Biotechnology Awards 2022 www.ghp-news.com Biotechnology Awards 2022 Best BiomarkerMonitoring Interstitial Fluid Developer - North America Kiffik Biomedical, Inc Interstitial fluid plays amajor role in the way the body works, but developing ways of gaining access to this vital part of our lives has been incredible complex. The teamat Kiffik Biomedical, Inc are leading the way when it comes to creating the studies onwhich scientific development can be built. In GHP’s Biotechnology Awards 2022, the teamhave achieved truly remarkable results. We take a closer look at how their developments have pushed forward the medical industry to new and unprecedented heights of success. ResBiotic®
2 GHP / Biotechnology Awards 2022 Editor’s Note , GHP News is delighted to announce the Biotechnology Awards 2022. Global Health & Pharma are proud to announce the return of the seventh annual Biotechnology Awards. The Biotechnology Awards will once again cast a shining light on the pioneers and leading innovators within this crucial and ever-evolving sector. The year of 2021 posed many threats to the health and wellbeing of millions worldwide, and with thanks to the developments and perseverance of the global biotechnology landscape, millions are able to live full and healthy lives. Boasting impressive market value growth, and with no signs of slowing down, the biotechnology sector continues to thrive as innovative solutions and cuttingedge advancements are developed in laboratories and boardrooms across the globe. The Biotechnology Awards are proud to recognise and acknowledge the innovative pioneers and devoted leaders across the sector. Sif Brookes, 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.
GHP / Biotechnology Awards 2022 3 Contents , Contents 4. Kiffik Biomedical, Inc: Best Biomarker Monitoring Interstitial Fluid Developer - North America 8. Arctoris Ltd: Leading Innovator in Data- Driven Drug Discovery 9. Snthesis, Inc: Bridging the gap between Data Collection and Data Analysis 10. Meteoric: Best Enzymes & Enzymatic Preparations Specialist - Asia 11. Bleunomics: Leading Specialists in Computational Genomics & Data Driven Drug Discovery - USA 12. Altasciences: Most Innovative Global CRO/ CDMO 2022 13. Dr. Mike Zurawski: Stem Cell Therapy Innovators of the Year - UK 14. Leo Cancer Care: Most Innovative Radiation Therapy Provider UK 15. Hofseth Biocare ASA: Best Sustainable Biotech Company 2022 16. Exquisite Biomedical Consulting: Best Clinical & Economical Evidence Generation Consulting Firm 2022 17. KEEEN BIOTECH GROUP: Most Innovative Biotechnology & Life Sciences Company - Asia Pacific 18. Lowen’s Natural Skincare: Best Natural Skincare Product Brand – Western Canada 19. Ochre Bio: Leading Developer of Genomic Medicine 2022 20. PDXen Biosystems: Best In Vitro Diagnostic Medical Devices Manufacturer – Korea & Best Cancer Patient Care Plaform (Korea): PDXCTM 21. ResBiotic: Most Innovative Probiotic Supplement Product 2022: resB™ Lung Support 22. FAScinate: Most Pioneering Neurodegenerative Disease Drug Development Company 2022 23. GENETICA US: Best AI-Powered Genetic Testing Biotech Company - USA 24. ICGEN Antibodies: Leading Innovators in Polyclonal Antibody Production 2022 25. MediMusic: Best AI-Based Music Neuroscience Solution 2022: MediMusic 26. BioPharma Services Inc: Leading Providers of Pharma Product Clinical Trial Services 2022 & Life Science eQMS Cloud Platform 2022: Dot Compliance 27. MiracleCord: Best Cord Blood Bank 2022 - USA 28. ValiRx PLC: Best Cancer & Women’s Health Treatments Developer – UK 29. Algalif Iceland: Best Natural Astaxanthin Products Supplier 2022 30. Rubedo Life Sciences: Leading Innovators in Senescent Cell Targeting Therapies 2022
4 GHP / Biotechnology Awards 2022 , Interstitial fluid plays a major role in the way the body works but developing ways of gaining access to this vital part of our anatomy has been incredible complex. Kiffik Biomedical, Inc has plans to leverage leading studies on which scientific development can be advanced. In GHP’s Biotechnology Awards 2022, the team at Kiffik has strived to reach truly remarkable results. We take a closer look at how their developments will push the medical industry to new and unprecedented breakthroughs. Interstitial fluid is a vital, yet often forgotten part of our anatomy. This fluid can be found between blood vessels and cells, containing various nutrients that keep us alive. On average, a person has about 11 liters (2.4 imperial gallons or about 2.9 U.S. gal) of interstitial fluid that provide the cells of the body with nutrients and a means of waste removal, yet for its proliferation, many do not know much about it, and those who do are aware that there is much more yet to be discovered. The team behind Kiffik Biomedical have found themselves at the forefront of providing continuous noninvasive access to this essential bio-fluid thanks to the knowledge and skill they have gained over the years. Kiffik Biomedical has developed a new device that is wearable and offers continuous access to native interstitial fluid in both humans and animals. Being able to cleanly extract this bio-fluid has allowed its founder and chief scientist to make incredible progress, patenting technology that will revolutionize the collection of this impressive resource. Interstitial fluid has been proven to contain both systemic and unique biomarkers and compared to other bodily fluids, provides a tremendous amount of value for the advancement of medicine in a variety of areas. Interstitial fluid has recently been defined as the largest organ in the human body, with more than 3000 biomarkers identified, it is a vast resource for bio-information. With analytes from simple ions to immunoglobulins and immune system cells, this tiny, but mighty part of who we are can tell us an enormous amount about our current health and how we are living. The development of this innovative technology to further explore both human and animal interstitial fluid is the “engine” behind Kiffik Biomedical’s market strategy and