The commentary included in the law echoes industry concern that more clarity is needed to ensure that preemption is not applied ‘too narrowly’. While the law may not be the best news for pharma, “it’s better to have one burdensome statute than to have 50 different ones with variable impacts; a statute that at least imposes  uniformity across states has value,” as John Kamp, Executive Director for the Coalition for Healthcare Communication put it to Pharm Exec. CMS responded to the issue by promising guidelines to clarify the preemption requirements, while at the same time adding a confusing caveat that state preemptions would be evaluated on a case-by-case basis. Kamp warns, “This case-by-case clause is a flag to industry that says, ‘This may not be over’.” Such a contingency gives the CMS the flexibility to gauge how Federal Reporting actually works and then to adjust its actions accordingly, versus simply living with the reality of what States currently do in their own reporting.

Alternatively, The Sunshine Act may have the effect of doing away with the clash that state laws present against the status quo in Washington. In January, Minnesota repealed its physician payment disclosure laws in anticipation of the Sunshine Act’s release. “There’s an element of logic that dictates states will fall back on the federal statute and reinforce the complexity of Sunshine as it is,” says Saul B. Helman MD, Managing Director and Life Sciences segment leader at Navigant Consulting, a company that advises life science companies on issues of compliance.

“On the other hand,” he counters, “states may realize that they require disclosure for payments that are not included in the federal Act, or that they may require different thresholds and additional areas of reporting.” For instance, if a state decides that CMS’ defined list of teaching hospitals fails to include facilities that that state’s government pays for to provide services, more specifically the prescribing of medical products, it may prompt further requirements to be introduced. As Helman puts it, there’s an ambiguous ‘wait and see’ period as to how states will respond on this issue.

The bottom line is that compliance remains a dynamic area, especially with the possibility of stepped up international requirements being introduced to the mix in the future.  For now, the Act urges that companies continue to comply with state and local authorities in their reporting requirements until August 1st, when the federal requirements take effect.

In the 12 month period to June 2012, Russia’s promotional spend increased 42% in comparison with the year before, followed by China with a 30% increase and Brazil with 22%. Commenting on the rising tide, Christopher Wooden, VP of Global Sales at Cegedim says, “In the last 18 months or so, these markets have leapfrogged some of the more conservative markets in Europe such as Spain and France in their use of digital.” This quick embrace of internet, mobile phones and even social media by physicians,  Wooden reports, is the result of laxer regulatory environments in emerging markets; by comparison, slower adopters in Europe are often simply suspicious of these platforms.

Nevertheless, markets across the board will see rises in digital spend, as digital channels are less costly in times where budgets are tight.  As Wooden points out, “the next generation of doctors just starting to practice are much more open to digital channels, because they’ve been exposed to it early on.” This trend, however, depends on how well drug companies adopt these technologies and integrate them into existing functions and organizational structures.  It remains a challenge to design and implement the tools in a seamless way.

The survey also points out that while digital spend is seeing an increase; companies are not necessarily scaling back on the more traditional methods of drug promotion. Sales representatives have a well-established share of the budget because physicians, who in a sense act as savvy consumers, want face-to-face interaction when weighing the decision to prescribe a new medicine. Spending has been diverted from more traditional channels not because they are less effective, but as a result of emergent technologies. So, in essence, pharma is still figuring out the perfect mix of channels, new and old, best suited to getting that brand noticed, in front of physicians.

How can the emerging field of data science help to fruitfully translate research and discovery into successful drug development? Academics and pharmaceutical executives at Mount Sinai’s School of Medicine discussed ways to build a bridge across the valley of death, and the growing importance of data across all business areas.

Academic institutions are good at identifying and planting seeds with the potential to flower, eventually, into life-saving medicines and devices. The National Institutes of Health, as a primary source of the fertilizer needed to germinate these seeds, has helped enable big pharma to focus on what it does best: middle and late-stage drug development and commercialization.

The path from discovery to product development, however, often detours into a “valley of death,” where academic research and early-stage clinical programs languish in the shadow of risk. Some academic institutions are addressing this problem by “building the infrastructure necessary to better demonstrate” the potential value of an early stage program, said Uwe Schoenbeck, chief scientific officer for external R&D innovation at Pfizer. Schoenbeck said Pfizer’s Centers for Therapeutic Innovation (CTI) is finding ways to work together with academic investigators to achieve better results.

