Case 1:14-cv-00113-RGA-MPT Document 276-2 Filed 09/24/15 Page 1 of 8 PageID #: 9301
`Case l:14—cv—OOl13—RGA—MPT Document 276-2 Filed 09/24/15 Page 1 of 8 Page|D #: 9301
`
`TAB B
`TAB B
`
`
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 276-2 Filed 09/24/15 Page 2 of 8 PageID #: 9302
`
`
`
`
`
`Date : 17.09.2015
`
`
`
`CURRICULUM VITAE
`
`Forename : Norbert
`
`Nationality : German
`
`:
`
`:
`
`:
`
`:
`
`:
`
`:
`
`:
`
`:
`
`Qualified person for manufacturing of drug products
`(§15 AMG, Herstellungsleiter)
`
`Continued education for specialist in pharmaceutical
`analytics (State Chamber of Pharmacists, Hesse) with
`the degree Pharmacist for Pharmaceutical Analytics
`
`Continued education for specialist in pharmaceutical
`technology (State Chamber of Pharmacists, Hesse)
`with the degree Pharmacist for Pharmaceutical
`Technology
`
`PhD, University of Regensburg
`
`Post-Graduate student in Pharmaceutics, University of
`Regensburg, Germany
`
`License as pharmacist (Approbation)
`
`Undergraduate education as Pharmacist, University
`Regensburg, Germany
`
`Secondary School (Gymnasium) in Weiden, Germany
`
`:
`:
`:
`
`German
`English
`French
`
`
`
`Name : Dr. Lill
`
`Date of Birth : 13.03.56
`
`
`
`1. EDUCATION
`
`
`1992 - 2012
`
`
`1990 – 1994
`
`
`1988 – 1990
`
`
`1985
`
`1981 - 1985
`
`
`1981
`
`1976 – 1980
`
`
`1966 - 1975
`
`
`
`
`
`2. LANGUAGES
`
`
`Mother tongue
`Fluent professional practice
`Basic:
`
`
`
`Page 1 of 7
`
`
`PTX-691.0001
`
`Sanofi v Eli Lilly
`
`PTX-691
`
`1-14-cv-00113-RGA-MPT
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 276-2 Filed 09/24/15 Page 3 of 8 PageID #: 9303
`
`
`
`
`
`Date : 17.09.2015
`
`2014 until now
`
`
`
`
`
`3. PROFESSIONAL EXPERIENCE WITHIN THE GROUP
`
`
`Sanofi-Aventis Deutschland GmbH
`Global Head Pharmaceutical Excellence and
`Drug Device Combination Integrator
`Member of PSO Board.
`
`Troubleshooting and risk mitigation of late stage
`projects: integrated development of drug device
`combination products
`
`Sanofi-Aventis Deutschland GmbH
`Head Pharmaceutical Sciences Operations Frankfurt
`Member of PSO Board. Integration of Industrial
`Development & Innovation (ID&I) Injectables Group.
`Reorientation of department towards additional
`industrialization support until product launch. PAI
`support for Lixisenatide. Fostering further cooperation
`with IA Frankfurt sites. Development of governance
`model. Continuation as R&D representative for Device
`Development Industrialization Launch Preparation
`Committee (DDIC) and Risk Management Board
`(RMB)since 2009. Repositioning for Peptide depot
`delivery systems development.
`
`Sanofi-Aventis Deutschland GmbH
`Head Pharmaceutical Sciences Department, Northern
`Europe
`
`Management of Alnwick (2005), Budapest and Frankfurt
`site. Member of PSD board. First regular chair of
`Regional Scientific Management Committee in
`preclinical and regional CMC project council in CMC for
`Northern Europe Region. R&D representative for
`Device Development Industrialization Launch
`Preparation Committee (DDIC) and Risk Management
`Board (RMB)since 2009.
`Hiring and integration of ~30 new associates (~15
`PhDs) in FF and BU. Fostering internalization of new
`technologies (Nanocrystalls; ELAN; Microspheres;
`BROOCKWOOD). Introducing pharmaceutical
`engineering into organization. Ensuring high standard in
`GMP and HSE without critical findings in internal and
`external audits (authorities). Enhancing cooperation
`with Discovery. Initiating close cooperation with IA PCII.
`Fostering creating new state-of-the-art parenteral pilot
`plant; refurbishing of radio-active clinical supply unit
`(BEX) and creation of new OEB4 area (HSE).
