Category Archives: Biotechnology

BETHESDA, Md., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (Gain), a biotechnology company focused on redefining drug discovery by identifying and optimizing novel allosteric binding sites on proteins responsible for neurodegenerative diseases and lysosomal storage disorders, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present a corporate overview at the BTIG Virtual Biotechnology Conference being held on August 9 10.

BTIG Virtual Biotechnology Conference

Date:

Monday, August 9TH

Time:

11:30 to 11:55 a.m. ET

Presenter:

Eric Richman, Chief Executive Officer

Please contact your BTIG representative to listen to the live event and schedule a virtual one-on-one meeting with Gains management team during the conference.

About BTIG Virtual Biotechnology ConferenceThe annual August conference will be held virtually. BTIG expects to host more than 120 corporate management teams throughout the two-day, private event which includes thematic panels featuring key opinion leaders, fireside chats, and one-on-one meetings.

For further information, please visit: http://www.BTIG.com

About Gain Therapeutics, Inc.Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support from The Michael J. Fox Foundation for Parkinsons Research (MJFF) and The Silverstein Foundation for Parkinsons with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

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For more information, visit https://www.gaintherapeutics.com/

Cautionary Note Regarding Forward-Looking Statements

This press release contains "forward-looking statements." In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms and other comparable terminology. These statements are not historical facts but instead represent the Company's belief regarding future results, many of which, by their nature, are inherently uncertain and outside the Company's control. It is possible that actual results, including with respect to any financial forecast or the possibility of any future regulatory approval or filing, may differ materially from those anticipated in these forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the Securities and Exchange Commission on May 5 2021, as well as other documents that may be filed by the Company from time to time.

New risks and uncertainties arise over time, and it is not possible for us to predict all such factors or how they may affect us. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. We are under no duty to update any of these forward-looking statements after the date of this earnings release to conform these statements to actual results or revised expectations. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this earnings release.

Investor Contact:Daniel FerryLifeSci Advisors+1 617-430-7576daniel@lifesciadvisors.com

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Gain Therapeutics to Present at the BTIG Virtual Biotechnology Conference - Yahoo Finance

New York, Aug. 02, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Biotechnology Reagents Market 2021-2025" - https://www.reportlinker.com/p04821786/?utm_source=GNW 39% during the forecast period. Our report on the biotechnology reagents market provides a holistic analysis, market size and forecast, trends, growth drivers, and challenges, as well as vendor analysis covering around 25 vendors.The report offers an up-to-date analysis regarding the current global market scenario, latest trends and drivers, and the overall market environment. The market is driven by the high usage of biotechnology reagents in diagnostic and therapeutic applications and increasing R&D investments by federal agencies and biotechnology firms. In addition, the high usage of biotechnology reagents in diagnostic and therapeutic applications is anticipated to boost the growth of the market as well.The biotechnology reagents market analysis includes the technology segment and geographic landscape.

The biotechnology reagents market is segmented as below:By Technology Chromatography In-vitro diagnostics Polymerase chain reaction Cell culture Others

By Geography North America Europe Asia ROW

This study identifies the presence of high throughput and novel technologies as one of the prime reasons driving the biotechnology reagents market growth during the next few years.

The analyst presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources by an analysis of key parameters. Our report on biotechnology reagents market covers the following areas: Biotechnology reagents market sizing Biotechnology reagents market forecast Biotechnology reagents market industry analysis

This robust vendor analysis is designed to help clients improve their market position, and in line with this, this report provides a detailed analysis of several leading biotechnology reagents market vendors that include Abbott Laboratories, Agilent Technologies Inc., Becton, Dickinson and Co., Bio Rad Laboratories, Inc, Danaher Corp., F. Hoffmann La Roche Ltd., General Electric Co., Merck KGaA, PerkinElmer Inc., and Thermo Fisher Scientific Inc. Also, the biotechnology reagents market analysis report includes information on upcoming trends and challenges that will influence market growth. This is to help companies strategize and leverage all forthcoming growth opportunities.The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to an analysis of the key vendors.

