Bruker Corporation | April 06, 2022
Bruker Corporation announced the acquisition of Optimal Industrial Automation and Technologies, a leader in pharma and biopharma process analytical technology pharma manufacturing automation and Quality Assurance (QA) software and systems integration, based in the United Kingdom. The Optimal biopharma tools acquisition strengthens Bruker as a key software and solutions provider for small molecule, biologics and new drug modalities pharma companies.
Financial details of the acquisition were not disclosed. Optimal’s 2022 revenue is expected to be approximately $10 million, and Optimal’s revenue growth rate and operating margins are projected to be accretive to Bruker in 2023 and beyond.
The Optimal biopharma tools and automation capabilities complement Bruker’s innovative and differentiated high-value NMR, mass spectrometry, SPR, molecular spectroscopy and X-ray scientific instruments, and life-science solutions for biopharma drug discovery and development, as well as for PAT analytical and QA solutions. Together these biopharma tools enable Bruker’s global biopharma customers to bring efficacious and safe medicines to market more quickly.
Optimal has a focus on the automation and optimization of batch and continuous processes in the biopharma industry – from R&D to manufacturing. As an integrated PAT solutions provider, Optimal offers development, testing, deployment and support of quality-centric pharmaceutical production systems. Optimal has more than 30 years of experience in successfully delivering regulatory-compliant biopharma solutions, ranging from the development of automated control systems for process control to the market-leading, vendor-agnostic PAT knowledge management software synTQ®.
The synTQ PAT software can interface between multiple analytical instruments (spectral and univariate), multi-variate analysis (MVA) packages, manufacturing control systems and a range of adjacent software solutions to ensure quality in real-time.
As a 2021 Pharma Innovation Award winner, synTQ is a proven enabler of quality-by-design (QbD) via PAT. For users of synTQ, this can significantly increase productivity and quality, while reducing waste, time-to-manufacture and time-to-market, with proven Optimal use cases tripling biopharma productivity.
While remaining a vendor-agnostic biopharma solutions provider, Optimal can integrate bioanalytical technologies such as nuclear magnetic resonance (NMR), mass spectrometry (MS) and FTIR/NIR/Raman systems into innovative drug discovery, development, PAT and quality control workflows. Combining next-generation, high-performance technologies with Optimal solutions eases the transition from development to biopharma manufacturing, while remaining in regulatory compliance.
“The acquisition of Optimal is a very exciting step for Bruker as it supports more comprehensive solutions for the biopharmaceutical industry, now adding the capabilities to integrate cutting-edge systems into biopharma manufacturing processes and workflows. We welcome the Optimal team with their strong PAT and automation expertise and, together, are eager to support biotech and pharmaceutical companies in increasing their manufacturing efficiency and flexibility – a global need highlighted by the response to the pandemic crisis.”
Dr. Falko Busse, President of the Bruker BioSpin Group
Mr. Martin Gadsby, the CEO and Co-Founder of Optimal Industrial Automation and Technologies, added: “We are delighted to become part of the Bruker family. Optimal and Bruker together are a perfect fit – we share the common ethos of innovation with integrity, together with our industry recognition as a high-quality solutions provider delivering tangible benefits to our customers. The whole Optimal team is excited by this new chapter in our history and looks forward to delivering benefits to even more biopharma customers and ultimately to patients around the world.”
About Optimal Industrial Technologies and Automation
A well-established system integrator with more than 30 years of experience, at Optimal we specialize in automating a client’s R&D or manufacturing system to ensure that their processes remain at the highest level of efficiency. The demands being placed on manufacturers in relation to production costs, product quality and business sustainability are ever increasing, and our primary aim within Optimal is to assist you in being the most competitive supplier of your product to the highest level of quality in the worldwide marketplace, and to ensure that you continue to maintain your lead in the years ahead.
