writersrinivasan

writersrinivasan

By SRINIVASAN RAMANUJAMBusinessEntrepreneurship
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  • The Role of Predictive Analytics Software in Drug Development

    The Role of Predictive Analytics Software in Drug Development


    The pharmaceutical industry brings us several benefits, including new drugs, so we can lead healthier and better lives, but the industry is not without its fair share of problems. Duplicating workflow, multiple data sources, and the risk associated with new drug discovery are just some of the problems the industry has to overcome in the discovery of new drugs. Fortunately, there is a solution thanks to predictive analytics software.

    The current challenges in developing new drugs

    To appreciate what predictive analytics software brings to the table, we need to take a look at some of the challenges the industry faces. Developing new drugs is not an easy process. Medical researchers have to overcome a slew of problems to make a new drug. Some of these problems include the risk associated with drug discovery, communicating with other departments, and replicated workflows.

    Developing new drugs comes with several risks. Some of these risks include but are not limited to, portfolio risks (does the medicine add value?), operational risks (data management), and resource risks. Pharmaceutical companies must manage all these risks while developing a new product. The challenge is further enhanced by the rise of the personalized medicine model, which more pharmaceutical companies are adopting.

    7 min
  • SAS Programming in Drug Development Process
    Statistics/ SAS programming in Drug Development

    Programmers and biostatisticians working in the clinical research industries have successfully used SAS for many years to transform data, generate safety and efficacy results, and submit data to FDA. SAS in Drug Development provides innovative capabilities to not only meet the historic needs of the industry, but to efficiently collaborate across trials, phases, therapeutic areas, departmental organizations and technologies, and ultimately get drugs, biologics and devices to market faster.

    What is a Clinical Trial?
    • An Investigation of a new pharmaceutical product or a new chemical entity in order to find out the safety and efficacy of the drug. On an average it takes 12 years for a drug to be approved for marketing. A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments.
      • Drug Approval Process: Before Conducting Clinical Trials:
      • Before the company starts its program of running clinical trials, it has to prepare an Investigational New Drug (IND) Application with the FDA. The IND application must contain information in three broad areas:
        • Manufacturing Information This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
        Animal Pharmacology and Toxicology Studies – Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans.
        Clinical Protocols and Investigator Information – Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks.
      • Pre-IND Meeting: Pharmaceutical Company meets with the FDA prior to submitting an IND.  At least 30 days prior to scheduled meeting, the IND applicant submits to FDA a meeting package consisting of
        • background information
        list of questions grouped by type (Product, Preclinical, Clinical and Regulatory)
        11 min

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