Service, like so many words in the business lexicon, seems to have lost it’s meaning as it has become a ubiquitous marketing term.   At Cadence, service speaks to not only what we do but also how we do it.  Service means consistently providing outstanding work AND a providing a great client experience.  Client experience is the foundation of everything we do.  Having walked in our client’s shoes, we understand the dynamic nature of their work environment and the daily demands that are placed upon them that go beyond a single project.   As such, our aim is to be a collaborative partner that our clients can rely on to consistently deliver high quality service.   Our biggest compliment is when our clients tell us that they don’t have to worry about any project that we are involved with.  Giving our clients this peace of mind is what we strive for in every single project.

Sugata Biswas

Innovation!

Innovation is a hot word right now in pharmaceutical strategy.  It is futuristic, creative, cutting-edge, energizing, and entrepreneurial.  Innovation is not hype, though.  It is the solution to the reality that internal R&D labs are losing productivity, drug approvals are down, and venture capital for start-ups is drying up.  Innovation has just a little do with a brilliant idea, though, and everything to do with executing it with discipline. 

How is this exciting?  This sounds dull.

There is a vibrant community of biotechs, academics, incubators, and accelerators teeming with cutting-edge science.  To forge the deals that will re-prime its development pump, pharma must take its careful processes, performance criteria, gates, and thresholds and apply them to this wild and exciting space.  Innovation is a methodical, stepwise process of diligence, negotiation, contracting, planning, and collaborating.

Inside Out

Innovation is about creating value.  Innovation centers are cropping up in scientific hot spots – outside of traditional pharma campuses – all over the globe.  Pharma’s goal is to embed its best and brightest in the scientific community to partner with entrepreneurs and academicians.  Innovation has, quite simply, turned the pharma model inside out. Done well, innovation can result in on-boarding new products and business models at a sustainable steady state over time.  By looking outside, innovation creates value inside.

Sherry Danese

With regard to the Sunshine Act, the pharmaceutical, biotechnology, and medical device industry are presently concerned with a number of issues:

1)  How will the Sunshine Act weigh on reporting indirect payments to physicians?

The CMS allows manufacturers to send payments to physicians through third-party agents if and only if they remain unaware of the identities of said physicians. Otherwise, the CMS is concerned that manufacturers might adjust their financial relationships to take advantage of an indirect model for sending payments. In addition, CMS will require third-party agents to track payment information on behalf of manufacturers, which can then be reported by either the third-party or the manufacturer, but not both.

2)  How will companies develop and execute aggregate spend plans?

Manufacturers will need to be highly confident in the quality and accuracy of their master databases, including verifying the accuracy of their physician information (including license numbers), removing duplicate records, and improving the usability of their database systems. In addition, manufacturers will need to designate someone within their organization to validate and communicate these payments to physicians, as well as to handle reporting disputes.

3)  How will the Sunshine Act affect physician learning and research?

Dr. Henry Black, a clinical professor in the Department of Medicine at NYU Langone Medical Center, views the Sunshine Act as an “abomination.” Of most concern is that the Sunshine Act requires documentation of gifts and dinners alongside grants that sponsor new research, and may have a chilling effect on the state of clinical research in America. Thus, the Act may prompt a decrease of medical innovation in the United States, shifting the tremendously expensive burden of novel drug and device development to an already overburdened public health system.

4)  How educated and prepared are physicians on the new guidelines?

The American Medical Association has developed an online resource for physicians to help educate themselves on the reporting process outlined by the Sunshine Act. This resource will include, as it becomes publicly available, a physician portal through CMS that will allow physicians to access reporting information, as well as an informational chart that characterizes the differences between federal and state Sunshine Laws.

5)  How can companies maintain relationships with physicians?

The relationships between manufacturers and physicians are essential for both scientific innovation and clinical research. However, relationships between the two are subject to more scrutiny now than ever before, from the CMS and state oversight laws, as well as hospitals and academic institutions. At present, the onus is on physicians to understand the reporting and transparency rules, but manufacturers can help by creating systems that are as simple and painless as possible.

