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Medelis Oncology CRO Services

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A basic presentation we use to introduce biotech and pharmaceutical companies to the oncology contract research services Medelis provides to sponsors in the U.S., Europe and Asia.

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Page 1: Medelis Oncology CRO Services
Page 2: Medelis Oncology CRO Services

Medelis is a full service oncology CRO.We deliver a complete array of

drug development services from preclinical through marketing

approval.

Page 3: Medelis Oncology CRO Services

We can provide an entire solution for your journey through the drug

development process…Or we can provide a la carte services to supplement your

existing resources.

Page 4: Medelis Oncology CRO Services

Services include: Oncology preclinical development

Quality assurance and regulatory complianceSite identification, qualification, management, contracting &

payment Medical writing

Protocol developmentDocument preparation and production

Investigator identification and recruitmentMedical monitoring and management

Oncology patient recruitment and accrual strategies

Page 5: Medelis Oncology CRO Services

Now delivers all of our services for European, US and Asian sponsors.

Page 6: Medelis Oncology CRO Services

Headed by Dr. Deirdre Tessman30 years of drug development experience and 10 years

managing oncology trials in the E.C.

Page 7: Medelis Oncology CRO Services

Our approach is driven by our deep oncology experience and focus…

It extends from our medical founders to our CRAs and statisticians.

Page 8: Medelis Oncology CRO Services

Our Medical Advisory Board has a combined 143 years of oncology drug development experience…

422 INDs and 76 NDAs filed.

Page 9: Medelis Oncology CRO Services
Page 10: Medelis Oncology CRO Services

Mace Rothenberg,Vanderbilt-Ingram Cancer Center

John Balser,Veristat

Michael Gordon,PremiereOncology

James Gourzis,Biopharma R&DConsultant

Dan Von Hoff,TGEN

Page 11: Medelis Oncology CRO Services

Our project managers have a minimum of 8 years of clinical research experience…

Our CRAs have a minimum of 4 years ofoncology hands-on experience.

Page 12: Medelis Oncology CRO Services

Our medical monitors are board-certified oncologists.

Page 13: Medelis Oncology CRO Services

Our team has hands-on experience in almost every type of oncology

indication and drug type.

Page 14: Medelis Oncology CRO Services

• AML• Bone marrow transplant

• Breast• Cervical• Cervical hyperplasia• CLL• CML• Colorectal• Endometrial• Gastrointestinal stroma tumor

• Genitourinary indications

• GI indications

• GIST• Glioblastoma• Gliomas • Head and neck• Hepatic• Hepatocellular• ITP• Leukemias• Lymphoma• Malignant ascites• Melanoma• Multiple myeloma• Neuro indications

• Neuroendocrine tumor• NSCLC• Oral mucositis• Ovarian• Pancreatic• Pediatrics• Prostate Renal• Sarcoma• Solid tumors• Solid tumors/lymphoma• Thoracic indications

Page 15: Medelis Oncology CRO Services

• Alkylating agent • Alkylator• Anthracycline• Anti-angiogenesis • Antibody• Antisense• AntiVEGF/ angiogenesis inhibitor• Biologic, gene therapy• Camptothecin derivative• Chemo• Chemo/antibody• Chemo/radiation• Diagnostic

• DNA aptamer/intercalator• Engineered MoAb • Fibrin sealant-biologic• Growth factors• Genitourinary indications• Monoclonal antibody• Multifunctional polypetide agonist• Oral rinse• Tubulin inhibitor• Tumour-VDA• Tyrosine kinase HER1 inhibitor• Tyrosine kinase inhibitor• Vaccine

Page 16: Medelis Oncology CRO Services

We manage our resources through a single point of contact to build a strong relationship with your team.

Page 17: Medelis Oncology CRO Services

Medical

SafetyMgt

Site

DataMgt

ClinicalMonitoring

Sponsor

Project Manager

Page 18: Medelis Oncology CRO Services

We have solid relationships with key academic centers, thought-leaders and research groups.

Page 19: Medelis Oncology CRO Services

• Corporate Affiliations– TGen TD2, Veristat, NFCR

• Key Opinion Leaders– All cancer types– Multiple disciplines

• Academic Centers– NCI-designated Comprehensive Cancer Centers

• Professional Orgs– ASCO, ASH, AACR, etc.

• Federal Agencies– FDA, NIH, NCI

• Cooperative Groups– ECOG, SWOG, RTOG, GOG, ACoSOG, etc.

Page 20: Medelis Oncology CRO Services

We can use sophisticated options like EDC and internet-based patient recruitment

for phase I and phase II trials.

Page 21: Medelis Oncology CRO Services

European OperationsFrance

US OperationsPhoenix, Arizona

US Clinical OperationsNashville, Tennessee

HeadquartersReno, Nevada

Data ManagementBoston, Massachusetts

Page 22: Medelis Oncology CRO Services

To learn more, please contact us today.

US Corporate Headquarters – Phoenix, ArizonaBob Bosserman, President & CEO

(602) 840-1101

Medelis Europe – Port Vendres, FranceDeirdre Tessman, Managing Director

+33 0666 622 723