In my opinion the issue really boils down to people. People can be influenced very easily, especially if there is $$$ in the mix. In contrast systems cannot.
I’ve spoken to many publication planners and medical writers about this very topic. Full disclosure, everyone I’ve spoken to, thinks its nuts and there is no way an automated system could ever replace a human being in such a complex set of processes. I think Larry Ellison said it best, “When you innovate, you've got to be prepared for everyone telling you you're nuts.” I’ll also cite the radiation technology industry. 10 years ago, aside from the visionaries no one thought that XRays could be read by a machine….well today they are. Not only are they screens read, they are analyzed and emailed to the physicians who can tend to patients while the processing is occurring. Nuts? Maybe, but who else is going to dream this stuff up?
I’d hope Larry Ellison would endorse this one…
There are volumes of data and warehouses of publicly available data on the Internet (e.g. PubMed.com, ClinicalTrials.gov). What medical (ghost) writers will typically do in a nutshell is troll the online data stores, confirm citations, garner permissions from publishers, create an outline, and draft the paper, format it to guidelines - rinse, repeat. This process of back and forth typically takes 30 weeks.
Often times not only are the data freely available but are also consumable by XML technologies. Enter Web 2.0. These XML technologies are commonly used to distribute or get information from disparate sources (e.g. Froogle, weather and news updates). Imagine a tool that pulls information from online medical repositories, based on parameters (search criteria) a user enters through a website. The website in the backend compiles online data intelligently, rendering at the very least an automatically generated set of references and perhaps an outline for the publication. Let’s take it one step further and give the application the ability generate data that is deemed regulatory “safe” and within online and traditional publisher guidelines. Futuristic? Yes. Crazy ? - You decide, but the technology exists today to get what I just outlined done. Of course there are caveats and much alignment needs to be performed to make something like this happen…but wouldn’t information that is disseminated more quickly, more transparently and more completely from sources that cannot be influenced help an industry that is accused of hiring professional writing talent to spin a drug’s messages in the medical literature? I think so.
Who loses? Well of course the ghostwriters. But do they have to lose? Couldn’t they change their business to adapt? Publication planners don’t want to become the Polaroid of the pharmaceutical industry. Take a lesson from Kodak. Moving from traditional writing role to service oriented architecture may give medical writing firms the nimbleness to change with technology as opposed to change with the law.
Enough already…I’m tired of reading and hearing about Web 2.0. Now they’ve even got the Web 3.0 thing. Why doesn’t someone actually tell me how to apply Web 2.0 methodologies that aren’t going to make me look like an idiot in front of my colleagues? I’ve had consultants come and lay out a grand plan, but it’s not practical in my business. HELP! It’s on the way, this is the first in a series of 4 editions that will provide real world practical examples of how to use Web 2.0 methodologies within you enterprise.
Before we start…the reason you know so much and have heard so much about Web 2.0 is because of Web 2.0. In one word it’s about community. If you want more background from every crime fighter in the world, Google ‘Web 2.0’. Also want to state if you and your team(s) are ever going to evolve then there will be a time where you have to leave your comfort zone. Generally smaller corporations are more successful in implementing Web 2.0 techniques because they have little or no money have to be creative. When you’re a multi-million dollar enterprise, it’s hard to go against the grain to think that you will do better because of a new methodology…change is slow, so baby steps are key. There are so many experts that could go on and on for days on this topics, but let’s get to Edition 1.0.
Edition 1.0 – “Star Search”
I loved Star Search – the Ed McMahon version. Ed had a tendency to be able to find the best of the best and the worst of the worst (for entertainment value of course). Ed was way ahead of his time – only if he had found William Hung as a youth (she bang). Even back in the Mid 80’s Ed knew for his show to be successful he had to showcase and develop real “stars” - whether they could tap dance, sing or my personal favorite juggle bowling pins a-fire.
The industries I’ve worked within, at times have felt like Star Search because their success was heavily contingent on the “stars” that they found and promoted. With broader adoption of technology and a trend to move things off shore, getting the right people and the right mix is not an easy task, not to mention the cost of fees associated with procuring the people or setting up an in-house recruiting department. If you’ve done this, ask yourself how much return are you getting on the later resources? I mentioned earlier, in my opinion the core concept of Web 2.0 is community. Why not turn to the community that surrounds you. YOUR EMPLOYEES!
Heck your employees are already recommending folks on sites such as LinkedIn and Plaxo. Imagine if you set up a simple database or utilized one of your existing technologies to track potential “stars” – if you’re small enough I’m sure email could be used as well.
