Product Development Project

Resume of Ahmed Abu Fayyad, PhD cand. Pharmaceutics

Ahmed Abu-Fayyad, Ph.D. Candidate, Pharmaceutics

Home address: Work address:

**** ********** **. ***# ** 1800 Bienville Dr, Lab. 376 Monroe, LA 71201 Monroe, LA 71201

Email: ********@********.***.*** Phone: 318-***-**** Cell phone: 318-***-****

Expert in designing and developing new pharmaceutical excipients for drug delivery, with application in oral and parenteral administration.

Expert in the physicochemical characterization of new pharmaceutical excipients; critical micelles concentration, (CMC), Thermal profile (DSC), imaging of the self-assembly is a solution using Cryo- transmission microscopy (Cryo-TEM) and zeta and particle size analysis. Expert in formulation development and optimization, scale up and data documentation per ICH guidelines. Expert in analytical and pharmaceutical instrumentation; HPLC, NMR, Mass spectroscopy. Expert in writing scientific manuscripts, presentation the data in conferences, and filling grants application. Can supervise other and be supervised, work with the team in a results-oriented way; to get things done and to troubleshoot every problem in short cut productive and efficient way. EDUCATION

Ph.D. candidate in Pharmaceutics, University of Louisiana at Monroe, Monroe, LA 2013 - 2017

M.Sc. Pharmacy, non-degree studies, Petra University, Amman-Jordan 2010-2012

B.Sc. in Pharmacy, Isra University, Amman-Jordan 2005 to 2010 Research and Technical Experience

My research and work experience when I served in the industry and while pursuing a master and doctorate encompass a wide range of skills and abilities about pharmaceutical product development of oral and non-oral small molecules. I have expertise in oral and injectable drug product development, manufacturing and analysis. I have successfully established a wet laboratory to perform the physical, chemical and biological characterization of the novel formulations. Skilled in conception and execution of experiments, interpretation of data, presentation of results, and preparation of manuscripts, grant application, and scientific publications.

The following is an excerpt of the research work during my master studies: My master work was conducted at TQ pharmaceutical company headquartered in Amman-Jordan as full-time researcher from July, 2012 – January, 2013. I have experience in the following Oral solid dosage form development using solid dispersion approach. My project aimed to develop a new oral dosage form for Ibuprofen using a new graft-copolymer introduced by BASF in 2009 called Soluplus®. This experience turned me as a capable formulation scientist able to perform pre-formulation studies, excipient-active pharmaceutical ingredient (API) interaction studies. Excelled in use FT-IR instrument to study the interaction, dissolution apparatus, UV-vis and HPLC analysis. Solid dosage form preparation using co-solvent approach. Preparation and report documentation per ICH guidelines. Capable to work under GMP and LMP general guidelines. Resume of Ahmed Abu Fayyad, PhD cand. Pharmaceutics The following is an excerpt of the research work during my doctoral studies: My doctoral work was on development alternative delivery platform for paclitaxel. My PhD work was very elaborative and merging chemistry, biology and pharmaceutics. The essence of the project to design new pharmaceutical excipient with innate pharmacological activity for drug delivery. The basic component of this new designed excipient is inspired from vitamin E. Soluble derivative of vitamin E, known as vitamin E TPGS, is widely used in pharmaceutical community as solubilizer. Vitamin E is another name for α-tocopherol, in addition to α-tocopherol, there are other isomers for vitamin E called tocotrienols with anticancer activity. My PhD project was then to replace the α-tocopherol in vitamin E TPGS with the other tocotrienols isomers. We used three tocotrienols isomers; α, γ, and δ as it was shown those isomers had different anticancer activity. The poly-ethylene-glycol (PEG) used in the project were 1000 molecular weight, which is comparable to the commercial vitamin E TPGS and 350 molecular weight in order to test the effect of the side chain length on the physical, chemical and pharmaceutical properties of the vitamin E TPGS. As tocotrienol isomers very scare. Palm oil was used as source for the tocotrienols isomers. the details of the project are mentioned below. In the project, we conjugated paclitaxel with vitamin E tocopherol and tocotrienol isomers to further study the effect of those natural isomers on the pharmaceutics- performance of paclitaxel. The details of the project as the following: Large scale extraction of the individual isomers of palm oil starting with approximately 500 gm raw materials. Palm oil raw materials are rich in vitamin E isomers. The oil was first loaded on 40 cm length 10 width column backed with around 1.5 kg silica gel.

(1) Chemical characterization of the isomers by Thin Layer Chromatograph (TLC), HPLC analysis, Raman spectroscopy, 1H- NMR and rheology.