`Closing of Alnwick (2006) and Budapest (2012) site
`
`
`
`
`
`Aventis Pharma Deutschland GmbH
`Head Pharmaceutical Sciences, Germany
`
`Introduction of early formulation concept.
`Fostering transfer, submission and world-wide launch of
`Apidra as well as Pre-approval inspection (PAI) by FDA
`
`:
`
`
`
`:
`
`
`
`
`2013 - 2014
`
`
`
`
`2005 - 2012
`
`
`2003 - 2004
`
`:
`
`
`
`Page 2 of 7
`
`
`PTX-691.0002
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 276-2 Filed 09/24/15 Page 4 of 8 PageID #: 9304
`
`
`
`Date : 17.09.2015
`
`
`
`
`
`: Aventis Pharma Deutschland GmbH
`
`Pharmaceutical Sciences
`
`Head Drug Delivery Liquids Development
`
`Hoechst Marion Roussel, Germany, Frankfurt
`Pharmaceutics Germany
`Head Drug Delivery Liquids
`
`Transfer, submission and world-wide launch of
`Lantus®. Pre-approval inspection (PAI) by FDA
`
`
`
`Hoechst Marion Roussel , Germany, Frankfurt
`Pharmaceutics Department
`Head Drug Delivery Systems & Parenterals
`
`Submission and market launch of Buserelin
`microparticles in Japan
`
`Hoechst AG, Germany, Frankfurt
`Pharmaceutics Department
`Head Special Dosage Forms
`
`Scale up of microparticle manufacture to industrial
`scale. Introducing first autoclavable spray dryer in
`cooperation with Industrial Operation and NIRO to
`production. External cooperation including pre-financing
`of new sterile facility with VETTER for double-chamber
`syringes.
`
`Hoechst AG, Germany, Frankfurt
`Pharmaceutics Department
`Head of Laboratory, Special Dosage Forms
`
`Formulation & process development for Buserelin
`microparticles in lab scale including GMP
`manufacturing. Introducing new excipient (PLGA50:50)
`to pharma market.
`
`
`
`Hoechst AG, Germany, Frankfurt
`Pharmaceutics Department
`Head of Laboratory, Dermal Dosage Forms
`
`Research program for peptide depot system based on
`biodegradable microparticles.
`
`:
`
`:
`
`:
`
`:
`
`:
`
`
`
`
`
`
`
`2001 - 2002
`
`
`
`
`
`1998 - 2000
`
`1994 – 1998
`
`1992 – 1994
`
`1989 – 1992
`
`1987 – 1989
`
`
`
`
`
`Page 3 of 7
`
`
`PTX-691.0003
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 276-2 Filed 09/24/15 Page 5 of 8 PageID #: 9305
`
`
`
`
`
`Date : 17.09.2015
`
`
`
`4. PROFESSIONAL EXPERIENCE OUTSIDE THE GROUP
`
`
`2008 – until now
`
`
`1985 – 1987
`
`
`1980 – 1981
`
`
`
`: Member of the Scientific Advisory Board; Faculty of
`Pharmacy, Phillips-University of Marburg, Germany
`
`:
`
`:
`
`Assistant Professor, Pharmaceutical Technology
`University of Regensburg
`
`Practical stage in a community pharmacy
`
`
`
`
`
`
`5. Publications / International Associations / Expert Reports (involvements) :
`
`Thesis:
`
`“Spektroskopische Untersuchungen von Dermatika und Wirkstoffsorbaten an Siliciumdioxid”;
`(Spectroscopic investigations of dermal dosage forms and drug substance adsorbates on silicium
`dioxide) 1985, University of Regensburg; supervised by Prof. H. Rupprecht
`
`
`
`Publications:
`
`1. Colloidal silica as drug carrier
`Eckert. Ch; Endres, W; Lill, N; Rupprecht, H; Valentin, B.
`Congr. Int. Technol. Pharm. 5 (240) 1983
`
`IR-spektroskopische Untersuchungen an Dermatika mit abgeschwächter totaler Reflexion (ATR-
`Technik)
`1. Salben und Pflaster
`Lill, N; Rupprecht, H.
`Pharm. Ztg. 129 (690) 1984
`
`3. Spektroskopische Untersuchungen an Phenol-SiO2-Sorbaten
`Lill, N; Eckert-Lill, Ch; Rupprecht, H.
