If you are a professional in Regulatory Affairs, Clinical Affairs, Quality Assurance, Quality Engineering, Medical Affairs, Drug Safety, Research and Development, Medical Writing, Marketing and Business Development or Licensing you’ve come to the right place.
We all know change is difficult when it comes to your career. Even though most people, on average, change jobs every 39 months, it is the thought of change that actually stalls or paralyzes them. You’ve heard it before, “paralysis by analysis”. Don’t let yourself fall into this trap.Discuss your options confidentially with one of our Life Sciences specialists. They know what you’re going through emotionally and professionally and can work closely with you to find your perfect opportunity.Our team of “industry insiders” know what the key motives for change are and will help you assess your true feelings for exploring change while helping you find what’s of critical importance to you in your next opportunity.We have found the following 6 issues to be behind over 90% of why people leave their current position
Lack of challenge
No career advancement (or slow career advancement)
Compensation is not commensurate with responsibilities
No sense of job security
Location (commute is brutal)
Co worker issues
If your need is immediate, we will confidentially discuss what is currently available in todays market and develop a plan of action for you.If your need is longer term, we will confidentially discuss what you would like to see in your next opportunity, keep their antenna up and contact you when we find it.Either way, if you are in any of our specialty areas, let us know about your career aspirations and how to contact you.Please submit a copy of your resume by clicking here.
Friday, July 25, 2008
Wednesday, April 9, 2008
Resume Writing Tips
Your resume writing should be succinct, clear and easy to read. No resume writing that is overly flowery, with hyperbole and superlatives that exaggerate your qualifications. Your resume writing should include lots of organization - bullets, lists and italics that make important points stand out, and plenty of white space.
Make sure that when you do your resume writing you catch all the grammatical and punctuation errors and all the typographical mistakes as well. There is nothing that will get your resume thrown on the junk pile faster than a grammar mistake or a misspelled word. No matter what experience you list or what qualifications you clarify you probably won't get the interview if your resume writing indicates you are sloppy or a poor communicator.
Your resume writing should be focused and powerful. If you don't want to state an objective (which, by the way, if stated, should be very specific) you should at least clarify a job title or industry somewhere up front. Your name and contact information should be immediately followed by "clinical professional," centered on a line by itself, for example.
While your resume writing should certainly be honest and factual you also want to stand out and put your best job search foot forward with the use of powerful words. Starting each sentence with a powerful word is one good way of making yourself unique. Some powerful words are "accomplished," "launched," "managed," "tackled," and "coordinated." See the powerful action in these? This type of resume writing makes you look proactive, strong, focused and determined.
Writing Your Qualifications
Resume writing is first and foremost about stating your qualifications and experience, of course. Here are some tips on writing this section of your resume.
You should always list the positions you held in reverse chronological order. In other words, list the most recent job first and the job you held first is last on the list when you do your resume writing. Those jobs that you held years ago and probably were more entry level than your later positions don't need much detail.
Where your resume writing should be more detailed is in the explanation of your most recent jobs and the ones whose responsibilities and achievements have the most relevance to the position for which you are now applying. Make sure the information you provide is detailed and quantifiable, not long, confusing or boring.
There is no hard and fast rule, when resume writing, about whether to begin each job with the job title or the name of the firm. Just decide on which will most impress the potential employer, and then start with that - and make it bold. Once decided, however, your resume writing must be consistent.
You should never start one job with the job title and your next position with the name of the firm. If the firm is not well known, it’s wise to parenthetically explain what the company does and is. Your dates of work should come last, and be italicized. There is never any reason, if you were employed more than a year, to include the months. All you need to state are the years of employment.
It is perfectly acceptable, when resume writing - and, in fact, is encouraged - to include volunteer work that is relevant.
If you're writing a resume for a Life Sciences position here are a few resume tips.
1) Technical Skills Come First
The first resume tip is to put your technical skills, training, education and knowledge at the top of your resume. Make sure it is detailed and organized and that your technical expertise is clear. Keep in mind that prior to finding its way to the prospective employer the resume is going to be read by a gatekeeper, and will likely be perused for important keywords. The best resume tip to get your resume in front of the employer is to make sure you include relevant keywords, such as industry or job jargon, an all operating systems and programs with which you are proficient.
