Those linked to stem cell board received more than $2.1 billion – Capitol Weekly

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by DAVID JENSEN posted 09.15.2020

Over the last 15 years, Californias stem cell agency has spent $2.7 billion on research ranging from arthritis and blindness to cancer and incontinence. The vast majority of the money has gone to enterprises that have ties to members of the agencys governing board.

All of which is legal. All of which is not likely to change.

Eight out of every ten dollars that agency has handed out have been collected by 25 institutions such as Stanford University, multiple campuses of the University of California and scientific research organizations. Their combined total exceeds $2.1 billion.

All 25 have links directly or indirectly to past or present members of the board of the agency, according to an analysis by the California Stem Cell Report, which has covered the agency since 2005.

They (the agencys directors) make proposals to themselves, essentially, regarding what should be funded. They cannot exert independent oversight, says Harold Shapiro, who led a 2012 study of the agency by the prestigious Institute of Medicine (IOM), which is now called the National Academy of Medicine. The study recommended a major restructuring of the agencys board to help deal with the problem.

The longstanding, conflict-of-interest issues are not addressed in Proposition 14 on the Nov. 3 ballot. The measure would give the agency, officially known as the California Institute for Regenerative Medicine (CIRM), $5.5 billion more and expand its scope of activities and research. The ballot measure is likely to increase the problems by increasing the size of the agencys governing board from 29 to 35.

Another ballot initiative, Proposition 71, created Californias stem cell program in 2004. Ever since, conflict of interest questions have dogged CIRM. Indeed, critics of the agency can today point to the top five recipients of CIRM largess as examples of conflict problems. Stanford University ranks as the No. 1 recipient with $388 million. UCLA is No. 2 with $307 million. It is followed by UC San Diego, $232 million; UC San Francisco, $199 million, and UC Davis, $143 million.

All have had a representative on the CIRM board since the inception of the program.

Editors note CIRMs totals may change slightly as the result of the agencys internal accounting procedures.

IOM and public confidence in CIRMThe IOM study, with its criticism of conflicts, was commissioned by CIRM at a cost of $700,000. Directors expected that it would provide a gold standard evaluation of the agency that would support a ballot measure for additional funding. The studys scope went well beyond conflicts of interest. In fact, it said it did not search for evidence of specific conflicts because the task was not part of the agreement with CIRM. The IOM did say that studies from psychology and behavioral economics show that conflict of interest leads to unconscious and unintentional self-serving bias and to a bias blind spot that prevents recognition of ones own bias. While all of the studys findings were consequential, the matter of conflicts attracted the most public attention.

Ties to stem cell board lucrative, said a headline in the Orange County Register shortly after the IOM report was released.

The agency has used more than half of its funding and one day will almost certainly want to ask taxpayers for more. It should remember that voters will look for evidence of public accountability as well as respected research, said the Los Angeles Times in an editorial in December 2012.

The IOM report itself said, Far too many board members represent organizations that receive CIRM funding or benefit from that funding. These competing personal and professional interests compromise the perceived independence of the ICOC (the CIRM governing board), introduce potential bias into the boards decision making, and threaten to undermine confidence in the board.

The IOM said the composition of the board makes it neither independent nor capable of oversight, although the board is legally dubbed the Citizens Independent Oversight Committee (ICOC).

Placing deans of medical schools and patient advocates on the board who are linked to specific diseases raises questions about whether decisions delegated to the boardparticularly decisions about the allocation of fundswill be made in the best interests of the public or will be unduly influenced by the special interests of board members and the institutions they represent. Such conflicts, real or perceived, are inevitable.

The situation involves more than legalisms. Properly understood, the IOM said, conflict of interest is not misconduct, but bias that skews the judgment of a board member in favor of interests that may be different from or narrower than the broader interests of the institution.

The IOM study additionally surveyed board members about conflicts of interest and reported, While a majority of respondents stated that personal interests did not play a role in their work on the ICOC, some responses were more equivocal. One respondent replied that it was hard to tell given that so many decisions take place off camera in secret meetings, while another acknowledged that ICOC members are human, and, of course, their decisions are influenced by personal beliefs and interests.

The inherent conflicts The conflicts were built in by Proposition 71, which dictated the composition of CIRMs 29-member board. CIRMs general counsel, James Harrison, once described the situation as inherent conflicts of interest.

Under Proposition 71, representatives from virtually all the California institutions that stood to benefit were given seats at the table where spending plans are approved and awards handed out. Directors are not allowed to vote on specific awards to their institution. But they control the direction of the agency and what CIRM calls concept plans, including specific elements and budgets for the award rounds. Some of those rounds run into hundreds of millions of dollars.

One of the concept plans created a $47 million program to help California institutions recruit star scientists to the Golden State. Another plan created the $50 million Alpha Clinic Network at five academic centers all connected to board members.

Following the IOM report, the CIRM board did remove most institutional directors from meetings where awards are ratified. Jonathan Thomas, chair of the board, declared then that financial conflict issues were put to bed once and for all, a position that the agency holds today. In May 2019, Thomas told directors that CIRM several authoritative entities have studied CIRM and produced written reports that dealt with conflict matters.

Thomas said, Each had in it sort of quite vehement language about the conflict of interest issue, which has always been just perceived..With respect to any given funding award, theres never been an actual conflict.

During the 2019 meeting, the board did not discuss issues involving board action on concept plans. They continue today to modify and approve concept plans.

Beyond the CIRM board Conflicts of interest at CIRM go beyond the 29-member board. In 2014, the agency was shocked by a case involving a former president of the agency, Alan Trounson, and StemCells, Inc., a company that was awarded $40 million while he was serving as the top executive at CIRM. (The company later declined one of the awards.) Only seven days after his final day at CIRM, Trounson was named to the board of directors of StemCells, Inc.

