Cell Reports, they argue for the WHO to establish an expert advisory committee to explore global standards.

What's next: Researchers are still hopeful stem cell therapies can be effective but emphasize the need for more research into how stem cells work and how they can be manipulated for therapies.

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The growing global "infodemic" around stem cell therapies - Axios

NanoString Launches nCounter Stem Cell Characterization Panel to Advance the Development of Stem Cell Therapy – Yahoo Finance

By Stell Cell Research

SEATTLE, Jun 22, 2021--(BUSINESS WIRE)--NanoString Technologies, Inc. (NASDAQ: NSTG), a leading provider of life science tools for discovery and translational research, today announced the launch of the nCounter Stem Cell Characterization Panel for the analysis and optimization of stem cell lines used in the development of potential novel therapeutics.

Recent breakthroughs in stem cell therapy, regenerative medicine, and CRISPR engineering have advanced the development of promising new treatments for debilitating diseases across a broad range of research areas, including neurological and cardiovascular disease, vision loss, and certain types of cancers. However, one of the biggest challenges with stem cell research is the high variability found within the development and manufacturing process that impacts the ability of the stem cells to differentiate and function. The new nCounter Stem Cell Characterization panel measures the eight essential components of stem cell biology and provides a novel, standardized assay for evaluating factors that influence and determine viability, functionality, and pluripotency.

"The simple, automated workflow and highly reproducible, digital results make the nCounter system an excellent fit for all types of stem cell applications," said Chad Brown, senior vice president of Sales and Marketing at NanoString. "With this panel, researchers have a powerful new tool that can quickly assess stem cell health to advance development efforts and optimize stem cell production, achieving robust results in less than 24 hours."

"The Process Development team at ARMI-BioFabUSA is very excited to use the nCounter Stem Cell Characterization panel across a number of our projects where we are developing human tissues composed of mature cells differentiated from stem cells. The Stem Cell Characterization Panel will give us greater insight into the differentiation status of our cells and the success of our current process development and manufacturing runs," said Damian Hile, senior process development scientist at Advanced Regenerative Manufacturing Institute-BioFabUSA (ARMI-BioFabUSA).

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The novel 770 gene panel is available for humans and mice and was designed at NanoString with input from leading stem cell experts. To learn more about the nCounter Stem Cell Characterization Panel, visit NanoString at the virtual 2021 ISSCR Conference June 21-26. In addition, NanoString is sponsoring the Cellular Identity: Pluripotency Dynamics session, with Joseph Beechem, Ph.D., chief scientific officer at NanoString.

To learn more about the panel and how the development of the panel can expedite stem cell research, visit the Brief nCounters stem cell experience.

About ARMI-BioFabUSA

The Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, NH, is an organization funded by the United States Department of Defense. ARMI's mission is to make practical the large-scale manufacturing of engineered tissues and tissue-related technologies to benefit existing industries and grow new ones. ARMI brings together a consortium of over 150 partners from across the industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs. For more information on ARMI-BioFabUSA, please visit http://www.ARMIUSA.org.

About NanoString Technologies, Inc.

NanoString Technologies is a leading provider of life science tools for discovery and translational research. The company's nCounter Analysis System is used in life sciences research and has been cited in more than 4,300 peer-reviewed publications. The nCounter Analysis System offers a cost-effective way to easily profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision, facilitating a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The company's GeoMx Digital Spatial Profiler enables highly-multiplexed spatial profiling of RNA and protein targets in a variety of sample types, including FFPE tissue sections.

For more information, please visit http://www.nanostring.com.

NanoString, NanoString Technologies, the NanoString logo, GeoMx, and nCounter are trademarks or registered trademarks of NanoString Technologies, Inc. in various jurisdictions.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210622005265/en/

Contacts

Doug Farrell, NanoString Vice President, Investor Relations & Corporate Communications dfarrell@nanostring.com Phone: 206-602-1768

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NanoString Launches nCounter Stem Cell Characterization Panel to Advance the Development of Stem Cell Therapy - Yahoo Finance

Catalent to Acquire RheinCell Therapeutics, Strengthening a Path Towards Industrialization of Induced Pluripotent Stem Cell-based Therapies – Yahoo…

By Stell Cell Research

Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it has reached an agreement to acquire RheinCell Therapeutics GmbH, a developer and manufacturer of GMP-grade human induced pluripotent stem cells (iPSCs). Upon completion, the acquisition will build upon Catalent's existing custom cell therapy process development and manufacturing capabilities with proprietary GMP cell lines for iPSC-based therapies. The deal will enable Catalent to offer the building blocks to scale iPSC-based cell therapies while reducing barriers to entry to the clinic for therapeutic companies and is expected to close before the end of 2021, subject to customary conditions. Financial details of the transaction have not been disclosed.

