Valarie Higgins, President & Managing Director, Almac Clinical Technologies

Almac Clinical Technologies designs and deploys complex software that helps trial sponsors automate complex decisions that occur in clinical trials. Almac Clinical Technologies (ACT) is one of five business units within the Almac Group, an established contract development and manufacturing organization. Where does ACT fit in? Almac Clinical Technologies, headquartered in the United States, provides our biopharmaceutical partners with innovative software and professional service solutions to simplify the management of the most critical elements in clinical trial conduct. More specifically, AC...

Trial, No Error: Facilitating the Best Possible Outcome

Accurate clinical trials are more important than ever as more patient-centric medicines are developed. To ensure accuracy of trials and their regulatory acceptance companies can benefit from digitalization and Big Data. Catherine Howe IMAGE: Frontage Clinical trials are inherently high risk and any errors can result in major disruptions or completely collapse the trial. It is extremely telling that only 12% of medicines in clinical trials make it to patients and, whilst there are many reasons that a trial could be unsuccessful, there is potential to mitigate some areas of risk and error.  ...

    Josh Grauso, Sales Manager, UL Consumer & Retail Services

    UL helps companies meet safety and compliance standards and regulations across the pharma industry. UL has had a 15- year learning partnership with the U.S. FDA. How extensive is UL’s U.S. footprint? Our relationship with the FDA remains intact, with our group formally known as UL Engineering now known as UL Performance to Compliance. Our software platform is utilized by both FDA to train their own inspectors and by many types of clients in either pharmaceuticals, foods, dietary supplements or medical devices to ensure that their own internal systems and procedures are accessible at point ...

    Quality: A means for Value Creation

    Firms must shift focus from Quality for Compliance to Quality as a Culture by keeping the end patient in mind. Rashida Najmi, Global head of Quality, Regulatory, Pharmacovigilance(PV) and Patents, Piramal Healthcare IMAGE: Piramal Healthcare Pharmaceutical firms and contract manufacturers that supply into the firms are regularly challenged with balancing the need to bring cutting edge and innovative medicines quickly and cost effectively to the patients, with the need to ensure that there is no compromise on their quality and safety. In a highly regulated industry such as pharma, quality as...

      Regulating Quality

      Maintaining Safeguards Whilst Lowering Barriers to Market Entry. Catherine Howe IMAGE:Corden Pharma GmbH The FDA continues to set the gold standard globally through its task of governing the U.S. industry and its responsibility for approvals for any international company with interests in the U.S. market. Providing the benchmark for quality, its Center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs, with the aim of enabling availability of safe and effective drugs. (more…) ...

      Christian Kopfli, CEO, Chromocell

      Chromocell is using its own Chrmovert technology to provide alternative pain blockers to opioids. Chromocell is a graduate of CCIT. How has the company developed from those early stages, and what support did it receive from the state?  Kambiz Shekdar, a scientist in New York, suggested the establishment of a company around the technology now known as Chromovert. I was working as a lawyer but left the firm to start the company in 2002. Initially, we wanted to establish the company in New York, but we could not find the lab space. Shekdar found an incubator facility, the CCIT in New Jersey, w...

      Renold Capocasale, CEO, FlowMetric Inc.

      FlowMetric offers scientific analysis using Flow Cytometry to advance drug development. FlowMetric was established in 2010 and today operates primarily as a contract research organization (CRO) from its facilities in Pennsylvania and Italy. What are the circumstances surrounding the company’s establishment and how has it developed? As early as 2004, I recognized the need for a more formal approach to flow cytometry as a platform to advance biologics while working as a bench scientist for Johnson & Johnson. In 2010, I formally incorporated FlowMetric and raised about $2.5 million to sta...

      Innovation: The Industry’s Backbone

      The cost of developing new drugs and cures is enormous. A delicate balance between encouraging innovation and controlling the cost of medicines has to be maintained. Catherine Howe IMAGE: Genomind When it comes to advancing medicine, the United States takes center stage, producing more than half of the world’s new molecules in the last decade. One of the most R&D-intensive industries in the United States, the pharmaceutical sector is accountable for a huge portion of global innovation and new medicine, investing over $50 billion into R&D annually. The U.S. biopharmaceutical indust...

      United States Biopharmaceuticals 2017

      Country: United States • Industry: Pharmaceuticals • Publication: Global Business Reports • Release Date: May 2017 • Authors: Irina Negoita, Catherine Howe, Sorina Dumitru Executive Summary: A global powerhouse and forerunner on the international stage, the U.S. biopharmaceutical industry is framed by uncertainty in light of the country’s recent political transition. Nevertheless, the industry is robust and ready to adapt, already reacting to recent negative media attention relating to drug pricing and price increases. With an increasing amount of innovation stemming from small...

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