2) Quantify Your Past Results
Be factual with your experience, quantifying it where you can. You could, for instance, highlight the regulatory submissions you’ve filed, the types of clinical trials you’ve managed, the products you’ve marketed, or the types of therapeutic areas you’ve researched. What was the quantifiable impact your actions had on the company? Did your actions help move a drug through a phase quicker, launch a drug or device sooner, thus saving money or making additional profits for your company? If so, state it unequivocally on your resume
3) Use Action Words
Be active rather than passive in your resume. Begin each sentence with an action, keeping it in the past tense. For example, which description do you think is better?:
I was a call Quality Engineer
Implemented effective quality systems resulting in ISO 13485 compliance
It is important to clearly describe the value you provided to the employer in the past tense and starting with an action word.
4) Give Yourself Credit
Blow your own horn. This is not the time to be shy. Treat your resume as a marketing and sales tool for yourself. Write it as if you are the product and the employer the consumer. Sell yourself. If you have a significant accomplishment that doesn't seem relevant to the job list it separately, but do list it.
5) Be As Short As Possible While Still Being Totally Clear
Keep your resume as concise as practical, without minimize the point size to make it hard to read, or eliminating needed white space. If your resume includes fewer than six years of experience you should be able to keep it to one page. Unless you are applying for a senior executive position, however, you shouldn't exceed three pages. Some of the ways to be concise is to leave out the details of projects of which you were not the key part. Articles and pronouns can be eliminated - you don't need a, an or the - and you definitely don't need I.
6) Don't Give Any More Information Than The Reader Needs
Eliminate all unimportant, or non-pertinent information, as well as those things that will give away your right to be considered without bias. You should never, for example, include your resume, your marital status, any indication of your health or age, or any associations that would make clear your religious, sexual preference or political affiliation. You don't need to tell a prospective employer, for example, that references are available, nor do you need to name supervisors at this point.
7) No Silly Mistakes
The final resume tip is to check for errors. Check yourself for grammatical and punctuation errors as well as typographical mistakes. Have someone else proofread your resume whose opinion and ability to catch errors you are confident about. This is probably the most important resume tip of all.
Make sure that when you do your resume writing you catch all the grammatical and punctuation errors and all the typographical mistakes as well. There is nothing that will get your resume thrown on the junk pile faster than a grammar mistake or a misspelled word. No matter what experience you list or what qualifications you clarify you probably won't get the interview if your resume writing indicates you are sloppy or a poor communicator.
Your resume writing should be focused and powerful. If you don't want to state an objective (which, by the way, if stated, should be very specific) you should at least clarify a job title or industry somewhere up front. Your name and contact information should be immediately followed by "clinical professional," centered on a line by itself, for example.
While your resume writing should certainly be honest and factual you also want to stand out and put your best job search foot forward with the use of powerful words. Starting each sentence with a powerful word is one good way of making yourself unique. Some powerful words are "accomplished," "launched," "managed," "tackled," and "coordinated." See the powerful action in these? This type of resume writing makes you look proactive, strong, focused and determined.
Writing Your Qualifications
Resume writing is first and foremost about stating your qualifications and experience, of course. Here are some tips on writing this section of your resume.
You should always list the positions you held in reverse chronological order. In other words, list the most recent job first and the job you held first is last on the list when you do your resume writing. Those jobs that you held years ago and probably were more entry level than your later positions don't need much detail.
Where your resume writing should be more detailed is in the explanation of your most recent jobs and the ones whose responsibilities and achievements have the most relevance to the position for which you are now applying. Make sure the information you provide is detailed and quantifiable, not long, confusing or boring.
There is no hard and fast rule, when resume writing, about whether to begin each job with the job title or the name of the firm. Just decide on which will most impress the potential employer, and then start with that - and make it bold. Once decided, however, your resume writing must be consistent.
