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Our state-of-the-art laboratories and manufacturing facilities are located in South San Francisco, California. We have a driven, ambitious, focused, hard-working, apolitical, fun, and collaborative culture that is more typical of Silicon Valley startups than large pharmaceutical companies. Our employees are compensated with salary, benefits and stock options.
Specialties
Solid Tumor Cancer Stem Cell Discovery & Targeted Therapeutics
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.
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.
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.
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.
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.
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.
• 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
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
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
.
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