Friday, February 27, 2009

Ranbaxy runs into problems with the FDA

Ranbaxy, and Indian drug manufacturer, has been accused by the FDA for falsifying data. They're halting the review of all applications from the Paonta Sahib Manufacturing plant. Among other things, they're accused of failing to test the shelf life of the drugs and lying about the results.

For more information, read the article at the Wall Street Heatlh Journal here.


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Wednesday, February 25, 2009

Green Pharma Summit

Have you heard about the Green Pharma Summit? It'll be taking place July 20-21 in Philadelphia, PA! Find out more information at our webpage and sign up to get the latest updates!

And if you're interested in networking and communicating with other professionals who are working on going green in the Pharma industry, join our Green Pharma LinkedIn Group!


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Tuesday, February 24, 2009

More on the shift of clinical trials

Yesterday, we posted about the new study from the New England Journal of Medicine. Yahoo also recently took a look at why trials have been exiting the US. One of the main concerns this raises is that those who are being tested outside of the US maybe living a different type of lifestyle than those who actually take the medicine. The article also noted that the three biggest factors pushing trials outside of the US are cost, faster approvals and less red tape.


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Monday, February 23, 2009

Raising alarms, study sees trials migrating abroad

John Carroll at FierceBiotech.com reports that the U.S. drug industry has shifted most of its clinical trials to overseas sites in a trend that experts warn raises serious ethical concerns. According to a study in the New England Journal of Medicine, 13,521 of 24,206 trial sites being sponsored by the top 20 U.S. drug companies in late 2007 were taking place beyond our borders, where data can be harvested cheaper and faster than the data gathered inside the U.S. And the study adds that the number of countries hosting trials has doubled in 10 years. Most of the countries hosting clinical trials may be using individuals who could never afford the medications and approval for these trials has been less than half. What are your thoughts?


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Friday, February 20, 2009

Is Outsourcing of Clinical Trials Faulty?

A recent article in the NY Times raises the question about the ethics of conducting clinical trials outside the US when these studies are meant to gather evidence for drug approval in the country.

The article which was written by several Duke University researchers and was published in the New England Journal of Medicine discusses how medication that is intended for the wealthy should not be tested on people in developing countries. The report questions whether or not testing drugs in developing countries is even relevant to American patients.

What are your thoughts?


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Thursday, February 19, 2009

Roche Holdings sells bonds to take over Genentech

As reported by the New York Times this morning, Roche Holdings generated $16 billion after selling off bonds. This will contribute to the funds to take over Genentech Inc. According to the New York Times, this is the second largest bond offering in US history.


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How to rescue a clinical trial

At ClinPage, they recently posted an article about the keys to resuming a clinical trial if you've taken over it midway through the process. So what should you do if you're asked to resume a project after everything's been started?

They suggest:
1) Assess and plan
2) No rushing
3) Create trust
4) Initial Visits
5) Ongoing oversight

For an in-depth look at the steps, read the article here.


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Wednesday, February 18, 2009

Pfizer Plans to Disclose Payments Made to Clinical Investigators

According to Clinical Trials Today, Pfizer plans to publicly report payments made to clinical investigators, physicians and other health care professionals by early next year, making it the first pharmaceutical company to commit to disclosing payments it makes for conducting clinical trials, speaking and consulting. It seems that Pfizer wants to aim for transparency of their practices, perhaps providing an easier system of due diligence within the pharmaceutical and CRO/Clinical Trials arenas. What do you think of this move by Pfizer?


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Thursday, February 12, 2009

Microdosing could be a win/win for pharma, CROs

According to Peter Mansell of Pharma Times, a new study by Frost & Sullivan, Strategic Analysis of Opportunities in the CRO Market – Phase 0, notes the increasing acceptance of microdosing and suggests it may be the antidote to industry’s much-discussed problems with drug productivity. Consolidation among CROs has raised concerns about quality of service and attention to detail in the sector, Frost & Sullivan points out. Mansell points out that companies need to ensure these elements are in place if they are to maintain their bargaining power with the pharmaceutical industry. For more information on the study or Peter Mansell's thoughts, check out the original article, here.


