Category: Clinical Trials

Avance Clinical Announces New Office Opening in Sydney

Avance Clinical, the largest premium Australian Contract Research Organisation (CRO) for international biotechs, has opened new offices in Sydney to support its growing clinical team in the greater Sydney region.

Avance Clinical’s CEO Yvonne Lungershausen said: “We continue to offer a hybrid working environment for our team however, they are increasingly wanting more in-office face-to-face time with colleagues and clients – while still having the flexibility of working remotely”.

“Avance is continuing to experience significant growth facilitating our expansion into North Sydney with new offices to accommodate our growing team,” she said.

Check for our latest positions open and join our Sydney team here. https://www.avancecro.com/careers/

Avance Clinical recently secured a significant investment from global private equity firm, The Riverside Company (Riverside), to support further regional and global expansion. The investment values the company in excess of $200m.

“With the support of Riverside and its powerful global footprint and deep healthcare experience, Avance Clinical will execute on its regional and international expansion plans organically and via acquisitions,” said Lungershausen.

Avance Clinical is the Australian-owned CRO that provides global regulatory standard clinical research services across all phases to the local and international biopharma industry.

The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which has allowed it to expand into clinical trials for vaccines and GMO therapies.

“We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biopharma clients require in this fast-moving, competitive and high-stakes sector,” said Lungershausen.

Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/

For more information about the benefits of running your next study with Avance Clinical contact us: https://www.avancecro.com/contact-us/

About Avance Clinical
Avance Clinical is the largest premium full-service Australian CRO delivering quality clinical trials, with globally accepted data, in Australia and New Zealand for international biotechs. The company’s clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for 24 years.

Pre-clinical through to Phase 1 and 2
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 105 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, and Medrio are just some of the technology partners.

Media Contacts:
Avance Clinical
Chris Thompson
media@avancecro.com

Therapeutic Goods Administration of Australia Authorizes Moderna’s Covid-19 Vaccine in Children (6-11 Years)

Moderna, Inc., (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna’s mRNA COVID-19 vaccine, Spikevax, in a 50 ug dose, two-dose series, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6-11 years.

“The TGA authorization for the use of our COVID-19 vaccine in children 6-11 years old in Australia is an important milestone for Moderna as it is the first regulatory authorization for the use of our vaccine in this age group. We are grateful to the TGA for their diligence and the Government of Australia for its continued confidence in our mRNA platform,” said Stephane Bancel, Chief Executive Officer of Moderna. “We are grateful for the opportunity to provide protection against COVID-19 to this important age group, keeping children safe and able to continue life as normally as possible.”

Professor Robert Booy from the Immunisation Coalition commented, “I welcome this decision by the TGA and look forward to the uptake of vaccination in children increasing even more to provide protection of children and maximize school attendance.”

Moderna’s vaccine was investigated in the ongoing Phase 2 “KidCOVE” study, a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of two 50 ug doses of Spikevax (mRNA-1273) given to healthy children 28 days apart. The study population was divided into three age groups (6 to under 12 years, 2 to under 6 years, and six months to under 2 years).

Data submitted to the TGA demonstrated that vaccination of children 6 to under 12 years of age with a 50 ug mRNA-1273 primary series is associated with non-inferior anti-SARS-CoV-2 neutralizing antibody responses when compared to that in individuals 18-25 years old from the Phase 3 Cove study. The geometric mean ratio (GMR) comparing the response in children to the response in young adults from the Phase 3 COVE study was 1.5 (95% CI: 1.3, 1.8), with a seroresponse rate of 99.3%. Two 50 ug doses of mRNA-1273 were generally well tolerated.

The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS). The ClinicalTrials.gov identifier is NCT04796896.

Moderna’s vaccine has already received regulatory approval for adults and adolescents in Australia. On 9 August 2021, the TGA granted provisional registration to the Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. On 3 September 2021, the provisional registration was extended to individuals 12 years of age and older.

