That question is best answered by considering how it would be addressed by the three most vocal types of industry critics – politicians, physicians, and the media.  Without being too cynical, I think we can all agree that politicians are beholden to the companies and individuals that fund their campaigns, despite protests to the contrary from those politicians.  And the gridlock in DC and state capitols across the country are evidence that legislators’ work quality is poor.  But gridlock is (seemingly) their job, so let’s move on to the other two types of critic since they will be more relevant to our discussion.

I’ve always been surprised that the most scathing criticism of pharmaceutical research comes from physicians themselves, many of whom feel their research-practicing colleagues are in pharma’s pocket and therefore cannot make objective decisions about patient care.  But all physicians make treatment decisions that also benefit them financially.  To suggest that there is even a subconscious financial motivation to order a certain test or perform a certain procedure brings howls of protest from the medical community, but just last month, nine specialty boards deemed 45 common tests and procedures unnecessary.  If we assume these care decisions are in fact made objectively, with no financial motivation whatsoever, then why is it impossible for research physicians to do the same?

Then there is the idealistic view of the media as champions of truth that present facts gathered through painstaking investigative journalism.  I doubt many journalists would concede that their articles/segments, or even the editorial philosophies of their employers, are influenced by financial interests.  But ultimately, every newspaper and television network is a business that is trying to attract as many readers/viewers as it can.  And many are part of conglomerates that include other types of businesses including entertainment media.  Like it or not, these realities help determine what stories are run, and how those stories are told.

The public needs to have faith in each of these institutions, so it is interesting that these entities cast so many stones at our industry while not finding our rebuttals just as compelling as theirs.

Adam Chasse, MHA

Vice President

RxTi

Originally, CROs were essentially like staffing agencies that could provide integrated, highly skilled project teams.  This helped pharma companies decrease the financial burden of having CRAs, data managers, and statisticians on payroll with nothing to do when there were fewer studies to manage – they could maintain a critical mass of employees to handle steady work, and retain CROs on a “just in time” basis when necessary.  Since most companies’ research pipelines have significant peaks and valleys, CROs filled a much-needed void.

Over time, of course, CROs have become much more than the “hired help;” they provide vital consultation to pharma in addition to deploying tactical resources.  More pharma companies are choosing a small number of CROs to be their long-term development partners in order to leverage the productivity gains that should result from greater familiarity and collaboration.  In some cases, a CRO may have a financial stake in co-developing a drug (a trend many experts feel will continue).

Interestingly, this may land CROs in the same place pharma companies were in thirty years ago.  If the large CROs eventually have a large percentage of their business spread across four or five pharma companies with whom they are strategically aligned, it would be reasonable to assume that their work volume will mirror their partners’ combined pipelines to a large extent.  So what will they do to smooth out the peaks and valleys?  It’s easy to envision a more organized class of niche CROs that the big CROs utilize when workloads are high.  That will require CROs to give up some of the revenue guaranteed by their pharma alliance deals, but there is a price point at which that would be worth it in exchange for the long-term consistency in delivery and customer satisfaction – especially if it is low margin activity being jettisoned to a nimble vendor, or if it is highly specialized consulting that CROs can’t afford to retain full time.

Let’s hear from you.  How do you see the industry evolving over the next 5 years?  Which services will be most important to pharma and the CROs, and who will perform them?

Adam Chasse, MHA

Vice President

RxTi

1)  Recognize your prospect’s place in your sales cycle:  Perhaps the most important step.  Even the best sales machines can’t always go from 0 to 60 in just a few weeks.  It is important to recognize that a prospect creates an opportunity for business, but it is up to us to understand how to help them become customers.  Here is a quick sales process example:

Meet the prospect

Qualify they are a fit for your business

Solve the obstacles they have in front of them

Propose how your service can be the right fix

Negotiate the right package

Close on the best value

Nurture with open communication

The great thing about exhibiting, is that you can “step on the gas” with a process like the one above.  A prospect might go from the “meet” to “propose” stages right on the expo floor.  Maybe your prospects responded favorably to an amazing pre-marketing job, and your next step is to negotiate.  Even then, plan the steps you need to take to move them into being a customer

I once read a statistic that more than 60% of exhibitors do NOTHING with their leads.  Turns out the majority of us were hoping to take prospects from “meet” all the way to “close”.  Think of all the lost contracts, in $ billions, that a small percentage of those stale leads would have yielded if the companies did not treat them all the same.

