Promotional Content Dissemination by your Sales Force

Featured Speakers:

    Elsa Chi Abruzzo, RAC, President and CEO, A...
Promotional Content Dissemination by your Sales Force



Our Sponsoring Partner:

Prolifiq
Prolifiq offers a sales-friendl...
Promotional Content Dissemination by your Sales Force




Elsa Chi Abruzzo, RAC, President and CEO, ARAC, LLC

           ...
Promotional Content Dissemination by your Sales Force




Benjamin S. Martin, Associate, Epstein Becker and Green, P.C.

 ...
Promotional Content Dissemination by
          your Sales Force


      Real Life Examples and Solutions
                 ...
Agenda
Promotional Content Dissemination by Your
Sales Force

•   Preparing for Success
•   Example #1: Trade Show Prep
• ...
Preparing for Success




            Sponsored by Prolifiq Software. ©2009
Changing Landscape
• Regulatory, Compliance and Legal
  – Expanding breadth and depth of
    regulations and guidelines
  ...
Learn from GMP and GCP

• Response to quality issues
  – Inefficient processes                        Efficient
• Central ...
Compliance isn’t always easy




                               www.mustreadblogs.blogspot.com


            Sponsored by ...
Good Promotional Practices
•   Many leading companies are
    developing their own GPPs

•   Essentially a risk management...
Promotional Content Dissemination by 
                             your Sales Force

Quick Poll:

Does your company have a...
GPP, an organizational commitment

Recommendation #1:
Formulate a Good Promotional Practices Statement to
codify your orga...
Promotional Review Committee

 •   A permanent organizational unit

 •   Composed of executives with
     approval authori...
An example of a systematic approach
PACE - A process for collaborative review of promotional content




                 ...
Case Study: Meet H2FMed
Company: H2FMED
Device: Drizzle infusion catheter
Context: US-based tradeshow for interventional r...
Case Study: Tradeshow Preparation




          Sponsored by Prolifiq Software. ©2009
Lay out your game plan
 Tradeshow Plan




                  Sponsored by Prolifiq Software. ©2009
Holistic Review
 • Pre-meeting emails/mailings
 • Non-CME Symposium
 • Booth
     • Videos and Graphics
     • At-show col...
Primary Filters for Promotional Content Review

1. Must be truthful and non-deceptive

2. Must have evidence to back up cl...
Sponsored by Prolifiq Software. ©2009
Drizzle™ Infusion Catheter
Product Code:                                                         iCr1
                    ...
is preferred for AV thrombolysis

         by 80% of physicians
The drizzle™ infusion catheter is
the latest in infusion t...
Sponsored by Prolifiq Software. ©2009
Video Concept Outline 

Discuss labeling of video if tangible. 

On Screen                                    Audio       ...
Combined with microfilament       •   1:1 torque—virtually nothing has 1:1 torque, how are we substantiating this statemen...
Post Approval Considerations

• Training the sales force

• Build compliance into sales processes

• Validate that approve...
Today’s Sponsor
•   Prolifiq Software – Sales-friendly solution for compliant
    distribution of sales and marketing mate...
Questions & Answers
• Elsa Chi Abruzzo, President, ARAC
   – abruzzorac@aol.com
• Benjamin S. Martin, Associate, EBG
   – ...
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Promotional Content Dissemination by your Sales Force

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Real Life Examples and Solutions for Dissemination of Promotional Content

Life Sciences companies cope with the myriad government regulations covering the distribution of promotional, educational, and scientific information.



This session provides practical advice and a methodology that helps Marketing, Regulatory and Sales work together to find the right balance between promotion and compliance. Industry experts will outline PACE, a four step methodology that is the cornerstone of an emerging standard of Good Promotional Practices for Life Science companies.

The session includes examples of how product literature is evaluated and classified, and identification of applicable regulations that impact promotional content.

