Director Analytical and Bioanalytical

LARRY M. MALLIS, Ph.D.

* ******* ***

Harleysville, PA 19438

215-***-****; *********@*******.***

PROFESSIONAL HISTORY

Lovelace Biomedical, Albuquerque, NM 01/2017-present

Director - Bioanalytical Operations

•Oversees and coordinates the daily activities of the bioanalytical chemistry laboratory. The bioanalytical chemistry lab provides core services in assay development, assay validation and sample analysis to meet the needs of the institute for both small and large molecule bioanalytical method development, validation, and sample analysis.

•Leverage experience in LC-MS/MS, bioanalytical sample extraction/preparation, bioanalytical guidance(s) and sample analysis to manage the Bioanalytical Chemistry Laboratory.

•Ensures compliance with current bioanalytical guidance documents (FDA, EMA, Health Canada, Crystal City White Papers, WRIB White Papers, GLP, EH&S, etc.).

•Work to improve the efficiency, productivity, and profitability of the Bioanalytical Laboratory. Responsible for overseeing project prioritization and timelines related to data interpretation, data summary, report writing, and interfacing with investigators who utilize this lab.

•Meet with clients (internal and external) for both technical and timeline project needs. Act as a subject matter expert internally as well as with business development.

•Internal consultant to the Mako Medical Laboratories, located at Lovelace, to aid in streamlining methodology for the quantitative analysis of drugs of abuse determined from oral fluids.

•Research interests include the PK and ADME properties of test articles and chemical agents following multiple routes of delivery, and robotic implementation of sample preparation for quantitative analysis (both Mako and Lovelace laboratories).

Frontage Laboratories, Inc., Exton, PA 01/2015-01/2017

Director - Bioanalytical Services

•Assist the VP, Bioanalytical Services, in planning and implementing strategic and operational initiatives to support continuous improvement of the bioanalytical function, as well as assist in implementing laboratory scale-up plan to meet Frontage USA growth and revenue targets for short-, mid-, and long-term plans.

•Trains and manages his/her direct reports, participates in project prioritization and ensures that timelines are followed, participates in and/or guides staff to develop bioanalytical assays, and analyze biological samples, using non-GLP or validated assays.

•Creates and/or reviews SOPs for laboratory assays using experienced and selected staff.

•Drives the hiring process with Frontage USA HR to recruit talent at all levels.

•Helps to develop the division’s budget, ensures adherence, performs budget follow-up for pertinent stakeholders and recommends actions in an effort to achieve the expected results by managing and controlling the cost of staff, supplies and instrumentation and other P+L management-related functions.

•Represents Frontage USA on technical issues with clients as required by providing technical and scientific input on Frontage USA assay services and client projects.

•Fulfills management responsibilities with respect to Good Laboratory Practices, processes and procedures that assure workplace efficiency, data integrity, and regulatory compliance.

•Research interests involve capillary microsampling techniques and implementation of an eNotebook (IDBS) within the Bioanalytical Department..

•Works closely with colleagues at Frontage China to harmonize and improve the company’s global processes

Critical Path Services, LLC, Garnet Valley, PA 3/2011–01/2015

Director-Scientific Services 8/2014-01/2015

Laboratory Director 3/2011-8/2014

Accountable for the overall operations of the laboratory division including safety, quality, efficiency, and strategic planning. The laboratory is equipped with Agilent (6410b) and Sciex (4000) triple quad LC/MS/MS instruments (each equipped with Agilent 1200 or 1290 HPLC or uHPLC systems). In addition the laboratory includes Agilent 1100 HPLC-DAD and Thermo DSQ II GC/MS systems. The 14C radiolabelled laboratory has a Waters Xevo-G2-XS Q-ToF (equipped with a Waters Acquity I-Class UPLC) for structure elucidation of metabolites and degradates.

The laboratory staff performs GLP trace level analysis under both EPA and FDA regulations. This includes (but is not limited to) method development, validation, and the extaction and analysis of compounds from a variety of matrices (e.g., plasma, tissue, crops, water, soil, etc.).

Accountable for the overall performance and operation of the document services group which performs technical writing for laboratory reports and other dossier related projects for the crop protection, industrial chemical, and health services sectors.

