Part II: What SOPs Does A Dietary Supplement Distributor Need?

Last summer, we received a lot of feedback on our post entitled “What SOPs Do I Need As A Dietary Supplement Distributor?”   To respond to your questions and comments about 21 CFR Part 111, we’re posting an expanded version of the original article.

If you look at the cGMP regulations for dietary supplements, you’ll notice that only 1 subpart includes the words “holding” or “distributing” in its title.  With only 10 or so individual requirements, the aptly-named Subpart M, “Holding and Distributing,” is shorter than most.  If you’re thinking this means there’s a much lighter regulatory burden placed on companies that simply hold or distribute dietary supplements than on companies that manufacture them, you’d be right.  At the same time, you’d be incorrect to assume that regulations for holding and distributing dietary supplements are restricted to this single subpart.  At least 8 of the 16 subparts that comprise 21 CFR Part 111 are applicable to holders and distributors, and all the activities outlined in these subparts require SOPs.

Subpart B, “Personnel” requires that your employees be qualified for the positions they hold and be trained in hygienic practices and warehouse operations.  Naturally, this training needs to be documented.  SOPs are needed to describe the procedures you have in place to comply with these staffing requirements.  That’s important, because as you read on, you’ll see the warehouse staff has a lot of responsibilities.

Subpart C, “Physical Plant and Grounds” dictates that your warehouse be clean and pest-free.  Dirt, insects, lubricants, or other agents could compromise the packaging or prevent labels from adhering.  Your facility also needs proper drainage, adequate space, and work lighting.  (Do cramped or dark conditions increase the likelihood of dangerous product mix-ups?  Is any of your product sitting directly on the floor rather than on pallets?)  You must also make sure that the product you hold is not exposed to more heat, cold, humidity, or light than the manufacturer recommends.  (Is the heat tunnel you use for sealing shrink wrap too hot?  Do you have backup refrigeration?  Is there sufficient ventilation?)

Any homeowner knows that conditions in a building are not uniform; buildings have hotspots, cold spots, and damp spots.  Just as the pharmaceutical industry has done, some dietary supplement holders are using a technique called “warehouse mapping” to help ensure safe product storage.  In warehouse mapping, the 3-dimensional warehouse space is logically divided into many smaller blocks, a sort of Rubik’s Cube.  Sensors that monitor temperature and humidity are placed in all 8 corners, the areas of the “cube” that are most subject to variations in environmental conditions.  Monitoring is performed at least seasonally, as temperature and moisture will fluctuate throughout the year in most locations.  Sensor data can help warehouse staff pinpoint specific areas of the facility that have inadequate ventilation or excess heat or moisture.  Additional fans, air conditioners, or dehumidifiers can then be deployed to remediate any adverse environmental conditions.

Subpart D, “Equipment and Utensils” discusses the care and feeding of all machines used to control environmental conditions, and to move, store, repack, or otherwise handle product.  SOPs describe proper cleaning procedures, permissible cleaning agents, and cleaning frequency.  (Could this cleaning solution cause labeling ink to fade?)  They describe inspection and maintenance requirements.  (According to the manufacturer, how often should this thermostat be calibrated?  How often is electronic inventory control data backed up?)  They outline installation and operational qualification procedures.  (Has your industrial scale been installed on a flat surface?  Is your packing peanut dispenser blowing so forcefully that it could damage labeling or product container-closure systems?)  Finally, SOPs describe all of the associated records that must be kept and the internal QA procedures to ensure it’s all being done. 

Because you cannot ensure the quality of the product you distribute without verifying the quality of the product you receive, holders and distributors must implement some of the measures identified in Subparts E and F which cover Process and Quality Controls.  The contents of incoming shipments must be confirmed against invoices and other paperwork, and applicable certificates of analysis must be verified.  Product should be visually inspected.  (Has any product reached or neared its expiry date?  Is any product damaged?)  SOPs which describe these activities, as well as the procedures for handling damaged/expired product must be documented and followed.

