If a patient or physician encounters pharma-created content that doesn’t pop with relevance or utility, it doesn’t matter how multitudinous the channels are that carry it. There is no patience online for bad content.

Pharma has the resources to create, or hire someone to create, great content. But the problem is that great content lies in the eye of the content beholder. Complicating matters further, that single set of eyes may find certain content relevant or useful in one channel on one day, but may have different needs or expectations in another channel, next week. Digital marketers hope the answer to the problem of effective mass personalization – a term that reads like an oxymoron – is big data and better analytical tools for parsing it. If enough data is compiled about a given patient, for example, it follows that sophisticated, real-time analytics will be able to predictably advise brand managers on precisely what information a patient needs at any stage of her journey, in whichever channel she prefers.

Needless to say, that level of sophistication hasn’t yet occurred in the healthcare industry. Speakers at the ePharma Summit in New York this week appear hopeful that it will happen soon, but many acknowledged the organizational changes that need to happen first.

Continuous questing for new data streams can be a quixotic endeavor, leading to “analysis paralysis,” said Nancy Phelan, VP, customer strategy and operations at Bristol-Myers Squibb. Internally, pharma needs to “think differently about the talent and skill set” needed on the commercial side, and organizations must liberate digital marketing from fixed events like budget cycles and calendar-based points of action (POAs). Companies should institute “real-time processes and decision-making” for digital marketing execution, said Phelan.

On a mobile health panel, Sharon DeBacco, senior director, customer communications and operations at Ironwood Pharmaceuticals (and formerly an AstraZeneca consumer marketing leader and brand director on Nexium and Crestor), said “mobile is a marketer’s dream,” but it’s stuck on the fringes of healthcare, in wellness and fitness apps on the one hand, and in sensors and devices for critical care on the other. Missing is the middle ground patient and his chronic condition. From a content management standpoint, mobile can be “challenging and confusing,” acknowledged Scott Wolf, EVP, sales, at Everyday Health. DeBacco said the challenge for mobile is how to combine the many transactional activities phones and tablets are typically used for, to develop first a greater understanding and then a unified program for consumers.

With regard to the future of professional promotion, “pharma needs to find its way back into doctors’ lives,” said Jordan Safirstein, an interventional cardiologist. “Taking a doctor out to eat and giving them journal articles is antiquated…it doesn’t work.” Sales reps are less effective today because “physicians have no say anymore in what drugs are on the formulary,” said Kecia Gaither, vice chairman, department of Ob/Gyn, director of maternal fetal medicine, at Brooklyn’s Brookdale University Hospital and Medical Center. “That decision comes from the chief financial officer,” and to a lesser extent, the head of pharmacy, she said.

Asked about what pharma can provide to physicians, Safirstein said embedding reference texts within EMRs is one opportunity. “The most common thing I see [in the hospital] is a resident walking down the hall, staring at a screen. Pharma must take advantage of this.” What about copay cards? “I’ve never heard a patient say, ‘Thank God you gave me that coupon card,’” said Safirstein, adding that the biggest innovation to the healthcare system in recent years was the launch of generic versions of Lipitor and Plavix.

Despite ongoing challenges in digital promotion on the consumer and professional side, 72% of the healthcare companies surveyed for a recent Best Practices report said they planned to increase their digital marketing budgets by more than 10% in the next two years. Even with additional resources, will pharma be able to craft relevant and useful messages for individual patients and physicians, and deliver them successfully? The best way to find out what questions a specific customer wants answered, right now, is to ask. The best way to meet that need is to provide an answer, fast. Whether big data, new technology and analytics can help pharma provide that kind of mass personalization – at an acceptable scale and in the context of strict regulatory controls – remains to be seen.

The report asserts that without continued and consistent US investment in global health research — which has so far “helped deliver some of the greatest advances the field has ever seen” — the momentum needed to do drive these advances “over the finish line” will be compromised.

The report will be released at a congressional briefing at noon, Tuesday, February 26,  at the Russell Senate Office Building, Washington, DC. An expert panel — including Dr Caroline Ryan, Director of Technical Leadership, Office of the Global AIDS Coordinator, Department of State, PEPFAR (President’s Emergency Plan for AIDS Relief) and Dr Alan Magill, Director of Malaria, Bill & Melinda Gates Foundation — will be speaking at the event.

For more information, contact Katy Lenard (klenard@burnesscommunications.com)
T: +1 301-280-5719

Falsified and substandard medicines can be ineffective, promote drug resistance and even cause severe illness and death, said panel chairman Lawrence Gostin, Georgetown University Law Center professor and director of the WHO Collaborating Center on Public Health Law and Human Rights. The report [“Countering the Problem of Falsified and Substandard Drugs” available at www.nap.edu] urged regulators to adopt international practices on surveillance, regulation and enforcement, including technical quality standards developed by the International Conference on Harmonization.

