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`Paul A. Laskar, Ph.D.
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`Paul A. Laskar, Ph.D.
`603 Montecito Blvd
`Napa, CA 94559
`707-299-9084(cell); 707-258-9050(office)
`plaskarassoc@gmail.com
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`Employing extensive drug development experience provide consulting services in
`pharmaceutical R&D for start-up or established pharmaceutical companies
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` Objective
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`Overview
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`o
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`o Extensive drug development experience with variety of sterile and non-sterile dosage
`forms from API and proof of principle through post-approval changes with start-up and
`established companies.
`o Wrote, edited, and/or approved CMC (Module 3) sections in eCTD format for more than 6
`NDAs/ANDAs, more than 10 INDs, and their ex-US regulatory counterparts; prepared
`Pharmaceutical Development Reports to support regulatory filings
`Interacted with FDA in various formats including meetings at various stages of
`development, telephone conferences, and PAIs. Prepared, reviewed, and approved pre-
`IND, End of Phase Two, and pre-NDA information packages and written responses to
`queries from FDA and European MOHs.
`o Developed, conducted GMP/GLP assessments, and managed relationships with variety
`of contractors (API synthesis, formulation development, drug product manufacture,
`clinical supply packaging and distribution, analytical chemistry support and stability
`assessment, and preclinical studies). Aided in realistic timeline development as well as
`assisting in project management of CMC activities.
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`President, Paul Laskar Associates, Inc, Napa, CA
`Provide consulting services in areas of strategic CMC, pharmaceutical, and preclinical
`development plans and timelines; formulation development focusing on ophthalmic,
`dermatological, respiratory, parenteral, oral, and nasal drug products; stability
`assessment design, execution, and reporting; CRO/CMO identification, qualification,
`GMP/GLP assessment, and management; API source evaluation; regulatory planning;
`preparation of clinical trial materials; and manufacturing process development and
`technology transfer. Aid in project management of CMC development activities. Prepare
`reports for regulatory filings from IND to NDA. Write and edit CMC (Module 3) sections in
`eCTD format for pre-INDs, INDs, IMPDs, and FDA meetings. Write and edit
`Pharmaceutical Development Reports. Participate in meetings and other interactions
`with regulatory agencies. Served as expert witness in various patent litigation in US and
`Canada.
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`Dey, L.P., Napa, CA
`Senior Director, Pharmaceutical Development
`Lead formulation development, clinical trial materials supply, preclinical development,
`pilot operations, manufacturing process development, and technology transfer functions
`for Dey’s respiratory and nasal projects. Identify CROs for preclinical, clinical packaging
`and distribution, and contract manufacturing activities. Write CMC and preclinical
`documentation in support of 1 NDA, 2 ANDAs, 2 INDs, 2 sNDAs, 1 Canadian NDS, 1
`IMPD, & 1 EU MAA. Prepare preclinical and CMC recommendations for in-license
`opportunities.
`• Managed department of 11 professionals (3 Ph.D.; 7 BS) with a budget of >$5000K
`(2006) in >10 development projects at various stages from preclinical to post-
`approval
`• Prepared CMC sections for NDA, ANDAs, MAA/NDS, several INDs, sNDAs, and
`IMPD. Prepared preclinical sections for 1 NDA and several INDs
`• Participated in several FDA meetings (pre-IND and end of Phase Two)
`• Prepared technical reviews of more than 10 in-license candidates annually
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`Experience
`Oct, 2006 –
`Present
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`2003 -
`Oct, 2006
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`IPR2018-01020 and IPR2018-01021, Exhibit 1037, Page 1
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`1994-2003
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`1993-1994
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`1989-1993
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`Paul A. Laskar, Ph.D.
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`Santen, Inc., Napa, CA
`Principal Director, Pharmaceutics and Technology
`Director/Vice President, Pharmaceutical Development
`Lead formulation development, analytical chemistry, clinical materials supply, stability
`assessment, preclinical function for Santen’s ophthalmic projects. Identify contractors to
`source manufacture of API and drug products, prepare clinical trial kits, conduct
`analytical and stability studies, and perform preclinical studies. Work with peers at
`headquarters in Japan and European subsidiary to develop formulation and preclinical
`development strategies and execute technology transfer. Write and approve CMC and
`preclinical documentation for regulatory submissions. Interact with FDA. Prepare
`recommendations following CMC review of in-license candidates. Project leader for early
`stage and feasibility projects.
