`
`Curriculum Vitae (CV)
`
`
`
`Vivian A. Gray
`9 Yorkridge Trail
`Hockessin, DE 19707
`Tel. 302-235-0621; Fax 443-946-1264 ; Cell 302-547-9780
`vagray@rcn.com
`www.vagrayconsulting.net
`www.dissolutiontech.com
`
`
`Career Summary: Vivian has spent the last 39 years involved in all aspects of dissolution
`testing and evaluating new dissolution technology. At the United States Pharmacopeia,
`she enjoyed a long career serving first as a bench chemist, supervisor and lastly as a
`liaison to various expert USP committees, including the Biopharmaceutics and
`Dissolution Expert Committee. In 1997, Vivian joined the DuPont Pharmaceuticals
`Company Analytical Research and Development Section as the Head of the Dissolution
`Group. In that position, she gained experience in developing discriminating dissolution
`methods, writing SOP’s and a variety of documents, adhering to strict cGMP practices,
`and filing CMC aspects of dissolution methods and specifications with regulatory
`agencies.
`Vivian has been an invited speaker for conferences on 56 occasions (Thirteen of these
`were International invitations), lecturing especially in the areas of calibration, dissolution
`equipment, sources of error in dissolution testing, method development and validation,
`new technology, and regulatory topics. She is a proactive participant in the field as
`demonstrated by 50 publications, including 6 book chapters, writing and revising USP
`Chapters, initiating change in USP methods, organizing workshops, serving on the USP
`Biopharmaceutics Expert Committee, the FIP Dissolution Working Group, and the
`Editorial Board for Dissolution Technologies. She served on the PhRMA Dissolution
`Committee from 1997 to 2001. Vivian has held several offices in the APQ Section of the
`AAPS, including Chair in 2008. Vivian received the American Society of Hospital
`Pharmacists Research and Education Foundation 1982 Research Award for co-authoring
`an article on packaging using USP calibrator model tablets and received the FDA
`Commissioner’s Special Citation for involvement in the FDA task force on Gelatin
`Crosslinking. Vivian has co-authored a book on dissolution testing called “Handbook of
`Dissolution Testing”, Third Edition, published in 2004.
`In 2002, she formed her own consulting business in dissolution testing and related areas.
`The company name is V. A. Gray, Consulting, Inc, www.vagrayconsulting.net . In June
`of 2003, she became Managing Director of Dissolution Technologies, a peer-reviewed
`journal dealing specifically with dissolution testing issues, www.dissolutiontech.com .
`
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`American Society of Hospital
`Pharmacists Research and Education
`Foundation
`
`FDA
`AAPS/APQ
`
`1998
`2012
`
`
`
`Honor
`
`Research Award
`
`Commissioner's Special Citation
`APQ Service Award
`
`
`
`
`
`
`
`
`
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`ACADEMIC AND PROFESSIONAL HONORS
`
`
`
`Institution/Organization
`
`
`Date
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`1982
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`PUBLICATIONS-Peer reviewed
`
`Vivian Gray and Tom Rosanske, “Dissolution”, Chapter 12 in the book titled,
`Specification of Drug Substances and Products: Development and Validation of
`Analytical Methods, Edited by Christopher M. Riley, Thomas W. Rosanske and Shelley
`R. Rabel Riley, published by Elsevier, 2014; pp 245–263.
`
`
`N. Fotaki, W. Brown, J. Kochling, Hitesh Chokshi, Mai Miao, Kin Tang, and V. Gray,
`“Rational for Selection of Dissolution Media: Three Case Studies”, Dissolution
`Technologies, 2013, Vol. 20 (3), 6-13.
`
`
`G. Martin and V. Gray, “General Considerations for Dissolution Methods: Development,
`Validation, and Transfer”, JVT, 2011, Vol. 17, Number 1, 8-11.
`
`
`G. Martin and V. Gray, “Potential Pitfalls when Performing Dissolution Instrument
`Qualification”, GXP, 2011, Vol. 15, Number 1, 6-12.
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`S. D’Souza, R. Lozano, S. Mayock, V. Gray, “AAPS Workshop on the Role of
`Dissolution in QBD and Drug Product Life Cycle: A Commentary”, Dissolution
`Technologies, 2010, Vol. 17 (4), 41-45
`
`G. Martin and V. Gray, “Dissolution Instrument Qualification”, JVT, 2010, Vol. 16,
`Number 4, 10-16.
`
`M. Marques, E. Cole, D. Kruep, V. Gray, D. Murachanian, W. Brown, G. Giancaspro,
`“Liquid-filled Gelatin Capsules”, Pharmacopeial Forum, 2009, Vol. 35 (4), 1029-1041
`
`V. Gray, T. Mirza, R. Lozano, C. Tong, R. Löebenberg, B. Nickerson, Q. Wang, “Role
`of Dissolution in Drug Development Continuum”, Pharmaceutical Technologies, April ,
`2009.
