PHARMACY MARKET

Rx-360 Launches New auditsPlus®

Rx-360 | June 10, 2021

Rx-360, a global pharmaceutical consortium committed to supply chain integrity and patient safety, is happy to announce the extension of our Audit Program. The release of the new Rx-360 auditsPlus database is the key driver of this growth. This interactive, user-friendly database will not only raise awareness of the Rx-360 Joint Audit Program®. Still, it will also provide Rx-360 program users with new and improved tools to minimize their audit burden.

Rx-360's CEO, Jim Fries, stated, "Maintaining quality in pharmaceutical materials is an ever-increasing problem for the pharmaceutical sector. To maintain our commitment to patient safety, this new tool will provide users of our software with better insight into Rx-360 audits. It's another benefit we can provide the industry and our members."

Jaye Greene, Rx-360's Head of Audit Operations and Quality, stated, "We are extremely excited to introduce the market to our new auditsPlus platform. The user experience has been greatly improved, and all of the Rx-360 Audit Programs are now easily accessible."

About Rx-360
Rx-360, an international pharmaceutical supply chain consortium, was founded in 2009 to support an industry-wide commitment to maintaining patient safety via improved quality and authenticity across the supply chain. The organization's objective is to ensure patient safety by exchanging information and developing processes related to the integrity of the healthcare supply chain and the quality of products used in the supply chain. Rx-360 contains work streams relating to audit and sharing review reports, supply chain security, monitoring and reporting, Asia-focused activities, supplier-focused initiatives, and external relations, communications, and membership to fulfill this mission.

Spotlight

Before placing a medical device on the European market, manufacturers need to produce technical documentation providing evidence of conformity with the relevant legislation. Technical documentation needs to be in compliance with the Medical Devices Directive (MDD) 93/42/EEC or the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC (referred to as ‘MDD/AIMDD’ hereafter).

Spotlight

Before placing a medical device on the European market, manufacturers need to produce technical documentation providing evidence of conformity with the relevant legislation. Technical documentation needs to be in compliance with the Medical Devices Directive (MDD) 93/42/EEC or the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC (referred to as ‘MDD/AIMDD’ hereafter).

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PHARMACY MARKET

CPhI India Concludes the 2021 Hybrid Edition of CPhI - P-MEC Expo along with Informa Pharma Intelligence

