Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Biotechnology professional with operations and project management experience supporting biomaterials engineering projects and applications. Multidisciplinary education, research, product management and business development experience in multiple biomaterial groups (ceramics, metals, polymers, liquids) to answer medical needs in orthopedics, ophthalmology and oncology utilizing medical devices and various drug delivery technologies. Highly credentialed Ph.D. experienced in the utilization of virtual development of biomaterials to create new pharmaceutical formulations for treatment of disease for the pharmaceutical industry, including development and support of GMP/USP/EP compliant manufacturing and analytics.

CORE COMPETENCIES

  • Project Management
  • Product/Process Development
  • Design/Development Planning
  • New Product Inception to Production
  • Component Specification
  • Critical Dimensions
  • Test/Analytical Methods
  • Product/Process Transfers/Adaptations
  • New Project Start-ups
  • Material/Bio-Material Specification
  • Supplier Specification
  • Risk Analysis
  • R&D
  • Program/Product Launches
  • Virtual Procurement/Logistics/Operations Feasibility Studies/Implementation
  • Technology Transfer Process Improvement Tools/Statistical Analysis

SELECTED ACCOMPLISHMENTS

  • Managed and/or executed various project activities for nano-drug delivery company including:
    • Initiated, developed and managed corporate operations/infrastructure of accountants, attorneys, consultants and collaborators necessary to launch and run virtual company.
    • Raised seed/angel capital from private investors.
    • Initiated and led search and intellectual property, scientific and market due diligence process to identify technology and patent portfolios for in-licensing.
    • Led negotiations and executed a worldwide license for a patent portfolio from a major US research university.
    • Managed ongoing prosecution of patent portfolio.
    • Developed business and commercialization plans for company and lead product.
    • Developed pre-clinical research and development plan for initial product.
  • • Facilitated, managed and/or executed various project activities for ophthalmic pharmaceutical company developing bio-erodible implant including:
    • Collaborated with a multidisciplinary team including the COO, VP of Preclinical Development, Director of Manufacturing, QA and Regulatory personnel, and numerous academic and contract partners on the formulation, preclinical development, scale-up to clinical GMP manufacturing, regulatory compliance, and business development of product.
    • Designed, directed and managed pre-clinical research and development, contract analytical testing.
    • Designed, directed and managed pre-clinical to clinical scale manufacturing process development. Based on the results of this work a proposal for a process development laboratory at our academic collaborator was authored, which was funded and installed.
  • Facilitated, managed and/or executed various project activities for ophthalmic pharmaceutical company developing nanoparticle suspension including:
    • Collaborated with a multidisciplinary team including the COO, VP of Preclinical Development, Director of Manufacturing, QA and Regulatory personnel, and numerous academic and contract partners on the formulation, preclinical development, GMP manufacturing, regulatory compliance, and business development of product.
    • Designed, directed, and managed research and development, contract analytical testing.
    • Held a primary leadership role in manufacturing scale-up and process development. Work resulted in the proof-of-concept development of a manufacturing process that increased the Phase I clinical trial batch size by at least 2-3 orders of magnitude and was viable for commercial scale manufacturing. Two manufacturing routes were investigated and development work was completed on a budget of less than 25K.
    • Initiated and successfully managed day to day relationships with a CMO & a CAO in a project that aimed to purify and re-qualify a technical grade raw material that is not approved by the FDA for late-stage clinical testing or commercial use, and make that material FDA/GMP compliant. Identified and completed proof of concept testing of a viable processing route as well as developed corresponding analytical testing (USP/EP and equivalents) and product specifications to accomplish task.
    • Researched, identified, developed, negotiated, budgeted, and managed several GMP contract research, manufacturing, packaging, and/or analytical agreements as part of the product’s CMC team. Project team oversaw multi-site Phase I clinical materials manufacturing project, managed multi-facility cold supply chain, and led the research, identification, development, and negotiation of several agreements worth several hundred thousand dollars, which enabled the production of Phase II clinical trial materials
    • Worked in collaboration with senior management on business development projects, participating and in some cases leading the research and development of scientific collaborations, budgets, term sheets, executive commercialization plans, etc.

PROFESSIONAL EXPERIENCE

  • Sanar Biosciences, Co-Founder/President (Edgewater, NJ) – 2010 to Present
  • Lux Biosciences, Senior Scientist/NJCST Fellow (Jersey City, NJ) – 2007 to 2009
  • Rutgers University, Graduate Research Fellow (Piscataway, NJ) – 2002 to 2007
  • I.B.M., Engineer (Yorktown Heights, NY) – 2000 to 2001

EDUCATION

  • Ph.D., Biomedical Engineering and Materials Science and Engineering, Rutgers University, New Brunswick, NJ – 2002 to 2007
  • Recognized Visiting Graduate Student, Department of Materials, Oxford University, Oxford, England – 2005
  • B.S, Biomedical Engineering, Columbia University, New York, NY – 1997 to 2001

TRAINING

  • GMP Regulations and Guidelines, International Pharmaceutical Academy, April 2009
  • Leadership and Strategy in Pharmaceuticals and Biotech, Harvard Business School, Boston, MA – 2009

PUBLICATIONS AND PRESENTATIONS

Patents

  • Riman RE, Burukhin A, Zlotnikov E, Haders D. Hydroxyapatite with Controllable Size and Morphology. United States Patent 7,998,219. Issued August 16th, 2011.