`
`V. Gray, G. Kelly, M. Xia, C. Butler, S. Thomas, S. Mayock, “Expert Review- The
`Science of USP 1 and 2 Dissolution: Present Challenges and Future Relevance”, Pharm.
`Research, on-line Jan. 2009,
`http://www.springerlink.com/content/4863020493817088/fulltext.pdf., Spring 2009.
`
`Vivian Gray, Jack Zheng, and Norman Sesi, “In Vitro Dissolution and Method
`Development”, chapter in the book titled, Formulation and Analytical Development for
`Low-Dose Oral Drug Products. Edited by Jack Zheng, published by John Wiley and
`Sons, Hoboken, NJ, 2009. ISBN: 978047005609.
`
`Vivian Gray, “Dissolution and Drug Release Testing”, chapter in the book titled,
`Pharmaceutical Dosage Forms: Tablets, Third Edition, Volume 3: Manufacture and
`Process Control. Edited by Larry Augsburger and Stephen Hoag, published by Informa
`Healthcare, New York, NY, 2008. ISBN: 9780849390166.
`
`V. A. Gray, A.J. Hickey, et al, “The Inhalation Ad Hoc Panel for the USP Performance
`Tests of Inhalation Dosage Forms”, Pharmacopeial Forum, 2008, 34 (4), 1068-1074.
`
`Anthony Palmieri and Vivian Gray, “Dissolution of Heterogeneous Dosage Forms”,
`chapter in the book titled, Dissolution Theory, Methodology, and Testing, edited by A.
`Palmieri, published by Dissolution Technologies, Hockessin, DE, 2007. ISBN 0-
`9761519-1-X.
`
`M.N. Martinez, P Bonate, R.L. Chapman, A. DeGroot, S. D’Souza, N. Ghilazi, V. Gray,
`V. K. Gupta, K. Huynh-Ba, S. Iyer, A. Jayatilaka, A. Joshi, H.T. Karnes, M. Khan, P. Liu,
`C. Lunte, C. R. McCurdy, M. E. Morris, K. J. Norris, P. Ramsey, Sanjay Sehgal, “2007
`Highlights of Advances in the Pharmaceutical Sciences: An American Association of
`
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`Pharmaceutical Scientists (AAPS) Perspective, The AAPS Journal, 2007, Article 024,
`June.
`
`Vivian Gray, “Challenges to the Dissolution Test, Including Equipment Calibration”,
`2006, Pharmaceutical Technology, Analytical Methods Primer, 4-13. Subsequently
`republished in Dissolution Technologies, 2006, 13(2), 6-9, and Pharmaceutical Canada,
`2006, 7 (2), 13-16.
`
`Royal Hanson and Vivian Gray, “Handbook for Dissolution Testing”, Third Edition,
`2004, Dissolution Technologies, Inc., Hockessin, DE.
`
`Qingxi Wang and Vivian Gray, “HPLC in Dissolution Testing”, Chapter for the book,
`Handbook of Pharmaceutical Analysis by HPLC, Volume 6 of the Separation Science and
`Technology Series, Elsevier Academic Press, USBN 0-12-088547-6. 2005
`
`Mauger J, Ballard J, Brockson R, De S, Gray V, Robinson D, “Intrinsic Dissolution
`Performance Testing of the USP Dissolution Apparatus 2 (Rotating Paddle) Using
`Modified Salicylic Acid Calibrator Tablets: Proof of Principal”, Dissolution
`Technologies, 10 (2), August 2003, 6-15.
`
`Vivian Gray, “Dissolution Testing Using Fiber Optics – A Regulatory Perspective,
`American Pharmaceutical Review, Volume 6 (2), 2003, 26-30 and Dissolution
`Technologies, Volume 10 (4), November 2003.
`
`Vivian Gray, “Fiber Optics Update”, posted on Internet website,
`www.dissolutionsolutions.net, March 2003.
`
`Vivian Gray, “Dissolution Testing -- Good Manufacturing Practices”, European
`Pharmaceutical Review, 1 (2003), 58-61.
`
`Vivian Gray, “Compendial Testing Equipment: Calibration, Qualification, and Sources of
`Error’, a Chapter in the book titled Pharmaceuticals Dissolution Testing, Published by
`Taylor and Francis. ISBN 0-8247-5467-0 , 2005.
`
`Jeffrey Hofer, and Vivian Gray., “Examination of Selection of Immediate Release
`Dissolution Acceptance Criteria”, Pharmacopeial Forum, Volume 29 Number 1, 2003
`and Dissolution Technologies, Volume 10 (1), 2003, 16-20.
