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1 of 12
Gavin Herbert & USC Vision (1977)
• Establish a clinical scientist fellowship
• “The clinical scientist will fill a new role in
pharmacy: an individual who is equally expert as a
pharmacist, in direct contact with the patient and
the physician, and as a basic scientist in the
laboratory”
• Deliver innovation to Allergan while providing drug
development and commercialization experience.
2
AllergAn’s 7 essentiAl skills
Growth &
Responsibility
Communication
Skills
Cross Functional
Relationships
Customer
Satisfaction
Decision Making
Execution/Results
/Process
Improvement
Leadership
People & Talent
Management
USC School of Pharmacy
Academic Component
• Serve as a preceptor for 4th year student pharmacists
• Participate as a guest lecturer and assist in the
development of the USC Pharmaceutical Industry
Elective course
• Attend USC Regulatory Science courses
• Opportunities to publish journal articles
4
5
2006 2007 2008 2009 2010 2011 2012
Global Regulatory
Affairs
•Global Regulatory Affairs
•Global Pharmaceutical
Sciences
•Clinical Pharmacology
Quantitative Sciences
•Pharmaceutical Development
•Global Regulatory Affairs
•Global Pharmaceutical Sciences
•Clinical Pharmacology Quantitative
Sciences
•Pharmaceutical Development
•Clinical Development
•Medical Affairs
•Medical Affairs
•Clinical Development
•Global Pharmaceutical Sciences
•Clinical Pharmacology
•Pharmaceutical Development
•Drug Delivery
Pharmaceutical Development
•Global Regulatory Affairs
•Global Pharmaceutical Sciences
6
Recent Past Fellows – 100% Success!
• 2006-2007 – (1) Rick Khuu
• 2007-2008 – (4) Lee Ming Boo, Renard Dubois,
Victoria Qian, David Truong
• 2008-2009 – (8) Ellen Huang, Danmy Loi, Leena Patel,
Sam Patel, Christina Phan, Phyllis Tai, Warren Tong,
David Truong*
• 2009-2010 – (1) Nazanin Yacobi
• 2010-2011 – (7) Tristan Beudette, Amy Chun, Khody
Farahmand, Deshawnt Jelani, Daya Perkins, Thejani
Rajapaksa, Freddi Zuniga
• 2011-2012 – (7) Daniel Ferris, Kevin Kerr*, Toan Vo, Heidi Yang, Freddi
Zuniga*, Lyndsay Zotian ( * = 2nd yr Fellow)
2011 – 2012 Accomplishments
Contribution to 7 clinical
studies
Contribution to numerous
regulatory submission
documents
Selection/recruitment of new
Fellows
Journal article accepted
Helped with Allergan events
All Pharm D.’s earned their
pharmacy license
Lecturers/TA in USC
industry elective
Attended USC Reg Sci
classes
Authored SOP’s and job
aids
Journal clubs at Allergan
7
Success Stories: Recent USC-AGN Fellows
• Toan Vo (2012)
• Senior Associate – Global CMC Regulatory Affairs, Allergan Inc
• Kevin Kerr (2012)
• Clinical Research Scientist – Clinical Development, Allergan Inc
• Heidi Yang (2012)
• Health Science Associate – Medical Affairs, Allergan Inc
• Lyndsay Zotian (2012)
• Medical Science Liaison, Boehringer Ingelheim
• Freddi Zuniga (2012)
• Global Labeling Compliance Specialist – Regulatory Affairs, Allergan Inc
8
A Shining Example: Toan Vo
Pharm D., MSRS, USC Class of 2011
– Global Pharm Sciences Fellow 2011-2012
– Learned all aspects of pharmaceutical CMC (Quality)
– Learned how to prepare AR’s, RtQ’s, IND/IMPD (CTA),
NDA/MAA regulatory documents for submission to FDA, EU,
ROW
– Managed one MAA Variance submission for Quality, and one
clinical trial application for the EU
– Rotation to Allergan RA CMC, now RA Sr. Associate in CMC
9
10
Present Fellows
• 2012-2013 – (8) Farah Al-Kurdi, Anthony Dao, Farnoosh Fazlollahi,
Kevin Leung, Robert Mo, Shuchi Parikh, Aneesh Patel, Andrew
Wahlert
11
Continued Interest for 2012 – 2013: 8 Fellows
• Clinical Development
• Clinical Pharmacology
• Global Pharmaceutical Sciences
• Medical Affairs
• Pharmaceutical Development
• Drug Delivery
• It is anticipated that this plan will be extended into 2013 – 2014.