Asked about the most frustrating aspect of collaborating with academic organizations, John Sninsky, VP, discovery research at Celera, a molecular diagnostics firm, said that academics can sometimes “overestimate the value of what has been done, in the context of what still needs to be done” to bring a drug or device to market. Noting that “IP is central to our existence,” Paul Stoffels, worldwide chairman of J&J’s Janssen Pharmaceuticals division, said, “If we’re spending between one and four billion dollars [to develop a drug], IP must be protected.” IP rights don’t come cheap, of course. In the antibody space specifically, Stoffels said “the cost of goods is becoming unbearable” when royalties start stacking up. Nowadays, companies pay 15% or more in royalties on the sales of most new drugs, said Stoffels.

Muzammil Mansuri, SVP, Gilead Pharmaceuticals, noted that a lack of exit options for venture capitalists (VCs) represents a key dilemma to financing early stage development programs. “Conditional exits mean less money up front,” said Mansuri. Pharma, VCs and academia “need to take the risk together,” he said.

In his keynote speech at Mount Sinai’s SinaInnovations conference this morning, Jeffrey Hammerbacher, formerly head of Facebook’s data team and co-founder of Cloudera, an open-source software firm, said healthcare is witnessing a “manifest destiny for data,” which will expand not from sea to shining sea, but from “atom to shining bit.” Ever-growing data sets and analytics are coming, so companies can either “ride the wave or complain about it, and get washed up.”

Hammerbacher, who recently joined Mount Sinai’s School of Medicine as an assistant professor, also stressed the importance of failure, a sentiment echoed later on by Stoffels. To illustrate his point, Hammerbacher referred to the Kremer prize in the UK, which offered a cash prize to the first engineer capable of designing an airplane powered by a single human being. Many engineering firms spent large sums of money to design and develop planes that, when tested for the prize, crashed into pieces. The engineer who finally won the contest, 18 years after it was first announced, won by taking a different approach to the problem, Hammerbacher said. “His approach was to design a plane that could be rebuilt quickly after it crashed, so that he could try out new ideas faster.” After failing in the initial tests, the engineer was able to quickly reassembled his plane, make modifications, and try again until he won the contest. “Building a harness for innovation, in order to fail quickly and try again,” is critical, said Hammerbacher.

The need for transparency and trust in producing and sharing data, whether it’s for licensing deals or regulatory approval, also necessitates a willingness to fail, said Stoffels. Pharmaceutical companies should “create an environment where [scientists and researchers] can fail, and leadership stands up for them.” If people lose their jobs every time they fail, it creates a strong incentive to fudge the data, which is bad for everyone.

The three-day SinaInnovations conference was held at Mount Sinai’s School of Medicine in New York City.

Promotional spending in the category has steadily risen since 2Q 2011, and was approaching half a billion dollars ($466 million) in the first quarter of this year – up from $360.3 million in 2Q 2011 – assuming first quarter DTC spend in 2012 was similar to 4Q 2011 DTC expenditures, according to a recent report from Encuity Research.

During the first quarter of 2012, three of the four biggest-budget US product launches were diabetes drugs: Amylin’s Bydureon, Merck’s Janumet XR, and Boehringer Ingelheim/Lilly’s Jentadueto, respectively. Combined with Boehgringer Ingelheim/Lilly’s Tradjenta, which received FDA approval in May 2011, and Merck’s Juvisync, which launched last October, these five diabetes drugs represent 23% of the total promotional spend for the diabetes market overall. However, brand teams working on these five drugs came to different conclusions about which media channels to prioritize with physicians, and sales figures differed – at least in part – as a result.

Twenty-four percent of first quarter spending in support of Bydureon, which received FDA approval at the end of January, went to meetings and events, and sales grew from $5.3 million to $27.7 million by the end of 2Q, according to IMS Health data. Juvisync – a Januvia/Zocor combo product – launched during 4Q 2011 with a $24.5 million professional spend during that period, but lagged behind the others in sales. Juvisync earned just $557 thousand during 1Q 2012, and $683 thousand in 2Q, according to the IMS data. It’s worth noting that Juvisync spent more on e-promotion than any of the other five launch brands, according to the Encuity report.

Professional spending in support of Tradjenta, the high roller of the bunch, topped $40 million during May to July, over 70% of which went to sales details, and very little of which went to e-promotion, the report found. Tradjenta’s sales in the US jumped 23%, from $25.8 million in Q1, to $33.7 million in Q2, according to IMS data.