He served on the companys board for about two years and received $443,500 in total compensation, including stock options, according to StemCells, Inc., documents filed with the Securities and Exchange Commission.

Following the announcement of the Trounson appointment, CIRM looked into some of Trounsons work at CIRM. In July of 2014, the agency said that its severely limited investigation found no evidence that its former president attempted to influence action on behalf of StemCells, Inc., during the previous month. The states political ethics agency, the Fair Political Practices Commission, said in a Feb. 6, 2015, letter to Trounson that there was insufficient evidence to demonstrate a legal violation.

Even before the agency was created, critics warned of conflict-of-interest problems. Writing in an opinion piece in October 2004 in the San Francisco Chronicle, David Winickoff, then a professor at UC Berkeley, said, Contrary to what its name suggests, the ICOC is neither independent of interest-group politics nor does it include any citizen members. Hard- driving university scientists, disease group advocates and private industry executives who will make up the ICOC all have vested interests in how the money is to be used.

A sampling of conflictsThe California Stem Cell Report, which calculated the percentage of awards linked to institutional directors, has chronicled the conflicts issues at CIRM over the past 15 years. In 2012, its analysis showed that 92 percent of awards had been collected by institutions tied to past and present directors. The figure dropped to 79 percent by this summer as the types of grantees have widened. Here is a sampling of conflict issues that have surfaced publicly over the years.

In 2007, violations involving five board members resulted in voiding applications from 10 researchers seeking $31 million. The applications included letters of support signed by deans of medical schools who also sat on the CIRM board of directors. Directors are barred from attempting to influence a decision regarding a grant. The agency blamed its employees for the problem.

In 2008, public complaints by one applicant from industry about conflicts of interest on the part of a reviewer were briefly aired at a public board meeting. The then chair of the CIRM board, Robert Klein, told the applicant the board needed instead to discuss naming CIRM-funded labs and then go to lunch. CIRM later refused to release the letter from the applicant detailing the problem.

In 2009, board member John Reed, then CEO of the Sanford-Burnham Institute, was warned by the states Fair Political Practices Commission about his violation of conflict of interest rules. Reed intervened with CIRM staff on behalf of a $638,000 grant to his organization. Reed took his action at the suggestion of then CIRM Chair Klein, an attorney who led the drafting of Proposition 71.

Also in 2009, then board member Ted Love, who had deep connections in the biomedical industry, served double duty for the agency. He was the interim chief scientific officer and helped to develop the agencys first, signature $225 million disease team round while he was still serving on the board. As chief scientific officer, Love would have had access to proprietary information and trade secrets in grant applications.

When questioned, CIRM said that Love would serve only as a part-time advisor to the agency president, not as chief scientific officer. Nonetheless, in 2012, the board adopted a resolution with high praise for Love and his performance specifically as the chief scientific officer.

Beginning in 2010, a stem cell firm, iPierian,Inc., whose major investors contributed nearly $6 million to the ballot measure that created the stem cell agency, received $3.9 million in awards from the agency. The contributions were 25 percent of the total in the campaign, which was headed by Bob Klein. (See here and see here.)

In 2011, the chairman of the CIRM grant review group resigned from his position as the result of another violation, which the agency felt necessary to report to the California legislature. John Sladek, former president of Cal Lutheran University in Los Angeles, co-authored scientific publications with a researcher who was listed as a consultant on a CIRM grant application.

In 2012, StemCells, Inc., was awarded $40 million by the CIRM board despite having one of its $20 million applications rejected twice by grant reviewers. The action came after the board was vigorously lobbied by Klein, who had left his post as chair the previous year. Klein, who ran the Proposition 71 campaign, had campaign connections to researcher Irv Weissman of Stanford, who founded StemCells, Inc., and was on its board. Weissman was featured in a TV campaign ad for Proposition 71 and helped to raise millions for the 2004 ballot campaign.

The StemCells, Inc., awards were the first time that CIRM had approved that much money for one company, and the first time Klein lobbied his former board.

In 2012, an incident surfaced that illustrated how non-profit, disease-oriented organizations sometimes expect increased funding as the result of the appointment of sympathetic individuals to the board. That occurred when Diane Winokur was appointed to the board as a patient advocate. The chief scientist for The ALS Association, said Winokur will be a tremendous asset in moving the ALS research field forward through CIRM funding.

The IOM study identified as a problem the personal conflicts of interest involving the 10 patient advocates on the board. It said, (P)ersonal conflicts of interest arising from ones own or a family members affliction with a particular disease or advocacy on behalf of a particular disease also can create bias for board members.

In 2013, internationally renowned scientist Lee Hood, winner of a National Medal of Science, violated the conflict of interest rules of the California stem cell agency when he was involved in reviewing applications in a $40 million round to create genomics centers in California. The conflict involved connections between Hood, Weissman and Trounson. It was not discovered by the agency during the closed-door review and was raised by another reviewer at the end of the review. The review had to be redone later in the year.

Hood never commented publicly, but CIRM said he acknowledged the conflict.

In January 2014, the genomics round surfaced again. The applications were by then before the CIRM board for public ratification of reviewers decisions. The reviewers actions are taken behind closed doors with no public disclosure of reviewers personal, professional or economic conflicts.

The genomics round riled some researchers who complained publicly in letters to the agencys board about unfairness, apparent preferential treatment and manipulation of scores.

Only seven of the 29 members of the 29-member board could vote on the applications. Conflicts of interest and CIRM rules barred the rest from voting. The final vote on the award was 6-1 for a group led by Stanford. Two years earlier, however, when the concept plan was approved by the CIRM board, no directors were disqualified, even though some of their institutions were likely to benefit. The plan was approved on a show of hands. The transcript of the meeting does not indicate any negative votes or absentions.

