ghpBiotechnology Awards 2024 Biotechnology Awards 2024 www.ghp-news.com Fethiann Molecule Applied Co Ltd: Herb Extract Research Innovator of the Year 2024 - APAC Featuring:
Global Health & Pharma (GHP) Magazine’s Biotechnology Awards 2024 has arrived! Biotechnology Awards 2024 With these prestigious awards we pay respect to the vital members of the Biotechnology industry whose contributions to health, science and education are invaluable. These awards have been a longstanding inclusion in GHP’s digital publication so that we may provide annual praise to the professionals who we believe are so instrumental to society. Biotechnology’s conception can arguably be traced back at least 6,000 years ago to the agricultural revolution; humanity’s first successful attempt at altering nature. However, its true development as a scientific discipline began in the late nineteenth century with the advent of Zymotechnology – the study of bio-fermentation processes. What started as an industrial pursuit focused primarily on mass food production soon evolved into a discipline which has helped to save lives and enlighten humanity on the inner workings of nature itself. By the end of the 20th century, biotech developments included antibiotics, advanced vaccines, genetic engineering and mammal cloning. Society today also benefits from recent biotechnology advancements such as Personalised Medicine and CRISPR-enabled gene editing. Biotechnology provides us with immeasurable value, from simply increasing convenience in our daily lives to entirely revolutionising how we heal, survive and thrive. Sofi Parry- Senior Editor Website: www.ghp-news.com AI Global Media, Ltd. (AI) takes reasonable measures to ensure the quality of the information on this web site. However, AI will not assume any legal liability or responsibility for the accuracy, correctness or completeness of any information that is available through this web site. If errors are brought to our attention, we will try to correct them. The information available through the website and our partner publications is for your general information and use and is not intended to address any particular finance or investment requirements. In particular, the information does not constitute any form of advice or recommendation by us or any of our partner publications and is not intended to be relied upon by users in making or refraining from making any investment or financial decisions. Appropriate independent advice should be obtained before making any such decision. Any arrangement made between you and any third party named in the site is at your sole risk and responsibility.
Contents 4. Fethiann Molecule Applied Co., Ltd.: Herb Extract Research Innovator of the Year 2024 - APAC 6. Antharis Therapeutics, Inc: Biopharmaceutical Company of the Year 2024 - California 8. MGI Tech: Most Innovative Next-Gen Sequencing Company 2024 9. NexPlasmaGen inc: Best MedTech Oncology Business 2024 - Canada 10. SICGEN Antibodies: Polyclonal Antibody Production Specialists of the Year 2024 & Client Service Excellence Award 11. Raadysan Biotech, Inc: Most Visionary Woman-Owned Biotech Company 2024 - USA 12. Trestle Compliance LLC: Best Life Science Commercial Business Compliance Specialists 2024 - USA 13. Azzur Group, LLC: Best Early-Phase BioTech Manufacturing Firm 2024 - North America & GHP Innovation Excellence Award 2024 14. VasoDynamics Ltd: Best Cancer Care Solutions Provider 2024 - UK
4 Headquartered in Taiwan, Fethiann Molecule Applied Co., Ltd. is an innovative research and development company dedicated to leveraging the power of bioactive extracts like Magnolia Figo and Litsea Cubeba to support the health of people across the world following the Covid-19 pandemic. To this end, the company supplies the biotechnology industry with natural medicinal extracts, as well as providing comprehensive solutions to the health science, pharmaceutical, and food and beverage sectors. Native to Taiwan, Magnolia Figo is an evergreen tree that is often cultivated as an ornamental plant for its fragrant cream-white, yellow, or purple flowers. Fethiann was the first to discover the precious components of natural Magnolia Figo extract, which are rich in phytochemicals and possess significant medicinal value, making them highly sought after. This inspired the company to develop a special concoction using customised extraction equipment with unique parameters. Ten kilograms of Magnolia Figo can be harvested and bioprocessed to produce one gram of the pure, highly active extract, which has the potential to treat non-small cell lung cancer, relieve atopic dermatitis, heal wounds, and more. These solutions and patents belong exclusively to Fethiann, which is why the extract is named FMO®️ (Fethiann Magnoliafigo Only). Fethiann’s mission is centred around solving the health issues faced by people across the world and helping to provide those afraid of disease with peace of mind. To accomplish this, the company combines molecular technology extraction, Molecurique®️ (Molecular Unique), with green energy, natural plants, and phytochemistry, driving advancements in biomedicine for the benefit of human health. It strives to share the unbelievable natural power of its discoveries with people and their families. Another product developed by Fethiann is a special herbal hydrogel named FLC®️ , made from the herbal plant Lauraceae of Litsea Cubeba. It is a valuable plant traditionally used to treat headaches, muscle aches, arthritis, and insect bites in Taiwan. Previous research also suggests that it has good antibacterial and anti-inflammatory abilities, but no systematic research on gouty joint inflammation had been carried out, and there was no scientific development model for topical products. This inspired Fethiann to develop a thermosensitive smart hydrogel for topical dressings, containing supercritical fluid extract of Litsea Cubeba fruit. In research, the company used UV light to graft and polymerise temperature sensitive polymers, which were then used to coat the extract. The resulting gel was applied to an experimental animal and found to significantly reduce swelling and inhibit inflammation, making it