Curriculum Vitae
`Audra L. Stinchcomb, Ph.D.
`Professor
`University of Maryland School of Pharmacy
`Department of Pharmaceutical Sciences
`Chief Scientific Officer, F6 Pharma, Inc
`20 N Pine St, Baltimore, MD 21201
`Tel. (410) 706-2646 Fax (410) 706-0886
`e-mail: astinchc@rx.umaryland.edu, audra@f6pharma.com
`
`I. Education
`University of Southern Colorado, Pueblo, CO
`1984-1986 Pre-Pharmacy
`University of Colorado, Boulder/Denver, CO
`1986-1989 B.S. Pharmacy
`The University of Michigan, Ann Arbor, MI
`1989-1995 Ph.D. Pharmaceutics
` Advisor: Dr. Gordon L. Flynn
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`II. Professional Experience
`11/85-8/86 Research Fellow
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`University of Southern Colorado
`Pueblo, CO
` Mentor: Dr. Paul Schnur
`1/87-5/88 Research Fellow
`University of Colorado
`Institute for Behavioral Genetics
`Boulder, CO
` Mentor: Dr. Jeanne Wehner
`5/88-8/88 NPC Research
`Ortho Pharmaceutical Corp.
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`Intensive Internship
`Raritan, NJ
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`Semisolids
`Geneva Pharmaceuticals, Inc.
`4/89-8/89
`Industrial Internship
`Broomfield, CO
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`Solid Dosage Forms
`Arbor Drugs, Michigan
`9/89-11/94 Relief Pharmacist
`Lederle Laboratories, Inc.
`6/90-8/90
`Industrial Internship
`Pearl River, NY
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`Ophthalmic Solutions
`University of California, San Francisco
`4/95-11/96 Postdoctoral Fellow
` School of Pharmacy:Biopharmaceutical Sciences
`& Pharmaceutical Chemistry, San Francisco, CA
` Mentors: Dr. Richard H. Guy/ Dr. Annette Bunge
`2004-14 CSO/Founder
`AllTranz Inc., transdermal cannabinoid company
`2014- Chief Scientific Officer/Founder
`F6Pharma, a palliative care product company
`2017- Co-founder
`Anti-Microbial Defense Solutions, LLC
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`III. Academic Appointments
`11/96-4/01 Assistant Professor
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`4/01-12/04 Assistant Professor
`1/05 - 4/11 Associate Professor
`9/06-11/11
`4/11-11/11 Professor
`11/11–now Professor
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`Albany College of Pharmacy
`Department of Basic & Pharmaceutical Sciences
`Univ. of KY College of Pharmacy, Lexington, KY
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`Graduate Faculty member, Nutritional Sciences
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`Dept. of Pharmaceutical Sciences, University of
`Maryland, Baltimore School of Pharmacy
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`IV. Instructional Activity
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`PHAR 535 Pharmaceutics, 2012-, PharmD students, Course Coordinator, 15 hrs
`PHAR 568 Applied Pharmaceutical Sciences, 2012-15, PharmD students, 1 lecture
`PHAR 601 Principles of Drug Development, 2013-, PhD students, Course Coordinator,10 hrs
`REGS 621 Clinical Research, 2013-, Masters students, Module 3 Manager for Early Stage
`Clinical Trials
`REGS 631 Drug and Biologics Development, 2013-, Masters students
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`8 lectures in Module 3 Pharmacokinetics and Module 3 Manager
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`2 lectures in Module 1 Dosage Forms
`IMET
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`Ratcliffe Environmental Entrepreneurs Fellowship (REEF) Program, 2015
`PHMY 5012 Pharmapreneurship Seminar and Pathway Co-Coordinator, 2019-
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`V. Research Advising Activity
`A. Postdoctoral Fellows
` Opinya Ekabo, Ph.D.
` Prasad V.N. Challapalli, Ph.D.
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` Satyanarayana Valiveti, Ph.D.
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` Omathanu Pillai Perumal, Ph.D.
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` Remigius Agu, Ph.D.
` H. Kumar Vaddi, Ph.D.
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` N. Buchi Naidu, Ph.D.
`Kalpana Srivastava Paudel, Ph.D. (Res. Asst. Prof.)
` R. Reddy Pinninti, Ph.D.
` Jing Chen, Ph.D.
` Inas Abdallah, Ph.D.
` Abhay Andar, Ph.D.
` Ameya Gokhale, Ph.D.
` Mingming Yu, Ph.D.
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`B. Professional Pharmacy Students
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` Todd A. Cooperman, Pharm.D.
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` Jennifer L. Browe, Pharm.D.
