GMO : Genetically modified organism
Big Pharma Large, traditional pharmaceutical companies.
BIO Biotechnology Industry Organization. The biotech industry's major lobbying and trade association. BIO sponsors a well-attended national meeting each year. Top tier and pre-emerging biotech companies will attend.
Co-Co Partnerships The relationship between two companies who have agreed to share, on a 50%/50% basis, the product development/marketing/sales of some product or IP.
CRADA Cooperative Research and Development Agreement. The biotechnology industry thrives on CRADAs, deals in which two companies join their resources to move a product concept or technology ahead. Often a big pharma company will partner with a pre-emerging biotech in a CRADA.
Deal Sheet An attachment to the resume or CV of a Business Development person. Describes his or her involvement in funding, in or out licensing, etc.
EPO European Patent Office. The Munich, Germany-based agency of the European Union that is responsible for common patent protection matters for all of the member countries. (By the way, according to a recent article from Next Wave Germany, the EPO is hiring big time right now.)
IP Intellectual Property. A company's patent portfolio, one indicator of its value.
PTO Patent and Trademark Office. Often referred to as USPTO.
Pre-Emerging Biotechs New, recently funded ventures. These are companies that, for the most part, are not on job seekers' radar screens.
ROFR Right of first refusal. An agreement written by business development and/or licensing staff which gives one party the right to advance their ownership of a technology, or turn it down.
Top Tier The largest biotech companies.
CRO Contract Research Organization. (Also commonly referred to as Clinical Research Organization.) A supplier firm that offers a contract service in testing, clinical trials, manufacturing, etc. There has been a tremendous growth of "outsourcing" in recent years, leading to a substantial increase in the number of CROs.
Phase 1 Clinical Trials The earliest stage of testing for a new drug entity. The investigators are primarily interested in learning about possible side effects and the dosage levels that can be used before the compound becomes toxic.
Phase 2 Clinical Trials These are small trials on people that actually are afflicted with the medical condition under investigation. The objective is to determine whether the experimental drug provides a beneficial effect. The trials are usually carried out with a treatment group who receive the drug and a matched control group who receive a placebo. Investigators typically are seeking dosage level information, administration schedules, and short-term safety data.
Phase 3 Clinical Trials These much larger trials are carefully controlled long-term studies on patients to determine whether the drug will be effective in normal medical settings. Information is also gained regarding long-term side effects and safety.
APHIS The Animal and Plant Health Inspection Service. An agency of the U.S. Department of Agriculture that is responsible for regulating field testing of genetically engineered plants and certain microorganisms.
BLA Biologic License Application. An all-encompassing application to the FDA to manufacture a new biologics product, incorporating details of the drug itself and the facility that has been established to produce the drug.
CANDA Computer-Assisted New Drug Application. An application to the FDA that seeks approval of a drug that has undergone Phase 2 and Phase 3 clinical trials. Submitted in the form of computer-readable data that provides the FDA with a sophisticated database that allows their reviewers to evaluate the clinical data themselves.
CBER Center for Biologics Evaluation and Research. One of the five divisions of the FDA (Food and Drug Administration), and the one responsible for the majority of biotechnology products.
CDER Center for Drug Evaluation and Research. The division of the FDA that is responsible for traditional small-molecule pharmaceutical products.
CMC Chemistry, Manufacturing, and Controls. A critical element of every new drug or biologics license application to the FDA. Describes the chemical composition of the product, the manufacturing process, and the tests developed to ensure its effectiveness and consistency.
CTX Clinical Trial Exemption. This is the U.K. version of the IND.
EMEA European Agency for the Evaluation of Medicinal Products. A London-based agency of the European Union that coordinates drug licensing and safety matters throughout the nations of the E.U.
GMO Genetically modified organism
ICH International Conference on Harmonization. This is a major worldwide group of regulatory agencies that formulates global standards and technical requirements for the pharmaceutical registration process.
IND Investigational New Drug. An application to the FDA to license a potential product for clinical trials.
NDA New Drug Application. The classical pharmaceutical application to the FDA for small-molecule products. The NDA is submitted after the product has proved effective and safe in clinical trials.
PTC Points to Consider. The FDA's governing rules for investigational new drug submissions.
483 A negative report from the FDA after an audit. Something was amiss that needs to be taken care of immediately
Batch Records Detailed, step-by-step sets of instructions with a "fill in the blanks" approach. These are kept on file at the company, and the FDA has the right to inspect them at any time in an audit.
DCS Distributive Control System. The computer systems that hook up a firm's process equipment, such as fermenters, bioreactors, air handling systems, pure water, etc.
GLP Good Laboratory Practices. A set of rules and regulations issued by the FDA that establishes methods for procedures and record keeping. GLPs are to be followed in laboratories involved in the testing and/or preparation of pharmaceuticals.
GMP Good Manufacturing Practices. Sometimes referred to as cGMP (current Good Manufacturing Practices). FDA-mandated general methodologies and procedures that are to be followed in the testing and manufacture of pharmaceuticals.
IQ Installation Qualification. The first step in qualifying or validating a new lab instrument or a piece of process equipment in a regulated environment. If your firm has a new fermenter, for example, this step determines whether the technical requirements necessary to run the tank are available (e.g., the proper utilities, clean water, etc.).
ISO9000 Quality assurance system developed by the International Organization for Standardization. Many companies use ISO9000 processes, or its derivatives (ISO9001, ISO9003) to ensure consistency in manufacturing processes.
OQ Operational Qualification. The next step in the equipment validation process is to plug in the equipment, hook it up, and run tests to see that each switch or user-controllable option does what it is supposed to do. To use our earlier example, fermenters have PLC (programmable logic controller) settings that require significant testing and setup.
PQ Performance Qualification. The final step to ensure that this equipment will be safe and will work properly in the regulated environment. PQs are performed with the fermenter functioning as it would be in a real situation, the objective being to ensure that it operates safely and effectively.
SOP Standard Operating Procedure. A huge number of SOPs make up a process that is used in a regulated environment and under Good Manufacturing Practices (GMP) to produce a product.
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