Do these figures suggest that budgets focused more on face-to-face interactions, at meetings and in physicians’ offices, provide a stronger ROI? There are many factors involved in a drug’s performance, not least of which are efficacy, safety, price and reimbursement. The patient perspective is particularly important in diabetes as well, since dietary management is a crucial aspect of any treatment regiment. With respect to engaging physicians at launch, most companies are introducing their new drugs in person, and are posting solid returns on the balance sheet, despite a crowded market.

by Elizabeth Hollis

The FDA and the Advanced Medical Technology Association (AdvaMed) gave cardiovascular device manufacturers plenty to think about over the holiday weekend with information presented at an Aug. 28 workshop. The two bodies came together to explain requirements for 30-day notices and annual change reports for Pre-Market Approvals (PMAs), an important gateway to medical device access and commercialization.

The six and a half hour meeting tackled a wide range of topics, from the role of risk assessment to supplier changes as agency officials attempted to shed more light on when companies need to submit 30-day notices for manufacturing changes. Those changes that qualify for a 30-day notice submission affect device safety and effectiveness and either the manufacturing procedure or the method of manufacture. But device manufacturers must beware; a 30-day notice containing inadequate information could face conversion to a 75-day Humanitarian Device Exception (HDE) supplement or a 135-day PMA supplement. In these instances, the company will need to offer additional information or take further actions in order for the FDA to accept the change.

FDA announced the workshop in the Federal Register on Aug. 13, took many months to prepare and came more than a year after the FDA issued guidance explaining what changes qualify for 30-day notices and which ones do not. This meeting also came as the agency prepares to move 30-day notice reviews from the Office of Compliance to the Office of Device Evaluation (ODE), with the cardiovascular devices division piloting the program.

As Lindsay Pack of the Center for Devices and Radiological Health noted during the workshop, nothing will change in terms of the 30-day notice content. However, companies should keep in mind that the same reviewers who went over its original PMA will now evaluate the 30-day notices. Explaining risks will be critical; test set-ups and acceptance criteria may be challenged.

Pack also emphasized the need for clear, concise writing to ensure reviewers know what’s being changed right away. Exclude extraneous facts that won’t help the reviewer.

The FDA hopes the implementation of this “total product life-cycle approach,” for 30-day notices will run smoothly, as Christy Foreman, director of ODE, told workshop attendees. But both a lack of understanding and inadequate data-sharing seem to have caused frustration on all sides. During the meeting, FDA staffers emphasized the need for companies to use risk analysis in justifying their submissions in either 30-day notice or an annual report. ODE’s Erin Keith noted that although she had not worked with the cardiac industry during her time at the Office of Compliance, other device segments’ grasp of the use of risk analysis to justify their manufacturing changes was “pretty non-existent.” Echoing her frustration was Pack, who said companies often didn’t include an explanation of the risks driving the testing of changes. “I almost never see that laid out,” she said.

However, some companies may think that sharing too much data could get them “penalized,” a fear Pack tried to assuage.

Still, cardiovascular device makers seem to be gaining a firm grasp of what should be included in a 30-day notice, as Bill MacFarland of CDRH’s Office of Compliance noted. He recently looked over the numbers and saw, on average, that cardiovascular 30-day notices were converted to 135-day supplements 14% to 25% of the time. This year, however, that number has tightened to 8% to 11%, figures that he attributes to program maturation and increasing experience of reviewers. On the flip side, industry executives are increasingly putting themselves in the shoes of reviewers. For example, they are including narrative, pictures or drawing to illustrate the manufacturing changes to make things more meaningful for reviewers.

According to the FDA data through April 2012, the agency has determined that a few submissions did not qualify as 30-day notices. While this number has generally been four or fewer for each month, March saw 10. Still, quite a few are completed in 30 days or less each month. A total of 691 were completed between October 2011 and April of this year, according to FDA data.

Other meeting presenters highlighted an area in which device manufacturers seem to get hung up on whether to submit changes in an annual report or 30-day notice: equipment and software changes. As AdvaMed’s Melanie Raska noted during her presentation, a number of companies have seen their equipment changes converted from annual reportable to 30-day notices — something one of the association’s working groups noted. It formed a subgroup to examine the situation and how to resolve it. She shared several points manufacturers should consider when trying determine if a 30-day notice is needed:

1) Does the software directly affect the manufacturing process?

2) Does the change impact a process control?

3) Does the change impact accept/reject activities?

4) Are you changing the specifications or process parameters?

Interested parties have until Sept. 26 to submit comments pertaining to the issues discussed at the meeting.

Elizabeth Hollis is a former editor-at-large in the life sciences group at FierceMarkets, covering the medical device sector, among other areas.