About Moderna
In 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

AUTHORIZED USE
The Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna’s mRNA COVID-19 vaccine, Spikevax for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six years of age and older.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company’s development of a vaccine against COVID-19 (mRNA-1273, or Spikevax); the ability of Spikevax to trigger a neutralizing antibody response in children similar to that in older populations and to protect against COVID-19; and the safety and tolerability profile for Spikevax. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent lings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

Moderna Contacts:
Media:
Luke Mircea Willats
Director, Corporate Communications
Luke.Mirceawillats@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

Moderna Announces Plan to Expand Footprint in Asia with Four Additional Subsidiaries

  • Announcement reinforces Moderna’s commitment to Asia and vision as a global commercial enterprise
  • New subsidiaries to be established in Malaysia, Taiwan, Singapore, and Hong Kong; providing local presence to support the delivery of mRNA vaccines and therapeutics

Moderna, Inc., (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced plans to expand its commercial network across Asia with the addition of four new subsidiaries in Malaysia, Taiwan, Singapore, and Hong Kong. This expansion comes as the Company continues to scale up the manufacturing and distribution of its COVID-19 vaccine and future mRNA vaccines and therapeutics.

The Asia-Pacific region represents an integral part of Moderna’s business, with established subsidiaries in Japan, South Korea, and Australia. In 2021, Moderna and the South Korean government announced a collaboration to explore local opportunities for research and manufacturing in South Korea. More recently, the Company announced an agreement in principle with the Australian Government to build a state-of-the-art mRNA vaccine manufacturing facility in Victoria, Australia.

“2021 was a year of impact for Moderna, and I am proud to see continued growth in 2022 as we expand our presence in Asia. After a decade of pioneering the development of our mRNA platform, we were ready to play a critical role in combating the COVID-19 pandemic globally,” said Stephane Bancel, Chief Executive Officer of Moderna. “With the addition of four subsidiaries in Asia, we look forward to new opportunities to leverage our mRNA platform to help solve health challenges, including those with a high burden of disease in the Asia-Pacific region.”

Asia bears the highest burden of infectious diseases, and the burden of non-communicable diseases is increasing as the population ages. Moderna’s growing portfolio in prophylactic vaccines, cardiovascular diseases, oncology, and rare diseases presents an unparalleled opportunity to use mRNA technology to maximize the potential impact the Company can have on human health in the region.

Moderna’s broader pipeline currently includes 40 development programs, of which 25 are in clinical trials. The Company continues to update its COVID-19 strategy to address variants of concern such as Omicron and pioneer new vaccines and therapeutics for a range of diseases and conditions. Moderna is developing mRNA medicines to potentially prevent and treat diseases with significant unmet needs across infectious diseases, immuno-oncology, rare and ultra-rare diseases, and autoimmune diseases.

Moderna currently has a presence in twelve markets globally. Regulators have approved Moderna’s COVID-19 vaccine in more than 70 markets, including Canada, Japan, the European Union, the UK, and Israel. In 2021, 807 million doses of Moderna’s COVID-19 vaccine were shipped globally, with approximately 25% of those doses shipped to low- and middle-income markets.

About Moderna’s Strategic Pillars
Moderna’s has four strategic pillars guiding the Company’s focus and impact for 2022 and beyond. Our strategic pillars are:

  • Developing a pan-respiratory annual booster vaccine and continuously customizing it. A pan-respiratory annual single booster vaccine covering multiple viruses, such as COVID-19, Flu, and Respiratory Syncytial Virus, could create value for the healthcare system through compliance, convenience to the customer (one vs. three injections), and reduction in vaccine administration cost
  • Developing first-in-class vaccines against latent viruses for which there are no approved vaccines today. Latent viruses infect the body, lay dormant, and do not replicate but possess the capacity to activate, causing disease. In addition, new emerging evidence highlights that latent viral infections may have yet unknown negative effects. Moderna has clinical candidates in development for several latent viruses, including Epstein-Barr Virus (Phase 1), human immunodeficiency virus (Phase 1), and Cytomegalovirus (Phase 3)
  • Developing therapeutics based on mRNA-encoded proteins across oncology, cardiovascular, auto-immune disorders, and rare genetic diseases
  • Developing therapeutics based on mRNA-encoded proteins across oncology, cardiovascular, auto-immune disorders, and rare genetic diseases

About Moderna
In 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company’s plans to expand its commercial network across Asia with the addition of four new subsidiaries in Hong Kong, Malaysia, Singapore, and Taiwan. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

Moderna Contacts
Media:
Luke Mircea Willats
Director, Corporate Communications
luke.mirceawillats@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

Novotech Recognized as Top 10 CRO in CenterWatch Site Relationship Benchmarking Report

Novotech, the leading Asia Pacific biotech specialist CRO, has been recognized as a top 10 CRO in the 2021 CenterWatch Global Site Relationship Benchmark Survey.