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` Amanda J. Dean
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`Haritha Gajjela
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`Jhansi Yedluri
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`Matt Worthy
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`C. Summer Undergrad/High School Students
`Michael Pearsall
`Julia Bartoszek
`Brian Humphreys
`Jamie Houghton
`Shannon Cox
`Diana Ramsey
`Chris Starr
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`04/00-04/01
`06/00-08/02
`09/02-11/04
`01/03-1/04
`03/03-11/04
`04/03-11/04
`04/03-10/05
`09/03-06/11
`09/04-09/10
`01/07-01/09
`01/14-01/16
`07/13-01/16
`01/14-12/14
`09/15-12/17
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`02/98-09/98
`01/00-04/01
`10/02-12/03
`11/04-06/05
` 9/04-05/05
`Summer 06
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`Summer 1998
`Summer 1999
`Summer 1999
`Summer 2000
`Summer 2002
`Summer 2002
`Summer 2002
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`Caitlin Milligan
`Nicole Scheff
`Juliana Quarterman
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`D. Graduate Students
`Paul Kiptoo
`Stan Banks
`Caroline Strasinger
`Mikolaj Milewski
`Courtney Swadley—NIH NRSA Fellowship
`Nicole K Brogden—NIH NRSA Fellowship
`Priyanka Ghosh
`Charity Wallace
`Soo Shin
`Sagar Shukla
`Sherin Thomas
`Paige Lane
`Qingzhao Zhang
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`Audra L. Stinchcomb
`Curriculum Vitae
`Page 3
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`01/04-05/05
`05/07-05/08
`09/15-08/16
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`02/03-05/07
`03/04-04/08
`08/05-01/09
`03/07-03/11
`06/07-02/11
`02/09-07/12
`03/09-04/13
`09/12-12/13
`08/13-01/18
`08/14-now
`08/14-now
`08/16-now
`08/16-now
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`E. Member of Thesis Committee
`Maggie Abbassi
`Daniel Liput
`Miranda Crowe
`Jason H Tucker
`Stephanie Morris
`Carol Gee, Monash University, Australia
`Josh Eldridge
`Bhavesh Kothari
`Mukul Kelkar
`Sheniqua Brown, UMBC
`Brittany Avaritt
`Jukkarin Srivilai, Naresuan University, Thailand
`Sophie Peng
`Yewon Joanna Pak
`Heather Boyce
`Tanvi Deshpande
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`VI. University Service
`Albany Medical Center Institutional Review Board member (1997-2001)
`Chair of Academic Standards Committee, Albany College of Pharmacy (1997-2000)
`Member of Academic Performance Committee, UK College of Pharmacy (2001-2002)
`Member of Bioanalytical Faculty Search Committee, UK College of Pharmacy (2001)
`Member of Pharmacokinetics/Pharmacodynamics Faculty Search Comm., UK (2003)
`Member of Biopharmaceutics/Pharmaceutical Technology Faculty Search Comm. (2006-7)
`Member of Instructional Technology Committee, UK College of Pharmacy (2001)
`Member of Curriculum Committee, UK College of Pharmacy (2002-2008)
`Interview, with Winnie Hu, New York Times, January 29, 2000.
`Interview, with Bob Edwards, NPR’s Morning Edition, January 21, 2000.
`Interview, with Brigid Kane, “Medical Marijuana: The Continuing Story”, Annals of Internal
`Medicine 134(12):19June2001 (159-162).