Patent applications

  • Riman RE, Burukhin A, Zlotnikov E, Haders D. Hydroxyapatite with Controllable Size and Morphology. European Patent Application Number – 2005854856.1, Publication Number – EP1846325. Filed December 21st, 2005.
  • Riman RE, Burukhin A, Zlotnikov E, Haders D. Hydroxyapatite with Controllable Size and Morphology. US Patent Application Number – 13/504,143. National Stage Application Filed April 26th, 2012.
  • Riman RE, Burukhin A, Zlotnikov E, Haders D. Hydroxyapatite with Controllable Size and Morphology. European Patent Application Number – 10827398.8-2124. International Application Filed October 26th, 2010

Scientific Publications

  • Haders D.J., Kazanecki C.C., Denhardt D.T., Riman R.E. Crystallographically Engineered, Hydrothermally Crystallized Hydroxyapatite Films: an In-Vitro Study of Bioactivity. Journal of Materials Science: Materials in Medicine 2010 March 16;21(5):1531-1542
  • Haders D.J., Burukhin A, Huang Y, Cockayne D.J.H., Riman R. E. Phase Sequenced Deposition of Calcium Titanate/Hydroxyapatite Films with Controllable Crystallographic Texture onto Ti6Al4V by TEP Regulated Hydrothermal Crystallization. Crystal Growth and Design 2009 Aug 5;9(8):3412-3422.
  • Haders D.J., Burukhin A, Zlotnikov E, Riman R. E. TEP/EDTA Doubly Regulated Hydrothermal Crystallization of Hydroxyapatite Films on Metal Substrates. Chemistry of Materials 2008 Oct 23; 20(22):7177-7187.
  • Haders D.J. Synthesis and Characterization of TEP-EDTA Regulated Bioactive Hydroxyapatite. Ph.D. Dissertation, Rutgers University 2008 May.
  • Haders D.J. Ocular Delivery: New Controlled Release Technologies Broaden Opportunities for Ophthalmic Therapies. Drug Delivery Technology 2008 July/Aug; 8(7):48-53.
  • Shaw TM, Jimerson D, Haders D, Murray CE, Grill A, Edelstein DC, Chidambarrao D. Moisture and Oxygen Uptake in Low k/Copper Interconnect Structures. Advanced Metallization Conference 2003 (AMC 2003), Materials Research Society 2004, 77-84.
  • Ligler FS, Breimer M, Golden JP, Nivens DA, Dodson JP, Green TM, Haders DJ, Sadik OA. Integrating Waveguide Biosensor. Analytical Chemistry 2002 Feb 1;74(3):713-719

Selected Oral Presentations

  • Synthesis and Characterization of a Solution Deposited, Biologically Inspired, Crystallographically Oriented Hydroxyapatite-Bone Interface. D.J. Haders, A. Burukhin, C.C. Kazenecki, E. Zlotnikov, D.T. Denhardt, D.J.H. Cockayne and R.E. Riman. DePuy Orthopaedics-Johnson & Johnson Company, July 19th, 2007, Warsaw, IN.
  • Triethyl Phosphate/EDTA Doubly Regulated Hydrothermal Crystallization of Hydroxyapatite Films on Metal Substrates. D. Haders, A. Burukhin, E. Zlotnikov, Y. Huang, D. J.H. Cockayne, R. E. Riman. American Chemical Society Mid-Atlantic Regional Meeting, May 15th – 18th, 2007. Ursinus College, Collegeville, PA.
  • Deposition of Crystallographically Tunable Hydroxyapatite Films with a CaTiO3 Interfacial Layer onto Ti6Al4V by TEP Regulated Hydrothermal Synthesis. D. Haders, A. Burukhin, Y. Huang, D. J.H. Cockayne, R. E. Riman. Materials Research Society (MRS) Spring 2007 Meeting, April 9th-13th 2007, San Francisco, CA.
  • Deposition of Crystallographically Tunable Hydroxyapatite Films by TEP/EDTA Doubly Regulated Hydrothermal Crystallization for Biomedical Applications. Daniel J. Haders, Alexander Burukhin, Christian Kazanecki, Eugene Zlotnikov, Yizhong Huang, David J.H. Cockayne, David T. Denhardt, Richard E. Riman. 21st Annual Symposium of the Laboratory for Surface Modification, March 2nd, 2007, Rutgers University, Piscataway, NJ.
    • Awarded Best Paper
  • Synthesis and Characterization of a Biologically Inspired, Crystallographically Oriented Hydroxyapatite-Bone Interface. D.J. Haders, A. Burukhin, C.C. Kazenecki, E. Zlotnikov, D.T. Denhardt, D.J.H. Cockayne and R.E. Riman. Schering-Plough Research Institute, March 1st, 2007, Union, NJ.
  • Biologically Inspired, Hydrothermal Crystallization of Hydroxyapatite Films for Biomedical Applications. D. Haders, A. Buruhkin, C. Kazanecki, E. Zlotnikov, Y. Huang, R. E. Riman, D. Denhardt, D. Cockayne. New Jersey Center for Biomaterials. February 8th 2007, Piscataway, NJ.
  • Bioactive Hydroxyapatite Coating for Improved Bone Implant Performance. D. Haders, A. Burukhin, C. Kazanecki, D. Denhardt, R. Riman. First Annual Symposium: Rutgers NSF IGERT on Biointerfaces, October, 20th 2004, Hyatt Regency Hotel, New Brunswick, New Jersey.

Other Publications

  • Logic and Passion: My Path to Entrepreneurship. D.J. Haders. Columnist Biocareers.com. Published July, 2010.
  • Graduate School: A Competence Training Ground. D.J. Haders. Columnist Biocareers.com. Published August 2010.
  • Hydroxyapatite Coating for Improved Bone Implant Performance. Cross Section – The Magazine of Research Across the Disciplines at the Graduate School-New Brunswick, Feature article on cross-disciplinary research and collaboration, Winter 2005.