`43 W. Carlos Road
`Memphis, Tennessee 38117
`Home Office: 901-763-2703
`University Office: 662-915-7134
`chamblissw@aol.com
`
`EDUCATION
`
`
`Ph. D. Pharmaceutics, University of Mississippi, December 1982
`M.S. Pharmaceutics, University of Mississippi, December 1980
`B.S. Pharmacy, University of Mississippi, May 1977
`
`
`
`
`
`WORK EXPERIENCE
`
`
`
`
`
`
`
` 1999 to Present
`
`
`
`
`
`
`
`
`
` 1987 to 1998
`
` 2004 to Present
`
`
`UNIVERSITY OF MISSISSIPPI
`
`Director of Technology Management; Research Professor,
`Research Institute of Pharmaceutical Sciences;
`Professor, Pharmaceutics and Drug Delivery, School of Pharmacy
`
`
`Responsible for business development, intellectual property management and licensing for the
`University. Responsible for managing late stage pharmaceutical development projects and for
`teaching
`in graduate
`level courses
`in Pharmaceutics, Pharmacology and Pharmacy
`Administration.
`
`Associate Director, National Center for Natural Products Research, 1999 to 2004
`Research Professor, Pharmaceutics; School of Pharmacy
`
`Responsible for business development, intellectual property management and licensing for the
`School of Pharmacy. Responsible for pharmaceutical product development projects for the
`National Center for Natural Products Research and for teaching graduate courses in
`Pharmaceutics and Pharmacy Administration.
`
`CHAMBLISS TECHNOLOGY DEVELOPMENT 1998 to Present
`AND TRANSFER, LLC
`Managing Director; Memphis, TN
`
`Founder of a consulting company to assist with R&D management, project management,
`preparation or review of technical documents, intellectual property management, and business
`development.
`
`SCHERING-PLOUGH HEALTHCARE PRODUCTS
`Vice President, Research and Development (1993-1998)
`Memphis, TN
`
`Led all technical groups in support of new and existing products under the Dr. Scholl’s,
`Coppertone and the Schering-Plough over-the-counter brands such as Afrin, Correctol, A&D,
`
`TEVA - EXHIBIT 1026
`
`
`
`WALTER GALLOWAY CHAMBLISS, Ph.D.
`
`Drixoral, Chlor-Trimeton, Lotrimin, Tinactin, and Gyne-Lotrimin. Supervised Formulation
`Development, Process Development/Validation, Analytical Methods Development/Validation,
`Stability, Project Management, Product Safety/Toxicology, Clinical Development, Package
`Development, International Technical Services, and Consumer Relations. Reviewed and
`approved consumer labeling. Responsible for a $10 million budget and over 100 professionals.
`Directly responsible for technical evaluation of business development and Rx-to-OTC switch
`opportunities.
`
`Key Accomplishments:
`
`
`• Launched an average of 30 new or improved products per year in the United States,
`Canada, Japan, Latin America, and Europe. New products represented 25% of annual
`sales.
`• Transferred 100 products with sales of over $200 million to 12 contract manufacturing
`sites over an 18-month period.
`• Developed a strategic plan for the division with an executive team.
`•
`Initiated and managed collaborative research alliances with European partners.
`• Developed and implemented a project team approach to product development.
`
`Senior Director, Scientific Affairs; Liberty Corner, New Jersey (1991-1993)
`
`
`
` A
`
` staff position reporting to the Senior Vice President of Scientific and Regulatory Affairs. Led
`the Rx-to-OTC switch program, coordinated internal and external research programs, served on
`the Label and Advertising Review Committee and represented the corporation on trade
`association task groups. Served as interim Medical Director.
`
`Key Accomplishments:
`
`
`• Chaired
`task group on
`the Non-Prescription Drug Manufacturers Association
`antihistamines in the common cold. This led to an FDA agreement that antihistamines
`were safe and effective for this indication.
`• Accelerated the completion of several NDA clinical programs while serving as interim
`Medical Director.
`• Created four multidisciplinary therapy teams to drive the new products program.
`
`
`
`
`
`
`
`Director, Pharmaceutical R&D; Memphis, TN (1990-1991)
`
`Led group of 30 professionals responsible for formulation development for the OTC product line,
`and clinical supplies and analytical methods for the Coppertone, Dr. Scholl’s, and the OTC
`product line.