With the CEO sets strategic direction for the laboratory division. This includes the development and implementation of GLP bioanalytical, environmental fate analysis, SOPs, method development, validation, and sample analysis.

Member of both the marketing and sales teams for the company, which includes website redesign. As such am responsible for laboratory business development, as well as all quotes and invoicing for laboratory work.

Research interests involve high throughput sample preparation and analysis as well as allergen protein quantitation using digestion followed by LC-MS/MS analysis.

Merck & Co., Inc., West Point, PA 11/2004 – 3/2011

Principal Analytical Chemist, Analytical Development & Commercialization 05/2007 – 3/2011

Research Fellow/Laboratory Manager, Biochemical Toxicology 11/2004 – 05/2007

As Laboratory Manager, responsible for managing a group of nine scientists (two Ph.D.; three M.S.; four B.S.). The responsibility of the group was to provide GLP bioanalytical data in support of animal safety studies using Sciex (3000, 4000, and 5000) triple quad LC/MS/MS systems each equipped with Agilent 1100 HPLC pumps. Research interests involved developing new Open-access software for streamlining sample analysis using LC/MS/MS chromatographic separation and quantitation. This includes the development and implementation of new open-access software (Cliquid ) and the GLP evaluation of the Spiderling 9-column switching device for chromatographic evaluation.

As a Research Fellow in Biochemical Toxicology (BCT) group in Safety Assessment, responsible for TK plasma sample analysis as well as project management for the BCT group.

As Principal Analytical Chemist in Analytical Development & Commercialization (ADC Pharm), responsible for the development and validation of all analytical methods for control and stability for clinical Phase IIb through commercialization, primarily using Agilent 1100 and 1200 HPLC systems. User of Atlas Chromatography LIMS system and Electronic Lab Notebook. Performed Dissolution, disintegration, KF, IR, hardness, potency, stability, and content uniformity testing. Performed release as well as stability testing for expiration dating. Worked with tablet, injectable, metered dose inhaler, drug coated device, and etc.

Responsible for the analysis of samples for clinical release and product stability as well as LC/MS/MS analysis for structure elucidation of impurities and degradates using Thermo LCQ ion trap LC/MS and Sciex API 4000 LC/MS systems, each equipped with Agilent 1100 HPLC systems.

Project Chemist for multiple late stage development programs (e.g., asthma, diabetes, Inter-ocular pressure).

Wyeth Research, Discovery Analytical Chemistry - Chemical Technologies,

Chemical and Screening Sciences, Collegeville, PA 7/1998 – 11/2004

Principal Research Scientist II, Discovery Analytical Chemistry 1/2004 – 11/2004

Senior Research Scientist II, Discovery Analytical Chemistry 7/1998 – 1/2004

Team Leader of the Structure Analysis and Pharmaceutical Profiling groups, as well as co-Leader of the Structure Elucidation group within the Discovery Analytical Chemistry (DAC) department in Collegeville.

Responsible for day-to-day operations while supervising seven chemists (two Ph.D.; three M.S.; one B.S.; one Post-doc). This included the writing of scientific proposals for additional space, instrumentation, and scientists as well as the development of a research program in the area of in-vitro metabolism, pharmacokinetics, and high throughput purity and integrity screening of discovery compounds.

The DAC group was involved in the analysis of Discovery Medicinal Chemistry compounds using NMR, mass spectrometry, analytical and preparative HPLC, and microanalysis techniques.

Research interests involve developing new methodologies for high-throughput stability, metabolic profiling, and metabolite structure identification of discovery compounds using LC/MS, LC/MS/MS, automated preparative HPLC, and LC/NMR instrumentation.

Interests also included the development and implementation of open-access methods using LC/MS technology as well as development of a rapid purity and integrity assay for the analysis of high throughput screening hits.

Magainin Pharmaceuticals, Inc., Plymouth Meeting, PA 3/1997 – 7/1998

Assistant Director, Analytical Chemistry

Responsible for the day-to-day operations of the Analytical Chemistry Group while supervising three chemists. This included the start-up, organization, and management of 21 stability campaigns as well as the design and oversight of the renovation of a new laboratory for analytical chemistry.