It’s rather refreshing, in these gloomy economic times, to attend an event that bucks the trend for austerity, and the Pharmaceutical Contract Management Group (PCMG) annual conference last week certainly did that. For the last four years of its eight-year history, the meeting has been held at locations rather quaintly described by its current chairman Andy Parrett as “by the sea”. This year saw it unfold at the Sheraton Pine Cliffs Resort in Portugal’s Algarve, amidst a playground of golfers and well-to-do sun seekers. Parrett asserts that “if it’s in a nice location and they are enjoying themselves, people will take home a lot more from the conference”. By the end of Day One I could see his point.

But content plays a big part; fortunately, the content was also very refreshing. On the agenda was innovation: Where is it in the client-vendor interface space? Is it really adding any value? Can it really be made sustainable? And, not least, is the CRO industry actually being more innovative than pharma?

From afar this might not look earth-shatteringly new, but PCMG like to turn things on their heads. This was apparent from the first morning when Parrett’s own presentation declared “the term ‘strategic partnership’ is an oxymoron”. This set the tone for the rest of the conference: it wasn’t going to be your usual two days of dry statistics, articulate griping and bouts of sober self-congratulation.

Many in the CRO camp (the conference adheres to a strict ratio of two CRO delegates to one pharma delegate) went on to emphasize the innovations achieved in the industry. Josef Von Rickenbach of Parexel noted the transformation of the business from “a kind of art” to an industrial process and pointed out the progress made in forecasting budgets for large clinical trials. Others talked about the CROs’ ability to do more with less, and waxed lyrical on the benefits of knowledge transfer. But the industry failed to win the day in the Oxford-style debate, provocatively titled, ‘This House Believes CROs are the Source of All Innovation” (which, admittedly, was quite a claim to live up to). Arguing from the pharma side, Craig A. Coffman of Endo was more convincing when he said, “Don’t lay the blame for lack of innovation at the feet of the CROs. They’re just a mirror image of what’s going on in pharma.”

So this was no big pat on the back for CROs. Indeed, IT processes came under fire, with their tendency to “over-promise”. John Bennett of JABPharma said CROs should limit or eliminate the need for accurate predictions when producing forecasts because it just can’t be done with accuracy in complex trials. And PCMG’s founder Mike Sitton had plenty of provocative things to say, such as CROs are not transparent enough, business development directors are paid too much, and the large organizations don’t treat mid-size pharmas as well as they treat Big Pharma.

Speakers such as Sitton and Professor John Seddon embodied the overall sense of a desire to puncture the conventional thinking on any topic; they got away with making quite controversial statements, albeit with a degree of mischief. (This is the first time I’ve heard the ‘F word’ used so casually in a pharma industry presentation — and I’m not talking about ‘FDA’.) “I’m not sure I’d call it courting controversy,” Parrett told me later, “but challenging the way we think is definitely important for us.”

The inclusion of Seddon, an occupation psychologist by trade and now a self-styled “management guru”, was  likely to shake things up a bit. PCMG is always keen to include speakers from external industries and academia as “people aren’t often aware of the benefits of crossing over different streams of thinking,” explains Parrett. “It’s not necessarily to import ideas from one industry to another, but we should be looking at where there may be overlap and be thinking outside the box.” Parrett mentions his own background in genetics. “I was interested in evolution, for example, and that alerted me to the crossover between the teachings of Darwin and psychology.”

How about Professor Richard Dawkins for next year then, I ask. Parrett laughs: “We do aim high as far as speakers are concerned, but obviously it comes down to what we can afford.”

Whatever that will be, it seems the ‘anti-austere’ approach will still hold as regards next year’s conference location. I hope I get an invite back.

John Lechleiter

Following his keynote address last week at the Financial Times US Healthcare and Life Sciences Conference in New York, Eli Lilly CEO John Lechleiter huddled into a corridor to speak with PharmExec about his agenda as incoming chairman of PhRMA, and how to fix innovation.

Ben Comer: Will PhRMA endorse a presidential candidate?

John Lechleiter: It’s not been our policy to endorse political parties. We support individual candidates who support our positions. We’ve been clear about what we think the important policies and legislation  are: those that at enable us to do the work of medical innovation, to make our products accessible and affordable for the people who need them, and that promote a balance between incentivizing new effective medicines and ensuring safety, which is very very important. I think in recent years you’ve seen evidence that we’re able and willing to work with people on both sides of the aisle to help achieve those ends.

The US leads the world in biomedical innovation, and we like to think we’re among the first to benefit from that innovation as well. That’s really at the heart of what we aim to do to keep this industry strong. And a strong industry will also control the rising costs of healthcare. We know that if medicines are  properly used, they will offset or eliminate other cost burdens; at  10 cents on the dollar, which is what medicines comprise as a percentage of total healthcare [costs], these are a great bargain. We want to make sure that the ecosystem that supports medical innovation is not undermined by wrong-headed policies.