(2) Design and implement a chemical bio-conjugation protocol to synthesize self-assembled PEGylated vitamin E isomers. The protocol is two-step chemical reaction, the first step is heat-activated succinic anhydride ring opening reaction

(succinate derivatives formation) and the second step is p-TsOH-catalyzed PEGylation with different molecular weight of mPEG chain lengths.

(3) Chemical characterization of the conjugates by HPLC, 1H-NMR and mass spectrometry analysis.

(4) Investigation the self-assembly and nano-micellaes formation characteristics of the PEGylated vitamin E isomers by studying their particle sizes, zeta potential, critical micelles concentration (CMC), vesicle formation by Cryo-TEM imaging.

(5) Established collaboration with Louisiana State University Health Sciences Center-Shreveport (LSUHSC-Sh) in order to test the PEGylated vitamin E isomers against a wide range of breast, pancreatic cancer cell lines as well as non- tumorigenic animal and human cell lines.

(6) I did internship with LSUHSC-Sh to master the in-vitro cell culture studies and western plot analysis,

(7) Design, synthesis and full characterization of chemical conjugates of Paclitaxel and Gemcitabine, entrapment into nano- emulsion, in-vitro release, anticancer activity and In-vivo bioavailability evaluation of nanomicellar in animal models. Paclitaxel and Gemcitabine were conjugated with saturated fatty acid of C-18 carbon chain; (stearic acid) and poly unsaturated mega-6 Linoleic acids. For comparison, Paclitaxel and Gemcitabine were conjugated with 2 vitamin E isomers; α-tocopherol and γ-tocotrieols, with overall objective to increase the lipophilicity of paclitaxel and gemcitabine in order to improve their loading into nanoemulsions.

(9) Using quality by design using 3-level 3- factors Box-Behnken design to reformulate TocosolTM paclitaxel formula, which was withdrawn form phase III clinical trials using free tocotrienols and our new PEGylated tocotrienols drug delivery platform.

(10) Performing in-vitro dissolution and HPLC analysis for sustained release oral dosage form. This work for Ahmad Hassan Ali, MD, Assistant Professor, Internal Medicine, Texas Tech University Health Science Center School of Medicine.

(11) Synthesis and preliminary characterization of Thymoquinone (TQ) and omega-3 fatty acid Docosahexaenoic acid (DHA) conjugates.

(12) Training new junior PhD students just getting started by providing them hands on experience for bench work, instrument orientation and paper writing and submissions

Resume of Ahmed Abu Fayyad, PhD cand. Pharmaceutics Instrumentation hands on experience:

HPCL by Thermo Electron Corp., San Jose, CA

Differential Scanning Calorimetry (DSC), TA 2920 modulated DSC, TA Instruments-Waters LLC, New Castle, DE)

NicompTM380 ZLS submicron particle size analyzer, Particle Sizing System, Port Richey, FL

Zeta potential analyzer, NicompTM380 ZLS submicron particle size analyzer, Particle Sizing System, Port Richey, FL

LA-960 Laser Particle Size Analyzer, HORIBA Scientific, New Jersey, NJ

SENTERRA Raman Microscope, Bruker Optics Inc. Billerica, MA

Advanced Rheometer, TA Instruments, New Castle, DE

Texture analyzer, Texture Technologies Corp, Hamilton, MA

Dissolution apparatus by Electrolab pvt. Ltd. India and by Varian, Agilent Technologies, USA

Hydraulic tableting machine, Carver press, Inc. Wabash, IN

Roto-evaporator, LABOROTA 4000 efficient, Heidolph North America, Elk Grove Village, IL

Model 150VT Ultrasonic Homogenizer, BioLogics, Inc. Manassas, Virginia.

High pressure homogenizer, EmulsiFlex-C3, AVESTIN, Inc. ON, Canada.

Cell culture techniques; Bio safety cabinets

1H -NMR, JEOL Eclipse NMR spectrometer, JEOL USA,Inc., MA

Mass spectrometer JEOL AccuTOFTM time-of-flight mass spectrometer by JEOL Ltd., Tokyo, Japan

Dry Ice Benchtop Freeze Dry System. Labconco Inc, Kansas City, MO. Software hands on experience:

GraphPad Prism 5

EndNote X5

Snagit 10

Design Expert 10

Work Experience

May 2013-present, Research and Teaching Assistant, School of Pharmacy, University of Louisiana at Monroe, Monroe, LA

May 2015- August 2015, Summer Internship, LSU Health Sciences Center Shreveport & Feist-Weiller Cancer Center’s Innovative North Louisiana Experimental Therapeutics (INLET), LBRN-Funded Internship Shreveport, LA. Evaluation of the anticancer activity of chemotherapeutics loaded-vitamin E based nano-polymeric carriers against a panel of breast, pancreatic cancer, and non-tumorigenic cell lines.