The hidden review processUnder CIRMs rules, the scientists who review the applications must come from out-of-state. They do not have to disclose publicly their economic, personal or professional conflicts despite the fact that they make the de facto decisions on the applications. The board rubber stamps nearly all of the reviewers actions to approve funding. A CIRM examination of the practice in 2013 showed that 98 percent of reviewers decisions were ratified by the board. Since then, the agency has not produced a similar report. Occasionally, however, the board will approve an application that was not recommended for funding.

The CIRM governing board has resisted requiring public disclosure of the interests of reviewers. The subject has come up several times, but board members have been concerned about losing reviewers who would not be pleased about disclosing their financial and other interests.

Nonetheless, public disclosure of economic interests among researchers is routine in scientific research articles. Many universities, including Stanford, also require public disclosure of financial interests of their researchers.

At the time of Hood-Weissman-Trounson flap, Stanfords policy said, No matter what the circumstances if an independent observer might reasonably question whether the individuals professional actions or decisions are determined by considerations of personal financial gain, the relationship should be disclosed to the public during presentations, in publications, teaching or other public venues.

Proposition 71 placed the legal authority for grant approvals in the hands of the CIRM board. Traditionally in the world of science, other scientists ( peer reviewers), however, are deemed to be the most capable of making the scientific decisions about grant applications. The traditional practice calls for the reviewers to be anonymous and meet in private, which is also CIRMs practice.

If the CIRM board concedes the decisions to the grant reviewers, state law is likely to require public disclosure of their financial interests, a move that the board has opposed for years. Former CIRM Chairman Klein repeatedly advised the board during its public grant approval processes that reviewers actions were only recommendations, and that the board was actually making the decisions.

Proposition 14 implicitly recognizes, however, that a problem exists with directors approving concept plans for awards that could benefit their institutions.

To ease that problem legally, Klein inserted language in the new proposition that excludes adoption of strategic plans, concept plans and research budgets from being considered as matters involving conflicts of interest.

The measure does nothing to deal with matters involving the de facto, closed-door approval of awards by researchers who are unknown to the public and who do not have to publicly disclose their interests.

At the time the IOM report was released nearly eight years ago, some board members complained that its recommendations were unrealistic because of the likely, lengthy difficulties of altering a state law that had been created by the initiative. But since then, directors have not asked state lawmakers to change the structure of the board or to comply with the other $700,000 worth of IOM recommendations.

CIRM directors, however, missed an opportunity last year to seek conflict-easing changes through the $5.5 billion stem cell measure now on the ballot, Proposition 14.

Some board members have said they discussed the initiative privately with Bob Klein, who crafted the proposal last year.

Revision of CIRMs conflict rules was discussed at a board meeting in May 2019. Several board members expressed concerns about the loss of valuable insights from board members who cannot vote on applications. Some also expressed concerns about whether loosening the rules would damage the possibility of voter approval of a ballot measure to refinance the agency. Several, including CIRM Chair Thomas, also said theres never been a conflict involving a funding award and a board member. No action involving conflicts was taken at the meeting. Editors Note: DavidJensen is a retired newsman who has followed the affairs of the $3 billion California stem cell agency since 2005 via his blog, the California Stem Cell Report. He has published thousands of items on California stem cell matters in the past 11 years. This story was an excerpt from his upcoming book, Californias Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures, which s available for pre-order on Amazon.

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Those linked to stem cell board received more than $2.1 billion - Capitol Weekly

Takeda Expands Cell Therapy Efforts with New R&D Manufacturing Plant in Boston – BioSpace

Takeda Pharmaceutical opened a new 24,000-square-foot R&D cell therapy manufacturing facility in Boston, Massachusetts. It is at the site of the companys R&D headquarters.

It will provide end-to-end R&D capabilities and advance the companys plans to develop next-generation cell therapies. The initial plan is to focus on oncology then expand into other areas.

We are collaborating with some of the best scientists and innovators around the world establishing a highly differentiated immuno-oncology pipeline leapfrogging into new modalities and mechanisms with curative potential, said Chris Arendt, Head of Takedas Oncology Therapeutic Area.

He went on to say, With three oncology cell therapy programs in the clinic and two more targeted to enter the clinic in fiscal year 2021, we are working with urgency and purpose for patients. This new facility helps us rapidly scale our manufacturing capabilities so we can simultaneously advance multiple highly differentiated cell therapy programs.

The facility will manufacture cell therapies all the way up to pivotal Phase IIb trials. Its current Good Manufacturing Practices (cGMP) facility meets all U.S., European Union and Japanese regulatory requirements for cell therapy manufacturing that can be used for Takeda clinical trials globally.

Takeda and MD Anderson are testing a possible best-in-class allogeneic cell therapy, TAK-007, a CD19-targeted CAR-NK cell therapy for off-the shelf use in patients with r/r non-Hodgkins lymphoma and chronic lymphocytic leukemia. It is currently in Phase I/II trials. Two more Phase I trials of the companys cell therapies were recently launched, including 19(T2)28z1xx CAR T-cells (TAK-940), a next-generation CAR-T signaling domain developed with MD Anderson Sloan Kettering Cancer Center for r/r B-cell cancer and a cytokine and chemokine armored CAR-T (TAK-102). TAK-102 was developed with Noile-Immune Biotech to treat GPC3-expressing previously treated tumors.

Late last week, Takeda released data from the Phase III TOURMALINE-MM2 trial of Ninlaro (ixazomib) to lenalidomide and dexamethasone compared to lenalidomide and dexamethasone plus placebo in treating newly diagnosed multiple myeloma patients who were not eligible for autologous stem cell transplant. The trial did not meet statistical significance for the primary endpoint of progression-free survival (PFS).