Most important to pharma companies, the panel backed a mandatory U.S. electronic drug track-and-trace system able to identify products at the unit level through unique serial numbers. This approach is supported by the Food and Drug Administration – which requested the report — but considered too costly and complex by manufacturers, pharmacists and wholesalers.

The expert panel also proposed to strengthen supply chain tracking through tighter state regulation of drug wholesalers, including creation of a public database of distribution firms that have had licenses suspended or revoked. And the federal government would help low- and middle-income countries detect substandard products by identifying new sampling and analytical technologies through a central repository at the National Institute of Standards and  Technology (NIST).

Counterfeits separate

One strategy for building support for all these activities is the panel’s decision to drop the term “counterfeit” in describing substandard drugs that pose a public health risk. The aim is to narrow the use of “counterfeit” to refer to products that infringe on trademarks and intellectual property protections, but are not necessarily substandard or adulterated. Calling all poor quality drugs “counterfeit,” the report notes, is seen by advocates for generic and low-cost medicines as a way to use the campaign against “bad drugs” as a guise to enforce patent and trademark regulations.

Similarly, the report  defines more clearly “substandard,” “falsified” and “unregistered” drugs to provide a basis for regulatory agencies to target their legal and regulatory efforts.

The panel also calls for international development and financing agencies to support drug manufacturers in low-income countries that seek to upgrade facilities to meet good manufacturing practices. Such investment efforts would counter fake drug marketing by boosting local capacity for producing quality medicines.

Although an international treaty enforcing drug quality standards is the ultimate goal, publication of guidance on best practices as an interim step “is more realistic,” noted panel member Hans Hogerzeil, professor of global health at Groningen University in the Netherlands. The IOM panel also is asking the World Health Assembly to support its basic recommendations at its May 2013 annual meeting.

There’s some optimism that this report may spur FDA, manufacturers, distributors and pharmacists to reach agreement on an effective drug track-and-track system, an issue that has generated heated debate for more than a decade. Congressional action is needed to authorize mandatory tracking, as well as to require states to support a database on licensed drug wholesalers. Added resources for FDA to take on these tasks also is a real challenge.

While cost is an issue everywhere in implementing new regulatory and oversight programs, Gostin noted that limiting the use of substandard drugs would bring notable benefits in terms of lower hospital costs and fewer drug-resistant medicines. Adopting the panel’s recommendations, he said, is “a very good investment.”

It has come to be expected that the successive Grand Ballroom PowerPoints – limited to twenty-five minutes apiece and kept tightly on schedule, almost uncannily so – given at J.P. Morgan each year by the largest healthcare companies in the world, don’t sparkle with revelation. The majority of presentations highlight the positives of the preceding year, gloss the negatives or omit them entirely, and project new positives – to be detailed in upcoming earnings reports or analyst meetings – on the years to come.

As everyone knows, the action at J.P. Morgan happens behind closed hotel room doors, or in San Francisco’s near limitless supply of coffee shops, restaurants and taverns. Absent a meeting beyond the bounds of the conference’s relentless schedule, attendees would do well to skip the formal presentations and plant themselves in one of the several breakout rooms, which often feature top management and an open microphone for questions. It was in this context that Vertex – still radiant from last year’s approval of Kalydeco, a drug targeting a small fraction of the cystic fibrosis patient population (and costing almost $300,000 a year) – that president and CEO Jeff Leiden told attendees that payers in mature markets have shown a willingness, so far, to pay a premium for the value Kalydeco provides to patients.

The company recently achieved a favorable reimbursement in England, one of the more frugal and skeptical nations in Europe with respect to drug pricing, which bodes well for reimbursement in Ireland and Wales, said Leiden. In France, the company is currently selling Kalydeco through a patient access program, but Leiden spoke optimistically about that country, as well as Australia, Canada and Germany. New Kalydeco trials for younger patients, aged two to five years, are set to commence this quarter.

There was plenty of talk about genetics, but outside of the success stories mostly in cancer, the enthusiasm of recent years seemed tempered by investors and others who feel that most of the current sequencing activity adds a layer of complexity but often doesn’t lead to actionable insights for drug development, or the treatment of patients in most settings. However, Life Technologies’ CEO, Gregory Lucier, said his goal is to “be the only company in the world that can read, write, and edit DNA,” which is difficult to fully explain in a twenty-five minute presentation (or in a blog post, for that matter). Like Illumina and other device and non-traditional pharma companies, Life Technologies drew capacity crowds, and Lucier described fascinating, almost sci-fi seeming technologies, such as the company’s Pervenio lung cancer molecular test, launched in September, which could dramatically affect survival rates for patients by making it much easier for physicians to determine the best course of therapy for an individual patient based on clear prognostic data in the early stages of the disease.