useful for topical dressings. Furthermore, with the addition of a promoter, the product’s positive effects came into fruition faster. Fethiann believes that its patented raw materials, obtained from natural and native plants using biotechnology processes, are at the core of its work. The company’s patents not only protect its technological developments and prevent competition from counterfeits but also enable it to license its products to others and earn licensing fees, thus attracting more investment and collaboration opportunities. Furthermore, proper patent deployment can enhance the negotiating value of products in licensing discussions and instil greater trust in the company amongst consumers and investors. Fethiann’s patented raw materials have a variety of potential applications, including life science research and the consumers market of healthcare. As a result, the company’s customer base is broad, ranging from Biomedical Research Organisations to other enterprises in the medical materials, pharmaceuticals, cosmetics, and food and beverage industries. Fethiann is honoured to serve clients in so many industries and proud of the role it plays in enhancing the daily lives of people across the world. Now standing out as a leading research and development company in the field of herbal extracts, Fethiann owes its success to its exceptional team, who play a crucial role in its ability to consistently meet the needs of consumers and achieve its corporate objectives. For this reason, the company strives to foster cohesion, efficiency, and high performance amongst its workforce by creating a sense of belonging, providing encouragement, and championing team spirit. Fethiann’s team is also expected to adhere to the organisation’s three core values: quality, responsibility, and sustainability. Quality Herb Extract Research Innovator of the Year 2024 - APAC
GHP Biotechnology Awards 2024 forms the foundation of its operations, which it embodies by adhering to the ISO 9001:2015 quality management certification and working towards ISO 13485:2016. Responsibility drives every interaction the company has with its consumers and investors, enabling it to foster trust with them. Sustainability is also a key focus for Fethiann, so it plans to pursue a future aligned with its ESG vision. In order to ensure that all new recruits align with its existing values and culture, Fethiann carries out a question-and-answer session with candidates during the hiring process, assessing their familyresponsibility, self-responsibility, team-responsibility, and potential to contribute towards the wider company responsibility. Beyond hiring, Fethiann builds strong partnerships with its employees and periodically provides them with training to enhance their personal and professional skills. They undergo continuous improvement, ensuring their ability to keep up with the changing needs of the market. The company’s goal is to inspire and guide its staff, driving them to be their best selves. As a result, they are committed to their work and enjoy sharing Fethiann’s story with clients, answering any questions they may have about the company. Thanks to the remarkable work of its team, Fethiann has been awarded the title of Herb Extract Research Innovator of the Year, APAC, in the Biotechnology Awards 2024. In the years to come, the company plans to focus on meeting the expectations of its investors, becoming the world’s top supplier of patented key raw materials, and licencing patents to establish supply chain relationships with large pharmaceutical manufacturers. Furthermore, aiming to alleviate the devastating impacts of the recent Covid-19 pandemic, Fethiann’s future research will be centred around the protective effects of the different extracts from Magnolia Figo’s flowers and leaves on the respiratory damage caused by acute lung injury and allergic asthma. The goal is that this research project will enable FMO®️ to be applied as a preventive healthcare product or used to develop a new botanical drug for lung health and respiration system care. Contact: Frederic J. Kuo | CEO Company: Fethiann Molecule Applied Co., Ltd. Web Address: www.fethiannglobal.com
6 Feb24196 Based in San Diego, Antharis Therapeutics, Inc. is an oncological biopharmaceutical company working to fulfil unmet medical needs with biotherapeutics that, among other strategies, harness and unleash the power of the immune system. In particular, its work centres around the development of monoclonal antibodies and antibodydrug conjugates that can be used to treat multiple cancer types. Here, we speak to CEO and Chairman Dr. Raphael R Pinaud, PhD, MBA to find out more about Antharis and its fascinating work. ancer cells often employ immune evasion mechanisms, which is why treatments like CAR T-cell therapy focus on exploiting the immuno-oncological interface by genetically engineering patients’ T-cells to recognise and attack cancer cells. In 2020, Antharis was established based on the belief that the future of cancer treatment holds greater promise on the targeted and optimised recruitment and activation of immune system cells to combat diseases. However, the company believes that monoclonal antibodies have the potential to modulate immune responses and disrupt cancer cell biology with high efficiency and potentially fewer adverse effects. Furthermore, unlike other methods, monoclonal antibodies are accessible and affordable for patients as they are readily available off-the-shelf and can be produced on a large scale. In light of these benefits, Antharis is working to develop monoclonal antibody therapies, leveraging cutting-edge science and technologies to achieve high success rates. The company boasts a number of distinct technical advantages, including its use of innovative and scientifically rigorous criteria for target selection. This not only ensures the therapeutic relevance of chosen targets but also supports, among a number of different mechanisms, the dynamic and robust engagement of immune cell responses to tackle diseases. As a result, Antharis is now equipped with one of the sector’s most prolific and strategic portfolios of oncological products capable of