`Interview, with Naomi Lubick, “Healing Haze?”, Scientific American online, 4June2001
`University of Kentucky Chemical Safety Committee, 2004-2005
`University of Kentucky Pharmaceutical Sciences Executive Committee, 2005-7
`University of Kentucky College of Pharmacy Executive Committee, 2006-7
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`Audra L. Stinchcomb
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`University of Kentucky College of Pharmacy Admissions Committee, 2008
`University of Kentucky Multi Year Fellowship Selection Panel, 2007-8
`Leadership Lexington Presentation-UK research, Commerce Lexington program, 2007-2008
`UK Center of Membrane Sciences program review, 2011
`UK cGLP Readiness Review Committee, 2011
`AAPS Student Chapter Faculty Advisor, UMB, 2012-15
`PharmD Class of 2020 Student Advisor
`Member then Chair of Assessment Committee, 2012-14
`Faculty Affairs Committee, 2012-15
`Student Affairs Committee, 2015-17
`Institutional Animal Care and Use Committee Member, 2015-17
`General Clinical Research Center Advisory Committee (GAC), 2017-
`Pharmapreneur Taskforce, UMB School of Pharmacy, 2018-
`Center for Women in Pharmapreneurship Task Force, UMB School of Pharmacy, 2018-
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`VII. Honors
`Biomedical Research Support Program Fellow (1985-1986)
`Dean’s Scholarship, University of Colorado (1986-1989)
`AACP Research Participation Program Fellowship (1987-1988)
`Rho Chi Pharmacy Honor Society (1988)
`National Pharmaceutical Council Research Intensive Internship (1988)
`Lilly Endowment Fellowship, The University of Michigan (1989-1990)
`Regent’s Fellowship, The University of Michigan (1989-1992)
`Featured Company, Lexington Venture Club, Who Got the Money, January 2010
`Springboard Portfolio Company, All Things Life Sciences 2010
`Kentucky Entrepreneurs’ Hall of Fame 2010
`AAPS Fellow 2011
`Plenary Speaker, Institute of Cannabis Research Annual Conf., Pueblo, CO, 4/2018
`Keynote Speaker, 15th Annual Louis C. Littlefield Celebrating Pharmacy Research
`Excellence Day, University of Texas, Austin, 4/2019
`
`VIII. Professional Activity and Service
`A. Professional Activities
` USP Expert Consultant to General Chapters—Dosage Forms Expert Committee
`Subcommittee B on Topical and Transdermal Drug Products, 2012-15
`Editorial Advisory Board, Transdermal, 2009-12
`Editorial Advisory Board, Therapeutic Delivery, 2009-
`Editorial Advisory Board, Journal of Pharmaceutical Sciences, 2008-2014
`Board of Directors, Kentucky BioAlliance, biotech economic development, 2008-
`Bluegrass Biotech Steering Committee, 2010-
`Editorial Board, Substance Abuse: Research and Treatment, 2007-
`Editorial Advisory Board, Recent Patents on Drug Delivery & Formulation, 2007-
`Editorial Advisory Board, Pharmaceutical Research, 2006-
`Editorial Advisory Board, Clinical Pharmacology: Current Research, 2011-
`Editorial Advisory Board, Medicinal Chemistry: Current Research, 2011-
`Editorial Advisory Board, Clinical and Experimental Pharmacology, 2011-
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`Editorial Advisory Board, Advances in Pharmacoepidem. & Drug Safety, 2011-
`United States Pharmacopeia member (1997-2000)
`American Association of Pharmaceutical Scientists member
`Controlled Release Society member
`International Cannabinoid Research Society (ICRS) member
`ICRS Student Presentations Awards Committee 6/03
`Licensed pharmacist: Colorado
`GLP and GMP training certification
`Vistage member, the world’s largest CEO membership organization, 2008-10
`Chair and Host of International Microneedles Meeting 2014
`International Microneedles Meeting Planning Committee 2016, 2018, 2020
`CoChair, Topical Drug Development-Evolution of Science & Regulatory Policy ‘19
`
`B. Journal Referee
`1. Pharmaceutical Research (1994-)
`2. Skin Pharmacology (1995-)
`3. Journal of Controlled Release (1996-)
`4. Journal of Pharmacy and Pharmacology (1996-)
`5. Journal of Pharmaceutical Sciences (1996-)
`6. International Journal of Pharmaceutics (1996-)
`7. Journal of Biomedical Optics (1997-)
`8. Lippincott, Williams, and Wilkins textbooks (1999-)
`9. Journal of Pharmacological and Toxicological Methods (2000-)
`10. PharmSci (2000-)
`11. International Journal of Pharmaceutical Compounding (2000-)
`12. PharmSci Tech (2000-)
`13. American Journal of Drug Delivery (2003-)
`14. Nutrition and Cancer (2003-)
`15. Pharmacological Research (2004-)
`16. Anesthesia and Analgesia (2004-)
`17. Journal of Pharmaceutical and Biomedical Analysis (2004-)
`18. Journal of Pharmacy and Pharmaceutical Sciences (2004-)
`19. Expert Opinion on Drug Delivery (2004-)
`20. Therapy (2005-)
`21. Talanta (2006-)
`22. Drug and Alcohol Dependence (2007-)
`23. Recent Patents on Drug Delivery & Formulation (2007-)
`24. Substance Abuse: Research and Treatment (2007-)
`25. Chromatographia (2007-)
`26. Food and Chemical Toxicology (2008-)
`27. Medicinal Chemistry (2009-)
`28. Current Pharmaceutical Design (2009-)
`29. Therapeutic Delivery (2009-)
`30. Transdermal (2009-)
`31. Pharmaceutical Development and Technology (2009-)
`32. Bioorganic and Medicinal Chemistry Letters (2009-)
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`C.
