You all know what buzzwords are. As a scientist, you're almost certainly familiar with dozens of technical and nontechnical buzzwords and acronyms that you use on a daily basis in you own particular niche. But imagine for a moment that you work in a biotech company, where hundreds of such niches come together in multidisciplinary teams. Can you picture the strain on communication that all of these buzzwords, combined, might cause? The situation is complicated by the fact that many of the biotechnology job categories generate their own jargon that has nothing to do with the language that each person brings from academia.
Here's an example. Two scientist types are walking down the hallway, towards the break room. ... Do you have any idea what they're talking about?
"Phil, how did those IQs go on that new bioreactor? John told me that the DCS has to go through final tweaking before they can do the PQs. To make it worse, the FDA is in here this week, and our department is still trying to recover from the last two 483's--I'm on my way to sort through the resulting stack of batch records right now. I don't know when I'll manage to get to that work on the CMC section for the new BLA. ..."
In this month's column, I will share with you some of the biotech buzzwords that you're bound to run into if you are actively interviewing in the industry. You'll find that I have divided them into categories based on job type, but in reality most will be used across many different job types and in many settings. In fact, most of these buzzwords have moved into common biotech parlance. Doubtless, they'll be showing up soon in Webster's and the Oxford English Dictionary.
Top Tier The largest biotech companies.
Pre-Emerging Biotechs New, recently funded ventures. These are companies that, for the most part, are not on job seekers' radar screens.
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.
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.
IP Intellectual Property. A company's patent portfolio, one indicator of its value.
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.
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.
PTO Patent and Trademark Office. Often referred to as USPTO.
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.)
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.
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.
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.
PTC Points to Consider. The FDA's governing rules for investigational new drug submissions.
IND Investigational New Drug. An application to the FDA to license a potential product for clinical trials.
CTX Clinical Trial Exemption. This is the U.K. version of the IND.
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.
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.
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.
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.
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.
Quality and Operations
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.).
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.
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.
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.
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.
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.
483 A negative report from the FDA after an audit. Something was amiss that needs to be taken care of immediately.
After reviewing this list, does it seem a bit intimidating? This is one reason why many job ads from companies state: "prior industry experience is preferred." A great deal of the "prior experience" that they're looking for has to do with the candidates' exposure to the culture and language of biotechnology firms.
And I'm sure you noticed that the Regulatory/Clinical Affairs areas are particularly full of jargon and acronyms--even more than most disciplines. As you reviewed these, you may have guessed that there must be terrific career opportunities for people who can write well and who can stay on top of the tremendous amount of paperwork and applications that are required in a regulated industry. If so, you'd be quite right--see Next Wave's recent feature on Clinical Writing for more details.
But for now, you'll have to excuse me ... I'm on my way to a TI (telephone interview) with someone who looks to me like a possible MPC (most placeable candidate). (See: biotechies are not the only ones with buzzwords! We recruiters have some of our own, too!)