Coordinated and participated in the validation/writing of stability indicating methodology for the NDA of Cytolex topical antibiotic cream.

Wrote the analytical/stability methods sections of the IND for Squalamine (anti-angiogenic).

Involved in HPLC methods development for the quantitation of non-UV active pharmaceutical compounds using derivatization (fluorescence detection) as well as identification of degradants formed on stability of drug products using LC/MS (Hewlett-Packard MS Engine with electrospray) and MALDI-TOF MS techniques (Perseptive Voyager). This also included the use of Hewlett-Packard 1090 and 1100 HPLC systems.

Coordinated efforts for the development of “rapid”, high-throughput methods for analysis of combinatorial and pharmacokinetic plasma samples.

Research interests involve the in-vitro metabolism of potential drug candidates with Cytochrome P450 enzymes as well as liver microsomes.

Bristol-Myers Squibb, Inc., New Brunswick, NJ 10/1991 – 03/1997

Senior Research Investigator I, Biologics Development & Stability 04/1996 – 03/1997

Senior Research Investigator I, Analytical Spectroscopy 09/1994 – 04/1996

Research Investigator II, Analytical Spectroscopy 10/1991 – 09/1994

As a Senior Investigator, performed LC/MS and LC/MS/MS impurity and degradant profiling (ionspray, electrospray, and thermospray) of early development drug candidates using Finnigan-MAT TSQ 700, SSQ 7000, and PE/Sciex API III mass spectrometers.

Was coordinator of structure elucidation projects (using HPLC, NMR, and MS techniques).

As Assistant Team Leader in the Biologics Development and Stability Group, responsible for team leadership focusing on structure characterization and impurity analysis of biologics under development.

Research interests involved automated HPLC methods development for peptide mapping and carbohydrate analysis using a Perseptive Biosystems Integral HPLC system coupled with bench-top MS detection.

Univ. of Iowa - High Res. Mass Spec. Facility, Iowa City, IA 01/1987 – 10/1991

Associate Research Scientist/Director 01/1989 – 10/1991

Assistant Research Scientist/Director 01/1987 – 01/1989

As Director, responsible for Facility staff training and scheduling, training of over 125 graduate students, faculty, and staff in the operation of a walk-on VG TRIO 1 GC/MS, and control of the Facility budget ($1.2M capital and $0.8M operating over a 4 year period).

Involved in the analysis of samples using high resolution MS techniques, as well as method development for LC/MS (thermospray and plasmaspray) and MS/MS (FAB and LC) experiments using the VG ZAB-HF and VG TRIO 3 mass spectrometers, respectively.

Research interests included the analysis and structure elucidation of peptides, nucleotides, highly sulfated heparin and chondroitin/dermatan derived polysaccharides, and synthetic organometallic compounds using MS/MS techniques.

EDUCATION

Ph.D. in Analytical Chemistry 1987

Texas A & M University, College Station, TX

Dissertation: “Some Aspects of the Chemistry of Organo-Alkali Metal Halide Clusters by Using Fast Atom Bombardment Ionization and Tandem Mass Spectrometry”

(Prof. David H. Russell)

B.S. in Chemistry 1982

Cook College/Rutgers The State University of New Jersey, New Brunswick, NJ

Internship: Analytical Chemist 5/1981-6/1982

U.S. Environmental Protection Agency

Edison, NJ

TRAINING COURSES

Scientific

04/17 User training for SalesForce software

04/16 Administrative and SuperUser training – IDBS Bioanalytical Electronic Lab Notebook

08/14 Annual GLP Training: Meaghan Mitchell – Trainer

12/13 Participation in Crystal City V Symposium and Review of New FDA Bioanalytical Method Validation Guidance Document

08/12 Biohazard Safety Training: Norm Henry, M.S. - Trainer

05/12 FDA and EPA FIFRA Good Laboratory Practice Regulations; 21 CFR Part 58 and 40 CFR Part 160

05/12 Bioanalytical Method Validation and Sample Analysis: FDA Guidance and Crystal City III Implementation

04/11 - pres CPS SOPs and policies, self-study

05/07 – 03/11 Merck SOPs and policies, online self-study (GMP)

