James Agalloco
`
`[908] 874-7558
`Jagalloco@aol.com
`www.agalloco.com
`
`Agalloco & Associates
`
`Mailing Address
`PO Box 899
`Belle Mead, NJ 08502-0899
`
`Physical Address
`22 Carriage Trail
`Belle Mead, NJ 08502-4904
`
`Forty+ years of management experience in pharmaceutical manufacturing, pharmaceutical process
`engineering, technical services and research and development.
`Internationally recognized expert on
`processvalidation, sterilization, aseptic processing, pharmaceutical manufacturing and isolation
`technology. Extensive knowledge of pharmaceutical, biological and API manufacturing technology.
`
`EXPERIENCE
`Agalloco & Associates Belle Mead, NJ (12/91 to present) - President - Provides a wide range of
`technical services to the pharmaceutical, biotechnology and medical device industry in the areas of
`process and product validation, sterilization, aseptic processing, isolation technology, sterility
`assurance, compliance and facility design. Works closely with other consultants on larger projects.
`Assisted more than 200 clients in the United States, Puerto Rico, Western Europe and elsewhere.
`
`Bristol-Myers Squibb Technical Operations New Brunswick, NJ (5/90 to 12/91) - Director, Validation
`and Technology - Directed validation, automation, and technical documentation activities for BMS
`New Brunswick. Served as an important technical resource for worldwide pharmaceutical
`manufacturing. Active participant on product introduction and facility upgrade task forces.
`
`Squibb Technical Operations New Brunswick, NJ (4/88 to 5/90) - Director, Worldwide Validation and
`Automated Technology — Responsible for Squibb facilities in 27 countries around the world. Served
`as major technical resourcefor facility design, facility start-up, sterilization, aseptic processing,
`validation, and automation. Participated actively on major product, process, facility, and equipment
`projects within STO. Directed the validation and automation phases of a $25 MM expansion of
`existing parenteral facility in New Brunswick. Major support provided to sterile bulk manufacturing.
`
`Pharmaceutical Engineering, Department Manager (2/80 to 4/88) - Managed the development,
`execution, and documentation of validation efforts for STO worldwide. Served as the principal source
`of validation expertise within Squibb Corporation. Successfully led the validation of a $62 MM sterile
`facility through FDA review. Primary spokesperson for validation to FDA and other regulatory
`agencies. Responsible for validation of all dosage forms.
`
`Pfizer Pharmaceuticals New York, NY (9/73-2/80)
`Engineering Project Manager(6/79-2/80) - Prepared capital project proposals for dosage form and
`BPC facilities. Provided facility planning, feasibility analysis, cost estimation, ROI, and technical input.
`
`Senior Production Supervisor (9/75-6/79) - Managed production operations for sixty (60) different
`sterile and oral liquid and powder products. Major areas of responsibility included cost control, cost
`reduction, CGMP compliance, scheduling, equipment selection, and process trouble shooting.
`
`Manufacturing Engineer (4/74-8/75) - Formulated, piloted and scaled-up numerous pharmaceutical
`dosage forms. Coordinated technology review for new products from R&D to commercial sites.
`
`Research Engineer (9/73-4/74) - Managed the ongoing developmentand isolation of an anti-cancer
`agent from fermentation extract through finished bulk drug. Managedthis activity part-time (1976 and
`1979) while serving full time in other capacities.
`
`Regeneron Exhibit 1006.001
`
`