`• Developed and managed project timelines and budgets (>$3000K)
`• Built lean and efficient department up to 10 persons (4 Ph.D.s; 1 DVM, 1 MS) despite
`evolving strategy for conducting pharmaceutical and preclinical development
`• Prepared and/or directed preparation of CMC sections of 5 INDs, 1 CTX, 3 approved
`NDAs, 1 NDS, 2 MAAs, and 2 sNDAs.
`• Directed development of systems to facilitate formulation development, technology
`transfer, stability assessment and clinical material tracking
`• Helped develop and implement CMC and preclinical development strategy for several
`projects
`• Served as CMC and preclinical liaison among R&D at Santen in Japan, US, and
`Finland
`• Established and maintained effective working relationships with Japanese and
`Finnish colleagues to facilitate progress of global preclinical and later stage
`development projects
`• Prepared technical reviews of in-license candidates
`• Guided process validation for API and drug products; participated in PAIs for API and
`drug product
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`CoCensys Inc., Irvine, CA
`Director, Pharmaceutical Sciences
`Guide preformulation, formulation development, stability assessment, clinical materials
`supply, and research QC functions in early stage development of neurosteroid and
`glystatin compounds. Develop and manage relationships with consultants and CROS
`and CMOs for development projects.
`• Wrote CMC sections for 2 INDs
`• Developed documentation and systems to ensure compliance with cGMPs
`•
`Initiated formulation development of 2 compounds (1 oral, 1 parenteral) in multiple
`presentations
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`Allergan/Herbert Laboratories, Irvine, CA
`Manager/Director, Product Development, Herbert Laboratories
`Guide formulation development, analytical chemistry, stability assessment, and research
`QC functions for skin care division. Interact with other discovery and other nonclinical &
`clinical departments, manufacturing, business development, and marketing. Interact with
`FDA verbally and in person to gain registration approval. Develop and manage budget of
`~$1200K. Evaluate, recommend, and suggest products for potential acquisition.
`• Grew department from 6 to 16 scientists and technicians
`• Developed formulations to meet global requirements including parenterals, solid
`(immediate and extended release), and topicals
`• Responsible for preparation of CMC sections of 11 INDs, NDAs and NDSs and a
`CTX
`• Scaled up several products from laboratory through pilot to commercial scale
`manufacture; guided site transfer of three products from US to Europe
`• Developed cost and timing estimates in project planning process
`• Developed and managed relationships with several third party contractors
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`IPR2018-01020 and IPR2018-01021, Exhibit 1037, Page 2
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`1988-1989
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`1982-1988
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`1974-1982
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`Education
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`Paul A. Laskar, Ph.D.
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`Procyte Corporation, Redmond, WA
`Director, Pharmaceutical Development
`• Developed proof of principle formulation for lead compound.
`• Developed and initiated implementation of pharmaceutical development manpower
`strategy (recruited two section heads)
`• Designed formulation and analytical chemistry laboratory
`• Shared responsibility with another person for preparation and filing of successful IND
`on lead compound
`• Contributed to contract negotiations on joint venture with a major pharmaceutical
`company
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`Allergan, Inc., Irvine, CA
`Scientist/Section Manager, Pharmaceutics,
` Brought two significant ophthalmic projects to registration status in Europe and US.
