Veeda Clinical Research Ltd.

DUBLIN and AHMEDABAD, India, March 26, 2024 /PRNewswire/ -- Veeda Clinical Research Limited, a full-service contract research organization (CRO) with a proven record of drug development success, announced that it has acquired Heads, a privately held European CRO, which specializes in conducting clinical trials in oncology. Established in 2010, Heads has an operational presence in 25 multiple strategically important locations across Europe, North America and the Asia Pacific region. Through this acquisition, Veeda enters the league of global CROs with integrated capabilities to extend contract research services from discovery to clinical development extending to post commercial launch. Sharing details related to common synergies between Veeda and Heads, Dr. Mahesh Bhalgat, Group – CEO of Veeda Clinical Research, said, "With the growing emphasis on global clinical trials, this acquisition now positions Veeda to offer access to a very diverse population for conducting large scale multi-geography trials efficiently. Both organizations are focused towards driving equitable access to trials and fostering the development of innovative treatments worldwide. The acquisition brings together a unique team of scientists and researchers, having deep therapeutic area expertise in the Oncology research. This equips Veeda to build long and enduring site relationships across geographies." Elaborating on the prospects of this partnership, Mr. Binoy Gardi, Executive Vice Chairperson of Veeda Clinical Research, said, "As we integrate the operations of both the companies, this is an exciting opportunity for Veeda and Heads to expand markets, leverage complimentary capabilities and add value to our clients. We believe that our combined strengths will enable us to drive greater efficiency, innovation, and excellence in delivering research outcomes for drug development programs of our clients worldwide." "There is a very strong cultural fit between Heads and Veeda," said Dr. George Kouvatseas, Partner, Heads. "Both companies share a dedication to scientific leadership, expansion of highly specialized services to meet the emerging needs of our clients, and an uncompromising focus on quality. During the integration phase, Heads will continue to offer uninterrupted support to client programs. The Veeda and Heads organization together are committed to nimble operations through a structured integration process without impact to ongoing client programs." About Veeda Clinical Research Limited: Veeda Clinical Research Limited ("Veeda") is one of the largest independent, full-service clinical research organizations, headquartered in Ahmedabad, India. Veeda offers a range of bioequivalence studies and early and late phase clinical trials. Veeda has successfully completed several regulatory inspections and is approved by USFDA, UK MHRA, ANVISA (Brazil), and WHO. Veeda has experience in conducting complex clinical studies. Visit . About Heads: Heads is a full-service Global Contract Research Organization (CRO) dedicated to the conduct of clinical studies, with expertise in haemato-oncology studies. It provides complete range of clinical trial services, from start-up to completion, from Phase I to IV. In addition, it offers strategic oncology drug development consulting and expert advice, as the team understands the challenges of developing anti-cancer drugs in the complex, highly competitive and rapidly developing oncology market. Visit . Media contact: Siddharth Baad Corporate Communications Veeda Clinical Research siddharth.b2274@veedacr.com Logo: View original content to download multimedia: SOURCE Veeda Clinical Research Limited

DUBLIN, June 24, 2022 /PRNewswire/ -- The "Bioanalytical Testing Services Market by Type, Application (Oncology, Neurology, Infectious Diseases, Gastroenterology, Cardiology), End User and Region (North America, Europe, APAC, Latin America, MEA) - Global Forecast to 2027" report has been added to ResearchAndMarkets.com's offering. The global bioanalytical testing services market is projected to reach USD 6.0 billion by 2027 from an estimated USD 2.9 billion in 2022, at a CAGR of 15.6% during the forecast period. Factors such as the rising focus on the analytical testing of biologics & biosimilars, an increasing preference for outsourcing analytical testing, growing R&D expenditure in the pharmaceutical & biopharmaceutical industries, and the rising adoption of the Quality by Design