targeting numerous types of cancer. Its goal is to alleviate the impact of severe diseases by realising the potential of these therapies, providing new optimism for patients across the world. Another factor that sets Antharis apart from the rest is its unique approach to asset production, which plays an important role in the generation of effective monoclonal antibodies. “Particularly, along with traditional methods, Antharis also employs DNA-based immunisation strategies, which leverage the cell’s machinery to produce target proteins of interest in-vivo,” explains Dr. Raphael R Pinaud. “This approach, relative to traditional immunisation strategies, may yield antibodies that preferentially recognise the native conformation of target proteins, as seen in disease states, thereby potentially enhancing our success rates in developing therapeutically efficacious monoclonal antibodies.” Currently, Antharis is at a pivotal stage in its work as it focuses on optimising the effectiveness of its monoclonal antibodies and advancing its most promising products towards the clinic. In order to swiftly bring its innovative solutions to those in critical need, the company is engaging in advanced research and development and preparing its regulatory structure. More recently, Antharis has initiated conversations with major investment banks, and has been carefully exploring the potential of taking the company to the public markets. Alongside this, it has engaged in preliminary discussions with relevant pharmaceutical companies, exploring the potential of partnering on asset co-development and licensing projects. Internally, Antharis is equipped with a diverse team of experts with backgrounds in various disciplines, from molecular and cellular biology to immunology and computer science. The company believes that its workforce plays a pivotal role in its overall success, serving as the foundation for its ability to tackle complex challenges and innovate in the competitive biotechnology landscape. For this reason, it is no surprise that Antharis takes a meticulous and strategic approach to hiring, thoroughly evaluating candidates’ qualifications, experience, personality, and values. In this, the company seeks to identify those who demonstrate technical expertise, a collaborative mindset, and passion for driving the advancement of therapeutic solutions. Raphael adds, “Our recruitment efforts extend beyond traditional channels, leveraging industry networks, relationships with academic institutions, and participation in conferences to connect with top-tier professionals.” In order to attract and retain the industry’s top talent, it is important for Antharis to maintain a focus on fostering a positive internal culture. The company is deeply committed to driving innovation and collaboration by encouraging respect, curiosity, critical thinking, and hard work amongst its team. It also provides them with boundless opportunities for continuous learning and professional growth. This creates a dynamic environment in which team members are prepared to work together to push the boundaries of scientific discovery and develop advanced treatments for patients in need. This shared vision is instrumental to the success of Antharis, leading to heightened efficiency, quicker problemsolving, and increased responsiveness to industry trends. As a result, it is always well-positioned to stay ahead of the curve, swiftly adapting to changes in market demands and developments in the ever-evolving world of science. “We believe that ground-breaking solutions often emerge at the intersection of different perspectives,” Raphael comments. “In essence, our culture is one of relentless pursuit, where each member is empowered to contribute their unique strengths, and together, we strive to make a meaningful treatments that hold great potential to impact patients’ lives.” For their revolutionary monoclonal antibody programme, we are pleased to present the team at Antharis with the title of Biopharmaceutical Company of the Year, California, in the Biotechnology Awards 2024. Looking towards the future, the company remains wholly dedicated to improving patient outcomes and bringing the next generation of therapies to the healthcare sector. In the long-term, it envisions the continued expansion of its existing biotherapeutics pipeline, enabling it to help patients Biopharmaceutical Company of the Year 2024 - California C
GHP Biotechnology Awards 2024 suffering from a broader spectrum of devastating diseases that lack satisfactory treatment. With a steadfast dedication to innovation, Antharis is positioned to contribute significantly to the healthcare landscape in the years to come. Contact: Cass Morrison Company: Antharis Therapeutics, Inc. Web Address: www.antharistherapeutics.com
8 GHP Q3 2023 As a leading producer of clinical highthroughput gene sequencers, MGI Tech has spent its years exploring the boundless potential of medical imaging, laboratory automation, and gene sequencing itself. One of only a few companies capable of independently developing and mass-producing medium and high throughput clinical gene sequencers from GB to TB, the company has long since distinguished itself as a standout entity. Join us as we explore how it interacts with scientific research institutions, university biology labs, and scientific healthcare institutions to foster further brilliance across the sphere. It’s an unfortunate truth that, within the world of medical advancement, it isn’t always the science that causes the roadblocks, sometimes is instead the money. The cost of gene sequencing is one that collectives have been trying to lower for years, and yet not many have been quite as successful as MGI Tech. As the proud producer of clinical high-throughput gene sequencers, it has managed to play a crucial role in the reduction of gene sequencing costs, cutting it to over half the price as usual. Where the field average is usually $200, MGI Tech has managed to develop a sequencer that dropped per genome sequencing cost down to below $100 – a reduction that certainly hasn’t gone unnoticed. Developed in 2023, DNBSEQ-T20 has quickly taken the sequencing sector by