BUSINESS INSIGHTS

PCI Pharma Services Selects Thoughtworks for Digital Platform Transformation with Agile Approach

Thoughtworks | July 11, 2022 | Read time : 2 min

PCI Pharma
Thoughtworks a global technology consultancy that integrates strategy, design and engineering to drive digital innovation, today announced the signing of a multi-year agreement with PCI Pharma Services, a leading global contract development and manufacturing organization.

Thoughtworks will help PCI in its journey to digitize its supply chain, with the goal of accelerating the time it takes to bring clients’ life-changing therapies to market for patients. By co-developing tools for digital business modernization, Thoughtworks will help PCI improve client visibility into its clinical and commercial drug supply chains for pharmaceutical and biotech companies of all sizes in 100+ countries.

By digitizing the supply chain, Thoughtworks will help PCI deliver greater insights to clients to increase their overall efficiency, support their business goals and ultimately produce high quality treatments for patients. The agreement includes expanding and adapting pci | bridge, an industry first-of-its-kind, end-to-end data platform that provides real-time status of projects, automatically identifies risks, spots trends and provides business analytics insights. With this modern application programming interface (API), clients have the ability to seamlessly integrate their systems with PCI’s, creating greater transparency and a more simplified process for decision-making.

Digital transformation has been a key differentiating factor for PCI’s business strategy, and the evolution of pci | bridge will be critical to increasing client engagement and maximizing the value of data and analytics for PCI and our external partners. With Thoughtworks’ 28+ years of experience at the forefront of innovation, we look forward to making our clients’ lives easier through this partnership."

Wayne Hull, Chief Digital and Technology Officer, PCI Pharma Services

With a shared commitment to customer-centricity, the Thoughtworks and PCI product and engineering teams will create a new level of intuitive self-service solutions for clients. The partnership will also simplify the collection and analysis of information to reach business insights faster and streamline processes to develop useful new products for clients. The teams will do this by working side-by-side using agile development methods, including pair programming, test-driven development and continuous integration/continuous delivery (CI/CD) automation.

“Recognized as a leader in global CDMO services, PCI Pharma Services is well on its digital transformation journey, providing clients with sophisticated supply chain solutions and a digitally integrated experience unlike anything else in the industry,” said Chris Murphy, Chief Executive Officer, Thoughtworks North America. “We are thrilled to partner with PCI Pharma Services as it empowers its clients to make even more powerful, life-impacting decisions through their expansive data and analytics ecosystems.”

About PCI Pharma Services
PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries and over 4,300 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives. For more information, please visit pci.com

About Thoughtworks
Thoughtworks is a global technology consultancy that integrates strategy, design and engineering to drive digital innovation. We are 11,000+ people strong across 49 offices in 17 countries. Over the last 25+ years, we’ve delivered extraordinary impact together with our clients by helping them solve complex business problems with technology as the differentiator.

