LINGO LIVE PRODUCT LEAD LICENSE

Pharmacy benefit manager (PBM): PBM clients are health plans. It can handle eligibility, enrollment, and premium payment oversight. Payers: The entity responsible for processing insurance claims. Health plans can be provided by public (Medicaid) or private (an employer) entities. Health plan: Health insurance coverage provided by an individual or group that provides or pays the cost of medical care. Specialty pharmacy can deliver ‘just in time’ products by working with treating providers to supply the appropriate drug in time for a patient visit at the location where the drug will be used. Manufacturers have been accused of using specialty pharmacies to limit access to a drug by potential generic or biosimilar competitors (limited distribution can make it difficult to obtain a drug sample if the entity is not a treating provider on a list approved by the manufacturer). Specialty drugs are typically (but not always) high cost, require special shipping and storage (freezing or cold storage), are indicated for relatively small patient populations treated by physician specialists. Their clients are drug manufacturers that want or need limited distribution of specialty drugs. Specialty pharmacy: These organizations may or may not take ownership of the drug product. Wholesalers buy very large quantities and then resell either direct to provider-purchasers (like a large health system, pharmacy or pharmacy chain), or resell to smaller, regional distributors for regional or local distribution to retail pharmacies and hospitals.

Wholesaler: In a simple distribution system, the wholesaler is the first purchaser of a drug product - direct from the manufacturer. In-line or post-market drugs: Products that are licensed and in the market. Pipeline drugs: Drugs (small or large molecule) under development by a manufacturer. They are infused or injected and are not typically self-administered. Large molecule products: These are known as ‘biologics’- and contain live active ingredients. Small molecule products: These are capsules, tablets, powders, ointments, sprays - that are generally self-administered and available at retail pharmacies with no live ingredients. Multisource drugs: Any and all the generic drugs (included the innovator) which are competing against each other. Innovator drug: The drug from which generics or biosimilars are made - the first product of its type. For instance, specialty drugs in the Medicare Part D program are only defined by cost - currently $670/month (2018) - and indexed annually. There is no single agreed-upon definition, so sometimes specialty drug will only mean high-cost. Specialty drug: A drug that is costly, requires special supply chain features (such as freezing or cold storage), typically indicated for a small group of patients, and where the patients may need special case management services. Physician-administered drugs: Any kind of drug that cannot typically be self-administered. Retail drugs: Any kind of drug typically available at a pharmacy counter. These drugs are not currently considered to be identical to the original product (because of the nature of manufacturing with live products), but are considered to be therapeutic alternatives.

LINGO LIVE PRODUCT LEAD LICENSE

Licensed under an Abbreviated New Drug Application by the FDA.īiologic: A therapeutic drug or a vaccine, made from living organisms - human, animal, yeast, or microorganisms - licensed under a Biologic License Application by the FDA.īiosimilar: Competitors to the first-in-class biologic product that has an expired patent. Generics are considered identical to the brand product. Generic drug: Competitors to a branded product that has an expired patent. It is licensed under a New Drug Application by the US Food and Drug Administration (FDA). It is protected by a patent or has an expired patent. A brand can be an innovator (first-in-class) or not. Brand product: Branded products are not generic drugs or products.

Lingo live product lead