`
`Vivian Gray, “Let’s Talk Fiber Optics”, posted on Internet website,
`www.dissolutionsolutions.net, September 2002.
`
`
`Vivian Gray, and Brent Miller, “Current Good Manufacturing Practices in the Dissolution
`Laboratory”, Pharmaceutical Canada, Volume 3 Number 3, 2002.
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`Vivian Gray, “Identifying Sources of Error in Calibration and Sample Testing”, American
`Pharmaceutical Review, summer 2002.
`
`Vivian Gray, Mary Beggy, Robert Brockson, Nancy Corrigan and John Mullen, ”A
`Comparison of Dissolution Results using O-ring versus Clipped Basket Shafts”,
`Dissolution Technologies, Volume 8, Issue 4, Nov. 2001.
`
`Vivian A. Gray, DuPont Pharmaceuticals Company (USP Biopharmaceutics Committee),
`Cynthia K. Brown, Quintiles, Inc., Jennifer B. Dressman, J.W. Goethe University, Lewis
`J. Leeson, LJL Associates, Inc. (USP Biopharmaceutics Committee). "A New General
`Chapter on Dissolution", Pharmacopeial Forum, Volume 27, Number 6, 2001.
`
`Vivian A. Gray, "Basic Dissolution Testing". Published as an AAPS Short Course, on
`CD-ROM (Microsoft Power Point electronic format). 2001
`
`PhRMA Subcommittee on Dissolution Calibration: Steve Brune (Pfizer); Jim Bucko (Eli
`Lilly); Sally Emr (Ortho-McNeil); Vivian A. Gray (DuPont Pharmaceutical Co.); Kathy
`Hippeli (Schering Plough); Al Kentrup (Hoescht Marion Roussel); Dave Whiteman
`(Hoescht Marion Roussel); Mark Loranger (Boeringer Ingelheim); Mary Oates,
`Chairperson (Warner Lambert), "Dissolution Calibrator: Recommendations for Reduced
`Chemical Testing and Enhanced Mechanical Calibration", Pharm. Forum, 2000, 26(4),
`1149-1166.
`
`Aubry, A. F.; Sebastian, D.; Hobson, T.; Xu, J. Q. and Gray, V. A., “In-Use Testing of
`Extemporaneously Prepared Suspension of New Non-nucleoside Reversed Transcriptase
`Inhibitors In Support of Phase I Clinical Studies”, J. Pharm. and Biomed. Anal., 23
`(2000), 535-542.
`
`Members of the Gelatin Capsule Working Group, "Collaborative Development of Two-
`Tier Dissolution Testing for Gelatin Capsules and Gelatin-Coated Tablets Using Enzyme-
`Containing Media", Pharm. Forum, 1998, 24(5), 7045-7050.
`
`Gray, V.A., “Two-Tier Dissolution Testing”, Dissolution Technologies, May, 1998, 5(2).
`
`Gray, V.A., “Report on the USP Dissolution and Bioavailability Subcommittee Activity
`Regarding the Peak Vessel”, Dissolution Technologies, Feb. 1998, from Roundtable
`Conference at AAPS meeting in Boston, MA, November, 1997
`
`Gray, V.A. and Foster, T.S., “Utility of USP Salicylic Acid Calibrator Tablets”, Pharm.
`Forum 1997, 23(6).
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`Gray, V.A. and Grady, L.T., “USP Dissolution Standards--Revisions, Initiatives and New
`Policies Since 1980”, Pharm Forum, 1997, 23(3), 4183-4197.
`
`Okeke, C.C.; Barletta, F.P.; Gray, V.A.; Krasowski, J.A.; Paul, W.L.; Belson, J.J. and
`Grady, L.T., “USP Standards and Activities Affecting Pharmacy Practice,” Am. J. Health-
`Syst. Pharm., 1997, 54.
`
`Foster, T.S. and Gray, V.A., “USP Dissolution <711>, Pooled Sampling--Response to
`Comments Received”, Pharm. Forum, 1997, 23(3), 4248-4249.
`
`Gray, V.A. and Rippere, R.A., “Labeling Issues for Recently Approved Abbreviated New
`Drug Applications for Extended-release Products”, Pharm. Forum, 1996, 22(1), 1942.
`
`Gray, V.A. and Dressman, J.B., “Change of pH Requirements for Simulated Intestinal
`Fluid TS”, Pharm. Forum, 1996, 22(1), 1943-1945.
`
`Gray, V.A. and Lovering, E.G., “Other Impurities Proposal--The 0.1% Level in Foreign
`Substances and Impurities”, Pharm. Forum, 1995, 21(6), 1650-1653.