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Wednesday, February 11, 2009

PPD Extends its Reach to Eastern and Central Europe

According to this article in novinite.com PPD is set to buy AbCRO, which is Bulgarian based CRO, in order to expand its drug testing businesses in Eastern and Central Europe.

The purchase which is expected to be completed in March will add Romania, Bulgaria, Serbia and Croatia to PPD’s operations in Europe and also help bolster its already existing operations in Poland, Russia and the Ukraine. What other clinical trials companies are investing heavily in Eastern and Central Europe?


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Pfizer Discloses Payment Information for Clinical Trials

According to this article on outsourcing-pharma.com Pfizer will disclose payments made to principal investigators, major academic institutions and research sites involved in Phase I to IV trials that exceed $500 a year and non-monetary items such as meals that cost more than $25.

Pfizer is getting closer than any drug maker in terms of full disclosure, but if the Physician Payments Sunshine Act of 2009 is passed into law, it would require companies to disclose all payments exceeding $100 a year and would face a fine of up to $1 million if they do not comply.


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Tuesday, February 10, 2009

Live from the ePharma Summit: Panel Discussion, Real Age

Moderator:

James Chase, Editor-In-Chief, MEDICAL, MARKETING & MEDIA

Panelists:


Dr. Michael Roizen, Chief Wellness Officer & Chairman of the Wellness Institute, CLEVELAND CLINIC
Mike Wojeck, Vice President, Strategic Solutions, REAL AGE INC.
Mary Pietrowski, Director of Consumer and eMarketing, HOLOGIC
Laura Plummer, Patient Perspective
Bob Harrell, Director eMarketing, SHIRE PHARMACEUTICALS


Laura and Dr. Roizen discuss Laura's success from 44, smoker and overweight to one year later, healthy, non-smoker and a "do-over." Laura went on medicine to quit and didn't gain weight after she stopped smoking, because of Dr. Roizen's guidance. Laura was featured on Oprah.

Laura, "You can't talk the talk unless you walk the walk."

Laura has become a drug salesman to help them get healthy, keep good cholesterol and keep her BP down.

Q: What is a way that we can market and educate consumers about health--what's your idea of a smart patient?

"Think about the whole patient, look at the drug and think about solutions for the patients. Lifestyle changes--we can promote them to help and educate people. Why can't we promote a more holistic view of what healthcare can be? ...Look at the whole life and the roles that medication can play."

"We should empower patients. Offer them support so they understand what will happen to them, not from a scientific point but on a personal level"

Q: What is the role of online media to promote dialogue with patients?

"Provide an audience that is engaged about their health and elegantly introducing Novasure. There are medications out there that don't necessarily need to be owned but can be rented to get a better understanding of their bodies. Understanding where we can find relationships, dialogue and how to get involved. Work toward driving demand from a physician side."

"Women think that they must suck it up and not talk about the heavy bleeding with menstrual cycles, and we thought to educate the women about this procedure and the effects that heavy bleeding has on the woman. By targeting specific audiences through the website, they are able to share the education in conjunction with the product."

"Finding ways to engage the participants as well as the physicians."

Q: Laura, how did you benefit from the online space?

"It told me foods to eat, why they were good for me and what benefit I was going to get with that food. It helped me even cook foods that I'd never heard of..."

"The target audience for Real Age is 45 and women, Laura's age."

Talk: http://www.mammosite.com/

Q: What is the nugget that we as digital marketers can do tomorrow?

"Step back and look at your marketing strategy? What is the message and what are you trying to tell them. Why are you ready for Facebook: what is your message and is it appropriate?"

"Can the emotional engagement be done on a website?"

"Look at ways to flip your perspective as a marketer. Bringing out these patients stories in their own voice. Capturing stories in audio, video is expensive. We can participate more authentically with people."

"Educate people on how to talk to their doctor. Diagnostic tests, conversing with your doctor--very critical."

Q: Dr. Roizen, can you speak to the right kind and depth of educational material to really motivate change?