Published in: Health & Medicine, Business
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Promotional Content Dissemination by your Sales Force

  1. 1. Promotional Content Dissemination by your Sales Force Featured Speakers: Elsa Chi Abruzzo, RAC, President and CEO, ARAC, LLC Benjamin S. Martin, Associate, Epstein Becker and Green, P.C. Copyright © 2009 Honeycomb Xtalks Inc.
  2. 2. Promotional Content Dissemination by your Sales Force Our Sponsoring Partner: Prolifiq Prolifiq offers a sales-friendly solution for compliant distribution of sales and marketing materials. Proactive rules are built into the software, to ensure increased compliance. Sales professionals access the entire marketing library and send materials from their mobile device, with the rules operating transparently in the background. For more information, please visit: www.prolifiq.net Our Media Partner: Copyright © 2009 Honeycomb Xtalks Inc.
  3. 3. Promotional Content Dissemination by your Sales Force Elsa Chi Abruzzo, RAC, President and CEO, ARAC, LLC Elsa has 20 years of experience in the medical device industry with a successful, domestic and international approval record for innovative medical devices in the areas of interventional neuroradiology/cardiology, cardiac/general surgery, electrophysiology, and orthopedics. She has served as head of Regulatory/Clinical Affairs and Quality Assurance for breakthrough start-up companies, including Percutaneous Valve Technologies, Inc. (PVT), through acquisition and emerging growth companies, including CryoLife, Inc. and AtriCure, Inc., through IPO and/or commercialization. Elsa has also worked for Fortune 100 companies, including Baxter and Cordis Johnson and Johnson, in manufacturing engineering, quality assurance, and regulatory and clinical affairs. Copyright © 2009 Honeycomb Xtalks Inc.
  4. 4. Promotional Content Dissemination by your Sales Force Benjamin S. Martin, Associate, Epstein Becker and Green, P.C. BEN MARTIN is a senior associate in the Health Care and Life Sciences Practice in the Washington, DC office of Epstein Becker & Green, P.C. Mr. Martin provides regulatory counselling and transactional and litigation support on a wide range of issues affecting manufacturers, distributors, pharmacies, providers, and other entities along the pharmaceutical and medical device supply chains, including: - Approval, manufacture, distribution, and promotion of pharmaceuticals and medical devices; - Coverage of pharmaceuticals and medical devices by governmental and private health care plans or programs; - Prevention of fraud, waste, and abuse associated with sales and marketing practices; and - All phases of government inquiries and investigations. Mr. Martin received his law degree in 1999 from the University of Virginia School of Law, where he was a member of the Virginia Law Review and was elected to the Order of the Coif. Copyright © 2009 Honeycomb Xtalks Inc.
  5. 5. Promotional Content Dissemination by your Sales Force Real Life Examples and Solutions (60 min) Sponsored by Prolifiq Software. ©2009
  6. 6. Agenda Promotional Content Dissemination by Your Sales Force • Preparing for Success • Example #1: Trade Show Prep • Example #2: Product Literature • Example #3: Video • Execution • Questions and Answers Sponsored by Prolifiq Software. ©2009
  7. 7. Preparing for Success Sponsored by Prolifiq Software. ©2009
  8. 8. Changing Landscape • Regulatory, Compliance and Legal – Expanding breadth and depth of regulations and guidelines – Increasing FDA, DOJ and SEC (FCPA) enforcement • Sales and Marketing – More decision makers – More sites of service • Less time and fewer resources Sponsored by Prolifiq Software. ©2009
  9. 9. Learn from GMP and GCP • Response to quality issues – Inefficient processes Efficient • Central aspects of GxP are: – Traceability: the ability to reconstruct history – Accountability: the ability to resolve who has done what and when • Established organizational ownership Sponsored by Prolifiq Software. ©2009
  10. 10. Compliance isn’t always easy www.mustreadblogs.blogspot.com Sponsored by Prolifiq Software. ©2009
  11. 11. Good Promotional Practices • Many leading companies are developing their own GPPs • Essentially a risk management tool—sets the company’s preferred path forward in a gray area • Looked favorably upon by regulators if done well • Become the basis for training and auditing Sponsored by Prolifiq Software. ©2009