The addition of Ninlaro resulted in a 13.5 month increase in median PFS, 35.3 months in the Ninlaro arm compared to 21.8 months in the placebo arm, but although there was a numerical improvement, it did not hit the threshold for statistical significance.

There is a specific need in newly diagnosed multiple myeloma, given there are currently no approved all-oral, proteasome inhibitor-based treatment options, said Thierry Facon, Lille University Hospital, principal investigator and lead author of TOURMALINE-MM2.

Facon added, Findings from the TOURMALINE-MM2 trial are important overall for this patient population as well as across multiple subgroups including patients with high-risk cytogenetics. We hope these data will help inform future research and further progress for the multiple myeloma community.

Ninlaro is an oral proteasome inhibitor. It is being evaluated across a broad range of MM treatment settings. It was first approved by the U.S. Food and Drug Administration (FDA) in November 2015 and is indicated in combination with lenalidomide and dexamethasone for patients with MM who have received at least one previous therapy. It is currently approved in more than 65 countries.

Earlier, Takeda indicated it had entered an agreement to sell some noncore prescription drugs that are sold primarily in Europe and Canada to Germanys Cheplapharm for $562 million. Last month the company sold off a big chunk of its consumer health products to Blackstone Group for $2.3 billion. The company has a goal of divesting $10 billion.

Takedas five key focus areas are gastroenterology, rare diseases, oncology, plasma-derived therapies and neuroscience. It has $59 billion in debt from acquiring Shire and is selling off noncore areas to help pay down that debt.

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Takeda Expands Cell Therapy Efforts with New R&D Manufacturing Plant in Boston - BioSpace

Allow your body to heal on its own with the help of Stemcure Clinic – Lowvelder

Platelet rich plasma treatment (PRP) and stem cell therapy encourage your body to heal on its own, by using its cells to stimulate the healing process.

PRP is a relatively new treatment for muscular-, skeletal-, orthopaedic- and brain-related injuries in South Africa. It uses part of the bodys natural inflammatory process to accelerate and enhance healing. Stemcure Clinic has the only specialists offering this treatment in Mpumalanga.

The clinic has been operating in White River for a number of years after Dr Hein van Wyks stem cell research yielded some interesting insight. He found that on their own, stem cells dont work as well as they should when used in treatments, as they are unable to grow when toxins are present.

The perfect environment is one where there is no inflammation and no toxins. So he took a new approach to this treatment by combining a specific type of detox (which focuses on cleansing the cells) with PRP therapy.

Stem cells have the remarkable potential to develop into many different cell types in the body during early life and growth. In addition, in many tissues they serve as a sort of internal repair system, dividing essentially without limit to replenish other cells, he said.

This combination proved to be the key to stem cells working optimally, as it drastically improved their survival rate. They hold a great deal of potential and with the current research, we are learning more about the capabilities of these unique cells, he continued.

Stem cell therapy is a non-invasive procedure, which means there is no surgery involved and there will be very little to no pain. The treatment at Stemcure Clinic consists of using stem cells from your own body. They have the ability to become whatever cells your body needs, which is what makes them so unique.

What is cellular therapy? Cellular therapy involves cellular material (living cells) being injected into the patient and is used to successfully treat a variety of conditions, while it is also used for cosmetic procedures. The clinic offers stem cell therapy to treat patients. Using those harvested from their own bodies, they help patients to regenerate cells quicker, in order to heal faster. What is a stem cell and why should you consider stem cell treatment? A stem cell is an undifferentiated cell which has the ability to become just about any kind your body needs. Our bodies are reservoirs of stem cells! Effective, safe and non-invasive are just a few of the words used to describe the treatment. Many patients have recovered from ailments and injuries faster when having stem cell therapy. What is PRP treatment?

PRP, or platelet rich plasma treatment is the ideal option for various kinds of pain. It involves using your own blood plasma to give your natural inflammatory system regenerative process a kick-start! This is relatively painless, non-invasive procedure.

Today, Hein and his son, Louis, who followed his fathers footsteps into the medical profession, treat patients from all over the country while also providing their expert services to people from Namibia, China and Malawi. You can look and feel great. This is just one of the things we tell our patients. At Stemcure Clinic, you will be in the most caring of hands.

We are a team that is exceptionally passionate about everything we do, and we are even more passionate about the health of our patients. Our practice has been helping people from all walks of life to improve their health, to treat chronic pain and to boost their bodys natural rejuvenation processes using safe, non-invasive medical procedures. And we can assist you too.

Vein Solutions is a centre of excellence in the comprehensive evaluation and treatment of vein disorders. Dr Gideon van Wyk has a profound understanding of the relationship between veins and the bodys overall circulation.

He utilises his unique knowledge, perspective, and experience of more than 16 years, to provide the best overall medical treatment for his patients. Vein Solutions features minimally invasive treatments that provide immediate and long-term results. Gideon is a member of the American College of Phlebology, which is the leading resource for vein-care physicians, health professionals and patients.

To determine if a venous problem exists, a comprehensive evaluation is performed through an in-depth medical history and a physical examination by an experienced specialist surgeon. In addition, an extensive ultrasound study is performed by a registered sonographer to help determine the diagnosis. At Vein Solutions, the physician and patient mutually discuss the findings to determine the best treatment plan for the problem.

According to Gideon, they are experienced in all vein treatment modalities and are able to recommend the best for the individual. These procedures are performed daily, in a patient-friendly environment and usually in less than an hour.

Almost all procedures are done under local anaesthesia, thereby reducing risk and increasing convenience. Most patients resume normal activities within 24 hours and return to work in days instead of weeks.

