SAN CARLOS, Calif., Nov. 19, 2019 (GLOBE NEWSWIRE) -- BioCardia, Inc.[Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and business highlights for the third quarter 2019 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2019 with the Securities and Exchange Commission.
Update on Ongoing CardiAMP Autologous Cell Therapy Pivotal Heart Failure Trial:The company recently received FDA approval for an IDE supplement for the Phase III pivotal CardiAMP Heart Failure Trial of its lead therapeutic candidate. This will enable patients in the control group to cross over to CardiAMP treatment once their follow-up for the CardiAMP Trial has been completed. The IDE supplement also enables BioCardia to cover all out-of-pocket insurance co-pays for patients with Medicare coverage, so their participation in the trial will now be free. These two areas were previously barriers to participation for patients, who were eager to receive the therapy and less interested in being in the control arm, and were also responsible for their own co-pays. The company expects these changes, coupled with site-specific action plans, to further accelerate trial enrollment, which currently stands at 58 patients enrolled to date at 24 world class U.S. centers.
Third Quarter 2019 Business Highlights:
Third Quarter 2019Financial Results:
Achievements around our investigational CardiAMP cell therapy were the highlights of the last quarter, with a positive DSMB review, FDA approval of our IDE supplement, and a new European patent recognizing the innovation inherent in our pre-treatment assay designed to optimize patient outcomes and lower costs, said BioCardia CEO Peter Altman, PhD. At the same time, we made great progress with our other innovations: the first commercial use of the new AVANCE steerable introducer sheath in September, which can leverage the growing market for transseptal procedures, and extension of our AstraZeneca relationship, which enables our Helix delivery system to be used with new therapies being developed outside of the company.
Anticipated Upcoming Milestones:
About BioCardiaBioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the Companys biotherapeutic product candidates in clinical development. The Company's current products include the Helix transendocardial delivery system, the Morph steerable guide and sheath catheter portfolio, and the new AVANCE steerable introducer family. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.
Forward Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the enrollment of our clinical trials, the availability of data from our clinical trials, filings with the FDA, FDA product clearances, the efficacy and safety of our products and therapies, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardias business and product development plans and overall market conditions. We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent development of our therapeutic candidates. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
We may use terms such as believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, approximately or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardias Form 10-Q filed with the Securities and Exchange Commission on August 9, 2019, including under the caption titled Risk Factors. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Media Contact: Michelle McAdam, Chronic Communications, Inc.Email:email@example.comPhone: 310-902-1274
Investor Contact: David McClung, Chief Financial OfficerEmail:investors@BioCardia.comPhone: 650-226-0120
BIOCARDIA, INC.Condensed Statements of Operations
(Unaudited In thousands, except share and per share amounts)
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BioCardia Reports 2019 Third Quarter Financial Results and Business Highlights - GlobeNewswire
The global cell and gene therapy market is growing at a CAGR of over 24% during the forecast period 2018-2024 – P&T Community
NEW YORK, Nov. 18, 2019 /PRNewswire/ --
The global cell and gene therapy market is growing at a CAGR of over 24% during the forecast period 20182024.
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The major drivers contributing to the growth of the global cell and gene therapy market are the growing incidence of several chronic and terminal diseases, including cancer, the launch of new products, the increasing availability in clinical evidences of these products in terms of safety and efficacy, the rapid adoption of CAR T-cell therapy, favorable regulatory support in the development of these treatment, and improved manufacturing expertise in these products.
The following factors are likely to contribute to the growth of the cell and gene therapy market during the forecast period: Increased Pool of Patient Population with Several Ailments Favorable Regulatory Support and Increasing Special Designations for Cell and Gene Therapy Products Growing Demand for CAR T-cell Therapy Products Increasing Strategic Acquisition Activities
The study considers the present scenario of the cell and gene therapy market and its market dynamics for the period 2018?2024. It covers a detailed overview of several market growth enablers, restraints, and trends. The study covers both the demand and supply aspects of the market. The report profiles and examines leading companies and other prominent companies operating in the market.
Cell and Gene Therapy Market: Segmentation
This research report includes detailed market segmentation by product, application, end-user, and geography. The global cell therapy market is growing at a steady rate, and this trend is expected to continue during the forecast period due to the increased patient base with a wide range of diseases/ailments. The segment is likely to witness upward growth on account of expanded expertise in the manufacturing of stem cell-based products.