`Scentia Pharm. 54 (212) 1986
`
`4. Chemisorbates of drugs on silica:
`A new approach to drug release modifaction
`Eckert-Lill, Ch; Lill, N; Endres, W; Rupprecht, H.
`Drug Dev. & Industrial Pharmacy 13 (9) 1987
`
`5. Phenylalkanol – adsorbates on silica as types of immobilized drugs
`1. Chemiadsorption on activated silica surfaces
`Eckert-Lill, Ch; Lill, N; Rupprecht, H.
`Colloid & Polymer Sci. 265 (1001) 1987
`
`Immobilized drugs: Phenol and benzoic acid derivatives chemiadsorbed on silica.
`I. Preparation of chemiadsorbates.
`Eckert-Lill, Ch.; Lill, N.; Endres, W; Rupprecht, H.
`Acta Pharm. Jugosl. 38/4 (373) 1988
`
`
`2.
`
`6.
`
`Page 4 of 7
`
`
`PTX-691.0004
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 276-2 Filed 09/24/15 Page 6 of 8 PageID #: 9306
`
`
`
`
`
`Date : 17.09.2015
`
`7. Spektroskopische Charakterisierung des Adsorbatzustandes in Physi- bzw. Chemisorbaten von
`Parahydroxy-Benzoesäure an SiO2
`Lill, N; Rupprecht, H.
`Archiv d. Pharmazie 9 (595) 1988
`
`8. Buserelin Microspheres: critical factors for drug release from monolithic microspheres
`Schmiedel, R; Lill, N; Sandow, J.
`Acta Pharm. Technol. 34/1 (10S) 1988
`
`9. Characterization of p-hydoxybenzoic acid methylester physi- and chemiadsorbates on silica by IR-
`and UV-spectroscopy
`Lill, N; Rupprecht, H.
`Colloid & Polymer Sci. 276 (74) 1989
`
`10. IR-spektroskopische Untersuchungen an Dermatika mit abgeschwächter totaler Reflexion (ATR-
`Technik)
`2. Transdermale therapeutische Systeme
`Lill, N; Rupprecht, H.
`Pharm. Ztg. Wiss. 3/2 (139) 1989
`
`11. Effect of a new LHRH antagonist on DMBA-induced mammary tumors
`Sandow, J; Stöckemann, K; Kibat, P-G; Lill, N; Neubauer, H; Jerabek-Sandow, G.
`Eur. J. Cancer 26/2 (175) 1990
`
`12. A new antagonist of Luteinizing Hormone - Releasing Hormone
`Sandow, J; Jerabek-Sandow, G; Stöckemann, K; Fraser, H-M; König, W; Lill, N.
`Acta Endocrinoll. 122/1, (122) 1990
`
`
`13. Biodegradable Buserelin Microspheres (PLG 50:50), a controlled release formulation
`Stöckemann, K; Sandow, J; Rechenberg, W. von; Hahn, M; Lill, N.
`Acta Endocrinol. 122/1 (89) 1990
`
`14. PHB/PLGA microspheres for controlled drug delivery of Buserelin
`Lill, N; Schmiedel, R; Sandow, J.
`Acta Pharm. Technol. 36/, (23S) 1990
`
`
`15. Controlled delivery of buserelin from biodegradable polylactide microparticles
`Lill, N, Sandow, J.
`Eur. J. Pharm. Biopharm. 38/2 (3S) 1992
`
`16. Mikropartikel aus bioabbaubaren Polymeren im pharmazeutisch-medizinischen Einsatz
`Bengs, H; Lill, N; Sandow, J; Walch, A.
`Spektrum d. Wissenschaft (118) 1994
`
`17. Polymerized tartaric acid derivatives for a second generation of drug delivery systems
`Ahler, M; Bayer, U; Bengs, H; Krone, V; Lill, N; Sandow, J; Walch, A.
`Proc. Control. Release Soc. 22 (792) 1995
`
`18. Injizierbare Arzneiformen auf Basis biodegradabler Polymere:
`Teil 1: Herstellmethoden
`Lill, N; Tertsch, K.
`PZ-Prisma 2/4 (269) 1995
`
`19. Injizierbare Arzneiformen auf Basis biodegradabler Polymere:
`Teil 2: Charakterisierung
`Lill, N; Tertsch, K.