"We can get everyone engaged online like Laura was. We have the Lifestyle 180 program, which is 12 four hour sessions. Low cost sessions that are an hour of cooking, physical therapy, stress management and disease management. How do we reverse disease? Lifestyle management may be more important in keeping them out of the hospital--21 diseases in all. Giving educational materials and instruction so that they don't have to come back--but they do and we encourage them to do so. It has to be attainable, fun and emotionally engaging. A program of basics to make great tasting food that is good for them. Need web support but it has to be emotionally engaging. Online or in person, they must be emotionally engaged. Buddies are important, like online media--buddies are important. Getting the patient involved with another patient and getting them both involved--works for medicine."


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Live from the ePharma Summit: RealAge and YOU: You staying Young?

Dr. Michael F. Roizen

Dr. Roizen discusses the "Two revolutions in Health"

Genomics & Stems

Personalized Medicine

Diverticulitis, getting emotionally involved in your body--how to get involved with your bodies and how they function. Must get enough fiber, 8-10 grams at breakfast and lunch so that you don't get the munchies the rest of the day. Most Americans get most of there fiber from dinner which is a waste. Getting to know and understanding your body helps to maintain and lower healthcare costs. The individuals have to keep up with their bodies to do what is best for them--understanding their bodies.

Goals

  • Understanding your body
  • You get a do-over
  • Why sugar and saturated fat injures your body
  • Why omentum is important to health
  • food, exercise and medicines are like friends

Prevention is different than wellness.

Bariatric procedures effect your desire to eat plus it cures diabetes and hypertension. Diabetic needs get removed after the operation. 70% cure rate of diabetes. Lifestyle changes can cure diseases and whether the genes are ratcheted up in the body to specific tendencies.

Type II Diabetes

Makes your RealAge 1.5. Older for each either with average and it adds on each year. With A1c, BP, LDL, HDL and TC Control.

Requires multiple medications to hit targets for diabetes management.

Name the drugs as "friends" to look at how that friends is helping them to achieve something positive for their bodies. Some have issues but more often than not, they are beneficial.

Tell patients: "You get to change your family history."

Smoking one pack a day makes you between 8-12 years older, but if you stop by age 35 you get all of that time back--a "do over."

Make your RealAge younger

  • BP Control
  • Cigarette Cessation
  • Stress Control
  • Patrol Own Health
  • Quality/Quantity of Sex
  • Nutritional Choices
Be sure to check out the Real Age books.

Aging at a worldwide concern...

All genes do is make proteins or watch other genes-- YOU control your genetic inheritance.
Walking 30 minutes per day can reverse your genetic heritage. Everyone one of us has weaknesses in our genes but it depends on how you enforce your body to do the right thing.

Our habits can change how and if we get breast cancer, colon cancer or prostate cancer. By doing exercise and correct eating habits--you get to determine whether your genes are on our not.

Adding 4 helping of broccoli per week can help knock out breast and prostate cancer. Adding one food in the diet can change the protein and the gene to change to eradicate the possibility of these cancers.

The USA has twice the disease prevalence as Europe. Why? We have twice as much illness and cost of illness because we have to change the Real Age number, people are younger they need much less care and less diseases occur in the population.

Fat in your belly is metabolic and it hormonally active and causes insulin resistance and inflammation in your body. Obesity is a 18yr problem in the US. We must make patients smart to drive the costs down.

Major Agers

  • Bad Genes
  • Oxidation & Inefficient Mitochondria
  • Stem-Cell slowdown
  • Declining Defences
...among others

Prevention is the key, not prescriptions.

You can't test to health, you have to live to health.

Lifestyle 180: enables patients to engage, attainable and provide practical ways for people to manage their lifestyle to prevent or care for a disease.

We must make patients smarter--we will stay competitive as a nation, is if we can drive down the cost of illness.


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Live from the ePharma Summit: Keynote Josh Bernoff "Groundswell: Winning in a World Transformed by Social Technologies"

Bernoff is going to help us better understand and leverage social technologies. Pharma's current position in social technology is unique. No issue makes us want to connect more than the issues we have around our health, they're looking for support around the subjects they have. A major road block for the pharma industry is that it is very regulated.