You should never start one job with the job title and your next position with the name of the firm. If the firm is not well known, it’s wise to parenthetically explain what the company does and is. Your dates of work should come last, and be italicized. There is never any reason, if you were employed more than a year, to include the months. All you need to state are the years of employment.
It is perfectly acceptable, when resume writing - and, in fact, is encouraged - to include volunteer work that is relevant.
If you're writing a resume for a Life Sciences position here are a few resume tips.
1) Technical Skills Come First
The first resume tip is to put your technical skills, training, education and knowledge at the top of your resume. Make sure it is detailed and organized and that your technical expertise is clear. Keep in mind that prior to finding its way to the prospective employer the resume is going to be read by a gatekeeper, and will likely be perused for important keywords. The best resume tip to get your resume in front of the employer is to make sure you include relevant keywords, such as industry or job jargon, an all operating systems and programs with which you are proficient.
2) Quantify Your Past Results
Be factual with your experience, quantifying it where you can. You could, for instance, highlight the regulatory submissions you’ve filed, the types of clinical trials you’ve managed, the products you’ve marketed, or the types of therapeutic areas you’ve researched. What was the quantifiable impact your actions had on the company? Did your actions help move a drug through a phase quicker, launch a drug or device sooner, thus saving money or making additional profits for your company? If so, state it unequivocally on your resume
3) Use Action Words
Be active rather than passive in your resume. Begin each sentence with an action, keeping it in the past tense. For example, which description do you think is better?:
I was a call Quality Engineer
Implemented effective quality systems resulting in ISO 13485 compliance
It is important to clearly describe the value you provided to the employer in the past tense and starting with an action word.
4) Give Yourself Credit
Blow your own horn. This is not the time to be shy. Treat your resume as a marketing and sales tool for yourself. Write it as if you are the product and the employer the consumer. Sell yourself. If you have a significant accomplishment that doesn't seem relevant to the job list it separately, but do list it.
5) Be As Short As Possible While Still Being Totally Clear
Keep your resume as concise as practical, without minimize the point size to make it hard to read, or eliminating needed white space. If your resume includes fewer than six years of experience you should be able to keep it to one page. Unless you are applying for a senior executive position, however, you shouldn't exceed three pages. Some of the ways to be concise is to leave out the details of projects of which you were not the key part. Articles and pronouns can be eliminated - you don't need a, an or the - and you definitely don't need I.
6) Don't Give Any More Information Than The Reader Needs
Eliminate all unimportant, or non-pertinent information, as well as those things that will give away your right to be considered without bias. You should never, for example, include your resume, your marital status, any indication of your health or age, or any associations that would make clear your religious, sexual preference or political affiliation. You don't need to tell a prospective employer, for example, that references are available, nor do you need to name supervisors at this point.
7) No Silly Mistakes
The final resume tip is to check for errors. Check yourself for grammatical and punctuation errors as well as typographical mistakes. Have someone else proofread your resume whose opinion and ability to catch errors you are confident about. This is probably the most important resume tip of all.
Friday, March 21, 2008
RA Manager / Senior Regulatory Affairs Manager
Regulatory Affairs Manager / Senior Regulatory Affairs Manager
Exciting opportunity for to work with an established multinational company in their vaccines division! This is a chance to be part of having a lasting impact on humanity as this division is working on vaccines in some critical areas such as pandemic flu, seasonal flu as well as others.
They are seeking an individual who have a strong scientific and regulatory skills who have some experience with vaccines.
The responsibilities are as follows:
Develop and execute regulatory plans for complex US Vaccine projects including new product development and maintenance of licenses/authorizations for existing marketing authorizations
Provide regulatory input on nonclinical, clinical and CMC development issues
Represent or lead the RA function on assigned cross-functional project teams
Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
Establish appropriate communication within RA and other functions primarily at project level
Perform gap analysis and propose solutions
Develop and document sound regulatory decisions and justifications
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
May provide direct supervision of individuals
May review promotional material or SOP’s for compliance with local and global regulations
The idea candidate will have the following qualifications:
Strong basis of Regulatory knowledge, previous experience in vaccine development will be an advantage
Strong Scientific Knowledge
Direct Experience with FDA and other Health Authorities
Experience with BLA/NDA and supplement submissions
Ability to manage complex projects and timelines in a matrix team environment
Experience working on global project teams
Strong verbal and written communication and presentation skills
Demonstrated interpersonal skills including strong negotiation skills
Ability to independently identify compliance risks and escalate when necessary
Ability to lead and coach others
Master's degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA, including managing people or projects.
Higher degree/PhD will be an advantage
All are encouraged to apply. For additional regulatory affairs openings please visit our website www.executivesg.com
Exciting opportunity for to work with an established multinational company in their vaccines division! This is a chance to be part of having a lasting impact on humanity as this division is working on vaccines in some critical areas such as pandemic flu, seasonal flu as well as others.
They are seeking an individual who have a strong scientific and regulatory skills who have some experience with vaccines.
The responsibilities are as follows:
Develop and execute regulatory plans for complex US Vaccine projects including new product development and maintenance of licenses/authorizations for existing marketing authorizations
Provide regulatory input on nonclinical, clinical and CMC development issues
Represent or lead the RA function on assigned cross-functional project teams
Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
Establish appropriate communication within RA and other functions primarily at project level
Perform gap analysis and propose solutions
Develop and document sound regulatory decisions and justifications
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
May provide direct supervision of individuals
May review promotional material or SOP’s for compliance with local and global regulations
The idea candidate will have the following qualifications:
Strong basis of Regulatory knowledge, previous experience in vaccine development will be an advantage
Strong Scientific Knowledge
Direct Experience with FDA and other Health Authorities
Experience with BLA/NDA and supplement submissions
Ability to manage complex projects and timelines in a matrix team environment
Experience working on global project teams
Strong verbal and written communication and presentation skills
Demonstrated interpersonal skills including strong negotiation skills
Ability to independently identify compliance risks and escalate when necessary
Ability to lead and coach others
Master's degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA, including managing people or projects.
Higher degree/PhD will be an advantage
All are encouraged to apply. For additional regulatory affairs openings please visit our website www.executivesg.com
Friday, March 14, 2008
Current Openings
Several Director Regulatory Affairs Positions - in both Pharmaceuticals and Medical Device
in the following locations: Chicago, Boston, LA , North Carolina
VP Chemistry Manufacturing and Control
Start up company - Philadelphia
VP Regulatory CMC
RTP, North Carolina
VP Regulatory Affairs - Biotechnology
Los Angeles, CA
Director of Clinical and Scientific Research
Hyderabad, India
in the following locations: Chicago, Boston, LA , North Carolina
VP Chemistry Manufacturing and Control
Start up company - Philadelphia
VP Regulatory CMC
RTP, North Carolina
VP Regulatory Affairs - Biotechnology
Los Angeles, CA
Director of Clinical and Scientific Research
Hyderabad, India
Regulatory Affairs Managers & Associate Directors
Rapidly growing leader in the Medical Device Industry is looking to add talented professionals to their regulatory affairs team.
This is an exciting opporunity with temendous professional growth potential. If you are looking to advance your career in regulatory affairs and have experiance with class II medical devices, particularly if you work with any software driven / electromechanical products you will find this position very exciting.
Some of the responsibitities include:
Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations;
Ensure that regulatory submissions for class II products, strong 510K submissions understanding
Monitor applicable regulatory requirements; assure compliance with company and external standards;
Identify risk areas and develop alternative courses of action including anticipation of Regulators responses through scenario planning and development of contingency plans;
Establish a leadership position on project development teams and ensure appropriate communication within RA and across other functional areas;
Develop and document sound regulatory decisions and justifications
Review of labels, labeling and promotional material for compliance with local and global regulations.
Lead and/or participate in RA and Corporate operational efficiency initiatives.
Requirements
Job Requirements
Bachelor’s degree in engineering or scientific discipline, with a minimum of 3 years direct experience in US regulatory submissions for hardware/software medical device regulatory submissions.
Higher degree/PhD will be an advantage.
International regulatory experience/exposure preferable.
Experience in hardware/software medical device development, regulations, standards, and current industry practices.
This company is offering a highly compedative salary and benifits package. For more information about these great Regulatory Affairs Jobs please call Katie Corliss @ 207-510-6666 or visit our website at www.executivesg.com to submitt your resume for consideration.
This is an exciting opporunity with temendous professional growth potential. If you are looking to advance your career in regulatory affairs and have experiance with class II medical devices, particularly if you work with any software driven / electromechanical products you will find this position very exciting.
Some of the responsibitities include:
Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations;
Ensure that regulatory submissions for class II products, strong 510K submissions understanding
Monitor applicable regulatory requirements; assure compliance with company and external standards;
Identify risk areas and develop alternative courses of action including anticipation of Regulators responses through scenario planning and development of contingency plans;
Establish a leadership position on project development teams and ensure appropriate communication within RA and across other functional areas;
Develop and document sound regulatory decisions and justifications
Review of labels, labeling and promotional material for compliance with local and global regulations.
Lead and/or participate in RA and Corporate operational efficiency initiatives.
Requirements
Job Requirements
Bachelor’s degree in engineering or scientific discipline, with a minimum of 3 years direct experience in US regulatory submissions for hardware/software medical device regulatory submissions.
Higher degree/PhD will be an advantage.
International regulatory experience/exposure preferable.
Experience in hardware/software medical device development, regulations, standards, and current industry practices.
This company is offering a highly compedative salary and benifits package. For more information about these great Regulatory Affairs Jobs please call Katie Corliss @ 207-510-6666 or visit our website at www.executivesg.com to submitt your resume for consideration.
Thursday, February 7, 2008
Current Openings
The positions that we are working are always changing. This is not a complete list but I think a good overview.
As you know I specialize in Regulatory & Drug Safety, however my recruiters all have different specialities and we can help in almost every area.
We work both nationally as well as internationally.
RA Manager - International
NJ
AD Regulatory - Consumer Products - OTC
NJ
Sr. Supplier Quality Engineer
MA
Chief MSL
Charlotte
NC
AD Regulatory and Project Mgt
Philadelphia
PA
VP of CMC
Philadelphia
Sr. RA Liscensing Specialist
Waltham
MA
Sr. RA Specialist
Waltham
MA
Sr. RA Specialist
Waltham
MA
RA Specialist
Waltham
MA
RA Specialist
Waltham
MA
Dir. Reg Affairs - Pharma
Chicago
IL
RA Publisher
Chicago North
RA Liscensing Specialist
Waltham
MA
Medical Science Liaison
San Fransisco
CA
RA Manager
Openings in MA, NJ, IL and PA
Director Drug Safety
NJ
RA Project Manager
NJ
Dir Reg Affairs -Medical Device
IL
RA Specialist -Pharmacueticals
Openings in Submissions, Liscening and Operations
MA, IL, NJ
As you know I specialize in Regulatory & Drug Safety, however my recruiters all have different specialities and we can help in almost every area.
We work both nationally as well as internationally.
RA Manager - International
NJ
AD Regulatory - Consumer Products - OTC
NJ
Sr. Supplier Quality Engineer
MA
Chief MSL
Charlotte
NC
AD Regulatory and Project Mgt
Philadelphia
PA
VP of CMC
Philadelphia
Sr. RA Liscensing Specialist
Waltham
MA
Sr. RA Specialist
Waltham
MA
Sr. RA Specialist
Waltham
MA
RA Specialist
Waltham
MA
RA Specialist
Waltham
MA
Dir. Reg Affairs - Pharma
Chicago
IL
RA Publisher
Chicago North
RA Liscensing Specialist
Waltham
MA
Medical Science Liaison
San Fransisco
CA
RA Manager
Openings in MA, NJ, IL and PA
Director Drug Safety
NJ
RA Project Manager
NJ
Dir Reg Affairs -Medical Device
IL
RA Specialist -Pharmacueticals
Openings in Submissions, Liscening and Operations
MA, IL, NJ
Wednesday, October 3, 2007
This is a great artical on Personalized Medicine
Advancing Personalized Medicine- FDA’s Perspective and Role
Credit: FDA Consumer Health Information
e-published on MedicineandBiotech.com October 1st, 2007
Each person has a unique set of chemical blueprints that determine how his or her body looks and functions. These blueprints are contained in their own DNA which is made up of two twisting sequences or single strands that are able to be paired with another.
Here we discuss the following important topics of interest:
* What is Personalized Medicine?
* How Does Personalized Medicine Work?
* What's Involved?
* What are the Benefits of Personalized Medicine?
* What are the Challenges?
* FDA's Role
Medications have been prescribed over the years mostly by trial-and-error to reach the best dose for each patient. Typically, doctors diagnosed a condition and then selected what they believed was the most promising drug for treatment. If one didn't work, they'd try another.
Today, as science gives way to the understanding that people and diseases differ at the genetic or molecular level, doctors are learning to tailor treatments—or personalize them—to individuals more effectively.
By using "genomics," or the identification of genes and how they relate to drug treatment, doctors will be able to treat patients based on the actual biology of a disease and not just according to symptoms, and as an individual, not just a member of a population.
The Food and Drug Administration is especially interested in clearing the pathway for the development of safe and effective, leading-edge products that this burgeoning field of genomics is spawning—multiple tools, technologies, and sciences that will translate into the discovery and safety of drugs and medical products that the agency regulates.
By ensuring that new products and technologies are developed and made available to doctors and patients as effectively as possible, FDA believes this can only enhance the health of all Americans.
What is Personalized Medicine?
Personalized medicine uses information about a person's genetic makeup to tailor products that will detect, treat, or prevent disease in that person. The goal is to get the best medical outcomes by choosing treatments that work well with a person's genetic profile, or with certain characteristics in the person's blood or cells.
Scientifically, personalized medicine is known as pharmacogenomics (drugs combined with genes), or how genetic differences in individuals affect the way people respond to drugs. The science of pharmacogenomics tries to answer questions like: Why do some people get cancer and others don't? Why is cancer more aggressive in this person and not in that one? Why does this drug work for him and not for her? Why do some people show toxicity to a drug while others don't? Why does someone need twice the standard dose to be effective? And why do others need only half of the standard dose?
How Does Personalized Medicine Work?
Someone diagnosed with colon cancer today would receive a treatment based on standard medication and dosing guidelines for that disease. The doctor might factor in weight, age, medical history, and how any blood relatives might have reacted to a certain medication. But the doctor cannot know how that person will respond to the medication, which may help the cancer or have no affect at all. The person could experience terrible side effects or none at all. And, it may be necessary for several revisits to the doctor for adjusting the dosage or to switch medications. This is considered the trial-and-error approach to medicine.
With personalized medicine, people may be able to take a genetic test that can help determine which diseases they are likely to develop, and a blood test to help determine which genetic variations they may have—even before they've taken a single dose of medicine. Based on test results, the doctor could tailor a patient's treatment by avoiding using a certain drug, prescribing another, or altering a dose to match the body's genetics. A person's unique genetic profile can help a doctor personalize treatments.
What's Involved?
New technologies and tools have been developed as a direct result of the nation's effort to understand DNA—deoxyribonucleic acid—the blueprint that determines how each person’s body looks and functions. Those technologies and what they intend to accomplish within personalized medicine include:
Functional genomics—measures gene expression under normal and troubled conditions and attempts to predict the gene expression profiles for these conditions.
Structural genomics—addresses questions concerning individual genetic differences and the impact that these genetic differences have on the development of disease.
Proteomics—seeks to discover all proteins in a living organism, and determine their function and how they affect each other.
Metabolomics—studies all the molecules involved in metabolism (metabolites) in a living organism by evaluating tissues and body fluids, such as urine, blood, plasma, and saliva for changes.
Genomics and Medical Devices—understands how certain diseases, or increased risks pass from generation to generation.
Nanotechnology—uses materials or devices at the level of molecules and atoms too small to be seen with a conventional laboratory microscope.
What are the Benefits of Personalized Medicine?
* Diagnosing disease or predicting risk of disease.
* Determining whether a treatment is working or not.
* Monitoring healthy people to detect early signs of disease.
* Producing safer drugs by predicting the potential for adverse effects earlier.