Let’s play this theory out in an example. Let's say Ed is looking for a Bear Trainer for an upcoming special that has experience with training bears on how to fire juggle. Ed has been searching for months for this position and either all the great bear trainers are happy in their current jobs or the ones available lack that pizzazz. Running out of ideas, Ed posts on the Star Search blog (just pretend there were blogs in the 80s) that he desperately needs assistance in finding a Bear Trainer for tomorrow’s show. Anatoly one of the gaffers sends Ed the name of two Russian bear trainers that he worked with on the Russian equivalent of Star Search. It works and Ed gets his bear trainer for the upcoming special. Fewwww…..Ed ponders for a moment, “I didn’t even know this Anatoly existed”. Realizing the potential on internal networking, Ed starts a corporate campaign to reward (not just financially) employees that help acquire talent for his shows. In fact he starts gathering “LinkedIn” type information internally providing a sustained stream of talent for the show. This internal networking then spawns an opportunity to begin syndicating Star Search in Germany where it become wildly popular due to the special host David Hasselhoff….on and on and on…
You get my point, talent is paramount for an organization and can be found sometimes in non-traditional formats. Why do I cite such a silly example? 1) for the obvious humor factor and 2) this example works, regardless of how specialized or obscure the skill sets you are looking for.
End of the day Ed’s paid out little or no money for a referral service, which probably provides candidates that are just as qualified, if not more than the ones brought in by 3rd parties or service oriented departments, because the people doing the recommending know what it’s like in the trenches. One thing Ed will need to be mindful of is “group think”. Innately his employees will recommend people like themselves, which breaks the diversity needed within an organization...regardless, if Ed adds this tactic to Star Search’s recruiting strategy, it just may save the studio money and get better talent more efficiently…your opinions welcome.
Look for Edition 2.0 coming soon.
Disclaimer: The examples in this series are for illustrative purposes only and much rigor would have to be applied to actually implement a Web 2.0 based Star Search application within your enterprise. You are correct Sir!
What is ghost writing? According to CBC News: The practice of drug companies procuring professional medical writers to draft articles endorsing new medicines and presenting them to prominent doctors and scientists to put their names to, in exchange for financial (or other) compensation. So what? Who cares?
Let’s put this into context.
Your father has severe plaque psoriasis and has had it for years. He faces issues with depression, discomfort and unsightly scaly skin. He’s taken every conventional therapy available. He’s sat under UV lights. He’s worn long sleeve shirts as long as you can remember. Essentially he has let psoriasis run his life and accepted there is not cure for the auto immune disease. Now imagine that there are 3 drugs at the disposal of your father’s dermatologist which could potentially help your father’s conditions. Your father’s dermatologist prescribes a biologic, “intolumab”, that has been proven to be very effective in treating psoriasis. The reason: Your father’s dermatologist read of the positive impact of intolumab in a prominent medical journal that was written by a prominent dermatological researcher Dr. Frankenstein. Your father begins treatment and finds out after 2 years of very costly treatment, his psoriasis is no better than it began. He’s had to pay approximately $4K out of his own pocket and his morale is lower than ever. I can hear him rumbling something about ghosts…
6-8 years where research is being conducted in phase II clinical trials for intolumab, the future biologic therapy that will be used to treat your father. intolumab is meeting all safety and efficacy endpoints. Intolumab evolves through the clinical development process and right around Phase III or Phase IV of the process, intolumab’s manufacturer “Bio Odyssey” begin dreaming of the impact their emerging product will have on psoriasis patients. Bio Odyssey begins a “publication planning” campaign; bringing together a cross-functional team consisting of medical affairs and marketing to prove to the world intolumab is the best therapy for treating psoriasis. A communication strategy is developed outlining how Bio Odyssey will promote the effectiveness of intolumab to the world. (Let’s face it everyone reading…the purpose of this “strategy” is to increase prescriptions. I hope we can all agree on this point)! As a part of the communication strategy the cross-functional team develops marketing messages or “key clinical findings” as some may refer to them.
The team hires a medical communications (aka ghost writing) firm to help them draft the publications. The accepted role of the firm is to do research, work with the authors in an iterative manner to more efficiently produce the article. By the way this is absolutely legal and practical to garner the assistance of a medical writing company to help craft a manuscript, review article etc since many researchers lack the ability to draft professionally written articles.