Since Subparts G through L apply only to manufacturers, packagers, and labelers, alphabetically we’re now up to Subpart M, “Holding and Distributing.”  Not surprisingly, this section requires that product be held in a manner that prevents its contamination and deterioration, and preserves its purity, strength, and composition. As we’ve seen, Subparts B through F outline many of the detailed regulations you need to follow in order to protect your products…but not all of them.  Temperature, ventilation, and moisture content are not just warehouse attributes; they apply to shipping environments, as well.  To ensure that product receives the same protection in transit as it received in the warehouse, distributors must conduct shipping tests at various times of year and over a variety of shipping routes. (Will our product survive the stretch of Interstate 10 between Phoenix and Tucson in the middle of August?)  Lastly, Subpart M requires that samples of each batch of product be retained for a specified period of time.  Holders and distributors should document and follow procedures for periodically reviewing the condition of the samples and for investigating the cause of any deviations discovered.  (Are the product labels legible?  Is the packaging holding up? What should you do if the the appearance of the product has changed during its shelf life?) 

Even after your product has been delivered, your regulatory obligations have not been fully discharged.  Subpart N, “Returned Dietary Supplements” outlines quarantine and disposal requirements you must follow and quality control responsibilities you must carry out when product is returned to you.  (Under what circumstances can we redistribute product?   What if the return is simply the result of excess retailer inventory?)

Subpart O, “Product Complaints” outlines your responsibilities surrounding any product complaints you may receive.  Remember those samples you’ve been storing according to Subpart M?  Get them out, because that’s where your investigation will begin.  Some of the activities here resemble those of a traditional CAPA program:  determine the root cause of the problem and take corrective and preventive action.  (What if the problem is not mine – what is the protocol for dealing with manufacturing, packaging, or labeling issues? What are my obligations if we receive an email from someone who claims that the product has made him sick?)    

Finally, as a distributor, you would likely play a key role in any product recall.
Subpart P, “Record and Record Keeping” enumerates the data you must keep in order to respond appropriately to a recall order (as well as demonstrate Part 111 compliance in general).  Conducting periodic mock recalls to test your recall SOPs will help ensure that inventory and distribution records provide the information necessary to successfully recall all targeted product.

Perhaps to those involved in pharmaceutical manufacturing or clinical research, the regulatory burden placed on holders and distributors of dietary supplements may seem light.  In fairness, comparatively, it is light.   But that doesn’t mean complying with all the necessary Part 111 provisions is easy or straight forward.  It takes even the veterans time, effort, and expertise to develop the procedures necessary to achieve compliance, and it takes vigilance to follow and maintain them.

If you’d like some assistance navigating your way through 21 CFR Part 111 compliance, please visit us at www.polarisconsultants.com.

by Laurie Meehan 

with Special Thanks to Rosanne Sylvia-Heeter, Director of GMP Compliance

This article appears in “Quality Lifeline”, a MasterControl publication.  http://www.mastercontrol.com/dietary_supplements/sops-dietary-supplement-distributor.html?source=n3w5quality|70130000000XEpx

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Examining the Slow Transition to Risk-based Monitoring

In August 2011, the FDA published its draft guidance to industry, Oversight of Clinical Investigations – A Risk-based Approach.  The EMA, MHRA, and European Commission have also published papers in support of risk-based or adaptive monitoring.  Judging by the sheer number of conference presentations, forum discussions, and webinars, not to mention all the new vendor offerings built to facilitate the process, risk-based monitoring might be one of the most frequently discussed topics in clinical research today.

The FDA guidance encourages organizations to forgo the former one-size-fits-all, gold standard of monitoring:  100% source data verification (SDV) and on-site visits every 4 to 6 weeks.  There are two distinct themes at play here.  First, information technology reduces, if not obviates, the need to review study data on-site.  That site visits might be less frequent as a result cannot be a wholly unexpected consequence.  A move towards remote data monitoring, and any associated decrease in on-site visits, does not necessarily represent a philosophical shift for FDA, so much as an acknowledgement of the inevitability of advancing technology.  Had the new guidance been titled Oversight of Clinical Investigations – A Remote Monitoring Approach, the industry might not have raised a collective eyebrow.

A far more philosophical departure is FDA’s position that traditional absolutes, such as100% SDV, are often overkill -- they don’t necessarily produce more reliable results or offer greater subject protection than less intensive approaches would.  Instead, FDA says that decisions about frequency, intensity, and type of monitoring should be made according to the risk that each study, and even each site, presents.  Variables to consider in these decisions are therapeutic area, protocol complexity, investigational product safety, population vulnerability, investigator experience, EDC capabilities, and study phase.