2)  Open the door with a referral:  The truth is that a large amount of your leads are not going to be qualified.  Sure, they may work for a company you would want to do business with, but their job title falls into a different department or several layers away from what we might classify as the “decision-maker”.  How can you get the lead to be the advocate you need?  The two H’s:

Highlight who your business is looking to reach, and ask the lead to share the best contact.  Even if your first step is to send out an email communication, ask them to share with the COO, or the appropriate title you hope to reach.  List other organizations you are working with that match their business-type, so they can relate to the context of your offering.

Help the contact stand out with their peers or team.  Your common denominator is the show, meeting, conference, or seminar you just left.  With your first communication, ask or offer the great takeaways from that shared experience, and with your next offering, share those ideas.  People thrive off of shared experience, help them highlight the best sessions, ideas, networking experiences, and they will remember you for it.

Even if your first follow up tool is an email, helping and highlighting can be quickly included into your message and make you stand out with direct-reports or team members.

3)  Handpick and then handhold your VIPs:  Reference those notes you took, or take a moment to recall the conversations you had that stood out during the expo. Had any customers stop by? Let them know you appreciated their visit.  I never understand companies who complain that they meet a lot of their current customers on a show floor, as if that did not validate their investment enough!  Your customers like seeing you, at the very least it shows staying power, but it also offers new opportunities to share new products or upsell on new features.

If your company handles prospects like a well-oiled machine, please remember to share the specifics of your interaction with the person handling the follow-up.  It makes all the difference.  I recently was vetting a new email service at a show, met a SVP who took me on a product tour, and showed me some pricing.  After 20 minutes of my time, he said thanks for stopping by, I’ll put your name in our database and have someone follow-up.  I’m going to have to go through that whole process again, you just lost my interest.

Take a different look at your follow-up, and help your prospects move to the next stage in your sales cycle by showing the value you provide.  Every event you participate in will reap the benefits!

Share your ideas with our audience! Find out why sites, sponsors, and CROs are partnering for success at the Site Solutions Summit, and exhibit with one of the clinical research industy’s fastest growing meetings!

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The development of complex biological compounds for first-in-human study has erupted in the US and globally.  Studying these compounds requires more sophistication and medical care than in previously discovered small molecular structures.  Phase I units are expected to become centers of excellence with minimal expertise in the management of complex adverse events that potentially could occur when studying these complex molecular compounds in the normal healthy population.

Each year, thousands of normal healthy volunteers consent to be enrolled in these complex trials.  One motivator for participation in a normal healthy volunteer clinical trial is financial.  A study subject could earn between $1,000 and $5,000 per week depending on the difficulty of the study.  These “professional” subjects have developed a sophisticated social network outlining the financial incentives, housing considerations of the unit, and the financial incentive per enrolled subject.   While these dollar amounts seem high, they are commensurate with the significant amount of time these patients must spend (often taking time off from work); however, some subjects are putting themselves at risk.

The biological drug development arena is complicated due to these compounds having long biological half-lives.  These compounds are held in the body for ninety to one hundred days before being totally eliminated.  This long half-life presents a challenge to study centers that conduct multiple clinical programs annually.  Many clinical protocols state as an inclusion criterion that a subject cannot have participated in a clinical trial in the last 30, 60, or 90 days or five half-lives of the parent compound.  This statement assumes that the study subject will be forthright with the study center personnel and answer the question honestly.  Often times this is not the case.  From a recent white paper, study subjects answered that question untruthfully a significant proportion of the time; the paper suggested that 2.4% of the time, subjects enroll in multiple studies within 30 days and 8.9% of the time they enroll in multiple studies within 90 days.  One can rapidly see that if a study subject were to enroll themselves in multiple clinical programs week after week – which can be tempting given the large stipends common to Phase 1 studies – that a potential serious adverse event could ensue.  This concern then poses a dilemma to the pharmaceutical companies, federal regulators, study centers, and most importantly to the study subjects.  A study subject has the potential to be harmed by the combination of two biological compounds unknowingly administered to a study subject.   All parties involved lose in this scenario.  So how can industry protect subjects while still ensuring sufficient participation in critical early phase research?

