Jose A Paulino Purdue University USA

Jose A Paulino

Purdue University
USA

Jose A Paulino was born in the Dominican Republic in 1963. There, he grew up and attended high school at Loyola Polytechnic Institute, graduating with top honors with an associate degree in Agronomy. After graduation, in 1981, he migrated to New York City, USA in search of a better future. He spent one and a half year learning the English language before going to the State University of New York at Oswego, New York to continue his education in 1982. There, he majored in Chemistry and graduate at the top of his class in 1985 with a Bachelor of Science, Suma Cum Laude. After graduation, he taught General Chemistry for one semester while waiting to start graduate school. For graduate school he attended Purdue University in West Lafayette, Indiana. He joined Professor Robert Squires’ research group in the Chemistry Department. His research focus was the determination of thermochemical and kinetic properties of reactive intermediates using gas phase ion/molecule reaction. In the course of this research, he developed specialized mass spectrometry instrumentation and published several papers in such journals as the Journal of the American Chemical Society. He graduated in 1992 with a Doctorate in Physical-Organic Chemistry. Then, he moved to the state of New Jersey where he still resides. He started his industry career at Exxon Corporation and then went into pharmaceuticals Analytical Chemistry research and development. Over more than 15 years he has worked at various pharmaceutical companies with increasing responsibilities in the area of Analytical Chemistry research and development.
links
https://www.facebook.com/japaulino/about
 https://www.linkedin.com/in/joseapaulinophd

 

 

Research Interest

·         Method Development and Validation to support products and new formulation in the pharmaceutical and chemical industries.

·         Characterization and structure elucidation of small and large molecule drug substances and drug products.

·         Analytical Chemistry research and development related to pharmaceutical, consumer and medical device products.

·         Instrumentation for mass spectrometry, chromatographyand spectroscopy.

·         Various dosage forms, including solid, liquid, topical, parenteral, combination devices, and consumer products.

·         Extractable and leachable studies for device components, container/ closures systems and manufacturing contact materials.

·         Stability indicating methods for the assay of active pharmaceutical ingredients and related impurities (small and large molecules) in complex matrixes, such as micro-encapsulated polymer, botanical extract and multiple actives pharmaceutical formulations.

·         Implementation of regulatory guidelines to support specifications for release and stability of raw materials, drug substances and finished products, such as GLP, cGMP and CFR 21 Part 11 regulations.

·         Inorganic elementalanalysis by ICP-OES, ICP-MS, Flame-AA, and XRF

·         Organic analysis by Ion chromatography, FT-IR, Karl Fischer, thermal analyses, titrations, UV/ Vis, GC, GC-MS, HPLC, UPLC, and LC-MS-MS.

 

Experience

Principal Scientist - Analytical Chemistry

Bellerophon Therapeutics

February 2015 – Present (1 year 3 months)North Brunswick, NJ

Analytical Chemistry development in support of the company product line, including innovative methods to determine trace level extractable and leachable impurities.

Analytical Research and Development Manager

Aurobindo Pharma

January 2014 – February 2015 (1 year 2 months)Dayton, New Jersey

Analytical Chemistry Manager for Research and Development in support of the company's products, including the following: small and large molecules, drug substances, drug products, release and stability specifications, method development, method validation, method transfer, chromatography, spectroscopy, mass spectrometry interpretation, wet chemistry, and project management.

Staff Scientist / Site Operations Manager

Johnson and Johnson

October 2010 – January 2014 (3 years 4 months)Raritan, NJ

Analytical Chemistry Research and Development and QC management for: small and large molecules, drug substance and drug products, release and stability studies, method development and validation in chromatography, spectroscopy, mass spectrometry, electrophoresis, and wet chemistry, project management, and process improvement.

Project Manager - Chemistry Analytical Research and Development

SGS

December 2009 – October 2010 (11 months)Fairfield, NJ

Project Manager for the Chemistry Department in the Life Science Testing Division of SGS. Additionally, managed the chemistry laboratory for the Consumer Products Testing Division of SGS.

Research Fellow and Project Manager

Intertek Caleb Brett - QTI

June 2003 – December 2009 (6 years 7 months)

Project Manager for Analytical Research and Development in support of pharmaceutical products and drug substances.

Principal Scientist

Schering-Plough

June 2001 – June 2003 (2 years 1 month)

Managed an Analytical Research and Development group responsible for several drug products and drug substances, method development, method validations, CMC documentation for NDA, and testing to support stability studies and for clinical release.

Project Leader

Intertek - QTI

June 1996 – June 2001 (5 years 1 month)

Analytical Research and Development in support of pharmaceutical products

Research Chemist

Anderol

1994 – 1996 (2 years)

Technical services to support product line as well as research and development activities.

Publications

Evaluation of Charged Aerosol Detector for Purity Assessment of Protein(Link)

Journal of Chromatography A

February 4, 2013

Commercially available protein reference standard materials are widely used for the quantitation of intact proteins in biopharmaceuticals, food, and consumer products. However, the purity of protein reference standard materials are often assumed to be 100% or they may be assigned an inaccurate value because the methods used to determine protein purity often lack specificity and accuracy. In this...more

Education

Purdue University

Ph.D., Physical Organic Chemistry

1986 – 1992

State University of New York College at Oswego

B.S., Chemistry

1982 – 1985
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Robert Lee Particle Sciences, Inc. USA

.