`
`Key Accomplishments:
`
`
`• Assembled and led a task group to upgrade R&D to develop products for NDA
`submissions. The result was the addition of 50 new R&D scientists across all
`disciplines, a total rewrite of the SOP’s, and initiation of 12 NDA projects.
`
`2
`
`
`
`WALTER GALLOWAY CHAMBLISS, Ph.D.
`
`
`
`Associate Director, Pharmaceutical R&D Memphis, TN (1987-1989)
`
`Managed a group of ten professionals responsible for formulation development and clinical
`supplies of OTC products and Dr. Scholl’s drug and cosmetic products.
`
`
`
`
`BRISTOL-MYERS PHARMACEUTICAL COMPANY,
`Manager, Pharmaceutical Development; Evansville, IN (1987)
`
`Developed new pharmaceutical products under NDA’s for the Animal Health Division.
`Supervised a group of three professionals responsible for all aspects of product development.
`
`Senior Research Scientist, Pharmaceutical R&D; Syracuse, New York (1986-1987)
`
`Conducted formulation development of new antibiotic compounds and independent research on
`novel controlled-release delivery systems.
`
`Department Head Process Development; Syracuse, New York (1984-1986)
`
`Managed a group of three professionals responsible for process development and technology
`transfer of new products for the Bristol Laboratories Division. The group, which reported to
`Operations, was responsible for solids, liquids, and sterile products.
`
`
`G. D. SEARLE PHARMACEUTICAL COMPANY
`Research Investigator, Pharmaceutical R&D; Skokie, IL.
`
`Responsible for formulation development, process development and transfer to production of new
`pharmaceutical products.
`
`
`RELIEF PHARMACIST
`Senatobia Hospital; Senatobia, Ms.
`Batesville Hospital; Batesville, Ms.
`Chaney’s Pharmacy; Oxford, Ms.
`
`Responsible for managing the pharmacies on weekends, holidays and vacations.
`
`UNIVERSITY OF MISSISSIPPI, SCHOOL OF PHARMACY
`Graduate teaching instructor
`
`Responsible for teaching pharmacy students how to prepare, label and dispense prescriptions.
`
`WALGREENS PHARMACY
`Pharmacist
`
`Responsible for filling prescriptions and managing
`approximately 300 prescriptions per day.
`
`
`
`1984 to 1987
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 1982 to 1984
`
` 1978 to 1982
`
`1978 TO 1982
`
`1978 TO 1978
`
`the pharmacy operations.
`
` Filled
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`3
`
`
`
`WALTER GALLOWAY CHAMBLISS, Ph.D.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1977 TO 1978
`
`1977 TO 1977
`
`
`
`
`
`TREASURY PHARMACY
`Pharmacist
`
`Responsible for filling prescriptions and managing the pharmacy operations. Filled
`approximately 300 prescriptions per day.
`
`DOCTORS HOSPITAL
`Pharmacist
`
`Responsible for filling prescriptions for a 100 bed hospital.
`
`PUBLICATIONS, PATENTS AND PRESENTATIONS
`
`
`Chambliss, W.G., Course Director & Instructor, “Pharmaceutical Technology Transfer and Post-
`Approval Changes”, Center for Professional Advancement, New Brunswick, New Jersey;
`Amsterdam, Netherlands; 2016 to present.
`
`Chambliss, W., “Building Local and Regional Partnerships in Pharmaceutical Development”,
`2015 SEC Symposium, September 22, 2015.
`
`Chambliss, W. Sam, T. and Yelvigi, M; “Scale-Up and Post Approval Changes (SUPAC)”, The
`Encyclopedia of Pharmaceutical Technology, 2013.
`
`Majumdar, S., Hippalgaonkar, K., Hingorani, T., and Chambliss, W., “Recent Patents and
`Regulatory Aspects on Ophthalmic Drug Delivery Systems”, in Treatise on Ocular Drug
`Delivery, Mitra, A.K. Editor, Bentham Science, 2013.