`
`Achanta, A.S.; Gray, V.A.; Cecil, T.L. and Grady, L.T., “Evaluation of the Performance of
`Prednisone and Salicylic Acid USP Dissolution Calibrators,” Drug Development and
`Industrial Pharmacy, 1995, 21(10), 1171-1182.
`
`Gray, V.A., Hubert, B.B. and Krasowski, J.A., “Calibration of Dissolution Apparatus 1
`and 2--What to do When Your Equipment Fails”, Pharm. Forum, 1994, 20(6), 8571-
`8573.
`
`Taborsky-Urdinola, C.J.; Gray, V.A. and Grady, L.T., “Effects of Packaging and Storage
`on the Dissolution of Model Prednisone Tablets”, J. of Hosp. Pharm., 1981, 38, 1322-
`1327.
`
`Thakker, K.D.; Naik, N.C.; Gray, V.A. and Sun, S., “Fine-Tuning of Dissolution
`Apparatus for Apparatus Suitability Test Using the USP Dissolution Calibrators”, Pharm.
`Forum, 1980, 6(4).
`
`Publications – Non- peer reviewed
`Vivian Gray, “Controlled Release Society Annual Meeting Report: Dissolution
`Highlights”, Dissolution Technologies, 2004, 11 (4), 30-31.
`
`C. Jeanne Taborsky and Vivian Gray, “Meeting Report, AAPS/USP/CRS Workshop on
`Dissolution; New Technologies and Regulatory Initiative”, Dissolution Technologies,
`Volume 11, Issue 2, 2004, 20-27.
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`Vivian Gray, “Dissolution Specifications Industry Update”, GMP Review, April 2004,
`pages 24-28.
`
`Tahseen Mirza and Vivian Gray, “Meeting Report: Conference on Dissolution,
`Bioequivalence, and Bioavailability”, Dissolution Technologies, 2004, 11 (1), 25-28.
`
`Vivian Gray, “Future Directions for Dissolution Testing in the Pharmaceutical Industry”,
`Dissolution Technologies, 2004, 11 (3), 13-14.
`
`Vivian Gray, “Dissolution Testing; An Overview and Summary of Recent Trends and
`Regulatory Activities”, Tablets and Capsules, 1 (1), October 2003, 20-24.
`
`Vivian Gray, “Meeting Report: AAPS/FDA Workshop on Biopharmaceutics
`Classification System” Dissolution Technologies, Volume 9, Issue 4, 2002.
`
`Vivian Gray, “Meeting Report: AAPS/FDA Workshop on Dissolution/In Vitro Release
`Testing and Specifications for Special Dosage Forms” Dissolution Technologies, Volume
`9, Issue 4, 2002.
`
`Vivian Gray, “Dissolution Summary: AAPS/FDA Workshop on Specifications”,
`Dissolution Technologies, Volume 9, Issue 2, April 2002.
`
`Vivian Gray, “Update on Dissolution Testing—Recent Activities and Trends, Dissolution
`Technologies, Volume 9, Issue 1, Feb. 2002.
`
`Vivian A. Gray, “Dissolution—Current Activities and Trends”, published in
`Pharmaceutical Canada, spring 2001, Volume 2, Number 2 and Dissolution
`Technologies Volume 8, Issue 4, Nov. 2001.
`
`
`PRESENTATIONS
`Invited Speaker:
`
`Vivian Gray, “Scientific Considerations using Similarity Factor, F2”, AAPS Annual
`Meeting, San Antonio, TX, USA, November 12, 2013.
`
`Vivian Gray, “Design of Experiments (DoE) for the Dissolution Test Methodology and
`Detection of Critical Quality Attributes”, Drug Development and Registration: Pharma-
`2020 Strategy Realization Conference, Moscow, Russia, October 29, 2013.
`
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`Vivian Gray, “Gelatin Capsules: Current Issues when Cross-linking is Observed, Related
`to Addition of Enzyme to Media”, Drug Development and Registration: Pharma-2020
`Strategy Realization Conference, Moscow, Russia, October 29, 2013.
`
`Vivian Gray, “Need for harmonized IVIVC Guidances to Expedite Global Approvals”,
`Annual Controlled Release Society, Honolulu, HI, USA, July 20, 2013.
`
`Vivian Gray, “Method Development and Setting Clinically Relevant Dissolution
`Specifications, Including Quality by Design”, AAPS Workshop on Dissolution Testing
`and Bioequivalence, National University of La Plata, La Plata, Argentina, March 7,
`2013.
`
`Vivian Gray, “Analytical issues Related to Enzymes Addition when Crosslinking
`Occurs”, AAPS Annual Meeting, Chicago, IL, October 18, 2012.
`
`Vivian Gray, “Setting Clinically Relevant In Vitro Release Specifications for Controlled
`Release Products”, Annual Controlled Release Society, Quebec City, Canada, July 14,
`2012.