Although most medicines are still impersonal instead of personalized, catering to patient needs as a way to create value and differentiate products came up again and again in discussions with biopharma executives. Biogen Idec CEO George Scangos talked up his company’s intramuscular injectable form of Avonex, approved last February, describing it as “remarkably popular with patients.” Kermit Crawford, president, pharmacy, health and wellness, at Wallgreens, gave the company’s inaugural PowerPoint at J.P. Morgan, in no less than the Grand Ballroom – the largest of the presentation halls – telling attendees during the breakout session that the retail pharmacy administered five million flu shots in 2012. Flu shots, by the way, are a lot less expensive at Walgreens than they are at most doctors’ offices, said Crawford. The company is building out new capabilities in the form of clinics and home care for patients with chronic diseases, and expanded its global footprint last summer with the purchase of a $6.7 billion, 45% stake in Alliance Boots, a European pharmacy retailer.

Anne Whitaker, Sanofi’s president of pharmaceuticals, North America, said in an interview with PharmExec that supporting patients in areas like diabetes, for example – not just providing medications, but focusing on services that help patients meet their goals – can help to differentiate the company and its products from competitors. “We don’t want to just be the Lantus company,” said Whitaker. Helping diabetic patients successfully control their glucose levels, which means keeping HbA1c levels below 7%, means fewer complications (and less cost to the healthcare system), and since only half of the eight million basil insulin users are hitting those numbers, according to Sanofi’s global R&D president Elias Zerhouni, success in this area would be good for other stakeholders as well. Whitaker alluded to risk-sharing pilot programs Sanofi is conducting with payers that might reward the company with favorable reimbursement based on patient adherence and outcomes.

It should be mentioned that both Abbott and AbbVie gave presentations, neither of which were terribly exciting, although Thomas Freyman, Abbott’s EVP, Finance and CFO, said the nutritionals (one of four core business areas within the new Abbott, the others being established products, diagnostics, and medical devices) market is expected to top $50 billion by 2016, up from $36 billion in 2011, an area in which the company continues to invest; Freyman said Abbott has recently opened the doors to a new nutrition research center in Singapore.

It’s literally impossible to see more than about a seventh of the presentations live on any given day, since they happen concurrently and successively, without breaks in between, and the hallways of the Westin St. Francis get notoriously bottlenecked in between sessions, but the PCSK9 target seemed present in many pipeline overviews, in addition to the use of product combinations to treat larger sub-populations within a given disease or therapeutic area. Outside of the lunchtime keynotes on Monday and Tuesday, given by journalist Bob Woodward and J.P. Morgan head honcho Jamie Dimon, respectively, politics was conspicuously absent from company presentations compared with last year, although Ken Frazier, Merck’s CEO, said at a breakout session that he “told Obama” not to use mandatory drug price cuts to achieve healthcare savings, but to instead create policies that better incentivize the commercialization of innovative new products, which control costs by preventing severe (and expensive) health complications and related hospital visits. Amgen CEO and president Bob Bradway said unspecified provisions of the fiscal cliff bill, signed into law by President Obama on January 3, would generate incremental gains for the company’s Sensipar product, indicated for patients with hyperparathyroidism who are on long-term dialysis for kidney disease, and also to lower calcium levels in people with cancer of the parathyroid gland.

The first two days of the conference offered an increasingly diverse group of companies, including a room and track dedicated exclusively to non-profits, and a lively group of suited attendees who pressed executives for answers in the breakout sessions. More than one CEO expressed relief to find himself in calmer waters, having finally navigated through treacherous patent expiries and R&D failures in recent years, and the mood from the stage was generally upbeat, which might be expected for an audience largely comprised of potential investors. Even so, lots of companies detailed lots of mid and late-stage pipeline candidates, offering new hope for patients and new bets for Wall Street.

Weighing in on the question of buying back stocks versus giving money back to investors in the form of higher dividends, J.P. Morgan’s Dimon said he tended to prefer higher dividends, unless a company can be sure it’s buying back stock at a very low price. But then again, “you know more about healthcare than I do,” Dimon told attendees. Asked what he had learned from J.P. Morgan’s billion dollar trading loss fiasco last spring, Dimon said: “Don’t screw up.”

It’s no secret that the pharmaceutical industry faces significant challenges. In his opening remarks as emcee of this year’s NYPF General Assembly, BIO president and CEO James Greenwood didn’t shy away from some of the starker realities, like the fact that annual venture capital funding for biotech hit an all time low this year, at $2.9 billion as of early November, compared with nearly double that amount in 2007.

