Friday, April 29, 2011

FDA Announces Opportunity for Public Comment on Proposed Collection of Information

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The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a series of studies, Examination of Online Direct-to-Consumer Prescription Drug Promotion. These studies are designed to test different ways of presenting benefit and risk information in online direct-to-consumer (DTC) prescription drug Web sites.

The open comment period began yesterday, April 28th and will last until June 27th, 2011. What do you think the results will show? Is this a step in the right direction for the regulation we've all been waiting for?

Join Lucy Rose of Lucy Rose and Associates and Peter Pitts of Porter Novelli as they use their personal experience at the FDA to interpret studies like these and give you the insight you need to develop an effective and "compliant" campaign. ePharma Summit West will be taking place July 25th - 27th in Santa Clara, California. Mention the code XP1656BLOG when registering to save 10% off of current rates.

For more information on the FDA's new initiative, click here.

Monday, April 25, 2011

Does Social Media Have a Place in Clinical Trials?

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A new clinical trial conducted through social media found that lithium didn't slow the progression of Lou Gehrig's disease. The new study, published in the journal Nature Biotechnology, is one of the first conducted exclusively through social media. But many are questioning the validity of the data given the strict procedures required to constitute a clinical trial.

"The approach has tremendous potential,'' said Lee Hartwell, a Nobel Prize-winning scientist now at Arizona State University. Dr. Hartwell, who wasn't involved in the study, said social-network trials aren't likely to replace conventional randomized, double-blinded, placebo-controlled trials, the gold-standard for generating medical evidence. But such trials have become so complicated and time-consuming that new models are needed, he said.

ePharma Summit West features a number of sessions focused on getting the most from social media, not only through speaking, but also through listening. Join us for sessions such as Partnering with Patient Advocates and Consumer Opinion Leaders, Patients Take Center Stage: Extending Quality of Life Through the Shift Toward the Consumer, and Dr. James Fowler's keynote presentation "Connected: The Power of Social Networks on Life Sciences and Health." Register using the code XP1656BLOG and save 10%

Paul Wicks, a co-author of the paper, said social network-run studies may be most useful for testing efficacy of so-called off-label or off-patent compounds that patients are using but are unlikely to ever attract pharmaceutical company interest.

More than 4,300 patients are on the PatientsLikeMe ALS site, where they frequently share information on how their disease is progressing and strategies they are using to fight it. Jamie Heywood, chairman and co-founder of PatientsLikeMe, said the idea for the new study came from patients. After the 2008 paper reporting lithium slowed down the disease in 16 ALS patients, some members of the site suggested posting their experiences with the drug in an online spreadsheet to figure out if it was working. PatientsLikeMe offered instead to run a more rigorous observational study with members of the network to increase chances of getting a valid result.

The company developed a tool to standardize collection of patient data, including lithium blood levels in patients. They used a questionnaire from conventional ALS trials to gather patients' self-reported data on functions such as swallowing, walking, and breathing.

Mr. Heywood said the result was apparent nine months after the study was launched. Conventional trials typically take more time just to enroll patients, he noted. Costs for drugs and recruiting patients were avoided.

Merit Cudkowicz, an ALS researcher at Harvard Medical School who was an investigator on a standard lithium clinical trial, said social network-generated data can offer valuable insights, but she cautioned that the PatientsLikeMe study was not a substitute for more rigorous studies. Two conventional on-going ALS studies are designed to see if lithium has a very small effect on survival, something the PatientsLikeMe study wouldn't be able to pick up.

Thursday, April 21, 2011

How Will Impending Facebook Changes Affect Your Product?

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Could changes be coming to Facebook pages that could heavily affect the Pharma industry soon? At ClickZ, they report changes that could soon be coming to Facebook that would not allow companies to disable the “Comment” feature on pages. While this is just a rumor, should it be true, Pharma marketers would face high regulatory scrutiny from the FDA, even though they still haven’t set guidelines for the use of social media mediums like this one.

The main point of concern in the article is the possibility that the Facebook users will post adverse affects of the drugs, which are then required to be reported to the FDA. Would this be your main concern for Facebook pages promoting your Pharma products? Would this hinder Pharma’s marketing advances into social media platforms?

ePharma West offers sessions led by regulatory experts to help you deal with the ever evolving world of social media. Lucy Rose of Lucy Rose & Associates and Peter Pitts of Porter Novelli will share their experiences with the FDA to give you a preview of what you can expect when regulations are actually released. You can also hear from Dr. James Fowler, author of “Connected,” as he discusses the impact of social networks, like Facebook, and the influence they have on ourhealth, tastes, happiness, and even weight. Join us July 25-27th to hear these topics and more at ePharma West. Mention the code XP1656BLOG when registering to save 10%.