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`Audra L. Stinchcomb
`Curriculum Vitae
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`33. Dermatology (2011-)
`34. Skin Pharmacology and Physiology (2012-)
`35. Journal of the Royal Society Interface (2012-)
`36. European Journal of Pharmaceutics and Biopharmaceutics (2013-)
`37. International Journal of Aesthetic and Anti-Ageing Medicine (2015-)
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`Peer Review Committees
`Air Force Office of Scientific Research/Chemistry and Life Sciences
`(ad hoc ‘00,’03)
`AACP New Investigator Grants Review (2000)
`NIH Study Section: Drug Delivery and Drug Discovery SSS-L
`(March + Nov. 2003)
`NIH Study Section: Neuro SBIR ZRG1 MDCN-3+BSCT(10) (3+12/03,12/04,
`7/05, 11/05)), NIDDK SBIR ZRG1 RUS-C 15B 8/08
`NSF Study Section: Drug Delivery Q (3/04)
`University of Kentucky Intramural Grants Review (ad hoc 2004, 2005, 2007)
`AAPS Annual Meeting Abstract Review Chair, Topical and Transdermal Drug
`Delivery section, +Pharmaceutics and Drug Delivery Meeting, 2004-08
`EPA FIFRA Scientific Advisory Panel- ad hoc member 2004, 2008
`National Institute for Occupational Safety and Health NORA Intramural
`Dermal Research Program Evaluation (Dec 2004)
`Austrian Science Fund (2006)
`Maryland Industrial Partnerships Program (2007)
`Health Research Board of Ireland (2009-10)
`NIH/NIDA Study Section: Development of Alternate Drug Delivery
`Dosage Forms for Drugs of Abuse Studies (Jan 2010-2012)
`U.S.-Israel Binational Science Foundation (April 2010)
`South African National Research Foundation (2010-11)
`Dr. Hadwen Trust for Humane Research, United Kingdom (2013)
`NIH Study Sections: NIDA CEBRA Review (Nov 2012), NIAMS Small
`Grant Program for New Investigators (Mar 2013), Emerging
`Technologies and Training in Neurosciences (ETTN July 2013 &
`Feb 2015), Gene & Drug Delivery Systems (Feb & Dec 2013, Feb &
`Oct 2014, Feb 2015), Synthetic Psychoactive Drugs and Strategic
`Approaches to Counteract Their Deleterious Effects (June 2015),
`National Institute on Drug Abuse (NIDA)'s Cutting-Edge Basic
`Research Awards (CEBRA, Nov 2015))
`NIH Development of Appropriate Pediatric Formulations & Pediatric
`Drug Delivery Systems: Nov 2012, March 2014, Feb 2015, Oct
`2015, Chair 2016-19
`NIH NCI Clinical and Translational Grants: Chair Oct 2018
`NIH Gene & Drug Delivery Systems Study Section Member: July 1,
`2016 to June 30, 2020
`Netherlands Organisation for Health & Development 2015
`Arthritis Research United Kingdom 2015
`French National Research Agency (ANR) 2016
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`Defense Threat Reduction Agency's Basic Research: Combating
`Weapons of Mass Destruction 2016
`American Foundation for Pharmaceutical Education Board of Grants
`Member 2015-16
`AAPS PPB Section Fellows Selection Committee Member 2016
`NSF Phase I and II: Drug Delivery Panels 2017-19
`NIH: National Center for Advancing Translational Sciences (NCATS)
`March 2018
`NIH: National Center for Complementary and Integrative Health
`(NCCIH), Behavioral Research to Improve Medication-Assisted
`Treatment (MAT) for Opioid Use Disorder (OUD) 2019
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`IX. Presentations
`Invited Seminars
`
`FDA Office of Pharmaceutical Quality Extramural Research Day, “Assessing the
`Roles of Chemical Penetration Enhancers and Strength in Transdermal
`Systems”, Silver Spring, MD, September 2018
`Drug Information Association Complex Drug-Device Generic Combination Products,
`“Scientific Challenges for Generic Transdermal Products: Recent Advances
`and Future Research”, Silver Spring, MD, October 2018
`The University of Michigan Green Wolverine Science Symposium, “Cannabis-Based
`Drug Delivery: University Lab to Clinical Trials”, Ross School of Business, Ann
`Arbor, MI, September 2018
`Annual Research Forum Speaker, College of Pharmacy, The University of Michigan,
`“PI-Initiated Public-Private Partnerships”, Ann Arbor, MI, March 2017
`Department of Pharmaceutical Sciences, College of Pharmacy, The University of
`Michigan, “Evaluation of In Vitro-In Vivo Correlations (IVIVC) of Selected
`Transdermal Delivery Systems (TDS) with Transient Heat Exposure”, Ann
`Arbor, MI, March 2017
`52nd AAPS Arden Conference “Development and Regulation of Combination
`Products through Design Controls“, Combination Drug Products in
`Transdermal and Intradermal Delivery, Rockville, MD, April 2017