July 2011- January 2013, Dosage Form Pre-Formulation Development, TQ Pharma, Amman-Jordan Development and characterization of Ibuprofen: Soluplus® solid dispersion, in-vitro dissolution, FT-IR excipient-API interaction, HPLC analysis.

December 2012- May 2013, Medical Representative, Sana Pharma, Amman-Jordan. Responsible for promoting topical products (glucosamine transdermal TGC® and Lialee®) to physicians and pharmacists.

June 2010- January 2013, Retail Pharmacist, Amman-Jordan. Serviced as community pharmacist to dispense OTC and prescribed medication and patient counseling.

Resume of Ahmed Abu Fayyad, PhD cand. Pharmaceutics Certifications, Awards, and Membership

Hands-on Tablet Technology: Postgraduate Course, School of Pharmacy, The University of Mississippi 2014.

Foreign Pharmacy Graduate Equivalency Examination (FPGEE), National Association of Boards of Pharmacy (NABP), 2015.

CITI Training, Animal Handling in Research Settings, University of Louisiana at Monroe,2013- 2016

Tommye Sue Mattison Graduate Scholarship in Cancer Research ($6.400), University of Louisiana at Monroe, 2016.

American Association of Pharmaceutical Scientists, 2014-present

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Publications

BOOK CHAPTERS

1. Alayoubi, A. Abu-Fayyad, T. Al Hagbani, and S. Nazzal*. The Parenteral Route: Simvastatin in Cancer Treatment. In: A. Pais, C. Vitorino, and J. Sousa [eds.] Simvastatin Delivery: Challenges and Opportunities. Nova Science Publishers, Hauppauge, NY. 2015.

2. Alayoubi, A. Abu-Fayyad, and S. Nazzal*. Vitamin E in Parenteral Lipid Emulsions. In: R. Rajendram, V. B. Patel and V. R. Preedy [eds.] Diet and Nutrition in Critical Care. Springer, New York, USA. 2015. PEER REVIEWED PUBLICATIONS

3. A. Abu-Fayyad, F. Behery, A.A. Sallam, S. Alqahtani, H. Ebrahim, K.A. El Sayed, A. Kaddoumi, P.W. Sylvester, J.L. Carroll, J.A. Cardelli, S. Nazzal*. PEGylated γ-tocotrienol isomer of vitamin E: Synthesis, characterization, in vitro cytotoxicity, and oral bioavailability, European Journal of Pharmaceutics and Biopharmaceutics, 96 (2015) 185-195 4. Ahmed Abu Fayyad, Sami Nazzal*. Synthesis, Characterization, and In-Vitro Antitumor Activity of the Polyethylene Glycol

(350 and 1000) Succinate Derivatives of the Tocopherol and Tocotrienol isomers of Vitamin E. Submitted, International Journal of Pharmaceutics 2017. Just accepted.

5. Ahmed Abu Fayyad, Jennifer L. Carroll, Ana-Maria Dragoi, Sami Nazzal*. Application of Quality by Design (QbD) approach in the reformulation of TocosolTM-paclitaxel nanoemulsion using free and PEGylated tocotrienol isomers of vitamin E. Submitted, International Journal of Pharmaceutics 2017. 6. Ahmed Abu Fayyad, Sami Nazzal*. Gemcitabine-vitamin E and fatty acid conjugates: Synthesis, characterization, entrapment into nanoemulsion and in-vitro deamination and antitumor activity. Submitted, European Journal of Pharmaceutical Sciences 2017.

7. Ahmed Abu Fayyad, Sami Nazzal*. A pH-sensitive hydrazone, and insensitive amide surfactants of a γ-tocotrienol isomer of vitamin E conjugated with methoxy-Poly(ethylene) glycol (mPEG): Synthesis, physicochemical characterization, and in- vitro antitumor activity. Submitted, European Journal of Pharmaceutical Sciences 2017. 8. Ahmed Abu Fayyad, Sami Nazzal*. Extraction of α-tocopherol and individual tocotrienols isomers with high purity and quantity from crude palm oil: Full chemical characterization, entrapment into nanoemulsions and in-vitro antitumor activity. Submitted, Food Chemistry 2017.

9. Alayoubi, A. Abu-Fayyad, MM. Rawas-Qalaji, PW. Sylvester, and S. Nazzal*. Effect of lipid viscosity and high-pressure homogenization on the physical stability of “Vitamin E” enriched emulsion. Pharm Dev Technol. 2015; 20(5):555-61. Resume of Ahmed Abu Fayyad, PhD cand. Pharmaceutics CONFERENCE PROCEEDINGS

10. Ahmed Abu Fayyad, Sami Nazzal*. Extraction, characterization and in-vitro anticancer activity of nanoemulsions of tocopherol and tocotrienol isomers from palm oil. 2016 AAPS Annual Meeting and Exposition. Colorado Convention Center, Denver, CO, November 2016.