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Allow your body to heal on its own with the help of Stemcure Clinic - Lowvelder

The Animal Stem Cell Therapy market to Undergo positive Transformation between 2017 and 2025 – The Daily Chronicle

Animal stem cell therapy is a usage of animals stem cell to treat a disease or disorder. The ability of stem cell is to divide and differentiate into a cell with specialized function useful for repairing body tissues damaged by injury or disease. The animal stem cell therapy process involve three steps which include collection of stem cell sample from animals and preparing the sample to concentrate the stem cells. Finally, the therapy includes transferring the stem cells into the injured site for treatment. Animal stem cell therapy increases the expectancy of life in animals with no side effects. It is available for the treatment of arthritis, degenerative joint disorders, tendon, and ligaments injuries in animals. Stem cell therapy is most often used to treat dogs, cats, and horses. But recent developments made it possible to use animal stem cell therapy in tiger, pig, etc. Present animal stem cell therapy is studied in treatments of the inflammatory bowel, kidney, liver, heart and immune-mediated diseases respectively.

Animal Stem Cell Therapy Market: Drivers and Restraints

Increasing prevalence of disease in animals with growing population and to increase the animals quality of life, the companies focus shifting towards animal stem cell therapies. Along with increasing government funding for the protection of animals and fast approvals of FDA contributing towards the rapid growth of the animal stem cell therapy. The research in animal stem cells offers great promise for understanding underlying mechanisms of animal development; it gives great opportunities to treat a broad range of diseases and conditions in animals. Animal stem cell therapy is increasingly recognized as critical translational models of human disease for treatment. All these factors act as drivers for the robust growth of the animal stem cell therapy market.

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Animal Stem Cell Therapy Market: Segmentation

Segmentation based on Applications

Segmentation based on End-user

Animal Stem Cell Therapy Market: Market Overview

Studies in the animal stem cell therapy continue at a breathtaking pace due to increasing demand and treatment cost covered in reimbursements. And animal stem cell therapy is more effective than traditional treatment available in the market which is boosting the companies to increase the spending in the R&D for innovative methods. Because of the novelty and complexity of animal stem cell therapy, FDA encourages individuals, universities and drug companies for further innovations. The future expected with double CAGR during the forecasted period.

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Animal Stem Cell Therapy Market: Region-wise Overview

Regarding geographies, North America is dominating the global animal stem cell therapy market due to the increased incidence rate and awareness about the therapy. U.S represents the largest market share in the North America due to the increasing demand for the therapy. Europe and Asia-Pacific are showing a significant growth rate during the forecasted period due to the growing adoption of the animal stem cell therapy. The animal stem cell therapy market in underdeveloped countries is slow when compared to the developed countries.

Animal Stem Cell Therapy Market: Key Participants

The key participants in the animal stem cell therapy market are Magellan Stem Cells, ANIMAL CELL THERAPIES, Abbott Animal Hospital, VETSTEM BIOPHARMA, Veterinary Hospital and Clinic Frisco, CO, etc. The companies are entering into the collaboration and partnership to keep up the pace of the innovations.

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The Animal Stem Cell Therapy market to Undergo positive Transformation between 2017 and 2025 - The Daily Chronicle

Dr. Hill on the Role of CAR T-Cell Therapy in Relapsed/Refractory DLBCL – OncLive

Brian T. Hill, MD, PhD, discussesthe role of CAR T-cell therapy in relapsed/refractory diffuse large B-cell lymphoma.

Brian T. Hill, MD, PhD, director of the Lymphoid Malignancies Program and staff physician, Taussig Cancer Institute, and assistant professor, Hematology and Oncology, Cleveland Clinic, discussesthe role of CAR T-cell therapy in relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

In October 2017,the FDA approved axicabtagene ciloleucel (axi-cel; Yescarta) for the treatment of adult patients with certain types of large B-cell lymphoma, including DLBCL, who have not responded to or who have relapsed after 2 or more treatments. Additionally, in May 2018, another CAR T-cell therapy product, tisagenlecleucel (Kymriah) was approved in a similar indication.

Prior to theseapprovals, therapeutic options were limited for patients who relapsed after autologous stem cell transplantor were ineligible for transplant.

However, the rate of durable remission is limited to 40% to 50% of patients with relapsed/refractory DLBCL. As such, there is a significant need to developadditional therapies in this space, Hill concludes.

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Dr. Hill on the Role of CAR T-Cell Therapy in Relapsed/Refractory DLBCL - OncLive

The 9th ISS R&D Conference Is Opening This Week, but This Year’s Setup Is Different – Science Times

The ninth annual International Space Station Research and Development Conference (ISSRDC) is set to open on Thursday, August 27, at 10 a.m. EDT, coinciding with the microgravity laboratory's 20th anniversary of continuous human presence in space.

NASA Administrator Jim Bridenstine will be opening this year's conference, with the theme "From Vision to Discovery," emphasizing how the past can help guide the future. The ISSRDC is going virtual this year, with the events spread over three nonconsecutive daysbut all falling on Thursdaysstarting this August 27, followed by a session on September 17, and the last being on October 22.

RELATED: Jeanette Epps Set to Be the First Black Woman to Join ISS Crew

According to NASA, the event is the only conference that explores in detail the full breadth of research and development currently underway on the orbiting laboratory, including future research to span the life of the ISS.

On the first Thursday of the ISSRDC, the session will focus on the space administration's commercialization initiative and updates from its leadership. The opening plenary session is also set to include a discussion regarding the evolution of the ISS US National Laboratory. Among the speakers set to appear on the August 27 session are Kathy Lueders, NASA's Human Exploration and Operations Mission Directorate Associate Administrator, and Dr. Thomas Zurbuchen, NASA Science Mission Directorate Associate Administrator.

The September 17 session will tackle business trends that affect the space station. Professor Alessandro Grattoni from the Houston Methodist Research Institute Department of Nanomedicine and Professor Aleksandar Ostrogorsky from the Illinois Institute of Technology's Mechanical and Materials Engineering Department will discuss how the ISS moves closer towards commercial applications.