Along the process, all parties realize the publication will have significant impact on the dermatology community and the positive impact for intoumab. Bio Odyssey asks the medical writing firm to identify a prominent dermatologist to include as an author in the late stages of developing a manuscript. You guessed it…Dr. Frankenstein. Dr. Frankenstein does contribute in periodic reviews and posting comments for the “ghosts” to incorporate, however Dr. Frankenstein has not analyzed any of the data. The medical writing firm has accidentally forgotten to include important subset of data that shows intolumab being not as effective in patients who are 50 and older. Uh Oh Casper, what’s that you say your father is 62?
Do you see the dilemma here? It’s not my intent to make you think that all pharma/biotech companies and medical communications firms are real monsters that don’t adhere to ethical publishing practices. It’s my intent for readers to recognize that this does occur. Even if the occurrence of inaccurate information posed by ghost writers is minimal, it should be none since the core publishing principal is “publish only your own work”.
I’m scared are you? Who’s to blame? It’s complicated since there are competing principles all which have merit. Many observers tend to point the finger at pharma/biotech and the medical writing firms. Regardless of where the blame falls, I think we can agree that a solution is needed so my hypothetical father can live a better life with psoriasis. I think the question we should all be asking is how do we solve this problem and make sure all the ghosts in the machine are friendly. Interested? Stay tuned.
Disclaimer on “intolumab” and “Bio Odyssey” are completely fictitious. Any accidental match of current drugs or organizations is simply coincidence.
When sanofi-Aventis sold its share of Exubera to Pfizer for $1.3 billion in 2005, they must have known what they were doing. Exubera which offers diabetes patients an alternative to injected insulin via inhalation of powdered form of the insulin has been made light of due to its resemblance to a marijuana bong. While comical, I don’t think that’s why Pfizer has canceled it’s agreement to market and distribute the drug. I imagine it has something to do with its lack luster performance this year of $12 million dollars and if I can venture a guess the unknown efficacy profile. Regardless of Exubera’s poor performance pulling a compound off the market that does not possess a poor safety profile is unprecedented. Abbott and NovoNordisk beware.
Form your opinion and say what you will about Exubera, one point is clear…even the big boys are focusing on developing biologics as opposed to traditional compounds. Certain analysts have called the failure of Exubera the largest failure in pharmaceutical history. Pfizer is no dummy, why would they risk so much on a biologic?
They wanna be like Mike
Michael Jordan was arguably the greatest NBA player of all time. Baseball is another story. MJ established a brand that provides automatic patent protection because of what he did and how he did it Do you think his performances will ever be duplicated or his compensations for that matter? You couldn’t just take any old players silhouette and put it on a sneaker that was not Nike. Who would buy it? Let me rephrase…who would want it? Biotech companies are similar to MJ, where they have innovative products to which the process for creating and duplicating them is way too complicated for generic manufacturers.
The biotechnology industry has always felt a need to break free of patterns set by traditional pharmaceutical firms since most products run into patent expiration after 8-10 years. Now the industry is trying to avoid the usual fate big drug companies suffer (aka MJ scoring 50 on them) when their top-selling drugs lose patent protection. Currently there are no laws to allow manufacturers to create generics for biologic drugs and a debate is percolating regarding this issue (stay tuned).
They’re trying to do the right thing…
Pharmaceutical organizations are so often accused of doing just enough for patients even though there mission statements are patient focused. Often comedians and analysts compare big pharma to drug dealers…stating that there is “more money in treatment as opposed to the cure”. Biologics allow a company to focus on the root causes of a disease, as opposed to flare ups and indications created by a disease. So what of the pundits? Of course pharma and biotech companies are trying to make money…it’s a business, however they are trying to also help physicians to effectively treat diseases which have been untouchable by traditional therapeutics. So can we all hold hands on this issue? Probably not…the treatment costs for biologic drugs are 10, 15 or even 20x greater than non-biologic drugs. Who’s gonna take care of those bills?
Times are a changing…
It’s hard to change on a dime especially when you are instituting change within a large drug organization. Different organizations such as Lilly have taken a path of creating in house biotech innovations centers while others such as sanof-Aventis have went on purchasing sprees gobbling up biotech left and right. Regardless of the strategy the time for biotech is now and traditional methodologies for sales representatives are changing due to marketplace demands. Did someone say e-Detailing?
Physicians are inundated day in and day out with messages, education, health care reform etc etc. The bandwidth for a physician is diminishing; therefore the traditional pharmaceutical sales rep faces challenges to keep a physician’s attention. (Side Bar: Honey please take note of this section). Physicians look primarily to increase their knowledge with continuing medical education (CME) and they often get this through highly knowledgeable biotech representatives. There is a rep of the future which is more knowledgeable and more scientific than today’s rep. That’s the rep that physicians will speak to because they get better educated not only a drug’s mechanism, but more importantly they gain information on disease state and emerging research trends which the may not have picked up in the literature.
