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Delivery Research

Location:
Wappingers Falls, NY, 12590
Posted:
April 25, 2011

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Resume:

* ****** ****

Wappingers Falls, New York *****

Home 845-***-****

Cell 845-***-****

Email: abhltb@r.postjobfree.com

Summary

Research scientist and team leader with expertise in molecular biology and

biochemistry. 10+ years of industry experience conducting hypothesis

driven biological research. Recent research focus on oral and pulmonary

drug delivery systems for proteins and small molecules using polarized cell

models. Additional experience with medium throughput cell based assays,

bioanalyitcs, and preclinical development of protein therapeutics.

Education

Ph.D. Molecular Pharmacology

Albert Einstein College of Medicine, Bronx, N.Y. June,

2000

M.S. Molecular Pharmacology

Albert Einstein College of Medicine, Bronx, N.Y.

January, 1996

B.S. Biochemistry

Pace University, Pleasantville, N.Y.

June, 1993

Professional Experience

Feb 2007- April 2011 Associate Director, Cell Based Studies

MannKind Corporation, Danbury CT

Pulmonary Insulin Delivery Research

. Directed day to day research activities to elucidate the mechanism of

action of delivery agents for pulmonary insulin and other proprietary

protein therapeutics using a wide range of research tools and

techniques including drug permeability studies (Calu-3 transwells,

PAMPA), cytotoxicity assays, P-gp assays, immunofluorescence, western

immunoblotting, Bis-ANS binding, DLS, and SDS/Native PAGE

. Developed and evaluated novel systems to administer dry powder

formulations to cell based systems to mimic pulmonary delivery in

vitro

. Investigated the impact of delivery agents on insulin signal

transduction pathways to characterize the effect of formulating on

drug activity

. Employed cell based assays to screen new chemical agents towards

developing a next generation delivery agent SAR project for

classifying permeability and cytotoxicity characteristics

. Reviewed and analyzed pulmonary delivery data from animal feasibility

studies for evaluation of new pipeline candidates and coordinating

appropriate cell based studies

. Provided frequent written reports on research progression and

presented formal updates to progress efforts in line with corporate

objectives

Bioassay Development

. Evaluated antibody performance in custom assays, and the cross-

reactivity of existing ELISAs to different targets and fusion proteins

as part of bioassay development to support research and preclinical

projects

. Conducted preclinical bioanalysis (ELISA) on serum samples to compare

PK profiles critical for evaluating new candidates for pulmonary

delivery

. Drafted bioanalytical sections of preclinical documentation

Analytical Analysis

. Supervised an analytical team of 5 staff members conducting RP-HPLC

assays and aerodynamics assays (ACI and Sympatec) designed to analyze

protein and small molecule stability and evaluate powder performance

of new formulations

. Evaluated chromatographic data, provided stability reports,

troubleshot chromatography, and correlated various characteristics

(water content/aerodynamics) of powders to rank their performance and

evaluate methods of accelerating stability studies

Protein Formulation

. Managed projects generating subcutaneous insulin formulations aimed at

developing rapid onset insulins and long term implantable insulin pump

technology

. Directed stability testing and conducted statistical analysis of data

to optimize insulin formulations for chemical stability and resistance

to amyloid fibrillation

. Formulated and evaluated the chemical stability of competitor's

products and patent applications (insulin formulations) as part of a

competitive intelligence campaign

. Drafted SOPs and Protocols for new sterile formulations

Regulatory

. GLP/GMP trained

. Reviewed and analyzed Pulmonary Functions Test results (PFTs) from

clinical trials and drafted narratives for FDA submission

June 2004 - Feb 2007 Associate Director, Cellular Science

Emisphere Technologies, Tarrytown NY

Oral Drug Delivery Research

. Directed day to day aspects of oral drug delivery transport mechanism

research for oral insulin, oral heparin, and other proprietary

projects

. Managed and directed cell based screening assays designed to identify

and classify drug delivery agents

. Conducted interdepartmental collaborations on focused research and

development projects

. Designed and implemented collaborative research projects with Roche

Pharmaceuticals and Novartis Pharmaceuticals which demonstrated

changes in the pathway of drug absorption in the presence of delivery

agents

. Provided formal reports and quarterly summaries for internal and

external collaborative projects

. Directed Circular Dichroism (CD) based SAR studies to investigate the

impact of various derivatives of active and inactive agents on the

secondary and tertiary structure of protein therapeutics

. Determined the long and short term effects of delivery agents on hGH

structure using HPLC to identify unmodified, deamidated and oxidized

states of a hGH

. Supervised four direct reports

May 2001 - May 2004 Research Scientist, Molecular Biophysics

Emisphere Technologies, Tarrytown NY

Oral Drug Delivery Transport Mechanism Studies

. Conducted drug transport experiments using the Caco-2 cell transwell

system as model for intestinal absorption, implementing fluorescent

and radioactive (125I, 3H, 14C) probes

. Characterized drug transport in Caco-2 monolayers by fluorescent

confocal microscopy and immunocytochemistry

. Studied the roles of various membrane proteins, signal transduction

molecules, and phosphorylation events during the drug transport

process

. Conducted various in vitro viability and cytotoxicity assays

. Developed an in vitro drug transport system using isolated brush

border vesicles

. Developed drug transport screening methods using flow cytometry

. Trained and oversaw interns and new employees

Proteomics

. Initiated proteomics projects in collaboration with an internal

genomics facility to evaluate changes to mRNA and protein levels

Drug Formulation

. Designed and prepared experimental drug formulations for oral drug

delivery

. Analyzed and interpreted primate data to assess preclinical

formulations

. Investigated the anti-protease activity of various drug delivery

excipients

. Analyzed protein constituents of solid dose formulations to evaluate

cross-linking and general stability

Assistant Radiation Safety Officer

. Maintained and monitored radioactive 14C, 3H, 32S, 125I isotopes on

site

(receiving/usage/disposal)

June 2000 - May 2001 Postdoctoral Research Associate

Charles S. Rubin Ph.D.