Tuesday, April 19, 2011

AMA challenges doctors to come up with the next App

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Over a quarter of all doctors using tablet devices and two-thirds are using SmartPhones to research medicine and conditions, checking email and taking online surveys. According to BizReport, this has lead the AMA to create their first App for doctors, The CPT® E/M Quick Reference App. In addition to this new app, they are challenging doctors and medical students to suggest ideas for the next big idea that will lead to an app that can help doctors better use this new technology to their advantage.  What do you think it will be?  Weigh in on our poll below.

Wednesday, April 13, 2011

See the future of technology at ePharma Summit West

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How will rapidly developing technologies such as low cost genomic sequencing, artificial intelligence, telemedicine, robotics, 24/7 body wearable monitors, smart pills, stem cells, synthetic biology, gene therapy, social networks, gamification of behavior, and crowd sourced health data affect the future of healthcare pharma and medicine?

Singularity University is pleased to present FutureMed, an Executive Program, to be held May 10th-15th on the NASA Ames Research Park in Silicon Valley. FutureMed is the first program of its kind; a multidisciplinary, immersive and hands-on experience uniquely designed for those interested in exploring the future of health, biomedicine and convergent exponential technologies.

FutureMed educates and prepares physicians (CME Credit provided), senior health care executives, entrepreneurs and investors to understand and recognize the opportunities and disruptive influences of exponentially growing technologies. These game changing technologies and innovations have great implications in medicine, healthcare and the biomedical industry in the decade ahead.
Join Singularity University at ePharma West
Daniel Kraft, MD.,
Chair of Medicine Track and FutureMed Program at Singularity University and Bob Harrell, Director of Integrated Marketing, Shire Pharmaceuticals will be speaking at ePharma West to give us an idea of what the future holds for the pharmaceutical industry. This fascinating talk will explore how exponential technologies will change our world, from 3-D printing to social networking. Click here for a preview
Core tracks include those which will explore the exponential trends in Information/Data-driven and internet enabled health care, Genomics and Personalized Medicine, Regenerative Medicine, Robotics & Future Interventional approaches, NeuroMedicine, Device & Drug development, and Entrepreneurship. Talks, Workshops and site visits will be led by a mix of world class faculty from across the biomedical and healthcare spectrum. A fun video primer is here on YouTube as well as a 2 minute introduction to FutureMed and a recent 'Future of Medicine' TEDx Talk by FutureMed's Executive Director, Daniel Kraft, MD.

Singularity University was Co-Founded by Ray Kurzweil (futurist, inventor, and author of The Singularity Is Near) and Peter Diamandis (Chairman & Founder of the X-PRIZE). SU’s mission is to assemble, educate and inspire leaders who strive to understand and facilitate the development of exponentially advancing technologies, in order to address humanity’s grand challenges.

Please visit the FutureMed website to learn more and to register to attend.
-Follow FutureMed on Twitter (@FutureMedTech)

Friday, April 8, 2011

UK gets social media guidance. Are we next?

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The UK’s Code of Practice regulator has issued guidance on social media and other digital communications tools.

It is the first time an industry regulator has addressed the area so directly and comes ahead of US guidelines from the FDA, which have once-again been delayed. The PMCPA has put together a Q&A document to explain how digital communication fits into its existing regulations. It took this step, rather than amend UK pharma’s self-regulatory Code, because “there have been few complaints about digital communication”.

The Q&A document explains the place of digital communication tools within the existing rules, which ultimately comes down to companies can use digital media if they stick to the Code. It also adds particular emphasis on the Code’s existing ban on promoting prescription-only medicines to the public. “Therefore, pharmaceutical companies need to identify ways of utilising digital communications whilst complying with this restriction."

The 1st annual ePharma Summit West will feature speakers with extensive first-hand knowledge of FDA proceedings such as Lucy Rose of Lucy Rose and Associates or Peter Pitts, Former Associate Commissioner of the FDA. Click here to download the brochure and be sure to mention code XP1656BLOG when registering to save 10%.

The Code of Practice applies to the promotion of medicines to healthcare professionals and to the provision of information about prescription-only medicines to the general public. It covers any kind of communication – from sales rep visits to doctors to public awareness campaigns. The PMCPA’snew Q&A document covers the use of Twitter, blogs, meta data in search engine optimisation, online meetings and linking to non-company websites. It introduces to the Code a “limited new use for [providing] reference information – a proactive use rather than a reactive use”. This is in the context of allowing a company to refer Wikipedia readers to its own information about a medicine via a link to “an appropriate landing page”. The document also notes that digital communication is a developing area and counsels pharma to bear in mind not just the letter of the Code but also the spirit in which it is intended.

Some highlights from the document include:

Can pharma use social media to communicate with healthcare professionals?

This is “very likely” to be seen as promotion under the Code if it covers prescription-only medicines. This would be allowed on social media, as it is in a face-to-face meeting with a sales rep, but companies would have to ensure only healthcare professionals could see the communications and the recipients would need to have agreed to receive the information. Singling out Twitter for special attention the PMCPA said: “Given these restrictions and the character limit on Twitter, it is highly unlikely that the use of this medium to promote prescription-only medicines would meet the requirement of the Code.” It also notes that using Twitter to alert  healthcare professionals about “the publication of a study on a medicine is likely to be considered promotion of that medicines”.

