The Experts below are selected from a list of 2544 Experts worldwide ranked by ideXlab platform

A. Ayers - One of the best experts on this subject based on the ideXlab platform.

  • Personalized Medicine – Future Impact, Pharma Industry Perspective
    Journal of biomolecular techniques, 2010
    Co-Authors: A. Ayers
    Abstract:

    s2-1 Scientific understanding of the genetic aberrations driving disease is advancing at a rapid pace, heralding the advent of the long awaited era of personalized medicine. For patients, personalized medicine promises the opportunity to benefit from the most effective treatment that targets the fundamental driver of their disease, while also potentially avoiding toxicity. For payers, personalized medicine is attractive as a mechanism to control usage of expensive drugs, and avoid wasteful expenditure on treatments that are ineffective. For the Pharmaceutical Industry personalized medicine presents both challenges and opportunities. Many Pharmaceutical companies have committed to the vision of ‘right drug, right patient, right time‘, particularly in therapeutic areas such as oncology and neuroscience. Pharma recognizes that this strategy provides the opportunity to achieve substantial clinical advances in specific patient populations, compared with currently available “non-specific” medications which is expected to create a compelling value proposition and to facilitate reimbursement by payers. Drug development timelines could be accelerated, and success rates improved by conducting trials in molecularly selected patient populations that result in more rapid proof of concept and more robust clinical outcomes, allowing smaller Phase 3 trials. However, there are also significant challenges. Most importantly, the drug developer must be able to achieve the requisite return on investment despite the restricted market size. In addition, drug development costs may be increased due to the complexities of biomarker analysis and diagnostic development. Molecular profiling is an emerging science, and several large and expensive drug development programs have faltered due to the selection of the wrong biomarker to guide patient selection. Trials involving biomarkers are attracting high interest from researchers, but require new competencies in trial design, data analysis and investigator expertise in sample collection and management. Greater statistical and computing power is necessary to mine data for complicated relationships between genetic, biological and environmental factors. Additionally, if the right biomarker was not identified prospectively, there is currently no regulatory pathway for approval via a retrospective analysis. Regulatory approval pathways for therapeutics and their companion diagnostics are not well established. In the US, the diagnostic and therapeutic are reviewed by different agencies, and the requirements of each are not completely aligned, creating additional complexity. Global regulatory processes for companion diagnostics are even more diverse and challenging. Additionally, the companion diagnostic needs to be available for validation during the clinical development phase, but with the risks inherent in drug development, and limited reimbursement, diagnostic manufacturers have little incentive to develop such tests “at risk”. Despite the challenges, personalized medicine is widely believed to offer the best prospect of effective treatment and cure for patients with serious diseases. The relevant stakeholders – Pharma and biotech, diagnostic companies, regulatory agencies, payers and policy makers, must be committed to working together to provide incentives and remove obstacles so that this goal can become a reality.

  • personalized medicine future impact Pharma Industry perspective
    Journal of biomolecular techniques, 2010
    Co-Authors: A. Ayers
    Abstract:

