I. Extensive Experience/Expertise in Designing, Evaluating, Shaping and Executing Phase I and II Drug Candidates/Programs
Have served in the capacity of evaluator and designer of more than 100 different early competing drug development programs at Roche, Genentech and others. This process involves extensive literature review and interacting with company basic scientists and clinicians as well as counterparts at academic centers. Have arranged numerous meetings of worldwide expert scientists and clinicians at several points in the development process ranging from having the initial idea to target a new therapeutic area up to organizing an investigator’s meeting to conduct phase 2 proof of concept trials. Extensive collaboration with statistical, regulatory, data management, operations and clinical science personnel. Extensive interactions with FDA reviewers at pre and post-IND stages. Extensive experience with re-analysis of early drug interaction and side effect data (e. g. , ECG abnormalities, coagulation abnormalities, transaminase elevations) and re-interpreting same for FDA reviewers for the purpose of removing serious unnecessary caveats from product label. Provided such analyses for NDA/BLA submissions. Extensive interaction with business experts to meld science, pharmacoeconomics and marketing data into decision-making. Extensive experience in advising and quantitating elements of go/no go decisions at all phases of discovery/development.
II. Extensive Experience /Expertise in Design and Conduct of Phase II-III Trials
Have served as medical monitor and designer of a pivotal phase III trial in liver transplantation, and multiple phase II trials including diabetic macular edema, osteoporosis, diabetic nephropathy, renal anemia and myelodysplastic sydrome. Have been a major participant in all aspects of phase III in renal, heart and liver transplantation: Investigator meetings, trial design, study report writing, manuscript writing, NDAs, correspondence with FDA, summary of safety, summary of efficacy, expert report author. Design of development programs for 2 biologicals in transplantation. Major participant in adefovir dipivoxil (antiretroviral) NDA, Gilead Sciences). Major author in efaluzimab (psoriasis) BLA. Design and conduct of Phase I and II osteoporosis trials. Major participant in NDA for osteoporosis, including histomorphometry and fracture diagnosis validation documents. Design and conduct of development programs in diabetic macular edema, age-related macular degeneration, allergy, psoriasis, extrarenal lupus, lupus nephritis, polycystic kidney disease, CHF, chronic kidney disease, membranous nephropathy, focal and segmental glomerulosclerosis, predialysis renal anemia, dialysis renal anemia, myelodysplastic syndrome, chemotherapy-related anemia, cancer-related anemia, diabetic nephropathy. Conduct, including implementation, of Phase 2 rheumatoid arthritis trial.
III. Extensive experience in analyzing new drug targets, assays, selection and development of compound screening tools and applying them to requisite factors of cell biology and then for early in vivo preclinical validation.
IV. Extensive Phase IV assessments for publication strategies versus label extension strategy.
V. Extensive experience in the liaison between basic scientists and clinical scientists and marketing executives to design, refine and redirect early drug discovery programs.
VI. Experience in Oversight of Company Clinical Science Publication Program
Involved writing of manuscripts for publication at two companies, extensive editing of many manuscripts written by sponsored investigators for biomedical journals.
VII. Experience with Company-Sponsored Scientific Grant Program for Clinical Investigators
VIII. Review and adjudication of extramural grant proposals for company funding.
IX. Experience with Design and Execution of Training Program for Industry Clinical Scientists at Two Companies.
X. Clinical and Preclinical Strategy Team Member for New Indications for Existing Drugs at Multiple Companies
XI. Evaluator of Numerous In-Licensing Opportunities Including Late-Stage Due Diligence.
XII. Major Therapeutic Areas
A. Transplantation, Solid Organ
Major participant in successful mycophenolate mofetil cardiac NDA and EU filing, writing the majority of the filing documents and having major input in the remainder of documents, medical monitor, major input into data analysis plan, organization of NDA, major input into decisions to deal with original study design difficulties. Design and execution of post-approval animal studies. Reported to Development Clinical VP. Design of Ph 2 and 3 programs for 2 biologicals. Reported to Director. Involved in development planning for 2 transplantation programs with biologic agents.