For the third plenary day of the ISSRDC, NASA's press release announces that it will "touch on a myriad of science and educational activities." The session will focus on 20 years of student investigations enabled by the international space station. Keynote speakers for the third day include Mayo Clinic Director of Transfusion Medicine and Stem Cell Therapy Abba Zubair, New York Stem Cell Foundation Senior Research Investigator Valentina Fossati, Quest Institute's Danny Kim, and Genes in Space Lead Katy Martin.

The full schedule, including the list of speakers and moderators, can be found on the ISS Conference website.

The ISS is a modular space station and a habitable artificial satellite hovering in the Earth's orbit first launched on November 20, 1998. It started as a collaborative effort between the space agencies of five nations: United States (NASA), Russia (Roscosmos), Europe (ESA), Japan (JAXA), and Canada (CSA).

(Photo: Nasa/Getty Images) he International Space Station (ISS) is Backdropped Against The Blue And White Horizon Scene Of Earth And The Blackness Of Space Following Separation From Discovery June 3, 1999.

Since it was launched into space, the ISS has become a space environment and a microgravity research platform for different countriesconducting studies in various fields including astrobiology, meteorology, physics, chemistry, and more. This coming November, according to NASA, its international and commercial partners will be celebrating the 20th year of having humans continuously live and work at the ISS.

RELATED: SpaceX, NASA On the Lookout Before Endeavor Splashdown

Since 2000, it has already accommodated 240 people from 19 countries, across almost 400 flights. Among the achievements by the space environment and microgravity lab include hosting more than 3,000 research inquiries designed by researchers from more than 100 countries.

Check out more news and information on Space and otherNASA Missionson Science Times.

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The 9th ISS R&D Conference Is Opening This Week, but This Year's Setup Is Different - Science Times

When old age catches up with you in your 30s – The Standard

Wayne Rooney was a football star during his time at Manchester United, accomplishing so much on the field. One of his greatest struggles was hair loss. At only 25, the football icon had started fighting with old age. Signs of old age start showing as early as when one is 30. By 40, you could develop sun spots, have shallow wrinkles or experience hair loss. While baldness in most men kicks in the 50s, like Wayne Rooney, you could experience it prematurely due to rare genetic conditions, says Arshni Malde, an aesthetic doctor at Tia Clinic in Nairobi.Some people are happy to embrace a new look and the challenges that come with old age but to others, sagging facial lines, deep wrinkles and a receding hairline can be a big blow to their confidence.I recommend a non-surgical facelift for people who want to look younger without incurring heavy financial costs, says Dr Arshni.As the skin matures, its structure weakens and it loses elasticity and firmness. This 60-minute anti-ageing procedure involves using products called threads that induce collagen in the skin, hence tightening it.The treatment works instantly in 70 per cent of patients I treat with the remaining small percentage experiencing full results by the end of two weeks. It will take one and a half to two years before the ageing process starts again at which we only do maintenance, Arshni says.The treatment costs an average Sh500,000.A solution to baldness

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When old age catches up with you in your 30s - The Standard

Stem Cell Concentration System Market Covid-19 Impact On 2020 In-depth Industry Size, Analysis, Growth, Opportunity and Forecast 2026: EmCyte, Terumo,…

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Stem Cell Concentration System Market Covid-19 Impact On 2020 In-depth Industry Size, Analysis, Growth, Opportunity and Forecast 2026: EmCyte, Terumo,...

Degenerative Disc Disease Therapeutics Market Industry Size, Growth, Analysis and Forecast to 2026 Osiris Therapeutics Inc, US Stem Cell Inc, Yuhan…

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Degenerative Disc Disease Therapeutics Market Industry Size, Growth, Analysis and Forecast to 2026 Osiris Therapeutics Inc, US Stem Cell Inc, Yuhan...

Burger Reviews BTK Inhibitors and Beyond in Frontline CLL – Targeted Oncology

During a virtual Case Based Peer Perspectives event, Jan A. Burger, MD, PhD, professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston, TX, discussed testing and the treatment options for chronic lymphocytic leukemia (CLL), based on the a case of 71-year-old female patient.

Targeted OncologyTM: What testing would you order to confirm diagnosis if you saw this patient in the clinic?

BURGER: We need to establish the diagnosis by flow cytometry and then we would do, at a minimum, FISH cytogenetics and, ideally, the mutational status. Cytogenetics can change, but mutational status usually doesnt change. If thats been established somewhere outside [of your clinic], then you dont have to repeat that test.

Its important to repeat cytogenetics if you talk about the relapse setting. But here, were treating in the frontline setting, and she was tested. She was found to be IGHV unmutated and [positive for] del(11q). That, traditionally, has been regarded as a higher-risk disease status because these patients respond OK to standard chemotherapy, but they have short remissions and survival times with FCR [fludarabine, cyclophosphamide, and rituximab (Rituxan)], BR [bendamustine plus rituximab], and those kinds of regimens compared with low-risk patients, such as those [who are positive for] deletion 13q and have IGHV mutated disease.

In terms of these sequences, when you see a patient with lymphocytosis, you send for flow cytometry, and part of the flow cytometry panel can test for additional markers, CD38 and ZAP-70. We have it [at MD Anderson], but Im not sure if there are any outside routine flow cytometry labs reporting CD38 positivity or negativity or ZAP-70. These markers used to be very popular 10 years or so ago when IGHV-mutation status was not so commonly done and was more complicated to get. Nowadays, theres a shift with sending a sample directly for IGHV-mutation testing.

