Cynthia


Cynthia Maryanoff, PhD
Blumberg Institute Distinguished Professor (In House Adjunct Faculty)
Ph: (215) 589-6411
Email: cynthia.maryanoff@bblumberg.org


TRAINING

Princeton University, Ph.D. in organic chemistry (1976)
Princeton University, Postdoctoral Fellow in organic synthesis chemistry (1976-1977)

Appointment at the Blumberg Institute: Distinguished Professor

Other appointments: Professor of Drug Development, Pennsylvania Drug Discovery Institute; Member, Executive Committee ACS Division of Organic Chemistry (1988-2018, by national election); Chairman, Awards Committee in ACS (1989-current), Member, ACS Governing Board for Publishing (2015-2019); Member, ACS Development Advisory Board, (2011-2017), Member, ACS Committee on International Affairs, (2013-2016), Member, Advisory Council of the College of Arts and Sciences at Drexel University (1998-present), Principal Member, Maryanoff & Maryanoff, LLC.

RESEARCH OVERVIEW

Throughout a long and successful career in industry, Dr. Cynthia A. Maryanoff has consistently demonstrated scientific excellence in taking products from the laboratory to commercial manufacture.  Her focus on early process research emphasized a green-chemistry approach.  She has influenced or directed the development of many drug candidates in the fields of antipsychotic and antiepileptic treatments, analgesics with transdermal delivery, pulmonary surfactants, cardiovascular disease, endocrine function, and antiviral agents.  Some of the more notable are: TOPAMAX (topiramate), an anti-epileptic drug; ULTRAM (tramadol), an atypical analgesic to treat moderate to severe moderate pain; and CYPHER Sirolimus-eluting Coronary Stent.  Although process development and scale-up are ordinarily considered engineering, in complex drug synthesis, basic chemistry is critical.  Maryanoff was the bridge between the lab and commercial operation.  She is generally recognized for an incredible track record of developing numerous commercial drug manufacturing processes and never having a commercial manufacturing failure.

RESEARCH

Drug Development:  Expert scientific leadership to move new molecular entities from small-scale chemical synthesis to large-scale, development of formulations for pharmaceutical use (oral, IV, topical) and for coated devices, toxicology studies, first-in-human and proof-of-principle studies, in a short time period.  Led scientists to solve difficult technical and regulatory problems involving convergent/combination products, Class II/III medical devices, consumer products, pharmaceutical and biological products.

Regulatory: Authored US and OUS regulations and regulatory filings for active pharmaceutical ingredients (APIs) and drug-eluting devices; routinely presented/interacted with regulatory authorities.  Skilled in Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), International Pharmaceutical Excipient Council guidelines (IPEC), Drug Master File (DMF) preparation, European regulatory practices, and International Conference on Harmonization (ICH) Guidelines. Subject Matter Expert for Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) including 21 Code of Federal Regulations (CFR) Part 210 / 211, 312 / 314, 21 CFR Part 820.

RESEARCH SUMMARY

Organic synthesis; scale-up of NMEs to commercial scale; stereochemistry; analytical and mechanical characterization of APIs and drug-eluting devices, by chromatography, vibrational spectroscopies, surface analysis, solid-state analysis, particulate analysis; biomedical polymers.

SELECTED PUBLICATIONS:

Adhesion between Suspended Polymeric Films and a Metallic Substrate: Experiments and Models, J. Du, E. P. Hampp, W. Shan, H. Li, G. Papandreou, C.A. Maryanoff, W. Soboyejo, J. Mat. Res., 2012, 27, 1797-1805.

Quantitative Surface Defect Analysis of Drug-eluting Coronary Stents by Scanning Electron Microscopy: Coating Integrity of the CYPHERâ Sirolimus-eluting Coronary Stent, K. M. Balss, V. Veselov, H. Li, E. Akerman-Revis, M. Interbitzen, J. Alvarez, C. Wendel, E. Pottinger-Cooper, L. A. Alquier, M. F. Chisholm, R. O’Brien, S. Garcia-Tunon, G. Papandreou, C. A. Maryanoff, Anal. Methods, 2012, 4, 3968-3973.