SOMERSET, N.J., June 24, 2021 /PRNewswire-PRWeb/ -- Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it has reached an agreement to acquire RheinCell Therapeutics GmbH, a developer and manufacturer of GMP-grade human induced pluripotent stem cells (iPSCs). Upon completion, the acquisition will build upon Catalent's existing custom cell therapy process development and manufacturing capabilities with proprietary GMP cell lines for iPSC-based therapies. The deal will enable Catalent to offer the building blocks to scale iPSC-based cell therapies while reducing barriers to entry to the clinic for therapeutic companies and is expected to close before the end of 2021, subject to customary conditions. Financial details of the transaction have not been disclosed.

iPSCs are cells that can be differentiated into various cell types to address a wide range of therapeutic indications. Founded in 2017, RheinCell has undertaken significant research and development of full GMP human leukocyte antigen (HLA)-matched cell banks with superior genomic integrity, as well as investing in development-scale operational capabilities. RheinCell is based in Langenfeld, near Dsseldorf, Germany. Upon closing, RheinCell's current employees will join Catalent's Cell & Gene Therapy business.

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"We formed RheinCell based on our deep scientific and regulatory expertise in the promising field of cell-based therapies," commented Juergen Weisser, Chief Executive Officer, RheinCell Therapeutics. He added, "We are convinced Catalent will be able to substantially accelerate RheinCell's future growth and help to support customers around the globe that are interested in our GMP-grade iPSC lines and iPSC-based services to feed their development pipelines in this exciting and highly demanding new therapeutic field."

"By offering a renewable, and standardized, source of cells for further product development, iPSCs have the potential to be a disruptive technology that could fuel the development of the next generation of cell therapies and substantially enhance the ability to manufacture at scale," said Julien Meissonnier, Vice President and Chief Scientific Officer, Catalent. He added, "Catalent is committed to building a full-scale value chain for emerging modalities and accelerating their path to market through expertise and innovation. This acquisition further strengthens Catalent's position in these new therapeutic areas, by pioneering tools and techniques to substantially advance scale-up to meet the demands of clinical and commercial manufacturing."

"This latest acquisition fuels the extraordinary growth of Catalent Cell & Gene Therapy, and the expertise and deep knowledge in iPSC cell lines that RheinCell brings will immediately boost our cell therapy portfolio, allowing us to offer iPSC banks to our customers as a premium source for their therapeutic development pathway," said Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. She added, "The addition of the RheinCell team to our growing cell therapy network will create an opportunity to share cutting-edge expertise across our global centers of excellence."

Since 2020, Catalent has invested in its cell therapy capabilities with four strategic expansions at its Gosselies, Belgium, campus the location of its European Center of Excellence for cell and gene therapy. Together with its U.S. cell and gene therapy facilities across Texas and Maryland, Catalent continues to increase its clinical and commercial-scale manufacturing capabilities across the full range of cell and gene therapy activity.

About RheinCell Therapeutics GmbH RheinCell develops and manufactures GMP-grade human induced pluripotent stem cells (iPSCs) for the next generation of cell therapies. Its production pipeline focuses on high immune compatibility and low rejection potential, with a spotlight on solutions for off-the-shelf, allogenic therapeutics. RheinCell provides exclusive access to clinically approved and consented cord blood cells, proprietary cell reprogramming protocols, state-of-the-art cleanroom and cell culture facilities, GMP-compliant manufacturing processes, and a first-class community of iPSC workflow experts who also develop GMP-compliant differentiation protocols in close cooperation with customers. For more information, visit http://www.rheincell.de

About Catalent Cell & Gene Therapy Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. Its comprehensive cell therapy portfolio includes a wide range of expertise across a variety of cell types including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs. With deep expertise in viral vector development, scale-up and manufacturing for gene therapies, Catalent is a full-service partner for plasmid DNA, adeno-associated viral (AAV), lentiviral and other viral vectors, oncolytic viruses, and live virus vaccines. An experienced and innovative partner, Catalent Cell & Gene Therapy has a global network of dedicated, small- and large-scale clinical and commercial manufacturing facilities, including an FDA-licensed viral vector facility, and fill/finish capabilities located in both the U.S. and Europe.

About Catalent Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 15,000 people, including approximately 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com

More products. Better treatments. Reliably supplied.

Media Contact

Chris Halling, Catalent, +447580041073, chris.halling@catalent.com

Richard Kerns, Northern Exposure Public Relations, +441617285880, chris.halling@catalent.com

SOURCE Catalent

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Catalent to Acquire RheinCell Therapeutics, Strengthening a Path Towards Industrialization of Induced Pluripotent Stem Cell-based Therapies - Yahoo...

Immusoft Announces Formation of Scientific Advisory Board – Business Wire

By Stell Cell Research

SEATTLE--(BUSINESS WIRE)--Immusoft, a cell therapy company dedicated to improving the lives of patients with rare diseases, announced today the formation of its Scientific Advisory Board (SAB) composed of world-renowned experts to provide external scientific review and high-level counsel on the Companys research and development programs.