`

`Merck & Co. Rahway, NJ (3/71-8/73)
`Junior Chemical Engineer - Assisted in the scale-up/start-up and troubleshooting for new and existing
`bulk pharmaceutical chemicals. Served on API facility start-up team in Puerto Rico for 3 months.
`
`EDUCATION
`M.B.A. (Pharmaceutical Studies) Fairleigh Dickinson University, Teaneck, NJ, 1983
`M.S.Ch.E. Polytechnic Institute of New York, Brooklyn, NY, 1979
`B.E.Ch.E. Pratt Institute, Brooklyn, NY, 1968
`
`MILITARY
`1st Lieutenant, United States Army (11/68-10/70) - Transportation Corps, platoon leader / convoy
`commander in continental United States and the Republic of Vietnam. Honor Graduate, TOBC 5-69.
`
`AFFILIATIONS
`USP, Member: Microbiology Expert Committee, 2005-2025; lead author / thought leader on
`completed revisions of <1211> Sterilization & <1229> Sterility Assurance. Active participantin all
`other activities of the MEC.
`
`Parenteral Drug Association (1980 to present): Honorary Member; President; Second Vice President;
`Director; Chairman, Scientific Advisory Board: Committee Chairman; Interest Group Leader;
`Committee and Task Force Member; Course Leader; Speaker; Volunteer; Founder, Metro Chapter.
`
`Validation Discussion Group: Co-founder and Member, 1980 to present
`Pharmaceutical Manufacturers Association: Member, CSVC, 1983-1991
`International Society for Pharmaceutical Engineering - Member, 1980 to present
`
`SCIENTIFIC & EDITORIAL ADVISORY BOARDS
`Eniware — developer of novel sterilization equipment — Scientific Advisory Board
`Medinstill — innovative developer of aseptic processing technologies — Scientific Advisory Board
`Pharmaceutical Technology — Editorial Advisory Board
`Pharmaceutical Manufacturing - Editorial Advisory Board
`
`PRESENTATIONS & TRAINING PROVIDED
`Presentations at numerous PharmTech, PDA, PHRMA, ISPE, ASQC and other industry meetings.
`Providestraining courses on aseptic processing, sterilization and processvalidation domestically and
`internationally. In-house presentations and training sessions provided on a variety of subjects.
`
`PUBLICATIONS
`Co-editor, Validation of Pharmaceutical Processes, expanded third edition with 58 chapters,
`published in November 2007 by InformaUSA. Twoprior editions published in 1986 &1997. Fourth
`edition is currently in-process.
`Co-editor, Advanced Aseptic Processing Technology 42 chapter text, published August 1010 by
`InformaUSA.
`
`Authored or co-authored more than 40 book chapters and over 150 technical papers on: process
`validation, aseptic processing, sterilization, change control, sterility assurance, sterilization-in-place,
`cleaning validation, environmental monitoring, and isolation technology.
`
`Regeneron Exhibit 1006.002
`
`

`

`Agalloco & Associates
`
`Agalloco & Associates is a New Jersey corporation led by James Agalloco, an internationally
`recognized expert on pharmaceutical technology, sterilization, aseptic processing, and
`process/system validation. A&A provides a wide range of technical services to the pharmaceutical
`and biotechnology industries. Our experience base includesall types of pharmaceutical dosage
`forms, medical devices, bulk pharmaceutical chemicals and biological products. A&A has particular
`expertise in the areas of validation, aseptic processing, sterilization, sterile bulk preparation, isolation
`/ barrier technology, quality assurance and facility design. A&A draws upon a network of highly
`qualified individuals and organizations for the execution of larger tasks. A&A has assisted more than
`200 clients since its founding in 1991.
`
`Completed Assignments
`
`Aseptic Processing
`Review of current and future technology; evaluation of contract facilities; review of parenteral
`technology and regulatory compliance; in-housetraining of professional staff; evaluation of facility
`design concepts; development of environmental monitoring program; review of classified environment
`design proposal; facility modification and reopening; conversion of aseptic fills to terminal sterilization;
`assistance in regulatory compliance; assessmentof international sites for US registration, evaluation
`of corporate policies and procedures; application of practices for medical devices; audit of admixture
`facilities; risk analysis for sterile products; design conceptfor pre-filled syringe manufacture;
`evaluation of aseptic sites for acquisition
`
`Biologics
`Assist in biological drug pre-approval inspection preparation; trouble shoot bioreactor contamination
`problem; conceptual design of isolator facility for fermentation / purification / formulation/filling;
`conceptual design review for facilities; application of isolation technology; review offacility and utility
`systems; definition of cleaning validation program; review of validation requirements for CGMP
`operations; development of environmental monitoring program; review of vaccine facility design and
`construction details; validation of aseptic processing; qualification of laboratory equipment; detailed
`design, validation and start-up of vaccinefilling suite; design and validation of a blow-fill-seal facility;
`qualification / validation of cell processing facility; evaluation of contract manufacturers; pre-approval
`audits for bulk biological production; due diligence assessments
`
`Bulk Pharmaceutical Chemicals / Active Pharmaceutical Ingredients
`Review of BPC validation requirements; validation of process control systems; review of design
`specification for distributed control system; definition of cleaning validation program; assistancein
`facility qualification / validation; validation master planning; assistance in aseptic processing and
`sterilization-in-place for sterile bulk operations; project manager for validation of BPC facility; review
`of Drug Master Files; conceptual developmentof facility renovation for sterile bulk operations; design
`review for sterile bulk manufacturing facility; development of protocols for production scale-up;
`assistance with regulatory interaction for sterile bulks; cost estimate for major API facility; design of
`sterile bulk packaging system
`
`Regeneron Exhibit 1006.003
`
`