`
`Vivian Gray, “Report on Activities of USP Panels on Use of Enzymes in Testing
`Capsules that are Crosslinked”, Challenges of Dissolution Testing Workshop, USP,
`Rockville, MD, June 11, 2012.
`
`Vivian Gray, “Comparison of Dissolution Profiles in Validation, Method Transfer and
`F2”, presented at the AAPS-Rhodes University Dissolution Workshop, Grahamstown,
`South Africa, December 6, 2011
`
`Vivian Gray, “General Concepts:Design of Dissolution Method Development, including
`Quality by Design”, presented at the AAPS-Sechenov First Moscow State Medical
`University Dissolution Workshop, Moscow, Russia, October 6, 2011.
`
`Vivian Gray, “GMP’s in the Dissolution Laboratory, including Preparing for a PAI”,
`presented at the AAPS-Sechenov First Moscow State Medical University Dissolution
`Workshop, Moscow, Russia, October 7, 2011.
`
`Vivian Gray, “General Concepts__Design of Dissolution Method Development,
`including Quality by Design”, presented at the AAPS-Croatian Pharmaceutical Society
`Dissolution Workshop, Zagrab, Croatia, October 3, 2011.
`
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`
`Vivian Gray, “GMP’s in the Dissolution Laboratory, including Preparing for a PAI”,
`presented at the AAPS-Croatian Pharmaceutical Society Dissolution Workshop, Zagrab,
`Croatia, October 4, 2011.
`
`Vivian Gray, “Recent Challenges in Dissolution Testing, Including USP Initiatives”,
`Philadelphia Pharmaceutical Forum, April, 2011
`
`Vivian Gray, “Determining Similarity of Products- F2 Criterion and Variability of
`Dissolution Test”, presented at the AAPS-Rhodes University Dissolution Workshop,
`Grahamstown, South Africa, December 10, 2009.
`
`Vivian Gray, “Trouble Shooting Dissolution Method Transfer Problems”, presented at the
`AAPS-IPA workshop held in Bangalore, India, May 15, 2009.
`
`Vivian Gray, “Dissolution Regulatory GMP Issues, Including Preparing for a PAI”,
`presented at the AAPS-IPA workshop held in Bangalore, India, May 16, 2009.
`
`Vivian Gray, “Dissolution Method Transfer, Including Sources of Problems”, presented at
`the AAPS Annual Meeting, held in San Diego, CA, November 13, 2008.
`
`Vivian Gray, “Current Challenges in Dissolution Testing, including the Role of QBD”,
`Philadelphia Pharmaceutical Forum, October 9, 2008
`
`Vivian Gray, “Dissolution Technology and Challenges for Novel Dosage Forms” and
`“Overview of Dissolution Methods and Technologies”, presented at the AAPS/SFDA
`Joint Conference held in Hangzhou, China, July 2, 2007.
`
`Vivian Gray, “Update on Emerging Trends on Quality by Design and GMP issues”,
`presented at the IPA conference on Dissolution Testing, held in Toronto, Canada, June 10,
`2007.
`
`Vivian Gray, “Dissolution Method Development, Including Poorly Soluble Drugs and
`Novel Dosage Forms”, a one day course presented at the Eastern Analytical Symposium,
`held in Somerset, NJ, on November 14, 2006.
`
`
`Vivian Gray, “Challenges to the Dissolution Method”, presented at the Tablets and
`Capsules Conference, held in Radison, NJ, on October 10, 2006.
`
`Vivian Gray, “Challenges to the Dissolution Test, Including Performance Verification”,
`presented at the USP Annual Meeting, held in Denver, Colorado, on September 29, 2006.
`
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`
`Vivian Gray, “Current Challenges to the Dissolution Test”, presented at the workshop
`“Forum on Studying of Dissolution Testing in Japan”, held in Osaka and Tokyo, Japan,
`on June 16 and 22, 2006.
`
`Vivian Gray, “Challenges to Dissolution Testing, Including Calibration, Rebuttal and
`Common Ground”, presented at the AAPS Workshop on Challenges for Dissolution
`Testing for the 21st Century, held in Arlington, VA on May 3, 2006.
`
`Vivian Gray, “Following GMP’s in the Dissolution Laboratory”, Presented at the
`Dissolution Testing, Bioavailability & Bioequivalence Conference, held in Budapest,
`Hungary on May 22, 2006.
`
`Vivian Gray, “Challenges in Developing Dissolution Methods for Novel dosage Forms”,
`Philadelphia Pharmaceutical Forum, March 9, 2006.
`
`Vivian Gray, ”Basic Dissolution Requirements” presented at the AAPS Sunrise School at
`the AAPS Annual Meeting held in Nashville, TN on November 9, 2005.