future success. This strategy includes exploring options to license their intellectual property to companies interested in wearable technologies and Best Biomarker Monitoring Interstitial Fluid Developer - North America affords the company the opportunity to develop new personal health monitoring platforms while speeding up the development of medical and life science solutions for a variety of disease states. Incorporating two patented, distinct technologies –Kiffik’s Electroporation and Extractor technology has been proven to offer transformative diagnostic advantages that can accelerate the understanding of chronic disease and the discovery of biopharmaceutical solutions. The impact of using these incredible devices is certain to have farreaching applications, as already mentioned in terms of monitoring pathogens for chronic and critically ill patients, developing new vaccines and providing artificial organ replacement. Additionally, the science and patents that support Kiffik’s device have demonstrated potential for future therapeutic applications via transdermal drug delivery. For the first time ever, extraction of ISF with all its components will be available for multiple health scenarios. This addition to the medical professional’s toolkit opens the door to a range of opportunities. For scientists, physicians, veterinarians, and hospital professionals, there is the chance to perform continuous or periodic monitoring of critical biomarkers. Biotechnologists will have the opportunity to produce antibodies, other therapeutic molecules, and therapeutic cells such as lymphocytes. Companies exploring pharmaceutical drug development in preclinical through phase 3 studies will benefit from this technology too. It has the potential to be quite the gamechanger for the healthcare industry, and it’s one which the team is determined to see used for the benefit of as many people as possible. By successfully completing the process of researching and prototyping their idea, Kiffik Biomedical has pushed open the doors into a world of exciting opportunity. The next stage of commercializing for Kiffik’s technology has already begun, with engineering for a
GHP / Biotechnology Awards 2022 5 Best Biomarker Monitoring Interstitial Fluid Developer - North America final design well on its way. This phase of product development is being done in preparation for FDA regulatory submission. The US is not the only region which is likely to benefit from the work the team has done, however. Kiffik Biomedical is seeking regulatory approval in several countries around the world with research opportunities already being explored both in the US and in Europe. The growth of new ideas for this incredible technology is only possible thanks to an approach which considers collaboration a boon. Instead of performing all their work in-house, the Kiffik team has made it a priority to hold discussions with likeminded organizations who have resources and strategic goals that align with their technologies and capacities. Finding the right leader organizations to work with is understandably a priority, as this will provide the impetus for the next several phases of development and growth. To make sure that Kiffik Biomedical remains at the forefront of what the industry has to offer, the team is focused on collaborating with and engaging highly experienced and well-connected individuals and companies. To this end, the culture at this impressive firm embraces a “fail fast” strategy which allows a free flow of creativity and innovative production. Greatness can only be achieved by allowing new and unique ideas to be heard *Investigational Device. Limited by federal law to investigational use.
6 GHP / Biotechnology Awards 2022 , and tested. This experience, alongside Kiffik’s culture for encouraging success and creativity has paid off for the company. Most candidates for key roles within Kiffik’s organization have come from industry referrals or direct work experiences. Good companies attract good people and Kiffik Biomedical is determined to create an environment that is inclusive, celebrates a positive work ethic and empathizes with those their technologies will ultimately serve. The secret of Kiffik Biomedical’s future success, however, will come from the disruptive nature and impact their technology will have on the healthcare industry. Not only will it have an enormous impact on the way the scientific industry operates, but it will open a door of opportunity that hasn’t been seen before. By partnering with organizations who will benefit from their advancements and attracting the best industry talent, the team hopes to accelerate this incredible achievement and push the boundaries into entirely new areas. The world of interstitial fluid opens a greater understanding of how humans can reach better health through continuous monitoring and better diagnostics. It will rapidly expand the understanding of diseases, expand possibilities in preventive medicine, accelerate the discovery and development of new therapeutics, and empower patients to proactively manage their health. These benefits cannot be simply calculated. The possibilities that come with studying interstitial fluid are limitless. Kiffik Biomedical is set to become a major player in the world of life sciences, due in no small part to the team’s ability to offer a product that is unlike anything else on the market. Kiffik Biomedical is not simply changing the future of health monitoring – though this would be achievement enough for most – it is a business that is set on accelerating the future of healthcare. With such strength of ideas and ideals behind it, this is certainly a company to keep an eye on! Company: Kiffik Biomedical, Inc Name: Hap Peterson Email: [email protected] Web Address: www.kiffik.com *Investigational Device. Limited by federal law to investigational use.
GHP / Biotechnology Awards 2022 7 Best Biomarker Monitoring Interstitial Fluid Developer - North America *Investigational Device. Limited by federal law to investigational use.