Zachary Moore

Whether or not the Sunshine Act will improve or diminish the practice of medicine in the United States remains to be seen. But it will not eliminate the role of bias in the medical field or the pharmaceutical industry. Earlier this year, the Department of Health and Human Services ruled that the so-called “Physician Payments Sunshine Act” (Section 6002 of The Patient Protection and Affordable Care Act), will go into effect. The goal of this Sunshine Act is to introduce more transparency into the financial relationships between drug, device, and biologic manufacturers and the physicians who advise, consult, and work with them. Any payment or gift greater in value than $10 given to any physician must be submitted to the Secretary of Health and Human Services, and be posted on a publicly-available website, or prompt a fine of as much as $10,000 per gift, which will be the responsibility of the company. Data will be collected by the Centers for Medicare and Medicaid Services (CMS) beginning August 1, and all 2013 data is due by March 31, 2014. The CMS will begin making these data public by September 30, 2014.

Ostensibly, this Sunshine Act has been created to limit the amount of physician bias in the modern healthcare system, something with which Dan Ariely is intimately acquainted. As a burn patient, he was at the mercy of forces beyond his control, and as he found, often beyond rationality itself. Now, as a noted behavioral economist and psychologist, he’s published widely on the irrationality of human behavior. In his blog, Ariely comments frequently on his research into irrationality and the effects of cognitive bias in the world around us.

In this video from TED, Ariely speaks about how physicians (and other researchers) can be motivated by their own biases to persuade their patients to follow a specific course of treatment.

For companies like Cadence Research and Consulting, the impact of the Act depends on the specifics of the project through which physicians are engaged. Guidance from CMS indicates that market research is exempted from reporting requirements due to the fact that a manufacturer is not paying physicians directly, and that the identity of the manufacturer is necessarily kept hidden from the physician. However, money spent on physician travel, food, and lodging for “promotional” activities like advisory board meetings or investigator meetings should already be recorded. For these items, Cadence proactively maintains a master list of these expenses for each physician that can be tailored to each individual client’s needs. In many cases, clients already provide us with individual reporting spreadsheets that can be completed and submitted with meeting deliverables and close-out files.

Of course, whether or not the Sunshine Act will improve or diminish the practice of medicine in the United States remains to be seen. But it will not eliminate the role of bias in the medical field or the pharmaceutical industry. As Dan Ariely notes, “It’s just a fact of human life: we are compelled to reciprocate favors, and an ingrained inability to disregard what’s in our financial interest.”

Zachary Moore

Mixologists practice mixology and bartenders tend bar.   Mixologists evolve the field of bartending, creating innovative cocktails the world has never seen.  A bartender serves the drinks that customers order.

It is time for the mixologists in all of us to shake up market research. Questions rarely come in a box and rarely are contained to a single department.  Now is the time to mix up the methodological approach to help all the stakeholders answer their questions.

Mixed Methods.  What are they?  For some, it means blending primary and secondary research techniques.  Others leverage epidemiology to inform subsequent phases of research.  And others apply social media analytics to augment their data collection beyond traditional channels.

We don’t think the definition really matters.  At Cadence, we like mixing methods to take the best advantage of research techniques across marketing, clinical development, business analytics and forecasting.  There’s no question that traditional concept testing using in-depth personal interviews provides deep qualitative input that is invaluable to answering key questions.   After all, sometimes all you really need from the bartender is a martini. 

But, let’s say our client really wants to know if the concept’s underlying technology meets an unmet need in a highly specialized facet of the oncology market.  And, if so, what is the market size and how would the technology be positioned?  And what would the forecast look like at various price points for a product used in this position?   It turns out our client didn’t really want a simple drink, but never imagined the perfection of a Melograno made with orange infused vodka, orange liqueur, fresh pomegranate and fresh pineapple.   To truly be of service to this client, we need to find our inner mixologist and bring a fresh, sophisticated approach. 