The gene therapy segment is expected to witness faster growth as the penetration of these products is increasing at a significant rate, especially in developed economies. The market is expected to grow during the forecast period due to the increased patient base for the existing gene remedy products, expected the launch of other gene therapy-based products for several indications, and expanded indication approvals for existing commercially available products.
The oncology segment accounts for the highest share of the global market. The growth of the oncology segment is increasing at a fast rate on account of the growing prevalence of several types of cancers. Currently, the available products not only modify the disease but also improve the quality of the patient's life, thereby decreasing the mortality rate. The market in the dermatology segment is increasing at a steady rate. This segment owns its growth to the increasing incidence and prevalence rate of several types of wounds, which are difficult to treat under normal conditions and the launch of innovative products. The dermatology segment is likely to showcase growth due to the high product availability of wound care products in the market.Hospitals are the leading end-user segment. The segment is growing mainly due to the increasing incidence/prevalence of chronic diseases such as cancer, cardiovascular diseases, diabetes, and chronic wound on account of diabetes feet, pressure ulcers, and other injuries.
Market Segmentation by Products Cell Therapy Gene TherapyMarket Segmentation by Distribution Channel Type Oncology Dermatology Musculoskeletal OthersMarket Segmentation by End-users Hospitals Wound Care Centers Cancer Care Centers Ambulatory Surgical Centers Others
The US market dominates the cell and gene therapy market in North America due to the high prevalence of chronic diseases and other conditions, which require these treatment methods. There is also comparably high utilization and wide accessibility of these therapies. The oncology segment is likely to witness significant growth in North America.The market in Europe is expected to witness upward growth in the near future on account of the growing prevalence of chronic diseases and rising elderly population. In Europe, cell and gene therapy products are considered to be part of the Advanced Therapy Medicinal Products (ATMPs), which are commonly known as regenerative medicine globally.
Market Segmentation by Geography North Americao USo Canada APACo Japano Chinao South Koreao Australia Europeo Germanyo Franceo UKo Spaino Italy Latin Americao Brazilo Mexico MEAo Turkeyo Saudi Arabiao UAE
Key Vendor AnalysisThe global market is characterized by the presence of a few global, large-scale companies and several small to medium-scale companies offering one or two cell and gene therapy products. Global players are majorly offering innovative products with the potential of disease-modifying characteristics that are generating significant revenues, especially in Europe and US regions. Most innovative and breakthrough products are approved in the European countries and the US. Vendors are targeting mostly developed economies such as the US, Germany, France, the UK, Spain, and Japan as the uptake of these products is higher in these countries than low and middle-income countries. However, the market in these regions is at the nascent stage.
Key Vendors Gilead Sciences Spark Therapeutics Novartis AG Organogenesis Amgen Osiris Therapeutics Dendreon Vericel
Other Prominent Vendors Anterogen Tego Sciences Japan Tissue Engineering JCR Pharmaceuticals Medipost MolMed AVITA Medical CollPlant Corestem Biosolution Stempeutics Research Orchard Therapeutics Takeda Pharmaceutical Company CHIESI Farmaceutici CO.DON AnGes GC Pharma JW CreaGene APAC Biotech Nipro Corp. Terumo Orthocell bluebird bio
Key Market InsightsThe report provides the following insights into the market for the forecast period 20192024. Offers sizing and growth prospects of the market for the forecast period 20192024. Provides comprehensive insights on the latest industry trends, forecast, and growth drivers in the market. Includes a detailed analysis of growth drivers, challenges, and investment opportunities. Delivers a complete overview of segments and the regional outlook of the market. Offers an exhaustive summary of the vendor landscape, competitive analysis, and key strategies to gain a competitive advantage.
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The Cell and Gene Therapy Market to Reach Revenues of Over $6.6 billion by 2024 – Market Research by Arizton – PRNewswire
CHICAGO, Nov. 13, 2019 /PRNewswire/ -- According to Arizton's recent research report, Cell and Gene Therapy Market - Global Outlook and Forecast 2019-2024 is expected to grow at a CAGR of more than 24% during the forecast period.
