Hurdles to Market: Moving from Medical Device

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Hurdles to Market Moving from Medical Device to
Pharmaceutical Markets Mitch Regnier, P.
Eng., Engineering Director David Field, Ph.D.,
Technology Director
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OVERVIEW

• About NUCRYST Pharmaceuticals History and
  Environment
• NUCRYST Pharmaceuticals as a medical device
  producer
• NUCRYSTs thinking behind becoming a
  pharmaceuticals producer
• Synopsis of pharmaceuticals efforts
• Lessons learned and key points
• Conclusion

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ORIGIN OF NUCRYST

• Worlds first producer of nanocrystalline silver
  coated wound dressings for treatment of
  infection.
• Origins go back to a partnering of Sherritt Inc.
  and various levels of Government to form the
  Westaim initiative. (Western Advanced Industrial
  Materials)
• Westaims purpose was to research and
  commercialize new industrial materials.

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ORIGIN OF NUCRYST (contd)

• Of Westaims original research projects only
  NUCRYST remains.
• NUCRYST Pharmaceuticals went through an IPO in
  Dec. 2006 and is currently traded on the TSE
  (NCS) and Nasdaq (NCST)

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ABOUT NUCRYST

• LOCATION City of Fort Saskatchewan, Alberta
• Fort Saskatchewan has appr. 2300 hours of
  sunshine per year.
• There are only 100 frost free days a year in Fort
  Saskatchewan.
• Seasonal Mean January -12C (10F).
• Latitude - 5343 N
• Population 16,500 as per the 2007 municipal
  census
• Fort Saskatchewan is the home to over 20
  world-scale companies.

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FACILITY SITE 90,000 sq ft. EMPLOYEES
100 DRESSINGS 2007 5M

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X

• X

ISO 134852003 CMDCAS 21 CFR PART 820 FDA
REGULATORY COMPLIANCE
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MEDICAL DEVICES

• Nanocrystalline films were identified as a
  potentially innovative technology for wound care
  dressings as medical devices.
• Patents and regulatory approval for sale of
  Acticoat dressings obtained and small sales
  force
  assembled in USA.
• Partnership and sale of brand
  to SN
  expanded market penetration
  and global presence.

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x

• x

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THE MOVE TO PHARMA

• Great potential seen based on growing experience
  with nano-film dressings in the lab and
  exceptional results in the clinic.
• Manufacturing of nano-silver as powder API not
  seen as large technical challenge.
• Promising results for nano-silver
  API powder as a
  combined
  anti-microbial and
  
  anti-inflammatory agent.

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THE MOVE TO PHARMA (contd)

• Regulatory path was thought to be shorter due to
  similarity of API with material already approved
  for medical devices.
• Smaller development costs assumed since material
  was already mostly developed and facilities and
  equipment were available for research and initial
  launch quantities.
• Great opportunity as platform technology for
  management of infection and inflammation.

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COPING WITH CHANGE - ORGANIZATION

• Move to pharma involved the opening of new labs
  and head office in Wakefield, MA.
• Project driven by head office with all research
  resources in US and manufacturing in Fort Sask.
• Limited internal resources and talent pool
  necessitated outsourcing. of project management,
  facility design / engineering and pharma quality
  systems development.

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COPING WITH CHANGE - MANUFACTURING

• Facility requirements and acceptable functional
  specifications sometimes elusive.
• Setting final specifications and test methods
  extremely challenging due to novel material.
• Difficult to switch between medical device and
  pharma mentalities although ICH guidance was very
  helpful.

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PHARMA AT NUCRYST - THE END RESULT

• Development of a pharmaceutical cream for
  treatment of dermatological conditions was
  discontinued in November 2006 due to failure of
  2nd Ph. II clinical trial.
• Continue to develop pharmaceutical products
  containing our nano-silver API including the
  search for a partner.
• Gained FDA clearance for use of topical
  prescription device containing nano-silver
  powder.

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LESSONS

• Recruitment
• Consultants and Outsourcing
• Project Leadership
• Essential Internal Resources

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RECRUITMENT

• Hiring local employees with pharmaceutical /
  medical device industry experience (or any
  experience?) is difficult in Alberta.
• Use of recruitment agencies very useful in
  finding candidates.
• Partner or satellite office near more vibrant
  life sciences industries such as Boston or
  Mississauga can be an asset.
• The job market and competition for talent is
  global.

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CONSULTANTS AND OUTSOURCING

• Often there is no choice but to outsource work or
  to bring in a consultant.
• Lack of human resource is a good reason to
  outsource work or bring in a consultant but
  beware
• Realize that it takes time to qualify and build
  relationships with outside help such as
  analytical labs and regulatory consultants.

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PROJECT LEADERSHIP

• Clear leadership roles and responsibilities are
  critical to project and / or business success.
• Leadership must have clear mandate and be able to
  effectively communicate and control required
  activities.
• Important to stick to the basics of project
  management such as the triple constraint.

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ESSENTIAL INTERNAL RESOURCES
Technical Services
RD
NPD
L.S.
Eng.
Mfg.
NPI
Val.
QA
P.T.
QS
QC
Project Leadership
Regulatory
Quality
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CONCLUSION

• NUCRYST continues exciting journey in life
  sciences industry.
• Much experience has been acquired and the
  challenge is to learn from those experiences
  throughout the organization.
• Many old challenges remain and new ones emerge as
  markets continue to evolve in all areas.
• QA

THANK YOU!