Informa Pharma Intelligence | December 06, 2021

Informa Pharma Intelligence, one of the leading business intelligence providers and knowledge partner, concluded its involvement at this year's CPhI & P-MEC Expo, a hybrid conclave hosted between 24th to 26th November 2021 at India Expo Centre – Greater Noida, New Delhi, and at the Online Conference & Networking event held between 15th to 30th November 2021. The conclave witnessed participation from key influencers and leading figures across the pharmaceutical industry, and hosted domestic and foreign drug makers, contract service providers and pharma machinery players under one roof, providing them with a chance to craft future growth plans together. India's pharmaceutical market is in the midst of a growth spurt, having increased in value from $21bn in 2016 to $29bn in 2020 – a figure that is expected to reach $41bn by 2024. Key industry drivers include a rise in disease prevalence, economic growth and higher disposable incomes, improvements in the healthcare infrastructure and a growth in the number of people covered by health insurance. In a bid to stay afloat during the need to step up the demand towards high quality, low-cost pharma solutions, CPhI & P-MEC India has curated a gateway to network with industry peers for the latest trends and innovative solutions that the market has to offer. The event is geared towards building pharma community engagements, network amongst the fraternity and source innovative solutions on-site from exhibitors who have footprints both domestically and globally and cover the entire pharma supply chain - from APIs, machinery, technology, packaging, outsourcing, finished products and biopharmaceuticals. Alongside the expo, and under the aegis of the India Pharma Week, an exclusive and strategic closed door CEO Roundtable meeting took place, inviting the top leaders of India's pharmaceutical companies. The 'CEO Roundtable' was conducted on November 24 in partnership with Informa Intelligence, whose perspectives and key discussion points will also yield a white paper report. The pharama industry is anticipated to have a steady growth trajectory and the event organised by CPhI India has focused on the key driving factors for the same. The expansion of medicine manufacturing pertaining to the evolving epidemiological profile of the country will be instrumental for India being the preferred drug manufacturing destination on a global scale. Additionally, the event aims to encourage the development of the research-based pharma fraternity. Concluding the CPhI – P-MEC India show, Mr Poornachandra Tejasvi, Senior Director, Emerging Markets, India, at Informa Pharma Intelligence, said, "We, at Informa Pharma Intelligence, were delighted to witness the overwhelming response at CPhI & P-MEC India 2021 event and we're glad that we could partner with CPhI to host this common platform for the pharmaceutical industry. With challenges and opportunities evolving at a global scale, through this event we looked to discuss the possibilities for not only providing solutions to the healthcare needs of the country but also to the world. With India's strength in global generics market, Indian pharma and biotech companies are now gearing up to transition into R&D and innovation to establish themselves as key players to develop Biosimilars, Novel Chemical Entities, Novel Biological Entities and Innovative Therapies for the global and Indian pharmaceutical markets, for which Informa Pharma Intelligence is closely partnering to aid in this effort. The event provided a great opportunity to reconnect with our stakeholders of the pharmaceutical world and offer data intelligence and analysis on par with the recent industry trends." "The Indian pharmaceutical market is growing exponentially, around twice the world market growth rate. While its generics market is growing strong, it is also evolving into a cradle for new drugs. Therefore, with India being one of the strongest emerging markets in the global pharma industry, it presents great opportunities for all international pharmaceutical companies to explore; we are glad that the platform by CPhI & P-MEC India could enrich the exhibitors with new pharma solutions and help businesses find the right partners, with the hybrid expo showcasing the full drug development supply-chain from exporting, outsourcing, manufacturing, machinery, regulations, pricing, and market access to, packaging, labelling, and digitalization. We look forward to hosting CPhI P-MEC in the coming year's again." Mr.Yogesh Mudras, Managing Director, Informa Markets in India CPhI India is a sister brand of CPhI Worldwide – A key event that all professionals from the international pharmaceutical and allied industries look forward to year on year. CPhI India and its co-located event, P-mec India, are the largest and most comprehensive pharmaceutical industry events in South Asia. This event is specifically important to the country as India is already known as the pharmacy of the world in addition to the vaccine manufacturing prowess showcased in 2019-2020. About Informa Pharma Intelligence Trusted by over 3,000 of the world's leading pharmaceutical, biotech, medical device companies, and CROs, the Pharma Intelligence suite of intelligence solutions, which include Datamonitor Healthcare™, Sitetrove™, Trialtrove™, Pharmaprojects™, Biomedtracker™, Scrip™, Pink Sheet™ and In Vivo™, deliver vital, accurate, and timely intelligence and analysis about the drug development pipeline to pharmaceutical and biomedical decision makers around the world. A global team of subject area experts track and analyse key diseases, clinical trials, drug approvals, and R&D activities, to deliver the data required to make critical decisions and create real-world opportunities for growth. About CPhI Conferences The world's largest pharmaceutical exhibition, CPhI Worldwide represents every stage of the pharmaceutical supply chain - from ingredients and FDF, to machinery, packaging, outsourcing and biopharmaceuticals. Each year the CPhI brand unites more than 100,000 pharmaceutical professionals from all over the world through exhibitions, conferences and online communities. CPhI offers healthcare experts a chance to network, identify business opportunities and expand the global market through online and in-person interactions, with events in Europe, China, Korea, India, Japan, Southeast Asia and North America.

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BUSINESS INSIGHTS

C-Path and Replica Analytics Collaboration Aims to Accelerate Rare Disease Research