The SAB will work closely with the Immusoft leadership team to advance and expand its leadership position in B cells as biofactories for therapeutic protein delivery, a novel approach that Immusoft has pioneered. The Company is currently preparing for the near-term clinical development of its lead investigational drug candidate ISP-001, a first-in-class investigational treatment for Hurler syndrome, the most severe form of mucopolysaccharidosis type 1 (MPS I), a rare lysosomal storage disease.

We are excited and privileged to have the opportunity to work with this group of rare disease and cell therapy experts, on the development of our pipeline, said Sean Ainsworth, Chief Executive Officer, Immusoft. These thought leaders bring tremendous understanding of rare diseases, as well as extensive experience in drug development from discovery through to late-stage clinical trials. We look forward to their continued contributions at Immusoft as we enter a new stage in advancing ISP-001 into clinical trials this year."

Members of the Immusoft Scientific Advisory Board are as follows:

Robert Sikorski, M.D., Ph.D., is Head of the SAB and consulting Chief Medical Officer at Immusoft. Dr. Sikorski currently serves as the Managing Director of Woodside Way Ventures, a consulting and investment firm that helps biotechnology companies and investors advance lifesaving technologies through clinical development. Prior to that, he was Chief Medical Officer of Five Prime Therapeutics (acquired by Amgen). Earlier in his career, he played a leading role in building MedImmunes oncology portfolio through partnering and acquisition efforts. Before joining Medimmune, he led late-stage clinical development and post-marketing efforts for several commercial drugs and drug candidates at Amgen. Dr. Sikorski began his career as a Howard Hughes Research Fellow and Visiting Scientist at the National Cancer Institute and the National Human Genome Research Institute in the laboratory of Nobel Laureate Harold Varmus. Additionally, he has served as an editor for the journal Science and Journal of the American Medical Association. Dr. Sikorski obtained his MD and PhD degrees as a Medical Scientist Training Program awardee at the Johns Hopkins School of Medicine.

Paula Cannon, Ph.D., is a Distinguished Professor of Molecular Microbiology and Immunology at the Keck School of Medicine of the University of Southern California, where she leads a research team that studies viruses, stem cells and gene therapy. She obtained her PhD from the University of Liverpool in the United Kingdom, and received postdoctoral training at both Oxford and Harvard universities. Her research uses gene editing technologies such as CRISPR/Cas9, to develop treatments for infectious and genetic diseases of the blood and immune systems. In 2010, her team was the first to show that gene editing could be used to mimic a natural mutation in the CCR5 gene that prevents HIV infection, and which has now progressed to a clinical trial in HIV-positive individuals.

Michael C. Carroll, Ph.D., is a Senior Investigator at Boston Children's Hospital and Professor of Pediatrics, Harvard Medical School. His recent research focuses on two major areas, i.e. neuroimmunology and peripheral autoimmunity. Using murine models of neuro-psychiatric lupus, his group is testing their hypothesis that interferon alpha from peripheral inflammation enters the brain and mediates synapse loss and symptoms of cognitive decline observed in patients. Following-up on a large genetic screen in schizophrenia patients, they recently reported that over-activation of a process known as complement-dependent, microglia-mediated synaptic pruning in novel strains of mice can induce psychiatric symptoms of schizophrenia. In a murine lupus model, his lab has identified that self-reactive B cells evolve with kinetics similar to that of foreign antigen responding B cells providing a novel explanation for epitope spreading. Dr. Carroll received his PhD from UT Southwestern Medical School and his postdoctoral training with the Nobel Laureate, Professor Rodney R. Porter at Oxford University. He is a recipient of awards from the Pew Foundation, American Arthritis Foundation and the National Alliance for Mental Health.

Hans-Peter Kiem, M.D., Ph.D. is the Stephanus Family Endowed Chair for Cell and Gene Therapy at Fred Hutchinson Cancer Research Center. He is a world-renowned pioneer in stem-cell and gene therapy and in the development of new gene-editing technologies. His focus has been the development of improved treatment and curative approaches for patients with genetic and infectious diseases or cancer. For gene editing, his lab works on the design and selection of enzymes, known as nucleases, which include CRISPR/Cas. These enzymes function as molecular scissors that are capable of accurately disabling defective genes. By combining gene therapys ability to repair problem-causing genes and stem cells regenerative capabilities, he hopes to achieve cures of diseases as diverse as HIV, leukemia and brain cancer. He is also pioneering in vivo gene therapy approaches to make gene therapy and gene editing more broadly available and accessible to patients and those living with HIV, especially in resource-limited settings. He received his M.D. and Ph.D. at the University of Ulm, Germany.

