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.

FDA Approves Combination Drug Janumet For Type 2 Diabetes
Article Date: 03 Apr 2007 - 0:00
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Article Also Appears In
Pharma Industry

US Food and Drug Administration has approved a new combination drug called Janumet that combines a new drug and an older drug in a more convenient form for people with type 2 diabetes.Janumet is made by Merck & Co and according to the company it is the first and only tablet that combines a dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin (also known as Januvia), and metformin for treating patients with type 2 diabetes.Januvia, also made by Merck, enhances the body's own ability to lower elevated blood sugar. It was approved by the FDA last October and received a European Commission licence yesterday. It is mostly taken in combination with other drugs.Metformin is an oral drug in the biguanide class. It is the most widely used drug in the treatment of diabetes in the US and was first made by Bristol-Myers Squibb over ten years ago as Glucophage but has since become available in generic form.Pharma analysts are predicting that Janumet will overtake combination treatments based on Januvia because of its convenient single tablet form.According to Merck's statement, the FDA approved Janumet based "upon clinical data including sitagliptin plus metformin as separate tablets."They say that a clinical bioequivalence study has demonstrated that the single tablet Janumet is equivalent to taking sitagliptin plus metformin as separate tablets.The FDA has approved Janumet as an adjunct to diet and exercise to "improve blood sugar (glucose) control in patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone, or in patients already being treated with the combination of sitagliptin and metformin".Merck says that Janumet should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.The FDA announced the decision to the press late last Friday.According to the American Diabetes Association more than 6 million Americans have diabetes and don't know it. Another 54 million are pre-diabetic, with an increased risk of having the disease.The ADA give the main risk factors for type 2 diabetes as:-- being overweight-- having a sendentary lifestyle-- being over 45 years old-- having a family history of diabetesAfrican Americans, Latinos, Native Americans, Asian Americans and Pacific Islanders carry an increased risk, as do women who give birth to babies weighing more than nine pounds (4.1 kilos).

Click here to take the ADA diabetes risk test.
Click here for FDA
Written by: Catharine Paddock
Writer: Medical News Today

List of Openings

Here is a list of some of the positions that we are working on right now!

Vice President Regulatory Affairs - Medical Device
Boston MA

Director Regulatory Affairs – Medical Device
Chicago

Director Regulatory Affairs – Pharmaceuticals
New Jersey

Director Regulatory Affairs – Pharmaceuticals
Chicago

Senior Director Regulatory Affairs – Pharmaceuticals
Chicago

Senior Manager Regulatory Affairs, Cell Therapy
Chicago

Senior Manager Regulatory Affairs - International
New Jersey

Senior Director Regulatory Affairs – Biologic
Hopkinton MA

Senior Manager Regulatory Affairs – Biologic
Hopkinton MA

Sr. Regulatory Affairs Specialist
Several Locations in Massachusetts:
Canton, Beverly, Bedford, Taunton, Davners, Waltham, Hopkinton, Mansfield

~Things are always changing so by the time this is posted something else maybe open or something maybe filled but is you are looking to make a change ~ give us a call and I will be happy to keep you informed as things come up that could be a good next step for you! I have a team of recruiters working for me now and we have a strong presence in the Research Triangle Park Areas as well as the West Coast!

HAVE A GREAT DAY!!

Katie Corliss
207-510-6666

Medical Devices

Well if you are a Regulatory Affairs Professional in Massachusetts with Medical Device experience this is your year!

I am working on dozens - yes dozens of jobs, with some great Bay State companies. From the big Fortune 500 device companies that we are all familiar with to some great European companies that are establishing North American Headquarters in MA. This is true the most exciting time I have seen in the medical device field in the past several years. The companies that I am working with are financially stable, growing, investing in their people, and are aggressively pursuing top people.

If you want to learn more feel free to give me a call anytime.