Replica Analytics | June 30, 2022

Critical Path Institute and Replica Analytics, an Aetion company, announced a new partnership that involves leveraging synthetic data to further catalyze the generation of actionable solutions to accelerate drug development for rare diseases. Replica Analytics will help generate synthetic datasets across rare and orphan indications in which patient-level datasets are often quite small, which heightens considerations regarding data privacy and accessibility. Together with real data, these synthetic data will help maximize the utility of C-Path's Rare Disease Cures Accelerator-Data and Analytics Platform which provides a centralized and standardized infrastructure to support and accelerate rare disease characterization targeted to accelerate drug development. Additionally, the platform includes a framework that supports the rigorous conduct of natural history studies, with attention to established data quality standards, to be most useful to clinical trial design and regulatory review. It includes a robust, integrated database and analytics hub that allows for the aggregation of rare disease data from various sources and the efficient and effective interrogation of that data. Once added to RDCA-DAP, the synthetic data will also represent valuable real-world, electronic health record (EHR) based data available on the platform, opening doors to modeling and research based on longitudinal focused analyses. "Our collaboration with Replica Analytics is important because synthetic data can add value to real-world data while observing data privacy considerations, which will help accelerate overall rare disease drug development. The goal of RDCA-DAP is to provide a centralized and standardized infrastructure to support and accelerate rare disease characterization and therapy development, this collaboration is in line with our efforts." RDCA-DAP Scientific Director Alexandre Betourne, Pharm.D., Ph.D Synthetic data generation is a privacy enhancing technology that has been gaining rapid adoption, particularly in the life sciences sector. SDG uses AI to create machine learning models that learn the statistical patterns and properties of real datasets to generate data that retain the same characteristics as the original dataset, but with no one-to-one mapping back to an identifiable person. SDG can help amplify small datasets, simulate virtual patients to augment patients in existing datasets, and optimize the design of small sample clinical trials. "We are certainly seeing a growing opportunity to partner with organizations like C-Path for generating datasets that are fit-for-purpose," says Khaled El Emam, Ph.D., SVP and GM of Replica Analytics. "Synthetic data, which preserves the integrity and utility of source data, as well as being privacy-protective, can be a very valuable tool to enable this collaboration." In May 2022, C-Path hosted a webinar in which the Replica Analytics team introduced SDG and discussed the role the technology can play in researching and treating rare diseases. The event was recorded and can be viewed on C-Path's YouTube channel. About C-Path Critical Path Institute is an independent, non-profit organization established in 2005 as a public and private partnership. C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona, C-Path in Europe is headquartered in Amsterdam, Netherlands and C-Path Ltd. operates from Dublin, Ireland with additional staff in multiple other locations. Critical Path Institute is supported by the Food and Drug Administration of the U.S. Department of Health and Human Services and is 54.2% funded by the FDA/HHS, totaling $13,239,950, and 45.8% funded by non-government sources, totaling $11,196,634. The contents are those by the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government. About Replica Analytics, an Aetion company Replica Analytics is the premier science-based SDG technology provider to the healthcare industry. The company a pioneer in the development of unique technologies for generating privacy-protective synthetic data that maintain the statistical properties of real-world data. The company was acquired in late 2021 by Aetion, the leading regulatory-grade real-world evidence technology provider. Replica Synthesis software provides a full suite of synthetic data generation and evaluation capabilities that can solve multiple grand challenges facing the life sciences industry, and health research in general. About Aetion Aetion is a healthcare analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. The Aetion Evidence Platform® analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs healthcare's most critical decisions—what works best, for whom, and when—to guide product development, commercialization, and payment innovation.

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PHARMA TECH

Piramal Pharma Solutions Announces Sterile Fill/Finish Program Theratechnologies Inc

Piramal Pharma Solutions, Theratechnologies Inc. | January 25, 2021

Piramal Pharma Limited's Pharma Solutions business, a leading contract development and manufacturing organization (CDMO), today declared that it is giving Theratechnologies Inc. with GMP manufacturing of sterile fill/finish drug item to help their developmental item as it goes into a first-in-people clinical investigation. The clinical material is being created at the Piramal Pharma Solutions (PPS) manufacturing site in Lexington, Kentucky, which is perceived around the world for its skill in sterile fill/finish administrations. It will be utilized in a Phase I preliminary for TH1902, Theratechnologies' lead peptide-drug conjugate (PDC) (docetaxel conjugate). The Phase I preliminary plan incorporates a portion acceleration study to assess the security, pharmacokinetics, most extreme endured portion (MTD) and fundamental enemy of tumor movement of TH1902 managed once at regular intervals in patients with cutting edge strong tumors headstrong to accessible enemy of malignant growth treatments. According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, "Our Lexington team went the extra mile to provide solutions to ensure timely formulation development and production of the material. It's yet another example of how we are focused on working with our customers to reduce the burden of disease on patients." About Piramal Pharma Solutions Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. We also offer specialized services like development and manufacture of highly potent APIs and antibody drug conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve innovator and generic companies worldwide. About Piramal Pharma Limited Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 14 global facilities and a global distribution network in over 100 countries. PPL includes an integrated contract development and manufacturing (CDMO) business, Complex hospital generics business, and India Consumer Products business, selling over-the-counter products in India. In addition, it has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market. In October 2020, PPL received 20% strategic growth investment from the Carlyle Group. About Theratechnologies Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

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