`
`Chambliss, W.G., Instructor, “Tablet Development: Practical Consideration” in the post-graduate
`course: “Hands-On Course in Tablet Technology (Formulation, Processing, Testing and FDA
`requirements)”, 2013-present.
`
`Chambliss, W.G., Acetic Acid, Glacial; Handbook of Pharmaceutical Excipients, 7th Edition,
`Rowe, Sheskey, Cook and Fenton, Editors, Pharmaceutical Press and APhA, 2012.
`
`Chambliss, W.G., Sodium Acetate; Handbook of Pharmaceutical Excipients, 7th Edition, Rowe,
`Sheskey Cook and Fenton, Editors, Pharmaceutical Press and APhA, 2012.
`
`Chambliss, W.G., Phosphoric Acid; Handbook of Pharmaceutical Excipients, 7th Edition, Rowe,
`Sheskey, Cook and Fenton, Editors, Pharmaceutical Press and APhA, 2012.
`
`Chambliss, W. G., Carroll, W.A., Kennedy, D., et al., “Role of the pharmacist in preventing
`distribution of counterfeit medications”, JAPhA, 52:2, 195-199; 2012.
`
`Chambliss, W.G., “Counterfeiting and the Integrity of the Supply Chain”, American Pharmacists
`Association, March 10, 2012.
`
`Yelvigi, M. and Chambliss, W., “The Role of a Target Product Profile in Pharmaceutical Product
`Development”, Pharma Times, Vol 42, No. 04:27-29, 2010.
`
`
`
`4
`
`
`
`WALTER GALLOWAY CHAMBLISS, Ph.D.
`
`
`Chambliss, W.G., “Technology Transfer: The Engine of Bioscience”, Bioworks Business
`Association, February 11, 2010.
`
`Chambliss, W.G., 2nd International GIS Cluster Conference, “Licensing Technologies from
`Universities”, January 11, 2010.
`
`Chambliss, W.G., Acetic Acid, Glacial; Handbook of Pharmaceutical Excipients, 6th Edition,
`Rowe, Sheskey and Quinn, Editors, Pharmaceutical Press and APhA, 2009.
`
`Chambliss, W.G., Sodium Acetate; Handbook of Pharmaceutical Excipients, 6th Edition, Rowe,
`Sheskey and Quinn, Editors, Pharmaceutical Press and APhA, 2009.
`
`Chambliss, W.G., Phosphoric Acid; Handbook of Pharmaceutical Excipients, 6th Edition, Rowe,
`Sheskey and Quinn, Editors, Pharmaceutical Press and APhA, 2009.
`
`Oben, J., Enonchong, E., Kothari, S., Chambliss, W., Garrison, R., and Dolnick, D.,
`“Phellodendron and Citrus extracts benefit cardiovascular health in osteoarthritis patients: a
`double-blind, placebo-controlled pilot study”, Nutr. J., 7:16, May 20, 2008.
`
`Chambliss, W.G., “Formulation Issues Related to Dietary Supplements and Nutraceuticals”,
`Formulation and Stability of Nutraceuticals Roundtable.
` American Association of
`Pharmaceutical Scientists Annual Meeting, 2007.
`
`Chambliss, W.G., Course Director & Instructor, “Pharmaceutical Technology Transfer”, Center
`for Professional Advancement, New Brunswick, New Jersey; Dublin, Ireland; Riga, Latvia; and
`Amsterdam, Netherlands; 2004 to 2015.
`
`Chambliss, W.G., Instructor, “Scale up and Post-Approval Changes Guidelines (SUPAC and
`BACPAC)”, Center for Professional Advancement, New Brunswick, N.J.; Boca Raton, Florida;
`and Amsterdam, Netherlands; 2004 to 2015.
`
`Chambliss, W.G., Course Director & Instructor, “Pharmaceutical Process Development and
`Technology Transfer”, Center for Professional Advancement, Sao Paulo, Brazil, 2007.
`
`Garrison, R., Chambliss, W., “Effect of a Proprietary Magnolia and Phellodendron Extract on
`Weight Management: A Pilot, Double-Blind, Placebo-Controlled Clinical Trial, Alternative
`Therapies
`in
`Health
`and
`Medicine”,
`Vol.
`12,
`No.
`1,
`2006.