Key Highlights Offered in the Report:
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Cell and Gene Therapy Market Segmentation
Market Segmentation by Products
Market Segmentation by Distribution Channel Type
Market Segmentation by End-users
Cell and Gene Therapy Market Dynamics
CAR T-cell therapy has gained significant traction in recent years. It is the single most rapidly growing type of product in the market that generates revenue at a phenomenal rate. At present, it is the fastest advancing technology in cancer treatment and has the capability to replace many existing therapies. CAR T-cell therapy addresses current challenges in cancer care through superior efficacy, safety, and delivery mechanisms. CAR T-cell therapy has brought itself into focus due to the personalized nature of this therapy and the utilization of advanced genetic engineering technology. The wide acceptance and use of CAR T-cell therapy is fueling the growth of the global cell and gene therapy market.
Key Drivers and Trends fueling Market Growth:
Cell and Gene Therapy MarketGeography
The US dominates the cell and gene therapy market in North America due to the high prevalence of chronic diseases and other conditions. There is also comparably high utilization and wide accessibility of these therapies. In Europe, cell and gene therapy products are considered to be part of the Advanced Therapy Medicinal Products (ATMPs), which are commonly known as regenerative medicine globally. The major factors leading to the growth in APAC region are the growing prevalence of cancers, osteoarthritis, burns, and other chronic wounds, the introduction of advanced products in Japan, advanced R&D activities in countries such as South Korea, India.
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Market Segmentation by Geography
Other vendors include - Anterogen, Tego Sciences, Japan Tissue Engineering, JCR Pharmaceuticals, Medipost, MolMed, AVITA Medical, CollPlant, Corestem, Biosolution, Stempeutics Research, Orchard Therapeutics, Takeda Pharmaceutical Company, CHIESI Farmaceutici, CO.DON, AnGes, GC Pharma, JW CreaGene, APAC Biotech, Nipro Corp., Terumo, Orthocell, and bluebird bio.
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The Cell and Advanced Therapies Supply Chain Management Market is Anticipated to Grow at an Annualized Rate of 11% till 2030, Claims Roots Analysis -…
Over time, biopharmaceutical companies have realized the importance of integrating advanced software into the cell and advanced therapies supply chain. Such upgrades have demonstrated the ability to offer both time and cost saving
LONDON, Nov. 19, 2019 /PRNewswire/ -- Roots Analysishas announced the addition of the "Cell and Advanced Therapies Supply Chain Management Market: Focus on Technological Solutions (Cell Orchestration Platforms, Enterprise Manufacturing Systems, Inventory Management Systems, Laboratory Information Management Systems, Logistics Management Systems, Patient Management Systems, Quality Management Systems, Tracking & Tracing Systems, and Other Software), 2019-2030" report to its list of offerings.
The cell and advanced therapies supply chain is complex, with several legacy challenges, such as those related to patient scheduling, resource planning, inventory management, and deliverable tracking. A number of innovative, software-enabled systems are available / under development to mitigate the aforementioned concerns and simplify the management of biopharmaceutical supply chains.
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Key Market Insights
Over 160 software-enabled supply chain management systems are currently available
Of these, more than 25% are inventory management systems (IMS), which are primarily used for tracking inventory, orders, sales and deliveries. Examples include (in alphabetical order) ATiM Software, Benchling Inventory, CryoTrackIMS, Cryotrax, CTM-STAR, Lynx Mobile, Mosaic FreezerManagement, and Stafa Apheresis.
~80% of marketed solutions are used in collection centers and sample storage warehousesFurther, about 49% of such systems are being implemented to streamline manufacturing operations of cell and advanced therapies.
Cloud-based deployment is gradually gaining popularity
Stakeholders claim that such deployment methods can be rapidly provisioned with minimal management effort (often over the internet), allowing for faster implementation. At present, about 47% of the software systems are being deployed via cloud; examples include (in alphabetical order) Chronicle automation software, Cryoportal, evo.is, PAS-X MES, STARLIMS, tempmate-CLOUD, and TrakCel.
Around 57% of the stakeholders in this industry are based in the US
This can be attributed to the increasing interest in cell and advanced therapies in this region, making North America the current hub of innovation in this field. It is followed by players in the EU (35%) and Asia Pacific (8%).
2,600+ tweets focused on the increasing interest and ongoing efforts of industry stakeholders
Social media analysis revealed that many biopharmaceutical developers are adopting software-enabled supply chain management solutions with increasing enthusiasm. In fact, many of the tweets were related to the ability of such systems to resolve the challenges associated with large volumes of supply chain data.