Win in a world transformed by social technologies...not just jumping in, but developing a long term strategy for your company to succeed. Social media changes very rapidly, and it's impossible to keep up with the latest technology.

Groundswell - A social trend in which people use technologies to get the things they need from each other, rather than from traditional institutions like corporations.

You company sends marketing messages out to consumers. Now, they're collaborating together to determine if the products are good. As a company, you can't block it, but you can join in on the conversation.

The four step Groundswell approach is:
P - People - Assess your customers, patients and doctors social activities. What tools and technologies do they use?
O - Objectives - Decide what you want to accomplish. Why are you setting up your community? You can then measure your objective. S - Strategy - Plan for how relationships with customers will change. This is a new and permanent relationship.
T - Technologies -- Decide which social technologies you want to use.

He goes over the social technographs later when assessing people. Be sure to check this out in his new book. As for those participating, age is a great way to predict who are using the tools online. The diseases with the most social participation online is mood disorder other than depression, and the lowest level of participation online is osteoporosis. The level of men and women online doesn't really change. As for medical professionals, they are participants but produce very little content. Groundswell activities include listening, talking, energizing, supporting and embracing, all of the ideas that come from your customers.

Listening: MD Anderson's community for their cancer patients
Energizing: Gardisil on Facebook
Supporting: AstraZeneca
Embracing: My Starbucks Idea

It's important to educate the professionals in the Pharma field, network with those in your company who want to do it, talk to your legal group early, and a few others. You can also connect with third party companies such as MedMD. Make sure that your target market is working with social media.

Find out more about the presentation here:




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Live from the ePharma Summit: Q&A Panel Discussion Tuesday AM

Q: How do we market to social media without creating an ad?

John Fish "Its not about controlling the social media spheres, its giving the correct information so that they can start the conversation."

Bob Lord, "Excellent Ads, provide brand principals and post creative briefs on the web and let nearly 8,000 people to create the ad and place it in the sphere. The conversation around the big brands are what makes social media valuable--its about the dialogue. Its getting information to you about the brand. To go from brand perception to brand reality."

Nancy Phelan, "We're struggling with the commercial model. We look at social media and it helps to have a discussion about what we know and what we don't know. If we can work within a model--even if we don't completely understand it, it starts the discussion about social media. It gets to competencies and process. We're starting to make progress but we haven't figured it out."

Nan Forte, "When we get out of this room, when we get interrupted its rude. The same with social media, we can't disrupt the conversation. Its complicated when we talk about patient views and perceptions of brand. You have to challenge the model of ads to consumers on social media."


Q: Are there lessons that we've learned from 10 years ago with social media?

Paul Ivans: "You have to care deeply about social media, really care. Its baby steps. My belief is that everyone in this room doesn't feel like we've hit it in social media. Its one of the few things we can do...but everyone is trying to figure this out. We have to stick with it. One lesson we can learn is to get the medical, legal and regulatory people to understand social media. Take them to a place where the conversation is going on... have them experience what's going on."

Nancy Phelan: "Its helpful if you start talking to the medical/legal people about what they are interested in...not pharma. Interest them in something that is meaningful to them and migrate them from what they are interested in to how they can use social media. Not starting them on your brand."

Nan Forte: "People support what they helped to create."

Q: Are those conversations going to happen online, regardless of how involved we're in with the conversations with brand? What are three different ways that you've evolved with learning about social networking.

Bob Lord: "Start in the listening mode and as you feel comfortable, then eventually get into a real active mode where you're actually leading the conversation. You have to put the real resources behind this and actually start listening. Understand the buzz..when you get the math, you can put a plan into place. Until you do that...you can't do anything. You may decide to be a participant the whole time...but you should ramp up, think about the commercial model. How do I make it better?"

John Fish: "Its easier to do with physicians than with consumers. You can tap into those social networking. Its easier to get docs and key opinion leaders to start and engage. If you're going to lead, you have to demonstrate value. If you're gonna follow, at least do it right."

Kathleen Oniel: "Pharma isn't really set up to do this. PR people are the only ones who have expertise in social media--with pharma. (This happened by default as the public brought the converstaion to Pharma). We're in the middle of it, its halted by organizational mishandling."

