Jakob Kristensen Page * of *

Jakob Kristensen, PhD

**** **** ***** **, ****** Island, WA 98040, US

acwfzu@r.postjobfree.com; 206-***-****

US Work Authorization, valid from 06/05-15

KEY COMPETENCIES

Formulation Scientist with 14 years post-doctoral experience in pharmaceutical formulation and process development of both liquid and solid dosage forms, covering technology development, pre-clinical, clinical and commercial development activities.

Experienced CRO/CMO manager.

Good communication skills and documented ability to impart scientific knowledge to others.

Broad knowledge of industrial processes and process development.

Experienced motivator and project leader.

Experienced with QbD.

Significant hands-on experience with conventional pharmaceutical processes, e.g. o Wet agglomeration, fluid bed and high shear mixer o Freeze-drying

o Melt agglomeration (spray congealing agglomeration) o Powder blending

o Direct compression and compression of agglomerate mixtures, both single punch and rotary tablet machines

o Tablet coating, functional coating, fluid bed and pan coated

Launguage skills: Danish (Native), English (Fluent), Swedish/German(basic) EXPERIENCE

cJakob Pharma (Pharmaceutical consultancy), Seattle Wa March 2015 – present Founder and sole proprietor

Provide consulting services to biotech and pharma companies in the areas of formulation development of new drug products, CRO/CMO management, and planning and evaluation of laboratory development activities. Jakob Kristensen Page 2 of 6

EXPERIENCE (cont.)

Ferring Pharmaceuticals, CPH, Denmark November 2012 – December 2014 Senior Scientist, Late Stage Development, Global Research Pharmaceutical Development

Responsible for formulation development of DP’s (large and small molecules), both in-house and in collaboration with external pharmaceutical companies.

Planned and supervised laboratory development activities, (e.g. freeze drying, granulation and characterization activities).

Planned and supervised up-scaling and tech-transfer activities of Phase III oral drug product at CMO.

Participate in gathering information and writing patent applications

Prepare and approve raw material, packaging material and drug product specifications for clinical (Phase I and III) and commercial products .

Write pharmaceutical development documentation covering formulation development, composition and manufacturing process for pre-clinical and phase III trials.

Planning, running and documenting QbD workshops for new drug products. Veloxis Pharmaceuticals A/S, Hørsholm, Denmark January 2008 – September 2012

(Previously called LifeCycle Pharma)

Principal Scientist, Formulation & Technology Development, Feb 11 – Sept 12 Principal Scientist, Drug Delivery Business Unit, Jun 10 – Feb 11 Senior Scientist, Formulation Development, Jan 08 – Jun 10

Responsible for formulation development of DP’s (low soluble small molecules and peptides)

Planned and participated in laboratory development activities (e.g. blending, spray congealing, compression and characterization).

Driver (project manager) for streamlining (LEAN) of pre-clinical and phase 1 clinical stage process’ at Veloxis.

Performed feasibility assessment of NCE’s or API’s for application with Veloxis proprietary MeltDose® technology.

Participate in gathering information and writing patent applications

Planned, supervised and reported pre-clinical stability investigations.

Write pharmaceutical development documentation covering formulation development, composition and manufacturing process for phase I clinical trials.

Planned and supervised animal (rodent/dog/mini pig) PK and Tox/safety testing in collaboration with CRO’s.

Support Business Development in partnering activities.

Main industrial supervisor for a PhD student and co-supervisor for two PhD students, part of Predictive Drug Absorption consortium under University of Copenhagen.

Jakob Kristensen Page 3 of 6

EXPERIENCE (cont.)

Ferrosan A/S (now Pfizer), Bagsvær, Denmark March 2006 - December 2007 R & D Chemist, Pharmaceutical Development

Developed formulations of new probiotic or food-supplement products in-house and in collaboration CRO/CMO

Identified, assessed and implemented novel pharmaceutical technologies for pro- biotic DP’s.

Planned and conducted laboratory and up-scaling activities

Project management for development projects (e.g. liquid probiotic product, probiotic encapsulation technology).

Assisted registration and quality control departments with documentation to ensure regulatory compliance.

