Research Topics
| J M ReichertSummaryAffiliation: Tufts University Country: USA Publications
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Detail Information
Publications
Therapeutic monoclonal antibodies: trends in development and approval in the USJanice M Reichert
Tufts Center for the Study of Drug Development, Boston, MA 02111, USA
Curr Opin Mol Ther 4:110-8. 2002..In addition, mAbs that are either in phase III, FDA-review, or are FDA approved for antineoplastic or immunological indications are described...
Antibody-based therapeutics to watch in 2011Janice M Reichert
Tufts Center for the Study of Drug Development, Boston, MA, USA
MAbs 3:76-99. 2011..Current as of September 2010, the information presented here will serve as a baseline against which future progress in the development of antibody-based therapeutics can be measured...- Technology evaluation: lumiliximab, Biogen IdecJanice M Reichert
Tufts Center for the Study of Drug Development, 192 South Street, Suite 550, Boston, MA 02111, USA
Curr Opin Mol Ther 6:675-83. 2004..Biogen Idec (formerly IDEC Pharmaceuticals) is developing lumiliximab, a primatized anti-CD23 macaque/human chimeric antibody that inhibits the production of the IgE antibody, for the potential treatment of allergic conditions... - Trends in development and approval times for new therapeutics in the United StatesJanice M Reichert
Tufts Center for the Study of Drug Development, 192 South Street, Suite 550, Boston, Massachussets 02111, USA
Nat Rev Drug Discov 2:695-702. 2003..Current efforts by the FDA, and the pharmaceutical and biopharmaceutical industry, to reverse the recent tendency toward fewer new approvals and longer approval times are discussed... - Trends in US approvals: new biopharmaceuticals and vaccinesJanice M Reichert
Tufts Center for the Study of Drug Development, Boston, MA 02111, USA
Trends Biotechnol 24:293-8. 2006..We predict that this might change in the future as government and industry respond to the twin threats of the global spread of infectious diseases and potential bioterrorism... 
The future of antibodies as cancer drugsJanice M Reichert
Center for the Study of Drug Development, Tufts University School of Medicine, 75 Kneeland Street, Suite 1100, Boston, MA 02111, USA
Drug Discov Today 17:954-63. 2012....- Trends in the development and approval of monoclonal antibodies for viral infectionsJanice M Reichert
Tufts University, Tufts Center for the Study of Drug Development, Boston, Massachusetts 02111, USA
BioDrugs 21:1-7. 2007..Public sector research into the use of mAbs against emerging pathogens, such as severe acute respiratory syndrome coronavirus, may have already provided candidates for further development... - Development trends for monoclonal antibody cancer therapeuticsJanice M Reichert
Tufts Center for the Study of Drug Development, Tufts University, 192 South Street, Suite 550, Boston, Massachusetts 02111, USA
Nat Rev Drug Discov 6:349-56. 2007..Here, we overview trends in the clinical development and regulatory approval of monoclonal antibodies for cancer since 1980, with the aim of informing future research and development for this class of therapeutics... - Development trends for new cancer therapeutics and vaccinesJanice M Reichert
Tufts Center for the Study of Drug Development, 75 Kneeland Street, Suite 1100, Boston, MA 02111, United States
Drug Discov Today 13:30-7. 2008..These results indicate that improvement in the efficiency of the development process for innovative cancer treatments is needed... - A decade of the Fast Track programmeJanice M Reichert
Janice M. Reichert and Stephanie L. Rochon are at the Tufts Center for the Study of Drug Development, 75 Kneeland Street, Suite 1100, Boston, Massachusetts 02111, USA
Nat Rev Drug Discov 7:885-6. 2008 - Monoclonal antibodies as innovative therapeuticsJanice M Reichert
Senior Research Fellow, Tufts University, Tufts Center for the Study of Drug Development, 75 Kneeland Street, Suite 1100, Boston, MA 02111, USA
Curr Pharm Biotechnol 9:423-30. 2008..Trends in these benchmarks for various types of mAbs, with an emphasis on those studied as anticancer and immunological therapeutics, are discussed... - Finding value in the U.S. Food and Drug Administration's Fast Track programJanice M Reichert
Tufts Center for the Study of Drug Development, Boston, Massachusetts 02111, USA
Drug News Perspect 22:53-8. 2009..Our results suggest that evaluation of the Fast Track program requires a nuanced approach, and estimates of the program's value should include assessment of the resulting marketed products... - Second International Conference on Accelerating Biopharmaceutical Development: March 9-12, 2009, Coronado, CA, USAJanice M Reichert
Tufts Center for the Study of Drug Development, 75 Kneeland Street, Suite 1100, Boston, MA 02111, USA