BC: Do you have a wish list of changes to the health reform bill?

JL: I think the major thrust of our activity subsequent to the passage of the Affordable Care Act in March 2010  has been to call for the repeal of the Medicare spending advisory board, IPAB. We’re not alone. As laudable as the  objective of controlling costs might be, we believe it’s a system that is just not going to work. It’s not going to serve the interest of patients; it’s certainly not going to accelerate progress in medical innovation.

BC: Polls show the American public looks at this question and says, well, price controls on drugs is a great idea.

JL: There is a tendency to look at price controls or controlling input cost as some sort of a solution.  But every time we try that experiment it backfires; we’ve seen that at the state level. The mirror image of that, on the positive side, is Medicare Part D. This is a program where the discounts that the system reflects in cost savings are negotiated between third party payers and the pharmaceutical company; we compete to get on Humana’s or UnitedHealth’s Part D formularies.  The estimated costs of Part D over this 10 year period has dropped by $40 billion because of this market-driven approach, which also means  that more and more medicines are available as generics.  Access thus comes at much lower cost.  Our conclusion?  The market works.  At the same time, I think we have to adopt a mindset that says while we do want people to  access our medicines, no one should  stand between them and their doctor on a decision about what’s the best medicine. Again, our industry role in Part D scores high because  seniors in most Part D plans pretty much have access to the full formulary.

BC: What is the industry contribution to addressing the debt crisis in Europe?

JL: We’re paying a certain price already, with challenges we have on receivables in certain countries, on arbitrary price cuts and a more stringent application of cross-border therapeutic reference pricing.  Germany has  a new system in place for a little more than a year  that we believe works against innovation by setting very stringent access controls for new medicines, in some cases comparing new medicines to very old and largely antiquated off patent drugs. This does nothing to reward innovation. Despite that, given the chance, we can demonstrate that the new medicines that we’re producing do add value, and save money in the long term. The evidence is there but it is not always reflected or accepted in the systems of health technology assessment adopted by many European countries, led by Germany and the UK.  The UK is rethinking its system, and we’re going to have to look at that very carefully.  The goal is to work diligently with the NHS to make sure  the UK remains a place, as it has been, that rewards innovation.  It’s in the interest of all parties to continue to foster a viable R&D industry in the country.

BC: In your keynote, you spoke about the importance of the long term, and taking the long view as a prerequisite to innovation. Are there any ways that investors or other stakeholders might be persuaded to take a longer view, and are there any emerging financial tools or tax restructurings that could be brought to bear on that?

JL: That’s a good question. Certainly we’ve argued, when we get back to this notion of innovation as an ecosystem, that tax policy is very important. Domains for establishing tax liability is a key concern, as is making the US R&D tax credit permanent.  Right now, unless it’s reauthorized later this year by Congress, the credit will  expire. Other countries have permanent and frankly more robust R&D tax credit systems, so that’s one thing we need to look at. As far as  other structural ways of incentivizing innovation, I think at the end of the day the biggest incentive for any investor, whether it’s a venture capitalist or whether it’s a person deciding whether or not to buy Lilly stock, is a level of confidence that new medicines can be taken through a clear and well-defined pathway, with the prospect at the end – if it’s successful – of being rewarded by gaining access to patients and being able to price the product at a level commensurate with its value. That is the number one incentive for anybody wanting to invest in this area, versus investing in automobiles or steel or Facebook. Capital is scare and investors do have a choice. So while I think the tax structure is important – we like other industries  argue for a territorially-based approach – I don’t think that’s decisive in our case. It has to be evaluated in terms of the broader investment environment.

BC: Is there one overriding action that could be done to fix the innovation problem?

JL: There is no magic bullet. We’ve talked about IP  protection: we should have longer data exclusivity guarantees and better enforcement of global standards in other countries.  We need regulatory systems that are timely, consistent, predictable, and scientifically based. Opportunity for access and market-based pricing are key incentives as well. There are other things in the constellation:  immigration reform is one.  It’s hard enough for us to hire the best scientists, who may happen to be foreign born and who went to US universities; but then we have to fight to keep them here. Why do we want them to go back to China and compete against us? Or the K-to-12 education system in this country; if it doesn’t improve in science and math, it’s going to undermine our competitiveness even further. There are primary elements and secondary elements, but I think patent data protection, regulation, market access and market-based pricing are probably, from a policy domain, the areas that represent the biggest levers, where we will need to continue to do the most work.

