.Robert Lee
Particle Sciences, Inc.USA
Particle Sciences, Inc.
3894 Courtney Street, Suite 180
Bethlehem, PA 18017
Office: (610) 861-4701
E-mail: rlee@particlesciences.com
Lee is Vice President of Pharmaceutical Development Services at Particle Sciences, a pharmaceutical contract development and manufacturing organization (www.particlesciences.com). He provides direction and is heavily involved with product and business development. Before joining Particle Sciences, Rob held senior management positions at Novavax, Inc., Lyotropic Therapeutics, Inc., and Imcor Pharmaceutical Co. He was one of the founding scientist at NanoSystems, built and led their Analytical Sciences Department and after NanoSystems was acquired by elan, built and was head of elan’s Sterile Products Department. Both of these positions were focused on developing and commercializing NanoCrystal™ Colloidal Dispersions. He holds BSs in Biology and Chemistry from the University of Washington and a PhD in Physical Bioorganic Chemistry from the University of California, Santa Barbara. Rob has published articles in numerous peer-reviewed journals and three book chapters plus holds over two dozen issued patents or provisional patent applications. He has 25 years of experience in pharmaceutical research and development of both therapeutic drugs and diagnostic imaging agents. Rob maintains strong academic ties, including an appointment as Adjunct Associate Professor of Pharmaceutical Chemistry at the University of Kansas in the early 1990s, serving as Vice Chair on the Executive Advisory Board for the Lehigh Nanotech Network, serving on the Editorial Advisory Board of Drug Development, and Delivery magazine, and serving as a reviewer for both the International Journal of Pharmaceutics and Journal of Pharmaceutical Sciences. He is currently a scientific advisor for Nanoscan Imaging, Eqalix, and MarginSurgical.
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- Vice President, Pharmaceutical Development at Particle SciencesApril 2008 to present
Studied Physical/Bio Organic Chemistry at University of California, Santa BarbaraPast: University of Washington and Laurel High
Lives in Boyertown, Pennsylvania
Robert Lee Ph.D.
Vice President, Pharmaceutical Development Services
Dr. Lee is responsible for product development. Before joining Particle Sciences, Rob held senior management positions at Novavax, Inc., Lyotropic Therapeutics, Inc., and Imcor Pharmaceutical Co. He holds BSs in Biology and Chemistry from the University of Washington and a PhD in Physical Bioorganic Chemistry from the University of California, Santa Barbara. Rob has published articles in numerous peer-reviewed journals and three book chapters plus holds 11 issued patents and 14 provisional or PCT patent applications. He has over 23 years of experience in pharmaceutical research and development of both therapeutic drugs and diagnostic imaging agents. Rob maintains strong academic ties, including an appointment as Adjunct Associate Professor of Pharmaceutical Chemistry at the University of Kansas in 1992, and serving as a reviewer for both the International Journal of Pharmaceutics and Journal of Pharmaceutical Sciences.Experience
VP, Pharmaceutical Development
Particle Sciences, Inc.
Providing
leadership for pharmaceutical product development. Areas of
responsibility include formulation development, Quality Control, Quality
Assurance, Regulatory Affairs, analytical method development,
technology evaluation and development, and clinical trial material
manufacturing.
• Scientific leadership – responsible for building and leading the Pharmaceutical Development Department. Building intellectual property (IP) portfolio to give Particle Sciences a competitive advantage.
• Business development – identifying opportunities and establishing relationships with potential partners, including giving technology and business presentations.
• Corporate management – providing strategic input to help guide Particle Sciences’ direction. Actively involved in management and leadership of Particle Sciences.
• Scientific leadership – responsible for building and leading the Pharmaceutical Development Department. Building intellectual property (IP) portfolio to give Particle Sciences a competitive advantage.
• Business development – identifying opportunities and establishing relationships with potential partners, including giving technology and business presentations.
• Corporate management – providing strategic input to help guide Particle Sciences’ direction. Actively involved in management and leadership of Particle Sciences.
VP, Pharmaceutical Development
Novavax, Inc.
Provided
leadership for pharmaceutical and biopharmaceutical product
development. Areas of responsibility included formulation development,
Quality Control, Quality Assurance, Regulatory Affairs, analytical
method development, technology evaluation and development, and
commercial manufacturing.
• Scientific leadership – responsible for building and leading the Pharmaceutical Development Department. Provided formulation and analytical support for the development of virus-like particle vaccines including seasonal and avian influenza. Assessed product and technology opportunities for possible acquisition. Identified gaps in and actively built intellectual property (IP) portfolio to give Novavax a competitive advantage – filed eight provisional and PCT applications in first two years with Novavax. Helped manage IP portfolio.