  12. 12. Promotional Content Dissemination by  your Sales Force Quick Poll: Does your company have a good promotional practices statement or something similar? 10% 20% Yes No Unsure 70% Copyright © 2009 Honeycomb Xtalks Inc.
  13. 13. GPP, an organizational commitment Recommendation #1: Formulate a Good Promotional Practices Statement to codify your organization’s commitment. Key Elements of a GPP statement • Committee for review • Commitment to promote on-label • Concise, high-level, executive view • Can reference other processes, procedures, documents Sponsored by Prolifiq Software. ©2009
  14. 14. Promotional Review Committee • A permanent organizational unit • Composed of executives with approval authority • Adopt a content life cycle approach, with oversight from concept through execution • Apply systematic approach Recommendation #2: Create a PRC to align the organization and support execution Sponsored by Prolifiq Software. ©2009
  15. 15. An example of a systematic approach PACE - A process for collaborative review of promotional content Sponsored by Prolifiq Software. ©2009
  16. 16. Case Study: Meet H2FMed Company: H2FMED Device: Drizzle infusion catheter Context: US-based tradeshow for interventional radiologists Approvals/Clearances: Class II 510(k) product Indication: Indicated to infuse various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with respective manufacturer's instructions for use. Sponsored by Prolifiq Software. ©2009
  17. 17. Case Study: Tradeshow Preparation Sponsored by Prolifiq Software. ©2009
  18. 18. Lay out your game plan Tradeshow Plan Sponsored by Prolifiq Software. ©2009
  19. 19. Holistic Review • Pre-meeting emails/mailings • Non-CME Symposium • Booth • Videos and Graphics • At-show collateral and emails • New Products Uncleared • Collateral, print and digital • Door drops • Post-show follow emails • Advisory Board/KOL meetings • Scientific Posters • Sponsorships • Sales product training for booth duty • Training materials Sponsored by Prolifiq Software. ©2009
  20. 20. Primary Filters for Promotional Content Review 1. Must be truthful and non-deceptive 2. Must have evidence to back up claims 3. Cannot be unfair 4. Risk Communication Guidance 5. Fair and balanced 6. Transparency Sponsored by Prolifiq Software. ©2009
  21. 21. Sponsored by Prolifiq Software. ©2009
  22. 22. Drizzle™ Infusion Catheter Product Code: iCr1 When you need to get there For ordering information in the Us, please call: 1.877.555.5555. R AdeliverD L Y and P I slowly! outside the Us, visit our website www.h2fmed.com/buynow for a number to contact. Please review the approved labeling for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use prior to using these devices. Federal law (Usa) restricts this device to sale, distribution, or use by or on the order of a physician. Us: [insert your Us indications here] international: [insert your oUs indications here] © 2009. H2FMed, inc. H2FMED 4145 sw watson ave Beaverton, or, 97005 www.h2fmed.com 1.877.555.5555 1.503.555.5555
  23. 23. is preferred for AV thrombolysis by 80% of physicians The drizzle™ infusion catheter is the latest in infusion technology from H2FMed. The thin-walled catheter is coated with slipper® coating – a proprietary blend of Teflon and silver which get delivers lubricious, anti-bacterial protection combined with microfilament braid to deliver with delivers for: 1:1 torque throughout tortuous •thRomboLYsIs anatomy. and, the conical one nanometer (1 nm) holes diffuse •LocAL DRug the medication gently to prevent DeLIVeRY jetting and intimal damage. before and After - seeing is believing! Courtesy of dr. Jones, st. Joes, ocean Grove
  24. 24. Sponsored by Prolifiq Software. ©2009
