A combination of sensory stimuli can help soothe crying babies, study reveals

news-medical | April 25, 2019

A frequently crying infant can have a major impact on both the infant itself and its parents. Parents of excessively crying infants are often exhausted and experience symptoms of depression. Excessive crying is even associated with infant hospitalization and shaken baby syndrome. There are, however, no proven effective prompt soothing methods for excessively crying infants under the age of 6 months. Child development experts Eline Möller, Wieke de Vente and Roos Rodenburg from SEIN and the UvA wanted to change this. They therefore investigated whether the combination of swaddling (wrapping the baby in a swaddle sack), sound (shushing) and movement (swinging) induce a spontaneous calming response when parents soothe their baby or when a 'smart crib' soothes the baby. They also examined whether the age of the baby influences the calming response. To do so, Möller, De Vente and Rodenburg looked at 69 babies aged 0 to 6 months. Each baby and one of its parents came to the UvA Family Lab. The researchers did a so-called counterbalanced experiment that consisted of two conditions: the parent and the smart crib. Each of the two conditions involved three two-minute phases: baseline (to be able to determine the baseline value), laying on the back, and soothing. Möller explains: 'During the baseline the baby sat on the parent's lap. We then induced fussiness by putting the baby on the back, followed by parental soothing - the parent shushed and rocked the swaddled baby. We went through the same phases with the smart crib as a comforter. The smart crib also swings the baby and also makes a shushing sound.' The researchers recorded the level of fussiness in the babies through observation; the baby's heart rate and heart rate variability were also measured to record physiological fussiness. If, while soothing the baby, the observed fussiness and heart rate decrease and the heart rate variability increases (compared to lying on the back), the infant reacts with a calming response.

Spotlight

The social, demographic and economic context in which the pharmaceutical industry (Pharma) operates is changing dramatically, as we noted in “Pharma 2020: The vision”.

Spotlight

The social, demographic and economic context in which the pharmaceutical industry (Pharma) operates is changing dramatically, as we noted in “Pharma 2020: The vision”.

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PHARMA TECH

Alimentiv, Satisfai Health, and Virgo Announce Partnership to use AI-driven technology to Enhance Clinical Trials in IBD and other GI Diseases

Alimentiv Inc. | October 06, 2022

Alimentiv Inc. Satisfai Health, Inc and Virgo Surgical Video Solutions, Inc. announced a strategic partnership to revolutionize central reading, data capture, decision support, and patient recruitment in the clinical trial domain for Inflammatory Bowel Disease and allied GI conditions. Satisfai, a global leader in developing artificial intelligence solutions for gastroenterology, and Virgo, an industry leader in endoscopy video capture technology, will leverage their combined strengths to work in partnership with Alimentiv, a leading CRO in gastroenterology, to realize the full potential of AI-powered precision imaging in the GI clinical trials space. "This synergy of Satisfai and Virgo with Alimentiv is a positive development for patients with IBD and the drug development space. Clinical trials have many pain points, and this strategic partnership will enable advances in improving the efficiency of clinical trials and make some significant changes to how trials are run. We are delighted to enter this arrangement to bring the next generation of imaging technology to clinical trials in gastroenterology." Jeff Smith, CEO of Alimentiv "Artificial Intelligence in medicine is being increasingly adopted across various clinical specialties, with gastroenterology being one key field of use, particularly endoscopy," said Dr. Michael Byrne, CEO and founder of Satisfai Health, Clinical Professor of Medicine and gastroenterologist in Vancouver. "Working with Virgo, we are excited to bring AI-driven solutions to the IBD clinical trials arena. To be able to do so with Alimentiv — a leading Gastroenterology and imaging CRO—is a great opportunity. Our clear ambition is to change the clinical trial paradigm for IBD and other disease states such as Eosinophilic Esophagitis. As three groups working together, we are confident we can do so." "Combining Satisfai's marquis AI solutions with Virgo's HIPAA and SOC 2 compliant automated cloud video capture technology and Alimentiv's 21CFR11 compliant solutions, expansive site community, and imaging expertise is very powerful. We truly look forward to realizing this vision and bringing real-time, in-line AI solutions to GI clinical trials worldwide," said Matthew Schwartz, CEO and co-founder at Virgo. This partnership will facilitate Alimentiv's continued leadership in GI Clinical Trials through exclusive access to Satisfai's SmartScore Central Reading tool and Virgo's fully integrated, hands-free, cloud-based high-definition video-capture fleet. In addition, this will provide pharmaceutical and biotech sponsors with access to the ongoing development of novel endpoints, scoring methodologies, and scalable solutions geared toward bringing novel therapies to market faster. About Alimentiv Inc. Alimentiv is a global contract research organization (CRO) providing clinical trials, central image management, precision medicine, and real-world evidence services to the pharmaceutical and biotechnology industries. Headquartered in London, Ontario, Alimentiv employs more than 500 people across its operations in Canada, the United States, Europe, Asia-Pacific, and Latin America. The organization's unique model combines the efforts of internationally recognized academic researchers and operational experts to offer integrated solutions to customers. Over the past 20 years, Alimentiv has become a recognized expert in clinical trial design, central image management solutions, outcome measure development, and precision medicine for drug development in IBD. Today, Alimentiv provides services in more than 50 countries worldwide, collaborates with leading universities and academic institutions across the globe, and partners with many leading pharmaceutical and biotechnology organizations to bring new and improved treatment options to patients. Alimentiv is committed to investment in medical research and development, focusing on identifying barriers to drug development and pursuing solutions that advance IBD research. The research findings are operationalized into an efficient clinical trial methodology for clients that aligns with emerging regulatory standards. In collaboration with leading experts, Alimentiv has pioneered the development, validation, and standardization of outcome measures and technology, shaping the evolving clinical trial landscape for multiple indications and providing meaningful long-term consequences for patients, their treatment, and society. About Satisfai Health Satisfai is a leading medical solutions provider specializing in AI applications applied to large addressable markets in gastroenterology. Satisfai's solutions deliver real-time medical imagery analysis, providing clinicians with decision support intelligence that dramatically improves patient outcomes. Satisfai is supported by a highly respected board of medical clinicians and key opinion leaders who operate at the top of their fields in the many areas of gastroenterology. Satisfai enjoys a strong voice on academic panels, leading GI societies, and direct access to prominent industry players seeking to adopt new AI technologies in gastroenterology. About Virgo Virgo provides the leading cloud video capture, management, and artificial intelligence analysis platform for endoscopic medicine. Academic, integrated, and private practice healthcare providers use the Virgo platform to advance patient care through video-based research and training initiatives. Since launching, Virgo has helped physicians capture over 400,000 endoscopy procedures using industry-leading HIPAA, HITRUST, and SOC 2-compliant cloud service providers. Virgo also supports integration with all leading electronic health records systems. In 2021, Virgo launched a suite of tools called VirgoTrials, which help pharmaceutical trial sponsors and their participating trial sites accelerate patient recruitment and shorten the overall enrollment period for trials.