Danish University of Pharmaceutical Sciences, CPH, Denmark March 2001 - Feb 2006

(Previously Royal Danish School of Pharmacy)

Assistant professor, Department of Pharmaceutics, Feb 02 – Feb 06 Teaching assistant, Department of Pharmaceutics, Mar 01 – Feb 02

Performed scientific research to be published in peer-reviewed journals.

Daily supervision of research assistants, master and graduate students.

Supervised graduate student projects in collaboration with pharma partners.

Lecturer, supervisor and examiner of pharmaceutical master students in subjects e.g. formulation development, pharmaceutical drug production and QC.

Research activities within development of solid dosage forms, with main emphasize on wet granulation and pelletization.

Royal Danish School of Pharmacy March, CPH, Denmark April 1998 – February 2001 Graduate Student – Department of Pharmaceutics.

Research activities within development of oral solid dosage forms. EDUCATION

Danish University of Pharmaceutical Sciences, Dept of Pharmaceutics February 2004 Higher Education Teaching and Teaching Practice

Royal Danish School of Pharmacy December 2001

PhD degree, Dept. of Pharmaceutics (Thesis: Direct Pelletization in rotary processors) Royal Danish School of Pharmacy January 1998

Master of Science in Pharmacy

Jakob Kristensen Page 4 of 6

LIST OF PUBLICATIONS

2015:

Ragna Berthelsen, René Holm, Jette Jacobsen, Jakob Kristensen, Bertil Abrahamsson, and Anette Müllertz

Kolliphor Surfactants Affect Solubilization and Bioavailability of Fenofibrate. Studies of in Vitro Digestion and Absorption in Rats Mol. Pharmaceutics, 2015, 12 (4), pp 1062–1071

Adam Bohr, Feng Wan, Jakob Kristensen, Mark Dyas, Eleanor Stride, Stefania Baldursdottír, Mohan Edirisinghe, Mingshi Yang

Pharmaceutical microparticle engineering with electrospraying: the role of mixed solvent systems in particle formation and characteristics Journal of Materials Science: Materials in Medicine, February 2015, 26:61 Martin Lau Christiansen, Anette Müllertz, Mats Garmer, Jakob Kristensen, Jette Jacobsen, Bertil Abrahamsson and Rene Holm

Evaluation of the Use of Göttingen Minipigs to Predict Food Effects on the Oral Absorption of Drugs in Humans

Journal of Pharmaceutical Sciences, Volume 104, Issue 1, pages 135–143, January 2015 2014:

Ragna Berthelsen, Erik Sjögren, Jette Jacobsen, Jakob Kristensen, René Holm, Bertil Abrahamsson, Anette Müllertz

Combining in vitro and in silico methods for better prediction of surfactant effects on the absorption of poorly water soluble drugs - a fenofibrate case example. International Journal of Pharmaceutics, Volume 473, Issues 1–2, 1 October 2014, Pages 356–365

Martin Lau Christiansen, Rene Holm, b, Jakob Kristensen, Mads Kreilgaard, Jette Jacobsen, Bertil Abrahamsson, Anette Müllertz

Cinnarizine food-effects in beagle dogs can be avoided by administration in a Self Nano Emulsifying Drug Delivery System (SNEDDS)

European Journal of Pharmaceutical Sciences, Volume 57, 16 June 2014, Pages 164–172 Philip Carsten Christophersen, Martin Lau Christiansen, Rene Holma, Jakob Kristensen, Jette Jacobsen, Bertil Abrahamsson, Anette Müllertz Fed and fasted state gastro-intestinal in vitro lipolysis: In vitro in vivo relations of a conventional tablet, a SNEDDS and a solidified SNEDDS European Journal of Pharmaceutical Sciences, Volume 57, 16 June 2014, Pages 232–239 Jakob Kristensen Page 5 of 6

LIST OF PUBLICATIONS (cont.)

2012:

Adam Bohr, Mingshi Yang, Stefanía Baldursdóttir, Jakob Kristensen, Mark Dyas, Eleanor Stride, Mohan Edirisinghe.