The analyst presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources by an analysis of key parameters such as profit, pricing, competition, and promotions. It presents various market facets by identifying the key industry influencers. The data presented is comprehensive, reliable, and a result of extensive research - both primary and secondary. Technavios market research reports provide a complete competitive landscape and an in-depth vendor selection methodology and analysis using qualitative and quantitative research to forecast the accurate market growth.Read the full report: https://www.reportlinker.com/p04821786/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The Global Biotechnology Reagents Market is expected to grow by USD 32.11 billion during 2021-2025, progressing at a CAGR of 7.39% during the forecast...

WESTLAKE VILLAGE, Calif., Aug. 03, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a Fireside Chat in the BTIG Virtual Biotechnology Conference 2021 on Tuesday, August 10, 2021 at 12:30 PM (ET).

BTIG hosted events are intended for prospective and existing BTIG clients only. To listen to the live event, please contact your BTIG representative with interest.

About MannKind CorporationMannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza (insulin human) Inhalation Powder, the Companys first FDA-approved product and the only inhaled ultra-rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil where it is commercialized by the Companys partner Biomm SA. MannKind was established in 1991, and is headquartered in Westlake Village, Calif., with a manufacturing and R&D facility in Danbury, Conn. The Company also employs field sales and medical representatives across the U.S. Please visit http://www.mannkindcorp.com to learn more.

MANNKIND CONTACT:Rose Alinaya, Investor Relations Phone: (818) 661-5000 Email: ir@mannkindcorp.com

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MannKind Corporation to Participate in the BTIG Virtual Biotechnology Conference 2021 - Yahoo Finance

SAN DIEGO, Aug. 02, 2021 (GLOBE NEWSWIRE) -- Oncternal Therapeutics (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that management will participate in the BTIG Virtual Biotechnology Conference being held August 9-10, 2021.

BTIG Virtual Biotechnology Conference August 9-10, 2021

James Breitmeyer, President and Chief Executive Officer will present a corporate overview on Monday, August 9th at 12:00pm (ET), and the company will be available for one-on-one meetings.

Live Link: To listen to the live event, please contact your BTIG representative.

About Oncternal Therapeutics:

Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of cancers with critical unmet medical need. Oncternal focuses drug development on promising yet untapped biological pathways implicated in cancer generation or progression. The clinical pipeline includes cirmtuzumab, an investigational monoclonal antibody designed to inhibit the ROR1 pathway, a type I tyrosine kinase-like orphan receptor, that is being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) and in an investigator-sponsored, Phase 1b clinical trial in combination with paclitaxel for the treatment of women with HER2-negative metastatic or locally advanced, unresectable breast cancer, as well as a Phase 2 clinical trial of cirmtuzumab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. Oncternal is also developing a chimeric antigen receptor T cell (CAR-T) therapy that targets ROR1, which is currently in preclinical development as a potential treatment for hematologic cancers and solid tumors. The clinical pipeline also includes TK216, an investigational targeted small-molecule inhibitor of the ETS family of oncoproteins, that is being evaluated in a Phase 1/2 clinical trial for patients with Ewing sarcoma alone and in combination with vincristine chemotherapy. More information is available at https://oncternal.com/.

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Oncternal Contacts:

Company ContactRichard Vincent 858-434-1113rvincent@oncternal.com

Investor ContactCorey Davis, Ph.D.LifeSci Advisors212-915-2577cdavis@lifesciadvisors.com

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Oncternal Therapeutics to Participate in the BTIG Virtual Biotechnology Conference - Yahoo Finance

The objective of the study is to define 1-Methylcyclopropene market sizes of different segments & countries in recent years and to forecast the values in the coming years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study.