approach are expected to drive the growth of this market during the forecast period. However, the dearth of skilled professionals is a major factor that is expected to restrain the growth of this market in the coming years. The Cell-based assays segment is expected to account for the largest share of the bioanalytical testing services market The increasing prevalence of chronic diseases and the rising number of clinical trials are expected to support the growth of the cell-based assays market. Cell-based assays are in vitro assays used for the quantitative and qualitative assessment of cellular mechanisms and functions using a wide range of reagents and cells. These assays are used to study the characteristics of a cell in natural conditions. The the oncology segment is expected to account for the largest share of the bioanalytical testing services market The oncology segment accounted for the largest share of the global bioanalytical testing services market in 2021. With the increasing burden of cancer on healthcare systems worldwide, both government and private organizations are increasingly focusing on developing novel cancer therapies. This is expected to drive the demand for bioanalytical testing services in the clinical trials of cancer drugs. ICON (Ireland), Syneos Health (US), and PAREXEL International (US) are the leading players offering services for the clinical trials of oncology drugs. The pharmaceutical and biopharmaceutical companies segment is expected to account for the largest share of the bioanalytical testing services market The pharmaceutical and biopharmaceutical companies segment accounted for the largest share of the global bioanalytical testing services market in 2021. Pharmaceutical and biopharmaceutical companies mainly focus on developing new drugs for the treatment of various diseases. These companies need to submit specific data related to drug development during the drug development process and subsequent filing of applications to regulatory bodies. This necessitates a wide spectrum of services in the early development phases and clinical phases to comply with regulatory requirements. Asia Pacific market to witness the highest growth during the forecast period The APAC market is estimated to grow at the highest CAGR during the forecast period. This is majorly attributed to the rapid growth in the pharmaceutical and biopharmaceutical industries, low cost of clinical trials, and favorable government policies in several countries in this region. Key Topics Covered: 1 Introduction 2 Research Methodology 3 Executive Summary 4 Premium Insights 4.1 Bioanalytical Testing Services Market Overview Figure 11 Rising Focus on Analytical Testing of Biologics and Biosimilars to Drive Market Growth 4.2 Asia-Pacific: Bioanalytical Testing Services Market, by Application & Country (2021) Figure 12 Oncology Segment to Dominate Asia-Pacific Bioanalytical Testing Services Market in 2021 4.3 Bioanalytical Testing Services Market: Geographic Growth Opportunities Figure 13 China to Register Highest Growth During Forecast Period 4.4 Regional Mix: Bioanalytical Testing Services Market Figure 14 North America to Dominate Market During Forecast Period 4.5 Bioanalytical Testing Services Market: Developing Vs. Developed Countries Figure 15 Developing Countries to Register Higher Growth During Forecast Period 5 Market Overview 5.1 Introduction 5.2 Market Dynamics 5.2.1 Drivers 5.2.1.1 Rising Focus on the Analytical Testing of Biologics and Biosimilars 5.2.1.2 Increasing Preference for Outsourcing Analytical Testing 5.2.1.3 Growing R&D Expenditure in the Pharmaceutical and Biopharmaceutical Industry 5.2.1.4 Rising Adoption of the Quality by Design Approach 5.2.2 Restraints 5.2.2.1 Dearth of Skilled Professionals 5.2.2.2 Pricing Pressure Faced by Major Players 5.2.3 Opportunities 5.2.3.1 Emerging Countries in the Asia-Pacific Region 5.2.3.2 Rising Demand for Specialized Bioanalytical Testing Services 5.2.4 Challenges 5.2.4.1 Innovative Formulations Demanding a Unique Bioanalytical Testing Approach 5.2.4.2 Growing Need to Improve the Sensitivity of Bioanalytical Methods 5.3 Assessment of COVID-19 Impact on the Economic Scenario in the Bioanalytical Testing Services Market 6 Bioanalytical Testing Services Market, by Type 6.1 Introduction 6.2 Cell-Based Assays 6.3 Virology Testing 6.4 Method Development Optimization and Validation 6.5 Serology, Immunogenicity, and Neutralizing Antibodies 6.6 Biomarker Testing 6.7 