`
`Vivian Gray,” Future Challenges of the Dissolution Performance Test”, presented at the
`AAPS Roundtable Symposium at the AAPS Annual Meeting held in Baltimore, MD, on
`November 10, 2004.
`
`Vivian Gray, “Dissolution Method Development and Validation”, presented at the USP
`Annual Meeting, held in Iselin, NJ, on September 28, 2004.
`
`Vivian Gray, “Design and Calibration of Dissolution Test Equipment”, presented at the
`FIP/WHO/CHINA Bioequivalence and Hands on Dissolution Workshop, held in Beijing,
`China on April 12-13 and Shanghai, China on April 15-16 2004.
`
`Vivian Gray, “Dissolution Testing with Fiber Optics: Industry Perspective on Regulatory
`Aspects”, presented at the AAPS Workshop on Dissolution: New Technology and
`Regulatory Initiatives held in Bethesda, MD on March 30, 2004.
`
`Vivian Gray, “Dissolution Regulatory GMP Issues, Including Preparing for a PAI”,
`presented at the Dissolution, Bioequivalence and Bioavailability Conference in
`Philadelphia on January 26, 2004.
`
`Vivian Gray, “Solubility Considerations in Dissolution Method Development”, presented
`at the Strategies for Improving Solubility Conference held in Brussels, Belgium on
`October 3, 2003.
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`
`Vivian Gray, “Method Validation in the Dissolution Lab” presented at the Dissolution,
`Bioequivalence and Bioavailability Conference held in Brussels, Belgium October 2,
`2003.
`
`Vivian Gray, “Dissolution Specifications Industry Update”, presented at the Dissolution,
`Bioequivalence and Bioavailability Conference in Brussels, Belgium October 3, 2003 and
`in Philadelphia January 26, 2004.
`
`Vivian Gray, “Challenges of Developing Dissolution Methods and In Vivo/In Vitro
`Correlations for Poorly Soluble Drugs, Including a Discussion of Novel Dosage Forms”,
`presented at the Dissolution, Bioequivalence and Bioavailability Conference in
`Philadelphia, PA on Feb. 3, 2003, June 23, 2003, and in Brussels, October 3, 2003.
`
`Vivian Gray, “Calibration and Qualification of Non-Compendial Dissolution Equipment,
`Including Sources of Error’, presented at the Dissolution Innovation Conference held in
`Raleigh, NC on August 5, 2003.
`
`Vivian Gray, “Dissolution Testing with Fiber Optics: Regulatory Perspective and
`Evaluation Tips”, presented at the Dissolution Innovation Conference held in Raleigh,
`NC on August 6, 2003.
`
`Vivian Gray, “Dissolution Testing of Special Dosage Forms: Summary of FIP Workshops
`and Publication”, presented at the Dissolution Innovation Conference held in Raleigh,
`NC on August 7, 2003.
`
`Vivian Gray, “Dissolution Regulatory GMP Issues”, presented at the International
`Pharmaceutical Academy Exposition 2002 in Toronto, Canada, on September 24, 2002.
`
`Vivian Gray, “Calibration and Qualification—Mechanical and Tablet Calibration”,
`presented at the AAPS/FDA Workshop on Dissolution/In Vitro Release Testing and
`Specifications for Special Dosage Forms In Arlington, VA on September 16, 2002.
`
`Vivian Gray, “Challenges in Developing Dissolution Methods and In Vivo and In Vitro
`Correlations for Poorly Soluble Drugs”, presented at the 44th Annual International
`Industrial Pharmaceutical Research and Development Conference on Strategies for
`formulating poorly soluble Drugs in Merrimac, Wisconsin on June 7, 2002.
`
`Vivian Gray, “Recent Trends and Initiatives in Dissolution, Including Calibration”,
`Presented at the DDG (Dissolution Discussion Group), in Chapel Hill, NC on May 23,
`2002.
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`
`Vivian Gray, Mary Beggy, Robert Brockson, Gina Stick, “Oral Dosage Forms—General
`Considerations: Calibration and Qualification”, Presented at Workshop sponsored by FIP,
`“Dissolution Testing of Special Dosage Forms”, in Frankfurt, Germany on 05MAR01.
`
`Vivian Gray, “Identifying Sources of Error and Variability and Sample Testing”,
`Presented at a Dissolution Conference in Philadelphia, PA, 27FEB01.
`
`Vivian A. Gray, John J. Mullen, and Robert W. Brockson,
`"Encapsulated Tablets - Dissolution Testing Considerations". Presented at Dissolution
`Testing Conference, Vienna, VA, November 30 to December 1, 2000.
`
`Vivian A. Gray and Munir Hussain, "Gelatin Cross-linking in Capsules and its Effect on
`Dissolution, Including a Case Study", Dissolution Testing Conference 2000, Philadelphia,
`PA.