Report available here.
https://novotech-cro.com/news/novotech-recognized-top-10-cro-centerwatch-site-relationship-benchmarking-report

CenterWatch, established in 1994, is a global benchmarking authority for the clinical trials sector.

The benchmarking report results reflect how more than 3,700 representatives from clinical trial sites around the world rate their clinical research organisation (CRO) relationships and their responses to the COVID-19 pandemic.

The criteria for benchmarking CROs included:
– Professionalism
– Organizational processes
– Preparedness
– Communications

Site respondents were asked to rank the overall reputation of 29 CROs and rate the relative importance of performance-related attributes.

“Strong site, sponsor, and CRO relationships form the essential foundation on which efficient and effective clinical trials are built. We conduct the CenterWatch Global Site Relationship Benchmark Survey as a service to the industry, highlighting behaviors and approaches that are strengthening partnerships and revealing areas that merit improvement. As COVID-19 has put additional strain on relationships of all types, we also requested feedback on partners’ pandemic response in this latest survey,” said Cynthia Carter, President, Market Intelligence and Insights at WCG.

Novotech CEO Dr. John Moller said we are very pleased to be benchmarked as a top 10 CRO among the world’s leading CROs. Sites are key to our client’s success so being ranked highly by sites for our professionalism, communications, and processes is a major achievement for our global team.

“Novotech serves biotechs globally and we pride ourselves on the depth of relationships that we have built with hundreds of Asia-Pacific sites over the last 25 years. In addition, Novotech has signed 45 Leading Site Partnership agreements over the last 3 years. As part of these agreements, Novotech works very closely with the leading sites in the region to promote their research strengths internationally, while enjoying preferential access to their clinical trial infrastructure.

“With more than 2,000 highly experienced professionals, our clients appreciate our strong site and KOL relationships, our deep regulatory expertise, and our ability to accelerate clinical trials across the Asia Pacific and in particular China.”

“Industry-leading technology is at the core of our business and ensures rapid and efficient processes, insightful analytics and reporting, and high quality data and compliance.”

Novotech recently announced a partnership and investment in tech firm Prospection to support accelerated clinical trials with healthcare data analytics using real-world data.

Novotech has also partnered with virtual research organisation ObvioHealth to expedite trials leveraging remote technologies. This patient-centric approach improves subject retention and allows sponsors to reach populations outside major cities for clinical trial participation.

About Novotech Health Holdings
Novotech Health Holdings Pte. Ltd. (“Novotech”) is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech Holdings is a CRO with integrated labs and phase I facilities providing drug development consulting and clinical development services. It has been instrumental in the success of approximately 3,700 clinical trials across all trial phases and broad range of therapeutic areas. Novotech Holdings is well positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally. For more information visit https://novotech-cro.com/contact

Media Contact
David James
communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Avance Clinical Announces Major PE Investment for US Expansion at Biotech Showcase 2022

Avance Clinical, the largest premium Australian Contract Research Organisation (CRO) for international biotechs, has secured a significant investment from global private equity firm, The Riverside Company (Riverside), to support further regional and global expansion. The investment values the company in excess of $200m.

Avance Clinical is taking meetings with biotechs to discuss the benefits of conducting trials in Australia, including no IND requirement and an attractive 43.5% rebate, at Biotech Showcase 2022 via PartneringOne.

Connect with the Avance Clinical Team here https://www.avancecro.com/contact-us/

Download the APAC clinical trial advantages report from Frost & Sullivan here
https://www.avancecro.com/download-apac-clinical-trial-report-frost-sullivan/

Avance Clinical is the Australian-owned CRO that provides global regulatory standard clinical research services across all phases to the local and international biopharma industry.

The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which has allowed it to expand into clinical trials for vaccines and GMO therapies.

Avance Clinical’s CEO Yvonne Lungershausen said: “With the support of Riverside and its powerful global footprint and deep healthcare experience, Avance Clinical will execute on its regional and international expansion plans organically and via acquisitions.”

“We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biopharma clients require in this fast-moving, competitive and high-stakes sector,” said Lungershausen.

Leading analyst firm Frost & Sullivan says the Asia-Pacific’s CRO market value, currently at $6.01 billion, is estimated to reach nearly $11.04 billion in 2026, growing at a compound annual rate of 12.2%.

Avance Clinical has more than 170 specialist clinical staff and has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Riverside Partner Nick Speer said: “We were highly attracted to Avance’s leading management team who have secured blue-chip customers from across the globe, providing them with world-class services. Riverside brings decades of global life sciences experience, which we will leverage to further support Avance’s growth objectives, with a particular focus on North America and Asia.”