Creating a national registry for the protection of study subjects appears to be a solid concept that requires academic and business engagement.  Such a relationship would create a safe environment for normal healthy volunteers to consent to these more complex and challenging clinical programs.

Additionally, study centers in the United States are not certified according to complexity of the study or the respective skill sets of their personnel.  There are very few in-hospital phase I study centers available to the pharmaceutical industry to perform complex clinical trials.  In the United Kingdom after the TGN1412 incident, the Medicines and Healthcare Products Regulatory Agency (MHRA) created strict phase I accreditation schemes to safeguard the public health.  This accreditation scheme certified phase I centers allowing only skilled centers to perform complex clinical programs.  One might argue that we should follow suit in the United States and certify clinical centers of excellence for the more complex biological compounds.

In summary, the creation of a national registry of potential normal healthy volunteers in combination with accreditation of phase I study centers could alleviate potential risk to the health of study subjects.  To address this topic Duke will be hosting and co-sponsoring with the DIA a symposium May 15, 2012 at the Washington Duke Inn entitled “Creating a Global Clinical Trial Platform: Partnering for Synergy.”

About Barry Mangum:

Dr. Mangum is a Associate Professor, Clinical Pharmacology and Assistant Professor, Pediatrics at Duke University Medical Center.  He is a graduate of The Medical University of South Carolina where he received his Doctorate in Pharmacy with special thesis emphasis on neonatal/pediatric pharmacology.  Currently, Dr. Mangum is working at the Duke Clinical Research Institute as Senior Pediatrics Faculty in pediatric clinical trials focusing on providing strategic planning and coordination of specialty pediatric population clinical research.  Additionally, Dr. Mangum is the Director of Clinical Pharmacology for the Duke Clinical Research Unit, an academic early phase clinical pharmacology unit designed to explore new therapies for diseases in children and adult patients.

Dr. Mangum has an extensive background in neonatal and pediatric pharmacology and is the co-author and co-publisher of the leading drug dosing manual, NeoFax®: A Manual of Drugs Used in Neonatal Care. NeoFax® is in the twenty-second year of publication as a source for neonatal drug dosing information. The NeoFax® content has been integrated into varying intranet and handheld device application used globally to aid in drug information and dose calculations (e.g. NeoFax-EM, NeoFax-Rx, and NeoFax-PN).  Dr. Mangum has been strategically involved with the design and the implementation of all clinical and business decisions related to the NeoFax® endeavors. 

Dr. Mangum continues to be active in national and global leadership of pediatric clinical research as an educator and committee member of academic and pharmaceutical industry organizations.  He has represented the interest of pediatric patients by chairing and speaking at meetings globally on the topic of neonatal pharmacology and legislative issues to support clinical research in children.  Currently, Dr. Mangum is serving a four- year appointment to the World Health Organization’s Expert Committee on the Selection and Use of Essential Medicines.

We were greeted with a wave of smiles, handshakes, and even a few hugs from ACRP staff members, customers, industry partners, and a  few new faces along the way.  Conversation seems focused on both individual and organizational development.  Our RxTrials team is graciously excited to have the opportunity to speak tomorrow on topics surrounding site performance and budget strategies to protect site profit and loss.  We learned from other attendees about what topics excited them most, and found a variety of subjects like:

business and finance,

clinical study management,

changing trends in communication and technology,

ethics and subject protection,

patient recruitment,

and perhaps most importantly, innovation.

It rings true in every industry that innovation leads the way to both professional and personal growth.  If you are reading this, and happen to be in Houston at ACRP, please visit the RxTrials and RxTi booths (601-603), and share what innovation you will take away from this conference.  We are excited to see you, and look forward to learning together over the next few days!