`
`Chambliss, W.G., Acetic Acid, Glacial; Handbook of Pharmaceutical Excipients, 5th Edition,
`Rowe, Sheskey and Owen, Editors, Pharmaceutical Press and APhA, 2006.
`
`Chambliss, W.G., Sodium Acetate; Handbook of Pharmaceutical Excipients, 5th Edition, Rowe,
`Sheskey and Owen, Editors, Pharmaceutical Press and APhA, 2006.
`
`Chambliss, W.G., Phosphoric Acid; Handbook of Pharmaceutical Excipients, 5th Edition, Rowe,
`Sheskey and Owen, Editors, Pharmaceutical Press and APhA, 2006.
`
`Cheboyina, S., Chambliss, W., and Wyandt, C., “A Novel Freeze Pelletization Technique for
`Preparing Matrix Pellets”, Pharmaceutical Technology, October, 100-110, 2004.
`
`
`
`
`5
`
`
`
`WALTER GALLOWAY CHAMBLISS, Ph.D.
`
`Chambliss, W.G., "JPharmSci: An International Source for Answers to Critical Research
`Questions", JAPhA 44:122-125, 2004.
`
`Glisson J.K., Rogers H.E., and Chambliss W.G., "Dietary Supplements: Important Concerns for
`the Clinician", Miss State Med Assoc: 44(2):35-38, 2003.
`
`Chambliss, W.G., Instructor, "Semi-solids Process Development", Center for Professional
`Advancement, 2003.
`
`Chambliss, W.G., Acetic Acid, Glacial; Handbook of Pharmaceutical Excipients, 4th Edition,
`Rowe, Sheskey and Weller, Editors, Pharmaceutical Press and APhA, 2003.
`
`Chambliss, W.G., Phosphoric Acid, Handbook of Pharmaceutical Excipients, 4th Edition, Rowe,
`Sheskey and Weller, Editors, Pharmaceutical Press and APhA, 2003.
`
`Chambliss, W.G., Hufford, C.D., Flagg, M.L., and Glisson, J.K., “Assessment of the Quality of
`Reference Books on Botanical Dietary Supplements”, JAPhA, 42:723-734, 2002.
`
`Chambliss, W., “Tolerability and Pharmacokinetics of Ascending Doses of Delta-9 THC-
`Hemisuccinate in Suppositories and Comparative Bioavailability with Oral Marinol”, Invited
`Speaker, International Cannabinoid Society Annual Meeting, July 2002.
`
`Chambliss, W., “Phase I Clinical Studies on THC-Hemisuccinate Suppositories”, Invited
`Speaker, Center for Medicinal Cannabis Research Workshop, July 2002.
`
`Bentley, P.J., Best, A.M., Reisetter, B.C. and Chambliss, W.G., "Experiences and Activities of
`Primary Care Physicians Regarding Patient Use of Herbal Products", Academy of Health
`Services Research and Health Policy Annual Meeting, Washington, D.C., June 2002.
`
`Bentley, P.J., Best, A.M., Reisetter, B.C. and Chambliss, W.G., "The Regulation of Herbal
`Products in the U.S.: What are the Views of Community Pharmacists and Primacy Care
`Physicians?" American Pharmaceutical Association Convention, March 2002.
`
`Avdeef, A., Strafford, M., Block, E., Balogh, M.P., Chambliss, W., and Khan, I., “Drug
`Absorption in vitro Model: Filter-Immobilized Artificial Membranes. 2. Studies of the
`Permeability Properties of Lactones in Piper methysticum Forst. Eur. J. Pharm. Sci., 14(4) 271-
`280, 2001.
`
`Chambliss, W.G., "Dietary Supplements and Controlled Release", Invited Speaker, 28th
`International Symposium on Controlled Release of Bioactive Materials, June 2001.
`
`Chambliss, W.G., "Nutraceutical Formulations: Impact on Bioavailability", in Examining the
`Science Behind Nutraceuticals, Proceedings of the AAPS Dietary Supplement Forum, AAPS
`Press, pps. 367-380, 2001.
`
`Sufka, K.J, Roach, J.T, Chambliss, W.G., Broom, S., Feltenstein, M.W., Wyandt, C., and Zeng,
`L., “Anxiolytic Properties of Botanical Extracts in the Chick Social Separation-Stress Procedure”,
`Psychopharmacology, Vol 153, Issue 2, 2001.
