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.
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.
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.
HCmed Innovations Co., Ltd | March 07, 2022
HCmed Innovations, Co., Ltd. (HCmed) has announced a strategic agreement with Formosa Laboratories, Inc. and Formosa Pharmaceuticals, Inc. to expand its inhalation therapy business by offering contract development and manufacturing services. The three parties expect to become a one-stop shop in the biopharmaceutical industry as a full-service contract development and manufacturing organization by combining HCmed's vibrating mesh nebulizers, Formosa Laboratories' drug development and manufacturing capabilities, and Formosa Pharmaceuticals' APNT nanotechnology platform (CDMO).
According to data, the global market for inhalation drugs will reach $25 billion in 2020. Furthermore, as the COVID-19 pandemic has increased demand for respiratory treatment drugs over the last two years, so needs for developing respiratory drugs, prompting several well-known global pharmaceutical companies to take the lead in incorporating HCmed's proprietary mesh technology into the development of their inhaled products.
"Currently, global CDMO companies that focus on developing drug-device combination products cannot only provide their Pharma partners with a platform to deliver drugs, but also with integrated services that extend to drug development, mass production, and product packaging. Through these services, the combination product development time can be shortened, and costs can be reduced. With this objective, HCmed, Formosa Laboratories, and Formosa Pharmaceuticals aim to provide a fully integrated CDMO service platform, which is expected to expand the companies' business further, providing fully-integrated solutions and creating long-term win-win relationships."
CEO of HCmed, Jason Cheng
The two companies have similar ideas on how to grow their CDMO businesses. In the respiratory medicine industry, the agreement represents the merging of three significant leaders in the biotechnology and high-end medical device industries. With Formosa Pharmaceuticals' nanotechnology platform, Formosa Laboratories' API, ADC, and injection development and production experience, and HCmed's technology in developing customized mesh nebulizers, the parties hope to provide a comprehensive service across the entire development process, including early drug development, clinical trial execution, mass production, and product launch. This partnership is
Cascade Chemistry | February 19, 2021
Cascade Chemistry, a main pharmaceutical contract development and manufacturing organization, today declared inception of development of new offices intended to expand the organization's ability to manufacture APIs (dynamic pharmaceutical ingredients) under cGMP (current Good Manufacturing Practices standards and procedures).
The new offices, expected to be operational in the main quarter of 2022, will eventually expand the organization's floor space just about three-overlay and essentially add to its cGMP manufacturing limit and scale. The extension likewise incorporates 2,200 square feet of new insightful labs, a powerful quality framework and extra office space.
“This $14 million expansion reflects our growing success as a reliable, experienced and flexible outsourcing partner with exceptional chemistry problem-solving expertise,” said Jeremiah Marsden, PhD, President of Cascade Chemistry. “Our customers are increasingly requesting our assistance in producing APIs for their clinical trials, and demand has outstripped our cGMP manufacturing capacity. We were fortunate to acquire two suitable buildings just 10 minutes from our current facility, and construction of new cGMP manufacturing suites that will greatly increase our clinical trial API production capacity is now underway.”
The 28,000-square-foot fabricating currently under development will at first incorporate five suites for Phase 1 and Phase 2 cGMP manufacturing with stream hydrogenation and reactors up to 400 liters. Extra limit with respect to API Phase 3 and business scale cGMP manufacturing up to 1,000 liters will be included 2022. The subsequent structure, with 7,000 square feet, is saved for future development.
Dr. Marsden continued, “We ultimately will expand into the second new building to build further cGMP capacity for commercial-stage low-volume, high-value pharmaceuticals. We are grateful for the support from our customers that is driving this expansion, as well as our employees’ dedication to excellence and their creativity and hard work that make it all possible.”
About Cascade Chemistry
Cascade Chemistry specializes in active pharmaceutical ingredient (API) process development, scale-up and cGMP (current Good Manufacturing Practices) manufacturing. Most of our chemists have advanced degrees and are capable of crafting process solutions tailored to the specific needs of our clients, while adhering to strict FDA quality standards. We offer cost effective and rapid solutions for the development and manufacturing of API cGMP batches at 1-10 kg scale, and we will begin offering greater capacity at our new facility in 2022. It has been our philosophy for almost 40 years that quality is a key component of successful cGMP manufacturing. We view quality as a guiding principle, achieved by rigorous due diligence at each step of the development and manufacturing process. Cascade Chemistry is headquartered in Eugene, Oregon.