Paul Ivans: "When social media is approached not by the marketing team but by a larger group of people--then you have a chance to move your organization forward."

Q: Having tough time prioritizing social media, can you provide some strategies that we can use?

Nancy Phelan: "Time is a precious commodity. No one has the perfect way to get things reviewed. If you can get someone in legal and medical to be a champion, then you can move forward. If you can find someone in a functional area, you can have some success. Celebrate the small steps and learn from them."

John Fish: "Establish processes with individuals who are really strong in social media and an expert on your brand. Everyone has dirty laundry."

Q: How do we scale digital marketing with strategy and organization?

John Fish: "Its more politics than process. If you are a global company, you would be wasting your money unless you have solid connections. You have to have IT at the table as soon as you can. You cannot effectively operate on a global scale w/o IT."

Nancy Phelan: "If you're talking about a specific brand, then global but if you're talking about products, then local."

Kathleen Onieal: "Because of DTC and DTP in Europe and the rest of the world, its difficult to implement. What we're figuring out is looking at relationship marketing with physicians. Shared content--but it came out of Europe. Focus on Physicians, focus on content and partner, not compete with Europe."

John Fish: "You have to really force and drive the efficiencies with your content and branding."

Paul Ivans: "You aren't the police. Don't force people to use the same website across the globe. If it can help them get to the goal, then help them."


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Live from the ePharma Summit: Panel Discussion, Tuesday AM

Nancy Phelan- Wyeth
Nan Forte- WebMD
John Fish- AstraZeneca
Kathleen Oniel-Hayes Oniel Consulting
Bob Lord-Razorfish
Paul Ivans, Chairperson

An increasing demand for emarketing, Pharma is going through a transition as the public asks more questions and we ask more questions of ourselves. More and more brands are putting patience assistance/coupons on their sites to drive the product. There will be a much larger increase for a demand in ePharma. Increased transparency and utility online, there should be a bigger emphasis on safety. We should see increased external and internal scrutiny and regulation.

Nan Forte--WebMD
Looking at Personal and Environmental Sustainability with its core values. Food and wellness manufacturers are repositioning themselves as "health and wellness" companies. Let's engage the right audience at the right time to go beyond DTC--beyond TV and TTYD is not a CTA anymore. Work toward branded engagement by Originality + The Perfect Fit = Purpose, your brand should fill a void or create a real need.

John Fish--AstraZeneca
Content at the point of consumption is the new pink...i.e., Web 4.0. Websites as destination strategies are dead. Micro blogging, applications, etc completely change how your customer views your product. Marketing Funnel is not a maze...look at timing, convenience and distribution. Keep a relationship with your content and with your grand. The customers are now the brand stewards--you don't have control anymore. You must relearn it. Web 3.0 and mobile location based services will game change online media and search advertising models. Web 4.0 will connect everything to the Internet that's worth connecting...

Kathleen Oniel--Hayes Oniel Consulting
Even with health care professionals, will go from audiences of millions to millions of audiences. The "new commercial model" developing in the industry will require Marketers to develop skills in Managed Carek Marketing and Health Economics and understand the art and operations of Mass Customization. Change must happen.

Bob Lord--Razorfish
Looking at the "Third Marketing Channel"-- social influence marketing. You must consider this, have a strategy and have a purpose for it. How do you want to accomplish it, how do you go about doing it... You want to get to the person to influences the buyers. The Power of Social is to get the "influencer" ROI...optimizing your way to great results.

Check out photos here!



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Live from the ePharma Summit: Chairperson Paul Ivans

Paul Ivans, President, EVOLUTION ROAD; Conference Chairman

Nancy Phelan, Executive Director, Consumer Communications & eMarketing, WYETH, Conference Co-Chair

--- Nancy was recently featured in Working Mother Magazine. Go Nancy!

Paul shares how the economy has impacted our business, but that its going forward. He also encourages attendees to network with the best of the best and anticipate working more with social media.