`
`Chambliss, W.G., "New Product Opportunities Through Formulation and Claim Support", Invited
`Speaker, Global Advisory Board, American Home Products, October 2000.
`
`
`
`6
`
`
`
`WALTER GALLOWAY CHAMBLISS, Ph.D.
`
`
`Chambliss, W.G., "Nutraceutical Formulations: Impact on Bioavailability", Invited Speaker,
`American Association of Pharmaceutical Scientists Dietary Supplement Forum, June 2000.
`
`Instructor, “The Postgraduate Course in Tablet Technology”, University of Tennessee, 10/98,
`3/99 and 6/99.
`
`Chambliss, W.G., “The Demands of Leadership", Invited Speaker; Honors Day, University of
`Mississippi, 4/98.
`
`Chambliss, W.G., "Management versus Leadership", Rho Chi Banquet, University of Mississippi,
`4/99.
`
`International Steering Committee, the Handbook of Pharmaceutical Excipients, 2nd, 3rd and 4th
`Editions (1992-2004).
`
`J. Haslwanter and W. Chambliss, "Non-cariogenic Confections", U.S. Patent #4,963,359, October
`16, 1990.
`
`J. Rider, E. Brunson, W. Chambliss, R. Cleary, G. Hemati, A Hakal, J. Johnson
`C. Rainey, L. Walker, and A. Jones, “Evaluation of an In Vitro Dissolution
`Apparatus for Medicated Chewing Gums”, Poster Session, AAPS National Meeting, Atlanta, GA,
`November 1989.
`
`Chambliss. W. G., “Conventional and Specialize Coating Pans”, in Pharmaceutical Pelletization
`Technology, Marcel Dekker, Inc., NY 1989.
`
`Chambliss. W.G., “Enteric Coatings”, The Encyclopedia of Pharmaceutical Technology, Marcel
`Dekker, Inc. NY, 1990.
`
`Patel, T. and Chambliss, W.G., “Formulation and Manufacture of Antibiotics”, Antibiotics and
`Microbial Transformation, CRC Press, 1987.
`
`Chambliss, W. G. and Hendrick, M.G., “One Approach to Reprocessing”, Pharmaceutical
`Technology, December 1986.
`
`Chambliss, W. G., “Shellac”, Lawrence Review of Natural Products, Vol. 6, No. 7, July, 1985.
`
`Chambliss, W. G., “Raw Material Characterization”, Pharmaceutical Technology, June, 1984.
`
`Chambliss, W. G., Chambliss, D. A., Cleary, R. W., Jones, A. B., Harland, E. and Kibbe, A. H.,
`“The Development and Evaluation of Enteric Coated Penicillamine Tablets”, Journal of
`Pharmaceutical Sciences, 73, 1215, 1984.
`
`Chambliss, W. G., “The Forgotten Dosage Form: Enteric Coated Tablets”, Pharmaceutical
`Technology, September 1983.
`
`Chambliss, W.G., and Kibbe, A.H., “Zomepirac Pharmacokinetics in Renal Failure Patients”,
`American Pharmaceutical Association Conference, Las Vegas, Nevada; April 1982.
`
`
`
`
`7
`
`
`
`WALTER GALLOWAY CHAMBLISS, Ph.D.
`
`Chambliss, W.G., Cleary, R. W., Fischer, R. Jones, A.B., Skierkowski, P., Nicholes, W., and
`Kibbe, A.H., “Effect of Docusate Sodium on Drug Release from a Controlled-Release Dosage
`Form”, Journal of Pharmaceutical Sciences, 70: 1248, 1981.
