YUSUF KEMAL DEMIR; Ph.D.

Formulation Scientist Prinston Pharmaceuticals 3801 Woodpark Blvd. Charlotte 28206 North Carolina

+1-919-***-**** adajw0@r.postjobfree.com

EDUCATION

Doctor of Philosophy (2012)

Institute of Health Sciences, Marmara University, Turkey

Thesis: Polymeric Microneedle Arrays for Transdermal Drug Delivery

Master of Philosophy (2010)

School of Pharmacy, The Queen’s University Belfast, United Kingdom

Thesis: Physicochemical Characterisation of Laser-Engineered Polymeric Microneedle Arrays

Bachelor of Science (2005)

Faculty of Pharmacy, Marmara University, Turkey Major: Pharmacy

EMPLOYMENT & EXPERIENCE

CURRENT POSITION

Formulation Scientist (Jun 2019 – Current)

Formulation Scientist, Prinston Pharmaceuticals, Charlotte, NC

Research: Pre-formulation, Formulation, Recipe Preparation, Technology Transfer, Scale up, Small Scale and Large Scale Manufacturing, Formulation and Manufacturing Related Troubleshooting, BPR, Protocol and Report Preparation, Literature and Patent Review.

PRIOR POSITIONS

Research & Development Scientist (Jun 2018 – Jun 2019)

Research & Development, Prinston Pharmaceuticals, Charlotte, NC

Research: Research and Method Development in Analysis of Solid Dosage Forms, ANDA file, Protocol and Report Preparation

Postdoctoral Research Collaborator (Jan 2018 – Apr 2018)

Center for Nanotechnology in Drug Delivery (CNDD), Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, USA

Research: Exosome Proteomics and Imaging

Postdoctoral Research Associate Dr (Jan 2017 – Jan 2018)

Center for Nanotechnology in Drug Delivery (CNDD), Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, USA

Research: Exosome Magnetic Nanoparticle Conjugated Systems in Cancer Nanotechnology

Visiting Postdoctoral Research Associate (Nov 2016 – Dec 2016)

Institute of Pharmacy, Martin Luther University Halle-Wittenberg, Germany Research: Hydrogel Synthesis, Microneedle Characterization

Assistant Professor Dr (July 2015 – Oct 2016) Faculty of Pharmacy, Marmara University, Turkey

Undergraduate Course Teaching: Cosmetology, Good Manufacturing Practice, Industrial Pharmacy, Medical Devices, Pharmaceutical Technology (I-II-III), Physical Pharmacy

MPhil Course Teaching: Biopharmaceutics, Trends in Solid Dosage Forms

Affiliate (Sept 2014 – March 2015)

Faculty of Pharmacy, The University of Sydney, Australia

Research: Development of a novel influenza vaccine formulation, Protein aggregation, Protein-dye interaction analysis

Visiting Research Fellow - Australian Government Endeavour Research Fellowship (March 2014 – Sept 2014) Faculty of Pharmacy, The University of Sydney, Australia

Research: Protein aggregation, Protein-dye interaction analysis

Assistant Professor Dr (Apr 2014 – Sept 2014) Faculty of Pharmacy, Marmara University, Turkey

Sabbatical Leave: Working as visiting Assistant Professor at The University of Sydney

Lecturer (Sept 2012 – Apr 2014)

Faculty of Pharmacy, Marmara University, Turkey

Teaching: Cosmetology, Industrial Pharmacy, Good Manufacturing Practice, Physical Pharmacy, and Pharmaceutical Technology (I-II-III)

President of Research Fellows (May 2012 – Jan 2013) Faculty of Pharmacy, Marmara University, Turkey

Research and Teaching Assistant (Jul 2010 – Sept 2012, Dec 2005 – Sept 2008) Faculty of Pharmacy, Marmara University, Turkey

Visiting Researcher (May 2011 – Jun 2011)

Department of Mechanical Engineering, Bilkent University, Turkey Research: Novel microfabrication technology for assembling microneedle arrays

Research and Teaching Assistant (Sept 2008 – Jun 2010)

School of Pharmacy, The Queen’s University Belfast, United Kingdom

Visiting Researcher (Jun 2007 – Sept 2007)

McClay Research Centre, The Queen’s University Belfast, United Kingdom

Research: Co-delivery of 5-aminolevulinic acid and the novel hydroxypyridinone iron chelator CP-94 from bioadhesive patches for enhanced topical photodynamic therapy

Teaching Assistant (Aug 2005 – Dec 2005)

Faculty of Pharmacy, Yeditepe University, Turkey

Trainee (Sept 2004 – Nov 2004)

Mustafa Nevzat Pharmaceuticals, Turkey

Trainee (July 2004 – Sept 2004) Acibadem Healthcare Group, Turkey

Trainee (3 months spanning 2001 – 2005)