Bruce Levine, Ph.D., Barbara and Edward Netter Professor in Cancer Gene Therapy is the Founding Director of the Clinical Cell and Vaccine Production Facility in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. First-in-human adoptive immunotherapy trials include the first use of a lentiviral vector, the first infusions of gene edited cells, and the first use of lentivirally-modified cells to treat cancer. Dr. Levine has overseen the production, testing and release of 3,100 cellular products administered to more than 1,300 patients in clinical trials since 1996. Dr. Levine is a recipient of the William Osler Patient Oriented Research Award, the Wallace H. Coulter Award for Healthcare Innovation, the National Marrow Donor Program/Be The Match ONE Forum 2020 Dennis Confer Innovate Award, serves as President of the International Society for Cell and Gene Therapy, and on the Board of Directors of the Alliance for Regenerative Medicine. Dr. Levine received a B.A. in Biology from the University of Pennsylvania and a Ph.D. in Immunology and Infectious Diseases from Johns Hopkins University.

Peter Sage, Ph.D., is an Assistant Professor of Medicine at Harvard Medical School and an Associate Immunologist at Brigham and Womens Hospital. Dr. Sage is also a member of the Committee on Immunology (COI) at Harvard Medical School. Dr. Sage obtained his PhD in Immunology from Harvard Medical School in 2013, during which he received the Jeffrey Modell Prize. He completed a post-doctoral fellowship in the laboratory of Dr. Arlene Sharpe in the Department of Immunology at Harvard Medical School in 2017. Dr. Sage started his independent laboratory in 2017 at the Transplantation Research Center in the Division of Renal Medicine of Brigham and Womens Hospital. Dr. Sages laboratory focuses on studying how the immune system controls B cell and antibody responses in settings of health and disease.

About Immusoft

Immusoft is a cell therapy company focused on developing a novel therapies for rare diseases using a sustained delivery of protein therapeutics from a patients own cells. The company is developing a technology platform called Immune System Programming (ISP), which modifies a patients B cells and instructs the cells to produce gene-encoded medicines. The B cells that are reprogrammed using ISP become miniature drug factories that are expected to survive in patients for many years. The company is based in Seattle, WA. For more information, visit http://www.immusoft.com.

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Immusoft Announces Formation of Scientific Advisory Board - Business Wire

Jasper Therapeutics and Aruvant Announce Research Collaboration to Study JSP191, an Antibody-Based Conditioning Agent, with ARU-1801, a Novel Gene…

By Stell Cell Research

REDWOOD CITY, Calif. and NEW YORK and BASEL, Switzerland, June 21, 2021 /PRNewswire/ --Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, andAruvant Sciences, a private company focused on developing gene therapies for rare diseases, today announced that they have entered a non-exclusive research collaboration to evaluate the use of JSP191, Jasper's anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning agent with ARU-1801, Aruvant's investigational lentiviral gene therapy for sickle cell disease (SCD). The objective of the collaboration is to evaluate the use of JSP191 as an effective and more tolerable conditioning agent that can expand the number of patients who can receive ARU-1801, a potentially curative treatment for SCD.

"This research collaboration with Aruvant is the first to use a clinical-stage antibody-based conditioning agent and a novel clinical-stage gene therapy, giving this combination a clear advantage by moving beyond the harsh conditioning agents currently used for gene therapy and establishing this next-generation potentially curative treatment as a leader in sickle cell disease," said Kevin N. Heller, M.D., executive vice president, research and development of Jasper. "Our goal is to establish JSP191 as a potential new standard of care conditioning agent, broadly in autologous gene therapy and allogeneic hematopoietic stem cell transplantation."

Gene therapies and gene editing technologies generally require that a patient's own hematopoietic stem cells first be depleted from the bone marrow to facilitate the engraftment of the new, gene-modified stem cells through a process called conditioning. Other investigational gene therapies and gene editing approaches in SCD use a high-dose chemotherapy such as busulfan for the conditioning regimen, which can place patients at prolonged risk for infection and bleeding, secondary malignancy and infertility. ARU-1801 is currently the only gene therapy that has demonstrated durable efficacy using both a lower dose of chemotherapy and a different agent than busulfan with a more limited side effect profile. The Aruvant-Jasper partnership is focused on evaluating the potential of using JSP191, a highly targeted anti-CD117 (stem cell factor receptor) monoclonal antibody agent, as the foundationof a novel conditioning regimen for use in combination with ARU-1801 to further reduce the negative side effects while maintaining efficacy.

"The unique attributes of ARU-1801 enable us to bring a potentially curative one-time therapy to individuals with sickle cell disease that can be delivered in the safest way possible," said Will Chou, M.D., Aruvant chief executive officer. "By partnering with Jasper to evaluate the use of JSP191 with ARU-1801, we are one step closer to developing a next-generation definitive therapy with an even more patient-friendly conditioning regimen. We believe that this combination may be able to further expand the number of patients who can benefit from ARU-1801 in the future, including potentially those with more moderate disease."