Biotechnol Prog 25:1198-215. 2009.... - Second International Conference on Accelerating Biopharmaceutical Development: March 9-12, 2009, Coronado, CA USAJanice M Reichert
Tufts Center for the Study of Drug Development Boston, MA 02111, USA
MAbs 1:190-209. 2009.... - Antibodies to watch in 2010Janice M Reichert
Tufts Center for the Study of Drug Development, Boston, MA, USA
MAbs 2:84-100. 2010..Current as of October 2009, the results presented here will serve as a baseline against which future progress can be measured... - Anti-infective monoclonal antibodies: perils and promise of developmentJanice M Reichert
Tufts University, Tufts Center for the Study of Drug Development, 192 South Street, Suite 550, Boston, Massachusetts 02111, USA
Nat Rev Drug Discov 5:191-5. 2006..Here, we analyse trends in the development and approval of anti-infective monoclonal antibodies, and discuss factors that influence their success... - Monoclonal antibody successes in the clinicJanice M Reichert
Tufts University Center for the Study of Drug Development CSDD, 192 South Street, Suite 550, Boston, Massachusetts 02111, USA
Nat Biotechnol 23:1073-8. 2005..Most monoclonal antibodies in clinical trials are owned by small biotech companies. But with blockbuster-sized revenues and approval rates higher than those for small-molecule drugs, that all may be set to change... - Biopharmaceuticals approved in the EU 1995-1999: a European Union-United States comparisonJ M Reichert
Tufts Center for the Study of Drug Development, Boston, MA 02111, USA
Eur J Pharm Biopharm 51:1-7. 2001..We compared EU and US approval times for these products by product category and by review status (exceptional/non-exceptional circumstance in the EU and priority/standard in the US)... - Therapeutic cancer vaccines on trialJanice M Reichert
Tufts Center for the Study of Drug Development, Boston, MA, USA
Nat Biotechnol 20:659-63. 2002 - Public and private sector contributions to the discovery and development of "impact" drugsJanice M Reichert
Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts 02111, USA
Am J Ther 9:543-55. 2002..What remains clear, however, is that the process still starts with good science and ends with good medicine... - Therapeutic recombinant proteins: trends in US approvals 1982 to 2002Janice M Reichert
Tufts Center for the Study of Drug Development, Suite 550, 192 South Street, Boston, MA 02111, USA
Curr Opin Mol Ther 5:139-47. 2003..Approval success rates, calculated using three methods that differ only in the definition of success, and the variation of approval success rates over five time periods are presented... - Clinical development of therapeutic recombinant proteinsJanice M Reichert
Tufts Center for the Study of Drug Development, Boston, MA, USA
Biotechniques 35:176-8, 180, 182-5. 2003..S. approval success rates ranged from 17% to 58%. Trends in clinical phase lengths over five time periods and an overview of the rDNA therapeutics currently under Food and Drug Administration review are discussed... - New biopharmaceuticals in the USA: trends in development and marketing approvals 1995-1999J M Reichert
Tufts Center for the Study of Drug Development, 192 South Street, Suite 550, Boston, MA 02111, USA
Trends Biotechnol 18:364-9. 2000..They are also compared with the data for approvals during the periods 1982-1989, 1990-1994 and 1996-1998... - European Medicines Agency workshop on biosimilar monoclonal antibodies: July 2, 2009, London, UKJanice M Reichert
Tufts Center for the Study of Drug Development, Boston, MA, USA
MAbs 1:394-416. 2009..Proceedings of the workshop are presented in Part 1 of this report, and discussed within the context of the legal, regulatory and business environments of the European Union, Asia and the United States in Parts 2, 3 and 4, respectively... - Current trends in the clinical development of peptide therapeuticsPauline M Saladin
Harvard University, Department of Health Policy and Management, School of Public Health, Kresge 4th floor, 677 Huntington Avenue, Boston, MA 02115, USA
IDrugs 12:779-84. 2009..The results provide an historical overview of the development of peptide therapeutics, and may inform strategic planning in this area... - Development trends for human monoclonal antibody therapeuticsAaron L Nelson
Tufts University School of Medicine, Boston, Massachusetts 02118, USA
Nat Rev Drug Discov 9:767-74. 2010..Here, we analyse data on 147 human mAbs that have entered clinical study to highlight trends in their development and approval, which may help inform future studies of this class of therapeutic agents... - Recombinant protein therapeutics--success rates, market trends and values to 2010Alex K Pavlou
Datamonitor plc, Charles House 108-110 Finchley Road, London, UK
Nat Biotechnol 22:1513-9. 2004 - Trends in the development of therapeutic anti-cytokine antibodiesJanice M Reichert
Drug Discov Today 9:348. 2004