8 GHP / Biotechnology Awards 2022 , Jan22248 Since its inception, Arctoris has been driven by a relentless pursuit to make drug discovery better. An industry where bringing a single drug to market costs more than $2 billion, and the success rates for actually doing so are below 5% must be reimagined. The key to doing so is leveraging technology: the same tools that have revolutionised so many other industries can now be harnessed to bring the drug discovery process into the 21st century. To this end, Arctoris has developed a unique research platform – one that combines robotics, data science, and machine learning – to generate better drugs in shorter timeframes. The foundation? Nothing less but a complete reimagination of how we approach the concept of data in the biotech and pharma industry – moving from decisions made based on small, poor quality, incompletely annotated datasets to ML-derived insights built on massive, proprietary, fully annotated and contextualised data generated in real-time. In its Oxford facility, Arctoris uses its research platform, Ulysses, to conduct experiments in full automation, generating data of sector-defining quality and depth in cell biology, molecular biology, and biochemistry/ biophysics. The core processes automated by Arctoris enable drug discovery programmes to move from target ID to target validation, hit ID, hit-to-lead, and lead optimisation within an accelerated timeframe. Importantly, Arctoris captures more and richer data with every experiment, including not only the primary results data, but also valuable metadata, such as environmental parameters, exact timings and assay performance data. In fact, Arctoris captures 100x more data per experiment compared to industry standard, which means critical decisions (such as which target to focus on, which hit to choose, which lead compound to progress, and which candidate to select) can be made with greater confidence. This leads to improved success rates in both the company’s wholly-owned and partnered discovery programmes. Throughout the pandemic, another aspect of the company’s focus on automation became apparent: increased resilience. While many researchers struggled to complete their projects with social distancing and labs in lockdowns, Arctoris’s automated platform generated data 24/7, without a single day of paused research progress. Looking at the wider ecosystem, Arctoris is part of a small group of companies leading the field in data-driven drug discovery. The success of Recursion Pharmaceuticals and Insitro demonstrates that the combination of robotics and data science is a winning one, joining Arctoris in shaping the future of drug discovery. In summary, Arctoris is an industry leader in data-driven drug discovery, leveraging its unique platform, Ulysses, to reimagine the discovery and development from idea to the clinic. With its experienced team and sector-defining technology, Arctoris is a true pioneer in 21st century drug discovery, with a mission to bring better drugs to patients faster. Company: Arctoris Ltd Contact: [email protected] Website: https://www.arctoris.com Leading Innovator in DataDriven Drug Discovery Arctoris, a biotech company headquartered in Oxford and Boston, has developed a novel techenabled platform for accelerated drug discovery and development. Combining advanced robotics and state-of-the-art data science and computational techniques, Arctoris is one of a small number of pioneers leading the way in data-driven drug discovery. This unique approach is the result of a convergence in several key trends in technology and biology, which are starting to effect a significant shift in the biotechnology and pharmaceutical industry. Augmenting human scientists with the power of automation and AI enables companies to design better molecules, progress programmes faster, and thereby help bring new and better treatments to patients sooner. Leading innovators like Arctoris make this shift a reality.
GHP / Biotechnology Awards 2022 9 , Jan22683 Bridging the gap between Data Collection and Data Analysis It’s no secret that Life Sciences is both blessed and challenged by the exponential growth in the volume of biological research data. Science is creating data at machine scale, yet in many cases working to manage data and leverage that data at human scale. By some measures, scientists spend 50% to 60% of their time finding and organizing data for analysis. And this doesn’t even consider that at least part of the reproducibility challenge stems from a lack of sufficient assay metadata or other data provenance issues. “Researchers have become habituated to the struggle”, says Emerson Huitt, Founder and CEO of Snthesis. “It’s difficult for many to imagine answering their questions quickly and gaining insight into the research pipeline that can yield organisational impacts.” Prior to founding Snthesis in 2018, Huitt spent over a dozen years building one-off custom software solutions focused on addressing this challenge for biological research firms. Those custom solutions generally got the job done, but they were inflexible, difficult to evolve, and prohibitively expensive for all but the larger players in industry or academia. Huitt knew there was a need for a broadly available, sourceagnostic data integration and harmonization platform that utilized Semantic Web Technology / Natural Language Processing to create broad datasets that are easily searchable in a more comprehensive fashion. Instead of searching for a certain type of data in a certain place or a particular word in a spreadsheet, this technology would let the researcher ask the question “Which samples that Kathy tested last year gave us positive results in a particular media?” After working with a handful of private clients for a couple of years, the Snthesis Bio® Platform was recently released for commercial availability. The platform is source agnostic – ingesting data from spreadsheets, Electronic Lab Notebooks, LIMS systems, Sequencers, EHR data and even public datasets such as Refine.Bio or NCBI and others. Even if the data sources include thousands of spreadsheets collected by many people over a period of years, the combined results are easily searched using the platform’s comprehensive graphical query tools. Huitt notes “We process the data and analyze the shapes of the data to define categories for the system to recognize. These categories may include the origin of samples and who collected them – we work with our clients to identify and extract the things that are important to them”. The result is a clean, harmonized, and living collection of all the research data within the organisation – all searchable, shareable, and reusable. Ordinarily, an implementation of Snthesis Bio® involves ingesting years of archival research data (including thousands of old spreadsheets), integrating with ELN or LIMS tools, and then creating processes with the client to ingest and incorporate new data going forward