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.

links
https://www.facebook.com/profile.php?id=1538324873

• Vice President, Pharmaceutical Development at Particle Sciences

  April 2008 to present
• 

  Studied Physical/Bio Organic Chemistry at University of California, Santa Barbara

  Past: University of Washington and Laurel High
• 

  Lives in Boyertown, Pennsylvania

  From Aiea, Hawaii · Lived in East Greenbush, New York

https://www.linkedin.com/in/robert-lee-1a2a7a2

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.

April 2008 – Present (8 years 1 month)Bethlehem, PA

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.

VP, Pharmaceutical Development

Novavax, Inc.

September 2005 – April 2008 (2 years 8 months)Malvern, PA & Rockville, MD

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.

VP, Product Development

Lyotropic Therapeutics, Inc.

May 2005 – September 2005 (5 months)

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.

2002 – May 2005 (3 years)New Hope, PA & San Diego, CA

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.

Sr. Manager, Sterile Products

élan Drug Delivery, Inc.

1999 – 2002 (3 years)King of Prussia, PA

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

Manager, Analytical Sciences

NanoSystems

1994 – 1999 (5 years)King of Prussia, PA

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

Sr. Research Investigator

Sterling Winthrop

1990 – 1994 (4 years)Rensselaer, NY & Collegeville, PA

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

Education

University of California, Santa Barbara

Ph.D., Physical BIoorganic Chemistry

1984 – 1990

University of Washington

BS, Chemistry, Biology

1977 – 1983

Laurel High School

1972 – 1976

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Prati Pal Singh Stanford University USA

Prati Pal Singh

Stanford University
USA

Dr. Prati Pal Singh,

Mobile: 09417196015

E-mail:

drppsingh2005@gmail.com

Professor Prati Pal Singh, National Institute of Pharmaceutical Education and Research (NIPER), S. A. S Nagar, India,  got his B. Sc. (1973) and M. Sc. (1975) degrees from The University of Lucknow, Lucknow. For his Ph. D. degree, he worked at the Central Drug Research Institute, Lucknow and got the degree from Kanpur University, Kanpur (1980). Prof. Singh did his postdoctoral research work at The Ohio State University, Columbus, Ohio, USA (1984-85) and at a very prestigious institution, The Stanford University, Stanford, Palo Alto, California, USA (1986). He was a visiting fellow at the Montreal General Hospital, Montreal, Canada (1985).Prof. Singh is a renowned molecular biologist, immunologist and neuroimmunopharmacologist. He conceptualized and reported that opiate class of drugs can be used for the treatment of parasitic and microbial infections.Prof. Singh has made some very important contributions to control and treatment of parasitic and microbial diseases like malaria, tuberculosis, leishmaniasis, amoebiasis and trichomoniasis. He has 202 publicationsincluding one in NatureMedicine, and 9 patents including one US patent. Prof. Singh is the Editor-in-Chief of the Journal of Parasitic Diseases and an Editorial Board Member of a US journal, Journal of Neuroimmune Pharmacology. Prof. Singh was elected Fellow of the National Academy of Sciences, India (2004) for his work on “biotechnology, parasitology and neuroimmunomodulation”, and Fellow of Association of Microbiologists ofIndia (2008). Prof. Singh has been awarded the prestigious TulasbaiSomani Educational Trust Award (1992) of the Indian Academy of Neurosciences. Prof. Singh has been awarded huge grant funds from Government of India for his researches on malaria, tuberculosis and leishmaniasis over the last two decades.  He is a co-investigator in an Indo-European Union Seventh Framework Programme (2008) to discover new drugs for tuberculosis. He has been invited for lectures/meetings in USA, Switzerland, France, Italy, Belgium, Germany, China and UK. Prof. Singh was awarded The Bill and Melinda Gates Foundation Global Health Award in 2008 to present his malaria immunology work in a Keystone Symposium, Austria. In the year 2006, National Institute on Drug Abuse, USA awarded Prof. Singh a travel award to present his work on neuroimmunomodulation in leishmanisis at Santa Fe, NM, USA. Prof. Singh is a Member, IBCs Leading Health Professional of the World – 2015. He is the Nodal Officer of NIPER, Raebareli,and has been the Member/Chairman of high-powered Scientific Advisory Committees/sub-committees and selection committees of the institutes of Indian Council of Medical Research, New Delhi.

Research Interest

Broad area of specialization: Pharmaceutical Sciences.
Areas of specialization: Parasitic andmicrobial infections (mainly tuberculosis, malaria, leishmaniasis, amoebiasis and trichmoniasis): new drug discovery, bioimmunotherapy, vaccination and pathogenesis; pharmacology, neuroimmunomodulation, biotechnology, forensic biotechnology, toxicology, and science administration, and communication/editing.


 links


 https://www.facebook.com/pratipal.singh.9887
 https://in.linkedin.com/in/dr-prati-pal-singh-5b664441

Experience

Research Associate

Stanford University Medical Centre, Palo Alto, CA, USA

July 1985 – August 1986 (1 year 2 months)

Postdoctoral Research Associate

The Ohio State University

July 1984 – December 1985 (1 year 6 months)Columbus, Ohio Area

Innate immunity, acute-phase reactant bilogy, immunogenetics, genetic basis of host resistance and susceptibilty

Education

Lucknow University/Kanpur University

M. Sc./Ph. D., Parasitic diseases/malaria

1973 – 1980

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