About JSP191 JSP191 is a humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or gene-corrected transplanted stem cells to engraft. While hematopoietic cell transplantation can be curative for patients, its use is limited because standard high dose myeloablative conditioning is associated with severe toxicities and standard low dose conditioning has limited efficacy. To date, JSP191 has been evaluated in more than 90 healthy volunteers and patients. It is currently enrolling in two clinical trials for myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML) and severe combined immunodeficiency (SCID) and expects to begin enrollment in four additional studies in 2021 for severe autoimmune disease, sickle cell disease, chronic granulomatous disease and Fanconi anemia patients undergoing hematopoietic cell transplantation.

About ARU-1801 ARU-1801 is designed to address the limitations of current curative treatment options, such as low donor availability and the risk of graft-versus-host disease (GvHD) seen with allogeneic stem cell transplants. Unlike investigational gene therapies and gene editing approaches which require fully myeloablative conditioning, the unique characteristics of ARU-1801 allow it to be given with reduced intensity conditioning ("RIC"). Compared to myeloablative approaches, the lower dose chemotherapy regimen underlying RIC has the potential to reduce not only hospital length of stay, but also the risk of short- and long-term adverse events such as infection and infertility. Preliminary clinical data from the MOMENTUMstudy, an ongoing Phase 1/2 trial of ARU-1801 in patients with severe sickle cell disease, demonstrate continuing durable reductions in disease burden.

The MOMENTUM Study Aruvant is conducting the MOMENTUM study, which is evaluating ARU-1801, a one-time potentially curative investigational gene therapy for patients with SCD. This Phase 1/2 study is currently enrolling participants, and information may be found at momentumtrials.comwhich includes a patient brochure, an eligibility questionnaireand information for healthcare providers.

About Jasper Therapeutics Jasper Therapeutics is a biotechnology company focused on the development of novel curative therapies based on the biology of the hematopoietic stem cell. The company is advancing two potentially groundbreaking programs. JSP191, a first-in-class anti-CD117 monoclonal antibody, is in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow in patients undergoing a hematopoietic cell transplantation. It is designed to enable safer and more effective curative allogeneic and autologous hematopoietic cell transplants and gene therapies. In parallel, Jasper Therapeutics is advancing its preclinical engineered hematopoietic stem cell (eHSC) platform, which is designed to overcome key limitations of allogeneic and autologous gene-edited stem cell grafts. Both innovative programs have the potential to transform the field and expand hematopoietic stem cell therapy cures to a greater number of patients with life-threatening cancers, genetic diseases and autoimmune diseases than is possible today. For more information, please visit us at jaspertherapeutics.com.

About Aruvant Sciences Aruvant Sciences, part of the Roivant family of companies, is a clinical-stage biopharmaceutical company focused on developing and commercializing gene therapies for the treatment of rare diseases. The company has a talented team with extensive experience in the development, manufacturing and commercialization of gene therapy products. Aruvant has an active research program with a lead product candidate, ARU-1801, in development for individuals suffering from sickle cell disease (SCD). ARU-1801, an investigational lentiviral gene therapy, is being studied in a Phase 1/2 clinical trial, the MOMENTUM study, as a one-time potentially curative treatment for SCD. Preliminary clinical data demonstrate engraftment of ARU-1801 and amelioration of SCD is possible with one dose of reduced intensity chemotherapy. The company's second product candidate, ARU-2801, is in development to cure hypophosphatasia, a devastating, ultra-orphan disorder that affects multiple organ systems and leads to high mortality when not treated. Data from pre-clinical studies with ARU-2801 shows durable improvement in disease biomarkers and increased survival. For more information on the ongoing ARU-1801 clinical study, please visit http://www.momentumtrials.comand for more on the company, please visit http://www.aruvant.com. Follow Aruvant on Facebook, Twitter @AruvantSciencesand on Instagram @Aruvant_Sciences.

About Roivant Roivant's mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch Vants nimble and focused biopharmaceutical and health technology companies. For more information, please visit http://www.roivant.com.

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Jasper Therapeutics and Aruvant Announce Research Collaboration to Study JSP191, an Antibody-Based Conditioning Agent, with ARU-1801, a Novel Gene...

Gamida Cell Announces Publication in Blood, the Journal of the American Society of Hematology, of the First Pivotal Trial to Evaluate a Cell Therapy…

By Stell Cell Research

BOSTON--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the results of a Phase 3 clinical study of omidubicel have been published in Blood, the official journal of the American Society of Hematology. Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant solution for patients with hematologic malignancies.

The results demonstrate that transplantation with omidubicel leads to faster neutrophil and platelet recovery compared to a standard umbilical cord blood graft, and results in fewer early bacterial and viral infections and less time in the hospital.

We are pleased that the data from this well-conducted international Phase 3 trial have been published in Blood, the highly respected, peer-reviewed journal of the American Society of Hematology, said Ronit Simantov, M.D., chief medical officer of Gamida Cell. The robust results of this clinical trial have demonstrated that omidubicel could provide an important new option for patients with hematologic malignancies in need of a bone marrow transplant.