    s2-1 Scientific understanding of the genetic aberrations driving disease is advancing at a rapid pace, heralding the advent of the long awaited era of personalized medicine. For patients, personalized medicine promises the opportunity to benefit from the most effective treatment that targets the fundamental driver of their disease, while also potentially avoiding toxicity. For payers, personalized medicine is attractive as a mechanism to control usage of expensive drugs, and avoid wasteful expenditure on treatments that are ineffective. For the Pharmaceutical Industry personalized medicine presents both challenges and opportunities. Many Pharmaceutical companies have committed to the vision of ‘right drug, right patient, right time‘, particularly in therapeutic areas such as oncology and neuroscience. Pharma recognizes that this strategy provides the opportunity to achieve substantial clinical advances in specific patient populations, compared with currently available “non-specific” medications which is expected to create a compelling value proposition and to facilitate reimbursement by payers. Drug development timelines could be accelerated, and success rates improved by conducting trials in molecularly selected patient populations that result in more rapid proof of concept and more robust clinical outcomes, allowing smaller Phase 3 trials. However, there are also significant challenges. Most importantly, the drug developer must be able to achieve the requisite return on investment despite the restricted market size. In addition, drug development costs may be increased due to the complexities of biomarker analysis and diagnostic development. Molecular profiling is an emerging science, and several large and expensive drug development programs have faltered due to the selection of the wrong biomarker to guide patient selection. Trials involving biomarkers are attracting high interest from researchers, but require new competencies in trial design, data analysis and investigator expertise in sample collection and management. Greater statistical and computing power is necessary to mine data for complicated relationships between genetic, biological and environmental factors. Additionally, if the right biomarker was not identified prospectively, there is currently no regulatory pathway for approval via a retrospective analysis. Regulatory approval pathways for therapeutics and their companion diagnostics are not well established. In the US, the diagnostic and therapeutic are reviewed by different agencies, and the requirements of each are not completely aligned, creating additional complexity. Global regulatory processes for companion diagnostics are even more diverse and challenging. Additionally, the companion diagnostic needs to be available for validation during the clinical development phase, but with the risks inherent in drug development, and limited reimbursement, diagnostic manufacturers have little incentive to develop such tests “at risk”. Despite the challenges, personalized medicine is widely believed to offer the best prospect of effective treatment and cure for patients with serious diseases. The relevant stakeholders – Pharma and biotech, diagnostic companies, regulatory agencies, payers and policy makers, must be committed to working together to provide incentives and remove obstacles so that this goal can become a reality.

Luca Velardita - One of the best experts on this subject based on the ideXlab platform.

  • A decentralized application for the traceability process in the Pharma Industry
    Procedia Manufacturing, 2020
    Co-Authors: Ferdinando Chiacchio, Lucio Compagno, Diego D'urso, Luca Velardita, Philipp G. Sandner
    Abstract:

    Abstract With the growth of a global market, new regulations aiming at preventing the fraud of counterfeiting drugs have been released all over the world. In the Pharma Industry, an innovative technology named serialization is becoming more and more popular as it allows to implement a packaging process based on a hierarchical aggregation. This guarantees that each box entering in the distribution network is marked with a unique identifier for an easy traceability by a central regulatory in charge to follow the life cycle of the product until given to the final patient. In this scenario, the blockchain might offer a breakthrough proposing a decentralized and immutable traceability mechanism able to increase the security of the data and to reduce the success of a fraud attempt. To demonstrate the effectiveness of this technology, in this paper, a DAPP based on the Ethereum blockchain has been coded and tested as prototype in a Pharma Industry.

  • Towards a Blockchain Based Traceability Process: A Case Study from Pharma Industry
    2019
    Co-Authors: Ferdinando Chiacchio, Lucio Compagno, Diego D’urso, Marcello Chiarenza, Luca Velardita
    Abstract:

    The technological boost brought by the world-wide program Industry 4.0 is leading the modernization of enterprises with solutions able to improve the automation of the factory. The Pharmaceutical Industry and the actors of the whole supply chain, adhering to strict regulations for ensuring the compliance to quality and safety standards, represents one of the most important stakeholders of the Industry 4.0 benefits.In this paper, the serialization regulation and the technological solution adopted by an Italian Pharmaceutical Industry for the packaging lines of the factory is presented. As it will be shown, the conception of a traceability solution based on the blockchain technology is under investigation.

  • towards a blockchain based traceability process a case study from Pharma Industry
    International Conference on Advances in Production Management Systems, 2019
    Co-Authors: Ferdinando Chiacchio, Lucio Compagno, Marcello Chiarenza, Diego Durso, Luca Velardita
    Abstract:

    The technological boost brought by the world-wide program Industry 4.0 is leading the modernization of enterprises with solutions able to improve the automation of the factory. The Pharmaceutical Industry and the actors of the whole supply chain, adhering to strict regulations for ensuring the compliance to quality and safety standards, represents one of the most important stakeholders of the Industry 4.0 benefits.