as it’s created. “When implementing this solution, an organisation doesn’t need to have its data properly structured,” reports Joe Insinga, Snthesis’s Chief Growth Officer. “The organisation just needs a vision of how it wants its data to be structured.” And they don’t have to do that alone. “We have a workshop on day one,” Insinga says. “We discuss what companies want the results to look like and what vernacular or data classifications they want the system to use.” He adds “Different teams often have different names for the same things, and researchers often have an inconsistent approach to labeling spreadsheet columns from week to week or project to project”. The Snthesis Bio® Platform delivers detailed data rather than conclusions or analytical results – Snthesis is focused on cleaning, integrating, and harmonizing the data so it’s available for any of the powerful analysis tools that their clients choose to use. Towards the end of 2021, Snthesis spun out a portion of their Semantic Comprehension Engine (the “intelligence” behind the Platform) and created Snthesis Merge®, a tool for harmonizing and extending public and private datasets. “There is a tremendous amount of valuable data within some public databases, such as Refine.Bio or NCBI” Huitt says, “but once you pull a particular dataset you may be dealing with the impossible task of cleaning that public data so it can be put to good use”. In one recent example, a dataset pulled from Refine.Bio ran to over 7,000 columns of data, with one fundamental datapoint – the name of the disease – scattered across more than 40 of those columns amid thousands of rows. After configuring the Merge® tool on what to look for, the gene expression results were pulled within minutes and matched up with ICD10 disease codes from a cohort within the UK BioBank database. Let’s repeat that: Within minutes after being configured, the Snthesis Merge® tool matched UK BioBank patient records with relevant gene expression data. And it can do the same for nearly any public or private datasets. Durham, NC based Snthesis has been revenue-funded from inception. While there may be venture capital or an equity partner in their future, they are focused for now on adding a few commercial customers and continuing to add new features to both the Bio® platform and the Merge® tool. Website: Snthesis.com Twitter: @SnthesisInc Inquiries: Joe Insinga, CGO via email [email protected] Snthesis, Inc
10 GHP / Biotechnology Awards 2022 , Jan22270 Havingworkedhardover the past 18months tomake itself a cornerstone of theworld’s pharmaceutical development industry,Meteoric Biopharmaceticals’s products have become known as some of themostwell-researched, competitive, andwell-supplied in the industry. It has funnelled significant effort into securing reliable supply lines during this time of tumult, able to in this manner continue to supply and createmuch-neededCovid-19medications and solutions across its industrydespite the constant disruptions to shipping and fulfilment inmost sectors. Best Enzymes & Enzymatic Preparations Specialist - Asia Meteoric Biopharmaceticals, an organisation that has been making a name for itself since its founding in 2006, is a onestop biological solutions company that offers services such enzyme production, probiotics, nutraceuticals, finished formulations, animal health care products, and plant and herbal extracts. Fundamentally, by handling each of these solutions in-house, it secures itself as a linchpin of its industry and a one-stop-solution for biological formulae both, being a B2B company that wishes to promote the utmost quality of service within itself and the wider food and pharmaceuticals industries both. Its focus, therefore, lies in biological solutions that will help the world to find new versions of the biological products that the world relies on, many of which are fast depleting or not being farmed in a sustainable manner due to abundance of demand. It hopes that these innovations will also replace the prevailing current synthetic solutions on the market that some of it peers have created, especially since some of these can be harmful when consumed over long periods of time. Thus, it has funnelled significant effort into researching the best of each of the currently available solutions, from the plant to the animal and those developed by bio-processes, bringing together these threads of knowledge to develop a new probiotic range. At present it holds 9 probiotic patents and has 10 more under process that it is sure will be ready to be widely released sooner rather than later, pulling through the tumult of the past 18 months by throwing itself into research and ensuring that each of the clients it has taken on are looked after. This has ensured that despite the disruptions to supply chains, the worldwide tumult, and other extraneous factors, Meteoric has continued operation flawlessly, securing new supply lines through which it could get its essential ingredients and throwing itself into helping the world’s pharmaceutical companies to find the components needed for Covid-19 medicines and formulations. The output and supply of essential ingredients was increased, and an efficient supply chain managed, gaining it more clients and partners as it consistently demonstrated its effectiveness. Additionally, it developed and launched various immunomodulators during this time, as well as supplements and end-to-end solutions. Each of these boasted a tight turnaround and a renewed focus for the company that directed it to immune function products, health supplements, and an increased awareness of biological processes, benefitting from the boom in the Indian biologics market and using its current success as a springboard to further research. At present, it exports to over 70 different countries, maintaining its pedigree as a HALAL, STAR K-KOSHER, FSSAI, ISO22000, and HACCP certified company, reducing comparative costs and risks posed by its competitors, and boasting a group of talented staff who have made this all possible. As it moves into the future, it plans to launch more probiotic and prebiotic solutions, increasingly demonstrating its dedication to social corporate responsibility along every step of the way. Company: Meteoric Biopharmaceticals Contact: Gaurav Kaushik Website: meteoricbiopharma.com