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PHARMA TECH

Apollomics Inc., a Late-Stage Clinical Biopharmaceutical Company to be Listed on Nasdaq Through Business Combination

Apollomics, Inc. | September 15, 2022

Apollomics Inc. a late-stage clinical biopharmaceutical company, and Maxpro Capital Acquisition Corp. announced a definitive agreement for a business combination that would result in Apollomics becoming a publicly traded company on the Nasdaq Global Market. The business combination is expected to close in the first quarter of 2023 and Apollomics is expected to be listed on Nasdaq under the ticker symbol “APLM.” Apollomics’ broad pipeline of drug candidates includes late-stage clinical assets for the treatment of patients with difficult-to-treat cancers. Apollomics’ mission is to develop assets in critically important areas of unmet need. The Company’s leading drug candidates address certain subpopulations within lung cancer and leukemia. Globally, both lung cancer and leukemia affect over 2 million people annually. The Company is dedicated to discovering and developing oncology therapies of different mechanisms of action to inhibit cancer. Its diverse portfolio of innovative drug candidates for treating difficult-to-treat cancers includes precision therapy targeting tumors with specific mutations, as well as assets addressing broader cancer conditions. The Company’s pipeline of nine clinical, preclinical and discovery drug candidates has the potential to improve treatment of a number of tumor types. Upon the closing of the transaction, Apollomics will continue to be led by current Chairman and CEO, Dr. Guo-Liang Yu, Ph.D., a serial entrepreneur, and his team. Dr. Yu is a pharmaceutical researcher with more than 300 patents. “Apollomics’ announcement represents the next major milestone on our journey to provide solutions for patients with difficult-to-treat cancers,” Dr. Yu said. “We anticipate that the funds available to us from this transaction will help us accelerate development of our oncology pipeline.” Apollomics expects results from its global Phase 2 multi-cohort clinical trial of vebreltinib in NSCLC and other solid tumors with cMET dysregulation in 2023, which the Company believes may support its first New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) while generating clinical data for different indications. In addition, the Company expects to complete patient recruitment of its uproleselan Phase 3 study in China in 2023. “Our goal was to find an exciting company with a growing pipeline of innovative product candidates that could positively affect the lives of millions of people. Our team is excited to combine with Apollomics as it has met and exceeded all our key selection criteria. Together with Apollomics, Maxpro will do everything we can to support the Company’s vision of treating patients with difficult-to-treat cancers.” Moses Chen, CEO of Maxpro About Apollomics Inc. Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics currently has a pipeline of nine drug candidates across multiple programs, six of which are currently in the clinical stage of development. Apollomics’ lead programs include investigating its core product, vebreltinib (APL-101), a potent, selective c-Met inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-Met alterations, which is currently in a Phase 2 multicohort clinical trial in the United States, and developing an anti-cancer enhancer drug candidate, uproleselan (APL-106), a specific E-Selectin antagonist that has the potential to be used adjunctively with standard chemotherapy to treat acute myeloid leukemia and other hematologic cancers, which is currently in Phase 1 and Phase 3 clinical trials in China. About Maxpro Capital Acquisition Corp. Maxpro is a blank check company formed for the purposes of effecting a merger, capital share exchange, asset acquisition, share purchase, reorganization, or similar business combination with one or more businesses in the healthcare and technology industries. In October 2021, Maxpro consummated a $103.5 million initial public offering of 10.35 million units (including the underwriters’ full exercise of their over-allotment option), each unit consists of one share of Class A common stock and one redeemable warrant, each warrant entitles the holder to purchase one share of Class A common stock at a price of $11.50 per share. EF Hutton, division of Benchmark Investments LLC, served as the sole book-running manager of Maxpro’s initial public offering.