Data from this study were previously presented at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research, and most recently during the Presidential Symposium at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation. The pivotal study was an international, multi-center, randomized Phase 3 trial designed to compare the safety and efficacy of omidubicel to standard umbilical cord blood transplant in patients with high-risk hematologic malignancies undergoing a bone marrow transplant.

Previous studies have shown that engraftment with omidubicel is durable, with some patients in the Phase 1/2 study now a decade past their transplant. The Phase 3 data reinforce omidubicels potential to be a new standard of care for patients who are in need of stem cell transplantation but do not have access to an appropriate matched donor, said Mitchell Horwitz, M.D., lead author of the paper and a professor of medicine at the Duke Cancer Institute.

The full Blood manuscript is available here: https://ashpublications.org/blood/article/doi/10.1182/blood.2021011719/476235/Omidubicel-Versus-Standard-Myeloablative-Umbilical.

Details of Phase 3 Efficacy and Safety Results Shared in Blood

The intent-to-treat analysis included 125 patients aged 1365 years with a median age of 41. Forty-four percent of the patients treated on study were non-Caucasian, a population known to be underrepresented in adult bone marrow donor registries. Patient demographics and baseline characteristics were well-balanced across the two study groups. Patients with acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome or lymphoma were enrolled at more than 30 clinical centers in the United States, Europe, Asia, and Latin America.

Gamida Cell previously reported in May 2020 that the study achieved its primary endpoint, showing that omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment, a measure of how quickly the stem cells a patient receives in a transplant are established and begin to make healthy new cells and a key milestone in a patients recovery from a bone marrow transplant. The median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p<0.001).

All three secondary endpoints, details of which were first reported in December 2020, demonstrated a statistically significant improvement among patients who were randomized to omidubicel compared to patients randomized to standard cord blood graft. Platelet engraftment was significantly accelerated with omidubicel, with 55 percent of patients randomized to omidubicel achieving platelet engraftment at day 42, compared to 35 percent for the comparator (p = 0.028). Hospitalization in the first 100 days after transplant was also reduced in patients randomized to omidubicel, with a median number of days alive and out of hospital for patients randomized to omidubicel of 61 days, compared to 48 days for the comparator (p=0.005). The rate of infection was significantly reduced for patients randomized to omidubicel, with the cumulative incidence of first grade 2 or grade 3 bacterial or invasive fungal infection for patients randomized to omidubicel of 37 percent, compared to 57 percent for the comparator (p=0.027). Additional data reported in the manuscript included a comparison of infection density, or the number of infections during the first year following transplantation, which showed that the risk for grade 2 and grade 3 infections was significantly lower among recipients of omidubicel compared to control (risk ratio 0.5, p<0.001).

Data from the study relating to exploratory endpoints also support the clinical benefit demonstrated by the studys primary and secondary endpoints. There was no statistically significant difference between the two patient groups in incidence of grade 3/4 acute GvHD (14 percent for omidubicel, 21 percent for the comparator) or all grades chronic GvHD at one year (35 percent for omidubicel, 29 percent for the comparator). Non-relapse mortality was shown to be 11 percent for patients randomized to omidubicel and 24 percent for patients randomized to the comparator (p=0.09).

These clinical data results form the basis of a Biologics License Application (BLA) that Gamida Cell plans to submit to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2021.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplants for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status by the FDA. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit http://www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About Gamida Cell

Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the potential for omidubicel to become a new standard of care and the anticipated submission of a BLA for omidubicel, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to Gamida Cells ability to prepare regulatory filings and the review process therefor; complications in Gamida Cells plans to manufacture its products for commercial distribution; and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on March 9, 2021, as amended on March 22, 2021, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Gamida Cell as of the date of this release.

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Gamida Cell Announces Publication in Blood, the Journal of the American Society of Hematology, of the First Pivotal Trial to Evaluate a Cell Therapy...

More than 800 medicines are in development for diseases that disproportionately affect racial and ethnic communities – PRNewswire

By Stell Cell Research

WASHINGTON, June 22, 2021 /PRNewswire/ -- We are in a new era of medicine where groundbreaking biopharmaceutical research and development is transforming medicine, but these innovations are meaningless if they don't reach patients, including those in underserved communities. Health disparities are not new, but the COVID-19 pandemic put a spotlight on long-standing health inequities that affect diverse racial and ethnic communities in America. Data shows these populations have been disproportionately impacted by COVID-19. In fact, American Indian/Alaskan Native, Hispanic, and Black populations are approximately twice as likely to die from COVID-19, as compared to non-Hispanic whites.

Researchers have found that people with certain health conditions, including chronic conditions such as Alzheimer's disease, certain cancers, chronic kidney disease, chronic lung diseases, type 2 diabetes, heart conditions, HIV infection, liver disease, obesity, sickle cell disease and stroke, are at higher risk of severe illness or death from COVID-19. Many of these conditions are tied to health disparities that disproportionality affect racial and ethnic communities for genetic and environmental reasons, or due to inequities in social and economic conditions.

