Compliance Zen

Reimbursement: Plan Early

In an interview I did with Clinica in the UK (which they turned into an article "Device Reimbursement: Plan Early, Says US Compliance Consultant"), I made the case that firms need to incorporate reimbursement evaluation and assessments as early as possible, preferably toward the end of the preclinical stage.

Some points from the article:

• The sooner you can evaluate reimbursement potential, the better your return on investment in clinical trials
• Try to build a reimbursement evaluation into the stage gate review process for moving a new medicine from preclinical to clinical
• Early reimbursement evaluation allows you to determine what potential customers (prospective patients, physicians, hospital administrators, etc.) will need to see when it comes to efficacy and safety claims
• Early reimbursement evaluation gives you the time to better shape your marketing messages to different customers
• Early reimbursement offers you the chance to set better cost controls for production and the rest of development; it will hardly benefit you as the company if you are making a product that costs you more than you will earn back in reimbursement

Key tactics to help incorporate reimbursement planning early in development include stage gates, regulatory affairs road-mapping, and clinical regulatory strategic plans, all of which I discuss in detail in my forthcoming book, Get to Market Now!

Bringing in reimbursement considerations as early as possible in development help demonstrate an integrated, holistic compliance and development strategy - and show how compliance departments such as regulatory affairs and quality management drive value to a company's bottom line.  And that's what I call Lean Compliance.

Are you ready?

SmarterCompliance #37 Regulatory Submission and Data Quality

The January 2010 issue of my FDA regulatory intelligence and quality systems advice newsletter, SmarterCompliance, has been published.  This issue (volume 4, issue 1), contains:

• Article:  Regulatory Submissions and Data Quality
• Article:  How to Protect Your Paper Records
• Enforcement Analysis:  Promotional enforcement trends
• Expert Advice:  Document management system service pack validations
• Leadership Tips:  Rapid onboarding
• Featured Reading:  Use Both Sides of Your Brain
• Plus 3 bonus documents from FDA, ICH, PIC/S, and EMA

If you'd like to subscribe to this FDA compliance newsletter, please visit http://www.ceruleanllc.com/Newsletter/Subscribe.htm

To see the complete library of past issues, visit http://www.ceruleanllc.com/Newsletter/Library_Newsletter.htm

Can Charles River Retune its Preclinical Operations?

Today’s news that contract research organization (CRO) Charles River Labs will be suspending its preclinical operations by mid-2010 in hopes of a biotech recovery is being met with the usual hand-wringing about the state of the industry following the near collapse of the global financial system in 2008.  I look at this a bit differently.  This suspension is a wonderful opportunity for Charles River to come roaring back with preclinical services better attuned and better able to take advantage of cutting-edge medicinal product development techniques.

In my book, Get to Market Now (slated for a May 2010 publication through Logos Press), I argue that firms can be making much better use of the preclinical stage through techniques such as:

• Crafting a clinical regulatory integrated strategic plan
• Bookshelving of previous studies into large databases
• Mining the data of those databases as part of an extended literature survey
• Capturing the voice of the customer (e.g., physicians, prospective patients, etc.)
• Summarizing preclinical studies to include potential critical product quality attributes (CQAs) and a risk analysis
• Planning and undertaking Phase 0 feasibility studies

Charles River has a good six months to put in place a strategy that incorporates tactics just like these, and offering them to clients (something that will save their clients money and time as well).  If your firm already has a number of preclinical studies underway - or planned - consider any of these tactics to help you improve R&D productivity and speed time to market.  Recent FDA and ICH guidelines encourage the adopting of many of these tactics through the quality by design philosophy.  Firms that ignore all the new product development options available to them in the 21^st century in the preclinical stage risk staying back at the 1 in 250 success rate of the 20^th century’s preclinical stage.

If you’d like to learn more about these tactics and adopting them into your preclinical development efforts, contact me through my firm.

Have a different opinion?  Share it.

Three Tips to Elevate Your Compliance Communications

Good communication is a hallmark of trust.  If people know they can count on you to communicate well, to articulate thoughts in ways that are understandable to any listener, then people will see you - and the programs you champion - as worth paying attention.  And when it comes to dealing with the FDA or the EMA or Health Canada or any other regulatory agency, communications speak volumes about the levels of trust and competence that regulatory authorities should assume about you.