`
`Reviewer:
`
`International Journal of Clinical Practice, 2013 to present
`
`European Journal of Pharmaceutics and Biopharmaceutics, 2007 to present
`
`National Science Foundation, Review Panel, Partnerships for Innovation Program, 2005
`
`Journal of the American Pharmacists Association, 2004 to present
`
`International Journal of Pharmaceutical Compounding, 2003 to present
`
`Journal of Biomolecular Screening, 2003 to present
`
`Natural Sciences and Engineering Research Council (NSERC), Ottawa, Canada, 2001 and 2002
`
`Journal of Pharmaceutical Marketing and Management, 2000 to present
`
`Journal of Natural Products, 2000 to present
`
`Journal of the American Pharmaceutical Association, 2000 to 2004
`
`National Center for Complementary and Alternative Medicine, Special Emphasis Panel, National
`Institutes of Health, March 2000, July 2000, October 2000, March 2001
`
`
`
`HONORS AND PROFESSIONAL ORGANIZATIONS
`
`
`Immediate Past President, Executive Counsel, Academy of Pharmaceutical Research and Science,
`American Pharmacists Association, 2012-2013
`
`Co-Chair, APhA-APRS, APhA-APPM Taskforce of Counterfeit Medications
`
`President, Academy of Pharmaceutical Research and Science, American Pharmacists Association,
`2010-2012
`
`Board of Trustees, American Pharmacists Association, 2010-2012
`
`Alumnus of the Year Award, Department of Pharmaceutics, University of Mississippi, 2009
`
`President-Elect, Academy of Pharmaceutical Research and Sciences, American Pharmacists
`Association, 2009 to 2010
`
`Fellow, American Association of Indian Pharmaceutical Sciences, 2006
`
`Chair, Strategic Alliance Committee, Licensing Executives Society, 2007 to 2008
`
`
`
`
`8
`
`
`
`WALTER GALLOWAY CHAMBLISS, Ph.D.
`
`Chair-Elect, Strategic Alliance Committee, Licensing Executives Society, 2006 to 2007
`
`Board of Directors, Phytochemical Services Inc., 2006 to 2010
`
`Board of Directors, Children’s GMP LLC, 2005 to present
`
`Executive Committee, Academy of Pharmaceutical Research and Sciences, American
`Pharmacists Association, 2003 to 2004
`
`Fellow, Academy of Pharmaceutical Research and Sciences, American Pharmaceutical
`Association, 2003
`
`Board of Directors, University of Mississippi Research Foundation, 2004 to present
`
`Board of Directors, Secretary and Treasurer, Technology Resources Foundation, 2003 to 2004
`
`External Research Advisory Committee, Mississippi State University, 1994 to 2002
`
`Scientific Advisory Board, Southern Regional Poison Control Center, 1996 to 2002 (Chairman-
`7/98 to 6/2000)
`
`Scientific Advisory Board, Next Pharmaceuticals, 1999 to 2003
`
`Technology Council Executive Committee, Memphis Area Regional Chamber of Commerce,
`2002 to 2004
`
`Technology Council Steering Committee, Oxford Lafayette County Economic Development
`Foundation, 2004 to 2006
`
`Chair, Basic Sciences Section, Academy of Pharmaceutical Research and Sciences, American
`Pharmaceutical Association, 2002-2003
`
`Chair-elect, Basic Sciences Section, Academy of Pharmaceutical Research and Sciences,
`American Pharmaceutical Association, 2001-2002
`
`Member at Large, Basic Sciences Section, Academy of Pharmaceutical Research and Sciences,
`American Pharmaceutical Association, 1999 - 2001
`
`Academy of Pharmaceutical Research and Sciences, American Pharmaceutical Association,
`Liaison to the Journal of Pharmaceutical Sciences, Editorial Advisory Board, 2001 – 2004
`
`Dietary Supplement Advisory Board, American Association of Pharmaceutical Sciences,
`2001 to 2002
`
`Tennessee State Governor's Biotechnology Task Force - Commercialization Committee member,
`2001 to 2003
`
`Distinguished Alumni Award, University of Mississippi School of Pharmacy, 1998
`
`Registered Pharmacist, State of Tennessee, 1977 to 2016
`
`
`
`
`9
`
`
`
`WALTER GALLOWAY CHAMBLISS, Ph.D.
`
`Who’s Who among Students in American Universities and Colleges, 1982
`
`National Register of Outstanding College Graduates, 1982
`
`Rho Chi Honor Society
`
`American Association of Pharmaceutical Scientists
`
`Association of University Technology Managers
`
`American Pharmacists Association
`
`Licensing Executives Society
`
`
`
`
`10