GHP / Biotechnology Awards 2022 11 , Jan22220 Bleunomics, the company behind one of the leading clinical drug discoverymethods, has made a name for itself bymaking datamapping easier, quicker, andmore accurate. By not having to rely on their research staff to do this and leaving it to its specially calibrated program instead, researchers can save time andmoney, eliminating human error. Bleunomics’ programalso offers incredibly useful andmethodologically excellent visualisations of the results it gathers, allowing researchers to get a comprehensive view of the data and its results at a glance without having the trawl through thousands of raw data points. Leading Specialists in Computational Genomics & Data Driven Drug Discovery - USA Combining therapeutics and DNA computing, Bleunomics offers a computational approach to clinical drug discovery that works with sophistication and diligence to create a leading drug discovery pipeline like no other. Critically, its efforts have developed pipelines that target the clinical level, working with potential partners for validating data and submitting FDA INDs and 510ks for new drugs, devices, tools, and discoveries. In a world still reeling from the pandemic, a company like Bleunomics developing better and more watertight ways to discover contemporary medical innovations is more important than ever – and it recognises this – responding by ensuring that its drug discovery process is a comprehensive solution informed by a variety of complex technologies. Empowered by DNA Computing, Data Mining, Statistical Analysis, Computational Therapeutics, Data Validation, and Clinical Delivery, each facet that makes up the whole of the pipelines it offers has been rigorously developed over the course of strictly controlled studies done by incredible, professional, tenacious minds. Fundamentally, this allows it to design complex DNA computing and genotyping chipsets, as well as storage methods, working extensively to allow a holistic approach to finding the required data from a study and analysing it appropriately in a manner that gives usable results. Currently, Bleunomics is also working hard to integrate genomic mapping and sequencing into its pipelines, targeting a variety of different genetic mutations and disorders in order to learn more about them. This has secured its place as a front runner of modern medical technology for researchers and medical peers all across the industry; it has been able to contribute this work to the Genbank sequence for BankIt2430198 Lepisosteus MW62911 as well as to independent sequences from other researchers’ data such as from FASTA data pools. Moreover, its thorough data analysis and visualisations allow a research professional the ability to get a birds-eye-view of the data through relevant graphs and visual representations of the findings that are calibrated to show the team everything they need to know, from the prevailing trends to the anomalies. Utilising extensive data visualisation software in order to do this, its other techniques and capabilities empower the efficacy of this program, able to map genomic data in a user intuitive manner that integrates statistical methodologies in order to create a scientifically invaluable resource for further study. Bleunomics, is short, is a modern company creating the data pipelines of the future, and it is endlessly excited to see where its current innovations can take its clients and the research sector at large in the future. Company: Bleunomics Contact: Andrew Kamal Website: bleunomics.com
12 GHP / Biotechnology Awards 2022 Jan22272 Altasciences is a forward-thinking,mid-size contract researchorganisationoffering pharmaceutical andbiotechnology companies aproven, flexible approach to earlyphase drug development.Wefindoutmore fromCEO, Chris Perkin. Most Innovative Global CRO/CDMO 2022 For over 25 years, drug development solution partner, Altasciences, has been teaming up with sponsors to help them make educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, and drug formulation and manufacturing — all customisable to specific sponsor requirements. CEO, Chris Perkin, tells us more about the industry. “The CRO/CDMO industry does not change quickly, and we recognised there was a gap in the market,” he begins, speaking of the rationale behind the organisation’s inception. “Often, outsourcing critical phases of early drug development means working with separate CROs and CDMOs, and the sponsor assumes the burden of managing and liaising across services and companies. Transferring data, projects and/ or methodologies between CROs/CDMOs can take time, is prone to error, and can lead to prolonged R&D timelines. From bottlenecks to handoffs, these challenges ultimately delay the arrival of potentially life-saving drugs to market. Many new biopharma companies are often semi-virtual, and typically light on infrastructure and personnel, so we figured there must be an opportunity to build a drug development solution platform that would comprise all the pieces these companies would need to progress their lead candidates through to clinical proof of concept.” Chris adds, with regards to the organisation’s vision, “Our philosophy is to have multiple points of entry, but a single coordinated response.” This would make Altasciences the first CRO/CDMO to do so. “We created an early phase drug development solution that provides simplified outsourcing with a proactive approach,” Chris further explains. Altasciences has been concentrating on developing its portfolio, streamlining the outsourcing paradigm, while entering new markets to offer its clients a comprehensive onestop solution to accelerate their early phase drug development. In 2020, they acquired a CDMO facility in Pennsylvania (formerly Alliance Contract Pharma). The following year, the organisation added two other companies: a clinical site in Los Angeles, CA, (formerly WCCT Global) and a preclinical site in Scranton, PA (Calvert Laboratories). And then in January of this year, Altasciences added Sinclair Research, a third preclinical site to its thriving organisation. “These acquisitions have further enabled our coast-tocoast offering and boosted our expertise and capabilities,” Chris elaborates. Differentiation in this sector is important in order to stay ahead, and Altasciences has modelled itself as a different kind of CRO/ CDMO. They have developed a solution called Proactive Drug Development. Altasciences’ Proactive Drug Development includes comprehensive communication plans, central program management and scheduling, and expertly designed roadmaps to get their clients from lead candidate selection to clinical proof of concept and beyond more efficiently. This is made possible by the organisation’s full-service solution offering, which enables a drug sponsor to partner with Altasciences for all its early phase drug development instead of contracting multiple service providers. “Whether they partner with us for an entire program, or for just one study, we use the same approach… seamless handoffs from milestone to milestone, to reduce complexities and save clients time and money, so that they can increase asset attractiveness to move on to the next stage,” says Chris. Internal culture plays a key role in the organisation’s continuing success. Despite geographic distance between its eight sites, Altasciences has the systems, procedures, and company culture to support its philosophy of moving in unison. In fact, it now has more than a thousand employees in North America partnering with its clients to provide solutions that get better drugs to the people who need them, faster. “We are committed to helping our clients reach critical decision-making milestones sooner by improving ‘speed and ease’ from lead candidate selection to clinical proof of concept. We continuously look for ways to build our relationships and range of capabilities, offer scientific guidance, and create an environment that provides value for our clients, respect for our participants, care for our research animals, as well as growth for our employees.” Recently, the company was recognised in the Global Health & Pharma Biotechnology Awards and named Most Innovative Global CRO/CDMO 2022, and with core values of respect, quality and excellence, integrity, customer focus, and employee development, Altasciences is well-placed for further growth and expansion in the near future. “We have no plans of stopping — We’re currently looking at expansion into Europe, and I should have some more exciting news to share soon.” Contact: Chris Perkin Company: Altasciences Web Address: www. altasciences.com Altasciences