Three tips to elevate your communications when it comes to regulatory compliance and quality systems:

1. Equate email with image.  Think of email as tiny bits of a virtual company image.  At a minimum, use spell check (but don't rely solely upon it), keep the number of recipients to a minimum, do not flag items as urgent or high priority if they really aren't, and understand that email is not private.  As a colleague once put it in a training session, "Don't put anything in your email that your mother would be ashamed of reading in tomorrow's New York Times."
2. Readability of memos and emails.  When it comes to memos, use your word processing program to check for the ease of comprehension (e.g., readability).  Microsoft Word, for instance, will allow you to check readability levels when you check spelling and grammar.  But when it comes to emails, you'll need to do the work, so some rules to keep in mind:  anything more than 3 paragraphs will encourage skimming so be cautious; when you can, number items rather than bullet point them; keep lists to under 5 items; and make sure to read through any email to a regulatory agency or your boss (at minimum) to ensure you've not inadvertently left out a word or two (something we're all guilty of occasionally).
3. Visit in person.  Know when to write, call, or visit.  If you're having trouble picking just the right words or phrases to use to avoid misunderstandings, that's the signal to step away from the computer and go talk to someone in person or on the phone.

The news is full of pharmaceutical and device firms who've gotten sued or otherwise involved in litigation, and have been forced to divulge their emails and internal business communications.  Don't join in.  Use these tips to help you think twice about recording comments and phrases that might later be taken out of context and used to portray you or your company in a negative, uncaring light.

For more advice you can use on controlling records and handling requests from FDA for records or emails, see my recorded seminar, FDA Quality Systems Records Requirements and Retention for Pharmaceutical, Biotech, and Device Firms - GLPs, GCPs, GMPs, QSRs.  You get a 9-page matrix detailing out various retention requirements under each regulation along with loads of tips and advice on how to build in retaining the right records to prove compliance and product safety, efficacy, and quality.

And if you need more advice, feel free to contact me directly.

FDA Regulatory Outlook and Forecast 2010 Newsletter Issue Available

My annual FDA regulatory forecast and planning issue of my SmarterCompliance newsletter has been published. In the December newsletter:

• 35 predictions for FDA activities for the coming year plus 30 specific recommendations
• Featured reading: The Predictioneer's Game
• Bonus downloads: 
• • 10 pages of analyses and recommendations on trends in new drug / device development
  • Report on the regulatory harmonization and collaboration between FDA and EMEA
  • Excerpt from my forthcoming book, Get to Market Now!, slated for publication in May 2010

You can a lot more content and bonus downloads with a full subscription to my monthly FDA newsletter here:   http://www.ceruleanllc.com/Newsletter/Subscribe.htm

Join my Cerulean mailing list here:  http://www.ceruleanllc.com/ContactReq.aspx

The first draft of the book manuscript is currently being slashed and burned by my editor at Logos Press in D.C. The next few weeks promise an unhealthy mix of gift-wrapping and manuscript revisioning. The goal is to get the book to the printers by January so it's ready for publication to coincide with BIO 2010. The book is all about regulatory compliance and quality systems over the next decade, from 2010 - 2020, and is a blueprint, if you will, of what biopharmaceutical and device executives need to do in order get their new drugs and devices on the market as we increasingly face medicine personalization, reimbursement challenges, and globally harmonized regulations. It, as my editor has at least graciously allowed, "a blueprint for success."

Over the coming months, I'm building a special website dedicated to the book with downloads, mini-seminars, and chapter extracts.

In two weeks, just after Christmas holidays here in the States, the December issue of my newsletter will be released with all my various FDA forecasts and recommendations for 2010. So stay tuned!

Applying Auto Companies' Lean to Pharma's Woes

News that AstraZeneca is looking to the automotive industry for advice on improving efficiency in its drug manufacturing operations reminds me of Ambrose Bierce's famous quip, "There is nothing new under the sun, but there are a lots of old things we don't know."