`
`Vivian A. Gray and Gina Leonard, "Overview of Semi-Automated Equipment in a
`Dissolution Laboratory", ISLAR, Boston, MA, 1999.
`
`Vivian A. Gray, "Calibration of Apparatus I and II: What to do When Your Equipment
`Fails", Calibration and Validation Group, 1998.
`
`Vivian A. Gray, "What Dissolution Can Do for You" DuPont Pharmaceuticals Company,
`1998.
`
`Vivian A. Gray, “USP Update: Chewable Tablets, Calibrator Tablets, Pooled Sampling,
`Two Tier Testing, and Other Issues”, Philadelphia Pharmaceutical Forum, 1997
`
`
`Vivian A. Gray, "Capsules Two Tier Dissolution Testing", AAPS Southeast Regional
`Meeting, 1997
`
`Vivian A. Gray, "Extended Release Standards", Pharm Tech Conference, 1997.
`
`Vivian A. Gray, "Dissolution Calibrators" AAPS Short Course on Dissolution, held at the
`AAPS Annual Meeting in November, 1996.
`
`Vivian A. Gray, "Dissolution Calibrators", Zentrallaboratorium Deutscher Apotheker,
`held in Frankfurt Germany in 1996.
`
`Vivian A. Gray, "Dissolution Calibrators", AAPS Dissolution Workshop held in Crystal
`City , MD on Sept. 26, 1995.
`
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`COMMITTEE AND SOCIETY MEMBERSHIPS
`
`
`
`Date
`
`
`Organization
`
`
`
`
`
`USP Expert Biopharmaceutics Committee
`AUG 2000-
`
`JUNE 2010
`JULY 2010- USP Expert Committee for General Chapters
`on Pharmaceutical Dosage Forms
`USP Calibration Project Team
`
`JULY 2001-
`Dec. 2005
`JANUARY 1,
`2006-JUNE
`2010
`FEBRUARY
`, 2011 -
`FEBRUARY,
`2011-
`FEB. 2011-
`JAN 2003-
`FEBRUARY
`2011-
`JAN 2004-
`JUNE 2010
`AUGUST
`2003-JUNE
`2010
`FEBRUARY,
`2011-
`
`FEBRUARY,
`2011-
`
`JAN 1998-
`
`JAN 1998-
`
`JAN 1995-
`
`USP Advisory Panel on Calibrator Tablets
`
`USP Subcommittee on Performance
`Verification Testing
`USP Subcommittee on Revision of <1092>
`
`USP Subcommittee on Mucosal
`USP Expert Panel on Liquid-filled Capsules
`USP Expert Panel on Use of Enzymes
`
`USP Reference Standards Committee
`
`USP Advisory Panel on Performance Testing
`of Aerosols
`
`USP Expert Subcommittee on Dietary
`Supplements, <2040>
`
`USP Expert Panel Extended Release Dietary
`Supplements, <2040>
`
`Delaware Valley Chromatography Forum
`
`American Chemical Society (ACS)
`
`Philadelphia Pharmaceutical Forum (PPF)
`
`
`
`
`
`Capacity
`
`
`Member
`
`Member
`
`Chair
`
`Chair
`
`Chair
`
`Member
`
`
`Chair
`Chair
`
`Member
`
`Co-Chair
`
`Member
`
`Member
`
`Member
`
`Member
`
`Member
`
`
`
`13
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`

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`JULY 1998-
`12/01
`
`PhRMA Dissolution Committee
`
`JAN 1996-
`
`Dissolution Discussion Group (DDG)
`
`JAN 1999- Editorial Board for Dissolution Technologies
`
`Dissolution Technologies
`FIP Dissolution Working Group
`
`JUNE 2003-
`JAN 1998-
`DEC. 2004
`JAN 1985-
`
`AAPS, APQ section
`
`JUNE 2003-
`JUNE 2004-
`
`June 2006-
`Feb. 2011
`March 2007-
`
`Controlled Release Society
`AAPS In Vitro Release and Dissolution
`Testing Focus Group
`ASTM Subcommittee E55
`
`AAPS Publications Committee
`
`
`
`PhRMA Subcommittee on
`Dissolution Calibration
`
`Member
`
`Research Editor
`
`Owner
`Member
`
`Past Chair 2009
`Chair 2008
`Secretary Treasurer, 2005
`Vice Chair, 2006
`Chair Elect, 2007
`Member
`Co-founder
`
`Member
`
`Member
`Vice Chair 2013
`
`
`
`EMPLOYMENT HISTORY
`6/10/03-Present
`Dissolution Technologies, Inc., President
`This is a quarterly peer-reviewed indexed journal consisting of technical articles on the
`subject of dissolution testing. A Question and Answer section is also included along with
`meeting reports.