GHP / Biotechnology Awards 2022 13 , Jan22525 MICA Biosystems is a preclinical biotech company whichwas founded in 2010 by worldleading scientists in the fields of regenerative technology and tissue engineering, Alicia el Haj and John Dobson, and led by a dynamic 26-year-old CEO, Mike Zurawski. We find out more in the wake of the company being named in the Biotechnology Awards 2022. Stem Cell Therapy Innovators of the Year - UK MICA Biosystems (MICA) uses cuttingedge, First-in-Class nanotechnology to enable researchers around the world to push further this frontier of science and medicine, truly unlocking the potential of stem cells to treat anything ranging from spinal injuries and diseases, to tendon damage, neurodegenerative diseases and oncology. “We developed a disruptive biotech platform nanotechnology which creates remote-controlled stem cells, and we’re at the cusp of beginning Phase 1 clinical trials after successful pre-clinical trials,” Mike Zurawski enthuses. “This technology answers the fundamental problem of selective stem cell differentiation, and holds the potential to truly revolutionise the field of regenerative medicine- bringing it from the fringes to the mainstream of medicine. Stem cells in their current form are placed into a patient and are hoped to create the desired tissue purely based on their environment - which has a high failure rate. Through nanotechnology, we allow clinicians to select the type of tissue they would like to create in situ.” This Remote-Controlled Stem Cell Therapy holds the promise to evolve regenerative medicine and improve the quality of life of millions of people worldwide- and importantly, is not traditional cell therapy at all- in that it uses the patients’ own cells, meaning there are no lengthy (and costly) cell culture steps to speak of. So, let us have a closer look at how it works. “Nanoparticles with a magnetic core, coated with a biocompatible layer, are linked to one or more binding molecules,” Alicia el Haj elaborates. “The tagged nanoparticles bind to ion-channels or other molecular receptors on the cell membrane. By subjecting the cells to a timevarying magnetic field, energy is transferred to the magnetic particles, which causes the specific receptor to be activated. This leads to protein regulation and controlled cell responses.” In addition to potentially improving and saving the lives of millions of patients around the world, the technology can also be used for drug screening by inducing a dynamic environment for drug screening through the patented Dynascreen™ platform- ensuring potentially beneficial drugs aren’t screened out needlessly during their preclinical stages. Further capitalising on the possibilities of nanotechnology, MICA has developed a bioreactor capable of growing cells and organoids in a dynamic, mechanically stimulated environment to open the window into scientific research around disease, development and discovery. MICA’s mission is simple: to unlock the potential of nanotechnology and stem cells in both the clinical and research fields by allowing for controlled cell differentiation and mechanical stimulation, both in vivo and in vitro. This will enable a new approach to controlling cell behaviour with applications in tissue engineering and regenerative medicine, stem cell research, pharmaceutical screening, and therapeutic applications. Leading figure in Bioengineering and Regenerative Medicine, Alicia has been involved in bringing together interdisciplinary groups within biomedicine, maths, physical sciences, and engineering. She has been awarded the IOM3 Chapman medal for her major contribution towards translation of biomedical materials into healthcare and is also ex-chair of the European Council for the Tissue Engineering & Regenerative Medicine International Society (TERMIS), and co-Founder Jon is one of the Top 50 most highly cited researchers in regenerative medicine in the world. CEO Mike Zurawski completed his PhD in the field of biotechnology in collaboration with the multinational giant, Zimmer-Biomet. Since he began his tenure at MICA biosystems, he has seen the business go from strength to strength- advancing preclinical trials, growing the team, structuring a brand-new Board of Directors and attracting external investment to fuel the company’s extraordinary ambitions. Recently, the company was recognised in the Global Health & Pharma Biotechnology Awards 2022 for its ground-breaking work and bestowed with the title of Stem Cell Therapy Innovators of the Year in the UK. And right now, the future is looking very good indeed, with the company opening its next equity raise in early Q2 of 2022. “We have recently concluded our successful pre-clinical trials and are gearing up to start Phase 1 human trials; paving the way to patients around the world,” Mike finalises. “The initial therapy area we focus our attention on is Spinal Fusion- changing what is currently an invasive surgery into an outpatient injection procedure. We aim to add years to the lives of patients and add life to their years by increasing their quality of life!” Contact: Dr. Mike Zurawski, [email protected] Company: MICA Biosystems Web Address: www.micabiosystems.co.uk