11/04 – 05/07 Merck SOPs and policies, online self-study (GLP)

05/08 Thermo LCQ Fleet Hands-on Training Course, Thermo, Inc. at Merck, West Point, PA

02/08 Sciex API 3000/4000 Hands-on Training Course, Sciex, Inc. at Merck, West Point, PA

11/07 Practical LC/MS Analysis, Jack Henion, Advion Biosciences, Inc. at Merck, West Point, PA

09/07 Dissolution Testing of Pharmaceutical Dosage Forms: Comprehensive Understanding of Principles and Applications, Banakar Consulting Services at Merck, West Point, PA

08/07 Pharmacokinetics & Biopharmaceutics, Faculty of Univ. of Sciences-Phila. at Merck, West Point, PA

06/07 Stability of Pharmaceuticals, School of Pharmacy, Univ. of Wisconsin at Merck, West Point, PA

09/06 Pharmaceutical Toxicology: Toxicology in the Nonclinical Development of Drugs and Biologics, PERI Course, Baltimore, MD

08/05 Sciex API 4000 Training Course, Sciex, Inc. at Merck, West Point, PA

03/05 Advanced Drug Metabolism, Faculty of Univ. of Washington, at Merck, West Point, PA

09/02 LC-TOF MUX-5 High Res. Acc. Mass Course, Micromass, Inc., at Wyeth, Collegeville, PA

06/02 GC-TOF Training Course, Micromass, Inc., Beverly, MA

07/01 WinNonlin Professional v. 3.1, Pharsight Inc., held at W-AR, Pearl River, NY

05/01 Multivariate Analysis Software, Umetrics, Inc., Clinton, NJ

08/00 Quattro Ultima System and Quantitation Training Course, Micromass, Inc., Beverly, MA

06/00 Quantitative Mass Spectrometry, ASMS Short Course-Long Beach, CA

04/00 Short Course in Medicinal Chemistry, W-AR, Princeton, NJ

01/00 Alliance-ZMD LC/MS System Training Course, Waters Corporation, Milford, MA

07/99 Introduction to Pharmacokinetics, W-AR, Princeton, NJ

11/98 NMR Short Course, Eastern Analytical Symposium, Somerset, NJ

11/96 Analytical Methods for Proteins, ACS-Short Course, EAS, Somerset, NJ

08/96 INTEGRAL HPLC Training Course - Perseptive Biosystems, Framingham, MA

11/95 Fundamentals and Practical Aspects of 1-, 2-, and 3-D NMR, EAS, Somerset, NJ

09/94 UX NMR-1 General Operation - Bruker Instruments, Billerica, MA

01-04/93 Modern Synthetic Organic Chemistry - B-MS, New Brunswick, NJ

08/92 API III General Operation - PE/Sciex, Thornhill, Ontario, CA

06/92 TSQ 700 Electrospray Operation - Finnigan-MAT Institute, Cincinnati, OH

04/92 TSQ 700 General Operation - Finnigan-MAT @ B-MS, New Brunswick, NJ

04/91 TRIO 3 Training Course - VG Masslab, Ltd., Manchester, UK

11/87 ZAB Training Course - VG Analytical, Ltd., Manchester, UK

Leadership

09/06 Managing for Success, Merck, Cokesbury, NJ

06-12/05 Managing @ Merck Leadership Training Course, Blue Bell, PA

04/05 John C. Maxwell: The Influential Leader: Unleashing Power in People, Maximum Impact Simulcast held in Harleysville, PA

04/04 John C. Maxwell: The Qualities of a Leader, Maximum Impact Simulcast held in Harleysville, PA

02/97 Senn-Delaney Team Building Course, B-MS, Syracuse, NY

07/96 Performance Partnership - B-MS Training & Development Center, Plainsboro, NJ

02/95 Foundations for Exempt Professionals - B-MS Training & Develop. Center, Plainsboro, NJ

01/95 Mentally Tough - B-MS Training & Develop. Center, Plainsboro, NJ

02/93 Situational Leadership - B-MS Training & Develop. Center, Plainsboro, NJ

PROFESSIONAL AND SCIENTIFIC ACTIVITIES

2010 Mass Spec Course – Quantitation Using QQQ Mass Specs – Merck, West Point, PA

2008 Conference Organizing Committee – ASMS, Denver, CO

06/06 Session Chair – Importance of LC/MS in Chemical Toxicology – MARM-ACS, Hershey, PA