Anna Fenton - One of the best experts on this subject based on the ideXlab platform.

Ferdinando Chiacchio - One of the best experts on this subject based on the ideXlab platform.

  • A decentralized application for the traceability process in the Pharma Industry
    Procedia Manufacturing, 2020
    Co-Authors: Ferdinando Chiacchio, Lucio Compagno, Diego D'urso, Luca Velardita, Philipp G. Sandner
    Abstract:

    Abstract With the growth of a global market, new regulations aiming at preventing the fraud of counterfeiting drugs have been released all over the world. In the Pharma Industry, an innovative technology named serialization is becoming more and more popular as it allows to implement a packaging process based on a hierarchical aggregation. This guarantees that each box entering in the distribution network is marked with a unique identifier for an easy traceability by a central regulatory in charge to follow the life cycle of the product until given to the final patient. In this scenario, the blockchain might offer a breakthrough proposing a decentralized and immutable traceability mechanism able to increase the security of the data and to reduce the success of a fraud attempt. To demonstrate the effectiveness of this technology, in this paper, a DAPP based on the Ethereum blockchain has been coded and tested as prototype in a Pharma Industry.

  • Towards a Blockchain Based Traceability Process: A Case Study from Pharma Industry
    2019
    Co-Authors: Ferdinando Chiacchio, Lucio Compagno, Diego D’urso, Marcello Chiarenza, Luca Velardita
    Abstract:

    The technological boost brought by the world-wide program Industry 4.0 is leading the modernization of enterprises with solutions able to improve the automation of the factory. The Pharmaceutical Industry and the actors of the whole supply chain, adhering to strict regulations for ensuring the compliance to quality and safety standards, represents one of the most important stakeholders of the Industry 4.0 benefits.In this paper, the serialization regulation and the technological solution adopted by an Italian Pharmaceutical Industry for the packaging lines of the factory is presented. As it will be shown, the conception of a traceability solution based on the blockchain technology is under investigation.

  • towards a blockchain based traceability process a case study from Pharma Industry
    International Conference on Advances in Production Management Systems, 2019
    Co-Authors: Ferdinando Chiacchio, Lucio Compagno, Marcello Chiarenza, Diego Durso, Luca Velardita
    Abstract:

    The technological boost brought by the world-wide program Industry 4.0 is leading the modernization of enterprises with solutions able to improve the automation of the factory. The Pharmaceutical Industry and the actors of the whole supply chain, adhering to strict regulations for ensuring the compliance to quality and safety standards, represents one of the most important stakeholders of the Industry 4.0 benefits.

E. Gunasundari - One of the best experts on this subject based on the ideXlab platform.

  • Best Practices in the Pharmaceutical Supply Chain Management
    Global Supply Chains in the Pharmaceutical Industry, 2019
    Co-Authors: E. Gunasundari
    Abstract:

    The Pharmaceutical Industry is under severe pressure due to complex supply chains that are underutilized, inefficient, and ill-equipped to cope with the sort of products. The Pharma supply chain must meet the demands of a fast-evolving marketplace and the shift from patient to an outcome to undergo a radical overhaul. Research and development (R&D) costs in the Pharma Industry are spiraling, development timelines are growing, and consumers are becoming increasingly knowledgeable about care options including drugs and treatment. The marketplace is fixed through the development cycle and increasing efficiency through rationalization or outsourcing of non-core activities. Recently, the Pharma Industry moved from the “one-size-fits-all” approach for the supply chain flexibility, responsiveness, and reliability. This chapter enables readers to understand the techniques for rapid commission and decommission new products and markets and alternate supply models, inventory tracking tools to eliminate counterfeiting and parallel-importing risks.