Careers in the Pharmaceutical Sciences
Roshan Tolani asked:
The pharmaceutical sciences have saved millions of lives and improved quality of life by playing an important role in the discovery and development of new drugs and drug therapies. As science and medicine evolve and discoveries are made at an astonishing rate, the pharmaceutical industry continues to generate billions of dollars and employ top researchers and professionals.
With accelerating advances in science and technology, the pharmaceutical industry has entered its most promising period yet for new drug development. Pharmaceutical companies are using new knowledge and techniques to attack the root causes—rather than just the symptoms—of diseases and thus are revolutionizing the ways in which new drugs are discovered and developed.
The Disciplines of the Pharmaceutical Sciences
The pharmaceutical sciences can be broadly categorized according to the following disciplines:
* Drug discovery: This discipline deals with the design and synthesis of new drug molecules and includes medicinal chemistry, combinatorial chemistry, and biotechnology.
* Drug delivery: This discipline deals with designing the forms of drug dosages and their delivery to patients. Those involved in drug delivery work to determine the best concentrations of and schedules for drugs. Sciences related to this field include pharmaceutics, biomaterials, and pharmacokinetics.
* Drug action: This discipline examines the actions of drugs in living systems. Sciences dealing with drug action include molecular biology, pharmacology, pharmacodynamics, toxicology, and biochemistry.
* Clinical sciences: This discipline deals with the use of drugs to treat diseases. Drugs’ properties, such as efficacy, adverse effects, drug-to-drug interactions, and bioavailability, are tested in clinical trials.
* Drug analysis: This discipline deals with the separation, identification, and quantification of components of drugs.
* Cost effectiveness: This discipline deals with the economics of drug usage.
* Regulatory affairs: This discipline deals with the coordination of academia, industry, and regulatory bodies.
Careers in the Pharmaceutical Industry
The research-based pharmaceutical industry is one of the strongest components of the American economy and leads the world in discovering and developing innovative new life-saving medicines.
Almost half of the most important global drugs developed between 1975 and 1994 originated in the U.S. U.S. companies developed 370 new medicines to fight dreaded diseases during this period. In 2000, the market value of the industry was greater than $379 million. The field offers a myriad of opportunities to pharmaceutical scientists.
Pharmaceutical companies employ several hundred thousand professionals in a variety of jobs in the U.S. In view of the demand for well-trained professionals, the earning potential of pharmacists is very high. According to an American Pharmaceutical Association report, pharmacists’ salaries range from around $40,000 to $70,000.
Is a Career in Pharmaceutical Sciences Right for Me?
The pharmaceutical field is a good choice for those who:
* want to work in laboratories
* desire to contribute to the health and well-being of society
* love science and excel in the subject
* enjoy professional challenges
* enjoy finding solutions to medical problems baffling scientific communities
How Can I Become a Pharmaceutical Scientist?
Get an undergraduate or advanced college degree in pharmacy, chemistry, biology, medicine, or a related field. There are many who became pharmaceutical scientists after obtaining degrees in economics, marketing, business, or other non-scientific subjects. To work as a registered pharmacist, one needs to satisfy both national and state licensing requirements. Some states require fulfillment of a certain number of continuing education credits annually to stay abreast of developments in the field.
The pharmaceutical sciences have saved millions of lives and improved quality of life by playing an important role in the discovery and development of new drugs and drug therapies. As science and medicine evolve and discoveries are made at an astonishing rate, the pharmaceutical industry continues to generate billions of dollars and employ top researchers and professionals.
With accelerating advances in science and technology, the pharmaceutical industry has entered its most promising period yet for new drug development. Pharmaceutical companies are using new knowledge and techniques to attack the root causes—rather than just the symptoms—of diseases and thus are revolutionizing the ways in which new drugs are discovered and developed.
The Disciplines of the Pharmaceutical Sciences
The pharmaceutical sciences can be broadly categorized according to the following disciplines:
* Drug discovery: This discipline deals with the design and synthesis of new drug molecules and includes medicinal chemistry, combinatorial chemistry, and biotechnology.
* Drug delivery: This discipline deals with designing the forms of drug dosages and their delivery to patients. Those involved in drug delivery work to determine the best concentrations of and schedules for drugs. Sciences related to this field include pharmaceutics, biomaterials, and pharmacokinetics.
* Drug action: This discipline examines the actions of drugs in living systems. Sciences dealing with drug action include molecular biology, pharmacology, pharmacodynamics, toxicology, and biochemistry.