Global 1-Methylcyclopropene Market Overview:

Global 1-Methylcyclopropene Market Report 2021 comes with an extensive industry analysis of development components, patterns, flows, and sizes. The report also calculates present and past market values to forecast potential market management through the forecast period between 2021-2026. This research study of 1-Methylcyclopropene involved the extensive usage of both primary and secondary data sources. This includes the study of various parameters affecting the industry, including the government policy, market environment, competitive landscape (including companies like XIAN YongTai, Xi Qin Biotechnology, Shanghai Xianda Bio-Technology, Shandong Yingyangyuan Food Technology, Lytone, HZPH, etc.), historical data, present trends in the market, technological innovation, upcoming technologies, and the technical progress in related industry.

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Regional bifurcation: North America, Europe, Asia-Pacific, South America, Middle East & Africa, South East Asia

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Key Businesses Segmentation of 1-Methylcyclopropene Market

On the basis of the end users/applications, this report focuses on the status and outlook for major applications/end users, sales volume, 1-Methylcyclopropene market share and growth rate of 1-Methylcyclopropene for each application, including-

On the basis of product, this report displays the sales volume, revenue (Million USD), product price, 1-Methylcyclopropene market share and growth rate of each type, primarily split into-

Historical data available in the report elaborates on the development of the 1-Methylcyclopropene on national, regional, and international levels. 1-Methylcyclopropene Market Research Report presents a detailed analysis based on the thorough research of the overall market, particularly on questions that border on the market size, growth scenario, potential opportunities, operation landscape, trend analysis, and competitive analysis.

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Excerpt from:
Qualitative Analysis of 1-Methylcyclopropene Market 2021-2026 Strategical Assessment of XIAN YongTai, Xi Qin Biotechnology, Shanghai Xianda...

The biotechnology industry has advanced significantly due to artificial intelligence and other computerized tools.

FREMONT, CA: Biotechnology companies and various health organizations worldwide maintain massive databases. Drug manufacturing, chemical analysis of multiple compounds, RNA and DNA sequencing, enzyme studies, and other similar biological processes require the strong support of computerized tools and applications to increase efficiency and reduce manual errors.

Today, the world is confronted with an unprecedented public health crisis in the form of a Coronavirus pandemic. Economies are collapsing, countries are being placed on lockdown, and all hope is being placed in the biotechnology industry to develop a safe, effective vaccine in the shortest amount of time possible. Artificial intelligence is critical in biotechnology and related applications for managing biological processes, increasing drug production, managing supply chains, and overlooking the industry's data pool.

Increased and improved predictability for both structured and unstructured data enables businesses to plan their operations more efficiently and effectively, resulting in increased productivity and a faster pace of work.

The following are some significant AI trends that will reshape the biotechnology industry.

Advancing Innovations: From the Laboratory to the Market

The demand for drugs, industrial chemicals, food-grade chemicals, and other biochemistry-related raw materials has increased over the last decade. Artificial intelligence in biotechnology is critical for accelerating drug discovery and development (right to the point where it reaches the market). AI-based tools and apps help develop molecule structures based on target markets. It uses machine learning to calculate permutations and combinations of various chemicals to find the best variety without manual experimentation in the lab. Predictive analysis can forecast market demand for a particular drug or chemical using artificial intelligence in biotechnology. AI in biotech can also help manage the intelligent distribution of raw materials required by the biotechnology industry.

Open-Source Artificial Intelligence Platforms: Accelerate Data Analysis

Scientists around the world are researching AI programs that can automate data maintenance and analysis. Using open-source AI programs such as CRISPR libraries and H2O.ai frees lab assistants from repetitive data entry and analysis tasks. Other critical informatics tasks are also systematically analyzed to produce more accurate and timely results. Removing manual functions from healthcare providers and scientists can focus on innovation-driven processes enabled by biotechnology AI.

Expanding Agricultural Biotechnology's Boundaries: Improving Quality and Quantity

Biotechnology is crucial in the development of more and better crops. AI-based tools are required to study crop features, note and compare qualities, and forecast plausible yield. Aside from these tools, the agricultural biotechnology industry uses robotics for packaging, harvesting, and other essential tasks. By combining weather forecasts, farmland data, and the availability of seeds, manure, and pesticides, AI in biotech helps plan future patterns in material movement.

