What is Drug Discovery?
Drug discovery refers to the process of finding and optimizing specific molecules for testing in humans. It precedes human testing via the drug development process. Discovery can be broken up into several steps including target identification and validation, hit generation, and lead generation and optimization.
Target identification is the process by which a target is identified for a potential drug to work on. There are many steps that can be taken to further validate this target as something that will modify the disease or symptoms- these tests are part of the target validation process.
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What are the phases of drug development?
Drug development refers to the phases when a drug gets studied in humans via clinical trails. Typically (but not always) there are 3 phases to drug development before an investigational agent can be considered for regulatory approval, with each phase including a larger number of patients in clinical trials.
Phase I trials are used to get a preliminary assessment of a drug’s safety as well as identification of a dose that is safe.
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What is a Contract Research Organization?
A contract research organization (CRO) is a firm that provides services to pharmaceutical companies around the conduct of various research activities including activities in discovery, preclinical, clinical development, or any other research activity including real world evidence generation. CROs have grown in use in recent years as pharma and biotech companies try to remain lean in terms of internal organizations.
Pharma companies contract with CROs to execute on specific studies and they own the overall direction of the study and what should be done including in the execution phase around specific decisions that need to be made.
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What is a drug product pipeline?
The pipeline refers to potential drugs or vaccines in development but not yet approved for a given company. It may consist of new agents that are not on market or agents already on market but being studied for new indications.
A company’s drug pipeline is often summarized by organizing investigational agents by where they are in the drug development cycle - specifically whether they are in discovery, pre-clinical testing, phase I, phase II, or phase III.
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What is Pharmacovigilance?
Pharmacovigilance (also called drug safety) is responsible for monitoring data for adverse events associated with drug therapy. The group collects, organizes, and analyzes a constant in-flow of data to look for potential adverse drug reactions and works with regulatory colleagues to report them to regulatory agencies as required.
Adverse event reports can come in through many different mechanisms including direct patient reports through avenues like medical information, reports from physicians on visits by field personnel, and large datasets that the company may license.
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What is Clinical Development?
Clinical Development teams lead the design and execution of clinical trials. They oversee cross-functional workstreams consisting of several potential areas including biostatistics, regulatory (if the trial is for approval or label enhancement), medical, clinical documentation/medical writing, and pharmacokinetics. Clinical Development is ultimately responsible for the details of a clinical trial including creation and finalization of the final study protocol. They also oversee any amendments to the protocol if needed.
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What is Clinical Trial Transparency?
Clinical Trial Transparency is function which is responsible for the accurate and compliant reporting of clinical trial data to required databases. In the United States, this includes appropriate updates to Clinicaltrials.gov per US law. For the European Union, this may include EudraCT. Professionals in this area are also responsible for responding to any inquiries or requests from government clinical trial registry organizations. They work with professionals in the clinical development organization to ensure that reporting is timely and accurate.
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What is life cycle management?
Life cycle management (LCM) is the process of planning for and managing the strategy around a drug’s place in the market from prior to regulatory approval through expiration of the patent or loss of exclusivity. LCM can include planning for follow-on studies after initial approval and potential label extensions.
Pricing can also be an important part of the LCM process as price hikes are typically lower in the earlier years of a drug’s life while focus is likely more on growth of the market and uptake, whereas when the drug nears generic or biosimilar competition, price hikes may be more common.
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