Today, PhRMA released a new report exploring the 829 medicines in development that aim to address the diseases and conditions that affect racial and ethnic communities at a higher rate and are also associated with worse COVID-19 outcomes.

Among the medicines in development to improve management of these diseases are:

It is critical that all patients, including historically underserved racial and ethnic communities, have access to medicines. One way to reduce barriers to health care access and enable everyone to benefit from new medicines is to ensure that clinical trials are diverse and inclusive and include participants representative of the population the medicine intends (or aims) to treat. The biopharmaceutical industry has been working with patients, communities, regulatory authorities, health care practitioners, academics and policymakers to enhance diversity in clinical trials, so the clinical trial population testing medicines better reflect the patients that will use the new therapies and medicines should they are approved by the U.S. Food and Drug Administration.

To this end, PhRMA and its member companies have voluntarily adopted first-ever industry-wide principles on clinical trials diversity, adding a new chapter to the already existing Principles on Conduct Clinical Trials & Communication of Clinical Trial Results.The new clinical trial diversity principles are designed to build trust, reduce barriers to clinical trial access, enhance an understanding of drug effects in diverse patient populations, and promote the sharing of information on policies and practices to increase clinical trial diversity.

Equity is critical to the health and well-being of diverse racial and ethnic communities, and it remains essential to a robust ecosystem of innovation. America's biopharmaceutical companies are pushing for necessary systemic and long-term change to better meet the needs of underserved communities in America.

To learn more about the PhRMA Equity Initiative and PhRMA's commitment to inclusion, visit https://phrma.org/Equity and tune in to The Atlantic's Health Equity Summit where PhRMA's Chief Operating Officer, Lori Reilly, and Genentech's Chief Diversity Officer, Quita Highsmith, will have a conversation about building trust in clinical trials.

Learn more about the medicines in development to address health equity here.

This post originally appeared on the Catalyst blog.

CONTACT:Andrew Powaleny,[emailprotected], 202-835-3460

SOURCE Pharmaceutical Research and Manufacturers of America (PhRMA)

https://phrma.org/

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More than 800 medicines are in development for diseases that disproportionately affect racial and ethnic communities - PRNewswire

Andrs Garca Receives Distinguished Professor Award | Research – Research Horizons

By Stell Cell Research

Vision. Collaboration. Innovation. The qualities for which Georgia Tech has become so well-known were embodied in people like Bob Nerem, founding director of the Parker H. Petit Institute for Bioengineering and Bioscience (IBB) from 1995 to 2009, Parker H. Petit Distinguished Chair for Engineering in Medicine, and Institute professor emeritus until his death in March 2020.

In 1997 Nerem recruited Andrs Garca and his wife, Michelle LaPlaca, to join the pioneering IBB program at Tech after they completed their work as postdoctoral fellows at the University of Pennsylvania his in cell and molecular biology, hers in neurotrauma.

In 1998 when Garca and LaPlaca joined Tech, IBB launched its National Science Foundation Engineering Research Center in Tissue Engineering with Emory University, making it a strategic community for Garca to join to start his research program in an emerging field. Now as executive director of IBB and a Regents Professor in the Woodruff School of Mechanical Engineering, Garca is continuing Nerems legacy of vision, collaboration, and innovation in everything he does. In recognition of his work, he is the 2021 recipient of the Class of 1934 Distinguished Professor Award, the highest honor given to a Georgia Tech professor. The award is presented to a professor who has made significant, long-term contributions to teaching, research, and public service.

Known as a global pioneer in developing biomaterials systems for translational applications in regenerative medicine, Garca holds more than a dozen U.S. patents. Discoveries include the development of hydrogels for protein and cell delivery in regenerative medicine, engineering biofunctional materials to improve islet survival, and the design of infection-fighting materials. His research focuses on creating an engineered class of materials that can be used for applications to transplant a graft without immune-suppressive drugs. Human studies are planned to start next year. Researchers in his lab are developing new ways to treat Type 1 diabetes, eventually working with adult stem cells to reprogram them into insulin-producing cells. Future applications include addressing kidney failure and other diseases.

Creating Opportunities for Collisions

Garca is enthusiastic about his research, as well as all of the collaborative research in IBB. IBB is a fantastic community of faculty, trainees, and staff who come together in making discoveries and developing the technologies in bioengineering and bioscience that will change the world, he said. His goal is that IBB will continue to expand research and integrative opportunities to have a major economic impact, creating an environment to translate research into commercial products and therapies. With IBB we want to provide opportunities for collisions, unexpected interactions that lead to the discoveries. It was Bob Nerems vision to drive that sort of collaboration, he said.