The dream of “going public” as a start-up biotech is more or less a pipedream for most organizations these days; while capital raised from an IPO has slowly crept back up from almost nothing in 2008 to around $13 billion in 2011, the number of deals done hasn’t kept pace. Roughly 10 deals were done in 2011, according to Greenwood’s slides, compared with nearly 30 deals and $28 billion in capital raised through IPOs in 2004. FDA approvals are up, relatively speaking, but VCs once active in the biopharmaceutical space are now taking their dollars elsewhere, to industries with clear exits on investment and shorter periods to payoff.

In what appears to be a show of solidarity, however, companies are combating external market forces by working together. Greenwood cited a collaboration between Pfizer, Lilly and Merck to create a not-for-profit cancer research partnership, which pools resources to bring down the costs of developing new treatments.

Part of this collaboration, the Asian Cancer Research Group, is tasked with creating “one of the most extensive pharmacogenomics cancer databases known to date…composed of data from approximately 2,000 tissue samples from patients with lung and gastric cancer,” that will be made publically available to researchers.

But emerging markets represent more than an opportunity for growth, balanced against stagnant Western markets. People living in these geographies are “facing problems we don’t fully comprehend,” noted Tadataka Yamada, EVP, board member, and chief medical and scientific officer at Takeda Pharmaceuticals. “Eight million children” – three billion in India alone – “under the age of five die every year from diseases that could be treated,” said Yamada. “We must become a partner in finding solutions to these countries’ biggest problems.” Yamada said innovation comes in two forms: evolutionary innovation and revolutionary innovation. The latter is most desirable, as it represents fundamental change and progress.

But what kind of environment is needed to facilitate this kind of innovation? One that doesn’t rely on peer review, for starters, said Yamada. “Innovators have no peers.” In addition, companies need to facilitate an environment that’s willing to “challenge dogma, to fail and to fail often…success is built on the backs of failure.” Reflecting on his time with the Bill & Melinda Gates Foundation, and emphasizing the importance of collaboration among industry and other groups, Yamada offered an African proverb: “If you want to walk fast, walk alone. If you want to walk far, walk together.”

Alan Paau, vice provost, president of the Cornell Research Foundation and executive director at the Cornell Center for Technology Enterprise and Commercialization, acknowledged the importance of working with industry to translate academic research into new treatments, but said companies should keep things simple. “Universities are not your competitors…you don’t need a six-figure salaried lawyer to write a contract with a university,” said Paau. Companies interested in partnering with academic institutions need to understand the two basic tenets of the university with respect to IP: “If we create it or invent it, we own it,” and secondly, “use it or lose it.”

Bringing things back to a local context, Ann Li, EVP, business development for the New York City Economic Development Corporation, underscored the importance of the biopharmaceutical industry as an engine for economic growth in New York, adding that New York City is second only to Boston in the amount of grant money received from NIH. Li provided several examples of municipal investment – including the Alexandria Center, on the East River, which, when completed, will house 1.1 million square feet of laboratory and office space; BioBAT, a commercial life science research park in Brooklyn’s Sunset Park neighborhood, which will provide over 500,000 square feet of lab and office space when completed; the New York Genome Center, an organization designed to facilitate resource sharing in genomics and bioinformatics, of which nine academic medical centers in New York have already joined; and a series of Small Business Innovative Research (SBIR) workshops aimed at helping NYC-based biotechs get access to over $2 billion in federal SBIR funding each year.

Greg Wiederrecht, VP and head of external scientific affairs, worldwide licensing and acquisitions at Merck, wrapped up the speakers portion of the General Assembly, noting that 55% of Merck’s $49 billion in human health revenue for 2011 came from licensed products and patents. While Merck continues to invest in internal research – to the tune of $8.5 billion a year – the company still relies on partnerships to bring new drugs to market. “More than one third of our current pipeline is licensed in,” said Widerrecht. In addition to direct partnerships and licensing deals, Merck also funds the California Institute for Biomedical Research, or Calibr, a non-profit led by Peter Schultz, formerly the director of the Genomics Institute of the Novartis Research Foundation. Calibr is funded “mostly by Merck,” which has earmarked $92 million for the cause, over the next few years, said Widerrecht.

Despite the fact that VCs “aren’t so venturesome anymore,” as Widerrecht put it, when it comes to biotech and pharmaceutical drug development, there is reason to believe that collaboration is on the rise, as industry takes stock of its predicament and concludes that together we stand, divided we fall.

No doubt the November 6^th election is going to be close, very close: close for the Presidency, close for the Senate, and possibly close for the House.  So close, in fact, it’s possible that no substantial political change will occur in Washington, as a result.

That said, for the U.S. pharmaceutical industry this is not going to be an election without consequence.  Obamacare, as I see it, will continue regardless of the results.  Yes, there will be various start/stops, driven by political and legal wrangling.  But, in fact, there is little in the probable results of this election that will halt the onset of Obamacare on January 2, 2014.