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BUSINESS INSIGHTS

IntegriChain Partners with PurpleLab to Enhance Pharmaceutical Channel Data for More Accurate GTN Forecasting and Accruals

IntegriChain | November 18, 2022

IntegriChain, delivering pharma's only comprehensive technology, data, consulting, and outsourcing platform for data-driven commercialization, announced a strategic data partnership with PurpleLab, a healthcare technology company delivering analytics to drive real-world evidence decision-making. As a first step to this partnership, IntegriChain will incorporate PurpleLab prescription drug claims data to address challenges in visibility to demand and inventory that has resulted from evolving pharmaceutical channels for new specialty pharmaceutical products. "As the Pharma industry has shifted to more fragmented non-retail therapies such as specialty lite and specialty self- and HCP-administered products, distribution channels are more diverse and complicated. These new channels have visibility gaps that create unreasonable risk of errors in gross-to-net forecasting and accrual management. PurpleLab data – covering more than 350 million patient lives, 4 billion annual claims, and 98% of payers – enhances our ability to deliver true demand and inventory visibility, more accurate gross-to-net forecasting and accruals, and most importantly data-driven commercialization for specialty products to Pharma commercial and financial teams." Gary Palgon, IntegriChain's General Manager and Senior Vice President, Data Solutions With this partnership, IntegriChain will seamlessly integrate PurpleLab pharmacy and medical claims data into the ICyte platform and the Inventory Analytics product, improving demand and inventory visibility to actual dispensing volumes at the site of dispense or administration. This data integration will deliver a more accurate depiction of demand attributed to individual outlets, ensuring a closer alignment between net sales and demand at a channel and more accurate pipeline inventory calculations. In addition, IntegriChain will deliver increased fidelity of national and subnational datasets for targeting by incorporating PurpleLab data into ICyte's unblinding process. The seamless addition of PurpleLab data into the ICyte Platform will be generally available in ICyte Inventory Analytics in January 2023. Additional future data enhancements will be announced in due course. About ICyte Data Solutions IntegriChain offers a full suite of channel data products, including: Channel Data Aggregation: Aggregation of all channel and distribution datasets including ExFactory Sales, Distributor Inventories, Demand, and Returns to deliver the highest quality master data, including industry-leading data science and enrichment algorithms to deliver end-to-end views of product distribution. Inventory Analytics: Manufacturers have few existing measures of the inventory held in retail stores, distribution centers, and third-party returns processors. IntegriChain Inventory Analytics reports 100% of inventory in the retail channel, even in pharmacy stores and distribution centers that do not report their inventories. Distribution Contract Management: Distribution Contract Management is a single, auditable application for managing all aspects of trade partner agreements. Configurable trade partner scorecard functionality features payment adjudication, custom pay-for-performance metrics, payment roll forward, and top- and bottom-line functionality adjustments. Channel Data Consulting Services: Based on IntegriChain pioneering the field of channel data aggregation, stewardship, and advanced analytics, the Channel Insights and Optimization practice delivers Market Demand Analysis, Class of Trade, Downstream Inventory Analytics, Returns Forecasting, and Revenue Analytics consulting services to Pharma manufacturers of all types and sizes. About PurpleLab PurpleLab is a healthtech company with a mission to spur value-driven innovation in healthcare to improve outcomes for patients. HealthNexus™, the company's no-code analytics platform empowers life sciences, payers, providers and other stakeholders with real-world evidence to solve conventional and emerging challenges faster and more cost effectively. About IntegriChain IntegriChain delivers pharma's only comprehensive technology, data, consulting, and outsourcing platform for market access departments. We provide the strategy and operational execution for data-driven product commercialization and market access. More than 400 manufacturers rely on our consulting expertise and ICyte Platform to orchestrate their prescription management, patient data management, inventory and demand visibility, enterprise GTN technology, and platform insights. ICyte is the first and only platform that unites the financial, operational, and commercial data sets required to support commercialization and access in the era of specialty and precision medicine.

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