storm. Not only is it an innovative product that has become the driving force of the global genetic industry’s expansion, but it has also introduced the potential to rapidly progress the understanding of human genomes, as well as how to extend their usage to medical applications. In addition, the product is capable of fundamentally reshaping the biotech industry’s ecology as a whole. Through lower sequencing costs, both precision medicine and treatment will benefit immensely, with multiple clinical applications possible as a direct result. Stemming from this is, of course, the potential for more clinical disease diagnosis and treatment alternatives, as well as sequencing-based health monitoring. MGI Tech has always had its sights set on elevating human health, and therefore went out of its way to develop cutting edge sequencing technologies that would actively assist the industry in pursuing this goal. Whether this manifests through its aforementioned product, or through its DNBSEQ-T7 and DNBSEQ-G99 – sequencers that compensates for the reduced speed of a lower cost product through unparalleled flexibility – it has managed to support a myriad of customers across the globe. Having already impacted clients in Thailand, Indonesia, and Brazil, MGI Tech has played a critical role in aiding in major national genome projects – a factor that has heavily contributed towards its immense level of recognition. MGI Tech has also been contributing to applications in precision medicine, oncology, rare disease diagnosis, agrigenomics, metagenomics and more. This combination of outstanding technology and costeffectiveness is what has truly placed MGI Tech on the map, with its products ultimately holding the key to the industry’s future. By demonstrating immense levels of aptitude in influencing the sphere as a whole, the company has set itself apart, not just on a national scale, but on a global one. Its impact it being felt far and wide, with a palpability that can’t be overlooked. Regardless of location, MGI Tech’s presence means the gene sequencing sector is ready to take its next large step, with the company’s hand there to guide it forward. Never before has innovation taken such a stark form, and it’s for this very reason that MGI Tech has quickly become such a widely recognised name. Synonymous with excellence, MGI Tech is a key player in what is sure to be a series of revelations across the gene sequencing scene. Its tireless production of revolutionary systems and gene sequencing products proves that it’s entirely possible to foster a better tomorrow for health sectors across the globe, and we can’t wait to see how its impact grows over time. For now, we congratulate MGI Tech on its determination to herald in change, and we hope it continues to achieve greatness throughout the remainder of 2024. Contact: Dada Zhang Company: MGI Tech Web Address: https://en.mgi-tech.com/ Most Innovative Next-Gen Sequencing Company 2024
9 GHP Biotechnology Awards 2024 t’s no secret that, among all cancers, breast cancer is by far the most common form seen in women worldwide. In 2020 alone, there were over 2.3 million diagnosed cases, with the vast majority identified in industrialised countries, such as the US and Canada. Though it’s a frightening truth that one in eight women will most likely develop an invasive breast cancer over the course of their lifetimes, this isn’t to say that the outlook has to be bleak. Ensuring this is NexPlasmaGen – an award-winning MedTech oncology business whose detailed research into reducing patient reoperation and cancer local recurrence is on the precipice of completely redefining breast cancer care. It achieves this through its ingenious product - the Convertible Plasma Jet. Able to channel the bountiful potential of technology, this product creates a plasma jet that’s only a few centimetres wide, and composed of a mixture of highly reactive gaseous species that are specifically targeted towards killing breast cancer cells. Through this, NexPlasmaGen has demonstrated that, since its inception, it has already made significant progress within the breast conversing therapy market. In fact, it wasn’t long before the business received US and Canada patent on the design of the first version of its technology, with a worldwide patent application submitted soon after Convertible Plasma Jet and granted rapidly in US. This worldwide patent would see that NexPlasmaGen could generate three plasma models in one device. For now, the Convertible Plasma Jet is the only cold plasma device that’s able to precisely – and cost effectively – generate a reactive oxygen species that’s renowned for its role in cancer cell cytotoxicity. Though, at present, the breast conserving therapy market is predominantly occupied by suppliers of electrosurgical cutters, cryosection equipment, conventional radiotherapy, and chemotherapy, NexPlasmaGen hopes to become the face of a more effective, less expensive, and safer mode of destroying breast cancer cells. In doing so, NexPlasmaGen has become a popular talking point within the industry, with its technology even presenting the potential to tackle other cancers such as sarcoma, ovarian, cervical, and melanoma in the future. Having received remarkable interest from the clinical community, with front-line breast cancer researchers and clinicians from the Montreal University Hospital Centre having recently wrapped up a selection of the Convertible Plasma Jet’s clinical trials, it seems as though NexPlasmaGen is well on its way to introducing a new age of breast cancer treatment. With first-in-human clinical trials planned for 2024 – following testing on twelve breast cancer cells Looking to become the global market leader in precision cold plasma technologies for cancer treatment, with its origins centered around breast cancer specifically, NexPlasmaGen has been continuously accomplishing monumental feats within the healthcare industry. As a creative, dynamic spin-off from McGill University – founded by Dr. Valérie Léveillé – the business has spent its years analysing how to reduce cancer local recurrence rates, and leverages its in-depth understanding of technology’s capabilities