`PZ-Prisma 3/1 (60) 1996
`
`
`
`Page 5 of 7
`
`
`PTX-691.0005
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 276-2 Filed 09/24/15 Page 7 of 8 PageID #: 9307
`
`
`
`
`
`Date : 17.09.2015
`
`20. Two poly(D,L-lactide-co-glycolide) 50:50 types: Same polymer but different properties?
`Lill, N; Sandow, J.
`Proc. Control. Release Soc. 23 (329) 1996
`
`21. Polytartrate – A new biodegradable polymer
`Bengs, H; Bayer, U; Krone, V; Lill, N; Sandow, J; Walch, A.
`Proc. Control. Release Soc. 23 (23) 1996
`
`22. Pharmacokinetics of buserelin mircoparticles in three animal species
`Sandow, J; Rechenber, W. von; Jerabek-Sandow, G; Krauss, B; Fenner-Nau, D; Lill, N.
`Gynecol Endocrinol. 10 (9) 1996
`
`23. Liposomen in Pharmazie und Kosmetik.
`Teil 1: Struktur und Herstellungsverfahren
`Lill, N; Krempel, H.
`PZ-Prisma 3/4 (262) 1996
`
`24. Liposomen in Pharmazie und Kosmetik.
`Teil 2: Anwendungen und Wirkungen
`Krempel, H; Lill, N.
`PZ-Prisma 4/1 (46) 1997
`
`25. Injizierbare Arzneiformen auf Basis biodegradabler Polymere
`Lill, N
`Chemie Ingenieur Technik 72 (939) 2000
`
`26. Insulinformulierungen: Herstellung schnell-wirkender Insuline und Verzögerungsinsuline - wie lässt
`sich diese Herausforderung technologisch lösen?
`Lill, N.
`Pharm.u.Z., 30/1 (56) 2001
`
`27. Moderne Arzneiformen für Peptide
`Lill, N.
`PZ-Prisma 8/3 (137) 2001
`
`28. Weg mit der Spritze
`Lill, N.
`Diabetes-Forum 10/2005, 52
`
`29. Formulierungen für Insulin – Von der Spritze zum künstlichen Pankreas
`Hagendorf, A.; Lill, N.
`Pharmakon, 2/2013, 128
`
`Patents
`
`1. HOE87F/335: Buserelin Mikropartikel – Verfahren zur Herstellung von bioabbaubaren
`Mikrokapseln wasserlöslicher Peptide und Proteine Buserelin Microparticles, manufacturing
`process)
`
`
`2. HOE91/F160; Polykondensate, die Weinsäure enthalten, Verfahren zu ihrer Herstellung und
`Verwendung derselben (Polytartraric acids, manufacturing process and use)
`
`
`3. HOE91/F092; Langwirkende bioabbaubare Mikropartikel und ein Verfahren zur Herstellung.
`(Long-acting microparticles and a process for manufacturing)
`
`
`4. DEAV2002/0040 Saure Insulinzubereitungen mit verbesserter Stabilität (Acidic Insulin formulation
`demonstrating an improved stability)
`
`
`5. DEAV2002 Zinkfreie und zinkarme Zubereitungen mit verbesserter Stabilität (Zincfree insulin
`formulations with improved stability)
`
`Page 6 of 7
`
`
`PTX-691.0006
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 276-2 Filed 09/24/15 Page 8 of 8 PageID #: 9308
`
`
`
`
`
`Date : 17.09.2015
`
`
`6. Patent application: Komplexe / Salze mit HOE140 und chemischen Verbindungen zur gesteuerten
`Wirkstofffreigabe (Complexes/Salts of HOE140 and chemical substances with modified release
`properties)
`
`
`
`International Assoiciation:
`
`Member
`• American Association of Pharmaceutical Scientists (AAPS)
`• Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik (APV)
`• Controlled Release Society (CRS)
`• Controlled Release Society (CRS) / Sektion Deutschland e.V. (Co-founder of the Section)
`
`
`
`Expert reports (involvement)
`
`
`NDA
`
` •
`
` HOE 766 microparticles (Suprecur MP®)
`• HOE 901 (Lantus®)
`• HMR 1964 (Apidra®)
`• HMR 1726 (Aubagio®)
`• AVE 0010 (Lyxumia®)
`• HOE 901 U300 (Toujeo®)
`
`
`
`BLA
`
` •
`
` SAR 236553 Alirocumab (Praluent®)
`• SAR 153191 Sarilumab
`• SAR 231893 Dupilomab
`
`
`
`Page 7 of 7
`
`
`PTX-691.0007