We have a rare and wide-ranging skill set covering a multitude of automation technologies, manufacturing processes and industry types, with very specific knowledge in highly regulated environments. In addition, we manufacture the world leading PAT Data Management software package - synTQ® and the widely used integrated Print and Inspect system - synTI®. The combination of our PAT implementation knowledge and synTQ® product together with our automation experience positions us with unique skills that can be leveraged to great advantage by our customers.
About Bruker Corporation
Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology.
AmerisourceBergen | April 22, 2022
Global healthcare company AmerisourceBergen announced its partnership with Chronicled, the administrator of the MediLedger Network, to leverage a new blockchain-powered solution designed to enhance pharmaceutical chargeback accuracy and significantly reduce chargeback rejections. The blockchain solution will allow AB to streamline and optimize the complex process of pharmaceutical chargebacks while creating greater connectivity for its suppliers and customers. Over the past three years, AB has collaborated closely with Chronicled to design and pilot the technology for commercial use.
Chronicled provides AB and industry partners with a shared, decentralized infrastructure that offers real-time visibility and contract updates to significantly reduce chargeback disputes and improve pricing accuracy. The blockchain-powered solution effectively enforces the accuracy and integrity of chargebacks submitted across AB’s pharmaceutical supply chain.
“At AmerisourceBergen, it’s our responsibility to develop and leverage innovative solutions that create seamless and efficient experiences for our customers and the patients they serve every day. This wouldn’t be possible without trusted partnerships across the supply chain. Being a part of the MediLedger Network and deploying this type of blockchain technology is a crucial step forward in AmerisourceBergen’s ongoing digital transformation journey.”
Dina Barton, Vice President, Contracts & Chargebacks at AmerisourceBergen
Chargeback errors can occur for many reasons, but always result in manual processing, duplicate effort, and back-and-forth communication between trading partners to resolve them. Suppliers, wholesalers, and GPOs are constantly looking for ways to reduce errors, minimize chargeback disputes, and streamline this process.
The Contracts & Chargebacks solution on the MediLedger Network will help AB provide its partner suppliers and GPOs a single source of truth for GPO membership, customer identifier data, and contract pricing data that stays aligned between trading partners on the network. The network itself uses this aligned reference data to enforce chargeback accuracy. Blockchain technology and increased collaboration across the industry are essential in driving efficiencies, reducing costly errors, and significantly improving the chargeback process.
"We are excited and thrilled to have AmerisourceBergen join the MediLedger Network," said Susanne Somerville CEO of Chronicled. "We share AmerisourceBergen’s commitment to innovation and driving efficiencies across the industry and look forward to supporting their partners joining the network.”
By creating greater connectivity with supplier partners and customers, AB expects this new solution will deliver higher quality results across its supply chain network.
AmerisourceBergen fosters a positive impact on the health of people and communities around the world by advancing the development and delivery of pharmaceuticals and healthcare products. As a leading global healthcare company, with a foundation in pharmaceutical distribution and solutions for manufacturers, pharmacies, and providers, we create unparalleled access, efficiency, and reliability for human and animal health. Our 42,000 global team members power our purpose: We are united in our responsibility to create healthier futures. AmerisourceBergen is ranked #8 on the Fortune 500 with more than $200 billion in annual revenue.
Chronicled, a San Francisco-based technology company, enables automation, trust, and automatic settlement for intra-company transactions in the Life Sciences and Healthcare industry. Through the industry leading blockchain-powered MediLedger Network, Chronicled offers trading partners a new way to manage revenue, automate manual processes, and eliminate revenue leakage, while ensuring pricing accuracy and efficiency for health care providers and dispensers.
Tikomed | May 09, 2022
Swedish biopharmaceutical company TikoMed AB and IQVIA announce a key strategic collaboration with the aim to accelerate the development of TikoMed's lead drug platform candidate ILB®, a broad-spectrum small molecule drug candidate with curative potential in a wide range of diseases driven by acute and chronic inflammation.