`
`Job Description
`Managing Director: Collects and reviews articles for journal. Coordinates peer-review
`and proofreading of articles. Organizes Themed issue. Solicits and manages advertising.
`
`1/01/02-Present V. A. Gray Consulting, Inc., President
`
`Job Description
`
`
`
`14
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`

`

`
`
`Provides consulting services in developing and validation of dissolution methods,
`writing regulatory documents and justifications for methodology and specifications,
`assessing current dissolution methods and analyzing data for troubleshooting problems,
`advice on regulations from USP, other pharmacopoeias, and regulatory agencies, FDA
`and others. Consults on developing methods and evaluating new technology for
`conventional and novel dosage forms. Prepares laboratory staff for audits and
`inspections, and training for method development, validation, recognizing sources of
`error and importance of observations during the test. Advice on the Biopharmaceutics
`Classification System filing and justification. Manages projects that involve laboratory
`work for method development and other dissolution testing in off-site testing facilities.
`Provides expert advice in litigation.
`
`
`12/97-12/01
`
`Job Description
`
`Bristol-Myers Squibb Pharmaceutical Company (DuPont
`Pharmaceuticals Company until October 1, 2001), Analytical
`Research and Development, Senior Research Scientist, Group
`Leader of Dissolution Testing
`
` Responsible for managing the group that performs dissolution testing of candidate
`formulations, including method development and selection of dissolution conditions,
`stability/clinical release testing, process optimization, technology transfer and
`cleaning certifications. This includes supervision of three supervisors in a group of 11
`chemists.
` Responsible for dissolution portion of CMC section within NDA and MAA
`submissions, justification of dissolution specifications, answers regulatory questions,
`participates in FDA teleconferences.
`
`In-depth knowledge of FDA guidances and USP issues
` Writes dissolution validation, and development reports, pertinent sections of FDA
`background packages and tech transfer reports, and protocols.
` Oversees the calibration of equipment and writing of SOP’s as applied to Dissolution
`testing.
` Prepared for pre-approval inspections and audits.
`
`Interacts frequently with formulators and PI’s to interpret dissolution data, support
`formulation development, and ensure project timelines are met.
` Responsible for dissolution technology transfer.
`
`
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`15
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` Training analyst in regulatory requirements and analytical techniques for dissolution.
` Evaluate new technology and automation to increase productivity and lab efficiency.
` Recommend and justify purchase requests.
` Performance reviews and mentoring analysts
`
`1990 - 1997
`
`
`
`
`
`
`
`United States Pharmacopeia (USP), Rockville, MD
`Scientist, Liaison to the USP Subcommittee on Dissolution and
`Bioavailability, General Chapters Subcommittee, and Chemistry 4
`Subcommittee
`
`Job Description
`
` Revise and propose new USP monographs, USP General Chapters, and Dissolution
`tests with approval and in cooperation with the Subcommittee of experts.
`Initiate requests for laboratory support for analytical issues. Review completed lab
`work.
`Interact with industry, FDA and other interested parties to improve standards and/or
`harmonize with other Pharmacopoeias, dissolution tests, General Chapters, and
`monograph tests.
` Review submissions and evaluate validation data for improved or new tests, answer
`questions regarding dissolution, calibration, USP General Chapters and other
`methods.
` Give presentations on dissolution issues, impurity topics and method validation
` Write articles on USP initiatives and guidelines on dissolution and monograph
`impurity issues.
` Plan workshops, open conferences, and Subcommittee meetings
`
`United States Pharmacopeia (USP), Rockville, MD
`
`1982-1990
`Supervisor, Methods Group
`
`
`
`
`Job Description
` Group Function: Development of new and evaluation of existing Dissolution tests,
`Assays, and organic volatile impurities and chromatographic purity methods. Purity
`analysis of USP Reference Standards.
`
`
`Supervisory duties:
`
` Develop plan for experimental work, review, interpret, and tabulate results
` Write or edit project reports, write laboratory policies and manuals
` Schedule chemists’ work and coordinate testing with other groups
`
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`16
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` Recommend capital equipment purchases
` Give performance reviews and conduct interviews
`
`United States Pharmacopeia (USP), Rockville, MD
`
`1974-1982
`Chemist III
`
`
`
`
`Job Description
` Perform experiments including HPLC, TLC, GC, UV, IR, NMR, and dissolution
`techniques
` Record data, write project reports
` Calibrate instruments and maintain log books
`
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`EDUCATION
`
`School
`
`Mary Washington College of
`the University of Virginia,
`Fredericksburg, VA
`
`
`
`Major
`
`Chemistry
`(Biology Minor)
`
`
`
`
`Degree
`
`BSc.
`
`
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`17
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