to reign in a new future for the oncology sphere. Joins us as we explore the details, and how NexPlasmaGen is reshaping what we think we know about breast cancer treatment. Best MedTech Oncology Business 2024 - Canada lines in vitro, on spheroids tumour models, and in vivo on mice – the future certainly looks bright for the healthcare industry as a whole, and NexPlasmaGen will be proudly leading the charge. Though it may not be a straightforward path, the one that NexPlasmaGen has tirelessly worked to be on proves to be a fruitful one indeed. However, we believe Valérie of NexPlasmaGen puts it best – “Every day when I get up, I remind myself … that our Vision is to be recognized worldwide as a provider of novel, precise medical solutions in oncology, enabling our clients to excel in their field. And our purpose is to improve the cancer treatment quality of care and improve patient quality of life using precise cold plasma technology.” We hope that this recent accolade can further help NexPlasmaGen along in its journey towards redefining the future of breast cancer treatment, and we look forward to seeing its continued success in the year ahead. Contact: Valérie Léveillé Company: NexPlasmaGen inc. Web Address: https://nexplasmagen.com/ I Feb24417
10 GHP Q3 2023 aving already successfully developed, produced, and marketed polyclonal antibodies that are now utilised in various life sciences research areas, SICGEN Antibodies is a company whose name has become synonymous with excellence in the field. Driven by the goal of being recognised worldwide as a global producer of its specialty antibodies, the collective has gone above and beyond to concoct new and astonishing antibodies that pose a variety of capabilities. One such example takes the form of antibodies against fluorescent proteins such as GFP, mCherry, and tdTomato. Having been featured in prestigious life science publications such as Nature, Cell, and Science, this product is just one of many that has garnered the unwavering attention of the wider community. When turning our attention to 2024, however, it appears that SICGEN Antibodies has only increased its pace. Since the start of the year, the company’s line has expanded to more than 300 products, each primarily used for research purposes, but still maintaining a focus on techniques such as Western Blotting, Immunofluorescence, and Immunocytochemistry. In addition to further applications in ELISA, immunoprecipitation, and other biochemical techniques, SICGEN Antibodies has certainly followed its forward momentum, without plans of ever slowing down. This is most likely a result of the collective’s avid passion for ongoing innovation – a quality that sees it continuously developing new antibody-related products. At present, SICGEN Antibodies supplies polyclonal antibodies to leading institutions both nationally and internationally, be they universities, research institutes, pharmaceutical manufacturers or biotechnology distributors – with its main markets consisting of those in North America, Europe, and the Far East. It achieves this through a combination of marketing methods, including direct sales, collaboration with countrywide distributors, and utilising the Feb24116 H Dedicated to the development, manufacturing, and marketing of polyclonal antibodies for Cell Biology research, SICGEN Antibodies is a multiaward-winning European company whose impact on the industry has been felt for over a decade. Created in 2009, and headquartered in the district of Coimbra, the company leverages cuttingedge biotechnologies in its avid pursuit of becoming the definitive global producer of high-quality polyclonal antibodies and antibody-related products and services. Partnered with its desire to do so at competitive prices, SICGEN Antibodies has truly captured the very essence of the market it seeks to champion. OEM system. In essence, SICGEN Antibodies relies on both the intrinsically impressive qualities of its products, in tandem with scientific papers that mention the use of its antibodies to prove its credibility, to thrive, and has allowed this very method to guide it through its consistent growth. Partnered with its commitment to continuous development, it’s unsurprising that SICGEN Antibodies has come such a long way since its inception. Whether it’s focused on creating, producing, and marketing new antibodies to address various gaps in the market, or expanding its reach to new customers in various other markets through the implementation of a free sample program and increased distribution channels, the company is clearly committed to achieving its goal. As expected from a holder of multiple accolades, each more impressive than the next, SICGEN Antibodies is well on its way to becoming a global producer of highquality polyclonal antibodies. Though it may seem like an ambitious venture, no company has displayed such avid determination quite like SICGEN Antibodies. Though the antibody industry has experienced significant growth in the past decade alone, with constant revelations emerging on a frequent basis, SICGEN Antibodies has remained at the very forefront of polyclonal antibody development. In doing so, it’s found a specialty for which it’s known, ultimately resulting in a fantastic market standing that’s sure to persist throughout the sector’s further evolution. We look forward to seeing how SICGEN Antibodies approaches the future of the antibody industry as it progresses further into 2024. Contact: José Ramalho Company: SICGEN Antibodies Web Address: www.sicgfen.pt Polyclonal Antibody Production Specialists of the Year 2024 & Client Service Excellence Award
