MICHAEL H. ALAIMO, PH.D.

** ******* *****, ********, ** 01913 ● 978-***-**** ● acam6h@r.postjobfree.com

.

Results-driven scientific research professional with diverse pharmaceutical industry experience which

includes drug development, research, clinical operations, and regulatory affairs. Skilled leader and

educator with demonstrated ability to present complex scientific and clinical data to audiences of

varying technical knowledge. Background includes early discovery, preclinical development, clinical

trial support, and new product launches. Possess thorough understanding of U.S. and global regulatory

submission processes including ICH, USP-NF and FDA eCTD specifications. Established and developed

peer-to-peer relationships with academic and clinical thought leaders commensurate with key opinion

leader (KOL) management essential to desired career goal as a medical science liaison (MSL).

Therapeutic expertise in oncology, immunology, cardiology, hematology, and neuroscience.

PROFESSIONAL EXPERIENCE

Pfizer Inc., Andover, MA 2012 – Present

Technology Transfer Scientist, Site Technical Services

Manage cross-functional technology transfer team which included manufacturing, R&D, analytical,

quality, regulatory, and business development units focused on reducing protein drug substance Cost of

Goods through development of a more efficient manufacturing process.

Evaluate and implement improvements in manufacturing proces s yield, robustness, and regulatory

compliance for Prevnar-13 and BeneFIX.

Authored tech transfer and process validation sections for new FDA/EMA marketing applications

for improved BeneFIX manufacturing processes.

Spearheaded implementation of the “Process Understanding Plan (PUP)”, a global initiative to

provide centralized access to the development, clinical, manufacturing and regulatory knowledge

accumulated over a product’s lifecycle.

Vertex Pharmaceuticals, Cambridge MA 2011 – 2012

Senior Scientist, Analytical Development

Analytical team leader on two cystic fibrosis projects ; responsible for End-of-Phase 2 (EOP2) close-out

activities that transitioned to Phase 3 clinical trials .

Delivered monthly presentations to senior scientific management, clinical operations and

business management with project updates on chemical, formulation, and analytical

development.

Managed relationships with Contract Research and Manufacturing Organizations (CRO/CMO)

for animal toxicology studies, synthesis of drug substance intermediates and metabolites, and the

formulation and sterile packaging of clinical trial material (CTM).

Provided post-commercial launch support cystic fibrosis drug Kalydeco (ivacaftor) by

conducting tablet formulation characterization studies for pediatric product line extension and

single-tablet combination therapy studies.

Managed and directed three associate-level scientists and was a contributing member of cross-

functional sub-teams and task forces for Clinical Phase II & III projects in Cystic Fibrosis.

Eisai Pharmaceuticals Inc., Andover, MA 1998 – 2011

Principal Scientist, Analytical Chemistry

Conducted research on structures and functions of chemical compounds essential to the synthesis of

oncology, neurology, and immunology/inflammatory disease drugs.

Researched, compiled, and presented critical analytical data for key milestones in the

development of breast cancer drug Halaven.

Authored ICH Common Technical Document (CTD) sections for inclusion in regulatory filings.

Prepared investigative (IND, CTA, IMPD), marketing (NDA, MAA, J-NDA), and post-approval

(PAC/PMC) regulatory documentation.

Made significant experimental and authorial contributions on two NDA, three BLA, and eight

IND filings.

Participated in pre-launch activities including pre-approval inspection (PAI).

Supervised $2M NMR facility, managed service and maintenance contracts, trained 50+ users.

Experience includes measurement of physical and chemical properties by spectroscopy,

chromatography and microscopy

Prepared SOPs, test methods for Quality Control testing, and created IQ/OQ/PQ and change

control protocols for validated instrument systems.

Harvard Medical School, Departments of Radiology and Cardiology, Boston, MA 1998

NMR Imaging Associate

Medical imaging of myocardial angiogenesis in a randomized, placebo-controlled clinical study

in human and porcine models of chronic ischaemia.

U.S. Department of Agriculture, Eastern Regional Research Center, Philadelphia, PA 1994 – 1997

Post-Doctoral Fellow

Studied protein structure/function relationships and peptide folding dynamics in food systems.

Northampton Community College, Bethlehem, PA 1992 – 1994

Adjunct Professor of Chemistry

Taught Quantitative Analytical Chemistry & General Chemistry.

EDUCATION

Ph.D. in Analytical Chemistry ● Lehigh University, Bethlehem, PA

Bachelor of Science in Chemistry ● Bloomsburg University of Pennsylvania, Bloomsburg, PA

Publications

1. M.J. Yu, J.D. Orr, M.H. Alaimo, M.J. Towle. "Eribulin and Beyond: Structurally Simplified

Analogues of Halichondrin B". In Gragg GM, Kingston DGI, Newman DJ. Anticancer Agents from

Natural Products, Second Edition. CRC Press. ISBN: 978**********. Publication Date: October 03,

2011.

2. E.L. Malin, M.H. Alaimo, E.M. Brown, G. King, H.M. Farrell, Jr., P.L. McSweeny, P.F. Fox, M.W.

Germann. "Solution Structures of Casein Peptides: NMR, CD and Molecular Modeling Studies of

S1-Casein(1-23)", J. Protein Chem. 2001, 20(5), 391-404.

3. M.H. Alaimo, E.D. Wickham, H.M. Farrell, Jr. "Effect of Self-Association of S1-Casein and its

Cleavage Fractions S1-Casein(136-196) and S1-Casein(1-197), on Aromatic Circular Dichroic Spectra:

Comparison with Predicted Models", Biochim. Biophys. Acta, 1999, 1431, 395-409.

4. M.H. Alaimo, M.W. Germann, H.M. Farrell, Jr. "Conformational Analysis of the Hydrophobic

Peptide S1-Casein(136-196)", Biochim. Biophys. Acta, 1999, 1431, 410-420.

5. M.H. Alaimo, T.F. Kumosinski. "Investigation of Hydrophobic Interactions in Colloidal and

Biological Systems by Molecular Dynamics Simulations and NMR Spectroscopy", Langmuir. 1997, 13,

2007-2018.

6. M.H. Alaimo, J.E. Roberts. "Effects of Paramagnetic Cations on the Nonexponential Spin -Lattice

Relaxation of Rare Spin Nuclei in Solids", Solid State Nuclear Magnetic Resonance. 1997, 8, 241-250.

Michael H. Alaimo, Ph.D. Page 2 of 3

7. M.H. Alaimo, H.M. Farrell, Jr and T.F Kumosinski. "High -Resolution Solid-State NMR of Milk

Products", J. Magn. Reson. Anal. 1996, 2, 267-274.

8. M.H. Alaimo, T.F. Kumosinski. "Secondary Structural Analysis of Proteins in the Solid State by 13C

Cross Polarization/Magic Angle Spinning Nuclear Magnetic Resonance Spectroscopy", J. Magn.

Reson. Anal. 1996, 2, 4-12.

9. J.E. Roberts, K.M. Coleman, M.H. Alaimo and J.W. Larsen. "Detection of Macroscopic Orientation

Effects in Illinois No. 6 Coal by Solid-State NMR Techniques", Energy and Fuels. 1991, 5, 619-624.

10. Doctoral Thesis: "Non-Exponential Spin Lattice Relaxation and Paramagnetic Interactions in Solid-

State Nuclear Magnetic Resonance Spectroscopy", Lehigh University, 1993.

Michael H. Alaimo, Ph.D. Page 3 of 3

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