Questions?
12

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Allergan Fellowship Report 2012-2013

  • 1.
  • 2. Gavin Herbert & USC Vision (1977) • Establish a clinical scientist fellowship • “The clinical scientist will fill a new role in pharmacy: an individual who is equally expert as a pharmacist, in direct contact with the patient and the physician, and as a basic scientist in the laboratory” • Deliver innovation to Allergan while providing drug development and commercialization experience. 2
  • 3. AllergAn’s 7 essentiAl skills Growth & Responsibility Communication Skills Cross Functional Relationships Customer Satisfaction Decision Making Execution/Results /Process Improvement Leadership People & Talent Management
  • 4. USC School of Pharmacy Academic Component • Serve as a preceptor for 4th year student pharmacists • Participate as a guest lecturer and assist in the development of the USC Pharmaceutical Industry Elective course • Attend USC Regulatory Science courses • Opportunities to publish journal articles 4
  • 5. 5 2006 2007 2008 2009 2010 2011 2012 Global Regulatory Affairs •Global Regulatory Affairs •Global Pharmaceutical Sciences •Clinical Pharmacology Quantitative Sciences •Pharmaceutical Development •Global Regulatory Affairs •Global Pharmaceutical Sciences •Clinical Pharmacology Quantitative Sciences •Pharmaceutical Development •Clinical Development •Medical Affairs •Medical Affairs •Clinical Development •Global Pharmaceutical Sciences •Clinical Pharmacology •Pharmaceutical Development •Drug Delivery Pharmaceutical Development •Global Regulatory Affairs •Global Pharmaceutical Sciences
  • 6. 6 Recent Past Fellows – 100% Success! • 2006-2007 – (1) Rick Khuu • 2007-2008 – (4) Lee Ming Boo, Renard Dubois, Victoria Qian, David Truong • 2008-2009 – (8) Ellen Huang, Danmy Loi, Leena Patel, Sam Patel, Christina Phan, Phyllis Tai, Warren Tong, David Truong* • 2009-2010 – (1) Nazanin Yacobi • 2010-2011 – (7) Tristan Beudette, Amy Chun, Khody Farahmand, Deshawnt Jelani, Daya Perkins, Thejani Rajapaksa, Freddi Zuniga • 2011-2012 – (7) Daniel Ferris, Kevin Kerr*, Toan Vo, Heidi Yang, Freddi Zuniga*, Lyndsay Zotian ( * = 2nd yr Fellow)
  • 7. 2011 – 2012 Accomplishments Contribution to 7 clinical studies Contribution to numerous regulatory submission documents Selection/recruitment of new Fellows Journal article accepted Helped with Allergan events All Pharm D.’s earned their pharmacy license Lecturers/TA in USC industry elective Attended USC Reg Sci classes Authored SOP’s and job aids Journal clubs at Allergan 7
  • 8. Success Stories: Recent USC-AGN Fellows • Toan Vo (2012) • Senior Associate – Global CMC Regulatory Affairs, Allergan Inc • Kevin Kerr (2012) • Clinical Research Scientist – Clinical Development, Allergan Inc • Heidi Yang (2012) • Health Science Associate – Medical Affairs, Allergan Inc • Lyndsay Zotian (2012) • Medical Science Liaison, Boehringer Ingelheim • Freddi Zuniga (2012) • Global Labeling Compliance Specialist – Regulatory Affairs, Allergan Inc 8
  • 9. A Shining Example: Toan Vo Pharm D., MSRS, USC Class of 2011 – Global Pharm Sciences Fellow 2011-2012 – Learned all aspects of pharmaceutical CMC (Quality) – Learned how to prepare AR’s, RtQ’s, IND/IMPD (CTA), NDA/MAA regulatory documents for submission to FDA, EU, ROW – Managed one MAA Variance submission for Quality, and one clinical trial application for the EU – Rotation to Allergan RA CMC, now RA Sr. Associate in CMC 9
  • 10. 10 Present Fellows • 2012-2013 – (8) Farah Al-Kurdi, Anthony Dao, Farnoosh Fazlollahi, Kevin Leung, Robert Mo, Shuchi Parikh, Aneesh Patel, Andrew Wahlert
  • 11. 11 Continued Interest for 2012 – 2013: 8 Fellows • Clinical Development • Clinical Pharmacology • Global Pharmaceutical Sciences • Medical Affairs • Pharmaceutical Development • Drug Delivery • It is anticipated that this plan will be extended into 2013 – 2014.