B. Fracture Healing
Design of phase II and III for two fracture healing agent programs, systemic and local. Member of Project Team. Involved seeking advice of orthopedists, physical therapists and radiologists worldwide and construction of trials, radiographic endpoints, functional endpoints, pharmacoeconomic models. Liason with preclinical scientists in formulation and animal ***** anization of expert meeting and Investigator Meeting. Reported to Project Leader and Director.
Design of phase I and II for osteoporosis multiple prevention/treatment agents. Member of Project Teams. Active participant in design of preclinical studies to discern safety/efficacy. Extensive participant in PK, metabolism, molecular biology of agents. Author of final study reports, manuscripts. Major scientific advisor to Roche in this area. Extensive regulatory, statistical, data management, operations experience. Reported to Preclinical/Clinical VP. Development assessments for biologicals in osteoporosis and bone growth.
Extensive participation in phase II and III of ibandronate program. Evaluation of dose-finding and pivotal trials. Design of phase III and IV activities. Recruitment of outside ***** anized trial designs with collaborators. Author of multiple protocols. Extensive safety evaluations. Design of safety-oriented trials. Author of final reports of pivotal trials. Major participant in ibandronate NDA. Author of pivotal and dose-finding trial study reports. Author of multiple bone histomorphometry reports. Author of fracture validation reports. Author of numerous bone and osteoporosis-related publications with academic co-authors, ongoing. Reported to Development VP and Discovery VP.
Multiple in-licensing due diligence projects in osteoporosis, small molecules and biologics.
Provided the initial idea to discover a drug in this new therapeutic area. Experience in design of cloning project, high throughput screening approach, selection and recruitment of outside scientific ***** anized expert meeting for therapeutic area. Design of phase I and II. Design of preclinical experiments. Reported to Clinical and Preclinical VPs.
E. Coronary Stent Restenosis
Scientific advisor to Guidant. Extensive input into pharmacology, drug applications, design of preclinical program for drug-coated coronary stents. Reported to senior scientists in charge of therapeutic area.
F. Native Coronary Stenosis and Restenosis
Extensive scientific evaluation of early drug discovery programs. Reported to Preclinical VP.
G. Investigation of Phase IV Side Effects
Design of animal and human studies to elucidate mechanism of side effects of approved drug. Selection of outside consultants and PIs to perform ***** anized selection of multiple formulations to circumvent side effect. Monitor and analyze data on ongoing basis.
H. Stable Angina Pectoris
Extensive re-analysis of phase II-III drug interaction and ECG data, writing extensive amendments to old Final Reports of Early phase II trials to remove caveats/side-effects/interactions. Preparation of associated FDA correspondence.
Design of phase I and II for asthma prophylaxis agent with new mechanism of action. Selection of consultants and organized Expert Meeting in preparation for phase I. Participation in phase 3 and 4 protocol design and strategy. Medical monitor for phase 4 asthma studies.
J. Renal Osteodystrophy
Evaluation of lead candidate compounds. Design of clinical program.
K. Prevention of Progression of Renal Insufficiency
Design of preclinical studies. Design of phase I and II studies in polycystic kidney disease and early program planning in general CKD and multiple glomerulonephritis indications including lupus nephritis and diabetic nephropathy. Development planning for biologicals in this indication. Design and execution of progession and albuminuria trials in diabetic nephropathy.
Experience with Iothalamate GFR in clinical trials.
L. Prevention of Pulmonary Emphysema
Selection of endpoints, development of methods to measure endpoint. Selection of expert consultants. Extensive scientific evaluation of potential side-effects.
M. Anti-Retroviral Agents
Extensive scientific evaluation of safety. Major participant in NDA for adefovir dipivoxil with substantial input into ISS, including decisions on how to evaluate safety data, additional testing to perform, coaching for advisory committee meeting. Member of ISS team. Extensive advice on safety correspondence with FDA. Correspondence and interactions with academic experts on same. Provided the principal nephrology input for NDA.
Extensive review of preclinical and phase I program in OA with focus on nephrotoxicity. Implementation, design and conduct of Ph 2 RA trial.
Evaluation and advice for preclinical program. Design of phase I-II. Major author of CSR and filing documents in BLA for efalizumab. Response author for FDA BLA queries.