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PHARMA TECH

Bexson Biomedical and Stevanato Group Awarded PDA Drug Delivery Innovation Award

Bexson Biomedical | October 20, 2022

Bexson Biomedical, Inc., a biopharmaceutical company focused on disrupting the $189 billion small molecule injectable market and enabling home health solutions, announced Bexson and Stevanato Group a leading global provider of drug containment and delivery solutions to the pharmaceutical, biotechnology, and life sciences industries, have been jointly awarded the Parenteral Drug Association's 2022 Drug Delivery Innovation Partnership Award. At PDA's annual conference in Palm Springs, CA on October 18th, PDA's leadership presented the award to Bexson Biomedical's Sr. VP of Drug Delivery, Sheldon Moberg, and to Stevanato Group's DDS Business Development Director, Paolo Golfetto. This award recognizes the collaboration between Bexson Biomedical and Stevanato Group to optimize Stevanato Group's innovative wearable device On Body Delivery System with Bexson's formulation technology. OBDS is a wearable infusion device that allows controlled drug dosing and delivery over extended durations, and which is positioned to enable patient therapy in the home setting. "I am pleased PDA has recognized the collaborative approach that Bexson Biomedical and Stevanato Group have taken to develop this innovative device for non-opioid pain management. In addition, merging Bexson's SEVALENT™ formulation technology with Stevanato Group's vertically integrated development capabilities has been a very rewarding program, and has great potential beyond the initial therapy." Bexson's Sheldon Moberg "It is an honor for Stevanato Group to receive this award, which recognizes the long collaboration with Bexson," adds Stevanato Group's, Paolo Golfetto. "Our work will continue to extend Stevanato Group's OBDS wearable device to additional therapeutic areas with Bexson's formulation platform. The common goal remains to offer patients more flexible and comfortable treatment modalities, reducing the impact on quality of life, along with overall treatment costs for pharmaceutical companies." Bexson Biomedical, Inc. Bexson Biomedical, Inc. is a biopharmaceutical company focused on disrupting the small molecule injectable market and enabling home health solutions through new formulations designed for subcutaneous delivery. Bexson's proprietary platform, SEVALENT™, can be applied to small molecules across a broad range of drug classes, enabling IV therapies to be delivered subcutaneously. Bexson's lead therapy, BB106, is a low-dose ketamine treatment for post-operative pain management, a $36B global market and leading driver of opioid addiction. Additionally, management believes its BB106 formulation technology can be utilized to address various mental health indications. Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group's core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients.

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BUSINESS INSIGHTS

Hovione expands drug product offering with a new manufacturing line dedicated to Continuous Tableting

Hovione | September 07, 2022

Hovione, the leader in spray drying and particle engineering, announced that it has expanded its continuous manufacturing offering and services. A new state-of-the-art continuous manufacturing facility is now coming online at the Loures site in Portugal. In addition, to support Hovione's commitment to providing access and services for continuous tableting, Hovione has further strengthened its capabilities by establishing a highly experienced multi-disciplinary global team in continuous tableting and upgrading its labs with the tools needed to support the drug product lifecycle, thereby further guaranteeing competency and capacity from research & development to production. Continuous manufacturing is expected to change the landscape of drug product development and commercial production. The Food and Drug Administration (FDA) is partnering with the International Council for Harmonization and leading a global initiative to advance continuous manufacturing of small molecules and other pharmaceutical modalities. Hovione is offering customers a commercial continuous tableting platform prepared to support key control needs and deliver on operational excellence, mechanistic modeling, and appropriate process analytical technology (PAT). Additionally, Hovione´s quality system has been designed to support the release of continuous tableting products through automated in-process controls, deployment of real time release, and compliant digital infrastructure. This cutting-edge technology offers a distinct set of features and advantages including faster development of simpler processes, agile manufacturing for variable demand, robust control strategies and high process quality standards. "Hovione has been historically focused on innovative technologies that benefit our customers and patients. With this investment in continuous tableting, our customers can rely on our support to bring much needed medicines to the market as fast as possible with the highest quality and manufacturing standards. We are investing to accelerate the adoption of this technology as we continue to innovate and enhance our offering around our areas of expertise." Jean-Luc Herbeaux, Hovione´s CEO "This investment in continuous tableting from R&D to production further strengthens Hovione´s CDMO offering and responds to the growing customer interest." says Filipe Neves, Hovione´s Strategic Business Director. This latest investment in Continuous Tableting is part of Hovione´s broader strategy to build differentiated and enabling capabilities and assets to meet customers unique needs for oral dosage forms manufacturing. About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API and formulation development to devices. Hovione´s culture is based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