“Australia is the global destination of choice for early phase and increasingly later phase clinical trials. We intend to work with Yvonne and her team to further accelerate the growth of Avance,” said Speer.

“Global sponsors are attracted to Australia and Avance Clinical for trial quality and efficient timeframes. Study start-up can be achieved in 5-6 weeks with the right CRO, leveraging the lack of IND requirement and the R&D tax rebate. This means clients can get into the clinic up to a year earlier than anywhere else in the world, saving significant associated costs while enabling life-saving treatments to reach market sooner.”

Avance Clinical was advised by Allier Capital and Riverside by Lazard Australia.

Learn about the Australian Advantage herehttps://www.avancecro.com/the-australian-advantage/

For more information about the benefits of running your next study with Avance Clinical contact us: https://www.avancecro.com/contact-us/

About Avance Clinical
Avance Clinical is the largest premium full-service Australian CRO delivering quality clinical trials, with globally accepted data, in Australia and New Zealand for international biotechs. The company’s clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for 24 years.

Pre-clinical through to Phase 1 and 2

Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 105 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, and Medrio are just some of the technology partners.

About The Riverside Company
The Riverside Company is a global private equity firm focused on investing in growing businesses valued at up to $400 million. Since its founding in 1988, Riverside has made more than 800 investments. The firm’s international private equity and structured capital portfolios include more than 140 companies.

Media Contacts:
Avance Clinical
Chris Thompson
media@avancecro.com

The Riverside Company
Holly Mueller
hmueller@riversidecompany.com

Olympus Launches Venture Capital Fund to Strengthen Medtech Leadership

  • Initial fund targets medical devices, digital solutions, and diagnostics

Olympus Corporation (Tokyo: 7733), a global leader in medical technology, has announced the establishment of Olympus Innovation Ventures to invest in pioneering startups with innovative technologies that improve clinical outcomes, reduce healthcare costs and enhance the quality of life for patients.

Olympus Innovation Ventures, a fully-owned subsidiary of Olympus Corporation of the Americas, is a venture capital fund focused on startups poised to improve patient outcomes, radically advance the detection and treatment of disease, and transform the surgery suite. The new fund expands upon Olympus’ strategy to strengthen endoscopy and pioneer next-generation tools and procedures for minimally invasive surgery.

Olympus’ venture fund is stage-agnostic, prioritizing early- and growth-stage companies globally with solutions in therapeutic areas including gastroenterology, respiratory, and urology. Olympus has allocated $50 million for initial commitments and follow-on investments in portfolio companies. In addition to capital, Olympus will help its portfolio companies succeed by contributing its clinical and technical expertise, access to healthcare professionals and hospitals, and ability to launch and scale innovative solutions in the global market.

Olympus has been a leader in optical and medical innovation for over 100 years, introducing a mass-produced microscope to Japan in 1919 and the world’s first gastrocamera for practical use in 1950. Olympus’ tools have aided the minimally invasive surgery revolution and have evolved to detect and treat disease. Yasuo Takeuchi, CEO of Olympus Corporation, says “Our investment underscores our commitment to make people’s lives safer, healthier, and more fulfilling. Our goal is for this fund to continue our history of innovation and support our long-term growth and transformation.”

Touchdown Ventures, a firm specializing in corporate venture capital, will help manage the Olympus Innovation Ventures fund. Touchdown will work closely with senior executives of Olympus in all aspects of operating the fund.

“We are excited about what Olympus can bring to entrepreneurs through the company’s technical strengths, industry relationships, vast distribution, and deep subject matter expertise,” noted Scott Lenet, co-founder and President of Touchdown Ventures. “The entire Olympus Innovation Ventures team is working to be the partner of choice for innovators and create a competitive advantage for their startups.”

Nacho Abia, Chief Operating Officer of Olympus Corporation, said “This effort is another way Olympus is demonstrating its commitment to excellence and creating tangible value for providers and patients. We believe we will play a meaningful role in the advancement of minimally invasive care and new ways to detect, monitor and treat conditions and diseases.”

For more information, please visit http://olympusamerica.com/venture-capital. Olympus Innovation Ventures can be contacted at ventures@olympus.com.