• Business development – identified opportunities and established relationships with potential partners; gave technology and business presentations. Responsible for managing P & L for Novavax’s state-of-the-art commercial manufacturing facility in Philadelphia.
• Corporate management – as a Company Officer, provided strategic input to help guide Novavax’s direction. Actively involved in management and leadership of Novavax. Significantly reduced burn rate by closing up research facility in California and downsizing/reorganizing resources.
• Scientific leadership – responsible for building and leading the Pharmaceutical Development Department. Provided formulation and analytical support for the development of virus-like particle vaccines including seasonal and avian influenza. Assessed product and technology opportunities for possible acquisition. Identified gaps in and actively built intellectual property (IP) portfolio to give Novavax a competitive advantage – filed eight provisional and PCT applications in first two years with Novavax. Helped manage IP portfolio.
• Business development – identified opportunities and established relationships with potential partners; gave technology and business presentations. Responsible for managing P & L for Novavax’s state-of-the-art commercial manufacturing facility in Philadelphia.
• Corporate management – as a Company Officer, provided strategic input to help guide Novavax’s direction. Actively involved in management and leadership of Novavax. Significantly reduced burn rate by closing up research facility in California and downsizing/reorganizing resources.
VP, Product Development
Lyotropic Therapeutics, Inc.
Provided
leadership for pharmaceutical product development. Areas of
responsibility included managing contract service organizations,
managing technology transfers from research into cGMP manufacturing,
Project Leadership and Management, and building the Company’s internal
and external capabilities (i.e., regulatory and quality) to support
pharmaceutical product development.
VP, Research and Development
IMCOR Pharmaceuticals, Inc.
Provided
leadership in the research and development of diagnostic imaging
agents. Areas of responsibility included formulation development,
analytical sciences, pre-clinical development, technology development,
and corporate management. As a member of the Senior Management team,
provided guidance on company direction.
• Helped IMCOR (formerly Photogen Technologies, Inc.) acquire the assets of Alliance related to medical imaging, including all manufacturing and marketing rights to Imagent® (formerly Imavist™), an FDA-approved ultrasound contrast agent and a sterile manufacturing facility. Helped to successfully integrate the two organizations.
• Was actively involved in business development activities, including constructing term sheets, review of licensing agreements, evaluating and forming strategic alliances, identifying and pursuing new business opportunities, and assisting in the preparation of presentation material used for investor relations and funding efforts.
• Helped IMCOR (formerly Photogen Technologies, Inc.) acquire the assets of Alliance related to medical imaging, including all manufacturing and marketing rights to Imagent® (formerly Imavist™), an FDA-approved ultrasound contrast agent and a sterile manufacturing facility. Helped to successfully integrate the two organizations.
• Was actively involved in business development activities, including constructing term sheets, review of licensing agreements, evaluating and forming strategic alliances, identifying and pursuing new business opportunities, and assisting in the preparation of presentation material used for investor relations and funding efforts.
Sr. Manager, Sterile Products
élan Drug Delivery, Inc.
Created
and was Head of élan Drug Delivery’s (EDD) Injectable Products
department. This involved providing direction and leadership for the
development of all injectable, ophthalmic, and sterile pulmonary
products.
• Responsibilities included planning, staffing, leading, organizing, and coordinating all activities of the group. Examples of specific activities are as follows:
* Evaluated and developed novel, patentable technology in the area of sterile product development and manufacturing that provided EDD with a competitive advantage
* Managed pre-clinical product development
* Served as Project Leader and managed sterile product candidates from feasibility through clinical development
* Represented EDD at scientific, business, and regulatory meetings
* Assisted in the development of aseptic manufacturing processes
* Identified and audited cGMP contractors (manufacturing and analytical) and equipment manufacturers
* Identified and secured new business opportunities
• Responsibilities included planning, staffing, leading, organizing, and coordinating all activities of the group. Examples of specific activities are as follows:
* Evaluated and developed novel, patentable technology in the area of sterile product development and manufacturing that provided EDD with a competitive advantage
* Managed pre-clinical product development
* Served as Project Leader and managed sterile product candidates from feasibility through clinical development
* Represented EDD at scientific, business, and regulatory meetings
* Assisted in the development of aseptic manufacturing processes
* Identified and audited cGMP contractors (manufacturing and analytical) and equipment manufacturers
* Identified and secured new business opportunities
Manager, Analytical Sciences
NanoSystems
Created
and served as Head of NanoSystems’ Analytical Sciences Department
(ASD). Grew the department from a group of three to 14 scientists (B.S.,
M.S., and Ph.D.). Function consisted of providing direction and
leadership for the ASD, which included both Quality Control (QC) and
Analytical Technology (AT – essentially Preformulation and molecular
characterization) groups.
