Acting VP of R&D working to advance the lead program MMP2/9 inhibitor into clinical studies

Responsible for leading Global early development consulting services Team to engage client companies and connect internal resources to support early stage drug development activities. Typical collaborations include pre-IND meeting support (Briefing Document writing, Meeting Request correspondence, meeting attendance and follow up), IND writing, GLP Tox oversight, required ADME support (CYP phenotyping, transporter studies, metabolite profiling) and safety pharmacology studies. Post IND submission and FIM study support is also provided by the early development group.

CSO responsible for all nonclinical and early clinical development of novel regenerative therapies in CV space.

Providing consulting services for all size companies in pharmaceutical global drug development. Experienced in all phases of development from discovery candidate selection through commercialization. In addition to helping companies with the drug development process, capable of developing life cycle management and positioning for parnering and acquisition. Connected to a large network of drug development professionals who can assist in filling other roles in QA, Regulatory, and CMC.Primarily introduced to new companies as a Clinical Pharmacologist with PK modeling capabilities. This introduction and further collaboration with a company usually leads to a greater breadth of involvement in the drug development project Team role.

Transition role following acquisition of Gloucester Pharmaceuticals.

Responsible for all non-clinical drug development activities to include external relationships with academic institutions and investigator initiated studies. Leading the nonclinical and clinical pharmacology presentation of data in potential partnering discussions. Hold sole ownership of the nonclinical safety, toxicology, ADME, pharmacology and clinical pharmacology sections of CTD preparation (submitted Q1 2009). Participated in successful US FDA ODAC for ISTODAX® (romidepsin, best in class pan-HDAC inhibitor) September 2009. ISTODAX was approved in the US for use in patients with CTCL in Nov 2009 and in patients with PTCL in June 2011. Collected critical ECG safety data from ongoing studies to include in NDA in order to prevent a “Black Box” CV safety warning. Established relationships with outside investigators to build Investigator Initiated/Sponsored research to support protocols for novel clinical and non-clinical research.

Responsible for establishment and operation of Preclinical Drug Development group, including In Vivo Pharmacology, Toxicology, Pharmacokinetics and Drug Metabolism, Clinical Pharmacology, Bioanalytical, Preclinical Documentation and Operations. Grew a functional Development group capable of supporting the IND enabling studies in two therapeutic areas; inflammation/arthritis (MMP-13 inhibitor) and metabolic disease (DPP-IV inhibitor). Established electronic documentation control compliant with CFR 21 part 11. Built new relationships between Alantos and several major CRO’s to support necessary GLP Toxicology and Safety Pharmacology studies. Interacted with the Investment community to secure $20M in Series B funding (2005). Key drug development contact for presenting data and interacting with Large Pharma partners. Established a partnership with Servier for the worldwide co-development of an oral DPP-IV inhibitor. Member of Alantos Pharmaceuticals Senior Management Team.Promoted to Senior Director following the completion of first IND submission and successful FIH program for diabetes project, advancing discovery candidate into the clinic in 11 months. Responsible for all aspects of program management and strategic product planning for two clinical lead programs. Assumed all Clinical and Regulatory responsibilities in addition to responsibilities listed below. Lead partnership discussions with several large Pharmaceutical companies, ultimately resulting in an M&A of Alantos Pharmaceuticals by Amgen for $300M.

Associate Director, Pharmacokinetics and Drug Metabolism Oct 2001-Oct 2004Additional responsibilities included supporting the commercialization of the first in class boronic acid proteasome inhibitor VELCADE™ during pre-launch and launch following US FDA approval by interacting with key opinion leaders in the treatment of patients with multiple myeloma. Negotiated Phase 4 commitments with US FDA to further describe the potential drug-drug liabilities of VELCADE with drugs that induce or inhibit cytochrome P450 mediated oxidative metabolism. Designed two organ dysfunction trials with NCI/CTEP Organ Dysfunction Group to evaluate the effect of renal and hepatic dysfunction on the kinetic disposition of VELCADE. Worked on CAMPATH (alemtuzumab, a CD52-directed cytolytic Ab) Registration Team following merger with Leukocyte. Assisted in commercialization of INTEGRILIN (eptifibatide, a IIb/IIIa inhibitor) following merger with COR Pharmaceuticals. Contributed to the LDP-02 clinical development with PK/PD modeling support (later approved as ENTYVIO, following Takeda acquisition of Millennium).

Responsible for creation of a DMPK group to support drug development from late stage discovery through early Phase 2 clinical Trials. Responsible for the preparation of documents to support regulatory submissions in Foreign and the US Agencies. Established relationships with several contract research organizations (Quintiles, PPD, MDS, Covance, Advion) for the conduct of pre clinical DMPK studies and the GLP analysis of biological samples. Created a system for setting up Master Service Agreements with large CRO’s in order to streamline the process of contracting and running pre clinical studies. Direct pre-clinical and in vitro studies in the support of ADME packages for drug registration. Serve as DMPK project leader in Development Project Teams in inflammation, oncology, cardiovascular and metabolic disease. Employed sophisticated PK models to describe and predict plasma levels of compounds and their PD effects. Prepare pre-clinical and clinical PK/PD data and conclusions for presentation at scientific meetings and biopharmaceutical presentations to US and Foreign Regulatory Agencies. Competent in the appropriate use of NOMEM, PCNOLIN/ WINNOLIN, TOPFIT, PK Analyst and PPHARM software packages for pharmacokinetic data analysis. Established an analytical chemistry team for the development of appropriate methods of analysis of NCEs and their major metabolites in biological sample matrices.