`Naresuan University, Workshop on Transdermal and Intradermal Delivery Systems,
`Phitsanulok, Thailand, July 2017
`Transdermal & Intradermal Drug Delivery 2017, Heat Effects and IVIVC in
`Transdermal and Topical Drug Delivery, Philadelphia, PA, September 2017
`Topical Dermatological Generic Drug Products: Overcoming Barriers to Development
`and Improving Patient Access, Public FDA Meeting, Characterizing In Vitro
`Bioavailability of Acyclovir and Metronidazole Topical Products, and In Vitro –
`In Vivo Correlation Results with Transdermal Systems, Silver Springs, MD,
`October 2017
`Center for Targeted Therapeutics & Translational Nanomedicine Symposium,
`University of Pennsylvania, IVIVC in Transdermal Drug Delivery: Academic
`Bench to Clinical Trials, Philadelphia, PA, December 2016
`Pierre Fabre R&D Topical Formulation Board, Microneedle Enhanced Transdermal
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`Delivery: Academic Bench to Clinical Trials, Toulouse, France, October 2016
`University of Kentucky National Institute on Drug Abuse Night, Abuse Deterrent
`Transdermal Patch Delivery Systems, Lexington, KY, April 2016
`Teva Pharmaceutical Industries, The Future of Transdermal Delivery, Israel, March
`2016.
`3rd Annual Bioequivalence Summit, Bioavailability and Bioequivalence of Products
`Applied to the Skin, Boston, MA, September 2016
`Transdermal and Intradermal Drug Delivery Conference, IVIVC in Transdermal Drug
`Delivery: Streamlining the Drug Approval Process, Philadelphia, PA,
`September 2016
`University of Kentucky College of Pharmacy, In Vitro/In Vivo Correlation in Dermal
`and Transdermal Drug Delivery: Streamlining the Drug Approval Process,
`Lexington, KY, April 2016
`Institute of Marine and Environmental Technology (IMET) and the Ratcliffe
`Environmental Entrepreneur Fellowship (REEF) Program, Baltimore, MD,
`November 2015
`Human Abuse Liability and Abuse Deterrent Formulations, Bethesda, MD, November
`2015, “Advance Transdermal Patch Delivery Systems Into Abuse Deterrence”
`AAPS Annual Meeting, Orlando, FL, October 2015, “Topical Bioequivalence:
`Performance Evaluation In Vivo and In Vitro by Skin Stripping and IVPT”
`Bioequivalence Summit, Boston, MA, Chair and Speaker, October 2015, “Challenges
`in the Development of Bioequivalent Topically Applied Drug Products”
`Evonik Meets Science, Jersey City, NJ, September 2015, “Microneedle Enhanced
`Dermal Delivery: Academic Bench to Clinical Trials”
`Transdermal and Intradermal Drug Delivery, Philadelphia, PA, May 2015,
`“Microneedle Enhanced Dermal Delivery: Academic Bench to Clinical Trials”
`US FDA Course, Silver Spring, MD, April 2015, “Recent Trends in Passive
`Transdermal Drug Delivery”
`Women in BIO, Biopark, Baltimore, MD, March 2015, “P4: PI-Initiated Public-Private
`Partnerships”
`Innovations in Dermatological Sciences Meeting, Rutgers University, New Jersey,
`October 2014, “Microneedle Enhanced Dermal Delivery: Academic Bench to
`Clinical Trials”
`Bioequivalence Summit, Boston, MA, September 2014, “Biopharmaceutical
`Considerations, IVIVC, and Heat Effects in the Development of Generic
`Dermal and Transdermal Delivery Systems”
`Canadian Society for Pharmaceutical Sciences, Montreal, June 2014, “7-Day
`Microneedle Enhanced Transdermal Delivery Bench to Bedside”
`University of Minnesota, Minneapolis, MN, May 2014, “7-Day Microneedle Enhanced
`Transdermal Delivery Bench to Bedside”
`3rd International Conference on Microneedles, Baltimore, MD, Conference Chair and
`Speaker, May 2014, “Microneedle-Enhanced Transdermal Delivery Up To 7 Days”
`Society for Biomaterials Annual Meeting, Denver, CO, April 2014, “P4: PI-Initiated
`Public-Private Partnerships”
`Department of Biochemistry and Molecular Biology Cancer Focus Group, University
`of Maryland, Baltimore, December 4, 2013 “7-Day Microneedle Enhanced
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`Transdermal Delivery Bench to Bedside”
`Institute of Marine and Environmental Technology, Baltimore, MD, June 19, 2013,
`“7-Day Microneedle Enhanced Transdermal Delivery Bench to Bedside”
`Albany College of Pharmacy, Albany, NY, June 2013, “7-Day Microneedle Enhanced
`Transdermal Delivery Bench to Bedside”
`Gordon Conference, Preclinical Form & Formulation for Drug Discovery, Waterville
`Valley, NH, June 2013, “Form and Formulation Optimization for Transdermal
`Delivery”
`U.S. Government’s Science and Technical Expert Partnership (STEP) Program, The