Over 10 supply chain orchestration solutions are currently available in the market
These solutions have demonstrated the ability to efficiently integrate core software systems, in order to offer needle-to-needle traceability within complex supply chains.
~USD 650 million has been invested by both private and public investors, since 2014
Of this, close to USD 300 million was raised through venture capital funding rounds, representing 47% of the total capital raised. Further, there were five instances of IPOs / secondary offerings, accounting for USD 280 million in raised capital.
Partnership activity has increased at an annualized rate of 14%
In fact, around 55% of the reported deals were established post 2016; the maximum partnership activity was observed in 2018. Majority of these agreements (75+) were observed to be focused on platform integration or the establishment of service alliances.
North America and Europe are anticipated to capture over 85% market share by 2030
In addition to North America and Europe, the market in China / broader Asia Pacific region is also anticipated to grow at a relatively faster rate.
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Key Questions Answered
The financial opportunity within the cell and advanced therapies supply chain management market has been analyzed across the following segments:
The report features inputs fromeminent industry stakeholders, according to whom software-enabled supply chain management systems have the potential to eliminating risks, and reducing time and capital investment in the cell and advanced therapy development process. The report includes detailed transcripts of discussions held with the following experts:
The research includes elaborate profiles of key stakeholders (listed below), featuring a brief company overview, its financial information (if available), and a detailed description of its platform(s), recent developments and an informed future outlook.
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5. Cell and Gene Therapy CROs Market, 2018-2030
Cell Therapy Market 2019 In-depth Analysis with Inputs from Key Industry Participants – Research Writeups
Cell therapy (also called cellular therapy or cytotherapy) is therapy in which cellular material is injected into a patient; this generally means intact, living cells. For example, T cells capable of fighting cancer cells via cell-mediated immunity may be injected in the course of immunotherapy.
This report on the globalCell Therapy Marketis a detailed research study that helps provides answers and related questions with respect to the emerging trends and growth opportunities in this particular industry. It also highlights each of the prominent factors related to the growth of the market are; growing GDP, demographics, increasing purchasing power, increasing demand, government incentives, government policies, regulatory policies, product standards.
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Top Companiesin the Global Cell Therapy Market (Sales, Price, Revenue, value, volume, market share)-:Dendreon, Mesoblast, Vericel, Novartis AG, GlaxoSmithKline plc, MEDIPOST, Osiris, PHARMICELL, NuVasive, Inc., JCR Pharmaceuticals Co., Ltd, ANTEROGEN.CO.,LTD., Cynata, CELLECTIS, BioNTech IMFS, EUFETS GmbH, Cognate, Pluristem, Grupo Praxis, Genzyme Corporation, Advanced Tissue,and others.
Market Segment by Type
Market Segment by Application
Hospitals and clinicsASCsRegenerative medicine centers
Cell therapy products, which are derived from stem cells, tissues, and organs grown in laboratories, are injected into patients. The growing number of clinical trials, government and private funding, and increasing number of partnerships between companies are driving the growth of the global cell therapy market. Cell therapy products that are available in the market are based on autologous and allogenic cells. The demand of cell therapy treatment is increasing. This is because cell therapy products can be used for personalized treatment.
Market Segment by Regions, regional analysis covers:
North America (the United States, Canada, and Mexico)
Europe (Germany, France, UK, Russia, and Italy)
Asia-Pacific (China, Japan, Korea, India, and Southeast Asia)
South America (Brazil, Argentina, Colombia, etc.)
The Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)
You will be able to rely on the comprehensive country coverage, including:
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All of the segments studied in the research study are analyzed on the market share, revenue, and other important factors. Our research study shows how different segments are contributing to the growth of the global Cell Therapy market. It also provides information on key trends related to the segments included in the report. This helps market players to concentrate on high-growth areas of the global Cell Therapy market. The research study also offers separate analysis on the segments on the basis of absolute dollar opportunity.
What is present in the report?