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BUSINESS INSIGHTS

Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT™

Iterative Scopes | September 23, 2022

Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced that SKOUT™ has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for adults undergoing colorectal cancer screening or surveillance. SKOUT, a real-time computer-aided polyp detection device developed by Iterative Scopes, uses advanced computer vision technology designed to recognize suspicious tissue and provide real-time feedback to gastroenterologists. The device was evaluated in the largest U.S.-based multicenter clinical study for a computer aided polyp detection (CADe) device completed to date, which determined that SKOUT significantly improved overall adenoma detection in screening and surveillance colonoscopy compared to standard colonoscopy.1 In March 2021, Provation and Iterative Scopes entered a partnership focused on delivering artificial intelligence-based solutions to healthcare providers and researchers. Provation is a market leader in gastrointestinal (GI) documentation, with more than 3,500 customer facilities including 80% of the top academic and large health systems, and the company will act as an exclusive distributor of SKOUT to help broaden the technology’s reach among the country’s top GI-focused organizations. Colorectal cancer is the second leading cause of cancer-related deaths in the United States and Europe,2 3 due in part to the high volumes of adenomas – approximately 26%4 – that endoscopists miss when conducting a colonoscopy. In its registration trial, SKOUT was found to improve adenoma detection, as measured by adenomas per colonoscopy (APC). Furthermore, increased detection was not limited to diminutive polyps. Higher APC rates have been shown to lead to improved patient outcomes; a recent study showed that the incidence of colorectal cancer within three years of examination decreases with higher APC rates.5 “Even among the best endoscopists, there is room for improvement in adenoma detection, which can impact patient outcomes. We are enthusiastic about the fact that even gastroenterologists with an already high baseline rate of adenoma detection demonstrated an improvement with SKOUT. Now that SKOUT is FDA-cleared, clinicians will be able to better detect adenomas with more efficiency, and ultimately change the standard of gastrointestinal care.” Sloane Allebes Phillips, VP of Clinical Operations at Iterative Scopes SKOUT is indicated as a computer-aided detection tool to assist qualified and trained endoscopists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. SKOUT demonstrated a 27% relative increase in the detection of adenomas per colonoscopy, with an average of one additional adenoma resected for every 4.5 patients examined. Importantly, in the proximal colon, SKOUT demonstrated a 44% relative increase in 5-9 mm polyp detection, and a 29% relative increase in 5-9 mm polyp detection overall.1 These results validate the need for technological advancements that can help improve colonoscopies, and SKOUT’s artificial intelligence capabilities position it to do so. “Knowing that patients can walk away from their appointment with the confidence that they received a high quality and detailed colonoscopy is what excites us most about SKOUT’s FDA clearance,” said Aasma Shaukat, MD, MPH, Robert M. and Mary H. Glickman Professor of Medicine and Gastroenterology at NYU Grossman School of Medicine, and a primary investigator on the SKOUT registration study. “Confidence and peace-of-mind on behalf of providers and patients alike will allow clinicians to provide stronger recommendations and solutions for their patients.” “We are thrilled that our partner Iterative Scopes has received FDA clearance for their AI-Assisted Polyp Detection device, SKOUT. We have been very impressed with its study results and are eager to share our vision for integrating this technology into our solutions,” said Daniel Hamburger, CEO at Provation. “SKOUT is a true game-changer for the field of gastroenterology, and we can’t wait to start seeing its impact on patient care.” SKOUT’s intuitive user interface seamlessly integrates with existing clinical workflows and does not increase total procedure or withdrawal time.1 When a potential polyp is detected, the system calls attention to the polyp on the procedure monitor by drawing a blue bounding box around it and tracking the polyp as it moves on the screen. If a medical tool enters the frame, the bounding box automatically disappears to avoid obstructing the physician’s view during polyp removal. About Iterative Scopes Iterative Scopes is a pioneer in the application of artificial intelligence-based precision medicine for gastroenterology with the aim of helping to optimize clinical trials investigating treatment of inflammatory bowel disease (IBD). The technology is also designed to potentially enhance colorectal cancer screenings. Its powerful, proprietary artificial intelligence and computer vision technologies have the potential to improve the accuracy and consistency of endoscopy readings. Iterative Scopes is initially applying these advances to impact polyp detection for colorectal cancer screenings and working to standardize disease severity characterization for inflammatory bowel disease. Longer term, the company plans to establish more meaningful endpoints for GI diseases, which may be better predictors of therapeutic response and disease outcomes. Spun out of MIT in 2017, the company is based in Cambridge, Massachusetts. About Provation Provation is a leading provider of healthcare software and SaaS solutions for clinical productivity, care coordination, quality reporting, and billing. Our purpose is to empower providers to deliver quality healthcare for all. Provation’s comprehensive portfolio spans the entire patient encounter, from pre-procedure through post-procedure, with solutions for physician and nursing documentation anesthesia documentation patient engagement, surgical care coordination, quality reporting, and billing capture order set and care plan management and EHR embedded clinical documentation. Provation has a loyal customer base, serving more than 5,000 hospitals, surgery centers, and medical offices, and 700 physician groups globally, including 19 of the top 20 U.S. hospitals. In 2021, Provation was acquired by Fortive Corporation, a Fortune 1000 company that builds essential technology and accelerates transformation in high-impact fields like workplace safety, engineering, and healthcare.