* Clinical sciences: This discipline deals with the use of drugs to treat diseases. Drugs’ properties, such as efficacy, adverse effects, drug-to-drug interactions, and bioavailability, are tested in clinical trials.
* Drug analysis: This discipline deals with the separation, identification, and quantification of components of drugs.
* Cost effectiveness: This discipline deals with the economics of drug usage.
* Regulatory affairs: This discipline deals with the coordination of academia, industry, and regulatory bodies.
Careers in the Pharmaceutical Industry
The research-based pharmaceutical industry is one of the strongest components of the American economy and leads the world in discovering and developing innovative new life-saving medicines.
Almost half of the most important global drugs developed between 1975 and 1994 originated in the U.S. U.S. companies developed 370 new medicines to fight dreaded diseases during this period. In 2000, the market value of the industry was greater than $379 million. The field offers a myriad of opportunities to pharmaceutical scientists.
Pharmaceutical companies employ several hundred thousand professionals in a variety of jobs in the U.S. In view of the demand for well-trained professionals, the earning potential of pharmacists is very high. According to an American Pharmaceutical Association report, pharmacists’ salaries range from around $40,000 to $70,000.
Is a Career in Pharmaceutical Sciences Right for Me?
The pharmaceutical field is a good choice for those who:
* want to work in laboratories
* desire to contribute to the health and well-being of society
* love science and excel in the subject
* enjoy professional challenges
* enjoy finding solutions to medical problems baffling scientific communities
How Can I Become a Pharmaceutical Scientist?
Get an undergraduate or advanced college degree in pharmacy, chemistry, biology, medicine, or a related field. There are many who became pharmaceutical scientists after obtaining degrees in economics, marketing, business, or other non-scientific subjects. To work as a registered pharmacist, one needs to satisfy both national and state licensing requirements. Some states require fulfillment of a certain number of continuing education credits annually to stay abreast of developments in the field.
Life Science Companies and the Fda: How Change Control Software Transforms a Combatant Fist Fight Into a Picnic in the Park
Marci Lynn Crane asked:
When you consider the relationship a life science company shares with the FDA it’s easy to visualize the love/hate kinship of a parent and child. It’s also simple to deduce who the parent might be. After all, the FDA Mama or Papa Bear has never been shy when it comes to playing by regulatory rules.
The Goals of Life Science and the Goals of the FDA: Mutually Compatible or Mutually Exclusive?
The goals of a life science company are likely to include the development, manufacture and sales of the best and most useful biotech equipment, medical devices, drugs, etc. The goals of the FDA include safety, the transparent communication of possible dangers or uncomfortable side effects, and the viable effectiveness of products produced. Each set of goals is noble and in theory supports the goals of the other. In practice however, the goals of these separate institutions seem almost mutually exclusive.
Change Control Software: Middle Ground for Two Separate Powers
Like most solutions to apparently irreparable problems, the solution that allows both life science companies and the FDA to find a cheerful middle ground is the solution that benefits both organizations. This solution includes the implementation and use of change control software. Change control software is valuable for the simple reason that it allows life science companies to artfully manage (without spending ridiculous man-hours) those changes that occur at any stage of a product’s development or manufacturing processes. Documentation, routing, tasks and employee accountability are also concerted via a solid change control software solution.
The benefits of a change control software solution are many but to truly understand these benefits it’s beneficial to first understand the problems that often maintain many life science professionals in a state of “regulated” frustration.
The Problems
Among the problems that lie within the walls of many life science companies is the problem of change management processes that are controlled 1) manually or 2) with a hybrid/decentralized solution. Most companies simply want to save their hard earned ROI, but when considered carefully it’s easy to see that manual and/or hybrid solutions won’t save companies money in the long run, and in addition, present a variety of problems that might have managed to stump even Solomon the wise.
Manual and Hybrid Solutions: Problems that Contribute to Greater Problems
Listed below are some of the problems that life science companies can avoid with a digitized and centralized change control software solution.
High Costs—Life science professionals may think they save money with a paper-based system but in all reality they spend a great deal to pay for the tedious man-hours spent on the manual routing of documents, the document approval process and on manual search and document retrieval (if the document can actually be found). A change control software solution however manages to automatically route documents, seek the appropriate approvals/electronic signatures, search for documents and retrieve them.
Validation Procedures—The FDA requires that processes (this includes change processes) be validated. If a life science company has to validate their processes manually it can be a far greater challenge than some companies care to undertake. Electronic validation presents a far more effective alternative that saves time, money, and effort. In the long run, manual validation can also cost more than a centralized solution. When searching for change control software, ask the software sellers if automated validation services are available.