Garca shared an example of one such collision: As part of a grant from the Juvenile Diabetes Research Foundation (JDRF), I was required to present unpublished research progress at a meeting with other researchers from throughout the country. After I made my presentation that morning, a JDRF director announced that for the next three-year cycle of funding we would need to collaborate with someone in the room on research. We went to lunch, and as I was building my sandwich, an immunologist introduced himself to me, complimented me on my presentation, and asked me if I thought I could develop a biomaterial to deliver the particular protein he was working with. You never ask an engineer if they think they can do something. Theyll find a way. I said I could, and we started working together.

An elected member of both the National Academy of Inventors and the National Academy of Engineering, Garca has established three startup companies in the past seven years. He has received numerous awards for his teaching and research and has published more than 230 peer-reviewed papers in prestigious journals.

Mentoring Students

Garca has supervised 15 postdoctoral researchers and advised/co-advised 37 Ph.D. students. He is known for his long-term commitment to his trainees, as well as mentoring students outside of his laboratory and classroom. While he has not taught for the past three years because of his responsibilities as IBB executive director, he still mentors students in his lab.

I take my responsibility as a mentor and supervisor seriously. It is important to have one-to-one interactions, Garca said. I take a practical approach and feel it is critical to explain why learning a topic is important, sharing practical applications, and offering experiential hands-on learning. I have had very supportive and engaged mentors and would like to pass that on to others.

Background

A native of Puerto Rico, Garca originally came to the states to study at Cornell University. He was very interested in the emerging field of biomedical engineering, but his father, an industrial engineer, advised him to major in another engineering discipline as a backup in case the biomedical field didnt develop as anticipated. Garca took his fathers advice, earning his bachelors degree in mechanical engineering and also taking biology and bioengineering classes.

During his senior year Garca participated in a project to design a structure to support fractured legs for horses. He worked to optimize the way a boot attached to the bone so that it wouldnt fracture again. He became interested in research, and his professors recommended that he go to graduate school. He earned his masters and Ph.D. in bioengineering from the University of Pennsylvania. Garca was the first person in his immediate family to earn a doctoral degree.

Garca and his family have embraced all things Georgia Tech. He and LaPlaca have two sons, Rafael, a Tech mechanical engineering (ME 2018) graduate working at GTRI, and Andrs, a fourth-year mechanical engineering student at Tech. They hold season basketball and football tickets. One of their dogs is named Buzz.

Garca said he was deeply honored, humbled, and shocked when Georgia Tech President ngel Cabrera called and told him he had been selected for this years Distinguished Professor Award. The award is special to me because it reflects the great contributions my friends, family, and peers have made in my life to get me to this point. I am grateful for my trainees, my collaborators, and colleagues, and for the support that Georgia Tech has provided in giving me the tools to succeed. Georgia Tech is the best, Garca said.

Quotes From Colleagues and Former Students

Professor Garca has been an integral part of growth of the international reputation of our bioengineering program and the Institute for Bioengineering and Bioscience. Having seen the sustained impact that he has had on students from K-12 (Project Engages) through graduate students, he is a remarkable educator who I feel is well deserving of this award.

Sam Graham Eugene C. Gwaltney Jr. School Chair in Mechanical Engineering Georgia Tech

He remains on my short list of speakers because I resonate so strongly with his approach very deep technical skills, outstanding problem definition, and tremendous colleague in service and collegiality. He is also a terrific mentor, and his former lab members are stars. He cares about doing great science and teaching people what he learned. Andrs Garca is a gem at Georgia Tech, and as an alum I hope you can keep him there he is doing some of the best biology on campus and is a superb attractor of the best students from MIT.

Linda G. Griffith S.E.T.I. Professor of Mechanical and Biological Engineering Director, MIT Center for Gynepathology Research Chair, MIT Biological Engineering Undergraduate Programs Committee

The lab around Professor Garca performs research at a unique broadness and depth. His remarkable combination of professional and personal skills is the key for his success and makes him a highly estimated collaboration partner for other scientists across disciplines and continents. He is the most invited American scientist at plenary lectures in European conferences on biomaterials. This is not only due to the high quality of his work, but also to his ability as a communicator and active discussion partner, his openness to address new topics in collaboration, and his passion for science and education that truly inspires and motivates young researchers.

Arnzazu del Campo Director INM-Leibniz Institute for New Materials Professor, Materials Synthesis, Saarland University

The five years that I spent in Andrs lab were transformative for me, and the influence of that experience is difficult to put into words. Andrs taught me many things how to be a scientist; how to develop creative and impactful ideas; how to execute on those ideas; how to write; how to present, etc. But more important than all the technical aspects of what I learned from Andrs, I learned from him who I wanted to be. Most of my professional life, and much of my personal life, is modeled after what I have learned from watching Andrs as a professor, colleague, friend, father, and husband.

Charles Gersbach Professor, Department of Biomedical Engineering Director, Center for Biomolecular and Tissue Engineering Director, Center for Advanced Genomic Technologies Duke University

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Andrs Garca Receives Distinguished Professor Award | Research - Research Horizons

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