If you have that and the routine CLL FISH panel, then you have a good amount of information about your patient to say this is high-, low-, or an intermediate-risk disease. I think the main purpose for doing these is, first, to identify [patients with] high-risk disease who have a deletion 17p [del(17p)] or TP53 mutations. If its a young patient, you want to know that to [be able to] avoid chemotherapy. If its a young patient, [you may want to] send those patients for evaluation for stem cell transplant. For some patients, that is still something that eventually needs to be considered for those with del(17p).

What systemic therapy would you offer?

If you have treated with ibrutinib [Imbruvica] and youre comfortable with that, I dont think at this time there is a strong reason to change. In selected patients, it might be reasonable to try switching them from one [agent] to the other. But right now, for this patient, consensus says a BTK [Bruton tyrosine kinase] inhibitor is a good treatment.

Both ibrutinib and acalabrutinib [Calquence] can be used as single agents or in combination with CD20 antibodies. Weve done a clinical study with ibrutinib where patients were randomized to receive monotherapy versus a combination with rituximab, and the outcome was virtually identicalwhere patients had the exact same progression-free survival [PFS] with a single agent versus the combination with a CD20 antibody.1

CD20 antibodies with BTK inhibitors dont seem to add benefit in terms of survival if you go with the long-term BTK inhibitor treatment and if youre not planning to stop your treatment at some point. What they do is they get patients into remission faster and you clear the disease faster if you add a CD20 antibody, but then you stop after 6 months. You continue your BTK inhibitor, and patients do great 2, 3, and 4 years later. Then, you dont see any effect in terms of longer-term PFS or overall survival [OS] from the addition of the CD20 antibody.

What data support the use of single-agent ibrutinib in patients with untreated CLL?

There are data from the RESONATE-2 study [NCT01722487], which randomized patients between ibrutinib and chlorambucil. This study was designed at the time when chlorambucil monotherapy was still the standard of care. Patients were randomized 1:1, and patients with del(17p) were excluded.2

What is nice about this study is that we have a long follow-up now.3 At the 5-year follow-up, you see this major difference in terms of PFS [HR, 0.146; 95% CI, 0.098-0.218]. There is also an overall survival benefit [HR, 0.450; 95% CI, 0.266-0.761].

What [we saw was] that patients with del(11q) seemed to have a better PFS than those patients who lack del(11q) when they are treated with ibrutinib. Patients with del(11q) who are treated with chemotherapy do not do as well as those who lack this cytogenetic abnormality. The same is true here for [IGHV] mutational status.

The PCYC-1102-CA study [NCT01105247] opened around 2010, and we now have 7 to 8 years of follow-up. If you use a BTK inhibitor in the frontline setting, you can expect that most patients are going to do well for an extended period of time. At 5, 6, and 7 years or longer, 70% to 80% of patients are still in remission and have not died.4

Another randomized study that created some waves [is the E1912 study (NCT02048813)]. Weve been big proponents of FCR, which was the comparator arm [of this trial] versus ibrutinib. Patients receive either 6 cycles FCR or continuous ibrutinib [with rituximab] for the first 6 cycles.5

That study showed that compared with FCR, there was a significant increase in PFS [HR, 0.39; 95% CI, 0.26-0.57; P <.0001] but also in OS benefit from the BTK inhibitorcontaining regimen [HR, 0.34; 95% CI, 0.15-0.79; P = .009].

Would you say ibrutinib is the standard of care for treatment of CLL in the frontline setting?

Ibrutinib monotherapy, I would say, is the standard of care, but ibrutinib plus rituximab can be used. Some of you use it and, based on the data we just saw, the FDA has now officially approved it.6 It doesnt mean you must use rituximab.

What other ibrutinib combinations are available?

The ALLIANCE trial [NCT01886872] had a single-agent ibrutinib arm versus ibrutinib plus rituximab versus bendamustine plus rituximab.7 When you have patients randomized to receive ibrutinib/rituximab versus ibrutinib as a single agent, the [Kaplan-Meier survival] curves are basically identical, and thats what we got as well in a slightly diff erent patient population, mostly relapsed patients. In terms of PFS, rituximab doesnt seem to add very much when you go with continuous ibrutinib treatment. You see the difference for bendamustine/rituximab, with which patients have significantly shorter PFS.

I think the theme is the same over and over again with these randomized studies. With the new targeted agents, such as the BTK inhibitors and venetoclax [Venclexta], we see the same pattern. The new agents are doing better than our traditional chemoimmunotherapy.

ILLUMINATE [NCT02264574] is the study comparing ibrutinib/obinutuzumab [Gazyva] with another chemoimmunotherapy regimen, which has been somewhat popular for older populations, more frail patients for whom you dont want to use FCR or BR. You traditionally use chlorambucil alone and then more recentlyits combined with CD20 antibodies. The patients were randomized to either [ibrutinib/obinutuzumab] versus chlorambucil/obinutuzumab treatment.8

The results show a major PFS benefits for patients on the BTK inhibitor [HR, 0.23; 95% CI, 0.15-0.37; P < .0001]. There was a big difference for genetically high-risk patients [HR, 0.15; P < .0001] or patients who had bulky disease.

What other BTK inhibitors would you consider here?

Now were going to the second-generation BTK inhibitor, acalabrutinib [Calquence], which is somewhat more selective and doesnt inhibit some other kinases that ibrutinib does. Its a new BTK inhibitor with not as much long-term follow-up data available.

[In the phase 3 ELEVATE TN trial (NCT02475681)], you have 3 arms: single-agent acalabrutinib, acalabrutinib combined with obinutuzumab, and the comparator arm of chlorambucil/obinutuzumab. 9 If you give that to treatment-nave patients, those receiving BTK inhibitor alone or with the CD20 antibody do well. Its debatable if the PFS difference is significant, but clearly, the BTK inhibitortreated patients do much better than those receiving chlorambucil plus obinutuzumab.