Pharmacokinetic Testing 7 Bioanalytical Testing Services Market, by Application 7.1 Introduction 7.2 Oncology 7.3 Neurology 7.4 Infectious Diseases 7.5 Gastroenterology 7.6 Cardiology 8 Bioanalytical Testing Services Market, by End-user 8.1 Introduction 8.2 Pharmaceutical & Biopharmaceutical Companies 8.3 Contract Development and Manufacturing Organizations 8.4 Contract Research Organizations 9 Bioanalytical Testing Services Market, by Region 10 Competitive Landscape Companies Mentioned Absorption Systems LLC Almac Group Altasciences Bioagilytix Labs Bioneeds India Private Limited Cd Biosciences Inc Celerion Charles River Eurofins Scientific Frontage Labs Icon plc Intertek Group plc Iqvia Inc. Laboratory Corporation of America Holdings LGC Limited Lotus Labs Pvt. Ltd. Medpace Holdings Pace Analytical Parexel International Corporation PPD, Inc. Sartorius Ag SGS Sa Syneos Health Vipragen Biosciences Wuxi Apptec For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

June 24, 2022 12:17 UTC Results of 100 subjects bridging study and 1,500 subjects placebo-controlled trial of Akston’s AKS-452 announced. Interim analysis shows a 91% seroconversion rate. Statistically-significant high antibody titers were maintained for six months in the bridging study. The vaccine was well tolerated, with no significant safety issues reported. AKS-452 is shelf-stable for over six months at room temperature at 25° C and maintains potency for one month at 37° C. Biolexis has licensed AKS-452 and plans to launch it as “AmbiVax-CTM” in global markets. Vaccine to be produced at Stelis Biopharma, the biotech CDMO division of Strides Group. BEVERLY, Mass. & BANGALORE, India--(BUSINESS WIRE)--Akston Biosciences Corporation and Biolexis, a Strides Group Company, today announced results from a Phase II/III clinical trial in India of the SARS-CoV-2 vaccine, AKS-452, in which 1,600 healthy volunteers participated – 100 in an open-label bridging study and 1,500 in Phase II/III, double-blind, placebo-controlled trial. An interim analysis of this data shows no significant safety issues and a 91% seroconversion rate at Day 56. Volunteers in the bridging study had antibody titers that persisted at statistically-significant high levels through six months, with serum taken from them showing protection against variants of concern. The results will be submitted as a prime vaccine in India for Emergency Use Authorization (EUA). Later clinical studies are planned to support approval for use as a booster shot to itself and other approved vaccines. Earlier studies in the Netherlands have demonstrated robust antibody neutralization of variants, including Delta and Omicron. Akston and Strides group have already signed a licensing, manufacturing, and commercialization agreement to launch this vaccine worldwide as AmbiVax-CTM. Under the agreement, Biolexis, the vaccine and biosimilar arm of the Strides Group, has the rights to manufacture and commercialize AmbiVax-CTM in India and over 130 countries in Asia, Latin America, and Africa, mainly covering the low-and-middle-income countries (LMICs) where a significant population lacks dependable access to vaccines as a result of insufficient infrastructure to support the cold chain requirements of other COVID-19 vaccines. The vaccine is a reliable, accessible alternative in these regions, allowing immunization and longevity of immunity with the boosters against the Covid variants of concern. The partnership will leverage the capabilities of Strides Group, which has an “in Africa for Africa” strategy and will offer the vaccine to countries with a deep market presence and established relationships. Arun Kumar, Founder of Strides Group, added, “We are pleased to know the encouraging results from the India studies of AmbiVax-CTM, particularly the high seroconversion rate that the vaccine demonstrated. This vaccine differentiates itself by allowing room-temperature stability, higher efficacy, and safety and can offer accessibility and affordability through the economical supply chain and infrastructure requirements. As we progress to receiving the approval, we will continue exploring opportunities to fast-track its launch for the global markets.” Todd Zion, Ph.D., President & CEO of Akston Biosciences, said, “The latest clinical data demonstrate the potential of this low-cost protein vaccine intended specifically for those most in need. We are very pleased to be working closely with Biolexis and Strides Group, which can