See Also:Top 10 EAM Solution Companies

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How Innovative AI Trends Can Reshape the Biotechnology Industry - CIOReview

There's no doubt that money can be made by owning shares of unprofitable businesses. For example, although software-as-a-service business Salesforce.com lost money for years while it grew recurring revenue, if you held shares since 2005, you'd have done very well indeed. Having said that, unprofitable companies are risky because they could potentially burn through all their cash and become distressed.

So should Lixte Biotechnology Holdings (NASDAQ:LIXT) shareholders be worried about its cash burn? In this article, we define cash burn as its annual (negative) free cash flow, which is the amount of money a company spends each year to fund its growth. We'll start by comparing its cash burn with its cash reserves in order to calculate its cash runway.

Check out our latest analysis for Lixte Biotechnology Holdings

A company's cash runway is the amount of time it would take to burn through its cash reserves at its current cash burn rate. When Lixte Biotechnology Holdings last reported its balance sheet in March 2021, it had zero debt and cash worth US$7.7m. Looking at the last year, the company burnt through US$2.7m. That means it had a cash runway of about 2.8 years as of March 2021. That's decent, giving the company a couple years to develop its business. You can see how its cash balance has changed over time in the image below.

Lixte Biotechnology Holdings didn't record any revenue over the last year, indicating that it's an early stage company still developing its business. So while we can't look to sales to understand growth, we can look at how the cash burn is changing to understand how expenditure is trending over time. During the last twelve months, its cash burn actually ramped up 61%. Oftentimes, increased cash burn simply means a company is accelerating its business development, but one should always be mindful that this causes the cash runway to shrink. Lixte Biotechnology Holdings makes us a little nervous due to its lack of substantial operating revenue. We prefer most of the stocks on this list of stocks that analysts expect to grow.

While Lixte Biotechnology Holdings does have a solid cash runway, its cash burn trajectory may have some shareholders thinking ahead to when the company may need to raise more cash. Generally speaking, a listed business can raise new cash through issuing shares or taking on debt. One of the main advantages held by publicly listed companies is that they can sell shares to investors to raise cash and fund growth. By looking at a company's cash burn relative to its market capitalisation, we gain insight on how much shareholders would be diluted if the company needed to raise enough cash to cover another year's cash burn.

Lixte Biotechnology Holdings has a market capitalisation of US$37m and burnt through US$2.7m last year, which is 7.5% of the company's market value. That's a low proportion, so we figure the company would be able to raise more cash to fund growth, with a little dilution, or even to simply borrow some money.

As you can probably tell by now, we're not too worried about Lixte Biotechnology Holdings' cash burn. For example, we think its cash runway suggests that the company is on a good path. Although its increasing cash burn does give us reason for pause, the other metrics we discussed in this article form a positive picture overall. After taking into account the various metrics mentioned in this report, we're pretty comfortable with how the company is spending its cash, as it seems on track to meet its needs over the medium term. Separately, we looked at different risks affecting the company and spotted 3 warning signs for Lixte Biotechnology Holdings (of which 1 is significant!) you should know about.

Of course Lixte Biotechnology Holdings may not be the best stock to buy. So you may wish to see this free collection of companies boasting high return on equity, or this list of stocks that insiders are buying.

PromotedIf you decide to trade Lixte Biotechnology Holdings, use the lowest-cost* platform that is rated #1 Overall by Barrons, Interactive Brokers. Trade stocks, options, futures, forex, bonds and funds on 135 markets, all from a single integrated account.

This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. *Interactive Brokers Rated Lowest Cost Broker by StockBrokers.com Annual Online Review 2020

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.