Look out for these great subjects:


  • Social Media and Web 2.0


  • Generating sales and ROI


  • Innovation


  • Integration


  • Web 3.0


  • Online Video


  • New Agency Models


  • Digital Research


  • Mobile


  • Helping People Live Healthier Lives
Paul stresses that Pharma is a good thing, providing information and support that allows people to live good lives. As digital marketers we are uniquely qualified to get the Pharm industry out of the valley.

People in this room will help people stay healthier, stay on the therapy that they need to be healthier.

As digital marketers we provide health info and support to make people make educated decisions about what pharmaceuticals that they should use.

Again, ePharma will help Pharma overcome huge challenges by driving the business.

Brand.com websites are driving--let's keep it moving.

Digital Connective Tissue:

But importantly, ePharma should address TV and Field Promotion issues, proving ROIs and driving millions to the right products and doctors--to ultimately drive people to better help.

Looking at the internet browswer, we can do so much--like advertising on steroids. Plus tomorrow, we can go beyond the browser to iPhone applications, Kindle and Wii Fit, etc.

Think of techonolgy and services as integral parts of what we do.

...and there are a lot of great starts from the FitBit to AT&T Telehealth.

What's in store for tomorrow?

Three things from Paul:

1. Think Big, really big and address the Industry's clinical issues
2. Get Pharma in The Game--social media, online video and mobile devices
3. Think products and services: Digital as Connective Tissue

Updated 2/11






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Monday, February 9, 2009

Live from the ePharma Summit!

We are live from the conference at the Hyatt Regency in Philadelphia. As a participant in the event, you can keep up with the conference by following us live online through our various channels.

Over the next two days, we’ll be covering the conference live here at the ePharma Summit Blog and also at the ePharma Summit Twitter feed — for those of you here in Philadelphia, take advantage and be sure to join us for a tweetup! We’ll also be recording excerpts from the presentations and exclusive interviews on the ePharma Summit webpage. We also encourage you to join the ePharma Summit LinkedIn Group, where you network with over 300 ePharma marketing professionals both during and after the ePharma Summit!


Take a minute to see what Lesly Atlas, the Conference Director, is looking forward to at this year's event.


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F.D.A. Approves Drug From Gene-Altered Goats

According to the NYTimes, the F.D.A. has approved a drug from gene-altered goats. This milestone for science has not been without critics who claim that this approval "could now encourage drug makers to consider this type of production." The Times reports that the drug was approved to prevent blood clots in people born with a rare hereditary deficiency of antithrombin while they undergo surgery or childbirth. At other times such people can reduce their clotting risks by taking blood thinners like warfarin, but during surgery or childbirth blood thinners are typically avoided because of the risk of excessive. What do you think of using these "Pharm" animals for drug purposes? We'd like to hear your thoughts.


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Thursday, February 5, 2009

New innovative chemotherapy goes directly to cancer source

ABC News recently wrote a piece on "target chemo" which has just passed Phase 1 clinical trials. When in trial with liver patients, targeted chemo only treated the liver area, and resulted in a reduction in the cancerous area in 50% of the patients. For more on this innovative form of chemo, read the article here.


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Are Direct-to-Consumer Drug Ads Doomed?

Direct-to-Consumer pharmaceutical ads may be on the way out. According to TIME, Direct-to-consumer (DTC) advertising by pharmaceutical companies has always been somewhat controversial. The U.S. is one of only two countries that permit it (New Zealand is the other). Critics claim that these advertisements encourage consumers to seek out overly expensive brand-name drugs from doctors. By having pharmaceutical ads on television, the general public may get the wrong idea of what Big Pharma is about, thinking they're out to deliver brands over disease medication. President Obama is trying hard to fight Big Pharma, and may have these controversial DTC ads taken off of the nation's television broadcast system--but that won't be for awhile. Do you think that these ads have a place within the public media sphere?


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Covance expands into Eastern Europe and Middle East

Covance has opened up new offices in Kiev, Ukraine; Bratislava, Slovakia; and Tel Aviv, Israel. The Ukraine and Slovakia offices will be in support of the CROs regional network and field based CRAs. The new office located in Tel Aviv will be a center to support staff for operations in Greece, Turkey and the Middle East.

For more information, read here.


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