Verifying anything less than 100% of source data is easier, cheaper, and faster than verifying all of it.  Applying more resources to critical areas and fewer resources to less important, less risky areas sounds obvious.  So why haven’t sponsors and CROs scrambled to implement these process changes as fast as possible? 

Assessing risk is hard.  You can download all the risk assessment tools you want, but it doesn’t change the fact that striking a smart balance between risk and benefit is the result of careful analysis, long experience, and good judgment.  You’ll probably never know if you overestimate the risk you face.  You’ll just end up performing unnecessary monitoring procedures that offer little benefit, but only after you’ve spent a lot of time and money on a useless risk assessment effort.  If you underestimate the risk you face and fail to sufficiently monitor the study, you defeat the entire essential purpose of study oversight, jeopardizing the safety of your patients and the reliability of your results.

Another reason sponsors and CROs have moved slowly towards an adaptive monitoring approach rests with the study sites themselves.  Without 100% SDV, sites need to integrate quality management into their processes, rather than rely on monitors to identify questionable data.  Risk-based monitoring requires more vigilance from site staff than is necessary with the traditional monitoring approach, and may require additional site training. 

Despite these difficulties, some sources report that companies are nevertheless beginning to implement risk-based approaches to clinical oversight.  In January, the Applied Clinical Trials website published a trend analysis developed by Medidata Insights.  Among their client companies, Medidata reports that median SDV percentage rates have been dropping steadily since 2007. 

Still, the perception is that transition to risk-based monitoring is slow.  An Outsourcing-Pharma article recently quoted the CEO of Annex Clinical who says firms are still checking every piece of data associated with a clinical trial, including data not central to data integrity or subject protection.  That same publication summarized the opinions of many attendees and speakers at this year’s Partnerships for Clinical Trials conference.  They believe that the guidances on risk-based monitoring lack clarity, and are urging regulatory authorities to make more solid rules.  Even Big Pharma concedes it has to understand risk-based monitoring better.  In September, Abbott, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson and Johnson, Pfizer, Roche’s Genentech division, and Sanofi formed the non-profit TransCelerate BioPharma, with the goal of improving the quality of clinical studies and accelerating the development of new medicines.  Among their stated objectives is the development of risk-based site monitoring approaches and standards.

If Big Pharma is still struggling to understand comprehensive risk-based monitoring, smaller biotech companies are even further from implementation.  Smaller companies are less likely to have the resources and experience necessary to conduct thorough risk assessments and then translate them into adapted monitoring plans.  Also, small biotechs are more likely to conduct significantly smaller studies, which may translate into smaller risk tolerance.

And then there’s this:  Big Pharma is notoriously risk averse when it comes to deciding what biotech firms to purchase or what new products to license.  A due diligence team needs to present an airtight case to its management, who, in turn, wants to make sure the company’s investment will be sound.  Smaller firms understand this.  They know that they may only have “one shot on goal” to either partner or sell, and are concerned that their Big Pharma suitors will be dissatisfied with anything less than 100% SDV and frequent on-site visits. 

So what happens from here?  Transition to a risk-based monitoring approach may continue to inch along at its current pace.  Organizations like TransCelerate may develop standards which set the stage for large-scale adoption.  Maybe a final version of the FDA guidance will offer clearer parameters for implementation.   Whatever happens in the industry at large, it’s likely that the need to reduce clinical development costs will motivate some companies to aggressively move toward risk-based approaches, with or without accepted industry standards or further regulatory guidance.  They’ll be the ones to watch.

By Laurie Meehan

Yes, SOPs Are Hard To Write…It’s Not Just You

Ask anyone who works in a regulated industry about the purpose of SOPs and you’ll be told it has to do with minimizing variation.  Consistency, they’ll say, promotes quality.  It follows, then, that SOPs must be straight-forward and unambiguous.  If procedures are too complex or can be interpreted in a number of ways, they will not produce consistent results, and quality of the end product, whatever it is, will be at risk.  Simple.  Obvious.  SOPs 101.

It’s too bad for us that tasks are not always simple or obvious.  Often, a worker can achieve a quality result only by correctly responding to a number of variables that could arise.  An SOP that outlines such procedures has to describe each situation the worker might encounter and then provide the appropriate corresponding response.  In complicated procedures, these situations can become nested.  (Is it A, B, or C?  If it’s C, is it X, Y, or Z?)  An otherwise simple, linear set of instructions can quickly become a complex decision tree.  Also, the distinction between situations that require different responses may not be clear cut, and may only be a matter of degree.  Unless decision criteria are thoroughly explained, each worker will devise his or her own, and consistency will be lost.  Naturally, the more complicated the instructions, the more subject to misinterpretation they are.  SOP writers are challenged to capture all this complexity in a clear, concise set of procedures.