[If you look at the] subgroups of patients benefitting from the BTK inhibitor treatment versus obinutuzumab/chlorambucil, it basically shows that all subgroups have benefit. Some may be a little more than others...but I think particularly patients that we traditionally called high risk are the ones who benefit the most from new agents. Theres less difference if you go into the lowrisk patient populations.

Are there data supporting the use of a BCL2 inhibition?

The other frontline option involves venetoclax, and thats coming from this CLL14 trial [NCT02242942]. Patients were receiving venetoclax/obinutuzumab or chlorambucil/obinutuzumab, and this is a finite treatment for 12 months. These are patients who were older and who have some comorbidities. Deletion(17p) was not excluded.10

There is a major difference in PFS favoring the new targeted agent venetoclax. Now its approved for the frontline treatment of selected patients,11 but you can also see in comparison to the BTK inhibitors [that] the follow-up is relatively short of 3 years.

With venetoclax, you get more complete remissions and some of these remissions are MRD [minimal residual disease] negative. As long as these differences are not translating into a survival benefit, those are just numbers.

Would you recommend venetoclax after the first line?

I dont think theres a reason to make that change [from BTK inhibitors] because venetoclax has its own issues in terms of how its used and adverse effects [AEs]. For that questionmaybe [we ask [is] venetoclax better in terms of outcome than a BTK inhibitor?

Its difficult to be better than the BTK inhibitor in the frontline CLL setting, and you need a very long follow-up to show any differences if there are any.

A substantial number of patients [treated with venetoclax] receive MRD-negative remissions with this combination. MRD negativity doesnt mean patients are cured. There is drop off in PFS, so MRD negativity doesnt mean those patients will survive and never need treatment again. Most likely, those patients eventually will lose MRD and eventually have disease progression and need treatment again. I think for those studies based on frontline venetoclax for 12 months, we just have to stay tuned and wait for what the long-term outcome is going to be.

What are the AEs of venetoclax?

You see more AEs that are reminiscent of chemotherapy days, where patients get more cytopenia. Its well established that venetoclax is myelosuppressive. Certainly, neutropenia can be seen, and less frequently, thrombocytopenia and anemia. If you treat a patient with venetoclax with or without a CD20 antibody, then you have to prepare for some patients having issues with neutropenia and some who cannot be fully dose-escalated because of those cytopenias.

If the patient was younger, would you treat differently?

My answer would be no. I dont see any difference. This patient was 71 years old. We wouldnt use chemoimmunotherapy.

Somebody voted no. I think thats interesting because its something Im interested in [finding out about]. Im wondering if we have to accept treating patients with BTK inhibitorsfor very long periods or if we can maybe try it at least as an alternative treatment just for a certain period of time until we have the best response. Then, some patients maybe stop. I think thats interesting for a clinical trial.

Outside of clinical trials, Im not so sure. We have no data. But if you have a low-risk patient and you want to stop after 2 years and just see what happens, you need to tell the patient we dont know whats going to happen and you have to watch that patient more closely. If its a patient with del(17p), a high-risk patient who was very symptomatic, I wouldnt do that. But in low-risk patients, I think its an interesting question and not totally unreasonable.

Over time, we will find new solutions. Everybodys working on transitioning BTK inhibitorsto limited-duration treatments for many reasons. Its not the optimal situation to have patients on kinase inhibitors for 5, 10, or 20 years. Right now, its a long-term treatment until we have better treatments.

References:

1. Burger JA, Sivina M, Jain N, et al. Randomized trial of ibrutinib vs ibrutinib plus rituximab in patients with chronic lymphocytic leukemia. Blood. 2019;133(10):1011-1019. doi:10.1182/blood-2018-10-879429

2. Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. N Engl J Med. 2015;373(25):2425-2437. doi:10.1056/NEJMoa1509388

3. Burger JA, Barr PM, Robak T, et al. Long-term effi cacy and safety of fi rst-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study. Leukemia. 2020;34(3):787-798. doi:10.1038/s41375-019-0602-x

4. Byrd JC, Furman RR, Coutre SE, et al. Ibrutinib treatment for fi rst-line and relapsed/ refractory chronic lymphocytic leukemia: fi nal analysis of the pivotal phase Ib/II PCYC- 1102 study. Clin Cancer Res. Published online March 24, 2020. doi:10.1158/1078-0432.CCR-19-2856

5. Shanafelt TD, Wang XV, Kay NE, et al. Ibrutinib and rituximab provides superior clinical outcome compared to FCR in younger patients with chronic lymphocytic leukemia (CLL): extended follow-up from the E1912 Trial. Blood. 2019;134(suppl 1):33. doi:10.1182/blood-2019-126824

6. FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia. News release. FDA. April 21, 2020. Accessed July 27, 2020. https://bit.ly/3jV1hGW

7. Woyach JA, Ruppert AS, Heerema NA, et al. Ibrutinib regimens versus chemoimmunotherapy in older patients with untreated CLL. N Engl J Med. 2018;379(26):2517-2528. doi:10.1056/NEJMoa1812836

8. Moreno C, Greil R, Demirkan F, et al. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in fi rst-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019;20(1):43-56. Published correction appears in Lancet Oncol. 2019;20(1):e10. doi:10.1016/S1470-2045(18)30788-5

9. Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. Lancet. 2020;395(10232):1278-1291. Published correction appears in Lancet. 2020;395(10238):1694. doi:10.1016/S0140-6736(20)30262-2

10. Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380(23):2225-2236. doi:10.1056/NEJMoa1815281

11. FDA approves venetoclax for CLL and SLL. News release. FDA. May 15, 2019.Accessed July 27, 2020. https://bit.ly/3jLnEOU

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Burger Reviews BTK Inhibitors and Beyond in Frontline CLL - Targeted Oncology