Detailed analysis of data center for specific country
Current opportunity and future potential identification
Most exhaustive and updated report
Helps to identify the current trends, challenges and market drivers
Covers value chain evolution and changing distribution dynamics
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Global CAR T-Cell Therapy for Multiple Myeloma Market 2019 Company Business Overview – Juno Therapeutics, Kite Pharma, Novartis, Collectis – Hitz…
Fior Markets has offered a new market study research namely Global CAR T-Cell Therapy for Multiple Myeloma Market 2019 by Manufacturers, Countries, Type and Application, Forecast to 2024, providing an overall analysis of the CAR T-Cell Therapy for Multiple Myeloma market. The goal of analyzing the complete market was achieved with the help of the previously collected chronological data, the exhaustive qualitative insights, and the statistical data of the market. This study is an effort to provide valuable intelligence for globalbusinesses that are taking effort to obtain dominance over the industry and maximum revenue outcome. It investigates substantial market occurrences from 2014 to 2018 and offers authentic and reliable predictions of up to 2024 that help market players make informed business decisions accordingly.
The report revolves around a historic and present market status to obtain valuable forecast analysis based on market size, share, trends, sales volume, revenue, and growth rate. Various statistics included in the report are made using technical data and industry figures sourced from the most reputable databases. Other aspects of the report that are beneficial to reader include investment feasibility analysis, recommendations for growth, investment return analysis, trends analysis, opportunity analysis, and SWOT analyses of competing companies.
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Market share of global CAR T-Cell Therapy for Multiple Myeloma industry is dominated by companies likeJuno Therapeutics, Kite Pharma, Novartis, Collectis,
On the basis of product, this report displays the production, revenue, price, market share, and growth rate of each type, primarily split into Monotherapy, Combination Therapy
On the basis on the end users/applications, this report focuses on the status and outlook for major applications/end users, sales volume, market share, and growth rate for each application, including Multiple Myeloma, Refractory or Relapsed Multiple Myeloma,
The market is analyzed on the basis of regions namely North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, Colombia), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)
The report divides the market into diverse segments such as types, applications, regions, end-users, technologies.CAR T-Cell Therapy for Multiple Myeloma market competitive scenario covers a study of participants core values, niche markets, missions, objectives, strengths, and weaknesses. The report mainly focuses on delivering competitive advantages to market players which will help them compete vigorously in the ever-changing business environment.
Furthermore, information related to current and future policies and regulations is organized in the report as well as the regulatory environment is an essential part of the CAR T-Cell Therapy for Multiple Myeloma market which needs special focus. The report presents substantial insights for forthcoming business opportunities, challenges, risks, obstacles, and restraints.Industry leading tools and techniques has been used to evaluate these market dynamics.
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You will come to know a thorough CAR T-Cell Therapy for Multiple Myeloma analysis of the growth sector and able to design and improve your product development and sales strategies accordance to it. You can develop market-entry strategies to sustain competition as the competitors are performing out of the way through precise and updated strategies. You will be able to analyze business frameworks of the known players.
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By Ed Miseta, Chief Editor, Clinical LeaderFollow Me On Twitter @EdClinical
When Joe Jimenez was promoted to CEO of Novartis in 2010, many in the industry probably thought, Joe who? Jimenez himself chuckles when telling the story, which he did earlier this year at the 2019 Veeva R&D Summit. Jimenez had been at Novartis for less than three years and had a background in the consumer-packaged goods industry. He was working in London when AstraZeneca asked him to sit on the board of the company. In that capacity he learned about the pharmaceutical industry and decided he wanted to be part of it.
When he joined Novartis as division head of Consumer Health, Jimenez took his skillsets from the consumer-packaged goods industry and applied them to pharma. After heading Novartis Consumer Health for a few months, Jimenez was asked to run the pharmaceutical division. That surprised me, he says. I was neither a physician nor a scientist. The board told me they had physicians and scientists. What they wanted was somebody who could look at how the world was changing and position the company to win in that emerging environment."
I said this is nuts, notes Jimenez. We can generate double digit growth if we just start investing in the commercial sales and marketing in China and in parts of Southeast Asia. By doing that, by making those allocation changes, the business took off and then three years later the board made me the CEO.
Partnerships Will Drive Innovation
When Jimenez joined Novartis, the company was launching a lot of products, but many were unsuccessful once they hit the marketplace. He felt the company was not thinking about the commercial potential of company products in the pipeline. To better oversee the income potential of treatments, Jimenez created a group called early commercial development, which he calls the commercial conscience of research.
That was a little nerve wracking, he now says. I was the only individual on the Innovation Management Board with an equal vote who was not an MD or a PhD. This got our scientists to realize that it's not good enough to create a molecule. You have to think about when you're going to launch that molecule and what the competitive landscape is going to look like.