Can pharma use social media to provide information to the public?

“Yes, providing the material complies with the Code – particularly Clause 22.” Clause 22 of the Code deals with relations with the public and the media and includes bars on advertising prescription medicines to the public and responding to individuals’ requests for with medical advice.

Can companies correct Wikipedia articles?

“Simple cross referring to the regulatory documents such as SPCs and PILs either on a company site or to the eMC, would not be considered to be unreasonable.” It suggests a simple “more information is available in the SPC or PIL” is probably better than referring to a particular section of those documents.

A pdf of the Q&A document can be found here.

Wednesday, April 6, 2011

View the Presentations from the ePharma Summit

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Want to see the presentations from the 2011 ePharma Summit which took place this February in New York City? All attendees are able to access ePharma Connect, our exclusive online networking tool. Simply log into your profile, and select the presentations tab.

View presentations from our three workshops, Thomas Abrams of the FDA, and our esteemed faculty of speakers from companies like AstraZenecaBayerBristol-Myers SquibbBoehringer-IngelheimMilleniumPfizerMerckShire PharmaceuticalsNovo NordiskPurdue PharmaViroPharmaDaiichi SankyoVertex PharmaceuticalsJanssen PharmaceuticalsAton PharmaAstellas PharmaGlaxoSmithKlineTakeda Pharmaceuticals.

If you didn't attend the ePharma Summit, you can still gain access to these informative presentations. Register for ePharma Summit West taking place this July in California and you'll get instant access to all the presentations as well as direct access to 400 attendees from our east coast event. Create a personalized agenda, connect with attendees and speakers from both events and get your company noticed before you even get on the plane. 

Click here to download the brochure for ePharma Summit West  Register before May 6th to save $500 and mention the code XP1656BLOG to save an extra 10%. 

Tuesday, April 5, 2011

The Sales Force of the Future: Progressive and Digitally Active

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New dynamics within the pharmaceutical industry are requiring a paradigm shift in the current business model. The focus should now be on reinventing -- rather than just re-engineering -- the personal sales approach. In order to continue to be successful, pharmaceutical companies need to redefine how they service their clients.

Virtual Pharma Rep Direct Connect 360 solves the problems of the traditional pharmaceutical sales model by employing a new Internet-driven approach that will engage clients to fulfill their educational requirements and service expectations. It focuses on the desires of clients rather than on products, and builds dominant relationships through personal, convenience-based real-time online interactions.

ePharma Summit West will give you insight into the future of your sales force with interactive sessions including "The Sales Force of the Future: Progressive and Digitally Active" and "Seamless Integration of E-Initiatives into your Multi-Channel Media Plans." For more on the ePharma Summit West program, download the brochure here. Be sure to use the code XP1656BLOG when registering to save 10%.

The features of Direct Connect 360 render contact efforts vastly more effective for both parties, with greatly increased participation, yet at a greatly reduced cost for pharmaceutical companies. Embracing industry changes and stepping forward to become a part of the process will yield great rewards.

Jim Rediehs, CEO and Co-Founder of Virtual Pharma Rep™, explains, "Solving the current challenges in providing education and knowledge to physicians and enhancing the all-important pharmaceutical-to-physician relationship were our goals, and we are extremely excited to introduce these new communications strategies to the industry."

Virtual Pharma Rep's Direct Connect 360 program will meet and surpass clients' needs while saving them significant money to assist current representatives in obtaining their goals, filling white space or utilizing the program as a complete sales system with measurable growth outcome.

The Virtual Pharma Rep™ white paper titled "Sustainable Success in Pharmaceutical Sales and Marketing" examines the current state of pharmaceutical sales and how technology and changing physician behavioral conventions are creating opportunity for a fundamental shift in the classic sales model. Get access to the white paper by visiting

Monday, April 4, 2011

Ogilvy Healthworld UK and OgilvyAction Combine to Create Ogilvy Digital Health

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Ogilvy Healthworld UK has combined expertise with sister company OgilvyAction to create a new marketing consultancy called Ogilvy Digital Health.

Caroline Howe and Simon Stebbing have been appointed managing partners for the new unit, which will benefit from both of its predecessors' practices and technology resources.

Ogilvy Healthworld and OgilvyAction have worked together in the past to conduct campaigns on behalf of companies such as Pfizer, GlaxoSmithKline and Roche.

Ms Howe said: "Ogilvy Digital Health will further drive and develop the digital healthcare capabilities of clients to reach both consumers and professional audiences."

Ogilvy Healthworld merged with CommonHealth last year to create a joint entity called Ogilvy CommonHealth Worldwide, though it maintains the Ogilvy Healthworld identity in many regions.ADNFCR-8000103-ID-800486612-ADNFCR