Community Pharmacists and Clinical Pharmacy Departments, Turkey

RELEVANT SKILLS & ABILITIES

Research Skills

oPharmaceutical manufacturing techniques: Direct compression, Wet and Dry Granulation, Oral solid dosage forms, semi-solid dosage forms, i.e.

oPharmaceutical and biopharmaceutical analysis techniques: HPLC, ELISA, SDS PAGE, fluorospectroscopy

oMicroneedle array fabrication: laser-based micro molding techniques, micro milling technologies, 3D printing, lab-on- a-chip (LOC) training

oPharmaceutical formulation and device preparation: liquid, semi-solid and solid dosage forms, polymeric patches, microneedle arrays

oDrug delivery systems: USP apparatus dissolution systems, Franz permeation systems, skin specimen preparation, animal models

oBiomaterial characterisation: DSC, tensile analysis, SEM, TEM

Computer Skills

oEmpower

oGraphpad Prism5 statistical analysis

oMinitab

oAdobe Photoshop CS5

oMS Office applications

oApple Macbook applications

oRefworks and Endnote online bibliographic management tools

oChemsketch 12 chemical drawing

oProteus Software for thermal analysis

oIgor Pro technical grapghing and data analysis

Languages

oTurkish (native)

oEnglish (advanced)

Independence/Decision-Making

Analytical and Problem-Solving Skills/Lateral Thinking

Quick Learning

Drive

Leadership

Teamworking

Planning, Organisation and Management

Integrity

Interpersonal Relations

SELECTED PROJECTS

Development of A Novel Influenza Vaccine Formulation

Grant by a Private Pharmaceutical Industry – Sep 2014 to March 2015 Project Number G175255

Protein Aggregation Analysis

Grant by Australian Government Minister of Education – 2014 Project Number ERF_PDR_3999_2014

Polymeric Microneedle Mediated Drug Delivery Grant by Marmara University BAPKO – 2011 Completed by 2012

Project Number SAG-C-DRP-130***-****

Physicochemical Characterisation of Laser-engineered Polymeric Microneedle Arrays

Scholarship by The Turkish Council of Higher Education – 2008 Completed by 2010 in the United Kingdom

Project Number BB/EO20534/1 and POC21A

SELECTED HONOURS & AWARDS

The Scientific and Technological Research Council of Turkey (TUBITAK) Scientific Publication Award (2015)

An award valued at 602 TL, granted for a publication under the Incentive Program for International Scientific Publications

The University of Sydney Allowance (2014)

12 months at the Faculty of Pharmacy, The University of Sydney, Australia. Sponsored by Pharmaceutical Company, USA.

Australian Government Endeavour Research Fellowship (2014)

6 months at the Faculty of Pharmacy, The University of Sydney, Australia

American Association of Pharmaceutical Scientists (AAPS) Pharmaceutical Research Meritorious Manuscript Award (2013)

The Scientific and Technological Research Council of Turkey (TUBITAK) Scientific Publication Award (2013)

2 awards valued at 1608 TL each, granted for 2 different publications under the Incentive Program for International Scientific Publications

The Scientific and Technological Research Council of Turkey (TUBITAK) Invention Commercialisation Support (2013) An award valued at 100000 TL, granted to start a company to commercialise my invention under the 1512 Entrepreneurship Support Program

The Scientific and Technological Research Council of Turkey (TUBITAK) Patent Application Support (2013)

An award valued at 3450 TL, granted to aid a patent application under the 1008 Patent Application Promotion and Funding Program

2nd International Research and Development Project Market Best Project Award (2012)

An award valued at 8000 TL, granted under the Drugs and Pharmaceutical Products category. The event was co-organised by the Turkish Ministry of Economy, Turkish Exporters Association, Mediterranean Exporters Association and Istanbul Chemicals & Chemical Products Exporters Association.

2nd International Workshop on Cleanroom Training for Critical and Sustainable Technologies: Lab-on-a-chip (LOC) Participation Support (2012)

Selected on merit by The United Nations Industrial Development Organization (UNIDO) and The Turkish National Nanotechnology Research Centre (UNAM) as one of the few Turkish scientists to attend the workshop for free

Marmara University Institute of Health Sciences PhD Thesis Award (2014)

An award for producing 2 publications out of my PhD research on 2 Scientific Citation Indexed journals

Marmara University (under the auspice of the Turkish Council of Higher Education) Postgraduate Research Abroad Scholarship (2008-2010)

The Scientific and Technological Research Council of Turkey (TUBITAK) Postgraduate Research Abroad Scholarship (2008)

Awarded but had to decline as it is not allowed to be given simultaneously with scholarship directly above (both are government scholarships)