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We Think Lixte Biotechnology Holdings (NASDAQ:LIXT) Can Afford To Drive Business Growth - Simply Wall St

In April 2020, Weida designed and started producing a highly comfortable protective overall made up of protective clothing, a pair of goggles and a mask after realizing that it was quite inconvenient for medical staff to put on and take off traditional protective gear with poor breathability as well as the separate set of goggles and mask that could easily leave marks on the face. Compared with traditional offerings, the protective overall extends the effective protection time from four hours to eight hours and reduces the number of individual pieces that make up a complete set from 15 to 7 while shortening the time required to suit up and later remove the outfit from 27 minutes to 9. The company has obtained six patents for the protective product based on its advantages, including virus isolation, a high level of air and moisture permeability, the wide window, no facial marks, anti-fog lens and a design that makes it easy to put on and take off.

In March 2020, Weida received approval from the United States Food and Drug Administration and the CE Mark in Europe to export medical masks and isolation gowns to Europe and the US. Notably, the firm's EIDA protective suits, isolation gowns and masks have been exported to 57 countries and regions worldwide, including Canada, France, Italy, Japan, Spain, the UK and the US.

Weida's protective suits, isolation gowns, masks and protective masks have become the preferred choice for the frontline workers at a number of public organizations across China, including the 301 Military Hospital in Beijing, airports in Qingdao and the mobile cabin hospitals in the Xinjiang Uygur Autonomous Region.

SOURCE Information Office of the People's Government of Shandong Province

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Within weeks of first COVID-19 outbreak, China's Qingdao Weida Biotechnology had switched all production capability over to PPE - PRNewswire

SAN FRANCISCO, July 15, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has been dosed in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial evaluating VIR-2218 together with VIR-3434 for the treatment of patients with chronic hepatitis B virus (HBV) infection a combination designed to achieve a functional cure.

VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) designed to inhibit the production of all HBV proteins (X, polymerase, S and core), which may be acting as immune tolerogens. VIR-3434 is an investigational HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes, as well as reduce the level of virions and subviral particles in the blood. It has also been Fc engineered to include the XX2 vaccinal mutation, allowing it to potentially function as a therapeutic T cell vaccine against HBV.

HBV infection remains an urgent global public health challenge associated with significant morbidity and mortality, and we believe that a combination approach focused on immune restoration will be critical to achieving a functional cure, said Phil Pang, M.D., Ph.D., Virs chief medical officer. We are excited about the potential of VIR-2218 to serve as the cornerstone of that approach. We believe that combining it with VIR-3434, which has already demonstrated the ability to markedly lower hepatitis B surface antigen at low doses in an ongoing Phase 1 trial, and, most importantly, has the potential to function as a therapeutic T cell vaccine, could be a game changer.

The multi-center, open-label Phase 2 trial is designed to evaluate the safety, tolerability and efficacy of the combination of VIR-2218 and VIR-3434 in approximately 90 adult patients (ages 18 to 65) with chronic HBV infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Both VIR-2218 and VIR-3434 will be administered via subcutaneous injection at varying dose levels over the course of the trial for a treatment period ranging from four to 20 weeks, and a follow-up period of up to 116 weeks, depending on the dosing cohort. The primary endpoints of the trial are the proportion of patients with treatment-emergent adverse events and serious adverse events; grading of post-treatment clinical laboratory parameters; and the proportion of patients achieving a functional cure (defined as undetectable HBsAg and sustained suppression of HBV DNA).

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About VIR-2218

VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. VIR-2218 is the first asset in the companys collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.

About VIR-3434

VIR-3434 is an investigational subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and reduce the level of virions and subviral particles in the blood. VIR-3434, which has been Fc engineered to potentially function as a T cell vaccine against HBV in infected patients, also incorporates Xencors Xtend in order to have an extended half-life.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit http://www.vir.bio.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, plan, potential, aim, promising and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Virs expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the ability of VIR-2218 and VIR-3434 (as monotherapies or combination therapies) to treat and/or prevent chronic HBV infection, and the timing, design and enrollment plans for the Phase 2 MARCH trial. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by Virs competitors, changes in expected or existing competition, delays in or disruptions to Virs business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Virs filings with the U.S. Securities and Exchange Commission, including the section titled Risk Factors contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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Vir Biotechnology Initiates Phase 2 Clinical Trial Evaluating the Combination of VIR-2218 and VIR-3434 as a Functional Cure Regimen for Chronic...