No Centralized Location—A paper-based system doesn’t allow life science professionals to maintain, protect and organize documents in one digitized and centralized location. A commendable change control software solution digitizes and centralizes information so that life science associates can find the organized information they need—when they need it. A good change control software solution will also manage almost any type of file required throughout any of the GxP processes.
Document Revision Processes—When change inevitably occurs the manual document revision process can be faulty in the extreme. Life science employees will unfortunately be subjected to manual searches for documents, and will be required to manually make changes on documents or SOPs. A good change control software solution however can provide revision control that is automatic and centralized so that once submitted, documents can be routed and approved quickly and effectually. Change tracking will also be automatic.
Also, when searching for the change control solution that will fit the needs of a life science company, professionals should look for a solution that is 1) customizable to their needs and that 2) require form explanations for changes that are being made. Accountability, after all should be an important aspect of change control.
A Picnic in the Park
Change control can take life science professionals one step further to a change management process that could potentially be compared to a picnic in the park.
When you consider the relationship a life science company shares with the FDA it’s easy to visualize the love/hate kinship of a parent and child. It’s also simple to deduce who the parent might be. After all, the FDA Mama or Papa Bear has never been shy when it comes to playing by regulatory rules.
The Goals of Life Science and the Goals of the FDA: Mutually Compatible or Mutually Exclusive?
The goals of a life science company are likely to include the development, manufacture and sales of the best and most useful biotech equipment, medical devices, drugs, etc. The goals of the FDA include safety, the transparent communication of possible dangers or uncomfortable side effects, and the viable effectiveness of products produced. Each set of goals is noble and in theory supports the goals of the other. In practice however, the goals of these separate institutions seem almost mutually exclusive.
Change Control Software: Middle Ground for Two Separate Powers
Like most solutions to apparently irreparable problems, the solution that allows both life science companies and the FDA to find a cheerful middle ground is the solution that benefits both organizations. This solution includes the implementation and use of change control software. Change control software is valuable for the simple reason that it allows life science companies to artfully manage (without spending ridiculous man-hours) those changes that occur at any stage of a product’s development or manufacturing processes. Documentation, routing, tasks and employee accountability are also concerted via a solid change control software solution.
The benefits of a change control software solution are many but to truly understand these benefits it’s beneficial to first understand the problems that often maintain many life science professionals in a state of “regulated” frustration.
The Problems
Among the problems that lie within the walls of many life science companies is the problem of change management processes that are controlled 1) manually or 2) with a hybrid/decentralized solution. Most companies simply want to save their hard earned ROI, but when considered carefully it’s easy to see that manual and/or hybrid solutions won’t save companies money in the long run, and in addition, present a variety of problems that might have managed to stump even Solomon the wise.
Manual and Hybrid Solutions: Problems that Contribute to Greater Problems
Listed below are some of the problems that life science companies can avoid with a digitized and centralized change control software solution.
High Costs—Life science professionals may think they save money with a paper-based system but in all reality they spend a great deal to pay for the tedious man-hours spent on the manual routing of documents, the document approval process and on manual search and document retrieval (if the document can actually be found). A change control software solution however manages to automatically route documents, seek the appropriate approvals/electronic signatures, search for documents and retrieve them.
Validation Procedures—The FDA requires that processes (this includes change processes) be validated. If a life science company has to validate their processes manually it can be a far greater challenge than some companies care to undertake. Electronic validation presents a far more effective alternative that saves time, money, and effort. In the long run, manual validation can also cost more than a centralized solution. When searching for change control software, ask the software sellers if automated validation services are available.
No Centralized Location—A paper-based system doesn’t allow life science professionals to maintain, protect and organize documents in one digitized and centralized location. A commendable change control software solution digitizes and centralizes information so that life science associates can find the organized information they need—when they need it. A good change control software solution will also manage almost any type of file required throughout any of the GxP processes.
Document Revision Processes—When change inevitably occurs the manual document revision process can be faulty in the extreme. Life science employees will unfortunately be subjected to manual searches for documents, and will be required to manually make changes on documents or SOPs. A good change control software solution however can provide revision control that is automatic and centralized so that once submitted, documents can be routed and approved quickly and effectually. Change tracking will also be automatic.
Also, when searching for the change control solution that will fit the needs of a life science company, professionals should look for a solution that is 1) customizable to their needs and that 2) require form explanations for changes that are being made. Accountability, after all should be an important aspect of change control.
A Picnic in the Park
Change control can take life science professionals one step further to a change management process that could potentially be compared to a picnic in the park.