A Novel Test Method to Evaluate Chronic Particulate Generation from Durable Polymer Stent Coatings: A Case Study of CYPHER® Sirolimus-eluting Coronary Stents, J. H. Cohen, K. M. Balss, E. Akerman-Revis, M. Inderbitzen, J. Lisk, A. Marathe, R. O’Brien, E. Pottinger-Cooper, W. Rudd, C. Wendel, G. Papandreou, C. A. Maryanoff, Anal. Methods, 2012, 4, 3961-3967.

Pore Networks and Polymer Rearrangement on a Drug-Eluting Stent as Revealed by Correlated Confocal Raman and Atomic Force Microscopy, K. B. Biggs, K. M. Balss, C. A. Maryanoff, Langmuir, 2012, 28, 8236-8243.

Thrombogenic Collagen-mimetic Peptides: Self-assembly of Triple Helix-based Fibrils Driven by Hydrophobic Interactions M. A. Cejas, W. A. Kinney, C. Chen, J. G. Vinter, H. R. Almond, Jr., C. A. Maryanoff, K. Balss, M. Breslav, E. Lacy, B. E. Maryanoff, Proc. Natl. Acad. Sci. USA, 2008, 105, 8513-18.

Multivariate Analysis Applied to the Study of Spatial Distributions Found in Drug-Eluting Stent Coatings by Confocal Raman Microscopy.  K. M. Balss, F. H. Long, V. Veselov, A. Orana, E. Akerman-Revis, G. Papandreou, C. A. Maryanoff, J. Anal. Chem., 2008, 80, 4853-59.

Cyclizations of N-Acyliminium Ions. B. E. Maryanoff, H.-C. Zhang, J. H. Cohen, I. J. Turchi, C. A. Maryanoff, Chem. Rev., 2004, 104, 1431-1628.

Solution Phase Synthesis of the Pulmonary Surfactant KL-4, a 21 Amino Acid Synthetic Protein. A. Abdel-Magid, M. E. Bos, U. Eggmann, C. A. Maryanoff, L. Scott, A. Thaler, F. J. Villani Jr., In Chemical Process Research; Abdel-Magid, A. F., Ed.; ACS Symposium Series 870; American Chemical Society: Washington, DC, 2004, 181-97

A Practical Synthesis of the Platelet Fibrinogen Antagonist, Elarofiban. J. H. Cohen, S. Cesco-Cancian, B. D. Harris, J. T. Hortenstine, M. Justus, C. A. Maryanoff, J. Mills, S. Muller, A. Roessler, L. Scott, K. L. Sorgi, F. J. Villani Jr., R. R. H. Webster, C. Weh, Org. Process Res. Dev, 2003, 7, 866-72.

Reaction Safety: An Improved Procedure for the Preparation of 1,3,4,12a-Tetrahydro-11H-[1,4]-oxanio[3,4-c]benzodiazepine-6,12-dione with Iron in Acetic Acid. J. S. Grimm, F. Liu, S. Stefanick, K. Sorgi, C. A. Maryanoff, Org. Process Res. Dev., 2003, 7, 1067-70.

Synthesis of Influenza Neuraminidase Inhibitors, A. F. Abdel-Magid, C. A. Maryanoff, S. J. Mehrman, Curr. Opin. Drug Discovery Dev., 2001, 4, 776-91.

Reductive Aminations of Aldehydes and Ketones With Sodium Triacetoxyborohydride.  Studies on Direct and Indirect Reductive Amination Procedures. A. F. Abdel-Magid, K. G. Carson, B. D. Harris,  R. D. Shah and C. A. Maryanoff, J. Org. Chem., 1996, 61, 3849-62.