`Developed oral formulation, which enhanced bioavailability 2 ½-fold in animal model
`• Formulated stable, elegant ocular solution product of 2 physically incompatible
`antimicrobials and developed a lyophilization cycle for its manufacture
`• Supervised 3 BS personnel in up to 10 projects
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`1. School of Pharmacy, Creighton University, Omaha, NE
`Associate Professor of Pharmacy
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`2. College of Pharmacy, University of Illinois-Medical Center, Chicago, IL
`Assistant Professor of Pharmacy
`• Taught basic pharmaceutics, pharmaceutical technology, pharmacokinetics, and
`therapeutics courses
`• Developed self-instructional and videotape educational materials
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`MBA, University of California at Irvine, (General Management, International
`Management, Marketing)
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`Ph.D., Pharmaceutical Sciences, Oregon State University
`(Minor: Biostatistics)
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`MS, Pharmacy, University of Illinois – Medical Center
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`BS, Pharmacy, University of Illinois – Medical Center
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`BA, General Science (Chemistry, Biology), University of Rochester
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`Presentations SR Nadkarni & PA Laskar, “Comparison of Release Kinetics of Indomethacin from
`Gelucire Dispersions”, AAPS, November 1992
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`S Matsumoto, et al., “Potential Irritation by Dermatological Vehicles Assessed with In
`Vivo and In Vitro Tests”, AAPS, November 1992
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`SR Nadkarni & PA Laskar, “Investigation of Solid Dispersions of Indomethacin in
`Gelucires as Potential Sustained Release Systems”, AAPS, November 1991
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`KA Kelley, PA Laskar, GD Ewing, SH Dromgoole, AA Sakr, JL Lichtin, “In Vitro
`Evaluation of Sunscreen Sustained Release Systems”, AAPS, November 1991
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`Publications KA Kelley, PA Laskar, GD Ewing, SH Dromgoole, JL Lichtin, & AA Sakr, “In Vitro Sun
`Protection Factor Evaluation of Sunscreen Products,” J Soc Cosmet Sci, 44(3):139-
`151(May-June 1993)
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`PA Laskar & JW Ayres, “Degradation of Carmustine in Mixed Solvent and Nonaqueous
`Media”, J Pharm Sci 66: 1976 (1977)
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`Patents
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`Other
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`HR Manasse Jr. & PA Laskar, “Some Considerations Regarding Norm-Referenced and
`Criterion Referenced Testing in Pharmaceutical Education”, Am J Pharm Educ 40:275
`(1976)
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`JW Ayres, D Lorskulsint, A Lock, L Kuhl, PA Laskar, “Absorption and Distribution of
`Radioactivity from Suppositories Containing 3H-Benzocaine in Rats”, J Pharm Sci 65:832
`(1976)
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`JW Ayres & PA Laskar, “Diffusion of Benzocaine from Ointment Bases”, J Pharm Sci
`64:1402 (1974)
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`JW Ayres & PA Laskar, “Evaluation of Mathematical Models for Diffusion from
`Semisolids”, J Pharm Sci 63:351 (1974)
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`JW Ayres & PA Laskar, “Student Experiments in Pharmaceutics: IV Additives, Chemical
`Incompatibilities, Kinetics, and the Arrhenius Equation”, Am J Pharm Educ 38:58 (1974)
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`PA Laskar & RG Mrtek, “Synthesis and Biological Activity of Deuterio-benzyl-d7-
`penicillin”, J Pharm Sci 59:1727 (1970)
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`WO/1993/020796, “Method and Composition for Treating Acne”, 28 October 1993, with S
`Nadkarni
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`Application (US20050009836), “Ophthalmic Composition Containing Quinolones &
`Method of Use,” with SD Hickok
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`Registered Pharmacist: California and Illinois (inactive)
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`Western Region, AAPS: Fundraising Chairperson, 1992-1993; Academic Award
`Chairperson, 1991; Publicity Chairperson, 1989-1991; Meeting Chairperson, 1988;
`Meeting Co-Chairperson, 1987; Program Chairperson, 1986; Poster Session & Publicity
`Chairperson, 1985
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`AAPS Provisional Biotechnology Section: Chairperson, Program Committee, 1988
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`Graduate student advisor & adjunct faculty, University of Cincinnati, College of
`Pharmacy, 1990-1993
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`Author/co-author, Instructional Videotapes, “Extemporaneous Preparation of Hard Gelatin
`Capsules,” Extemporaneous Preparation of Ointments,” and “Extemporaneous
`Preparation of Suppositories,” UIMC, 1973-4
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`Member, vice chair, and chair, Napa County Tobacco Advisory Board, 2011 to May 2018
`(Board disbanded in May 2018)
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`IPR2018-01020 and IPR2018-01021, Exhibit 1037, Page 4
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