14 GHP / Biotechnology Awards 2022 Jan22215 Leo Cancer Care was founded withmore than 100 years of Radiation Therapy experience by a teamdedicated to challenging the norms. We find out more about this pioneering company and its innovative product range as we speak to Co-Founder, RockMackie and CEO, Stephen Towe as it wins this prestigious award. Originally founded in Australia, Leo Cancer Care has been built on research from across the globe showing the clinical benefits of upright patient positioning. Combining this with a shift from machine rotation to patient rotation, Leo Cancer Care is set to change the face of Radiation Therapy for good. “Patients’ lives influence us to find a better way, a better way to improve patient care and how a patient experiences it,” explains Thomas ‘Rock’ Mackie, Chairman and Co-Founder of the organisation. “A better way to increase the accessibility of cancer treatments for more patients in more places. We believe our technology is that better way. Our family of world class products can provide a streamlined and efficient treatment while making the patient feel in control and hopeful.” Rock is Professor Emeritus of Medical Physics and Human Oncology at the University of Wisconsin-Madison and serial entrepreneur who has co-founded many not-for-profit and for-profit organisations. Rock co-founded TomoTherapy in 1997, an imageguided intensity modulated radiotherapy machine company, and was Chair of the Board from founding through exit. Rock was also awarded the ASTRO Gold Medal in 2019 for his service to the field of radiation oncology. “It’s estimated that we spend two thirds of our lives upright, on our feet or seated,” begins Stephen Towe, CEO of Leo Cancer Care. “The clinical evidence is clear; our bodies naturally move less in the upright position. When targeting a cancerous tumour, this reduction in motion allows us to be more accurate when targeting radiation.” Stephen Towe is the Chief Executive Officer and CoFounder of Leo Cancer Care. Having successfully driven the design of the Leo Cancer Care technology in Australia Stephen took over the role of CEO in 2018. Since then, Stephen has led the expansion of Leo across both the US and Europe. He has a successful track record of delivering the most innovative products in radiotherapy, having led development teams in the completion and release of the Elekta Unity MRI guided radiotherapy system. Meet Marie™ Leo Cancer Care’s innovative products have been designed with the patient in mind. Named after Marie Curie, a pioneer in radiotherapy, the Marie™ Particle Therapy solution combines Leo Cancer Care’s sophisticated, upright patient positioning system and dual-energy diagnostic quality CT. Utilizing a fixed beam and patient rotation means the treatment machine does not require a large gantry and can be installed in new and existing treatment facilities, quickly and easily. With the inclusion of stateof-the-art software, designed with the company’s partners at Cosylab, combined with its bespoke technology, the GUI is fast, intuitive and simple to use, bringing even more efficiencies to the clinical environment. The benefits to being treated in an upright position are emotional, as well as clinical, as Stephen elaborates, “Humans feel most empowered when they are upright or on their feet, we believe that cancer patients should be able to face cancer in this way, eye to eye with their clinician and able to take in their surroundings.” Meet Ruby™ Likewise, the Ruby™ photon therapy solution, named after Ruby Payne-Scott, a pioneer of radio physics and radio astronomy, is the complete upright treatment solution: a real-time, image-guided photon radiotherapy treatment system. “We are making Photon Therapy more accessible than ever before, Ruby™ can be supplied fully-shielded, which means bunkers can be a thing of the past,” says Rock. “We understand that workflow is everything so our of state-ofthe-art control system combines imaging, positioning and treatment delivery into a simple, intuitive workflow allowing clinicians to spend more time thinking about patients.” Meet Aida™ Finally, the Aida™ radiology solution named after Florence Ada Stoney, the first female radiologist in the United Kingdom who served as the Head of x-ray departments in makeshift hospitals throughout World War I, is a versatile multi-axis computed tomography scanner and patient positioning system which allows for imaging in the seated, perched, standing and recumbent positions. “This versatile solution will provide clinicians with highquality, 3D images that can image the full body with the opportunity to scan in various positions to ensure the most accurate detection, diagnosis and follow-up of patients’ condition, treatment outcomes and recovery progress. Award Winners Recently, Leo Cancer Care was recognised in the Global Health & Pharma Biotechnology Awards 2022 for its pioneering technologies which have been designed to improve the patients treatment experience, whilst also improving their chances of survival, when facing cancer. Contact: Fiona Redford Email: [email protected] Company: Leo Cancer Care Web Address: www.leocancercare.com Most Innovative Radiation Therapy Provider UK
GHP / Biotechnology Awards 2022 15 , Jan22253 With headquarters in Ålesund, Norway, and branches in Oslo, Chicago, Mumbai, Tokyo, Zurich andMenlo Park, California, Hofseth Biocare ASA operates in the industry of sustainable marine biotech by processingmarine rawmaterial into products to enhance global health. Dr Crawford Currie talks to us about the company and its incredible work. Best Sustainable Biotech Company 2022 Founded on the core values of sustainability, traceability, and optimal utilisation of natural resources, Hofseth Biocare (HBC) has been conducting research, healthcare innovation, and new product development for more than 15 years. HBC has been progressively shifting its sales away from basic animal feeds towards the exclusive supplements market for human health. It preserves the quality of the lipids, proteins, lipo-proteins and calcium/collagen from fresh salmon off-cuts unlike any other organisation of its kind. Today, production and supply chains in salmon production generate an enormous amount of waste. HBC’s ingredients are based on by-products from aquaculture food production, which would otherwise have been considered as such. By finding a new use for these products, HBC can minimize all these side streams and contribute to upcycling of fresh sashimi grade fish that just misses out on being used as food. “We are transforming the part of the fish that is not used in the production of fillet, portions and sashimi slices, into high value health nutritional products for people and pets,” says Dr Crawford Currie, Head of Medical R&D. “Off-cuts from salmon were once regarded an input source for a fish meal, or at best, for pet feed. We have now demonstrated that unsurprisingly, there are unique properties found in fresh fish, that can form the basis of new consumer health products and possibly even provide leads for new drug development .” Collaborative research is ongoing in multiple clinics and university research labs in a number of countries. Lead clinical studies are assessing the potential to improve health outcomes in respiratory diseases including asthma & Covid19-patients as well as reducing inflammation and improving Gastro-Intestinal (GI) health. HBC’s research also points to therapeutic effects relevant to sarcopenia, anaemia and restless leg syndrome. HBC’s mission is to explore the medical and pharmaceutical potential of unique molecules discovered in its ingredients, derived from their patent-protected, innovative