Dermatological Clinical Research at Robert Wood Johnson Medical ...

DermatologicalClinical Research atRobert Wood JohnsonMedical SchoolMelissa A. Magliocco, MD, CPIAssistant Professor of MedicineUniversity of Medicine andDentistry of New Jersey-RobertWood Johnson Medical School(UMDNJ-RWJMS)

Our CenterDivision of ClinicalPharmacology inthe Department ofMedicinePsoriasis Center ofExcellence (PCE)Division staff. From left -Top to right row:Patricia Hanas, Wendy Myers, Angelina i- Callo, Irina Lipets. Bottom row: Joyce Morin,Melissa Magliocco, Claudia Van Saders

Our Center, cont’dThe Clinical Pharmacology Divisionrepresents a unique collaboration ofscientific innovation and vision for theadvancement of medicine and patientcareWe are located on the New Brunswickcampus of Robert Wood Johnson MedicalSchoolWe can provide the key components forsuccess along the drug developmentpathway

MissionTo improve the lives of patients withpsoriasis and other skin diseases through:• Clinical and translational research• Patient and health care provider educationTo be the first choice of industry,government, and other scientists for theplacement of clinical research studies inNew Jersey

Team ExperienceThe Clinical Pharmacology division hasaccess to world-class facilities and staff,including the following:• A multidisciplinary team• Faculty physician• A large, diverse patient population• Laboratory and investigative drug pharmacyservices

Team Experience, cont’d Research coordination by a team ofprofessional nurses with experiencein Phase I-IV trials in the followingfields:• Dermatology• Cardiology• Psychology• Endocrinology• Radiology• Infectious Diseases• Gastroenterology• Pediatrics• Rheumatology• Oncology• Geriatrics• Surgery

Team Experience, cont’dExperience in dermatological studies:• Psoriasis• Psoriatic arthritis• Atopic dermatitis (eczema)• Vitiligo• Acne• Skin cancer prevention

“Firsts” at the Division of ClinicalPharmacology/PCEOne of the first to publish on biologics forpsoriasisHelped develop pharmacodynamicmarkers of response to psoriasis therapyFirst clinical (Arch Dermatol, , 2004) andfirst pivotal trial (NEJM, 2004) ofetanercept for psoriasisFirst monotherapy trial of a TNF-blocker inpsoriasis (The Lancet, 2001)First clinical trial of efalizumab in psoriasis(JAAD, 2000)

Scope of ServicesThe Division’s s team delivers qualityservices within expected time frames andoffers comprehensive range of services toother investigators in academia and thepharmaceutical industry

Scope of Services, cont’dServices include:• Conducting Phase II-IV trials• Pharmacokinetic and Pharmacodynamic studies• Data Management and Biostatistics• Clinical Plan Development Consulting• Design of Case Report Form• Design of Source Documents• Regulatory Management• Medical Writing and Editorial Services• Research Coordination by a team ofprofessional nurses experienced in any route ofdrug administration

The Institutional Review BoardThe Division of Clinical Pharmacologycurrently receives research study approvalthrough the UMDNJ Institutional ReviewBoard (IRB) and the Western IRB (WIRB),committees that review research studiesin order to protect people participating intrials

Collaborating CompaniesThe Division of Clinical Pharmacology has beeninvolved in clinical research for approximately 15years. The team has worked with a variety ofcompanies including:• Allergan, Inc.• Amgen Inc.• Astellas Pharma US (formerlyFujisawa Healthcare, Inc)• Berlex, Inc.• Biogen Idec• Boehringer Ingelheim• Bristol-Myers Squibb Company• Celgene Corporation• Cellgate, Inc.• Centocor, Inc.• CombinatoRx• Connetics Corporation• Corixa Corportaion• Elan Pharmaceitcals• F. Hoffman LaRoche Ltd.• GD Searle & Co.• Genentech, Inc• Geomed• GlaxoSmithKline• Immune Response Corporation• Immunex Corporation• Johnson and Johnson• Ligand Pharmaceuticals• Medimmune, Inc.• Merck and Co, Inc.• Novartis AG Parke-Davis• Pfizer, Inc.• Protein Design Las, Inc• Quatrx Pharmaceuticals Company• Versicor, Inc• Warner Chilcott• Xoma LLC

Collaborating ContractResearch Organizations (CROs(CROs)The Division of Clinical Pharmacology hasworked with a variety of CROs including:• Averion, Inc.• Covance, Inc.• ICON Clinical research Ltd.• Industrial Common Ownership Finance Ltd. (ICOF)• Kendall• MDS Pharma Services• Paragon Biomedical• Parexel International• Pharmaceutical Product Development, Inc. (PPD)• Quintiles Transnational Corporation• Target Research Associates• Terre Clinical Research Services, Inc.

Collaborating InstitutionsRutgers University:• Dr. Allan ConneyAn Investigator Initiated, Phase II, Randomized, Double-Blind, Placebo Controlled Clinical Trial Evaluating theEffects of Topically Applied Constituents of Green Tea(Caffeine or (-)-Epigallocatechin gallate; EGCG) on UVInduced Increase in p53 and Apoptotic Markers in theSkin of Human Volunteers (AKA Effect of Caffeine onUVB-Induced Skin Cancer)An Investigator Initiated, Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating theEffects of Topically Applied Caffeine on Actinic Keratosis(AKA Inhibition of Skin Cancer by Caffeine)• Drs. Bozena Michniak and Larisa SheihetNanospheres as Delivery Vehicles for PsoriasisTherapeutics

Collaborating Institutions, cont’dTufts-NEMC:• Dr. Alice GottliebAscending-Dose, Double Blind, Placebo-Controlled,Bilateral Study of Intralesional Fluphenazine Decanoatefor Psoriasis

EducationStaff members at the division of ClinicalPharmacology have published numerousarticles in a variety of journals andpublicationsMembers have attended national academicmeetings and presented researchFellows; resident and student rotationsSummer Research Lecture SeriesIntegrated Cases with second-year medicalstudents

Education, cont’d

OutreachSeek opportunities to educate thecommunity regarding new research andpatient care results from the Center’s s work

Questions?

Thank you!