The collaboration will support TikoMed's clinical development, regulatory and commercial strategies. IQVIA brings together deep therapeutic expertise, unparalleled data, and technology alongside flexible operating models to enable biopharma organisations such as TikoMed to accelerate the clinical development and commercialisation of innovative products that improve patient lives.
"We are thrilled to have IQVIA involved supporting TikoMed with the next steps in our journey to improve human life by enhancing the body's natural ability to self-repair and regenerate. With our highly scalable proprietary drug platform we aim to provide safe, effective and affordable therapies to as many patients as possible across the globe",
CEO Anders Kristensson
Fiona Stewart, Head of Strategic Alliance Management Europe from IQVIA said "We are delighted TikoMed has selected IQVIA to strategically collaborate in the development of ILB®. We look forward to leveraging our depth of experience to help accelerate the availability of these medicines to the patients who need them the most."
TikoMed was advised by The Connecting Architects on this strategic collaboration.
TikoMed is committed to improve human life by exploring and harnessing the medical potential of the body's ability to self-repair and regenerate. With an adaptive, multi modal mechanism of action, TikoMed's drug platform rebalances the body's inflammatory, immune and fibrotic responses to acute and chronic inflammation in order to enhance self-repair and regeneration. Currently applied as a therapy in neurodegeneration and an enabling technology for advanced therapies, the initial development programs include ALS, TBI and islet cell transplantation. Broader use of the drug platform will be considered for a wider range of diseases using a creative business and financing model. TikoMed's highly scalable proprietary technology aims to provide safe, qualitative and affordable medicine to as many patients as possible across the globe. TikoMed is privately-owned and based in Viken, Sweden.
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility - enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 79,000 employees, IQVIA conducts operations in more than 100 countries.
Telix Pharmaceuticals Limited | March 29, 2022
Telix Pharmaceuticals Limited announces that the United States Food and Drug Administration has granted Orphan Drug Designation for TLX66 for conditioning treatment prior to hematopoietic stem cell transplant. The granting of an ODD for TLX66 qualifies Telix for various drug development incentives, which may include FDA administered market exclusivity for seven years, waived FDA prescription drug user fees, and tax credits for R&D and clinical development costs.
Bone marrow conditioning is performed prior to HSCT, a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells (cells that can develop into different types of cells), to encourage production of new bone marrow that produces healthy blood cells. Traditional conditioning regimens are associated with morbidity and mortality from chemotherapy, limiting their use particularly in pediatric and rare diseases.
TLX66 has the potential to add to the depth of conditioning, thereby removing additional disease-causing cells. In addition, TLX66's potential to reduce the toxicity of existing conditioning regimens could increase the number of patients that are eligible for transplant.
HSCT is being used increasingly in malignant hematological conditions, such as multiple myeloma and acute myeloid leukemia, and in non-hematological malignancies and rare / immune-mediated diseases. In 2018, 22,729 HSCTs were performed in the United States.
During 2021, the Company reported initial results for safety and tolerability for the Targeted Radiotherapy for AL-amyloidosis, a Phase I trial conducted at the University of Southampton, United Kingdom. The study found that TLX66 was well-tolerated in patients with systemic amyloid light chain amyloidosis, enabling successful engraftment of the patients' own transplanted stem cells without the need for toxic chemotherapy in this rare immune condition with a poor prognosis.
"The granting of an Orphan Drug Designation by the FDA for TLX66, combined with recent encouraging data from prior studies in hematological malignancies and autoimmune disease provides a strong impetus to advance our development plans for TLX66. This treatment has potential application in a number of hematological cancers and rare diseases and potentially also in the future for conditioning for cell and gene therapies."
Telix Chief Medical Officer, Dr Colin Hayward
TLX66 has also previously been granted ODD status by the European Medicines Agency in Europe for treatment in hematopoietic stem cell transplantation. TLX66 has not received a marketing authorisation approval in any jurisdiction.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange.