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.

RAPS Conference 2007

It was great to see so many of you at RAPS 2007!!!!

Those of you who I didn't get a chance to meet hopeful we can connect another time. What an exciting time to be in regulatory. I am always just thrilled to hear about all of the new products and so many companies are working on.

Have a great day!

Katie

RAPS 2007 Annual Conference

I am going to be attending the RAPS 2007 Annual Conference in Boston on Monday September 24th.

My hope is to continue learning about this exciting field and how I as a recruiter can best serve all of you in filling positions or searching for a new job.

I am looking to network with as many regulatory professionals as possible and an open to your suggestion about what trainings it maybe helpful for me to attend and who else I should meet while I am there.

If you are planning to attend please let me know I would love to meet up and say hello!

Katie Corliss
207-510-6666 ext 122
kcorliss@executivesg.com

3rd Quarter Update

I just wanted to drop you a quick note to let all of you know that with the 3rd quarter quickly coming to an end there are a lot of companies looking at ramping up their regulatory groups.

I am working on some great new openings and would love the chance to share them with you. If you haven't been currently looking for a new position this maybe a great time to just listen to what is out there and see if something peeks your interest.

Please let me know the best way for us to catch up by phone.

Have a great day!

Katie Corliss
Senior Vice President, Life Science Practice
Executive Search Group
207-510-6666 ext 122
kcorliss@executivesg.com

Awesome Quality Trainer / Audit Position

My client is a 60 year old company. They were one of the first to bring dialysis treatment out of the hospitals and into the free standing clinics that we see today. They have over 1500 clinics nationwide.

Over the past 20 years they have branch out into the medical device and pharmaceutical area and have marketed products used for dialysis treatment. They now have 4 manufactures plants of there own; 2 in the US 1 in Mexico and 1 in Canada. This is a great opportunity to work with both pharmaceutical and medical device products.

The exciting part of working for this company is that have tremendous resources available to them, they have recently purchased and NDA and they have a plan for continued growth.

They are looking for a Quality Systems Auditor/Trainer to be based in at their North American Headquarter in Waltham MA. There would be about 40% travel involved and it would be a mix of auditing as well as doing training on quality systems as various locations.

If you have a the following background, we should talk! 207-510-6666 ext 122

BS/BA in Engineering, Life Sciences, Quality Management, or significant work experience providing a knowledge base is required.
3-5 years quality system auditing experience in a medical manufacturing environment.
5-7 years working in quality assurance in a medical products manufacturing environment.
Working knowledge of the requirements of 21 CFR 820, 21 CFR 211, and ISO 13485:2003 (knowledge of Canadian and Mexican regulations desired).
Able to travel 40% international and domestic

Current openings!

Dir Reg Affairs -Bio Surgery Division
ChicagoIL
130-170K

Dir Reg Affairs - Pharma - nj
New Providence NJ
160-185K

Dir. Reg Affairs - Pharma-renal
ChicagoIL
160-185K

Sr. Dir. Reg Affairs - Pharma- Clintec
ChicagoIL
175-225K

Sr. Mrg RA, Cell Therapy
Chicago IL
110-125K

Sr. Mrg RA - International
New ProvidenceNJ
90-120K

Sr. Director RA
Hopkinton MA
185-225K

Sr. Manager RA
HopkintonMA
95-125K

RA Specialist
NewtonMA
60-80K

RA Specialist
Beverly MA
60-80K

RA Specialist
Bedford MA
70-80K

RA Specialist
Waltham MA
80-90K

RA Specialist
Rockland MA
85-95K

RA Specialist
Mansfield MA
85-95K

RA Specialist
Danvers/TauntonMA
70-80K

RA Specialist
Rayham MA
85-95K

RA Manager
Canton MA
90-110K

RA Specialist
Bedford MA
70-80K


This is not a complete list things are changing everyday. So please call anytime if you want to learn about what we are working on that maybe a good fit with your background!

Katie Corliss
Executive Search Group
207-510-6666 ext 122

Bio2007 was great!

I just wanted to say how good it was to see some many of you last week at Bio2007 in Boston. It was a tremendous show!

It really was a great way to see what a truely exciting time it is to be working in this industry.