It seems impossible to have a bad experience.  Usually, the attendee traffic is a specific demographic that you have identified as an attractive one, so customers should be lining up with contracts in hand right?  Like everything, good performance requires a blueprint or plan.  Hoping things go well in your exhibit usually leads to missed expectations, and sidestepping accountability as we blame poor traffic, bad food, rough city, crazy schedule, and whatever else we can lump into our own lackluster results.

Unfortunately, I’ve been on poor planning side one too many times.  Here are a few quick tips to get your team ready for your next event:

1)  Challenge yourself with objectives:  I know, super obvious.  However, try to think of your objectives as challenges, not guarantees.  It will completely change the way you manage booth traffic, and is the most important and vital piece of a successful exhibit.  In many cases, just a handful of great leads can be the difference between an incredible or just plain vanilla exhibit.

2)  Run the numbers:  What is a good amount of customer conversation for your business?  If sales is a number game, you need to think about the amount of folks you can speak with in your booth, at lunch, waiting for the keynote to start, during the next reception.  Your exhibit experience does not start and end in the expo hall!  It’s the event or conference’s job to get folks through the door, it is our job to engage them with value.  How many prospects do you normally speak with before getting a good lead, 5-10-20?  Your ratio should be based on qualifying the right leads.  A quick classification system can help you plan:

A= Great lead, short close time, decision maker or even a current customer

B= Direct report to the decision maker, or just starting their evaluation process, you need to help them solve their issues with your solution.  They may not yet be convinced of the need or require more time.

C=Just looking, not directly your ideal customer, but maybe a potential referral .

3)  Bring your A-Game:  How many A-level customers will you need to be successful?  A-Level prospects are uniquely qualified for your services, can be nurtured farther along your sales funnel, and are also the most difficult to meet.  They are there, you just need to be asking the right questions and providing opportunities to create a good relationship.  Make sure your staff knows exactly what makes your services unique and irresistible, or plan for far fewer A-conversions.

4)  Believe in the power of B’s:  How many B-level prospects can you elevate into A-level in the short term?  This is the difference between great exhibitors and average ones.  Most attendees will not be a slam dunk for your business, for example, maybe their job titles are not your usual decision-making superstars.  Sometimes, we need to work a few steps further before getting to the right person, and treating your B-level prospects as important ambassadors for your services can do just that.   Turn your B-level prospects into advocates for your business, and plan a few open-ended questions to help guide both your B-level prospect and your team to the next level.

What brings you to this conference?

What session or speaker are you most excited to see and why?

Tell me a bit about your work?

What’s the next big thing at your office?  (project or launch perhaps)

Have you ever considered a service like ours?

Who on your team could use a service like ours?

When your team researches new products and services, what are some of the key factors you look for?  (price, timelines, experience)

If I could quickly follow-up with you after this conference, would you be able to help introduce me to XYZ?

Think your team can convert 10% of your total conversations into A-level?  That would be an amazing exhibit outcome!

5)  See past a badge:  Not every attendee will be a fit for your business.  They might be a year or two away from being in a position to make purchasing decisions, or not have a career path that jives with your sales model.  First impressions count.  Your organization has invested in a storefront, and will engage a lot of folks who will never do business with you.  Make sure you leave them with a great impression of your team.  Be a resource.  If you can’t provide what they are looking for, see if you have a partner who can.

True story.  While I was typing this, I thought of the largest investment my organization ever made from a conference, a $100,000+ CRM product install.  That is a huge purchase for a small business, or even a large one!  The vendor we went with…had a table top display with his laptop running.  He was in the midst of about a dozen large, impressive booths.  What stood out?  His questions….he said hello, asked my name, and simply asked what the hardest part of my sales day was.  He then used his services to solve our issue.  I was a C prospect all the way, but he made a good impression, set a follow-up, and 8 weeks later…got the business from our CEO.

Your next customer is out there!

Have any exhibit tips you want to share?  Maybe a good ice breaker question?  Let us know, and please learn more about other marketing and business development topcs at www.rxti.net and the upcoming Site Solutions Summit!