11. Ahmed Abu Fayyad, Sami Nazzal*. PEGylation of Tocopherol and Tocotrienol Isomers of Vitamin E: Synthesis, Characterization, and In Vitro Cytotoxic Activity. 2016 AAPS Annual Meeting and Exposition. Colorado Convention Center, Denver, CO, November 2016.

12. Ahmed Abu Fayyad, Sami Nazzal*. Characterization and In Vitro Anticancer Activity of PEGConjugate of ү-tocotrienol Isomer of Vitamin E as a Dual Functional Carrier for Paclitaxel. 2016 AAPS Annual Meeting and Exposition. Colorado Convention Center, Denver, CO, November 2016.

13. Ahmed Abu Fayyad, Sami Nazzal*. Synthesis, Characterization, and In Vitro Anticancer Activity of Vitamin E Isomers and Fatty Acids Conjugates of Paclitaxel. 2016 AAPS Annual Meeting and Exposition. Colorado Convention Center, Denver, CO, November 2016.

14. Ahmed Abu Fayyad, Al-Sayed A. Sallam, Sami Nazzal*. Preparation, Characterization and Intrinsic Dissolution of Ibuprofen: Soluplus® Solid Dispersions. 2016 AAPS Annual Meeting and Exposition Colorado. Convention Center, Denver, CO, November 2016.

15. Ahmed Abu Fayyad, Mohammad Kamal, Amal Kaddoumi, Saeed Alqahtani, Sami Nazzal* PEGylation Enhances the Oral Bioavailability of γ-tocotrienol Isomer of Vitamin E. 32nd SBEC Conference, Shreveport, LA, March 2016. 16. Ahmed Abu Fayyad, Mohammad Kamal, Amal Kaddoumi, Saeed Alqahtani, Sami Nazzal*: PEGylation Enhances the Oral Bioavailability of γ-tocotrienol Isomer of Vitamin E. 32nd SBEC Conference, Shreveport, LA, March, 2016 17. Mohammad Kamal, Ahmed Abu Fayyad, Alaadin Alayoubi, Seetharama Satyanarayanajois, Paul Sylvester, Sami Nazzal*: Simultaneous delivery of tocotrienols and simvastatin by lipid nanoemulsion: a promising approach for enhanced antitumor activity against human mammary adenocarcinoma cells. 32nd SBEC Conference, Shreveport, LA, March, 2016. 18. Ahmad Salawi, Ahmed Abu Fayyad, Mohammad Kamal, Alsayad Al Arabi Sallam, Sami Nazzal*: Preparation and In- vitro Dissolution of Ibuprofen: Soluplus Solid Dispersion. 32nd SBEC Conference, Shreveport, LA, March, 2016. 19. Ahmed Abu-Fayyad, Paul W. Sylvester, Jennifer L. Carroll, James A. Cardelli, Sami Nazzal*: Design, Optimization and Biological Evaluation of TocosolTM Paclitaxel Formula Using a Quality-by-Design Approach. 2015 Southeast Regional IDeA Conference, Biloxi, MS, November, 2015.

20. Ahmed Abu Fayyad, Saeed Alqahtani, Amal Kaddoumi, Sami Nazzal*. Self-assembeled PEGylated γ-tocotrienol with Enahnced Oral Bioavailability: Synthesis, Characterization and in Vitro Cytotoxicity. 2015 AAPS Annual Meeting and Exposition. Orange County Convention and Exposition, Orlando, FL, October, 2015. 21. Ahmed Abu Fayyad, Turki Al Hagbani, Khaled H. Elfakhri, and Sami Nazzal*. Enhancement of the antitumor and biopharmaceutical activity of drugs by means of Nanotechnology: Current Research at School of Pharmacy. LSU Health CBERS Industry Day, LA Tech LA Tech Shreveport Center, September 2014. 22. Turki Al Hagbani, Khaled H. Elfakhri, Ahmed Abu Fayyad, and Sami Nazzal*. Formulation, Dosage Form Design, and Drug Product Development Capabilities at the School of Pharmacy of the University of Louisiana at Monroe. LSU Health CBERS Industry Day, LA Tech LA Tech Shreveport Center, September 2014. 23. Prashant Sharma, Ruta Gabregiorgis, Ahmed Sleem, Ahmed Abu Fayyad, Khalid El Sayed and Sami Nazzal*. The Effect of Cyclodextrin on the Solubility of Phenylmethylene Hydantoin. ULM, 14th Annual Student Research Symposium, Monroe, LA, February 2014.

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