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...

      Dirk van Peteghem, UPS Vice President of Global Healthcare Strategy

      UPS recently improved its offering to the pharmaceutical industry with the acquisition of Marken. Could you start with a brief introduction to UPS and the significance of the Marken acquisition? Healthcare logistics is a strategic priority within our company, and we are proud to provide best-in-class supply chain solutions and compliance expertise to pharmaceutical, biopharma and medical device companies. We have 60+ healthcare-dedicated facilities representing 7 million square feet of cGMP- or cGDP-compliant healthcare distribution space, and maintain the world’s largest network of field ...

      Scott Cubbler, COO Life Sciences & Healthcare, Global, DHL Supply Chain

      DHL Supply Chain explains how the company keeps pace with changes such as recent demand for more biosimilars and personalized drugs. How far has the company progressed along its 2020 strategy as outlined in 2015? Our Strategy 2020 remains our complete focus and has been since 2015. We have been working towards increasing our ability to react and respond, especially in healthcare logistics. Within life sciences we have nine key initiatives in support of Strategy 2020, of which the most important is to be number one in quality and compliance. Ultimately, our goal is to have a positive impact o...

      Logistics and Distribution: From Factory to Patient

      Consolidation and the requirements of new and personalized drugs are changing the playing field. Catherine Howe IMAGE: PCI Pharma Services Although drug manufacturers have historically been disinclined to outsource logistics to third-party logistics (3PL) providers, the drive towards cost efficiency has made the option more appealing. The logistics space has become highly consolidated, with key players such as DHL and UPS continuing to make acquisitions. For example, UPS’ acquisition of Marken at the end of 2016 greatly extended capabilities into clinical trial services and biological sa...

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