2004 Lecturer/Course Development Team Member – Center for Business Intelligence Course on LC/MS in Drug Discovery and Development, 2-Day Course, Research Triangle Park, NC (01/04), Somerset, NJ (04/04), Chicago, IL (09/04), and San Diego, CA (11/04)

10/01, 09/02 Recruiter for Wyeth Research – Dept. of Chemistry, Texas A & M University

2002 Lead Trainer/Moderator/Course Development Team Member – Pharmaceutical Profiling 1-Day Training Course, Wyeth Research – Collegeville, PA and Princeton, NJ

11/00 Recruiter for Wyeth Research – Dept. of Chemistry, Purdue University

09/99 Recruiter for Wyeth Research – Dept. of Chemistry, University of Illinois

10/91–pres. Member - Mass Spectrometry Discussion Group (Delaware Valley, North Jersey - ACS)

09/95–08/96 Chair - MSDG, North Jersey Section – ACS

09/94–08/95 Chair Elect - MSDG, North Jersey Section - ACS

09/93–08/94 Treasurer - MSDG, North Jersey Section - ACS

06/90–06/91 Chairman - Manufacturers Forum - ASMS Academic Lab Managers Interest Group

01/91–08/91 Chairman - Iowa Award Committee (Iowa Section - ACS)

06/89–09/91 Chapter Advisor - Alpha Chi Sigma (AX ) Professional Chemistry Fraternity

1985–pres. Member – American Society for Mass Spectrometry

1982–pres. Member – American Chemical Society

GRANTS, FELLOWSHIPS, AND AWARDS

10/10 “Award of Excellence”, GMP Notebook Remediation Team, Merck, ADC-Pharm

05/10 “Safety Award”, Developing a plan for lab work using a high potency compound, Merck, ADC-Pharm

08/09 “REALISE Award”, Critical Filing Review, Merck, ADC-Pharm

2/08 “REALISE Award”, Method Development and Degradate Identification for a Late Stage Compound, Merck, ADC-Pharm

10/07 “Peer to Peer and REALISE Awards”, Tech Transfer of Development Compound, Merck, ADC-Pharm

08/07 “Special Recognition Award”, Cross function Task Force on Training, Merck, SA

06/07 “Special Achievement Award”, Versatile Workforce Task Team, Merck, SA

12/06 “Special Recognition Award”, FDA Lab Tours, Merck, SA

11/06 “Special Recognition Award”, LSIT Retreat Organizing Committee, Merck, SA

11/03 “Wyeth Award”, Collegeville Poster Session Coordinator – Chemical & Screening Sciences

12/01 “Above and Beyond Award”, Move to Collegeville, Wyeth Research - Chemical Sciences

11/01 “Certificate of Recognition”, Wyeth Headquarters On the Road to Collegeville Relo Project

12/96 “On-the-Spot Award” for Implementation of New Department Structure, B-MS

07/95 “On-the-Spot Award” for the Development and Implementation of an LC/MS Method Which Uses Non-Volatile Phosphate Buffers, B-MS

1991 NIH Small Instrumentation Grant for Perkin Elmer Elemental Analyzer ($45K, UI)

10/88–09/89 NIH Shared Instrumentation Grant for Triple Quadrupole Mass Spectrometer ($400K, UI)

03/86 Arthur E. Martell Graduate Student Travel Award (TAMU)

05/83–09/83 Robert A. Welch Predoctoral Fellowship (TAMU)

09/78–05/82 Manufacturers' Hanover Trust Co. College Scholarship (RU)

PUBLICATIONS

(name in bold when senior author)

1.NMR Characterization of an S-Linked Glucuronide Metabolite of the Potent, Novel, Nonsteroidal Progesterone Agonist Tanaproget, Kelly A. Keating, Oliver McConnell, Yingru Zhang, Li Shen, William DeMaio, Larry Mallis, Sayed Elmarakby, Appavu Chandrasekaran, Drug Metabolism and Disposition, 2006, 34, 1283–1287.

