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`SCD Pharma Consulting
`101 Melinda Circle
`Savannah, GA 31406
`Telephone: 734-834-7099
`E-mail: craigdyar@scdpharmaconsulting.com
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`SUMMARY
`Pharmaceutical research and development consultant with the following strengths:
`• Highly organized critical thinker with strong engineering and mechanical knowledge
`• Recognized expert in drug delivery technology for oral, sublingual, topical, parenteral,
`ophthalmic, and transdermal drug delivery systems
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`S. Craig Dyar, Ph.D.
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`CAREER HIGHLIGHTS
`• Consultant to the pharmaceutical industry on drug development including ensuring quality
`products are developed from discovery to post-launch, life-cycle planning, intellectual property,
`project management, compound licensing and business development with a focus on drug
`delivery technologies including immediate, sustained (including osmotic systems) and dual
`release oral tablets, topical solutions, creams and ointments (dermal and ophthalmic),
`sublingual tablets, transdermal formulations, targeted delivery systems (dendrimer and others),
`orally dissolving tablets, and others.
`• Directed Drug Delivery Assessment group to enable compound development and product
`enhancement for early- and late-stage compounds.
`o Served on global drug delivery group to define strategy for external collaborations based
`upon a careful review of the current portfolio
`o Managed the science for drug delivery projects for immediate and sustained release oral
`tablets, topical creams and ointments, sublingual tablets, transdermal formulations,
`targeted delivery systems (dendrimer and others), orally dissolving tablets and others
`o Designed, developed, and maintained a global database of 300 drug delivery technology
`companies by directly contacting each company
`o Adapted technology from the food, plastics, and other industries for use in the
`pharmaceutical industry to solve issues related to polymer mixing
`o Directed scale-up of a hot-melt extruded solid dispersion formulation for a launched
`product, troglitazone
`• Led Pharmaceutical Sciences Teams on ophthalmology and dermatology projects
`o Serve as the single point of accountability and technical expert for projects from
`Preclinical to Phase III stages of development. Responsible for managing the timelines
`and resources including a multimillion-dollar budget
`o Led multi-disciplinary global teams composed of 8 – 12 colleagues in analytical,
`formulation, regulatory, quality assurance and supply chain areas
`o Led team in the resolution of several manufacturing and formulation issues and
`developed guidelines to improve the manufacture practices to ensure the quality of the
`products
`• Utilized Quality by Design principles to develop novel conventional and controlled-release solid
`dose for tablet and capsule drug delivery systems using solubility and bioavailability
`enhancement techniques such as hot-melt solid dispersions, supercritical fluids, and lipids
`• Defined procedures and led compound licensing activities for pharmaceutical science in
`Michigan and served on global licensing team. Responsible for the due diligence activities for 8
`licensing opportunities, which led to 3 Phase III licensing deals
`• Authored numerous Good Manufacturing Practice/Good Laboratory Practice guidelines
`(GMP/GLP) and standard operating procedures (SOP)
`• Managed the COX-2 (celecoxib and others) franchise for Worldwide Pharmaceutical Science at
`Pfizer
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`o Served as the pharmaceutical science member of COX-2 lifecycle team composed of
`members from Marketing, Regulatory, Clinical PK, Medical, Legal
`o Chaired celecoxib reformulation team composed of members from above groups
`o Developed proposal and obtained endorsement for multimillion dollar proof of concept
`studies leading to a program in late-stage development
`o Defined pharmaceutical science strategy for COX-2 programs and obtained
`endorsement from senior leaders in marketing, medical, regulatory, and legal
`o Provided guidance to pharmaceutical science COX-2 teams regarding above strategy
`o Pioneered endorsed idea, which used an alternate formulation approach reducing cost
`($8 M) and time (2 years), required to reach the market
`o Chaired two cross-functional product enhancement management teams
`• Taught graduate level courses in Pharmacokinetics and Pharmaceutics covering topics such as
`formulation development of solutions, tablets (immediate and controlled release), emulsions,
`transdermal, injectable and topicals (dermal and ophthalmic) including release profiles.
`• Chaired local Pharmaceutical Science Technology Board and was an inaugural member.
`• Acted as Intellectual Property Liaison for scientists, management, and patent attorneys.
`o Ensured intellectual property protection by interfacing with scientist and patent attorneys
`on a daily basis. Recognized expert in defining compound IP strategy.
`• Defined site and global IP strategy and procedures while serving on the global Intellectual
`Property Board composed of 3 senior scientists and 3 patent attorneys.