Other reasons or comments? Please post.
You’ve been there, you’ve heard it. Dominatrix CIO has laid down the law not once, not twice but 3 times…”failure is not an option for this initiative”. The earth shakes and everyone under her cowers. But they still fail…why? Was there lack of motivation? Did she not yell or point her finger enough? I don’t think so.
No matter how much that CIO rants and raves, sometimes people still fail, when implementing business software, web portals, and applications. But all is not lost: There are some strategies to help avoid the perils of a bad software implementation.
It’s true. After a company puts themselves through the rigor of an RFP-driven software selection process, they might think they are on the trail towards software bliss. Committees of users, executive sponsors, line managers, consultants and other miscellaneous bits and pieces have aligned to help select a system via arduous all day demonstrations and PowerPoint decks articulating the benefits and ROI of said system (aka by committee). How could this effective process not result in the right tool for the organization? It’s inconceivable, but maybe they weren’t focusing on the most important things.
When implementing a system there are 3 success factors that will ultimately determine your success or demise. 1 – The Software 2 – The Consultants 3 – You. Hold on there Tiger, did you say me. Yes I did, just keep reading.
Success Factor #1
First, the software. Most people believe the most important factor for success is the actual code and/or platform. If we could only take each of the Christmas ornaments (features) and hang them on our tree (application) then implementation nirvana will ensue. It’s true if an application has features you need, then you logically have a better chance of success, but get ready for success factor #1. Your ability to easily change the software is more important than the features.
Does the software allow you to change or customize it all? If so, how expensive is it to make the changes? Changing a process can at times be much more costly than simply changing an application. Do you own the source code? When the vendor mention’s flexibility to what extent is it flexible? What are the reports like? Regardless of how attractive your software package looks like (even if it looks like Eva Longoria), don’t purchase it if you can’t customize it within reason. You know your business will change.
Success Factor #2
Next consider the consulting firm you work with to implement the system. You might think the consultant’s knowledge of your industry is the most important factor for success and I’ll admit it can be very helpful if a consultant knows your business, but here is success factor #2 – experience in a wide variety of industries may be better than specialized experience. Yes, your industry may have some very specific needs (it’s called self-preservation), but it’s also true your industry has many things in common with other industries. A consultant with broad experience could bring to light some best practices from other industries that may apply to your business that may be overlooked by consultants working in a cookie cutter format. Tying back to success factor #1, the consulting firm should have the ability and flexibility to change the software in a cost-effective way (yes this sometimes means outsourcing). Looking at the consultant’s history should give you an idea on their philosophy and approach to such tasks. Ask for examples and case studies.
Success Factor #3
Let’s talk about you. You are the missing link, assuming you picked a good software package and consultancy. You and your team will tip the project scorecard to red or green. Ask yourself: Is your executive team fully aligned with the change? Are the users aligned with the change? Do you manage internal projects well? If you answered no to any of the later, that’s ok. You’re being honest. So how do you surpass your shortcomings? Plan A – rely heavily on the consultants. That’s expensive and often the consultants don’t have the authority to drive change within your organization. You must do something else, it’s Plan B or success factor #3.
You don’t have to alter the personalities of all your people, send them to desensitizing chamber or try to brainwash them. (Side bar: perhaps water torture would work? Maybe another post?) The key to success here is you need an internal champion A change maven that have the power and desire to make the change happen.
All those nay sayers will come along for the ride if they see real progress occurring starting from the top down. Sometimes this person comes from accounting, sometimes from client services, sometimes from marketing but always they have business savvy, computer skills, and intelligence. They should be very aggressive about learning and have the curiosity and hunger to tackle new challenges. You must find this person within the ranks or hire them. Also you must structure their job so the change maven has time to adequately focus on the new system.
This person will work with users as they are getting started with the new system and be a first line of defense of issues. This person will drive the business processes, training, change control and ultimately a sustainable plan for the solution within your organization. For a small to mid size company this individual can make or break the project. I know what you’re thinking…there are no more Jedi, but try to think creatively. Do you currently have a FTE that is itching to do something new and is well respected professionally within the organization?
So will you achieve Implementation Nirvana? That’s entirely up to you, the team you work with and the key decisions you make along the way. I know I know, that doesn’t tell you anything, but hopefully these 3 success factors will help you avoid common pitfalls.
Oh by the way when you’re done, you’ll be cursing me for not mentioning anything about “waterfall” or “agile” techniques consultants use….stay tuned.