When Jimenez made the move from Big Pharma to small biotech, he also learned about how quickly companies can move. At Novartis, he remembers being in meetings that would last hours simply trying to make a decision that should have taken five minutes. He is now an advisor for several small biotech companies where those long meetings do not take place.
Bureaucracy doesn't necessarily have to be a bad word, he admits. Bureaucracy can certainly mean red tape, but if you have a huge pharmaceutical company without a clear decision making structure, what you are left with is chaos.
One successful strategy that was used at Novartis was in creating a Venture Group, which Jimenez describes as a successful and independent effort. The company put money into a venture fund and told the fund to do its thing. It had access to the resources of Novartis but was not linked to the company.
One thing that makes pharma different from a small biotech is deep resources and the scale and type of people available, says Jimenez. There is an R&D infrastructure and the ability to work on many different projects. In a small biotech we struggle to determine if we are going to focus on one or two projects. A portfolio review at Novartis would discuss 100 different programs. When you are making a small number of bets, you really need to think carefully about those bets. If you make the wrong bet, you will be out of business. A VC firm will help pharma find the good bets by looking for innovation outside their four walls even before those therapies reach the clinical stage."
Jimenez believes we will see more partnering models emerge between pharma and biotech companies, particularly with the explosion of innovation going on in the industry. He believes new treatments being developed in the cell and gene space will drive a lot of the innovation. Those treatments will be assisted by advanced analytics that allow the industry to target disease like never before. That combination will create a new ecosystem of innovation and partnering between Big Pharma and biotech companies.
CAR T Therapy Opens Doors
Shortly after he was promoted to CEO at Novartis, the company was the first to pursue a CAR T therapy. When Novartis invested in the therapy, it still appeared to be science fiction.
We were discussing the concept of taking blood from a cancer patient, genetically engineering the T-cells in that blood to recognize and go after the tumor, and then reinfuse it back into the patient, says Jimenez. This was in 2012, and I remember my oncology people coming into my office with stunned looks on their faces. They had just become aware of Carl June's work at the University of Pennsylvania. His early work was with chronic lymphocytic leukemia, and his CAR T therapy was being used on patients who had no other hope.
Novartis looked at Junes work and decided they had to be involved with it. At the time, no other large pharma companies opted to make an investment. Kite and Juno were two biotechs that emerged in the space and were quickly purchased by Big Pharma.
We were the original pioneers and decided we would do whatever it takes to get those treatments to the patients that needed them, states Jimenez. There were patients who had no other options. We knew this type of therapy had the potential to save thousands of lives. That may not have been our most successful endeavor, but I do think it is the one that has had the biggest impact.
Now that gene editing is a reality, Jimenez believes regenerative medicine holds huge hope for patients. The U.S. population is aging, and Novartis has been investigating how treatments can increase life expectancy and prolong vision, hearing, and muscle as humans age. These are areas where there is significant degeneration.
We can look at muscle as an example, says Jimenez. When humans age they lose a lot of muscle. That makes us frail, which leads to injuries, hip fractures, and eventual death. If we can build muscle among the elderly by finding a way to increase muscle mass, we could potentially extend life. There are currently several small biotech companies looking at muscle, as well as hearing and sight. I believe we may see significant increases in life expectancy in our lifetime.
A Revolution Of Advanced Analytics
Looking towards the future, Jimenez believes advanced analytics and other emerging technologies will revolutionize all elements of the pharma industry, including research, drug development, and commercialization. New technologies can help the entire drug development process work faster, easier, and less expensively.
Jimenez is also a big believer in decentralized trials, which are taking trials to where the patients are instead of to the trial sites that have been used in the past. That model will speed clinical development but also enable patients who would otherwise not be able to participate in a trial. Now anyone can participate even if they dont live near a clinic or medical center.
All of this is happening because of technology, data, and data science, he states. I believe that in the next 10 years we are going to see radical changes in the way that research, development, and commercial are executed. Soon everything will be driven by data.
Today around 40 percent of all investment is going into the area of immuno-oncology. Jimenez believes thats good, since patients will now have new treatment options that they never thought possible. He notes there are around 3,500 immuno-oncology therapies currently being investigated. Still, he worries about what that might mean for more traditional diseases that still have a large unmet medical need. For example, he sees some companies almost completely abandoning respiratory disease, rheumatology, dermatology, GI, and cardiovascular disease. While the news is good for oncology patients, the swing in funding could leave other patients in need.