P. Alzheimers Disease
Review of preclinical and phase I program. Design of phase II. Design of further preclinical protocols. Development assessment in this indication.
Extensive clinical and preclinical evaluation of agents in this area for in-licensing.
R. Diuretics and Aquaretics
Extensive clinical and preclinical evaluation of agents in this area for in-licensing.
S. Wound Healing
Design of Ph 1-3 in a biologics wound healing program.
Design and conduct of multiple clinical and preclinical programs in diabetic macular edema and age-related macular degeneration, both biologic agents and small molecule agents. Served as medical monitor in ph 2 trial. Analysis of phase 2 and 3 safety and efficacy data in large age-related macular degeneration program. Design and execution of pre-clinical AMD program.
U. Diabetes and Metabolism
Evaluation of in-licensing opportunities and strategic portfolio management in this area. Conduct and design of DN progression program. Medical monitor in ph 2 DN study. Design of ph 2 program for hypoglycemic agent.
V. Lupus Nephritis
Design of clinical program for lupus nephritis.
W. Extrarenal Lupus
Design of clinical program for extrarenal lupus with rituximab.
X. Polycystic Kidney Disease
Design of clinical program for attenuation of progression of autosomal dominant polycystic kidney disease.
Y. Peanut Anaphylaxis
Design of clinical program in prevention of peanut allergic reactions. Assessment of basic science supporting double blind food challenge primary endpoint and design of label-enabling trial.
Z. Second Generation Erythropoietin, ESRD Development Program
Design of phase 2 and 3 trials for development of a long acting biologic. Provided the major in-house nephrology expertise for this large development program.
AA. Nephrotoxicity of Small Molecules and Biologics
Have acted as the major nephrology advisor to several companies in evaluating data from an planning of toxicology studies in several species regarding nephrotoxic findings, both immunological, mechanism-based and compound-based.
BB. Evaluation of Changes in Renal Function
Have worked with several companies to analyze existing iothalamate, inulin and creatinine GFR and other renal function data as basis to enhance clinical trial design to include endpoints and precise measurements that highlight mechanism-based changes in renal function. In some cases, the primary endpoint of a label-enabling trial was based on renal function. Designs applied in diabetic nephropathy, acute CHF, Lupus nephritis and other indications.
CC. Oral Agents in Renal Anemia
Design of multiple phase 1 and 2 studies and overall clinical program for 3 agents. Medical Monitor of multiple phase 2 trials. Author on phase abstracts.
DD. Myelodysplastic Syndrome
Design of phase 2 trial and medical monitor.
EE. Chemotherapy Induced Anemia
Design of phase 2 trial.
FF. Acute CHF
Design of phase 4 trials. Re-analysis of phase 2 and phase 3 data.
GG. Treatment of COPD
Design of human mechanistic studies in COPD patients. Design of multiple phase 1b and phase 2 studies in COPD. Experience with inhalational delivery and bridging studies for evaluation of alternate delivery methods. Evaluation of numerous in-licensing COPD agents. Served as Clinical Development Representative on an early development team re an inhaled biologic.
HH. Treatment and prevention of pulmonary fungal infections.
Design of phase 2 and phase 3 trials in immunosuppressed populations re inhaled anti-fungal agents.
II. Iron Metabolism and Ferrokinetics
Design of both preclinical and clinical ph 2 studies in all aspects of iron transport and ferrokinetic measurements, including intestinal iron absorption, iron transport from RES stores, ineffective erythropoiesis, red cell survival.
JJ. Rheumatoid Arthritis
Design and conduct of ph 2 studies. Evaluation of post marketing side effects.
KK. Multiple Sclerosis
Design of phase 2 studies. Evaluation of post marketing side effects.
LL. Idiopathic Pulmonary Fibrosis
Analysis of ph 1 data and design of ph 2 studies. Design and analysis of preclinical studies
MM. Hepatic Fibrosis
Design of phase 2 trial. Design and analysis of preclinical studies.
NN. Renal Fibrosis
Design of multiple ph 2 trials. Analysis and med monitor of ph 2 trials. Extensive design and analysis of preclinical studies.
XII. Exceptional knowledge of the medical and related basic science literature and ability to apply it rapidly to incipient or very mature pharmaceutical and device programs.