  25. 25. Video Concept Outline  Discuss labeling of video if tangible.  On Screen  Audio  Notes  Drizzle™ infusion catheter – When you  Upbeat music  • Verify you have FDA clearance for product  need to get there rapidly and deliver  • Reasonable support for the claim  slowly!  o Comparison    o Measured  o Definition of slowly is available and spelled out  Show skinny purple tube winding along  The Drizzle™ infusion catheter  • Accurate representation of the product  the page with tip coming towards you in  is the latest in infusion  o Engineering or other knowledgeable resource validates the image/illustration is accurate  perspective so that it is large enough to  technology from H2FMed.    see the pattern of numerous small holes.   Background in blue.  The thin‐walled catheter is  • Verify coating statement is true and meets product specifications. Is entire catheter coated, or just  coated with Slipper® coating –  the tip?  a proprietary blend of Teflon  • What does proprietary mean? Is it patented or patent‐pending? If so, where citation?  and silver which delivers  • Lubricious—how is this validated? Need actual data supporting this term. What is the % difference vs  +  lubricious, anti‐bacterial  protection.   • uncoated? Difference should be meaningful. (1% vs 20%)  Anti‐bacterial—  o What guidance are applicable to the coating claims?  o This is preventative, not the treatment since it is the coating. Be clear, you don’t’ want to  imply you are a therapy.  o What is the length of time of the effect, what is the effect?  o  Is it reasonably proven? What is the substantiation?   o Not in indication  o Was there specific testing that covered anti‐bacterial claims? What did the FDA say  regarding this?  • Images—Ensure proper trademark/copyright disclaimer is included for Teflon.                 
  26. 26. Combined with microfilament  • 1:1 torque—virtually nothing has 1:1 torque, how are we substantiating this statement? In what  braid to deliver 1:1 torque  scenario have we proven this? Was the testing/simulation reasonable?   throughout tortuous  • Image implies that it traverses the entire vascular system, is this true?   anatomy.    • Throughout implies all.  • Tortuous anatomy—  o Claim was only for vascular, need to clarify that it is tortuous vascular anatomy.  o What is the testing for this? How many configurations? Was a real case tested? Were  reasonable clinical scenarios simulated?    [Creative image #: 200177314‐001]  With picture of catheter wrapped around  pencil.        Close up of distal tip with fluid oozing  And, the conical one  • Picture needs to be representative of real life and what has been tested. Flow rate should accurately  nanometer (1 nm) holes  match testing results.  diffuse the medication gently   • Conical one nanometer hole—Ensure these match to the nominal spec.    • What is gently? Gently implies lack of injury or reduced pain? Is this realistic? Have any complaints  been filed that are contradictive?  preventing jetting and  • Is there data to support claim that jetting does not occur based on the flow rates in the instructions  preserving the intima.  for use?  • How do you substantiate that it preserves the intima?  o In the range of patients reasonably receiving this therapy?  • Pictures  o What tissue/medium is this?  o Where in the vasculature is this?  o What were the infusion parameters?  o How long, which catheter and flow rate?  o Do these represent the best result or reasonable, mean result?  o Fair/balance and transparency—need to be very clear about what you are implying.    Did you know?  Drizzle is preferred for AV  Did you know?  Drizzle is  • Data, data, data  thrombolysis by 80% (flashing) of  preferred for AV thrombolysis  o Is it reasonable?  physicians.  by 80% of physicians.  o US survey      o Survey count 
  27. 27. Post Approval Considerations • Training the sales force • Build compliance into sales processes • Validate that approved content is properly managed • PRC retains visibility to use of content • Communications History Records Sponsored by Prolifiq Software. ©2009
  28. 28. Today’s Sponsor • Prolifiq Software – Sales-friendly solution for compliant distribution of sales and marketing materials – Documented history of digital communication with customers and prospects – End-to-end traceability for Monitoring and immediate action Sponsored by Prolifiq Software. ©2009
  29. 29. Questions & Answers • Elsa Chi Abruzzo, President, ARAC – abruzzorac@aol.com • Benjamin S. Martin, Associate, EBG – bmartin@ebglaw.com Sponsored by: • Prolifiq Software, www.prolifiq.net/lifesciences • Maureen Shaffer, VP Life Sciences, Prolifiq – maureen.shaffer@prolifiq.net Sponsored by Prolifiq Software. ©2009

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