BCG Welcomes Dr. Janice Wilson & Dr. Nebojsa Djordjevic
An Early Look at FDA Regulation of Nanotechnology
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JANICE M. WILSON, PH.D. Dr. Wilson joined the group in December 2007. She is a quality and compliance executive with over 25 years of global and international experience in the highly regulated bioscience industries. Dr. Wilson was most recently the Global Head of Compliance for Novartis Vaccine and Diagnostics working out of the Emeryville, CA office where she was a member of the executive team providing oversight for the development and implementation of the division's Quality Manual. Her experience includes development, implementation, and directing of sustainable Quality Systems, Quality Assurance programs, and extensive Regulatory Compliance programs for GMP and ISO activities. Read Announcement See Curriculum Vitae NEBOJSA M. DJORDJEVIC, PH.D. Dr. Djordjevic joined BCG in January of 2008. Dr. Djordjevic has over 20 years of experience in Analytical Chemistry utilized in Pharmaceutical and Biopharmaceutical Industry. During this time he has played an active role at virtually every phase of drug development from target identification, lead identification, compound selection and characterization, and pharmaceutical product development. He was most recently the Director of Analytical Chemistry at Cytokinetics Inc., a biopharmaceutical company involved in the discovery and development of oncology and cardiovascular drugs. Read Announcement See Curriculum Vitae
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The November issue of RAPS Focus Magazine highlights Outsourcing and includes contributions by both Michael Trapani, MS, MBA and David Pepperl, Ph.D. Quality
& Compliance: The Quality Agreement Preclinical
Outsourcing in 2008: Key Considerations for Study Success |
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| Nanotechnology,
broadly defined, is the field of applied science whose unifying theme
is the fabrication of materials and products on the atomic and molecular
scale -- normally 1 to 100 nanometers (nms). There is currently a
wellspring of academic and private sector research and development
exploring the myriad potentials for nanotechnology to provide enhanced
performance of existing technologies (e.g., improved efficiency of
photovoltaic cells) and to offer novel solutions to historically vexing
problems (e.g., targeting chemotherapy drugs for release at tumor
sites while sparing healthy tissues).
Nanomedicine Nanomedicine
is an area of biomedical research that seeks to use nanoscale tools
to improve health. Current medical uses of nanotechnology include
sunscreens, dental-bonding agents, novel wound dressings, and liposomal
drug delivery platforms. |
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BCG consultants attend numerous conferences every year during which they are available to provide company information or consulting expertise. Below are some conferences that BCG consultants will be attending in the near future. Please feel free to contact the attending consultant either before, or during the conference for company information or to discuss a business opportunity. |
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Date
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Sponsoring
Organization
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Conference
and Presentation Title
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BCG
Attendee(s)/ Speaker (s)
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Location
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| January 14 - 15, 2008 | IBC China | US FDA Biological Approval Process | Lei
Zhang, MD, Ph.D. (speaker) |
Seoul, South Korea |
| January 14 - 16, 2008 | ALS Association | ALSA Research Workshop | Wilson
W. Bryan, M.D. (speaker) |
Tampa, FL |
| January 17 - 18, 2008 | IBC China | US FDA Biological Approval Process | Lei
Zhang, MD, Ph.D. (speaker) |
Taipei, Taiwan |
| January 21-23, 2008 | Institute for International Research |
5th Annual Formulation & Forced Degradation "Implementation of a flexible yet cGMP complaint Stability Program for Phase I, II and III Studies" |
Nanda
Subbaro, Ph.D. (speaker) |
San Diego, CA |
| January 27-30, 2008 | CASSS |
Current Practices for Assessing the Comparability and Stability of Gene Therapy Products |
Andra
Miller, Ph.D. Maritza C. McIntyte, Ph.D. Nadine Ritter, Ph.D. (co-leader) Darin Weber, Ph.D. |
Washington, DC |
| January 27-30, 2008 | CASSS |
Extractables and Leachables: Challenges and Strategies in Biopharmaceutical Development |
Keith
Wells, Ph.D. Ruth Wolff, Ph.D. |
Washington, DC |
| January 27-30, 2008 | CASSS | Nadine
Ritter, Ph.D. (speaker) Keith Wells, Ph.D. Ruth Wolff, Ph.D. |
Washington, DC | |
| January 28-29, 2008 | International Pharamceutical Academy (IPA) |
"FDA approval processes and combination device and biologics inspections" |
John
R. Godshalk, MSE, MBA (speaker) |
Toronto, Canada |
| January 28-30, 2008 | Phacilitate | Phacilitate Cell & Gene Therapy Forum 2008 | Andra
Miller, Ph.D. Maritza C. McIntyte, Ph.D. Darin Weber, Ph.D. |
Washington DC |
| February 9-10, 2008 | ISCTR (International Society for Cardiovascular Translational Research) |
"Regulatory Considerations for Cell Manufacturing and Cell Delivery" |
Darin
Weber, Ph.D. (speaker) |
San Diego, CA |
| February 21-22, 2008 | Texas Scottish Rite Hospital for Children | 30th Annual Carrell-Krusen Neuromuscular Symposium | Wilson W. Bryan, M.D. | Dallas, TX |
| February 25-29, 2008 | Seton
Hall Law School |
Health
Care Compliance Certification Program "Advertising & Promotion of Medical Devices" |
Stuart
Portnoy, MD (speaker) |
Newark, NJ |
| March 6-7, 2008 | ASENT (American Society of Experimental NeuroTherapeutics) | Annual Meeting | Wilson
W. Bryan, MD (course co-director) |
Washington, DC |
| March 16-20, 2008 | Society of Toxicology | SOT Annual Meeting and Tox Expo | John Jessop, Ph.D., MPH | Seattle, WA |
| March 28-29, 2008 | AABB
(American Association of Blood Banks) |
Regulatory Considerations of Using Stem Cells for Cardiac Applications |
Ellen
M. Areman, MS, SBB (speaker) |
Orlando, FL |
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Us:
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