We expect a lot from our SOPs.  In many companies, SOPs don’t just supplement training, they are training.  Once upon a time, new employees were mentored by seasoned workers who would teach them the rationales behind the procedures and share undocumented nuances that they’d learned over the years.  Now, with mentorship programs becoming an extravagance most companies can no longer afford, we increasingly rely on SOPs to communicate that accumulated wisdom.  We also use SOPs to demonstrate regulatory compliance.  Sometimes, we even expect to use our SOPs as a means of legal defense, should our conduct be called into question.  Is it any surprise that the more we try to cram into our SOPs, and the more masters we have them serve, the harder it is for us to write them in a concise, easy-to-follow manner?

Smaller companies, with minimal or non-existent training staff, may rely more heavily on SOPs than their larger counterparts do, yet maintaining SOPs requires a significant resource commitment of its own.  Subject matter experts are needed to research the latest regulations, determine their impact on existing procedures, and author updates.  It’s difficult for experts in small companies to move steadily through this process because SOP maintenance is necessarily put on the back burner when profit-generating work demands. 

So, if all along you’ve been wondering why writing and revising your set of SOPs seems so hard or takes so long, maybe you can take some comfort from the fact that it’s not just you!

By Laurie Meehan

If you think you might like some help writing or maintaining your SOPs, contact us at info@polarisconsultants.com and we’ll set up some time to talk.

FDA's Response To Globalization Results In Domestic Efficiencies

It’s been widely acknowledged both inside and outside the FDA that increased globalization is putting enormous pressure on the agency and its resources.  In 2011, FDA published a Special Report entitled “Pathway to Global Product Safety and Quality” which outlined the challenges the agency faces from globalization, and its planned response to those challenges.  The report is eye-opening to say the least.  This is sentence #4:

“Half of all medical devices used in this country are imported, while 80% of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere.”

Even if you don’t get past the Executive Summary, you’ll get a feel for just how monumental a task it is, and will continue to be, to ensure the safety of our food, drugs, biologics, and medical devices.  The world may be shrinking but the pressures of globalization are growing.  Imports of both finished product and product components are increasing, foreign manufacturing facilities are proliferating, supply chains are getting more complex, and opportunities for contamination, adulteration, and fraud are expanding.  Keeping pace means FDA has to adopt a new international operating model that fundamentally, as the Special Report says, “changes the way it fulfills its mission to protect and promote the health of the American people.”

Harmonization with the EMA is one of the strategies FDA is pursuing to fulfill that mission.  To maximize their resources, FDA and EMA have stepped up efforts to coordinate their inspection visits and rely on each other’s results, It’s little surprise that in the course of performing these activities, the two agencies have identified some of the differences between them.  Traditionally, FDA has focused heavily on inspecting data and verifying compliance.  EMA, on the other hand, has concentrated on inspecting the systems and processes in place to obtain the data, an approach toward which FDA may be migrating.  Aligning the agencies’ approaches to inspections has obvious advantages to their increased cooperation, but for FDA and the industries that it regulates, there is an added advantage.  Data, by nature, is study-specific; processes are not.  A focus on processes makes it easier to apply lessons learned from past inspections and to confer knowledge to future inspections.  This extends the value of inspection resources that FDA invests beyond the individual inspection.

Keeping pace with globalization also means doing more with less domestically, because it seems the only thing that’s not growing by leaps and bounds in this global economy are FDA resources.   At industry forums such as ACRP, DIA, and RAPS this year, FDA announced its intent to perform inspections earlier in the clinical trial process than it has in the past.  There are a number of benefits to this shift.  First, only a mid-trial inspection could uncover an issue that the sponsor or investigator could correct in time to save the study; an inspection after the NDA is filed cannot.  Earlier FDA inspections argue for earlier internal and third-party audits, increasing the likelihood that problems can be identified and corrected before the cost of doing so becomes prohibitive.   Also, earlier inspections mean they will be conducted even if the study results in no submission, which benefits clinical research as a whole.  Aborted studies cost the industry tremendous amounts of money and time, much of which is wasted when there is no resulting new drug or device.  When inspections are conducted before NDA submission, both FDA and the inspected party will be able to add to their knowledge base from the experience, even if the study is canceled post-inspection.