For the contact:
Olympus Corporation of the Americas
Christos Monovoukas
Vice President, Global Business Development
Christos.Monovoukas@Olympus.com

Touchdown Ventures
Deborah Zajac
Director, Investments
deborah@touchdownvc.com

About Olympus
Olympus is passionate about creating customer-driven solutions for the medical, life sciences, and industrial equipment industries. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping to detect, prevent, and treat disease; furthering scientific research; and ensuring public safety. As a leading medical technology company, our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients and their safety. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

About Touchdown Ventures
Touchdown Ventures partners with corporations to manage their venture capital programs. Touchdown works closely with each corporation to achieve the financial and strategic benefits from venture capital investments. The firm is a Registered Investment Adviser and maintains offices in Los Angeles, Philadelphia, and San Francisco. More information on Touchdown can be found at www.touchdownvc.com

Olympus Contact (Tokyo)
Yuka Horimoto
+81-90-2490-1071
yuka.horimoto@olympus.com

Olympus Contact (USA)
Susan Scerbo
+1-610-909-9153
sue.scerbo@olympus.com

Touchdown Ventures Contact
Deborah Zajac
Director, Investments
+1-917-558-4403
deborah@touchdownvc.com

Agilex Biolabs Shares How to Select the Right Bioanalytical Tools for Immuno-oncology and Vaccines Studies – OCT Webinar

Agilex Biolabs, the Australian regulated bioanalytical and toxicology laboratory facilities for clinical trials is presenting a new webinar entitled “Getting it right! Considerations for Immuno-oncology and Vaccine Studies and the Bioanalytical Tools used” in partnership with Outsourcing Clinical Trials (OCT).

Agilex Biolabs’ Director, Immunoassay, Kurt J. Sales (B.Sc; B.Sc (MED) Hons; M.Sc, Ph.D, PGCM) said:

“Choosing the right bioanalytical platform for your immunology or vaccines clinical trial is critical to data collection. But navigating the intricate bioanalytical process and selection of assay platforms can be difficult. This webinar covers these platforms in detail and the selection process.”

Agilex Biolabs is the largest regulated bioanalytical laboratory in Australia with over 24 years’ experience in early phase clinical trials with a track record of enabling the movement of new drug entities to market.

Agilex Biolabs specialises in pharmacokinetics, pharmacodynamics, and biomarker evaluation, which is key to understanding the drug absorption, distribution, metabolism, and excretion as well as target engagement and efficacy of the drug during clinical development.

“This webinar will demystify the bioanalytical requirements for clinical studies and will discuss the most common bioanalytical platforms used during clinical trials to measure vaccine responses and levels of inflammatory mediators in biological fluids,” said Dr. Sales.

Key Learning Objectives
– Learn how to determine the right bioanalytical platform for your immunology or vaccines clinical trial
– Understand what do these bioanalytical platforms look like in use
– Understand the process of selecting the right bioanalytical platform
– Demystify the bioanalytical requirements for clinical studies

The webinar will also cover Australian research, and regulatory and clinical infrastructure, which provides a favorable environment for rapid vaccine development. It will also include discussion of a case study for rapid vaccine development based on non-clinical research conducted with a novel COVID-19 protein subunit vaccine.

Register Here https://bit.ly/3aPlWsx
Date: 4 November
Time: 2PM London/3PM CET
Speaker: Dr Kurt Sales: Director, Immunoassay, Agilex Biolabs

Agilex Biolabs’ world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and digital droplet quantitative real-time RT-PCR.

The company offers services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.

Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Agilex Biolabs has more than 140 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.

Book a confidential briefing with our scientists before you start your next clinical trial. https://calendly.com/agilexbiolabs/30min

About Agilex Biolabs https://www.agilexbiolabs.com/

Agilex Biolabs, the Australian specialist bioanalytical and toxicology laboratory facilities for clinical trials, has more than 24 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from around the world where customers choose Australia for the streamlined regulatory process and access to the world’s most attractive R&D rebate of more up to 43.5% on clinical trial work conducted in Australia.

Agilex Biolabs also offers toxicology services through its company TetraQ.

Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

The company has recently expanded its main labs by more than 30% to accommodate biotech demand from APAC and the USA. In addition it has launched a new Immunobiology lab – watch the video here. https://www.agilexbiolabs.com/launch-of-immunobiology-laboratory/

Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).

Agilex offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
– Immunophenotyping
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
– PBMC assays and cellular mechanism of action assays

Agilex Biolabs Media Contact:
Kate Newton
Media@AgilexBiolabs.com