`Biosciences Working Group (BSWG) meeting on Drug Delivery, McLean, VA,
`June 2013, “7-day Drug Delivery For Small and Large Molecules Via the
`Transdermal Route”
`Skin Trailblazer Annual Meeting, Boston, MA, August 2011, “Writing for a Successful
`Grant in the United States”
`Controlled Release Society Meeting, National Harbor, MD, July 2011, Soapbox
`session, “AllTranz”
`University of New Mexico College of Pharmacy, May 2011, “Pore lifetime and
`formulation aspects in microneedle-assisted transdermal delivery”
`NIDA Training Grant Night, Lexington, KY, May 2011, “Transdermal Prodrugs for
`Drug and Alcohol Dependence Treatment”
`PharmaEd Resources, Transdermal Drug Delivery Systems, Philadelphia, PA,
`February 2011, “Pore lifetime and formulation aspects in microneedle-assisted
`delivery”
`Ohio Valley Affiliates for Life Sciences annual meeting, Louisville, KY, April 16, 2010,
`“OVALS Innovation and Economic Spotlight”
`Perspectives in Percutaneous Penetration, La Grand Motte, France, April 7, 2010,
`“Pore lifetime in microneedle-assisted delivery”
`Kentucky BioAlliance annual meeting, Louisville, KY, December 9, 2009, “Life
`Science Opportunities in Kentucky”
`UK Commercialization and Economic Development/Center for Clinical and
`Translational Science, University of Kentucky, Lexington, KY, July 30, 2009,
`“Faculty Business StartUp Share Session”
`New York Venture Summit, Young Startup Ventures, 50 Top Innovator Company
`Award Speaker, New York, NY, June 16, 2009, “AllTranz”
`College of Health Sciences Faculty Retreat, University of Kentucky, Lexington, KY,
`February 20, 2009, “Successes and Hurdles of Starting a Company”
`Leadership Lexington Program, Commerce Lexington, KY, December 11, 2008,
`“Start-Up Pharmaceutical Company Development at the University of
`Kentucky”
`UK Commercialization and Economic Development Bench2Business, Lexington, KY,
`October 22, 2008, “Emerging Technology Presentation”
`2nd World Conference on Magic Bullets, EHRLICH II, Nurnberg, Germany, October 3,
`2008, “Transdermal delivery of naltrexone, in vitro testing to human volunteers”
`MidAmerica Healthcare Venture Forum, Cincinnati, OH, October 1, 2008,
`“Biotechnology and Pharmaceutical Company Showcase”
`Kentucky Girls Science, Technology, Engineering & Mathematics Collaborative
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`Conference, Lexington, KY, May 23, 2008, “Unique science career
`opportunities in Kentucky at the academic/private sector interface”
`University of Maryland, Baltimore, MD, May 8, 2008, “Microneedle-enhanced
`transdermal delivery of naltrexone, in vitro testing to human volunteers”
`Leadership Lexington Program, Commerce Lexington, KY, December 13, 2007,
`“Start-Up Pharmaceutical Company Development at the University of
`Kentucky”
`Gordon Conference, “Barrier Function of Mammalian Skin”, Newport, RI, August 8,
`2007, “Prodrugs and Codrugs as Strategies to Improve Percutaneous
`Absorption”
`Chulalongkorn University, Bangkok, Thailand, November 23, 2006, “Transdermal
`Naltrexone Prodrugs for Treatment of Alcoholism”
`Pfizer, Ann Arbor, MI, June 27, 2006, “Infrared Spectrometry for the Quantification of
`Dermal Drug Absorption” and “Improving Topical and Transdermal Drug
`Delivery with Prodrugs and Bioengineering”
`University of Maryland, Baltimore, MD, April 21, 2006, “Transdermal Naltrexone
`Prodrugs for Treatment of Alcoholism”
`Rutgers University, Piscataway, NJ, April 19, 2006, “Transdermal Naltrexone
`Prodrugs for Treatment of Alcoholism”
`University of Otago, Dunedin, New Zealand, February 16, 2006, Symposium on
`Topical Treatments for Modulating the Immune Response, “The Process of
`Developing and Commercializing Skin Products”
`University of Otago, Dunedin, New Zealand, February 15, 2006, CRS Formulation
`and Delivery of Bioactives Conference, “Improving Transdermal Drug Delivery
`with Prodrugs and Bioengineering”
`Array BioPharma, Boulder, CO, November 2005, “Critical Issues in Topical Drug
`Delivery”
`University of Cincinnati College of Pharmacy, OH, October 2005, “Transdermal
`Naltrexone Prodrugs for Treatment of Alcoholism”
`University of Kentucky Graduate Center for Nutritional Sciences, September 2005,
`“Transdermal Drug Delivery for Appetite Stimulation and Suppression”
`Stinchcomb AL, Hammell DC, Paudel KS, Valiveti S, Hamad MO, Crooks PA. In
`Vivo Evaluation of 3-O-Alkyl Ester Prodrugs of Naltrexone for Transdermal
`Delivery. Controlled Release Society Annual Meeting, Honolulu, HI, June 2004.