Marmara University, Faculty of Pharmacy Academic Merit Award (2005)

Honoured as the 6th student amongst 110 cohorts

PROFESSIONAL MEMBERSHIP

American Association of Pharmaceutical Scientists (AAPS) - Australian Local Chapter (2014-2015)

Turkish Pharmacists’ Association - Chamber of Pharmacists of Istanbul’s 1st District

Controlled Release Society - Turkey Local Chapter

European Chitin Society - Active Member (2013-2014)

PUBLICATIONS - Scholar Google Citations: 344 ORCID ID: orcid.org/0000-0001-7754-7192

PATENT (1)

Demir, Y.K. (2012). “Mikro iğne dizileri cihazı ve aplikatörü”. Patent NO. TR 2012/09058 B. (Gave up my rights on 2018).

JOURNAL ARTICLES (8)

Demir, Y.K.*, Metin, A.U., Satiroglu, B., Solmaz, M.E., Kayser, V., Karsten, M. (2017). “Poly(methyl vinyl ether-co-maleic acid)- Pectin Based Hydrogel-Forming Systems: Gel, Film and Microneedles”, European Journal of Pharmacetutics and Biopharmaceutics, vol. 117, pp. 182-194. PMID: 28438549.

Reslan M.*, Demir, Y.K.*, Trout, B.L., Chan, H.K., Kayser, V. (In Press 2016) “Lack of a Synergistic effect of Arginine- Glutamic acid on the Physical Stability of Spray-Dried Bovine Serum Albumin”. Pharmaceutical Development and Technology. PMID: 27194596.

Sahin Z.*, Demir, Y.K., Kayser, V. (2016). “Global Kinetic Analysis of Seeded BSA Aggregation”. Journal of Pharmaceutical Sciences, vol. 86, pp. 115-124. PMID: 26970282.

Demir, Y.K., Kerimoglu, O. (2015). “Novel Use of Pectin as a Microneedle Base”. Chemical and Pharmaceutical Bulletin, vol. 63, no. 4, pp. 300-304. PMID: 25832025.

Demir, Y.K., Akan, Z., Kerimoglu,O. (2013). “Characterization of Polymeric Microneedle Arrays for Transdermal Drug Delivery”. PLoSONE, vol. 8, no. 10, e77289. PMID: 24194879.

Demir, Y.K., Akan, Z., Kerimoglu, O. (2013), “Sodium Alginate Microneedle Arrays Mediate the Transdermal Delivery of Bovine Serum Albumin”, PLoSONE, vol. 8, no. 5, e63819. PMID: 23675508.

Donnelly, R.F., Majithiya, R., Thakur, R.R.S., Morrow, D.I.J., Garland, M.J., Demir, Y.K., Migalska, K., Ryan, E., Gillen, D., Scott, C.J., Woolfson, A.D. (2011). “Design, Optimization and Characterisation of Polymeric Microneedle Arrays Prepared by a Novel Laser-Based Micromoulding Technique”, Pharmaceutical Research, vol. 28, no. 1, pp. 41-57. PMID: 20490627.

Singh, T.R.R., Garland, M.J., Cassidy, C.M., Migalska, K., Demir, Y.K., Abdelghany, S., Ryan, E., Woolfson, A.D., Donnelly, R.F. (2010). “Microporation Techniques for Enhanced Delivery of Therapeutic Agents”, Recent Patents on Drug Delivery & Formulation, vol. 4, no. 1, pp. 1-17. PMID: 19807682.

SCIENTIFIC MAGAZINE ARTICLES / MEDIA PROMOTIONS (3)

Singh, T.R.R., Majithiya, R., Demir, Y.K., Shaikh, R., Donnelly, R.F. (2010). “Microneedle Magic”, Pharmaceutical Manufacturing and Packing Sourcer, Issue 48, pp. 26-29.

Demir, Y.K. (2014). “Mikroiğne”, Eczanem Dergisi, vol. 3, no. 4, pp. 68-70.

Dr Yusuf Kemal Demir, Endeavour Research Fellowship 2015, https://internationaleducation.gov.au/Endeavour%20program/Scholarships-and- Fellowships/endeavour_bulletin/Pages/December%202015/Dr-Yusuf-Kemal-Demir.aspx

CONFERENCE PROCEEDINGS / PRESENTATIONS / ABSTRACTS (10)

•Demir, Y.K. (2014). “Polymeric Microneedle Arrays for Transdermal Drug Delivery”. Proceedings of the 13th Marmara University Institute of Health Sciences MSc and PhD Graduation Days, Istanbul, TR, (December 14-15, 2014). (Oral Presentation).