The challenges of globalization aren’t just growing, they’re accelerating.  In this work-smarter-not-harder, bigger-bang-for-the-buck world, we’re all being forced to look for inventive ways to wring every last bit of value out of the resources we invest.  By focusing on processes instead of data and conducting inspections earlier, FDA is increasing the value that both the agency and the industry derive from its compliance enforcement efforts.

by Laurie Meehan

This blog discusses trends and issues in the pharmaceutical and dietary supplement industries.  Click the SIGN UP link to subscribe to occasional notifications of new blog posts.

What SOPs Do You Need As A Dietary Supplement Distributor?

If you look at the cGMP regulations for Dietary Supplements, you’ll notice that only 1 subpart includes the words “holding” or “distributing” in its title.  With only 10 or so individual requirements, the aptly-named Subpart M, “Holding and Distributing,” is shorter than most.  If you’re thinking this means there’s a much lighter regulatory burden placed on companies that simply hold or distribute Dietary Supplements than on companies that manufacture them, you’d be right.  At the same time, it’s incorrect to assume that regulations for holding and distributing Dietary Supplements are restricted to this single subpart.  At least 8 of the 16 subparts that comprise 21 CFR Part 111 are applicable to holders and distributors.

Subpart M requires that product be held in a manner that prevents its contamination and deterioration, and preserves its purity, strength, and composition.  Subpart M may require it, but Subparts B, C, and D provide the detailed regulations your facilities, equipment, and personnel need to follow to comply with it.  To start, your warehouse has to be clean and pest-free.  Dirt, insects, lubricants, or other agents could compromise the packaging or prevent labels from adhering.  Your facility also needs proper drainage, ventilation, adequate space, and work lighting.  (Is there sufficient airflow around products that are stored on upper warehouse levels?  Do cramped or dark conditions increase the likelihood of dangerous product mix-ups?)  You must also make sure that the product you hold is not exposed to more heat, cold, humidity, or light than the manufacturer recommends.  (Is the heat tunnel you use for sealing shrink wrap too hot?  Do you have backup refrigeration?  Do you need moisture sensors?  Have all the machines you use to maintain environmental conditions been cleaned, serviced, inspected, and calibrated.  When and by whom?)   Finally, your employees have to be trained in warehouse operations and hygienic practices, and they have to be qualified for the positions they hold.  And naturally, this training needs to be documented.

Because you cannot ensure the quality of the product you distribute without verifying the quality of the product you receive, distributors must institute some of the Quality Control measures identified in Subparts E and F.  Incoming shipments must be checked against invoices and other paperwork, and applicable certificates of analysis must be verified.  Product must be inspected for damage, and the procedures for storage and handling of damaged product must be documented and followed.

Even after your product has been delivered, your regulatory obligations have not been fully discharged.  Subpart N outlines requirements you must follow when product is returned to you.  Subpart O outlines your investigative and documentation responsibilities for any product complaints you may receive.  Finally, as a distributor, you would likely play a key role in any product recall.  Subpart P enumerates the records you must keep to respond appropriately to a recall, as well as demonstrate Part 111 compliance in general.

Perhaps to those involved in pharmaceutical manufacturing or clinical research, the regulatory burden placed on holders and distributors of Dietary Supplements may seem light.  In fairness, comparatively, it is light.   But that doesn’t mean complying with all the necessary Part 111 provisions is easy or straight forward.  It takes even the veterans time, effort, and expertise to achieve compliance, and it takes vigilance to maintain it.

We at Polaris hope you find this information helpful.  Contact us at info@polarisconsultants.com with a question or post a comment.

by Laurie Meehan

This blog discusses trends and issues in the pharmaceutical and dietary supplement industries.  Click the SIGN UP link to subscribe to occasional notifications of new blog posts.

