Opportunities and Challenges for Advancing Non-Prescription Medicines

pharmtech | May 29, 2019

FDA officials are proposing new rules, beefing up regulatory resources, and promoting digital technologies to support the development and marketing of safe and innovative over-the-counter (OTC) therapies. The agency and manufacturers continue to hope that Congress will approve legislation authorizing new user fees to modernize the OTC monograph review program, a plan that has been high on the legislative agenda for several years. But even without final agreement on that reform initiative, officials at the Center for Drug Evaluation and Research (CDER) expect to establish an expanded review office for nonprescription drugs as part of a broader reorganization of the Office of New Drugs (OND). In addition, the revamped office will better manage new drug applications (NDAs) for non-prescription medicines, including the new Nonprescription Safe Use Regulatory Expansion (NSURE) initiative to facilitate switches of prescription therapies to nonprescription status. “OTC monograph reform remains a top priority for the agency,” stated FDA Chief of Staff Lauren Silvis at the recent meeting of the Consumer Health Products Association (CHPA). She described agency plans to facilitate prescription-to-OTC switches to increase consumer access to medicines that can be used safely without a prescription. Draft guidance issued in 2018 should encourage manufacturers to provide additional information on proper product use than what is found in the approved drug facts label (DFL). CDER also is working to finalize a proposed rule for developing and marketing OTC sunscreens, an issue that has raised a host of issues relevant to ensuring safe and proper use of these widely available products. FDA seeks additional data to document the safety of ingredients commonly used in sunscreens that can be absorbed in ways to possibly have systemic effects on the body.

Spotlight

At Digitalnauts, we provide XR solutions that help companies achieve real business impact. We support organisations with the technology and expertise to strategically implement XR at scale, resulting in a future-ready workforce and a positive effect on their bottom line.

Spotlight

At Digitalnauts, we provide XR solutions that help companies achieve real business impact. We support organisations with the technology and expertise to strategically implement XR at scale, resulting in a future-ready workforce and a positive effect on their bottom line.

Related News

BUSINESS INSIGHTS, PHARMA TECH

Neochromosome Announces Successful Collaboration with Sumitovant Biopharma

Sumitovant Biopharma, Inc. | January 20, 2023

On January 19, 2023, Neochromosome, Inc., announced a partnership with Sumitovant Biopharma, Inc., a technology-driven biopharmaceutical firm expediting the discovery and commercialization of novel therapeutics. This collaboration blends Neochromosome's neoYeast™ platform with Sumitovant's DrugOME™ computational ecosystem to identify new proteins that would benefit from non-canonical amino acid chemistries that are unavailable in nature. As part of the collaboration, Sumitovant used a combination of natural language processing (NLP), artificial intelligence (AI), machine learning (ML), and computational algorithms to identify opportunities for Neochromosome to enhance the discovery and production of proteins limited by evolution and traditional fabrication processes. For example, non-canonical amino acid inclusion allows new-to-nature proteins with improved structures and functions but often requires chemical synthesis, which is expensive, size- and complexity-restricted, and environmentally damaging. neoYeast™, based on Neochromosome's world-leading genome-scale cell engineering technology stack, enables the highly efficient and environmentally friendly integration of non-canonical amino acids into proteins, with both discovery and manufacturing possible in a single genome-engineered yeast strain. Sumitovant used DrugOME to explore libraries of traditional and non-traditional sources of data to recommend targeted protein development candidates for neoYeast. Co-Founder and CEO of Neochromosome, Leslie Mitchell, commented, "The combination of Sumitovant's technology platform and life-sciences expertise with Neochromosome's ability to both discover and biomanufacture novel proteins in a single system enables Neochromosome to accelerate and streamline the delivery of better therapies for patients." She added, "We are excited to partner with the world-class team at Sumitovant to identify opportunities to create better versions of existing drugs, along with new-to-nature compounds, and to manufacture them efficiently at scale." (Source – Business Wire) Sumitovant Biopharma, Inc. The firm has supported the development of multiple FDA-approved products and a strong pipeline of early-through late-stage investigational assets addressing unmet needs in pediatrics, oncology, urology, women's health, specialty respiratory, and infectious diseases through its proprietary computing and data platforms, scientific expertise, and diverse company portfolio. It is a wholly-owned subsidiary of Sumitomo Pharma.