Dept. of Molecular Pharmacology

Albert Einstein College of Medicine, Bronx NY

Molecular Biology/Biochemistry

. Studied cyclic AMP dependent protein kinase signal transduction and

the role subcellular localization of PKA on signal dissemination

. Managed projects aimed at discerning the identity and characteristics

of mammalian RI/PKAI binding proteins

. Re-engineered AKAP binding sites to modulate specificity and affinity

. Refined and implemented various technical skills including, phage

library screening/cloning novel cDNAs, yeast two hybrid system,

subcloning, mutagenesis, PCR, RT-PCR, tissue culturing, C.elegans

maintenance, radioactive isotope handling (32P, 14C, 3H),

immunocytochemistry, protein binding assays, recombinant protein

expression and purification, purification of native proteins from

liver, brain and C.elegans, FPLC, HPLC, ion exchange, size exclusion,

western blot, southern blot northern blot, and many other fundamental

biochemical and molecular biological procedures

Sept. 1993 - May 2000 Graduate Student

Charles S. Rubin Ph.D.

Dept. of Molecular Pharmacology

Albert Einstein College of Medicine, Bronx NY

. Discovered and characterized of an A Kinase Anchor Protein in

C.elegans (AKAPCE)

. Acquired fundamental knowledge of experimental design and a wide array

of biochemical and molecular biological techniques

June 1992 - 1993 Laboratory Technician

Ira Schwartz Ph.D.

Dept. of Biochemistry

New York Medical College, Valhalla NY

. Native isolation of mutant and wild type prokaryotic translation

initiation factor 3 (IF3) and assessment of ribosome binding

Dec 1992 - June 1992 Undergraduate Student Research

Pace University, Pleasantville, NY

. Determined the effects on growth and lactate dehydrogenase

expression of tomato seeds exposed to varied levels of

cosmic radiation (provided by NASA)

Computer Skills

Proficient with Microsoft Word, Excel, PowerPoint, Access, and Adobe

Photoshop

Rudimentary understanding of programming languages

Awards and Honors

. Poster Presentation: "Technosphere Insulin: Defining the Mechanism of

Action", EASD 44th Annual Meeting Sept. 6-11, 2008

. Poster Presentation: "Technosphere Insulin: Defining the Mechanism of

Action", 68th Scientific Sessions American Diabetes Association (ADA)

June 6-10 2008

. Technical Excellence Award, Emisphere Technologies, 2006

. Technical Excellence Award, Emisphere Technologies, 2005

. Special Project Group Award, Emisphere Technologies, 2004

. Cell Based Assay Team Award, Emisphere Technologies, 2003

. Technical Excellence Award, Emisphere Technologies, 2002

. Poster Presentation: "Oral Insulin Absorption with EMISPHERE Drug

Delivery Agents. Mechanistic Studies Using Intestinal Epithelial

Cells", Second Annual Diabetes Technology Meeting, 2002

. Poster Presentation: "Characterization Caenorhabditis elegans protein

kinase A. Insights into the anchoring of PKAI isoforms", Gorden

Conference: 2nd Messengers and Protein Phosphorylation, 1998

. Presentation: "Purification and ribosome binding of mutant and wild

type IF3",

. 41st annual Undergraduate research symposium at Fordham University,

1993

Publications

Angelo R, Rousseau K, Grant M, Leone-Bay A, Richardson P. (2009)

Technosphere Insulin: Defining the Role of Technosphere Particles at the

Cellular Level. J Diabetes Sci. Technol. Vol. 3, Issue 3, pp. 545-554

Malkov D, Angelo R, Wang H, Flanders E, Tang H, Gomez-Orellana I. (2005)

Oral Delivery of Insulin with the eligen Technology: Mechanistic Studies.

Current Drug Delivery. Volume 2, No. 2, pp.191-197

Ding X, Rath P, Angelo R, Stringfellow T, Flanders E, Dinh S, Gomez-

Orellana I, Robinson JR. (2004) Oral Absorption Enhancement of Cromolyn

Sodium Through Noncovalent Complexation. Pharm. Res. Dec;21(12):2196-206.

Angelo, R.G. and Rubin, C.S. (2000) Characterization of Structural Features

That Mediate the Tethering of Caenorhabdtitis elegans Protein Kinase A to a

Novel A Kinase Anchor Protein, J. Bio. Chem. 275-****-****.

Angelo, R and Rubin, C.S. (1998) Molecular Characterization of an Anchor

Protein (AKAPCE) That Binds the RI Subunit (RCE) of Type I Protein Kinase A

from Caenorhabditis elegans. J. Bio. Chem. 273 146**-*****.



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