•Demir, Y.K., Gumus, A., Akan, Z., Kerimoglu, O. (2012). “Physical Characterization and Fabrication of Polymeric Microneedle Arrays for Transdermal Drug Delivery”. Proceedings of the 16th International Pharmaceutical Technology Symposium, Antalya, TR, P62 (September 10-12, 2012). (Oral and Poster Presentation).

•Demir, Y.K., Gumus, A., (2012). “Ouchless Microneedles Could Revolutionize The Vaccination Devices”. 2nd International Research and Development Project Market, Istanbul, TR, I106 (September 18-19, 2012). (Best Project Award, 8000 TL, in Drugs and Pharmaceutical Products).

•Demir, Y.K., Gumus, A., (2012). “Polymeric Microneedles As Beauty Device”. 2nd International Research and Development Project Market, Istanbul, TR, K107 (September 18-19, 2012). (Poster Presentation).

•Singh, R.R.T., Demir, Y.K., Majithiya, R., Garland, M.J., Morrow, D.I.J., Migalska, K., Ryan, E., Gillen, D., Woolfson, A.D., Donnelly, R.F. (2010). “A Novel Laser-Engineering Method for Fabrication of Polymeric Microneedles”. Proc. of the 1st International Conference on Microneedles, Atlanta, http://microneedles.gatech.edu/poster-session (Poster Presentation).

•Singh, R.R.T., Demir, Y.K., Majithiya, R., Garland, M.J., Morrow, D.I.J., Migalska, K., Ryan, E., Gillen, D., Woolfson, A.D., Donnelly, R.F. (2010). “Fabrication and Mechanical Characteriasation of Laser-engineered Polymeric Microneedles”. Proceedings of the 11th Annual Meeting of Skin Forum, Edinburgh, UK, P18. (Poster Presentation).

•Majithiya, R., Singh, R.R.T., Garland, M., Demir, Y., Woolfson, D., Donnelly, R.F. (2010) “Soluble Polymeric Microneedle Arrays: A Promising Transdermal Delivery System for Hydrophilic Drug”. Proceedings of the 1st International Conference on Microneedles, Atlanta, Georgia, http://microneedles.gatech.edu/poster-session (Poster Presentation).

•Majithiya, R., Singh, R.R.T., Garland, M., Demir, Y.K., Woolfson, D., Donnelly, R.F. (2010) “Transdermal Delivery of Theophylline with Soluble Polymeric Microneedles” Proceedings of the 11th Annual Meeting of Skin Forum, Edinburgh, UK, P19. (Poster Presentation).

•Demir, Y.K., Morrow, D.I.J., Scott, C.J., Donnelly, R.F. (2010). “An Optimized Method for Quantification of Ovalbumin in Microneedle Matrix Systems”. Proceedings of the 32nd Joint Schools of Pharmacy Research Seminar, Belfast. UK (Poster Presentation).

•Demir, Y., Morrow, D., Gillen, D., Scott, C., Woolfson, D., Donnelly, R. (2009). “A novel laser-machining method for preparation of polymeric microneedle arrays”. Proceedings of the British Pharmaceutical Conference, Manchester, UK. In: Journal of Pharmacy and Pharmacology, 61: A128-A128, 174, Supplement 1. (Abstract and Poster Presentation).

REVIEWED PROJECTS (2)

•Medtrain Marie Sklodowska-Curie COFUND Fellowship Programme-CURAM (Center for Research in Medical Devices) Development of novel three-dimensional conduit microstructures for transdermal drug delivery and bioanalysis

•Medtrain Marie Sklodowska-Curie COFUND Fellowship Programme-CURAM (Center for Research in Medical Devices) Development of a Platform Technology for Buccal Delivery of Therapeutic Proteins (BuccaPLAT)

REVIEWED ARTICLES (OVER 35)

EDITORIAL BOARD MEMBERSHIP (2)

Referee List

Referee #1: Prof Alexander Kabanov University of North Carolina at Chapel Hill

Faculty of Pharmacy, 27599, Chapel Hill, North Carolina, USA Email: adajw0@r.postjobfree.com

Referee #2: Associate Prof Veysel Kayser The University of Sydney

Faculty of Pharmacy

2006, NSW, Sydney, Australia Phone: +61 2 9351 3391

Email: adajw0@r.postjobfree.com

Referee #3: Prof Ryan F Donnelly The Queen's University of Belfast School of Pharmacy

BT9 7BL, Belfast, United Kingdom Phone: +44 (0-28-909*-****

Email: adajw0@r.postjobfree.com

Referee #4: Prof Chris Scott

The Queen's University of Belfast School of Pharmacy

BT9 7BL, Belfast, United Kingdom Phone: +44 (0-28-909*-****

Email: adajw0@r.postjobfree.com

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