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BUSINESS INSIGHTS

Inversago Pharma Raises $95 million CAD in Series C Financing

Inversago Pharma Inc. | October 18, 2022

Inversago Pharma Inc. a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, announced the completion of a Series C funding of $95 million CAD led by New Enterprise Associates. Additional new investors Forbion’s Growth Opportunities Fund and Amgen Ventures joined current investors including Forbion’s Ventures Fund IV Fonds de solidarité FTQ, Genesys Capital, AmorChem, JDRF T1D Fund and adMare BioInnovations in the financing round. Proceeds from the Series C financing will be used to move Inversago’s lead program, INV-202, into a Phase 2 clinical trial in Diabetic Kidney Disease in Q4 2022. This follows the previously announced IND clearance from the FDA and the upcoming promising Phase 1b topline results in subjects with metabolic syndrome. Additionally, the funds will accelerate the Company’s other key programs currently in pre-clinical development, while establishing its leadership in the field of CB1 blockers. “We are privileged to have the support and commitment of such an impressive investor syndicate at this critical stage of the Company’s development. This new round of financing is a strong endorsement of the whole Inversago team, who have carried the vision to leverage the potential of the CB1 blockade in developing potent treatments for a growing number of patients suffering from metabolic conditions, such as Diabetic Kidney Diseases and other diabetes-related conditions”. François Ravenelle, PhD, Chief Executive Officer of Inversago Pharma Commenting on the investment, Ed Mathers, General Partner at NEA, said: “Inversago has demonstrated that peripherally-acting CB1 blockers have an untapped potential to create a new class of target therapies that serve diabetic patient populations. Today’s financing reflects our shared vision and collaboration with the Company’s management as they initiate a Phase 2 clinical trial with INV-202”. Nanna Lüneborg, General Partner at Forbion Growth, added: “We are delighted to join this Series C financing of Inversago, and support the Company to develop a pipeline of new therapies which promise to make a profound impact on the lives of patients with cardiometabolic diseases. We have been impressed by the terrific progress of Inversago since Forbion led the Company’s Series B round two years ago and are excited to further support the Company from both Forbion Growth and Forbion Ventures”. About NEA New Enterprise Associates, Inc. is a global venture capital firm focused on helping entrepreneurs build transformational businesses across multiple stages, sectors and geographies. With nearly $24 billion in cumulative committed capital since the firm's founding in 1977, NEA invests in technology and healthcare companies at all stages in a company's lifecycle, from seed stage through IPO. The firm's track record of investing includes more than 260 portfolio company IPOs and more than 440 mergers and acquisitions. About Forbion Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion manages well over EUR 2 billion across multiple fund strategies that cover all stages of pharmaceutical drug development. Forbion’s current team consists of over 30 life sciences investment professionals that have built an impressive performance track record since the late nineties with investments in 92 companies. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. The firm is a signatory to the United Nations Principles for Responsible Investment. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany. About Amgen Ventures Amgen Ventures is Amgen's corporate venture capital fund, dedicated to investing in emerging companies and technologies to advance promising new medicines and solutions to healthcare’s biggest challenges. About Inversago Pharma Located in Montreal, Inversago Pharma is a privately owned Canadian biotech company at clinical stage, specialized in the development of new therapies focusing on CB1 blockade, based on first-in-class, peripherally-acting CB1 inverse agonists. Inversago aims to provide new treatment options that improve the lives of patients affected by metabolic conditions such as Diabetic Kidney Disease including Diabetic Nephropathy Type 1 and Type 2 Diabetes Non-Alcoholic Steatohepatitis complications of obesity and hypertriglyceridemia as well as fibrotic indications like Progressive Fibrosis-Interstitial Lung Disease including Idiopathic Pulmonary Fibrosis and other conditions.

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Spotlight

This in-depth paper will show you how to become data agile – tackling both technological issues and solutions, and the cultural and strategic framework needed around this to ensure success.

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