So, for US Pharma, it’s time to think about some of the more important tenets of Obamacare and how, if at all, this election may impact these programs.

I am sure everyone has a few favorites, but I have chosen three that I think are extremely potent, and almost certain to continue forward.  I suggest that the Rx industry carefully review these three, no matter what happens on November 6th.

1. Accountable Care Organizations – As many of you know, the so-called Accountable Care Organizations, or ACO’s, have caused considerable market confusion since they were first introduced in 2010.  The primary concern was and is, what is an ACO?  Designed as cost cutters, the uncertainty centers on how ACO’s will actually control costs.  The one big imponderable, according to the law, is that patients are not “locked in” to any physician or system and can go to any provider they want for care, seemingly making cost containment difficult.  Therefore, it’s clear an ACO is not an HMO, a healthcare model that gained much notoriety in the past for utilizing strict “lock in” rules to control costs.  So if ACOs are not HMOs, what are they and how will they save money?  Frankly, although numerous “pilot ACOs” have been launched, and CMS has modified rules regarding ACO administration, we still don’t  know the answer to that question.

Nevertheless, in April 2012, HHS officially launched the ACO concept.  And although the actual start-ups of these entities have been slow due to the cost containment question, I would be looking for a rapid acceleration in ACO start-ups, early in 2013. Especially if President Obama wins.  Confused or not, ACOs will be pressed forward by Obama and HHS.  But if Romney wins, I also wouldn’t count out the ACO concept.  Remember “Romneycare.”   He could easily end up continuing the ACO idea, if devising a clearer cost savings guideline.  Consider this: Would Romney, given his experiences in Massachusetts, “lock in” patients to ACOs to achieve real savings?

So the question for Pharma on ACOs is what to do about the 2 million new Medicare patients who are supposed to be swept into the ACO models by 2016?  How does Pharma fit into the ACO scheme, whatever it may end up being?  Can ACO’s really operate without restricting drug access?  Does the current no “lock-in” policy for ACOs actually work in Pharma’s favor?  And how does US Pharma plan and manage for this very unclear ACO concept?  Good questions especially since, as I said, I look for ACOs to continue forward under either Obama or Romney.

2. Independent Payment Advisory Board – I think everyone understands that “IPAB” has been controversial since the day it was first presented in Obamacare.  But let’s go back to why?

It’s because its 15 non-elected bureaucrats, who are deemed “healthcare experts,” will be responsible for figuring out ways to control the annual per capita cost of all 50 million Medicare recipients.  Although simple in theory, the social enormity and potential healthcare impact of what IPAB has been designed to undertake is staggering.  As a result, the future IPAB panel has been termed everything from “medical saints” to “the death panel”.

But is IPAB a real concern to Pharma?  Yes.  For starters, no individual with current ties to the Rx industry will be allowed to sit on the IPAB panel.  The same goes for doctors, insurers, hospital admins, etc.  The panelists are to be dedicated only to IPAB service, with all other professional affiliations cut off.  The positions themselves are designed as “real” jobs – pegged at $165,000 a year – and to run for up to two consecutive six year terms.

If Obama wins, I look for very few people to be named to the board who are supportive of industry.  If Romney wins, the appointees will have a different look and feel.  But let’s be honest:  It’s sad but true that both men likely will want the panel functioning at some level since IPAB is designed to serve as a non-Congressional “hammer” on Medicare costs.  So IPAB likely will move forward and I would bet a lot that the make-up of the IPAB board is likely to be a problem for Pharma.

Second, assuming IPAB goes on line in 2013, how will it restrain expenditures?  Going after the “drug line” to restrain medical costs is certainly a tactic that both Democratic and Republican politicians have pursued for many years.  Think Medicaid and Public Health recommendations that have included all generic formularies, therapeutic substitution, “fail first” step care,  maybe even “one drug availability” per medical indication?  Right, rationing, even though “rationing” is supposedly prohibited under the law, but you get the picture.  The IPAB panel could easily recommend such approaches.

So, given the high likelihood that the Medicare budget for 2015 will require reductions to balance it, you have to believe that the next President, whether Obama or Romney, will be tempted to quickly empanel IPAB and put the group to work.

Overall, IPAB, already an industry hot button, could quietly become a very serious problem for industry soon after Nov. 6^th.  If Obama wins, I would expect that we will see several appointments made to IPAB shortly after the election.  If Romney wins, again going back to his Romneycare experience, I still think it’s possible he could move IPAB forward, too.

3. The Patient Centered Outcomes Research Institute – “PCORI” is part of the Obamacare law dedicated to undertaking extensive comparative effectiveness research (CER).  It defines “comparative clinical effectiveness research” as research that evaluates and compares the patient health outcomes and benefits of two or more medical treatments or services.