Read More

BUSINESS INSIGHTS, PHARMA TECH

USP Introduces Analytical R&D to Optimize Continuous Manufacturing Technologies

US Pharmacopeia | January 04, 2023

The United States Pharmacopeia (USP) has announced the launch of the USP Advanced Manufacturing Technology Lab in Richmond, Virginia, as a part of its launch of a suite of R&D analytical solutions. These analytical lab services will aid drug manufacturers in adopting advanced manufacturing technologies, such as pharmaceutical continuous manufacturing (PCM), to increase geographic diversity in pharmaceutical manufacturing and support medicine supply chain resilience. The new R&D analytical solutions will include analytical lab services that take advantage of USP's in-house scientific expertise and cutting-edge facilities at the USP Advanced Manufacturing Technology Lab in Richmond, as well as its headquarters in Rockville, Maryland. These capabilities will be utilized to characterize materials and qualify and develop ways to help ensure the quality of PCM-based medicines. PCM involves a continuous flow of materials through a process pipeline in which two or more unit operations are directly connected and the sequential transformation of those materials. As the input materials are fed in, the process output, such as an active pharmaceutical ingredient or drug product, is collected, and the complete procedure is carried out in a single facility. USP's emphasis on R&D analytical solutions and PCM-specific quality assessments is part of a broader set of activities aimed at addressing the problems of PCM adoption and bolstering pharmaceuticals' supply chain resilience. Consulting services provided by a USP company, Pharmatech Associates, Inc., can assist manufacturers with decision-making and problems associated with PCM adoption. Pharmatech Associates consulting services, which operate independently of USP's standards-setting processes, provide manufacturers interested in PCM and other advanced manufacturing technologies with technical, business, and regulatory strategies, workforce training, and equipment and process design. About The U.S. Pharmacopeia (USP) USP is a non-profit, independent scientific organization that provides safe, high-quality pharmaceuticals. The organization has strived to establish confidence in the world's drugs, dietary supplements, and foods for more than two centuries. It protects patient safety and enhances global health via rigorous science and the establishment of public quality standards.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

PCI Pharma Services Expands Biologics Leadership with new Center of Excellence Facility in the Midwest

PCI Pharma Services | March 20, 2023

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), announced plans for a new 200,000-square-foot facility in Rockford, Illinois to enhance the organization’s capacity in injectable drug-device combination product assembly of both biologics and small molecules. Building on PCI’s leadership in this space with its Philadelphia Biotech Center of Excellence, the new facility is the second expansion building off the success in Philadelphia and will house over 20 dedicated customer suites with multiformat machines for the assembly and packaging of vials, pre-filled syringes, auto-injectors, and pen-cartridge combinations. This machinery can be used for the glucagon-like peptide 1 agonists (GLP-1) class of drugs prescribed to treat diabetes and obesity, as well as those needed for oncology treatment and autoimmune diseases. PCI’s Rockford location will have extensive product testing capability, state-of-the art top-load cartoning technology, and industry leading injector and pen assembly equipment. Additional capabilities include on-site cold storage, high-speed vial labeling, assembly, and packaging of multiformat autoinjectors, serialization, testing, and drug product release. “We see the tremendous impact that we can make with patients with this investment,” said Salim Haffar, CEO of PCI Pharma Services. “The need for injectable drug-delivery device combination product capacity and expertise is critical, and we are responding with a world-class facility to address the future demands of our global clients so they can focus on developing therapies to improve the lives of patients with serious chronic conditions.” The $50 million investment in Rockford will amplify PCI’s specialty drug leadership presence in the Midwest, adding to clinical and commercial sterile fill-finish capabilities in Madison, Wisconsin. The new facility will provide a second hub within the U.S., expanding from PCI’s foundation in the Northeast, with Bedford, New Hampshire’s campus growth in aseptic processing. PCI also has sterile fill-finish capabilities at its Leon, Spain; San Diego, California; and Melbourne, Australia locations. The expansion in Rockford is expected to bring 250 jobs to the region in the next two years, with continued growth over three to five years. The site is expected to be fully operational in summer 2024. “With this new facility, we will be able to serve all clients focused on injectable drug products including biologics with the equipment and capacity to make life-changing medicines,” said Gil Valadez, Senior Vice President, Commercial Packaging Technology, PCI Pharma Services. “We want to help our clients by managing the technical aspects of drug manufacturing, engineering, and delivery, so they can focus on what’s most important: delivering quality products to meet patient needs. That's what PCI is ultimately all about.” About the Rockford, IL Facility Rockford is the largest of PCI’s 30 locations across the U.S., European, and Asia Pacific regions, providing industry-leading services for the clinical and commercial packaging of a diverse portfolio of products and specialized delivery forms destined to reach more than 100 countries across the world. The gated secured facility is classified by the Drug Enforcement Administration (DEA) as Schedule 3. It features temperature and humidity control, an approved Foreign Trade Zone (FTZ) and offers TF1 and Uhlmann blistering, vibratory and slat filler bottling, powder filling, cartoning, carding, kitting and serialization capabilities. Warehouse storage includes freezer storage -15°C to -30°C and cold storage 2°C to 8°C. 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 (Australia, Canada, U.S., Ireland, Wales, Germany and Spain) and over 5,000 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.

Read More