Don’t respond to phone calls/emails.  If the sponsor/CRO hasn’t heard from you, it should just assume that you’ll review the documents in due time and stop calling, right?  It doesn’t matter that half a dozen people are having their feet held to the fire due to being unable to report progress on the startup front – the 60 seconds it would take you to respond that, “sorry, we’re swamped here, but I promise you feedback by Wednesday” is more important.

Negotiate only by email.  As mentioned last week, emailing instead of picking up the phone guarantees slower resolution of a sticky issue.

Don’t justify your budget requests.  Force the sponsor/CRO to question your really high line-items or one-time costs, especially when there are several tasks bundled into one fee.  And when they do, give the unproductive answer that “that’s just what it costs at our site.”

Ignore instructions.  Look, you’re a busy site and you’ve done plenty of startups before – you’ve earned the right to do things as you see fit.  The detailed instructions from the sponsor/CRO are probably just standard boilerplate and surely don’t have study-specific information about what names and/or addresses to list on the 1572, how to format CVs to meet sponsor standards, etc.

Make changes to your consent form before you submit it the IRB, but don’t run them by the sponsor/CRO first.  This will increase the odds that the sponsor/CRO will not approve the changes and you’ll have to send it back to the IRB.  And it usually means you can delay having to execute that pesky enrollment plan for another few weeks.

Does anyone have others?

Adam Chasse MHA

Vice President, RxTi

You want your staff to succeed… and presumably you want them to succeed at your company and not somewhere else… so invest in their futures while helping your organization by doing the following:

Help them understand your job.  This will help them to broaden their perspectives and understand the additional complexities that come with more advanced roles.  It also preps them in the event one of them moves into your job at some point, when you move on to bigger and better things.  Clearly you can’t discuss personnel issues, but try bouncing operational, strategic, or financial issues off them and give them the opportunity to provide input – and also to hear how you think through issues.

Guide them, don’t direct them.  They will never learn to solve problems if you always do it for them.  When you coach them, try to refrain from giving them the recipe for how you would tackle an issue – instead, ask them questions that introduce certain concepts that may not have occurred to them and guide them through their own thought processes.

Get them involved with cross-functional task forces or project teams.  This may be more applicable in larger organizations, but this exposes your staff member(s) to other departments and helps them learn what other groups do.  You’ll need to allocate time for them to do this, but the long term ROI of that investment makes it worthwhile.  How do you decide which activities to involve him/her in?  Hopefully you have made an effort to learn each staff member’s aspirations and development areas… so give them the chance to either get hands-on experience in what they’re passionate about, or that help them improve certain skill sets they will need as they climb the corporate ladder.

Give them stretch assignments.  You should occasionally give a staff member a chance to do something outside his/her comfort zone.  These should not be high-stakes endeavors – they should be projects that the employee will look back on and realize they learned something from (whether the outcome of the “journey” or the journey itself).  Which goes hand in hand with…

Let them fail.  When you allow this without intervening (albeit with appropriate guidance to let them make their own decisions), in a relatively controlled environment, you give your staff member the chance to learn lessons that will last his/her entire career.  I’ll never forget talking with a senior exec that had green-lighted a project I had pitched the year before, and saying that I wish the outcome of the project had been better.  He told me, “I knew all along it probably wouldn’t work but you needed to see that yourself; the cost of the project was basically tuition.”  And I’m grateful the company paid it and that he had my development in mind.

What tips do you have?

Adam Chasse, MHA

Vice President

RxTi

Don’t sync your site selection activities with your startup activities.  This mainly applies when you use local IRB sites, which have well-established IRB submission dates each month.  Say your deadline for choosing your sites is March 20.  If there is a “must-have” site whose IRB meets March 25 and therefore needs to submit the protocol and consent by March 15, then be sure not to prioritize that site’s selection so that they are selected a few days before March 15 so they can put your study into the March review cycle.  Better yet, don’t even ask for IRB meeting dates in your questionnaire, that keeps everything exciting and ensures some sites will lose a month.

