Phil Maples

Phil Maples Email and Phone Number

Executive Director, Laurus Bio LLC @ Laurus Bio
Plot 204 and 237, Bommasandra-Jigani Link Road, KIADB Industrial Area,India
Phil Maples's Location
Portugal, Portugal
Phil Maples's Contact Details

Phil Maples personal email

n/a

Phil Maples phone numbers

About Phil Maples

• More than 36 years of experience in Biotechnology / Healthcare• Cell, Tissue and Gene Therapies Development focused on Cancers, Immunotherapies, Inherited Diseases and Healingo Antigen-specific T Cells, Dendritic Cells and Stem Cells o Autologous and Allogeneic Cancer Cell Vaccineso Oncolytic Viruseso Viral Based Gene Delivery – AAV, Adenovirus, Retrovirus, Vacciniao Nonviral Based Gene Delivery – Electroporation / Liposomal• Liposomal, other Nanoparticle Drug Delivery Formulations Development• Protein-based Therapeutics Development• Combination Device Products• CPC and cGMP Facility Design / Build Out / Operation / Compliance• GMP Process Design / Implementation / Analytical Support• Stability Studies / Packaging / Labeling / Placebo Controls• Regulatory Planning and Submissions / FDA / RAC / International• IND (CMC) Preparation / Reporting • Preclinical Study Designs / Execution• Clinical Trials Designs / Coordination• Quality Assurance Structure / SOP Development / Training / Audits • Supply Chain / Inventory Control / Logistics

Phil Maples's Current Company Details
Laurus Bio

Laurus Bio

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Executive Director, Laurus Bio LLC
Plot 204 and 237, Bommasandra-Jigani Link Road, KIADB Industrial Area,India
Employees:
420
Phil Maples Work Experience Details
  • Laurus Bio
    Laurus Bio
    Portugal
  • Laurus Bio
    Executive Director
    Laurus Bio 2014 - Present
    Biotechnology Consulting for Biologics Development and cGMP Production Facilities
  • H M Bio, Llc
    Co-Owner And Manager
    H M Bio, Llc Sep 2016 - Present
    Immunotherapeutics
  • Abeona Therapeutics
    Vp, Process Development
    Abeona Therapeutics May 2017 - Jun 2022
    Cleveland, Oh, Us
  • Abeona Therapeutics
    Vp, Process Development
    Abeona Therapeutics May 2017 - Jun 2022
    Cleveland, Oh, Us
  • Gradalis, Inc.
    Executive V.P. And Chief Technical Officer, Formerly Vp Technical Operations
    Gradalis, Inc. May 2005 - Jan 2014
    Designed and built current development labs with two sets of GMP suites: Phase I/II trials manufacturing of Cancer Vaccines (TAG, then FANG) and plasmid DNAs for bi-shRNA (RNAi) trials (STMN I and PDX-1)Developed FANG vaccine from concept to Phase II in less than two years (3 Phase II studies)6 INDs, 6 Phase I and 5 Phase II studies submitted, approved and initiated since 2007Built IP portfolio for both vaccines and RNAi / delivery franchises Developed and was responsible for GMP Manufacturing, Product Development, Inventory Control, Purchasing and Quality Assurance (QC)Successful in obtaining non-dilutive funds to support initiatives (ETF, CPRIT, STTR, SBIR) Co-created founding IP for G-Con, LLC – manufacturer of GMP Pod systems (www.gconbio.com)
  • Cellexsys / Chromos
    Vp Clinical Development And Manufacturing And Corporate Officer
    Cellexsys / Chromos Aug 2001 - May 2005
    Developed Ag-specific T Cell Therapy for chronic HBV (REM Expansion TechnologyRaised key corporate funding in JapanTransitioned Company through Chromos mergerDeveloped additional Cancer / Infectious Disease Applications of technology Developed clinical sites, protocols, etc. in Asia, North America and Europe with supporting strategic manufacturing initiatives
  • Us Oncology (Formerly Prn)
    Scientific Director, Head Of The Molecular/Cell Processing Center
    Us Oncology (Formerly Prn) Mar 1998 - Aug 2001
    Designed and oversaw construction of cell processing facility as a Baxter programEstablished multistate GTP-compliant PBSC transplant processing network for USONDeveloped / performed Phase I/II Manufacturing for Clients (ex. GVAX NSCLC vaccine)Performed first successful viral-based IV gene therapy trial (ONYX-015 oncolytic Ad)
  • Baxter Healthcare
    Associate Scientific Director (Operating Division Facility Quality Manager)
    Baxter Healthcare Aug 1986 - Feb 1998
    Deerfield, Illinois, Us
    Created successful ex vivo gene therapy for CGD; used ex vivo processing system for X-linked SCID and other ex vivo cell and gene therapiesTwo CRADAs with NIH; develop new Cell Processing Center and CGD gene therapyGenerated an ISO 9000 Quality System for Operating Division; obtained CE Mark (TUV)Substantially improved Division’s cash flow by working with Sales and Marketing to develop new market segments and through CE Mark generated salesDeveloped neutrophil expansion system for CD34+ cells (patented)Manufacturing and 510k submissions for ex vivo closed cell processing componentsDesigned Cell Processing Centers for Baxter clients using Isolex

Phil Maples Skills

Biotechnology Biochemistry Fda Gmp Clinical Development Biopharmaceuticals Life Sciences Cell Culture Medical Devices Molecular Biology R&d Cell Cancer Strategy Validation Pcr Elisa Technology Transfer Cell Biology Lifesciences Pharmaceutical Industry Integration Quality Assurance Cross Functional Team Leadership Change Control Clinical Trials Vaccines Quality System Protocol Oncology Assay Development Laboratory Clinical Research Quality Control Product Development Commercialization Patents Glp Sop Regulatory Affairs Capa V&v Ind Manufacturing Iso 13485 Design Control Regulatory Submissions Dna Bioinformatics Gcp

Phil Maples Education Details

  • University Of Chicago
    University Of Chicago
    Erythropoietin In Dr. Eugene Goldwasser'S Laboratory
  • Ou Health Sciences Center
    Ou Health Sciences Center
    Biochemistry And Molecular Biology
  • Wood'S Hole Marine Biology Laboratory
    Wood'S Hole Marine Biology Laboratory
    Summer Embryology Course
  • Ou Health Sciences Center
    Ou Health Sciences Center
    Attended College Of Pharmacy
  • The University Of Tulsa
    The University Of Tulsa
    Microbiology

Frequently Asked Questions about Phil Maples

What company does Phil Maples work for?

Phil Maples works for Laurus Bio

What is Phil Maples's role at the current company?

Phil Maples's current role is Executive Director, Laurus Bio LLC.

What is Phil Maples's email address?

Phil Maples's email address is pm****@****ics.com

What is Phil Maples's direct phone number?

Phil Maples's direct phone number is +197295*****

What schools did Phil Maples attend?

Phil Maples attended University Of Chicago, Ou Health Sciences Center, Wood's Hole Marine Biology Laboratory, Ou Health Sciences Center, The University Of Tulsa.

What skills is Phil Maples known for?

Phil Maples has skills like Biotechnology, Biochemistry, Fda, Gmp, Clinical Development, Biopharmaceuticals, Life Sciences, Cell Culture, Medical Devices, Molecular Biology, R&d, Cell.

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