I cited Bierce back in early 2007 in an article I wrote for Bioprocess International entitled Lessons from the Auto Industry (click the link to download the PDF).  In it, I advocated that biopharmaceutical firms could learn a lot of lessons inexpensively from the automobile industry's experiences.  Concepts like "lean" and kaizen (continual improvement) are directly applicable to manufacturing, product development, and business support groups like Quality, Regulatory Affairs, IT, and Records Management.

Indeed, it was a year later, in 2008, when FDA officials like Kim Trautman and Deb Autor began to publicly encourage companies to adopt "continuous improvement" as a core component of good FDA compliance.

Examples of this lean, kaizen approach include FDA compliance process mapping, retention of the right records, a focus on electronic data integrity (as the goal as opposed to "computer validation"), cohesive compliance and quality programs, and so on - all strategies I've advocated (and consult on) for years.

If you're going to undertake your own lean project, here is the general outline I suggest you consider along with a few hard won tips:

1. First, do a gap assessment - either yourself or through an independent, outside consultant.  You may not want to do this as an actual mock FDA audit, but rather use the guise but make it more holistic, less QSIT-focused.  You need to get the picture of gaps in your operations and how interwoven compliance is ... or isn't.
2. Second, hold a process mapping workshop.  Most people tends to do this as a stand-alone, "here's how you process map" training session.  I think this is less valuable than dividing time between the basics and then applying it to your real-world.  For instance, with clients, we'll spend 2-3 hours on "how to process map" and then we'll spend the rest of the day actually process mapping at least 2-3 of their current procedures (if you already have SOPs, then doing the process mapping is not only easier, but it will very, very quickly lead to improvements - it's a fantastic feeling to get such a quick ROI).
3. Third, translate the process maps into actual SOPs - that can take a bit of work, but as you start to get in the swing of things, you'll see how much easier ... and more "followable" ... it makes your SOPs and policies.

A couple of further tips to consider:

• Try to keep your process maps at 20 steps or less - you want the map to fit on one page legibly (i.e., not 8 pt font)
• (I know this will upset the apple cart for some) This is not the time to tackle Six Sigma.  It's so tempting but don't do this.  Please.  Here's what will happen:  at best you'll dilute your efforts; at worst, you'll end up bogging down in an unintended, massive Six Sigma project.  Reserve Six Sigma for your next big step - tackle that a year or two down the road when it's time to step up your lean game.

Good luck ... and get lean.

Are you ready?

Hosting an FDA Supplier Management Event

The folks at FDAnews have asked me to reprise my role as host for their November 18th webinar on supplier qualification and oversight:  Medical Device Supplier Risk Management: Ensuring Your Suppliers are FDA Compliant

Speakers will include (in addition to myself) Kim Trautman of FDA's CDRH, Jim Shore of Boston Scientific, Jacqueline Torfin of Arizant Healthcare, Jeff Kasoff of Life-Tech, and others.

If you'd like to attend, it's not too late.  You can sign up here: http://www.fdanews.com/conference/detail?eventId=2837

Speaking Event in D.C.

I'll be speaking at the 4th Annual Medical Device Regulatory, Reimbursement and Compliance Congress in Washington, D.C. on Wednesday, November 11th.

I'm giving a three-hour (fun! fun!) workshop along with a former FDA prosecutor on making regulatory compliance training actually enjoyable.  We'll be covering basics such as how to get your attendees involved and motivated (aside from arm-twisting), why standard "attendance sheets" are meaningless, how to build in effectiveness measures into your training and annual reviews, and how to use the outputs of training to prove compliance.

In case you're wondering, we also do this as a private, more tailored webinar and teleconference wherein we speak exactly to the issues you might be having.  Feel free to contact me for more details on that.

Bulletproof Redux

I've fielded many email requests on whether or not I'll do another live Bulletproof Yourself against FDA Enforcement webinar and teleconference.

After saying "I'm not sure" for a month and a half, I've finally agreed and will be hosting an encore version on Tuesday, December 15th.  You can sign up here http://www.ceruleanllc.com/Webinar/default.htm through December 11th.

And if you can't make it, there's always the recorded version.  You can download a PDF of the full agenda at either of the above links.