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`EXPERIENCE
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`SCD Pharma Consulting
`• President
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`Roivant Sciences
`• Senior Director, Quality Operations
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`EDUCATION AND PROFESSIONAL DEVELOPMENT
`Doctor of Philosophy in Pharmaceutical Science, Medical University of South Carolina, Charleston
`Bachelor of Science in Pharmacy, Medical University of South Carolina, Charleston
`Bachelor of Science in Biology, University of South Carolina, Spartanburg
`Level II and III Management Training, University of Michigan, Executive Education Center
`Kepner-Tregoe Certification in Problem Solving and Decision Making
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`ACHIEVEMENTS AND AWARDS
`Member of Rho Chi Honor Society and American Association of Pharmaceutical Sciences
`Fellow of the American Foundation for Pharmaceutical Education (AFPE)
`Chair, AAPS Year-round Task Force on Novel Drug Delivery Technology
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`South University – School of Pharmacy
`• Assistant Professor
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`Pfizer US
`• Associate Research Fellow
`• Senior Principal Scientist
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`• Senior Scientist
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`• Scientist
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`Registered Pharmacist, Pharmacist in Charge
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`2008-Present
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`2022-Present
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`2008-2016
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`2004-2008
`2001-2004
`2000-2001
`1998-2000
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`1987-1994
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`S. Craig Dyar
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`PATENTS, PUBLICATIONS, PRESENTATIONS and POSTERS
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`S. Craig Dyar, Curtis E. Jones, John P. Kennedy, Kiowa Kavovit, and Andrew Kavovit. Patent
`publication entitled “Liquid Bandage”, December,3, 2015 – US Patent Application Publication (US
`20150343112 A1)
`Curtis E. Jones, S. Craig Dyar, and Andrea L. McKeever, Small-Team Active Learning in an Integrated
`Pharmacokinetics Course Series Am J Pharm Educ. 2012 Oct 12; 76(8): 153.
`S. Craig Dyar, Numerous lectures (25-30 per year) in Pharmaceutics and Pharmacokinetics at South
`University School of Pharmacy on topics such as Chemical Kinetics, Solutions, Suspensions, Topicals,
`Transdermals, Solid Oral Dosage Forms, Novel Drug Delivery Systems, Protein and Peptide Delivery
`Systems, and numerous other physical pharmacy topics. (2008 to Current).
`S. Craig Dyar, Invited panelist and moderator on “How to Pursue and Assess Potential Technologies
`as Synergistic Fits for your Program” at the Institute for International Research’s 12th Annual Drug
`Delivery Partnerships Conference. San Diego, CA (2008).
`S. Craig Dyar, Invited presentation on “Navigating the Challenges of Early Phase Development in
`Ophthalmology” at Financial Research Associates’ 2nd Annual Drug Delivery Conference. San Diego,
`CA (2007).
`S. Craig Dyar, Patent publication entitled “Pharmaceutical Compositions of Amorphous Atorvastatin
`and Process for Preparing Same” (WO06059224 A1 2006, CA2589537 AA 2006, EP1819319 A1
`2007).
`S. Craig Dyar, Keynote Panelist on “The Next Wave of Partnerships and Investment in Drug Delivery
`and Specialty Pharmaceuticals” at Strategic Research Institute’s 11th Annual Forum on Drug Delivery
`Technologies & Deal-Making. New Brunswick, NJ (2006).
`S. Craig Dyar, Patent publication entitled “Process and System for Controlled-Release Drug Delivery”
`(AT293439 E 2005, BRPI0105909 A 2002, CA2363902 AA 2002, C 2006, DE60110192 D1 2005,
`DE60110192 T2 2006, EP1213014 A2 2002, A3 2002, B1 2005, ES2240313 T3 2005, JP2002212061
`A2 2002, MXPA01012456 A1 2005, US2002119197 AA 2002).
`S. Craig Dyar, Invited presentation on “Language of Marketing – A Scientist’s Interpretation” at
`Strategic Research Institute’s 11th Annual Forum on Drug Delivery Technologies & Deal-Making. New
`Brunswick, NJ (2006).
`S. Craig Dyar and Michael Wider, Workshop on “Constructing Mutually Beneficial Drug Delivery
`Licensing Agreements” at CBI’s 7th Forum on Drug Delivery Systems. Philadelphia, Pa (2004).
`S. Craig Dyar, Panelist on “Technology Differentiation: How are Similar Technologies Effectively
`Evaluated?” at the 8th Annual Drug Delivery Partnerships meeting. Beverly Hills, CA (2004).
`S. Craig Dyar, Melt-Extruded Particulate Dispersions in Pharmaceutical Extrusion Technology (I.
`Ghebre-Sellassie, ed.), Marcel Dekker, Inc, New York, (2003), pp. 261-276.
`S. Craig Dyar, M. Mollan, S. Khan, L. Tang, J. Cook and I. Ghebre-Sellassie, Evaluation of three
`dissolution enhancement methods on bioavailability, AAPS Poster in New Orleans (1999).
`S. Craig Dyar and Robert E. Notari, A nomogram to evaluate intrinsic absorption rate constants of
`potential oral prolonged-release candidates, Pharmaceutical Development and Technology, 4(3): 305-
`312 (1999); AAPS Poster in San Francisco (1998).
`S. Craig Dyar and Robert E. Notari, Hydrolysis kinetics and stability predictions for a mixture of R and
`S temocillin isomers, International Journal of Pharmaceutics, 173(1,2): 225-236 (1998).
`S. Craig Dyar and Robert E. Notari, Defining the rate-controlling step for absorption following oral
`administration of zero-order prolonged-release formulations, Pharmaceutical Research, 14(11): 243
`(1997); AAPS Poster in Boston (1997).
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