11 GHP Biotechnology Awards 2024 Feb24553 Occurring when the cells in the breast mutate, become cancerous, and form tumors, breast cancer is the second highest cause of death, highest cancer related cause of death, and most common form of cancer in women across the world. However, when the disease is identified in its earliest stages, almost all individuals with breast cancer survive for five years or more. This makes its prompt detection incredibly important, for which mammography is currently most routinely used. Another factor that is important when it comes to decreasing the number of deaths caused by breast cancer is being able to effectively treat the disease. Thus far, there has been encouraging progress made in this area. Most of the drugs available target the endocrine or growth factor receptors, making them effective for the treatment of estrogen/progesterone receptor (ER/PR) positive and HER2 positive breast cancers. However, triple negative breast cancer, which accounts for about 10 to 15 percent of all breast cancers, lacks all of these receptors. This makes existing target-based therapies ineffective, resulting in poor survival rates and high levels of recurrence. In addition to its lack of ER/PR and HER2 receptors, the manifestation of triple negative breast cancer is associated with complex heterogeneity and ethnic disparity, which further complicates its treatment options. Consequently, there is an urgent need to identify molecular targets that are receptor independent and develop effective therapies that target the cell proliferation machinery of cancer cells. Raadysan Biotech’s purpose is to fulfil this need. The company has identified a unique biomarker for triple negative breast cancer that is endocrine and growth receptor independent and directly involved in all stages of cell proliferation. Alongside this, it has also identified a drug lead that directly inhibits the target, thereby selectively killing cancer cells by necroptosis. As a result of these discoveries, Raadysan Biotech is able to develop both therapeutics as well as companion diagnostic kits. Raadysan Biotech’s biomarker will serve as a non-invasive diagnostic tool for the detection of not only triple negative breast cancer but also other gynecological cancers like ovarian, uterine, and cervical. It also has the potential to detect blood cancers like acute and chronic myeloid leukemia. Furthermore, with a predictive pathway, the biomarker will overcome the issues of physician doubt and payers’ reluctance. Moreover, Raadysan Biotech’s drug lead directly targets the DNA replication and proliferation machinery of the cancer cells, causing them to die by necroptosis. This prevents them from both regrowing and developing resistance. However, the treatment does not directly damage the DNA, selectively targeting only cancer cells to allow adjacent normal cells to repair and regrow. Furthermore, being receptor independent, Raadysan Biotech’s drug will serve as an Situated in New York, Raadysan Biotech, Inc. is a woman-owned biotechnology company involved in the research and development of highly differentiated therapies and diagnostic tools for triple negative breast cancer. Here, we dive deeper into the organization’s work as it is recognized for its unparalleled innovation in our Biotechnology Awards 2024. Most Visionary Woman-Owned Biotech Company 2024 - USA effective therapy for all sub-types of triple negative breast cancer and can even be an effective alternate treatment for apoptotic resistant cancer cells. The ingenious mind behind Raadysan Biotech’s incredible work is CEO and President Rakhee Gupte, MS, PhD, a seasoned scientist with over two decades of academic and pharmaceutical experience in the fields of microbiology, biochemistry, molecular and cell biology, and immunology. Throughout her impressive career, she has obtained five US patents and published over 20 abstracts and 21 full-length publications in peer-reviewed scientific journals. Dr. Gupte’s research includes identifying the mechanisms involved in the stalling of DNA replication and cytokinesis in adult rat cardiac myocytes. She has also played a role in the identification of several novel signaling pathways involved in DNA replication, mitosis, and cytokinesis in cancer cells, leading to the discovery of unique molecular targets for therapeutic intervention. Over the years, Dr. Gupte’s groundbreaking work has led her to receive numerous accolades for her academic achievements. Today, at Raadysan Biotech, Dr. Gupte stands at the helm of an exceptional team of scientists, clinicians, advisors, and managers, whose visionary outlook has driven the revolutionary discoveries reflected in the company’s portfolio. Thanks to their remarkable work, the organization has been named Most Visionary WomanOwned Biotech Company, USA, in the Biotechnology Awards 2024. Considering its discoveries thus far, there is no doubt that Raadysan Biotech looks towards a bright future, and we look forward to seeing what its future holds. Contact: Rakhee Gupte Company: Raadysan Biotech, Inc. Web Address: raadysanbiotech.com
12 GHP Q3 2023 An expert in the design, creation, and implementation of precise compliance risk assessments and custom compliance programmes that measurably propel the growth of its clients, TRESTLE Compliance LLC strives to constantly deliver tailored solutions and partner-level expertise in 100% of cases. Founded by President/ CEO Steve Vincze a little over seven years ago, this business is nestled in the heart of the Boston biotech hub, a region that has become synonymous with biotech excellence, as more than 1000 developments already call the greater city area home. We catch up with Steve to find out more. Bolstered by a dedicated and knowledgeable team who are determined to find tailored methods of compliance that result in the growth of its clients’ businesses, TRESTLE is comprised of a group of budding entrepreneurs, all of whom are well-versed in the finer points of the market, including the importance of providing solutions that are as agile as they are swift. Proudly at the centre of operations, Steve’s journey to get to this point has been diverse, and as he tells us, “I’ve served in a multitude of senior executive compliance roles, as well as a Deloitte senior leader, and an officer in the U.S. Marine Corps.” Across this multi-faceted career, Steve has proudly built a legacy defined by the effective compliance solutions that he creates, and by leveraging an unrivalled expertise in areas such as sales, antikickback, false claims, anti-corruption, and privacy issues, Steve constantly uses this knowledge to guide his team to sustained success. On the back of this, clients have