We see some progress in Japan, the second biggest drug market in the world.  It recently ended its traditional approach of cutting prices every two years for new innovative products. So now we have the hope that there will be greater price stability in Japan for new patented products as they’re introduced, which is a tremendous incentive for us to invest more there. The government  also recognizes that  a lot of medicines approved outside of Japan have never been approved in Japan, so they want to close that drug lag. Specifically, they’ve said their regulatory system needs to become timelier, consistent, predictable, and science based. Dr. Hondo, the official  who runs Japan’s registration authority,  has hired more reviewers, review times are now more predictable, faster, more thorough, better communication with the companies.  This is real progress.  What’s happened as a result is that Japan is getting more medicines in a time frame that’s more consistent with the rest of the world.  The lesson is what  happens when you look at these levers I’m talking about, and make the changes required. You see more clinical trials taking place  in Japan and more new drugs are being approved, many of which are already on the market elsewhere. So reforms can  work.

BC: On Lilly. Do you have any thoughts on research work with academic institutions in terms of the value of those relationships?

JL: The traditional model of academic industry collaboration is evolving and that’s a good thing. Companies and academic institutions are taking different approaches. I think we have to recognize that t academic institutions have different cultures, and different approaches that they want to pursue consistent with their own mission.  This is a refreshing contrast from the  traditional quid pro quo:  here’s a certain amount of money, you do a certain amount of work, and we’ll see if we like what comes out or not. Through our open innovation platform, Lilly is partnering with over 200 universities, research institutes and biotechs around the world, to open our laboratories up as a way of testing molecules that these institutions synthesized or developed. A range of screens provide confidential data t that remains the intellectual property of the submitter. What we ask for is the first right to negotiate a deal, and we’ve struck several of these already, so this is one way that we are establishing a fairly broad connection with academic labs around the world. Other companies have chosen to do broader and higher-dollar cost partnerships.  Likewise, I think the tightening of funding at the NIH has caused academic institutions to think more positively about the merits of doing things with us, in  new ways.

BC: With respect to outsourcing, what are the core functions that shouldn’t be outsourced, if any?

JL: At Lilly, what’s most important is to maintain a strong in-house research enterprise.  Even if we partner and collaborate with universities or other research partners around the world, we must maintain a critical mass of world class scientists who are really expert in the therapeutic areas we intend to focus on. In development, we’ve shown in the last decade that we can bring partners in to many different parts of the cycle. Again, I think we aim to retain a core base of functionality where, beyond a given project, we will understand not only how the processes works – this is that embedded knowledge that is so important in this industry – but also to understand how we can improve on that and really drive improvement over time.

BC: What’s Lilly’s most exciting product stream? Is there a transformative therapeutic target for the company?

JL: The key therapeutic areas of focus remain neuroscience, diabetes and cancer. We also have a very promising program in autoimmune disease, and a presence still in bone disorders and bone and muscular/skeletal disease. I think we’re very competitive across a whole number of different kinds of targets, and today we have twelve molecules in phase 3 that are good representatives of all of these therapeutic areas, and 11 of those were discovered in our laboratories. That’s an indication of  what we think is a new upsurge in productivity.

In 2011, the patient’s clout as a stakeholder was firmly established, as reflected in several industry conferences. What’s next for the patient in 2012?

In 2011, many healthcare organizations came around to the idea that patients should be included in discussions that had customarily taken place about them, but without their direct participation. This shift was evident at several healthcare conferences last year, and bodes well for 2012 as a year when further overtures – and partnerships – will be formed with and between patients.

Health2.0

The Health2.0 conference in San Francisco brought a deluge of innovation and shiny, new healthcare applications. Data plus IT and innovation represent the future of healthcare, and individual patients are a critical component of this equation (not just their data). This was a key theme of the Health2.0 conference. “Patient stories” have often been highlighted at conferences, and used as bookends to infuse a dose of reality to educational sessions.  What impressed me about the Health2.0 conference was the inclusion of patients and caregivers in the conversations, allowing for bi-directional exchange. Patients2.0, an offshoot of Health2.0, is a movement that aims to revolutionize healthcare delivery around the patients. The goal is to leverage the Health2.0 phenomenon and develop a hub for patients to exchange experiences through peer-to-peer networks, to obtain information, and most importantly, to have a collective voice in healthcare decision-making. By sharing stories, co-creating health data, and aggregating issues across the healthcare spectrum, the voices of Patients2.0 are empowered to be part of the larger conversation, and to exert influence on the health system by shaping future policy. Patients are the new healthcare disruption that can help transform the landscape, and using forums such as Health2.0 to involve them every step of the way is truly ahead of the curve.