The patients with respiratory disease deserve new medicines as well, says Jimenez. We have to make sure we prevent what happened in anti-infectives, where there is currently very little activity. We are on the verge of turning several cancers into chronic diseases. That is very exciting news, but we will need companies to pick up the slack in these other disease areas.
Finally, for everyone involved in drug development, Jimenez recommends that you disrupt. Look at what you're working on today and find new ways to radically change the status quo. Data, data science, and advanced analytics are going to be key, he states. The early adopters of technologies that improve efficiency are going to be the ones who win. We are living in an amazing time for healthcare. Our focus is on patients and human health. I just don't think there's a greater mission and purpose.
Global CAR T-Cell Therapy Market 2019 Development Status, Competition Analysis and Application 2024 – News Adopt
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The market currently witnesses the presence of several major and other key vendors, contributing toward the market growth. The major players functioning the market were identified through the second survey and the market rankings were determined through the first and second surveys. New product development and technological advancements remain essential for competitors to capitalize upon in the industry across the globe. A comprehensive understanding of the market is essential to understanding and facilitating the complete value chain.
For competitor segment, the report includes globalkey playersofCAR T-Cell Therapyas well as some small players covering:Celgene (Juno Therapeutics), Novartis, Gilead (Kite Pharma), Pfizer, CARsgen Therapeutics, Autolus Therapeutics, Aurora BioPharma, Sorrento Therapeutics, Mustang Bio, Bluebird Bio, Collectis, Allogene Therapeutics, Celyad
For geography segment, regional supply, application-wise, and type-wise demand, major players, price is presented from 2014 to 2024. This report covers the following regions: [Americas (United States, Canada, Mexico, Brazil), APAC (China, Japan, Korea, Southeast Asia, India, Australia), Europe (Germany, France, UK, Italy, Russia, Spain), Middle East & Africa (Egypt, South Africa, Israel, Turkey, GCC Countries).
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Global CAR T-Cell Therapy Market 2019 Development Status, Competition Analysis and Application 2024 - News Adopt
The first patients in each of two early-stage clinical trials testing CRISPR-based treatments for inherited blood disorders have been symptom free for several months with normalized hemoglobin levels, the companies developing the therapies announced today (November 19). Both participants experienced only treatable, temporary side effects, according to the data.
Last fall, Switzerland-headquartered CRISPR Therapeutics and Vertex Pharmaceuticals in Boston teamed up to launch a trial in Germany testing a CRISPR-based approach to treating -thalassemia. The therapy, known as CTX001, is applied to blood stem cells removed from the patient to cleave the BCL11A gene that represses the production of fetal hemoglobin. These cells are then reinfused to provide a healthy supply this protein, normally only produced in infancy, to overcome problems associated with mutations in the gene encoding the adult version. A few months later, the two companies launched a parallel trial in Nashville, Tennessee, to test CTX001 in sickle cell patients, who also suffer from mutations in the gene for adult hemoglobin.
The data released this week pertains to the first patients treated, one in each of these trials. In both participants, the CRISPRed cells successfully homed to the bone marrow. In the nine months since she received the treatment, the -thalassemia patient has required no blood transfusions, which she had needed regularly for 16 years, and her total hemoglobin levels are near-normal, STATreports. Meanwhile, the sickle-cell patient has not suffered any of the painful and organ-damaging events known as vaso-occlusive crises, where the misshapen blood cells characteristic of the disease stick to and clog small blood vessels, since she received her treatment in July, and her total hemoglobin levels have also normalized, according to STAT.
We are very, very excited, Haydar Frangoul, the treating physician at the Sarah Cannon Research Institute in Nashville, tells NPR. This preliminary data shows for the first time that gene editing has actually helped a patient with sickle cell disease. This is definitely a huge deal.
Both patients experienced only minimal side effects, which the treating physicians attributed to the drug busulfan, used to wipe out the patients mutant bone marrow cells before receiving the infusion of CRISPRed blood stem cells.
These results are remarkable because they represent the first clinical evidence that CRISPR-Cas9 has real curative potential, Jeff Leiden, the president and chief executive officer of Vertex Pharmaceuticals, tells STAT. Vertex and CRISPR Therapeutics say they will now proceed with enrolling a total of 45 patients in each trial.
Jef Akst is managing editor ofThe Scientist. Email her email@example.com.
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Early Results Are Positive for Experimental CRISPR Therapies - The Scientist