Send documents to the wrong person.  This will increase the odds that the documents will sit in an email inbox, on a desk, or in a mailroom for days (or more) before a human being (probably the busy physician) looks at them and sends them to the correct site manager.

Encourage your staff to discuss contracts, budgets, and consent forms by email ONLY.  There’s no reason these often-complex discussions need to occur by phone, where both parties can have productive discussion about each others’ perspectives and reach resolution quickly.  If mediocre is your goal, your staff should spend lots of time typing emails (or forwarding someone else’s email) and taking several weeks of back-and-forth to get to the crux of the issue that is in contention.  This has the added benefit of there being lots of sites willing to play the same game.

Offer contract fallback language in sequential order, and require non-value-add documentation that your staff actually did so.  This takes a lot more time than simply cutting to the chase and (verbally) offering what the site actually needs.

Don’t empower your staff to make decisions on the spot.  Instead, make sure even the most minor changes require multiple levels of approval, creating a bottleneck that adds time to the process.  This also saves you the trouble of adequately training your staff so that they can develop professionally.

Over-rely on past budgets to negotiate with sites.  Sites appreciate your diligence in looking up what they agreed to be paid for a chest X-ray on a study you ran in 2008, without the background knowledge that that was a concession made because another area of the budget was more robust (or because it was a business decision so that the study wouldn’t be pulled).  Operate under the assumption that a site budget is a collection of line items, without regard to business conditions or study complexity, and the ensuing negotiations will help you elongate your timelines.  (Bonus Tip: Why should that work both ways?  Cherry-pick the items that you want the site to agree to based on past budgets, but turn a deaf ear when sites make the same argument on other items).

We hope this helps you sabotage your startup process, if that is your goal.  If for some reason you want to IMPROVE your startup timelines, then this article isn’t for you… or is it?  And if you are a site, don’t fret -  next week we will publish a similar list for sites that want to beef up their startup saboteur skills.

Adam Chasse MHA

Vice President, RxTi

Imagine my surprise when the subheadline and introductory paragraph subtly implied that modern clinical research has not moved far beyond the atrocities of Nazi Germany.

The article’s author – Harriet Washington, who was promoting her new book on vulnerable populations being coerced into clinical trials – used inflammatory language, stated partial truths, and avoided context to make points that are misleading at best, geared toward a segment of the general public that is quick to believe that everyone in our field has sinister intent.  Among her implications are that US minority populations are routinely exploited for research purposes without their consent and that unconscious trauma victims are experimented on unethically.

No one can deny that certain populations have been unknowingly experimented on through the decades, completely outside the bounds of universally accepted ethics – and that some of those incidents (as the author states) have been in the past 20 years.  There is no excuse for that, and the research industry must be diligent about learning from those mistakes and work tirelessly to never repeat them.  But the examples cited in the article, however inexcusable, are isolated incidents that don’t even begin to reflect the efforts put forth on more than 120,000 clinical trials listed on clinicaltrials.gov over the past several years, which have been conducted collectively in almost 180 countries.

Additionally, studies for trauma indications – an infinitesimally small proportion of all clinical research – cannot be conducted any other way.  The ethics committees, physicians, and communities involved in such trials go to great lengths to maximize awareness of such studies and provide opt-out mechanisms.  Those types of studies are rare but provide critical insights into how to treat life-threatening injuries so that the entire population benefits in the future.  Will any of us be satisfied in 2050 if life-saving techniques for trauma victims are no better than they are in 2012?

Articles like this are a disservice to the hundreds of thousands of dedicated people who have made a career out of helping bring new medicines to our families, friends, and neighbors.  But more importantly they are a disservice to the billions of people on this planet who need (or will need) treatment for diseases that affect their quality of life – because when the general public forms perceptions based on irresponsible journalism, it has a chilling effect on volunteerism that will stall development of new life-saving medicines.

Adam Chasse, MHA

Vice President

RxTi

For more on this theme, don’t miss the next installment of RxTi’s GCP webinar series, Ensuring Protections of Vulnerable Populations on April 17, featuring Jeff Cooper, MD, MMM of Huron Consulting.