Epatient Connections

The key theme at the Epatient Connections, held in Philadelphia, was that “Healthcare is Social.” Physician, medical and patient communities are forming connections through various social media channels, but there are a still a few less progressive entities a step behind as they figure out how to navigate uncharted regulatory waters. As connections are made, patients are becoming further engaged in their care as they learn from what others are doing. The key is to take those connections one-step further and bridge the various pockets of connection. There needs to be further inter-connectivity between patient voices, scientific publications, medical results and records, and medical education geared towards healthcare professionals, and these need to set the stage for a longitudinal data set. Patient engagement tools that were showcased included everything from health management tools to game-ification that integrated feedback mechanisms and incentives to an Internet enabled robotic telepresence, allowing immobile patients to interact with their healthcare community.

SXSH Unconference

The SXSH Unconference also took place in Philadelphia (Sharing, Exchanging, Social Health). Todd Park, CTO, US Department of Health & Human Services opened up the conference with an introduction to the Data Liberation initiative: New Incentives+ Information Liberation= Rocket Fuel for Innovation. Medicare, Medicaid, and the Veteran’s Administration represent the largest repository of public health data in the world. Patient data liquidity and information about the public health, stripped of personal identification, is being made available so that innovators can use it to create health-maximizing options.

2012

2011 was a year where a foundation for the “patient voice” was established as a critical component of the healthcare system. 2012 will be an even more important year, as healthcare organizations empower more patients by personalizing communications for individual patients. Patients are often overwhelmed with the amount of information they must retain to successfully manage their health. How will healthcare organizations come together to simplify navigation of the healthcare system? How will different healthcare systems, records and applications that serve different purposes connect with one another to prevent redundancy? How will patient stories be further synthesized and culminated into “patient issues” that a roundtable of healthcare sectors can further troubleshoot at future conferences? If 2011 was the year of dipping toes in the waters of “patient engagement” …2012 should be the year of swimming alongside others towards a unified goal—a year of patient engagement through an open network of inter-connectivity.

Sarah Krüg is CEO/executive director of CANCER101, a patient outreach and advocacy organization. She is also president-elect of The Society for Participatory Medicine.

Amidst yellow sandstone arches and California Mission Revival architecture, The Medicine 2.0 +Stanford Summit (otherwise known as the Fourth World Congress on Social Media and Web 2.0 in Health Medicine) set out on a three day journey to challenge its diverse audience to break down silos and expand beyond traditional boundaries. From a focus on research findings and scientific data to dialogue around the future of science, medicine and emerging technology, innovators and thought leaders congregated from around the globe at the state-of the-art Stanford venue, Li Ka Shing Center for Learning & Knowledge. Through the congress, Stanford extended an invitation for open scientific inquiries into the pursuit of teaching, learning, and research, in alignment with its motto. ¹

The energy in the room was contagious starting with the unique conference badges that featured personal QR codes (eliminating the need for business cards), lively twitter feed and building of a #med2 community (over 5,000 tweets!), to the theatrical presentations that conveyed unconventional solutions to healthcare issues. From theory to practice–patients, healthcare professionals, academics and executives discussed and debated concepts such as participatory medicine, patient self management, behavioral change, decision making, the quantified self, communities of practice, social networking, gamification, personalized healthcare, and innovation in medical education. There were so many interesting points made at Med2.0, but I’ve captured a few highlights below:

Abraham Verghese, MD eloquently walked us through the bedside ritual of examining the patient as a critical but threatened skill that is the foundation to the patient-physician relationship. He explained the potential of displacing the patient during the digital age and reliance on technology during the clinical encounter —with more emphasis placed on patient data, rather than the person being treated.

Jennifer Aaker, PhD delivered a brilliant keynote that demonstrated the impact of social media saving lives through storytelling, collaboration, and enabling the wider community to quickly act. The story began with 2 Indian men with AML in search of bone marrow matches and ended with 20,000 South Asians registering as a result of a powerful awareness and social media campaign. Attendees had the opportunity to have their cheeks swabbed and sign up for the Be The Match Registry during the break in the corridors.

The eclectic BJ Fogg, PhD shared his behavior change model which shows that three elements must converge at the same moment for a behavior to occur: B = MAT (Behavior = Motivation x Ability x Trigger).

Susannah Fox gave the closing keynote on the impact of “peer to peer healthcare” where patients are seeking and sharing health advice online. Roadblocks included pockets of offline patients, patients not motivated to engage in their healthcare, silo tools/communities, and lack of awareness of resources. Opportunities included leveraging the power of online caregivers, engagement prompted by life changing diagnoses/events, rise of mobile adoption, and emerging focus of technology that bridges silos and allows data flow. The beacons of change in these efforts include patient, clinician, and technology leaders.