* Targeting specific groups of people most likely to benefit from a drug, while keeping its use from those who may be harmed by it.
* Providing researchers the opportunity to get a global view of the events that are always changing within a cell.
* Producing new classes of structural materials that are expected to bring about lighter, stronger, smarter, cheaper, cleaner, and more precise medical products.
What are the Challenges of Personalized Medicine?
Personalized medicine is new and still in the early stages. Using a pharmacogenomic test to determine who will respond to a treatment or who should not get a treatment may narrow the market for certain drugs—manufacturers may be reluctant to invest time and money. Identifying all of the genetic variations (perhaps millions) that may exist could take years. How a person responds to a medication may not be determined by just one gene, but rather, several genes and their products interacting with each other.
This new way of doing things likely will be expensive and time-consuming.
FDA's Role
Tests that scientists are beginning to use on body fluids and cells to determine the variations of disease were not available in the past. Such tests, coupled with the understanding of the expression of each individual’s genes, will allow scientists to detect differences between patients and diseases much more precisely. FDA's Critical Path Initiative—the scientific process through which a medical product is transformed from discovery to development—is organizing work across 76 science and regulatory areas to improve medical product development, especially for gene-oriented drugs and diagnostic tests.
FDA encourages applications for approval of new tools and technologies for a number of reasons:
* The ability to bridge data gaps that exist in preclinical studies (animals) and clinical studies (humans) used to assess the safety and effectiveness of products it regulates.
* Technologies can be used not only in the discovery phase of potential products, but also in the safety and effectiveness evaluation phase of development and submission to the agency.
* Adverse events likely can be predicted prior to the approval and marketing of a product.
FDA's role in personalized medicine will be to bring balance to an evolving science in a way that does not inhibit its growth. Thousands of cancer patients are already benefiting from several targeted drugs, such as Tarceva and Gleevec, both known to work better in people with certain genetic profiles. Hope for the future is that personalized medicine will improve the safety, quality and effectiveness of health care for every American.
Credit: FDA Consumer Health Information
e-published on MedicineandBiotech.com October 1st, 2007
Each person has a unique set of chemical blueprints that determine how his or her body looks and functions. These blueprints are contained in their own DNA which is made up of two twisting sequences or single strands that are able to be paired with another.
Here we discuss the following important topics of interest:
* What is Personalized Medicine?
* How Does Personalized Medicine Work?
* What's Involved?
* What are the Benefits of Personalized Medicine?
* What are the Challenges?
* FDA's Role
Medications have been prescribed over the years mostly by trial-and-error to reach the best dose for each patient. Typically, doctors diagnosed a condition and then selected what they believed was the most promising drug for treatment. If one didn't work, they'd try another.
Today, as science gives way to the understanding that people and diseases differ at the genetic or molecular level, doctors are learning to tailor treatments—or personalize them—to individuals more effectively.
By using "genomics," or the identification of genes and how they relate to drug treatment, doctors will be able to treat patients based on the actual biology of a disease and not just according to symptoms, and as an individual, not just a member of a population.
The Food and Drug Administration is especially interested in clearing the pathway for the development of safe and effective, leading-edge products that this burgeoning field of genomics is spawning—multiple tools, technologies, and sciences that will translate into the discovery and safety of drugs and medical products that the agency regulates.
By ensuring that new products and technologies are developed and made available to doctors and patients as effectively as possible, FDA believes this can only enhance the health of all Americans.
What is Personalized Medicine?
Personalized medicine uses information about a person's genetic makeup to tailor products that will detect, treat, or prevent disease in that person. The goal is to get the best medical outcomes by choosing treatments that work well with a person's genetic profile, or with certain characteristics in the person's blood or cells.
Scientifically, personalized medicine is known as pharmacogenomics (drugs combined with genes), or how genetic differences in individuals affect the way people respond to drugs. The science of pharmacogenomics tries to answer questions like: Why do some people get cancer and others don't? Why is cancer more aggressive in this person and not in that one? Why does this drug work for him and not for her? Why do some people show toxicity to a drug while others don't? Why does someone need twice the standard dose to be effective? And why do others need only half of the standard dose?