`

`Isolation and Barrier Technology
`In-house training programs; assistance with liquid fill isolator qualification / validation; isolator based
`sterility test system validation; application of isolation technology concepts for clinical production;
`conceptual design of isolation technology basedfilling system; design concepts for integration of
`isolation technology to solid dosage formulation; validation master plan for cytotoxic parenteral
`facility; design and validation of microbial sampling system; application for medical device production;
`application for radio-pharmaceutical production; application for medical device pilot plant; design
`concept for parenteral pilot plant; applications for sterile API’s; design of systems for rapid
`decontamination
`
`Medical Devices & Diagnostics
`Conceptual review offacility design; conduct custom validation training program; validation of
`controlled environments; validation of aseptic processing; design of environmental monitoring
`program; isolator basedsterility test system validation; qualification / validation of medical device
`intermediates; application of isolation technology; review of cleaning validation program; assistance
`with clean room design, classification and operation; review of process validation program; regulatory
`submission of device sterilization methods; qualification of medical device production equipment;
`selection of clean room contractor; assistance with clean room injection molding; process design
`review for novel drug delivery system; integration of drugs and device manufacture on single site;
`preparation of corporate quality manual; assistance with component depyrogenation
`
`Oral & Solid Dosage Forms
`Review offacility design concepts; developmentof cleaning validation program; cost estimate for oral
`products facility; review of standard operating procedures; evaluation of contract manufacturing site;
`assistance in manufacturing process development; validation support for non-sterile products facility
`start-up; validation protocols and reports for tablet products; validation of cleaning procedures; dust
`control assessment; development of environmental monitoring program; assistance with validation
`deviations; definition of microbial controls
`
`Pharmaceutical Manufacturing
`SOP and validation audits; facility design reviews; sterile powder manufacturing technology; facility
`conversion from cephalosporin production; facility and equipment design review; qualification /
`validation of parenteral facilities; preparation and review of standard operating procedures; SOP
`preparation; preparation of components; pre-approval inspections; development of manufacturing
`instructions; facility layout assistance; troubleshooting ampoule filling; conceptual design for
`compounding area; evaluation of contract manufacturers; validation of manual and automated
`inspection; arbitration of client-CMO dispute
`
`Processing Equipment
`Design and validation of sterilizer control systems; conceptual and detailed design of novel
`sterilization system; development of equipment manuals and qualification documentation; design of
`isolators for various applications; developmentof factory acceptance test protocols; bench-marking
`for injectable filling equipment; design of tanks for SIP compatibility; design of formulation/filling
`system for sterile suspension; design of SIP systems for process trains; design of self-contained
`sterilization equipment: design of H2O2z decontamination system; design of BIER vessels for various
`sterilization processes,
`
`Regeneron Exhibit 1006.004
`
`

`

`Regulatory Affairs & Compliance
`Assistance in regulatory interaction; assistance with FD 483 response; assistance with regulatory
`letters; assistance with regulatory interface; NDA submission preparation assistance; assistance with
`international regulatory compliance; critique of internal developmentreports prior to regulatory
`submission; validation readiness assessment; conduct of internal and external audits; screening
`formulations for terminal sterilization potential; actively participate in FDA meetings with clients;
`preparation of NDAsterilization sections for EEC submission; preparation of site referencefile;
`assistance with container-closure integrity confirmation; review of facility master plans; assistance
`with comprehensivesterility failure investigation; development of corporate quality manual; conduct of
`PAI preparation audits; consent decree remediation activities; due diligence support for acquisitions;
`assistance with DMF preparation; assistance with 510(k) preparation; expert witness on compliance
`
`Research & Development
`Preparation of process development reports for oral products; cleaning validation master plan for
`clinical operations; review of parenteral formulation design; review of operating procedures and test
`methods; audit and review for pre-PAl assessment; pre-approval inspection preparation; assistance
`in scale-up/validation of lyophilized formulation; design and implementation of isolator based
`manufacturing system; development of qualification protocols for analytical laboratory equipment;
`development of experimental plans; qualification / validation of clinical / stability facility; packaging of
`sterile bulk clinical materials; scale-up of ointment processes; assistance with patentlitigation
`
`Sterilization
`Developmentand validation of sterilization processes; validation of sterilization-in-place procedures;
`sterilization science training program; validation of terminal sterilization; conceptual design of CIP/SIP
`systems; sterilization process trouble shooting; validation of radiation sterilization; sterilization of
`packaging components; assistancein patentlitigation; literature search for novel sterilization
`methods; validation of CoH40, H2O2, ClO2 and CH20sterilization procedures; implementation ofin-
`line electron beam sterilization; terminal sterilization of pre-filled syringes; dry heatsterilization of
`API's; terminal sterilization by irradiation; validation of liquid chemical sterilization; expert witness on
`patentlitigation; establishment and developmentof novel sterilization methods
`
`Training
`Established courses on Aseptic Processing; Sterilization; Isolation/Barrier Technology; Sterilization-
`In-Place; Master Planning; Process Validation; Cleanroom Qualification; Pharmaceutical Compliance;
`open and in-house course; participate in corporate training programs; assistance in developmentof
`curriculum content; development and presentation of custom training content
`
`Validation
`Validation master plan preparation and review; developmentof validation master summary; review &
`refinement of corporate validation programs; preparation of validation protocols and reports; process
`and system validation; review of validation programs; systems and documentation; develop WFI and
`DI water system validation program; audit ofcritical utility system validations; design of retrospective
`validation program; preparation and review of NDA CMC sterilization section; managementof major
`re-validation program for parenteral facilities; conformance to FDA & EMA ProcessValidation
`Guidance.
`
`Regeneron Exhibit 1006.005
`
`