What is PCORI research supposed to do?  Initially, the primary job of PCORI is to feed its findings and recommended prioritizations into IPAB – and IPAB is to use these recommendations as its basis for maintaining and/or lowering Medicare costs.  In the future, I would look for PCORI to expand its influence beyond IPAB.

What’s the status of PCORI?  Well, unlike ACOs and IPAB, PCORI is very much a going concern.  Staffed since 2010, PCORI has a rapidly growing budget ($50 million in 2011; $150 million in 2012) and recently issued its first set of priorities for American medicine. They are:

1. Assessment of Prevention, Diagnosis, and Treatment Options - Comparing the

effectiveness and safety of alternative prevention, diagnosis, and treatment options to

see which ones work best for different people with a particular health problem.

2. Improving Healthcare Systems - Comparing health system-level approaches to

improving access, supporting patient self-care, innovative use of health information

technology, coordinating care for complex conditions, and deploying workforce

effectively.

3. Communication and Dissemination Research - Comparing approaches to providing

comparative effectiveness research information and supporting shared decision-making

between patients and their providers.

4. Addressing Disparities - Identifying potential differences in prevention, diagnosis or

treatment effectiveness, or preferred clinical outcomes across patient populations and

the healthcare required to achieve best outcomes in each population.

5. Accelerating Patient-Centered Outcomes Research and Methodological Research -

Improving the nation’s capacity to conduct patient-centered outcomes research, by

building data infrastructure, improving analytic methods, and training researchers,

patients and other stakeholders to participate in this research.

Although there are only five “priorities” listed here, I don’t think you have to be much of a healthcare expert to understand that PCORI is carving out a mandate for itself that reaches into virtually every aspect of American medicine.  US Pharma, therefore, will very likely be a major center of interest in any PCORI recommendation to IPAB.

And regarding Pharma, what will PCORI be looking at?  Although PCORI staffers have repeatedly said they will not be making cost-based recommendations, few believe them.  With that in mind, here are a few guesses:  “The cost justification for apparent outcomes”; “The social value of a prescribed drug versus the seriousness of the disease treated”; “The need for and access to a prescribed drug in different communities around the country versus cost”, etc., etc.

And so, with PCORI very much on track, what are the concerns for US Pharma prior to this election?   Frankly, I would think timing.  To date, I think only the November election has contained PCORI’s public activities.  Once the election is over, I look for PCORI diktats to be rapidly fed into the IPAB apparatus.  Clearly, whoever is President may be able to shape some of the final CER recommendations PCORI puts out, but as noted, this machine is running very smoothly right now.  I look for them to start issuing the results of their CER work very soon.  And I can’t help but believe that a lot of whatever PCORI determines is going to be unpleasant news for the Rx business.

In sum, these three areas of Obamacare are very likely bound for rapid, substantial action no matter who wins on November 6^th.  Indeed, the three bureaucracies noted here are currently well funded and are being  administered by robust, dedicated staffs.  Therefore, Nov. 7^th could well turn out to be the official starting point for the full-on launch of the ACO, IPAB, and PCORI concepts in Obamacare, and that that could be serious trouble for US Pharma.

Those are my thoughts on Obamacare and the November 6^th election.  I look forward to hearing from you with you thinking on this matter.

Tom Norton is Principal, NHD Smart Communications of Illinois, Inc. He can be reached at tnorton@nhdcomm.com.

Ethics is a matter of trust, which in the regulatory space requires transparency and openness among all stakeholders, including patients and industry.  This was the consensus of FDA Commissioner Margaret Hamburg and European Medicines Agency (EMA) Executive Director Guido Rasi, both of whom shared the podium with Nobel Laureate Professor Elie Wiesel at a plenary lunch panel on “Ethics of Innovation” at Tuesday’s Prix Galien Forum in New York.  Rasi also emphasized the need for increased communication and collaboration within a regulatory community that is now global in scope and reach.  “We must be more than just the sum of our parts.”

The regulators also identified certainty and predictability in the regulatory process as critical factors in fostering new medicines innovation, the more so for those companies that are seeking to provide complex biologic therapies for unmet medical needs, where agency guidance is often needed on how to proceed.   Hamburg sees the role of FDA as a “gateway” to innovation in speeding medicines access for patients with few available treatments for their conditions.  But to do so she underscored that regulatory agencies need to develop more tools to clarify scientific uncertainty as new technologies advance our knowledge of disease.  Rasi added that in the European Union a key issue is the question of what is innovation, given that EMA has to act on the basis of collaboration with 27 member states, each with their own perspective.