How Social Media Is Advancing Healthcare

With its recent IPO, Facebook has received a lot of media attention lately.  While the news has been mostly financial, the huge sums of money being discussed are not the only numbers that can give pause.  Facebook boasts a staggering 900,000,000+ users.  To put that in perspective, if Facebook were a country, it would be the 3rd largest in the world.  And while Facebook is the biggest, it’s not the only social networking giant.  Depending what source you consult and how you count, there’s another dozen or so social media sites with 100,000,000 or more active users.  It’s hard to believe that, as little as seven years ago, Facebook was still in its infancy, unavailable to the general public, and many of the other popular sites didn’t yet exist.  Journalist Tom Friedman humorously observed that, “way back then”, Twitter was just a sound, the Cloud was something in the sky, applications were something you sent to college, and Skype was a typo.

It’s barely possible to exaggerate the extent to which the internet has influenced every aspect of our world, so, of course, healthcare is no exception.  For example, the FDA recently announced that it is considering expanding the definition of nonprescription drugs, in part because of the wealth of health-related resources available on the internet.  Janet Woodcock of the FDA said, “The rules for nonprescription status were established in an age when widespread access to information technology did not exist. The world is evolving.”

Internet sites on which users actively engage each other directly, known collectively as social networking, amplify the role the internet has played in both improving the health of individuals and advancing the healthcare industry.  What may have started as two early chat room denizens debating over dial-up the curative powers of chicken soup has evolved into myriad online communities that have become invaluable to patients, care-givers, suppliers, researchers, and policy makers. 

In 2000, the National Institute of Health launched ClinicalTrials.gov to improve public access to clinical trials.  Anyone suffering from a particular disease or condition can use this site to find clinical trials in which he or she can participate.  Patients also have access to a number of commercial sites to learn about trials planned in their area.  Clintrialsforyou.com is such a site; funded by sponsors, investigators, CROs, and SMOs, it provides free clinical trial information to prospective subjects.  These websites help reduce the high cost and long lead time associated with clinical trial recruitment while enabling individuals to seek experimental treatment for their conditions. 

There’s no doubt that sites such as these provide considerable value to their subscribers.  While not social networking sites per se, they do connect patients with researchers, who can then interact with each other, albeit outside the purview of the website.  Adding social networking to the mix only adds to the empowerment, influence, and advocacy the general internet offers patients.  Meanwhile health science organizations benefit from a fortunate byproduct of all that discussion: vast pools of patient-related, condition-specific data.

Disaboom.com is a social networking site for those living with disabilities.  Like Clintrialsforyou.com, it includes clinical trial information.  But Disaboom.com members can use the resources available on the site and engage in discussions with each other about a much broader array of topics, including treatments, assistive technologies, pain management, accessible travel, adaptive sports, scholarship opportunities, emergency preparedness, support organizations, fundraising efforts, job advocacy services, and the rights of the disabled.   

Rareconnect.org hosts 24 online communities for patients with rare diseases.  Twenty years ago, these individuals were…well…individuals; social media has allowed them to find each other.  Members can use the site to connect with others who share their rare condition, recount their experiences, help each other to improve dialogues with doctors, and otherwise offer advice and support.  In that regard, Rareconnect.org is not that different from other online communities.  However, simply by assembling, members give themselves lobbying power to influence research and, at the same time, create a set of candidate subjects for that research. 

In partnership with patient advocacy groups, Inspire.com hosts 190 disease-specific patient communities.  Members use the social networking site free of charge to connect with each other, and strict privacy settings control what can be shared outside the community.  Life science organizations can then pay for access to these patient populations and data they wish to share, using the site to recruit patients for studies, perform market research, and promote brand awareness.  With more than 230,000 members, Inspire.com is itself a form of advocacy group, thanks to the sheer number of highly engaged members it brings together.

PatientsLikeMe.com is a social networking site of over 150,000 individuals with over 1000 different conditions.  Like other social networking sites, members of PatientsLikeMe.com can find each other and engage in discussions.  In addition, PatientLikeMe.com is a “health data-sharing platform” that uses creative data capturing tools to standardize the data it collects, and offers strong analysis techniques that allow users to assess, among other things, likely outcomes of particular therapies.  The ultimate goal is to improve existing treatments and accelerate the pace of clinical research by strategically mining rich repositories of patient data.  (While most companies promote their privacy policies, PatientsLikeMe.com touts its “openness policy” and the benefit of data transparency to the global healthcare system.)  Last year, the company used data collected from 596 subscribers to challenge the results of a 16-subject study on the effects of lithium on ALS.  Critics argue that this approach to evaluating outcomes can never replace conventional randomized, double-blinded, placebo-controlled clinical studies.  Advocates counter that such trials have become so expensive and time-consuming that it’s imperative the industry explore other models.  Click here to read more.

