NUVISAN GROUP. Our Philosophy

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2 NUVISAN GROUP Our Philosophy 2

3 EARLY DEVELOPMENT Introduction to Nuvisan Fully integrated Contract Research Organisation headquarted in Neu-Ulm, southern part of Germany. Nuvisan - Early Development Headquartered in Neu Ulm, Germany, with more than 30 years of successful business operations offers services in Bioanalytics, Pharmaceutical Analytics, Phase I/IIa, Clinical Trial Supplies, CDM & Biometrics, Regulatory Affairs. Nuvisan Oncology Headquartered in Paris, France, is a global group of experienced professionals in Clinical Research and Development in Oncology, a core competency of Nuvisan Pharma Services. Nuvisan - Clinical Development Solutions Headquartered in Madrid, Spain, offers all Clinical Services in Phase II-IV. 3

4 NUVISAN GROUP The Nuvisan Group is established through three Business Units 4

5 EARLY DEVELOPMENT Pharmaceutical Development 20 years of Formulation Development experience Proven expertise in Phase I Development Rapid Phase I approach / Quick proof of concept Unique development campus with all disciplines under one roof Dosage forms: capsules, tablets, OPCs (oral powders for constitution) plus liquid vehicles, powder blends, wet granulation, sachets, fluid bed coating 5

6 Clinical Trial Supplies - Services EARLY DEVELOPMENT CTS Packaging and Logistics Primary Packaging: Blisters, bottles, sachets, tubes Secondary Packaging: Blister cards, wallets, patient kits Label Printing: Randomised, double blind, multilingual International Clinical Distribution incl. Depot Network Import / QP Release Manufacturing Capsules Over-encapsulation Tablets 30+ professional staff 6

7 EARLY DEVELOPMENT Pharmaceutical Analytical Services ICH Stability Testing (API, Formulations) CTS Comparator Stability Studies Method Development Method Validation Cleaning Validation Pharmaceutical Batch Control Batch Release CTS Raw Material Testing and Release Special tasks (e.g. infusion compatibility etc.) 30+ professional staff 7

8 EARLY DEVELOPMENT Bioanalytics One of the largest bioanalytical laboratories in Europe 2500 m² arranged over four laboratories 60+ Professional staff Analysis of drugs and their metabolites in biological matrices Method Development and Validation (more than 500 non-proprietary assays) Method Adaptation and Revalidation Method Transfer Cross Validation Biomarkers / Protein-Binding 8

9 EARLY DEVELOPMENT Bioanalytics / Quality GLP certified since 1994 Last FDA Inspection 2009 LC-MS/MS incl. 2x Sciex API 5000 GC-MS ICP- MS (PE Elan) HPLC Units (detectors: UV, ECD, F) Immunoassay Lab / Clinical Chemistry 9

10 EARLY DEVELOPMENT Phase I Clinical Pharmacology Strategic Planning & Project Management Phase I IIa (healthy volunteers and patients) 80 beds, 12 bed Intensive Care unit First in Man BA/BE Interaction studies (drug / drug & food) Special Populations 35+ professional staff including 8 MD s PK/PD expertise On site clinical chemistry and bioanalysis Pharmacy, QP release and on-site IMP support On site catering - special diets 10

11 ONCOLOGY Oncology drug development and clinical trial management Our expertise resides in: Support for product development for cancer therapy Clinical optimization of single agent and combination therapies, notably for first-in-man molecules Exploration of treatments for targeted populations with unmet needs Implementation of the trials necessary to achieve successful registration 11

12 ONCOLOGY We have assisted various companies in early product development through MTD definition PK analysis and recommendation of Phase II/III strategies Solid experience in performing international Phase I, II and Phase III studies for registration purposes Our experience covers a wide range of solid tumors, hematological diseases, and a variety of cancer therapies. Our involvement results in pertinent and well executed trials with expedited approval for marketing and rapid adoption of new cancer treatments. 12

13 ONCOLOGY Medical oncology input at every step: Unique protocol design by our medical oncologists with medical and scientific input to ensure feasibility Real-time data evaluation in Phase I studies to optimize the dose and schedule, and maximize patient safety Targeted Phase II-III study design (eligibility criteria, endpoints, appropriate controls, etc.) On-site medical source review by oncologists Medical involvement throughout all stages of clinical development, from Phase I to Phase III Access to a global network of experienced investigators 13

14 Clinical operations expertise: ONCOLOGY Rigorous project management by experienced staff ensuring timely and seamless study implementation Quality clinical monitoring with oncology-specific training, GCP/ICH compliance, up-to-date in the field, e-crf experience Medically-driven data management (MedDRA, WHO-DRUG, NCI-CTCAE, etc.) and statistical analyses, using validated systems (SAS /SPSS /Oracle Clinical - FDA 21 CFR Part 11, Clintrial ) Medical writing: protocols, clinical study reports, peer-reviewed publications (preclinical/clinical), IBs, IMPDs, abstracts, posters, clinical summaries, etc. 14

15 ONCOLOGY Clinical operations expertise: Pharmacovigilance: SAE reporting, narratives, Competent Authority reporting, Oracle AERS, following FDA, ICH, EMEA PV guidelines Regulatory Affairs: Ethics Committees, Competent Authorities, regulatory submission Quality Assurance: global SOPs, audit plan, site audits Database cleaning Training in oncology tailored to the Sponsor s needs 15

16 Clinical Solutions Clinical Trial Services (Ph II IV) 60 experienced Professionals across Western/Eastern Europe Strategic planning & project management Feasibility & Site selection Preparation of essential documents Submission to EC and CA Clinical monitoring Pharmacovigilance QP trained Data management & statistical analysis, PK/PD Medical writing IMP manufacturing, packaging, labelling & distribution 16

17 ADCURAM GROUP Organigram 17

18 ADCURAM GROUP Nuvisan is Part of a Family-Owned International Industry Group ADCURAM is a family-owned international group that invests in companies with good substance and significant growth potential. Led by entrepreneurs, ADCURAM develops its businesses with a longterm approach. Hence, ADCURAM provides its group companies with financial resources and expert teams to invest in operational improvement, research and development, growth, and complementary acquisitions. ADCURAM is based in Munich, Germany, and currently employs ~ 2500 highly qualified and motivated employees worldwide. ADCURAM group companies have subsidiaries in all major regions, including USA and Canada, South America, Western and Eastern Europe, Russia, and China. ADCURAM expects to grow strongly in the coming years. 18

19 Contact NUVISAN HEADQUARTERS NUVISAN Pharma Services Wegenerstrasse Neu-Ulm Germany Headquarters Tel Fax