hydrolysis technology. Management is confident that its research work in collaboration with world leading universities & academic institutions will form the basis for new pharmaceutical drugs in the future. In addition to this, HBC is already developing the consumer health market with these new innovative ingredients already available across Europe, North and South America and Asia, in total over 40 different countries. “Our patented enzymatic hydrolysis process is able to process very large amounts of raw material into 100% human grade ingredients capable of significantly enhancing human health,” Dr Currie continues. “The incomparable access to fresh salmon is the key to maximize the quality of the end product. Hence our patents and demonstrated health benefits shouldn’t come as a surprise” he says. “The production starts with the transportation of our precious raw material directly from our own salmon processing factory, in our own certified, clean bins, several times a day to ensure optimal flow of fresh off-cuts.” Recently, HBC was recognised in the Global Health & Pharma Biotechnology Awards and named Best Sustainable Biotech Company 2022 for its groundbreaking research work, and Dr Currie is excited about what the future holds for the firm. “Proudly, we say ‘This Is Different!’” he enthuses, “and in our case, different is better and unique! Our approach to research, our technology and hence our ingredient output set us apart from any comparable companies. Fresh fish raw material, with minimal processing makes unique products with differentiated one-of-a-kind health benefits. We strive to live by and highlight this difference!” Contact: Dr Crawford Currie Company: Hofseth Biocare ASA
16 GHP / Biotechnology Awards 2022 Feb22407 ExquisiteBiomedical Consulting (EBC) is a boutique-stylemedical affairs consultingfirm based inVancouver, BC, Canadawith roots inSanAntonio, TX, USA. The company is led byphysician ShabnamVaezzadeh, whohas extensive experience in thisfield in corporate and consulting capacities. She is joined by expert clinicians, biostatisticians, and reimbursement professionals tobest serve the needs of clients as required. Best Clinical & Economical Evidence Generation Consulting Firm 2022 A tremendous amount of innovation occurs in academia and the medical industry, where businesses develop medical products to improve the lives of populations and produce favourable clinical and economic outcomes. Exquisite Biomedical Consulting delivers consulting to these entities, with typical clients including funded medical device, regenerative medicine , and pharmaceutical companies who either have not convened their own medical affairs teams yet, or need experts to augment their manpower. EBC CEO, Shabnam Vaezzadeh, MD, MPA, BCMAS, through leading large medical and clinical affairs teams in established corporations, believes in the power of medical affairs, when well executed, in establishing support and advocacy for medical products and overall company brands. As the liaison between the company and the medical community, Medical affairs is in a unique position to communicate the merits of the products and build peer to peer collaborative initiatives with healthcare professionals, within compliance guardrails, and without ties to generating revenue. EBC helps innovators and manufacturers with critical considerations as they are approved by regulatory bodies, covered by private and government insurers, and further included in the formulary of healthcare institutions--with the hope they will be utilized safely and effectively and received well by patients and caregivers. Gaining acceptance with stakeholders and addressing their inquiries requires thoughtful generation and communication of clinical and economic evidence. Educational and marketing communications should be founded on evidence-based scientific platforms. In the absence of such a foundation, many innovative products have failed in the marketplace, depriving patients of the benefits and the companies from the successes they would have experienced. The strategy for evidence generation involves understanding the requirements and timelines of stakeholders and geographies, identifying gaps in existing evidence, selecting an appropriate level of evidence, designing studies, partnering with field experts, securing budgets, selecting journals for publication, and specifying appropriate forums for presenting the data. Types of clinical studies include phase I-IV studies, randomised clinical trials (RCT) to case series, and prospective and retrospective studies collecting clinical and economic data. Also, secondary analysis of existing data sets, evaluating real world evidence, systematic reviews, and metaanalysis of published literature can help establish safety, efficacy, and economic outcomes of medical products. Generating and utilizing evidence at the appropriate phase of product lifecycle, communication and preparation of an evidence-based scientific platform to support the products are within the expertise of Exquisite Biomedical Consulting. In one client case, EBC worked with a medical company that had acquired a new product quite effective in clinical use. However, adequate evidence was not available to solidify reimbursement with private payers or push for market adoption. EBC reviewed the company’s existing data and customer experience, including case studies, pilot studies, presented posters and abstracts. It also reviewed the timelines and requirement of payers, alongside questions and concerns expressed by potential customers. An RCT was needed by private payers for reimbursement. A study was designed that would capture clinical data, as well as economically related data points such as impact on length of stay, rate of complications, and rate of and time to achieve treatment goals. This study, once completed, demonstrated not only the clinical efficacy but also the value provided by the product, versus its cost across total cost of care for patients. As the longer timeline of an RCT would not accommodate the shorter-term needs for customer introductions, a post-market study was also designed to collect real world evidence on use of the product by institutions who had long-standing experience with the product. EBC has been recognized with the Biotechnology Awards 2022 based on its extensive expertise, dedication to improving patients’ lives and meeting the needs of the medical community through generation and communication of evidence. Now looking towards a bright future, the company remains focused on building long-term relationships with clients. Having spent five years doing so in the US and establishing a footprint in Canada as of 2021, the company is looking forward to extending its service to clients globally. Company: Exquisite Biomedical Consulting Contact: Shabnam Vaezzadeh, MD, MPA, BCMAS Email: [email protected] Website: www.exquisitebiomedical.com Exquisite Biomedical Consultingwww.ghp-news.com