Summary

Almost 20 years total of biotech experience. The last fourteen years of comprising clinical experience including operational responsibilities, generating protocols, analyzing data and contributing to regulatory documents. Prior to that headed up a variety of pre-clinical responsibilities.

Custom

PATENTS

Mathiowitz E, Bernstein H, Morrel EM, and Schwaller K.

Method for Producing Protein Microspheres. Patent Number 5,271,961. Issued 12/21/93

Bernstein H, Morrel EM, Mathiowitz E, Schwaller K, and Beck TR

Protein Microspheres and Methods of Using Them. Patent Number 5,679,377. Issued 10/21/97

PUBLICATIONS

Morrel EM, Friden PM and Goldberg D. Significant and Rapid Intradermal Delivery of Acyclovir Using a Novel Iontophoretic Device and Acyclovir Gel Formulation: A Clinical Pharmacokinetic Study. Presentated at the 2009 American Association for Dermatology Meeting, San Francisco, CA.

Morrel EM, Spruance SL, Goldberg D, and Iontophoretic Acyclovir Study Cold Sore Group.  Topical Iontophoretic Administration of Acyclovir for the Episodic Treatment of Herpes Labialis; A Randomized, Double-Blind, Placebo-Controlled, Clinic-Initiated Study. Clin. Inf. Dis. 43:460-467, 2006..

Roth DA, Tawa NE, Proper J, Morrel EM Treco DA, Schuetz T, Selden RF and the Factor VIII Transkaryotic Therapy Study Group. Implantation of Non-Viral Ex Vivo Genetically Modified Autologous Dermal Fibroblasts That Express B-Domain Deleted Human Factor VIII in 12 Severe Hemophilia A Study Subjects. Presented by Roth at the 2002 Meeting of American Society of Hematologists, Philadelphia, PA.

Roth DA, Tawa NE, O'Brien JM, Treco DA, and Selden RF, For the Factor VIII Transkaryotic Therapy Study Group.  Nonviral Transfer of the Gene Encoding Coagulation Factro VIII in Patients with Severe Hemophilia A. NEJM 344(23): 1735-1742, 2001.

Morrel, EM.  The Unmet Medical Need. Pediatrics and Asthma.  Presented at the SMi Conference on Asthma Drug Therapy and Healthcare.  September, 1999. London, UK.

Ahmed M, Morrel EM and Clemente E. Bioavailability and Pharmacokinetics of a New Liquid Prednisolone Formulation in Comparison with Two Commercially Available Liquid Prednisolone Products. Curr. Ther. Res. 62(7): 548-556, 2001.

Ahmed M, Morrel EM, Sloan JE, and Lane EA. Controlled Release Acetaminophen Sprinkles: Pharmacokinetics in Healthy Children and Adults. J. Ped. Pharm. Ther. 6(4): 304-310, 2001

DiBiase MD and Morrel EM. Oral Delivery of Microencapsulated Proteins. Protein Delivery: Physical Systems. Sanders LM and Hendren RW, eds. Plenum Press, NY 1997

Morrel E, Tompkins RG, Fishman A J, Wilkinson PA, Burke JF, Rubin RH, Strauss HW and Yarmush ML. Imaging Infections with Antibodies: A Quantitative Autoradiographic Analysis.

J. Immunol. Methods. 130: 39-48, 1990.

Morrel E, Tompkins RG, Fishman A J, Wilkinson PA, Burke JF, Rubin RH, Strauss HW and Yarmush ML. Autoradiographic Method for Quantitation of Radiolabelled Proteins Using Indium-111.

J. Nuclear Medicine. 30: 1538-1545, 1989.

Morrel EM, Holland JA, Pritchard KA, Colton CK and Stemerman MB. Endothelial Cell Perturbation and Low Density Lipoprotein: Quantitative Autoradiography. Proc. New York Academy of Science. 516: 412-417, 1988

Work History

Work History
May 2003 - Present

VP Clinical Research

http://www.transportpharma.com

Responsible for design and writing of all clinical protocols Phases 1 - 3. Current programs in the use of novel iontophoretic combination products to treat herpes labialis and onychomycosis. Responsible for overseeing data analysis for all Transport clinical trials. Acting as primary contact with clinical sites and CROs with regard to all protocol design related questions and assisting Clinical Operations with regard to day to day interactions with sites, e.g. questions on proper conduct of study. Responsible for writing of all clinical and clinically related regulatory documents including Investigator’s Brochures, Clinical Study Reports, and relevant sections of any regulatory submissions (Transport has filed two INDs to date).

2000 - 2003

Assoc. Director Clinical Operations

Transkaryotic Therapies Inc. (TKT)

Responsible for the direction and management of all operational aspects of clinical trials relating to gene therapy, including protocol design and execution, study monitoring, and study related Regulatory submissions. Responsible for identifying Principal Investigators, surveying and qualifying investigational sites, negotiating and managing contracts with Contract Research Organizations and clinical sites, and monitoring and auditing of CROs and investigational sites to ensure that clinical studies are executed properly, Participate in the development, establishment, and implementation of protocols and coordinate IRB submissions.

Sep 1994 - Jan 2000

Asst. Director Medical Affairs

Ascent Pediatrics, Inc.
Responsible for management of all Phase I studies including protocol development, monitoring of study, data analysis (both pharmacokinetic and statistical), and review of study reports. As all clinical studies were contracted out, responsibilities included selection of CRO, negotiation of budgets for studies, and all interactions with personnel at CRO. Managed over 20 Phase I studies during a 5 year period including 3 studies with healthy normal children. Assisted in the conduct of 7 Phase II/III studies including protocol generation, monitoring, review of data, and generation of study reports. Contributed various clinical sections as part of submissions for 3 NDA's and 2 IND's. Responsible for management of all pre-clinical studies including study design, data analysis, review of reports, and all interactions with sub-contracted laboratories conducting studies.
Feb 1989 - Aug 1994

Sr. Research Scientist

Alkermes

Oringally with Enzytech: 1989-1991 when Alkermes acquired Enzytech Alkermes: Responsible for coordinating and executing all pre-clinical studies, both in-house and subcontracted, for parenteral and oral delivery systems based on Enzytech technology. These studies included all pharm/tox and pharmacokinetic investigations, and validation of bioassays. Responsible for all aspects of process development for manufacturing a protein/peptide oral delivery formulation for clinical studies. Enzytech: Responsible for development of an oral drug delivery program, development of animal research models, and establishment of an animal research facility.

1989 - 1991

Sr. Research Scientist

Enzytech

Responsible for development of an oral drug delivery program, development of animal research models, and establishment of an animal research facility.

Education

Education

Woodmere Academy
1987

PhD

Massachusetts Institute of Technology

Conducted studies of the transport of Iow density lipoproteins within the rabbit arterial wall. Investigation included the collection of extensive morphological and quantitative data for use in the development of mathematical models of macromolecular transport.

Thesis Advisors: Profs. Clark K. Colton and Kenneth A. Smith

Research Assistant - January, 1984 to June, 1987

1986

MS in Chemical Engineering Practice

Massachusetts Institute of Technology

Chemical Engineering Practice School project sites:

General Electric/Noryl Products and Silicone Products Business Division; Bethlehem Steel

1983

MS Chemical Engineering

Massachusetts Institute of Technology

Research: Developed a method of quantitative autoradiography for study of biological transport of radioiodinated proteins.

1974 - 1978

BSE

Princeton University