How Does Personalized Medicine Work?
Someone diagnosed with colon cancer today would receive a treatment based on standard medication and dosing guidelines for that disease. The doctor might factor in weight, age, medical history, and how any blood relatives might have reacted to a certain medication. But the doctor cannot know how that person will respond to the medication, which may help the cancer or have no affect at all. The person could experience terrible side effects or none at all. And, it may be necessary for several revisits to the doctor for adjusting the dosage or to switch medications. This is considered the trial-and-error approach to medicine.
With personalized medicine, people may be able to take a genetic test that can help determine which diseases they are likely to develop, and a blood test to help determine which genetic variations they may have—even before they've taken a single dose of medicine. Based on test results, the doctor could tailor a patient's treatment by avoiding using a certain drug, prescribing another, or altering a dose to match the body's genetics. A person's unique genetic profile can help a doctor personalize treatments.
What's Involved?
New technologies and tools have been developed as a direct result of the nation's effort to understand DNA—deoxyribonucleic acid—the blueprint that determines how each person’s body looks and functions. Those technologies and what they intend to accomplish within personalized medicine include:
Functional genomics—measures gene expression under normal and troubled conditions and attempts to predict the gene expression profiles for these conditions.
Structural genomics—addresses questions concerning individual genetic differences and the impact that these genetic differences have on the development of disease.
Proteomics—seeks to discover all proteins in a living organism, and determine their function and how they affect each other.
Metabolomics—studies all the molecules involved in metabolism (metabolites) in a living organism by evaluating tissues and body fluids, such as urine, blood, plasma, and saliva for changes.
Genomics and Medical Devices—understands how certain diseases, or increased risks pass from generation to generation.
Nanotechnology—uses materials or devices at the level of molecules and atoms too small to be seen with a conventional laboratory microscope.
What are the Benefits of Personalized Medicine?
* Diagnosing disease or predicting risk of disease.
* Determining whether a treatment is working or not.
* Monitoring healthy people to detect early signs of disease.
* Producing safer drugs by predicting the potential for adverse effects earlier.
* Targeting specific groups of people most likely to benefit from a drug, while keeping its use from those who may be harmed by it.
* Providing researchers the opportunity to get a global view of the events that are always changing within a cell.
* Producing new classes of structural materials that are expected to bring about lighter, stronger, smarter, cheaper, cleaner, and more precise medical products.
What are the Challenges of Personalized Medicine?
Personalized medicine is new and still in the early stages. Using a pharmacogenomic test to determine who will respond to a treatment or who should not get a treatment may narrow the market for certain drugs—manufacturers may be reluctant to invest time and money. Identifying all of the genetic variations (perhaps millions) that may exist could take years. How a person responds to a medication may not be determined by just one gene, but rather, several genes and their products interacting with each other.
This new way of doing things likely will be expensive and time-consuming.
FDA's Role
Tests that scientists are beginning to use on body fluids and cells to determine the variations of disease were not available in the past. Such tests, coupled with the understanding of the expression of each individual’s genes, will allow scientists to detect differences between patients and diseases much more precisely. FDA's Critical Path Initiative—the scientific process through which a medical product is transformed from discovery to development—is organizing work across 76 science and regulatory areas to improve medical product development, especially for gene-oriented drugs and diagnostic tests.
FDA encourages applications for approval of new tools and technologies for a number of reasons:
* The ability to bridge data gaps that exist in preclinical studies (animals) and clinical studies (humans) used to assess the safety and effectiveness of products it regulates.
* Technologies can be used not only in the discovery phase of potential products, but also in the safety and effectiveness evaluation phase of development and submission to the agency.
* Adverse events likely can be predicted prior to the approval and marketing of a product.
FDA's role in personalized medicine will be to bring balance to an evolving science in a way that does not inhibit its growth. Thousands of cancer patients are already benefiting from several targeted drugs, such as Tarceva and Gleevec, both known to work better in people with certain genetic profiles. Hope for the future is that personalized medicine will improve the safety, quality and effectiveness of health care for every American.
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