There was a major focus on patient self management platforms in chronic diseases, the Quantified Self and use of digital devices to collect real-time quantifiable patient data, decision support tools to make informed choices, and gaming to change behavior by rewarding patients for meeting health related goals. With all the data being collected, the question is how do you give back the data to patients, synthesize, and set context in a way they can understand?

The use of technology as a catalyst in healthcare improvement was prevalent.  From the use of social media and mobile health tools by physicians to communicate and improve clinical workflow to the use of virtual community platforms by patients to share experiences, understand options and obtain social support–It was clear that patients and healthcare professionals are embracing the impact of technology—although not necessarily at the same pace. Patient online usage to share and obtain healthcare information is on the rise; however a research abstract (764) demonstrating physician attitudes towards social media for their own professional education and knowledge sharing showed that usage and intent to use is fairly low. Plagued with social media privacy concerns and associated risks, traditional modes of learning, and lack of clear guidance and policies—physician usage is growing at a snail’s pace in comparison.

There was a spotlight on the e-patients, of which 23 received scholarships to attend the conference. Each had a compelling story to tell regarding their personal but at times unfavorable experiences with the healthcare system and how they made informed medical decisions by becoming more empowered and engaged in their healthcare. These real life interactions crystallized key themes conveyed throughout the conference.

Larry Chu, MD was the skilled conductor of this colorful performance, which set the bar high for future Med2.0 conferences. We were each given the opportunity to challenge both established and new orthodoxies in healthcare, infuse innovation and creativity into potential solutions, and explore collaborations among the diverse Med2.0 community to make things happen!

Planning for the 2012 Med2.0 Congress is underway to be held September 15-16^th at Harvard Medical School. Stanford will also debut MedicineX in 2012 focused on the intersection of emerging technology and the future of medicine.

¹ Die Luft der Freiheit Weht-unofficial Stanford Motto, Ulrich von hutten, 16^th century

Sarah Krüg is executive director at Cancer101, a patient organization. She was previously Global Education Director in the Medical Education Group at Pfizer

Abram’s comments, made during a panel this morning at the Drug Information Association’s (DIA) annual meeting in Chicago, prompted audience members to probe Abrams, and his CBER colleague Lisa Stockbridge, branch chief of the Advertising and Promotional Labeling Branch, about specific policies governing online promotion. One audience member wondered whether unbranded, educational campaigns online could link to branded sites, or if that kind of activity would generate an enforcement letter. Abrams responded that his own question, in that instance, would be, “Why are you linking to a brand site?” if a campaign is designed specifically to educate about a disease, as opposed to a branded campaign designed to sell a product. When pressed, he said an educational or awareness campaign – which isn’t required to present risk information, since no drug is being promoted – linking to a brand site would “have to be considered on a case by case basis.” Industry has been browbeating DDMAC about issuing social media guidelines for years.

On FDA’s Bad Ad program, one audience member asked what sort of proof would be required to verify improper promotion by a sales rep, given that a discussion between a rep and a physician would likely be verbal and unrecorded. Abrams said that an extensive review of the complaint would happen before moving forward, and then a signed affidavit from the physician, testifying to what was said during a sales meeting, would most likely be required. John Kamp, executive director at the Coalition for Healthcare Communications, and moderator of the panel, wondered aloud about whether a sales rep making hundreds of calls a week would be able to recall exactly what was said during a specific detail. “Couldn’t a sales rep say, ‘I don’t remember what I said, but my training and common response in this situation would be X.’ Would that kind of [defense] fly?” asked Kamp. Abrams didn’t answer the question directly, but insisted that DDMAC was diligent in investigating complaints, and the circumstances surrounding a potentially illicit conversation.

Abrams also discussed a proposed update to Section 502(n) of the Federal Food Drug and Cosmetic Act (FDCA) dealing with “clear, conspicuous, and neutral” major statements, or legally-mandated statements on major risks associated with a given drug. The update was announced in March of last year, and deals with DTC advertising, specifically television and radio, said Abrams. One of the four proposals put forward by DDMAC would require that an “advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of a major statement.” Anyone who has seen a drug ad on television will recognize the target of this proposal; the last seconds of a DTC ad are typically used for a voiceover announcing a drug’s “major” risks, while simultaneously providing unrelated images associated with the actors or visual narrative of the commercial.

DDMAC is in the process of being elevated from a division to an office, a process that is “slow even by government standards,” joked Abrams. The new office will be separated into two divisions, healthcare professional and consumer, he said.