2.Automated Accurate Mass Data Processing Using a Gas Chromatograph/ Time-of-Flight Mass Spectrometer in Drug Discovery, Chris Petucci and Larry Mallis, Rapid Communications in Mass Spectrometry, 2005, 19, 1492–1498.

3.Streamlining Pharmaceutical Research and Development Using an Interdisciplinary Analytical Approach: One Scientist’s Perspective, Larry M. Mallis, Journal of Pharmaceutical & Biopharmaceutical Contract Manufacturing & Packaging, 2005, 6, 36–45.

4.Integrity Profiling of High Throughput Screening Hits Using LC-MS and Related Techniques, Edward H. Kerns, Li Di, Jim Bourassa, Jonathan Gross, Nelson Huang, Hanlan Liu, Teresa Kleintop, Lisa Nogle, Larry Mallis, Chris Petucci, Susan Petusky, Mark Tischler, Chantel Sabus, Ani Sarkahian, Mairead Young, Mei-yi Zhang, Donna Huryn, Oliver McConnell, and Guy Carter, Combinatorial Chemistry & High Throughput Screening, 2005, 8, 459–466.

5.Integrated High Capacity Solid Phase Extraction-MS-MS System for Pharmaceutical Profiling in Drug Discovery, Edward Kerns, Teresa Kleintop, David Little, Thomas Tobien, Larry Mallis, Li Di, Mei Hu, and Oliver McConnell, Journal of Pharmaceutical and Biomedical Analysis, 2004, 34, 1–9.

6.The Determination of Rat Oral Bioavailability of Soy-Derived Phytoestrogens Using an Automated On-Column Extraction Procedure and Electrospray Tandem Mass Spectrometry, Larry M. Mallis, Ani B. Sarkahian, Heather Harris, Mei-Yi Zhang, and Oliver J. McConnell, Journal Chromatography B, 2003, 796, 71–86.

7.SPECIAL FEATURE: TUTORIAL - Open-Access Liquid Chromatography/Mass Spectrometry in a Drug Discovery Environment, Larry M. Mallis, Ani B. Sarkahian, John M. Kulishoff, Jr. and William L. Watts, Jr., Journal of Mass Spectrometry, 2002, 37, 889-896.

8.Differential Effects of Estradiol and Estradiol-BSA Conjugates, P. E. Stevis, D. C. Deecher, L. Suhadolnik, L. M. Mallis, and D. E. Frail, Endocrinology, 1999, 140, 5455.

9.Synthesis of Squalamine Utilizing a Readily Accessible Spermidine Equivalent, X. Zhang, M. N. Rao, S. Jones, B. Shao, P. Feibush, M. McGuigan, Z. Shaked, N. Tzodikov, B. Feibush, I. Sharkansky, B. Snyder, L. M. Mallis, A. Sarkahian, S. Wilder, J. E. Turse, W. A. Kinney, H. J. Kjaersgaard, and R. S. Michalak, Journal of Organic Chemistry, 1998 63, 8599.

10.Analysis of Glycosaminoglycan-Derived Oligosaccharides Using Fast Atom Bombardment Mass Spectrometry, R. J. Linhardt, H. M. Wang, D. Loganathan, D. J. Lamb, and L. M. Mallis, Carbohydrate Research, 1992, 225, 137.

11.Negative Ion Fast-Atom Bombardment Tandem Mass Spectrometry to Determine Sulfate and Linkage Position in Glycosaminoglycan-Derived Dissaccharides, D. J. Lamb, H. M. Wang, L. M. Mallis, and R. J. Linhardt, Journal American Society Mass Spectrometry, 1992, 3, 797.

12.Reaction of [( 6-C6(CH3)6)Mn(CO)2( 1-SCHSCPh3)]BF4: Fast Atom Bombardment Tandem mass Spectrometry of Dithio Formate and Thioformamide Complexes. Crystal Structure of [( 6-C6(CH3)6)Mn (CO)2( 1-SCHSCPh3)]+BF4-, J. L. Moler, D. P. Eyman, and L. M. Mallis, Inorganic Chemistry, 1992, 31, 1816.