`The Third National Clinical Conference on Cannabis Therapeutics, Charlottesville,
`VA, May 2004, “Transdermal and Intranasal Delivery of Cannabinoids”
`ICOS Corporation, Bothell, WA, February 2004, “Drug Absorption Across the Skin”
`University of Kentucky Division of Pharmaceutical Sciences Post-Graduate
`Conference, May 2002
`“Transdermal Delivery of Naltrexone Prodrugs”
`The Second National Clinical Conference on Cannabis Therapeutics, Portland, OR,
`May 2002
`“Alternative Delivery Systems: Transdermal Cannabinoid Patches”
`University of Colorado Health Sciences Center School of Pharmacy, May 2000
`“Percutaneous Absorption Assessment”
`Pharmacy Practice Institute XX, Albany College of Pharmacy Postgraduate
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`Audra L. Stinchcomb
`Curriculum Vitae
`Page 11
`
`
`Professional Education, March 1998
`“Recent Advances in Transdermal Drug Delivery”
`University of California, San Francisco, School of Pharmacy, March 1996
`“ATR-FTIR as a Quantitative Method to Measure Dermal Absorption from
`Volatile Solvents”
`The University of Michigan College of Pharmacy, March 1994
`“Buprenorphine Alkyl-Ester Prodrugs for Transdermal Delivery”
`The University of Michigan College of Pharmacy, April 1993
`“Transdermal Buprenorphine for Opiate Addiction Therapy”
`
`X. Research Productivity
`A. Research Projects
`Dr. Stinchcomb’s research work involves the design and testing of novel prodrugs and
`codrugs for transdermal delivery, as well as intranasal delivery, testing of novel materials for
`transdermal patches, development of bioanalytical methods
`to determine
`topical
`bioequivalence, dermal metabolism, and cannabinoid drug delivery optimization. The
`transdermal drug delivery focus has been on efforts to improve delivery of drugs by altering
`their physicochemical properties, i.e. via prodrugs and codrugs. Her specific therapeutic areas
`of interest include cannabinoid therapies and treatments for opiate, tobacco and alcohol abuse.
`Transdermal delivery of naltrexone is desirable for opioid addicts and alcoholics in order
`to help reduce side effects associated with oral therapy and improve compliance. Naltrexone
`itself does not have the essential physicochemical properties that would allow a therapeutic
`dose of the drug to cross the human skin barrier. Prodrugs are being designed and synthesized
`to improve the transdermal delivery rate of naltrexone, in order to make a therapeutically
`successful drug delivery system. These prodrugs make excellent research tools for
`investigating quantitative structure-permeability relationships (QSPRs) for transdermal flux and
`concurrent metabolism. Correlation of in vitro data with the in vivo models (guinea pig and
`swine) will aid in the creation of a reliable QSPR database, as well as help to identify the most
`promising prodrug for eventual human use.
`The overall objective of the transdermal codrug project is two-fold: 1) to improve
`pharmacotherapy for alcohol and tobacco addiction recovery by creating a transdermal codrug
`dosage form and 2) to increase understanding of the transdermal codrug as a viable drug-
`delivery option for other therapies. A codrug or mutual prodrug consists of two synergistic drugs
`chemically linked together, in order to improve the drug delivery properties of one or both drugs.