Particle formation and characteristics of Celecoxib-loaded poly(lactic-co-glycolic acid) microparticles prepared in different solvents using electrospraying Polymer (May 2012), doi:10.1016/j.polymer.2012.05.002 Adam Bohr, Jakob Kristensen, Mark Dyas, Mohan Edirisinghe and Eleanor Stride. Release profile and characteristics of electrosprayed particles for oral delivery of a practically insoluble drug

Journal of the Royal Society Interface. published April 25, 2012 2011:

Adam Bohr, Jakob Kristensen, Eleanor Stride, Mark Dyas, Mohan Edirisinghe Preparation of microspheres containing low solubility drug compound by electrohydrodynamic spraying

International Journal of Pharmaceutics, Volume 412, Issues 1–2, June 2011, Pages 59-67 2007:

Charlotte Bacher, Peder Mohr Olesen, Povl Bertelsen, Jakob Kristensen, Jørn Møller Sonnergaard

Improving the compaction properties of roller compacted calcium carbonate. International Journal of Pharmaceutics, Volume 342, Issue 1-2, September 2007, Pages 115- 123

Pia Thybo, Jakob Kristensen, Lars Hovgaard

Characterization and physical stability of tolfenamic acid-PVP K30 solid dispersion. Pharmaceutical Development and Technology, 12[1], 43-53, 2007. 2006:

Jakob Kristensen

Investigation of a 2-step agglomeration process performed in a rotary processor using polyethylene glycol solutions as primary binder liquid. AAPS PharmSciTech, 7[4] Article 89 (http://www.aapspharmscitech.org), 2006 Jakob Kristensen, Vibeke Wallaert Hansen

Wet granulation in a rotary processor and fluid bed: comparison of granule and tablet properties.

AAPS PharmSciTech, 7[1] Article 22 (http://www.aapspharmscitech.org), 2006 Jakob Kristensen Page 6 of 6

LIST OF PUBLICATIONS (cont.)

Anne Flachs Nielsen, Poul Bertelsen, Henning Gjelstrup Kristensen, Jakob Kristensen, Lars Hovgaard.

Investigation and comparison of preformance of effervecent and standard pneumatic atomizer intended for soluble aqueous coating. Pharmaceutical Development and Technology, 11[2], 242-253, 2006 2004 ->:

Jakob Kristensen.

Direct pelletization in a rotary processor controlled by torque measurements. III: Investigation of microcrystalline cellulose and lactose grade. AAPS PharmSciTech. 6[3] Article 62 (http://www.aapspharmscitech.org, 2005 Jakob Kristensen, Torben Schæfer, Ole Wørts, Bernhard Luy. Preparation of spherical and freeflowing agglomerates with high drug content using a robust direct agglomeration process in a rotary processor. Proceedings, 2004 AAPS Annual Meeting and Exposition, Baltimore, 7-11 November 2004 Thomas Vilhelmsen, Jakob Kristensen, Torben Schæfer. Melt Pelletization with polyethylene glycol in a rotary processor. International Journal of Pharmaceutics 275, 141-153. 2004. Jakob Kristensen, Torben Schæfer, Peter Kleinebudde. Development of fast disintegration pellets in a rotary processor. Drug Development and Industrial Pharmacy 28[10], 1201-1212. 2001. Jakob Kristensen

Direct Pelletization in Rotary Processors. A literature review. Danish University of Pharmaceutical Sciences, PhD-thesis, December 2001 Jakob Kristensen, Torben Schæfer, Peter Kleinebudde. Direct pelletization in a rotary processor controlled by torque measurement. II: Effect of changes in the content of microcrystalline cellulose. AAPS PharmSci 2[3], article 24-(http://www.pharmsci.org/). 2000. Jakob Kristensen, Torben Schæfer, Peter Kleinebudde. Direct pelletization in a rotary processor controlled by torque measurements. I: Influence of process variables.

Pharmaceutical Development and Technology 5[2], 247-256. 2000. Li-Sing Wang, Jakob Kristensen, Duane E. Ruffner.

Delivery of antisense oligonucleotides using HPMA polymer: synthesis of A thiol polymer and its conjugation to water-soluble molecules. Bioconjugated Chemistry 9[6], 749-757. 1998.

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