been secured such as the U.S. Congress, some of The Big Four consulting and law firms, a series of attorneys, reimbursement specialists, creative designers, and software innovators, to name just a few. Much of this success stems from the fact that clients will never be provided with a junior level consultant, with a direct path afforded to a professional whose ability to identify the necessary risks and implement a series of resourceful, effective solutions is second to none. Through this knowledge, the TRESTLE team are proud to craft compliance solutions that greatly support life science businesses, with frameworks utilised that offer immense support and value, regardless of the organisation’s stage. So, whether investors are being sought out, a first product is ready to ship, or a new product is on the way to market, TRESTLE can help. With services available inclusive of monitoring and auditing and the creation and delivery of policies, procedures, and training, actionable plans are created for clients at every turn. Beyond this, Steve explains, “we are currently working on implementing a comprehensive HIPAA risk assessment and US-focused privacy programme for an ex-US international biotech company with commercial operations in the US.” With this representing a push towards ensuring that biotech companies are updated on trends, such as the increasing reliance on the virtual communications element of commercial operations. Moreover, Steve states, “as biotech companies increasingly focus on rare diseases and therapies that often are injectable and require significant patient support, proper privacy protocols are essential, not only internally, but also with third parties.” Thus, it is becoming increasingly important to stay current with developments in both state and national legislation, with this serving as one of the primary challenges that TRESTLE and its clients face today. Exacerbating this further is a series of ongoing sales and marketing difficulties, brought about by reduced accessibility to the offices of health care professionals. Despite such challenges, TRESTLE succeeds by staying ahead of the curve, remaining current to nurture success for itself and its clients, something that its can-do attitude, exemplary business culture, and leveraging of the unique skills of some of the best and brightest employees in the industry all contribute demonstrably towards. Steve himself also makes sure to be well updated on the trends of the industry, and he shares this invaluable knowledge through podcast appearances, webinars, and at numerous inperson conferences and events. By uniquely combining the power of thought and software, TRESTLE Compliance LLC offers a series of bespoke solutions to clients that guarantee life sciences compliance is achieved. The business is also looking forward to the release of its new book, Winning with Compliance -- Driving Business Performance with Integrity, later this year, with a huge rollout planned. Steve signs off by saying, “we use compliance to catapult the business of our clients with the knowledge that with compliance peace of mind, employees can aggressively compete and win in the market place, knowing they have a team of experts supporting them.” Contact: Steve Vincze Company: Trestle Compliance LLC Web Address: www.trestlecompliance.com Best Life Science Commercial Business Compliance Specialists 2024 - USA
13 GHP Biotechnology Awards 2024 ith a long-standing customer portfolio including industry innovators such as Moderna and Editas Medicine, Azzur Group, LLC has enabled considerable growth and clinical success over recent years. Underpinning this success was the launch of Azzur Cleanrooms on Demand(™), a hybrid manufacturing capacity model designed to pre-empt and overcome the challenges faced with niche, specialist product development and manufacturing, such as the need for flexibility, the ability to pivot priorities, and speed to clinical and commercial milestones. Additionally, Azzur Group recently launched analytical lab testing capabilities for advanced therapeutic medicinal products (ATMPs). Having announced this new investment in February, Stevens comments, “More than 3,000 advanced therapies and treatments are already in the global pipeline. Azzur’s new ATMP holistic, platform service encapsulates manufacturing infrastructure, expertise and testing capability that meets the continuum of demand across the development to commercial lifecycle. This model ensures risk mitigation, flexibility and absolute IP protection for innovators within fit for phase and scale infrastructure. Azzur was founded as a premier GMP consulting firm in 2010, specializing in the compliance needs of clients in the regulated space. In 2012, the organization added Azzur Labs, which provides microbiology and analytical lab services tailored to the needs of the life science community. It is this array of solutions, combined with a unique ability to help clients operate across all aspects of a multi-faceted drug pipeline, that truly distinguishes the business. As Stevens explains, “We continue to evolve to support customers throughout the entire process, offering solutions to help start, scale, and sustain their GMP [good manufacturing practice] business.” As Stevens tells us, “Azzur Group sets its clients up for success with the strategies, processes, and people to manage risk, enhance quality, and maintain regulatory compliance.” Elaborating further, Stevens states, “We feel optimistic about a 2024 financial rebound, and see that strategies such as partnerships and creative collaborations are increasingly important, along with pragmatic and thoughtful approaches to investing in early-stage progress of treatments and therapies.” Azzur Groups unique ways of enabling such strategies become even more relevant, Stevens explains, “in addition to our fully operational cleanroom infrastructure, testing capabilities and expertise, our consulting team can support end-to-end - from working with academia and healthcare operations to ensure that they are well-equipped to comply with good manufacturing practices and have the available laboratory space required to manufacture batches in