Katie Corliss
Vice President, Life Sciences Practice
207-510-6666 ext 122

Senior Director of Regulatory Affairs - IL

Position Title:
Senior Director Regulatory Affairs
Location:
Deerfield, IL
Description:
The Director, Global Regulatory Affairs, is responsible for strategic direction of the RA function supporting the Global Business of the Medication Delivery Division for a company with an 80% market share in this space.This is a very key roll with responsibilities for strategic direction and performance of the RA function within multiple portfolios, regions, or business units including development, implementation and management of plans and standards. Accountable for relationship and communication with Regulatory Authorities. Accountable for regulatory strategy and vision across multiple businesses or divisions The position will direct and manage a team of regulatory professionals responsible for development of global regulatory strategic plans for new product development, as well as life cycle management of existing products. Responsibilities include management of all US submissions (INDs, NDAs, SNDAs), in addition to oversight and support for all international registrations. The Director will be accountable for relationship and communication with FDA, as well as business management and international affiliates
.1) Guide, direct, and lead a team of regulatory professionals in development of strategic plans and regulatory submissions
2) Foster and maintain relationships with regulatory authorities to facilitate interactions on behalf of Baxter
3) Ensure alignment of regulatory strategy to business strategy across all functional areas
4) Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global or regional registrations
5) Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements
6) Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
7) Act as business liaison to the Business Unit, representing Global Regulatory Affairs on the business management team
8) Develop and manage budget as appropriate
9) Act as primary contact with the regulatory authorities including the planning and leadership of meetings

Job Requirements
QUALIFICATIONS
1. Sound basis of scientific knowledge
2. Expert knowledge of pharmaceutical regulations, standards, current industry practices, and strong experience with interpretation and application.
3. Excellent written and verbal communication, presentation, and facilitation skills
4. Demonstrated leadership skills
5. Proven negotiation skills and significant experience in interacting with regulatory authorities
6. Risk management and problem solving skills
7. Ability to lead, mentor, and develop others for future growth and development8. Demonstrated ability to manage and build relationships with colleagues and regulatory authorities
9. Established credibility with regulatory authorities

EDUCATION AND EXPERIENCE

Advanced Degree or country equivalent in related scientific discipline with a minimum of 10 years experience in RA, including at least 5 years experience managing people. Higher degree/PhD will be an advantage. International experience/exposure preferred

Director of Regulatory Affairs Opening

The Director, Global Regulatory Affairs, is responsible for strategic direction of the RA function supporting the a Global Business Unit for one of our key clients in the pharmaceutical industry. The position will direct and manage a team of regulatory professionals responsible for development of global regulatory strategic plans for new product development as well as life cycle management of existing products. Responsibilities include management of all US submissions (INDs, NDAs, ANDAs, SNDAs), and oversight of international registrations. The Director will be accountable for relationship and communication with FDA, as well as business management and international affiliates.

ESSENTIAL DUTIES AND RESPONSIBILITIES

1. Guide, direct, and lead a team of regulatory professionals in development of strategic plans and regulatory submissions

2. Foster and maintain relationships with regulatory authorities to facilitate interactions on behalf of our client

3. Ensure alignment of regulatory strategy to business strategy across all functional areas

4. Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global or regional registrations

5. Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements

6. Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans

7. Act as business liaison to the Anesthesia Business Business Unit

8. Develop and manage budget as appropriate

9. Act as primary contact with the regulatory authorities including the planning and leadership of meetings

QUALIFICATIONS


1. Sound basis of scientific knowledge
2. Expert knowledge of pharmaceutical regulations, standards, current industry practices, and strong experience with interpretation and application.
3. Excellent written and verbal communication, presentation, and facilitation skills
4. Proven negotiation skills and significant experience in interacting with regulatory authorities
5. Risk management and problem solving skills
6. Ability to lead, mentor, and develop others for future growth and development
7. Demonstrated ability to manage and build relationships with colleagues and regulatory authorities
8. Established credibility with regulatory authorities

EDUCATION AND EXPERIENCE

Advanced Degree or country equivalent in related scientific discipline with a minimum of 10 years experience in RA, including at least 5 years experience managing people. Higher degree/PhD will be an advantage. International experience/exposure preferred

If you have an interest in this position please send your resume and email expressing your interst to kcorliss@executivesg.com or give me a call at 207-510-6666.

What is the goal of my blog?

This blog will be a place that I can keep my candidates informed of new positions, share the exciting new of my clients and publish information important to those working in Regulatory Affairs.

Who is Katie Corliss?

I am the Executive Director of the Life Sciences Practice for the Executive Search Group. I am proud to work with a dedicated team of professionals the strive everyday to meet the needs of our clients and bring great opportunities to our candidates.

I specialize in recruiting Regulatory Affairs Professionals. I work closely with my clients to understand the needs of their organization. Having a true understanding of the clients’ objectives allows me to be successful in bringing them the regulatory professionals that will help them achieve their goals. I have made it my goal to reach out to dedicated group of regulatory professionals, learn what they do, why the do it, and what they are looking for in their long term career goals. I am then able to see my candidates grow professionally in positions that they enjoy and watch my clients achieve their goals and continue to grow,I am please to have strong relationships with both small up coming biotechs and large multinational pharmaceutical companies and medical device companies.

I bring to ESG a background in healthcare administration that gives me a unique view of the industry and ability to understand the long terms goals my clients have to bring new healthcare solutions to their customers.