Prompted by panel moderator William Looney of Pharm Exec, Hamburg and Rasi also addressed the current environment where patient access to medicines is in practice being defined by reimbursement authorities rather than through traditional registration approval.  Both agency heads stressed that neither has a legal mandate to include reimbursement or cost effectiveness in their review and approval determinations.  However, they did see a role for their respective agencies in consulting with cost containment entities – such as the Centers for Medicare and Medicaid (CMS) in the US and national health technology assessment institutions in Europe – on the safety and efficacy factors that led to the initial marketing authorization decision.

Bringing CMS into the FDA’s pre-approval drug review process on a trial basis is in part intended to facilitate CMS reimbursement decision-making by getting it into gear earlier, according to Hamburg.  Rasi noted that in Europe, the EMA is engaged in a similar exercise bringing together, well prior to marketing approval, the drug sponsor and representatives from the major reimbursement agencies to facilitate what amounts to a parallel process of review.  In addition, EMA has expanded the information that is included in the European Public Assessment Report (EPAR) as a way to assist national reimbursement decisions. The goal is to avoid situations where the EMA and local reimbursement agencies might be asking for the same information, which can strain the innovator’s resources and end up delaying access.

The moderator also noted the impact on FDA of a mandatory budget sequestration if there is no progress on avoiding the year-end tax and fiscal cliff.  Hamburg expressed optimism on an eventual resolution of the impasse, but added the stakes were as high as they could be:  sequestration could end up barring introduction of the new user fees that are critical to FDA’s ability to fulfill its mission in advancing innovation.

Amidst jokes about the red tape constraining pharmaceutical marketing efforts in online social platforms were insights into where the industry should move to better incorporate social media, mobile, and digital content into marketing plans.

Kerri Sparling, a type I diabetes patient and avid blogger stressed the importance of using tactful, personable communication to influential ePatients when canvassing them to write and advocate new therapies, as well as to address issues pertinent to a company’s agenda. Her ePatient manifesto also drew upon the insight that pharma companies should focus less on creating online communities themselves, but instead should join existing, neutral platforms that promote honest, healthy discussion, as opposed to excessive, disjointed efforts that usually result in lax participation,  tepid dialogue, and an eventual decline into one more digital desert.

An informed panel of physicians gave their often convergent points of view on how they use mobile and other technologies in making decisions in prescribing medicine. One of the common opinions expressed was that although it is good to have access to drug information on a mobile platform (not only for the physician’s reference but for the patient’s as well), the physicians preferred face-to-face interaction with pharmaceutical reps so that they could engage and ask questions directly, and to simply enjoy the human element. This preference jibes with a recent report suggesting similar physician preferences.

One of the conference’s keynote speakers, Sinan Aral, a Professor of Informatics, Operations & Management Sciences at NYU’s Stern Business School, spoke on what makes online content viral; using social media to change behavior; and what to make of the huge quantity of data that social media platforms are generating. He stressed the importance of the development and use of apps such as pregnancy tracking and pill reminders as a way to effectively cull data for marketing and research purposes. In this context, Aral also referenced the Quantified Self movement and the enormous amount of data this movement represents, as a growing number of people begin to measure different aspects of themselves, using trackers and mobile devices in an effort to gain further understanding of the world within the body, and what such self-studies suggest about the world outside.

These are just a few examples of some of the pockets of wisdom embedded at Digital Pharma East. Let us know if you attended the conference and if so, what were your takeaways?

By Frederick R. Ball, Partner, Duane Morris LLP.

From September 9-12, , members of the US food and drug law bar met with their Brazilian counterparts for the Food and Drug Law Institute’s conference US & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device & Food Law & Regulation in São Paulo. Participants included industry representatives, top regulators from the U.S. Food and Drug Administration (FDA) and the Brazilian National Health Surveillance Agency (ANVISA) as well as members of the legal community from both countries.

The sessions focused heavily on the state of doing business in Brazil.  A common theme across panels was that  Brazil is ranked as one of the most difficult countries in which to do business.  Primarily, it appears ed to be an issue of simple  bureaucratic inertia.  Many  panelists pointed out that because the government is a major purchaser of health care, it plays an inordinate role in price-setting. Panelists also noted that ANVISA sometimes pursued policies that favored local industry over their foreign counterparts.

The conference kicked off with a keynote address by Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy at the FDA. Autor emphasized that, given the global reach of the pharmaceutical industry, the FDA could not go it alone in protecting the health of the American consumer.  She stated that the agency must (1) form global coalitions with regulators in other countries, (2) develop global data systems. (3) rely on advanced risk analytics, and (4) work to develop strong relationships with third-party inspectors both private and public. She pointed out that ANVISA and the FDA have already taken steps in this direction by agreeing to share information related to manufacturing and product risk pursuant to a confidentiality agreement. She also noted that ANVISA, FDA, Health Canada, and Australia are working on developing a single audit pilot program for medical devices that all four regulatory agencies will be able to rely on.