A recent documentary allowed me to see for myself how one set of parents has been using social media to make advantageous connections on behalf of their mentally ill daughter.  In 2009 at age 6, Jani Schofield was diagnosed with Childhood Onset Schizophrenia (COS), a very rare psychosis.  Jani was prescribed Risperidone, which the documentary noted was the only drug approved by the FDA to treat schizophrenia in children.  Jani’s parents created a Facebook page to reach out to other care-givers and to give parents of mentally ill children a voice.  The day after the documentary aired, I found the Schofield’s Facebook page.  I didn’t have to scroll down very far to encounter a May 2012 posting from a researcher who was interested in establishing contact with patients and parents to collect data and discuss a study on the development of COS.  I then navigated to the Yahoo Health site and performed a group search on “Schizophrenia”.   There were 110 discussion groups that matched my search.  On the very first results page, I encountered two groups, “Schizophrenia – parents” and “The Odd Parent Journey”, both of which dealt with, among other mental illnesses, the rare COS.

No one can predict for sure just what the future of social networking or the future of healthcare might look like, but I think it’s a safe bet that their futures will be intertwined and here before we know it.

by Laurie Meehan

This blog discusses trends and issues in the pharmaceutical and dietary supplement industries.  Click the SIGN UP link to subscribe to occasional notifications of new blog posts.

What Trend in Big Pharma Means To Smaller Industry Players

There’s been a shift lately in the way Big Pharma is doing business.  Traditionally, large pharmaceutical companies would outsource clinical study responsibilities to a wide variety of external vendors, essentially distributing the work across many service providers.  Large CROs routinely performed work for both large and small pharmaceutical companies to keep their top-notch resources utilized to capacity and add to their bottom line.

More recently, economic pressures have moved Big Pharma away from transaction-based, fee for service arrangements with their CROs, and towards strategic alliances with them.  The advantages for sponsor companies are many: shared risk, knowledge transfer, and shorter time to market.  Strategic alliances are arguably as advantageous for the CROs, providing a steady pipeline of work that’s larger in scope and longer in duration than is typical under traditional arrangements.  The industry journals are replete with sage warnings about culture incompatibilities and intellectual property protection, but done correctly, there may be few significant downsides to these strategic alliances.

As is frequently the case, a new advantage for one segment of the industry is a new disadvantage for another.  Small and medium-sized pharmaceutical companies, like their large counterparts, have been feeling the strain of higher costs and smaller staffs.  Adding to these economic pressures, the trend towards alliances among the large players increases competition for top-drawer CRO resources. The reduced availability of these outsourcing options likely means smaller sponsor companies will pay higher prices for services.  It could also mean that at the same time they are paying more, the quality of service and level of commitment they receive may be reduced, as the best and most experienced CRO staff members are dedicated to projects associated with strategic alliances.

Just as Big Pharma has taken a look at the economic environment and has begun forming nontraditional business relationships, small and medium-sized should take stock and make some adjustments, as well.  They should begin looking beyond their traditional outsourcing choices and consider selecting smaller outsourcing partners who may well be in a better position to focus on individual projects and give priority to shorter term engagements.  After all, a project that’s small to a big CRO will be comparatively big to a small CRO.

Effective vendor prequalification has always been important, yet this new environment may elevate its priority.  If small and medium-sized sponsors look to expand their set of outsourcing partners, they will need to increase both the time and resources they currently invest in prequalification activities.  To further ensure that potential new service providers have the ability to deliver quality and timely results, companies may increasingly opt to engage third-party consultants to perform additional prequalification audits or to develop comprehensive in-house vendor qualification programs.

Bottom line:  The trend toward strategic alliances among large companies will change the terrain for many industry players; competition for the services of large, established CROs is likely to increase.   Smaller sponsor companies can compensate by emphasizing vendor prequalification procedures and subsequently contracting with capable, smaller services providers.

Expert consultants at Polaris would be happy to talk to you about any CRO prequalification needs you may have.  Contact us at info@polarisconsultants.com or visit our website at www.polarisconsultants.com.

by Laurie Meehan

This blog discusses trends and issues in the pharmaceutical and dietary supplement industries.  Click the SIGN UP link to subscribe to occasional notifications of new blog posts.