`

`Agalloco & Associates
`Abbreviated Client List
`
`Abbott (multiple sites / projects)
`Abbvie (multiple sites / projects)
`ACS Dobfar
`Acorda Therapeutics (multiple projects)
`Alcon Laboratories (multiple sites / projects)
`Alkermes (multiple sites / projects)
`Allergan (multiple sites / projects)
`Alliance Medical Products
`Avid Radiopharmaceuticals
`Amgen (multiple sites / projects)
`Albany Molecular ResearchInstitute
`AstraZeneca (multiple sites / projects)
`Athena Neuroscience
`BASF Bioresearch
`Bausch & Lomb
`Bausch & Stroebel
`Baxter Healthcare (multiple sites / projects)
`Bayer (multiple projects)
`B.Braun Medical (multiple sites / projects)
`Becton-Dickinson (multiple sites / projects)
`Biogen Idec (multiple sites / projects)
`bioMerieux (multiple projects)
`Bioject
`Boehringer Ingelheim (multiple projects)
`Bracco Diagnostics (multiple sites / projects)
`Bristol Myers Squibb (multiple sites / projects)
`Catalent (multiple sites / projects)
`CellTech
`Cerulean (multiple projects)
`Chiron
`CooperVision
`Covance
`Covidien (multiple projects)
`CSM OnDemand (multiple sites / projects)
`Daiichi-Sankyo (multiple sites / projects)
`Dabur Oncology
`Delcath Systems (multiple projects)
`Dow Corning Medical
`DPT Laboratories (multiple projects)
`ECO Animal Health
`Eli Lilly & Co. (multiple sites / projects)
`Enzon (multiple projects)
`Fedegari Autoclavi (multiple projects)
`Fuji-Film DioSynth
`Food & Drug Administration
`
`Fresenius-Kabi (multiple subsidiaries / sites /
`projects)
`G.C. Hanford Manufacturing (multiple projects)
`GE Healthcare (multiple subsidiaries / sites /
`projects)
`General Econopak (multiple projects)
`Gilead Sciences (multiple projects)
`GlaxoSmithKline (multiple sites / projects)
`Greer Laboratories (multiple projects)
`Guilford Pharmaceuticals
`Health Canada
`Hoffmann-La Roche (multiple sites / projects)
`Hospira (multiple sites / projects)
`Integra LifeScience (multiple projects)
`Johnson & Johnson (multiple subsidiaries / sites /
`projects)
`LEO Pharma A/S
`Life Technologies
`Lonza (multiple sites / projects)
`Lundbeck Pharmaceuticals (multiple projects)
`Lyne Laboratories (multiple projects)
`3M (multiple subsidiaries / sites / projects)
`Meda (multiple projects / sites)
`Medinstill (multiple projects)
`Medpointe (mutiple projects)
`Medtronic
`Merck & Co. (multiple subsidiaries / sites /
`projects)
`Merial Limited
`Millennium (multiple projects)
`Novartis (multiple sites / projects)
`Novocol (multiple projects)
`Novo Nordisk
`Patheon (multiple projects / sites)
`Pfizer (multiple subsidiaries / sites / projects)
`Otsuka Pharmaceuticals (multiple projects)
`Sanofi-Aventis (multiple subsidiaries / sites /
`projects)
`Synta Laboratories (multiple projects)
`Therapure (multiple projects)
`Terumo Medical
`Unilife (multiple projects)
`Watson Pharmaceuticals
`The West Company
`Westward Pharmaceuticals
`
`Regeneron Exhibit 1006.006
`
`