ISPE announced a world-class line-up of eight leading biotech experts as keynote presenters for the 2021 ISPE Biotechnology Virtual Conference & Workshop. This unparalleled fully interactive virtual event will bring together leading pharmaceutical and biopharmaceutical manufacturers, technology providers, academic scientists, and international regulators to network, share knowledge, and provide an outlook on the evolving landscape and future of biopharmaceutical manufacturing and therapies.

NORTH BETHESDA, Md., July 15, 2021 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) announced a world-class line-up of eight leading biotech experts as keynote presenters for the 2021 ISPE Biotechnology Virtual Conference & Workshop. Taking place 22-24 September 2021, this unparalleled fully interactive virtual event will bring together leading pharmaceutical and biopharmaceutical manufacturers, technology providers, academic scientists, and international regulators to network, share knowledge, and provide an outlook on the evolving landscape and future of biopharmaceutical manufacturing and therapies.

"This year, in particular, the industry rallied together to innovate at record speed and partnered in ways that were unprecedented to address not only the public health crisis brought on by the pandemic, but also to ensure patients worldwide would continue to have access to necessary therapies," said Program Co-Chair David Doleski, Head of Global Quality Audit, Sanofi. "This conference will help prepare biopharmaceutical professionals and their organizations for the impact of innovations in biologics that will influence their operations and shape the future."

Keynote presenters will kick off day one of the conference with presentations on industry-critical topics such as regulatory aspects for advanced therapy medicinal products (ATMPs), cell and gene therapies, and COVID-19 therapies and vaccines. Then they will come together for a compelling panel discussion.

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Keynote Presenters:

Matthew JH Davis Senior GMP Inspector Therapeutic Goods Administration

Raj Puri Director, Division of Cellular and Gene Therapies CBER/FDA

Wilson Bryan Director, Office of Tissues and Advanced Therapies CBER/FDA

Francesco Cicirello Director, Quality Assurance Evelo Biosciences

Jessica Beyer Director, Cell Therapy Manufacturing Bristol Myers Squibb

Oliver Henning Senior Vice President Operations BioNTech SE

Rino Rappuoli Chief Scientist GSK

Sandy Douglas Academic Clinician University of Oxford

The ISPE Biotechnology Virtual Conference & Workshop is a leading interdisciplinary forum for all stakeholders of the pharmaceutical and biopharmaceutical value chain to unite and learn about the latest innovations and trends, and openly discuss practical challenges and solutions, from a technical, logistical, and regulatory perspective.

Event exclusives include plant tours featuring state-of-the-art facilities and two in-depth workshops. Workshop participants will be presented with a case study and practice finding solutions with the help of trainers. Topics include control strategy, technology transfer, CMC, computer-based modeling, ATMPs, facility design, and GXP compliance.

"The impact of the evolving regulatory environment and the need to ensure continued innovation and continuity in the supply chain in light of this crisis and assuring preparedness for future crises will be integrated throughout the conference agenda, panel discussions, and accompanying workshops," said Program Co-Chair Prof. Dr. Michelangelo Canzoneri, Global Head of Digital and Data, Healthcare, Merck KGaA, Darmstadt, Germany.

To explore the educational agenda and to register, please visit ISPE.org/Bio21.

About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world's largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,500 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.

For more information, contact: Amy Henry Marketing Communications Manager International Society for Pharmaceutical Engineering (ISPE) Email: ahenry@ispe.org ISPE.org

Media Contact

Amy Henry, ISPE, 8139602105, AHENRY@ISPE.ORG

SOURCE ISPE

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Top Biotech Experts to Speak at the 2021 ISPE Biotechnology Virtual Conference & Workshops - Yahoo Finance