`Transdermal prodrugs and drug combination patches are extensively studied, and a practical
`augmentation of these two delivery options is the transdermal codrug.
`Dr. Stinchcomb’s first specialty pharmaceutical company, AllTranz (now Zynerba), was
`founded in 2004. The overall company goal was to develop topical and transdermal dosage
`forms. Several cannabinoid dosage forms were developed based on Dr. Stinchcomb’s patents.
`The second company, F6Pharma, is a palliative care product company. The third company is
`Anti-Microbial Defense Solutions, a company developing better antimicrobial treatments
`through alternate routes of drug delivery.
`Research interests have also included microneedle-enhanced delivery and translational
`research models for public-private partnerships. Currently Dr. Stinchcomb is focusing
`significant effort in concert with the FDA on the evaluation of multiple dermal dosage forms in
`
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`human subjects, with the end goal of creating validated in vitro-in vivo correlation studies that
`may help to improve the efficiency and cost of the drug development process. The research
`group is also developing the best way to formulate and evaluate drug delivery from oromucosal
`systems in vitro.
`
`B.
`
`Current Research Support
`U01FD004955 (Stinchcomb PI) 09/01/13-08/31/20
`FDA/OGD
`
`Heat Effect on Generic Transdermal Drug Delivery Systems
`The goal of this project is to determine the effect of direct heat applied to various TDDS.
`
`
`
`U01FD004947 (Stinchcomb PI) 09/01/13-08/31/20
`FDA/OGD
`
`Bioequivalence of topical drug products: in vitro - in vivo correlations
`The goal of this project is to identify in vitro methods and non-invasive measurement
`methods in human subjects to determine topical product bioequivalence.
`
`
`
`2R44AI129122-03 (Stinchcomb CoI)
`NIH/NIAID
`Microneedle Delivery of Zanamivir for Treatment of Influenza
`
`03/01/2017 – 03/31/2022
`
`Past Research Support
`C.
`U01FD004275, NIPTE/FDA (Stinchcomb coPI) 1/15/15-8/14/18
`Transdermal Drug Delivery Systems-Fentanyl
`
`U01FD004275, NIPTE/FDA (Stinchcomb coPI) 3/1/16-8/31/18
`
`Identification of chemical enhancer specification requirements for TDDS
`Characterization of Methods to Determine the Enhancer Specification in a Transdermal Drug
`Delivery System
`
`
`09/19/2016 – 08/31/2017
`R41HD088223-01 (Stinchcomb coI)
`Painless, Bloodless & Safe Glucose Sensing System for the Pediatric Intensive Care Unit
`NIH/NICHD, Fluorometrix Biomedical Company subcontract to UMB
`
`R01AA022082 (Weiss (Scripps) PI)
`NIH/NIAAA
`
`Ethanol Seeking and Relapse: Therapeutic Potential of Transdermal Cannabidiol
`
`02/01/14-01/31/19
`
`
`
`U01FD004955S1 (Stinchcomb coPI)
`FDA/OGD (OrthoEvra project)
`Characterization of Methods to Measure the Drug Release (Rate) from a Transdermal Drug
`Delivery System
`
`09/01/14-08/31/15
`
`R03OH009815, CDC (Stinchcomb coPI)
`Efficacy Study of A Nicotine Barrier Cream
`The goal of this study is to prevent dangerous nicotine absorption across the skin during
`tobacco harvest.
`
`11/01/13-10/31/15
`
`R21DA31439 (Stinchcomb PI)
`NIH/NIDA
`Microneedle-enhanced codrug delivery for smoking cessation and appetite
`suppression
`
`07/15/12-04/30/15
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`Audra L. Stinchcomb
`Curriculum Vitae
`Page 8
`
`The goal of this project is to develop transdermal codrugs of hydroxybupropion and
`naltrexone.
`
`U01FD005275-01 (Hoag, Steve and Stinchcomb, A Co-PI) 3/1/12-03/1/14
`NIPTE-FDA
`Quantitative Detection of Cold Flow in Transdermal Systems
`The goal of this project is to predict cold flow in transdermal systems using NIR
`spectroscopy.
`
`R03DA030570 (Stinchcomb PI, Paudel original PI) 7/1/11-6/30/14
`NIH/NIDA
`Transdermal delivery of 2-Arachidonoyl glycerol (2-AG) for the treatment of arthritis
`The major goal of this project is to optimize topical delivery of endocannabinoid-like
`structures.
`
`R42DA32191 (Stinchcomb PI)
`NIH/NIDA
`Transdermal Naltrexone for Opiate Addiction and Alcoholism
`The goal of this project is to develop a microneedle enhanced naltrexone trans