sufficient quantities for clinical trials, through to commercialisation.” Headquartered in Hatboro, Pennsylvania, Azzur Group, LLC has played an instrumental role in supporting the biopharma community and progressing advanced therapeutics from development to patient. Bolstered by almost four decades of innovative service to the life sciences sector, the company is a trusted partner to some of the world’s most pioneering biopharma, medical device and associated healthcare technology companies. Sarah Stevens, President, tells us more. Best Early-Phase BioTech Manufacturing Firm 2024 - North America & GHP Innovation Excellence Award 2024 “By working with Azzur Group, companies can progress and succeed flexibly and at speed whilst minimising risk ” Steven said. We agree with this sentiment and are proud to bestow Azzur Group, LLC, with two prestigious awards celebrating its innovation, excellence, and skill in this sphere. Contact: Katie Brown Company: Azzur Group, LLC Web Address: https://azzur.com/ W Azzur Group, LLC
14 GHP Q3 2023 s the first and only UK company that is currently able to boast an innovative drug repositioning and repurposing technology platform, with this system having resulted in the successful development of a range of preventative pharmaceutical products designed to reduce some of the adverse effects of cancer treatment, VasoDynamics Ltd (VDL) is in the development process of a range of pioneering products for use both before and after cancer treatment. Focusing on the key areas of hair, mouth, and skin, as demonstrated above, Founder and CEO Dr Ningfeng Fiona Li is at the helm of this most noble operation, which strives to benefit the lives of those all over the world who are facing unimaginable hardship. Presently, one of the clinical trials that is ongoing for the company is its NG11-2 mouthwash medicine, with this product having been designed to prevent severe mouth ulcers in those patients Feb24404 A Established in 2020, VasoDynamics Ltd is a biopharmaceutical company that is based in England and specialises in the development of a series of cost-effective, patient-friendly, and preventative therapies that are designed to reduce, or prevent, some of the more common complications that stem from cancer treatment. Whether it be hair loss, painful mouth ulcers, or radiodermatitis, the side effects of treatment for this horrific disease can severely impact a person’s confidence and health, and the overall efficacy of the control on cancer disease. With products from this company, however, not only can a patient experience an improved quality of life, but improved tolerability to repeated cancer treatment, improved life journey living with cancer for long term and reduced healthcare burden caused by the sideeffects. Founder and CEO Dr Ningfeng Fiona Li is on hand for more. who are currently undergoing chemotherapy or radiotherapy for head and neck cancers. Fiona tells us, “VDL’s current NG11-2 Phase Ib trial has successfully completed the dose escalation phase and is initiating the dose-expansion phase. […] The initial clinical readout is promising, and VDL’s abstract [has been] accepted by the European Society of Radiotherapy and Oncology (ESTRO) 2024 Annual Congress, and [it] will be presenting the clinical readouts in the conference in Glasgow in May.” Beyond this, Fiona is also pleased to announce that the team have secured follow-up funding for an optimisation to their innovative NG13 drug, an advanced offering that can prevent hair-loss induced by chemotherapy, with this set to be ready to enter Phase II trials sometime over the next two years. These are just some examples of the pioneering work that is being carried out, a duty that, for Fiona, represents the future of preventative treatment. She explains, “the existing products are symptomatic control, wound dressing, pain control, and treatment for secondary infections. There is a clearly underserved, unmet need for an effective, preventive, and patient-friendly medicine to reduce/prevent these debilitating and traumatising side effects.” Utilising its aforementioned state-of-the-art drug repositioning and repurposing technology to appease this very need, all of the technologies and products used by VDL are patent protected and adhere strictly to all of the policies of the market, including data confidentially. Leveraging such technologies, Fiona and her team are highly experienced, diversified, and passionate, with these experts having either been through or witnessed for themselves the debilitating side effects that many cancer treatments and therapies can have. On the back of this, the team are steadfast in their support for others, determined to minimise their burdens. With such togetherness to boot, Fiona describes the collaborative culture that has arisen as a result as having, “enabled the team to function as a whole to move the development of a complex of technologies and products into clinics in a cost- […] and timeefficient manner.” In a similar vein, when Fiona and her team are seeking out new members for their team, one of the first things that candidates are asked about is what their understanding is of cancer patients’ unmet needs, this in addition to them having to state what they believe they can bring to the table to remedy this, before speaking with other members of the team to ensure that they fit in seamlessly. This wholly united team are all looking forward to an exciting rest of the year for VasoDynamics Ltd, confident that the upcoming phases of the clinical trials that are set to take place later this year will lead to the promising results that we are all hoping for. No matter what the future holds for Dr Ningfeng Fiona Li and her team, their dedication to managing the cancer treatment side effects for patients through preventative, patient-friendly solutions remains unwavering, and we wish this team nothing less than the best of luck as they continue to pioneer in this space. Contact: Dr Ningfeng Fiona Li Email: [email protected] Company: VasoDynamics Ltd Web Address: https://vasodynamics.co.uk/ Best Cancer Care Solutions Provider 2024 - UK
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