supply the vaccine at scale to countries that need a practical and affordable way to protect their populations during this worldwide pandemic.” The Phase II/III trial, managed by Ahmedabad-based Veeda Clinical Research Limited, evaluated the safety, tolerability, and humoral immunogenicity profile, i.e., SP/RBD-specific IgG titers. Of the 1,500 healthy volunteers, 1,125 received the two 90 µg doses 28 days apart, with the first dose including AKS-452 and an adjuvant, while the second dose consisted of only AKS-452. The remaining 375 also received two doses, with the first dose including placebo and the adjuvant, while the second dose consisted only of placebo. AKS-452 does not include mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus. It has been engineered to use established, low-cost antibody manufacturing techniques, such that a single production line could be capable of producing over one billion doses per year. Stability studies have demonstrated thermostability at room temperature for over six months at 25° Celsius (77° Fahrenheit) and maintenance of potency for one month at 37° Celsius (99° Fahrenheit). About Akston Biosciences Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. It was founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.). Besides out-licensing AmbiVax-CTM to Biolexis, Akston has partnered with Dechra Pharmaceuticals PLC (DPH) to commercialize once-a-week canine and feline insulin therapies. It operates a GMP biologics manufacturing cleanroom facility and research laboratory at its Beverly, Mass. location. Additional information is available at . About Strides Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE (532531) and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets, has an “in Africa for Africa” strategy, and an institutional business to service donor-funded needs. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi), and the United States (New York). The Company focuses on “difficult to manufacture” products sold in over 100 countries. Additional information is available at . About Stelis Stelis Biopharma Limited (Stelis) is an emerging global biopharmaceutical CDMO with a complete and integrated end-to-end offering. It is equipped with world-class Process Development (PD) and manufacturing infrastructure for both drug substances (mammalian and microbial-based therapeutic proteins and other emerging modalities) and drug products (lyophilized vials, liquid vials, pre-filled syringes, cartridges, and devices). Stelis offers the complete spectrum of services, from cell line tech transfer to clinical and commercial manufacturing, with in-house capability to convert drug substances to stable formulations and fill and finish in all formats. Stelis has three state-of-the-art facilities, with ~85,000 square meters of PD and manufacturing space and over 800 highly talented professionals. Its facilities are highly automated to increase accuracy, efficiency, and speed at every process stage. Additional details are available at . About Biolexis Biolexis Private Limited (Biolexis) is an emerging biotech and vaccine company capable of developing and commercializing products for the Global markets. The Company is a wholly-owned subsidiary of Stelis and is focused on building and in-licensing a portfolio of advanced biosimilars, peptides, and vaccines. The Company endeavors to attain leadership in commercializing its portfolio of products with a high focus on quality, affordability, and accessibility. Besides in-licensing AmbiVax-CTM from Akston, Biolexis has a proprietary platform technology to develop and commercialize recombinant insulin and insulin analogs with high purity and consistent quality. The current programs of the Company include Rh-Teriparatide (biosimilar to Forteo® and Forsteo®), Insulin glargine (biosimilar to Sanofi’s Lantus®), Insulin Lispro (biosimilar to Eli-Lilly’s Humalog®), Insulin Aspart (biosimilar to Novo Nordisk’s Novolog®), a recently filed peptide for diabetes and a novel anti-hemorrhoid. About Veeda Clinical Research Limited Veeda Clinical Research Limited (“Veeda”) is one of the largest independent, full-service clinical research organizations headquartered in Ahmedabad, India. Veeda offers a range of bioequivalence studies and early and late phase clinical trials. Veeda has completed several regulatory inspections and is approved by USFDA, UK MHRA, ANVISA (Brazil), and WHO. Veeda has experience in conducting complex clinical studies. Visit