• Responsibilities included planning, budgeting, staffing, leading, and coordinating activities of the ASD. The activities of the department were as follows:
* Developed and implemented the infrastructure to support cGMP compliance, which included bringing ASD laboratories up to full regulatory compliance, writing and implementing appropriate SOP’s and systems, and ensuring that ASD personnel were adequately trained
* Evaluated and audited contract organizations which were used to supplement NanoSystems’ capabilities
* Evaluated and purchased new technologies/instrumentation to ensure that NanoSystems had the most suitable methodology to characterize NanoCrystal™ Colloidal Dispersions
* Managed technology transfers to NanoSystems’ contract clinical manufacturing facility (Pharmaceutical Manufacturing Research Services, Inc., Horsham, PA) and clients with strategic licensing agreements (Merck and Wyeth)
* Supported successful pre-approval inspection for Rapamune®, the first NanoCrystal Technology™-based product (NDA filed 29-Oct-1999) co-developed by Wyeth and NanoSystems
• Responsibilities included planning, budgeting, staffing, leading, and coordinating activities of the ASD. The activities of the department were as follows:
* Developed and implemented the infrastructure to support cGMP compliance, which included bringing ASD laboratories up to full regulatory compliance, writing and implementing appropriate SOP’s and systems, and ensuring that ASD personnel were adequately trained
* Evaluated and audited contract organizations which were used to supplement NanoSystems’ capabilities
* Evaluated and purchased new technologies/instrumentation to ensure that NanoSystems had the most suitable methodology to characterize NanoCrystal™ Colloidal Dispersions
* Managed technology transfers to NanoSystems’ contract clinical manufacturing facility (Pharmaceutical Manufacturing Research Services, Inc., Horsham, PA) and clients with strategic licensing agreements (Merck and Wyeth)
* Supported successful pre-approval inspection for Rapamune®, the first NanoCrystal Technology™-based product (NDA filed 29-Oct-1999) co-developed by Wyeth and NanoSystems
Sr. Research Investigator
Sterling Winthrop
Supervised Preformulation and Oral Liquids Formulation Development groups.
• Specific activities included the following:
* Supported the development of parenteral X-ray contrast agents
* Served as group and/or departmental representative at project development meetings
*Provided scientific leadership in the area of physical organic chemistry
• Established research programs designed to expedite the drug discovery and development process. These programs included the following:
* Conducted research to develop techniques, including NanoCrystal™ Technology, for the delivery of poorly water-soluble drugs
* Collaboration with Professors Richard Schowen and Chris Riley (University of Kansas) on a computer program to predict drug stability in aqueous solutions and define the response surface describing the pH vs. temperature vs. rate of degradation behavior of drugs
* Collaboration with Professor Lionel Carreira (University of Georgia) on a computer program developed by the EPA and University of Georgia that predicts physical properties of organic and inorganic compounds
* Collaboration with Eastman Kodak’s Scientific Computing group on the development of a novel Quantitative Structure Activity Relationship (QSAR) modeling paradigm
* Co-invented and developed an automated Robotics NanoCrystal™ Colloidal Dispersion milling and particle sizing system
• Specific activities included the following:
* Supported the development of parenteral X-ray contrast agents
* Served as group and/or departmental representative at project development meetings
*Provided scientific leadership in the area of physical organic chemistry
• Established research programs designed to expedite the drug discovery and development process. These programs included the following:
* Conducted research to develop techniques, including NanoCrystal™ Technology, for the delivery of poorly water-soluble drugs
* Collaboration with Professors Richard Schowen and Chris Riley (University of Kansas) on a computer program to predict drug stability in aqueous solutions and define the response surface describing the pH vs. temperature vs. rate of degradation behavior of drugs
* Collaboration with Professor Lionel Carreira (University of Georgia) on a computer program developed by the EPA and University of Georgia that predicts physical properties of organic and inorganic compounds
* Collaboration with Eastman Kodak’s Scientific Computing group on the development of a novel Quantitative Structure Activity Relationship (QSAR) modeling paradigm
* Co-invented and developed an automated Robotics NanoCrystal™ Colloidal Dispersion milling and particle sizing system
Education
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