Participants did make clear that Brazil is a ready market for clinical trials.  It has a large diverse population that mirrors the rest of the world.  It has a well-developed national health care system that is capable of helping to identify appropriate patients for such trials  However, there was broad agreement that there remain significant bureaucratic challenges to getting a clinical trial approved.  My conversations with conference participants confirmed both these points.

The evening of September 10, N. Gerard Zapian, a specialist with the U.S. International Trade Administration, convened an off-the-record roundtable for American companies seeking to import medical technology into Brazil  Well over twenty industry representatives participated and held a frank discussion of the challenges they faced importing those products, including the current backlog of GMP facility inspections at ANVISA, a recent worker strike, and the challenges of helping the country’s regulators understand the benefits of advanced technology.

The second day of the conference began with a plenary session on trade associations in the two countries..  Panel participants focused on the importance of supply chain safety, including voluntary codes of conduct.  Panelists discussed the rise of consumer groups in both countries and the influence they have on supply chain issues, such as environmental degradation, child labor issues and forced labor.

The conference concluded with closing remarks by Michael Rogers, director of the FDA’s Latin American Office. Rogers pointed out that 50 percent of fresh fruit, 20 percent of fresh vegetables, 80 percent of seafood and 80 percent of API consumed by Americans was imported.  He noted that Brazil made up 41 percent of the regulated imports from Latin America to the U.S., of which the largest two categories were medical devices and food. Rogers reiterated a conference theme: there is a great need for international cooperation due to the globalization of the supply chain.  He pointed out this was a jointly shared responsibility: of regulators, industry and consumers.

Frederick R. Ball is a partner in the Boston office of international law firm Duane Morris LLP. He is the head of the firm’s Pharmaceutical, Pharmacy and Food Industry Group . He can be reached at FRBall@duanemorris.com.

Cegedim Relationship Management held its annual conference on trends in the life sciences industry last week, with two days of speakers and workshops focused on the interrelated themes of Transformation and Innovation.  The central question: if the business of pharma is changing at warp speed, then what new strategies and practices are best poised to help companies maintain a competitive advantage?

On central display at the conference were the significant – and growing – capabilities of vendors like Cegedim in marshaling data points that reveal the identity, incentives and motivations of the customer.

Some of the more interesting factoids:

• 22 percent of US physicians have specific “no see” bans on detailing visits by pharma sales reps; more than half now restrict “walk ins” by requiring reps to make appointments in advance.
• Detailing “face time” with physicians is also declining, with the average time for a visit with a GP clinician down to less than five minutes; for specialists it is about 10 minutes.
• Cegedim research shows that the encounter most likely to result in a pledge to prescribe lasts around 15 minutes, and if that time is supplemented with a customized IPAD display and written leave behinds, the prescribing intent ratio increases by two thirds.
• Boehringer-Ingelheim and Forest Labs scored the highest among big Pharma companies in details to GPs that produced prescriptions; Lilly came out on top for specialists.
• Approximately one fifth of drug co-pay cards issued to consumers for medicines are not being redeemed.
• One in four of every prescription in the US is today filed electronically, and these prescriptions are more likely to be dispensed to patients who also tend to stay compliant with therapy for a longer period of time.
• As the deadline nears for physician practices to implement federal EHR standards, there are more than 400 vendors offering software and related services to help facilitate the transition.  Only a decade ago, this flourishing business did not exist.
• Mobile technology is big – and getting bigger.  Worldwide, more people have access to mobile phones than to toilets, with some 4 billion units in use today.

The overall conclusion is obvious: technology companies have the scale and scope to lead in solving the world’s health problems. On a strictly commercial level, pharma companies are coming to recognize that technology solutions eliminate many of the routine barriers they encounter in attempting to get closer to patients and the customer.  The right agenda is to access patients directly where they seek information.  And their platform of choice is increasingly digital.  Instead of focusing on “pushing” out data compiled internally, the more important task is to come up with new ways to “pull it in,” through tools like social media.  Likewise, the so-called conflict between print and online is a distraction.  Companies must be agnostic; what matters is the principle of designing every communication from the perspective of the patient experience.

Finally, on the institutional side, one of the more interesting trends to emerge from the discussions is the growing visibility and clout of allied health professionals – a neglected target.  Nurse practitioners, for example, are replacing physicians in many routine tasks and are now often authorized to be prescribers of medicines. In fact, while the position of the pharmaceutical industry is being upended by all the churn in the health care system, this is no less true for other players.  One physician, speaking at a panel on how to increase value to customers, noted his profession faced a stark new reality, which he summarized as “No outcome? Then no income.”