13.Preparation, Characterization, and Reactivity of 6-pentamethylbenzyl Manganese Tricarbonyl, D. M. LaBrush, D. P. Eyman, N. C. Baenziger, and L. M. Mallis, Organometallics, 1991, 10, 1026.

14.Synthesis and Reactivity of [( 6-C6H6)Mn(CO)2S2CH and [( 6-C6(CH3)6)Mn(CO)2S2CH, S. J. Schauer, D. P. Eyman, R. J. Bernhardt, M. A. Wolff, and L. M. Mallis, Inorganic Chemistry, 1991, 30, 570.

15.Cyclodextrin Sulfates: Characterization as Polydisperse and Amorphous Mixtures, T. Irie, K. Vekama, J. Pitha, d. J. Lamb, and L. M. Mallis, Pharmaceutical Research, 1991, 37, 261.

16.Plasma Serine in Schizophrenics and Controls Measured by Gas Chromatography-Mass Spectrometry, S. Baruah, R. Waziri, T. S. Hegwood, and L. M. Mallis, Psychiatry Research, 1991, 37, 261.

17.GC/MS in Education, L. M. Mallis and P. Jump, Contact Note #32, Fisons Instruments, VG Masslab, Ltd., 1991.

18.Structural Variation in the Antithrombin III Binding Sites and its Occurrence in Heparin from Different Sources, D. K. Loganathan, H. M. Wang, L. M. Mallis, and R. J. Linhardt, Biochemistry, 1990, 29, 4362.

19.Matrix Effects on the Fast Atom Bombardment Mass Spectra of Palladium Complexes, W. J. Scott and L. M. Mallis, Organic Mass Spectrometry, 1990, 25, 415.

20.Sequence Analysis of Highly Sulfated, Heparin-Derived Polyoligosaccharides Using Fast Atom bombardment Mass Spectrometry, L. M. Mallis, H. M. Wang, D. K. Loganathan, and R. J. Linhardt, Analytical Chemistry, 1989, 61, 1453.

21.An Inexpensive Sample Holder for Storage and Introduction of Air-Sensitive Organometallic Compounds Into a Mass Spectrometer with Inert-Atmosphere Blanketing, L. Messerle, L. M. Mallis, and P. J. Hatch, Journal of Chemical Education, 1989, 66, 618.

22.Fast Atom Bombardment-Tandem Mass Spectrometry Studies of Organo-Alkali Metal Ions of Small Peptides. Competitive Interaction of Sodium with Basic Amino Acid Substituents, L. M. Mallis, E. S. McGlohan, and D. H. Russell, Analytical Chemistry, 1988, 60, 1818.

23.Differentiation of Isotopically Labelled Nucleotides by Fast Atom Bombardment Tandem Mass Spectrometry, L. M. Mallis, F. M. Raushel, and D. H. Russell, Analytical Chemistry, 1987, 59, 980.

24.Some General Aspects of the Chemistry of Organo-Alkali Metal Ions - An Overview of Recent Work, L. M. Mallis and D. H. Russell, Int. J. Mass Spectrom. Ion Proc., 1987, 78, 147, a review with 101 refs.

25.Some Aspects of the Chemistry of Ionic Organo-Alkali Metal Halide Clusters Formed by Desorption Ionization, L. M. Mallis, M. E. Castro, and D. H. Russell, Secondary Ion Mass Spectrometry – SIMS V, Benninghoven, A.; Coltor, R. J.; Simons, D. J.; Werner, H. W., Ed.; Springer-Verlag: New York, 1986; Springer Series in Chemical Physics, 44, p. 506.

26.Fourier Transform Mass Spectrometry for High Mass Applications, M. E. Castro, L. M. Mallis, and D. H. Russell, Secondary Ion Mass Spectrometry – SIMS V, Benninghoven, A.; Coltor, R. J.; Simons, D. J.; Werner, H. W., Ed.; Springer-Verlag: New York, 1986; Springer Series in Chemical Physics, 44, p. 51.

27.Fast Atom Bombardment Tandem Mass Spectrometry Studies of Organo-Alkali Metal Ions of Small Peptides, L. M. Mallis and D. H. Russell, Analytical Chemistry, 1986, 58, 1076.