On March 27, 2013, the Wall Street Journal reported that ASCO announced a new clinical tool in development called CancerLinQ.  This is a database that essentially converts all cancer patients in the U.S. to clinical study participants.  The system collects data that doctors record in a patient’s files, such as age, gender, medications and other illnesses, along with the patient’s diagnosis, treatment and, eventually, date of death.   Doctors tap the database for help in developing treatments for other patients.

Our methodology for this client can borrow analytic techniques from epidemiologist and use this new data set to mix it up:

1.     Quantify the market:  Connect to the CancerLinQ database to query real patient data

2.     Assess the technology on-line:  Specialists are too far-flung for in-person research and are too busy for telephone interviews.  Undertake a technology assessment using a longitudinal on-line focus group that allows users to log in and out for short periods of time over several days.  You actually get broader and deeper data at a lower cost. 

3.     Leverage social media analytics to determine what is being said in the millions of conversations happening in patient groups, physician networks, Twitter YouTube, Facebook; the possibilities are endless.  Algorithms being employed to look at back-of-mind sentiment and attitudinal behavior are as powerful and complex as those employed by the FBI.

4.     Build a model:  Feed the market size and adoption data into a forecasting model using scenarios for various price points. You can use a choice model if you are after a dynamic assessment or start with a univariate test if you have discrete price points and a fixed product profile.

 So, in the end, we mixed a database query, a technology assessment using an on-line longitudinal format, and a dynamic forecast to answer what started out as a “concept assessment” question.  Dig a little deeper, mix up the methods, and deliver truly impactful research. 

Sherry Danese

We think we have something pretty special at Cadence that you may never see directly.  It is technically invisible and a little hard to describe, but we think it’s tangibly felt by all our clients.  What is it?  It’s simply our internal culture.   Perhaps you are thinking, “Sure, but why should I care about it?”

I’ll give you 3 good reasons that impact you and the work you do every day with a vendor:

  1. Staffing Turnover
  2. Deliverable Quality
  3. Partnership Skills

It’s undeniable that when you work with a vendor, you’d prefer to have a consistently knowledgeable team, quality output and a great service over and over again.

1. Turnover (or the lack thereof)

A company’s internal culture has a big impact on whether you will see the same staff at the next engagement. If internal culture is poor, it results in high turnover leaving you exposed. You may face new team members who need to come up the learning curve on your project once again. The Harvard Business Review recounts a surgeon that achieved 2.5 times more surgeries than his peers with better outcomes by building teams that worked well together for long periods of time.  (HBR Dec 2013).   At Cadence we focus on staffing our projects from start to finish with the same experienced team, and building a great place to work that leads to high staff retention. For you, this means longer-term support with real continuity.

2. Quality

It’s somewhat simple.  The quality of the work is a function of not just the intelligence of the team working on it, but their ability to focus and deliver valuable insights.  Ultimately, a team of people deliver the work. The environment that they operate in has a huge impact on their focus and effectiveness.  Are team members in a culture that helps them resolve conflicts? Is it a place that supports creative thinking and honest conversation? Does the culture empower them to contribute their best?  If not, you aren’t getting the best output on your project.

3. Partnership

In my view, the best partners are a bit like a good friend.  They can tell you the straight story even if it is hard to hear, they show up for you, and your interactions are genuine and beneficial.  These relationships feel authentic to you for good reason.  You have mutual trust, they have your best interest at heart and you succeed together.  What does culture have to do with this?  Well, if we can’t build strong relationships inside our organization, how are we going to foster them outside of it?   Teams are more successful in providing services when they have these partnership qualities – authenticity, a proactive work ethic, team orientation, strong communication skills, etc.   We look for these qualities in bringing staff in the door, and work with them to consistently deliver a great partnership – inside and outside Cadence.

Do these factors seem obviously simple?   Maybe so, but we bet you’ll find they deliver a powerful experience.

Laura Smith Biswas