28.Cesium Desorption Ionization Studies of β-Cyclodextrin by Fourier Transform Mass Spectrometry, M. E. Castro, L. M. Mallis, and D. H. Russell, Journal American Chemical Society, 1985, 107, 5652.

PRESENTATIONS (148 total; name in bold when senior author/presenter)

Oral Presentations at National Meetings (20 total)

1.A Capillary Micro-sampling (CMS) Technique for Low Volume Bioanalytical Plasma Analysis in Support of a Regulated Study2015, Larry M. Mallis, Wei Zhang, Li Yuan, and Zhongping (John) Lin, 11th Annual APA Meeting, Boston, MA, September 2015.

2.Acceptance Criteria for GLP Validation of Quantitative Analytical Methods for Proteins by ELISA and LC-MS/MS, Larry M. Mallis, Julie E. Eble, Cynthia Chen, and Guomin Shan, 246th ACS National Meeting, Indianapolis, IN, September 2013.

3.Development and Implementation of High throughput Techniques for Use in Residue and Soil Dissipation Studies, Larry M. Mallis, Michael F. Pennell, Shakera A. Guess, Cynthia Chen, Sid J. Hill, and Julie E. Eble, 246th ACS National Meeting, Indianapolis, IN, September 2013.

4.Analytical issues with ion suppression and enhancement in the quantitative analysis of small molecules in various matrices, Larry M. Mallis, Connell Cunningham, Julie E. Eble, 242nd ACS National Meeting, Denver, CO, August 28, 2011.

5.Comparison of LC-MS/MS and ELISA methodology for a Typical Allergen, Chris J. Miller, Connell Cunningham, Larry M. Mallis and Julie E. Eble. 244th ACS National Meeting, Philadelphia, PA, August 2012Accelerated Column and Mobile Phase Selection in LC/MS/MS Method Development, Cathy Gordon, Kasia Hopek, Tonya Jackson, Kari Lynn, Larry Mallis, Frederic Poignant, and Michelle Schreier, 2006 Eastern Analytical Symposium, Somerset, NJ, November, 2006.

6.Utilization of Multiplexed Liquid Chromatography Mass Spectrometry in the Purity and Accurate Mass Determination of Pharmaceutical Compound Libraries, Lisa M. Nogle and Larry M. Mallis, Pharmaceutical Interest Group Meeting at the 52th ASMS Conference on Mass Spectrometry and Allied Topics, Nashville, TN, May 23-27, 2004.

7.Streamlining Pharmaceutical Research and Development Using An Interdisclipinary Analytical Approach, Larry M. Mallis, Ani B. Sarkahian, Chris J. Petucci, Lisa M. Nogle, Kelly A. Keating, Scott J. Brecker, Rebecca J. Dooley, William L. Watts, Yingru Zhang, and Oliver J. McConnell, Center for Pharmaceutical Training Conference on Method Validation and Laboratory Instrument Qualification, Philadelphia, PA, October 20–22, 2003.

8.Collaborative Impact of Pharmaceutical Profiling on Drug Discovery, Edward Kerns, Li Di, Mark Tischler, Larry Mallis, Nelson Huang, Donna Huryn, Guy Carter, IBC Conference: Accelerating Drug Discovery via Cutting Edge ADMET, Boston, MA, September 15–16, 2003.

9.Stability Profiling in Drug Discovery, Edward Kerns, Li Di, Mark Tischler, Larry Mallis, Y. Hong, Rachel Garlish, Theresa Kleintop, Oliver McConnell, and Guy Carter, Pittsburgh Conference on Analytical Chemistry, New Orleans, LA, March 9–14, 2003.

10.Physicochemical Profiling in Drug Discovery, Edward Kerns, Li Di, Mark Tischler, Larry Mallis, Susan Petusky, Teresa Kleintop, Oliver McConnell, Guy Carter, NJ-ACS Symposium Pharmaceutical Profiling Symposium, Edison, NJ, January 14, 2003.

11.Automated Preparative Isolation Using Open-Access Gradient LC/MS, Scott J. Brecker, John M. Kulishoff, Jr., Bill Watts

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