Project Manager Development

ROBERT J. ANDERS, Pharm.D., FAHA

**** ***** *** **** ***** Vernon Hills, IL 60061

Home: 847-***-**** **********@*****.*** Cell: 847-***-****

CLINICAL DEVELOPMENT / OPERATIONS / PROJECT MANAGEMENT

Accomplished executive with broad-based experience directing global clinical development, strategic development planning, clinical operations, project management, and regulatory support programs with leading pharmaceutical and innovative biotech companies.

EDUCATION

University of Illinois at Chicago

Cardiology Research Fellowship Department of Pharmacy Practice 1986 – 1987

Cardiovascular Specialty Residency Department of Pharmacy Practice 1985 – 1986

Doctor of Pharmacy, with Honors College of Pharmacy 1983 – 1985

BS Pharmacy, with Honors College of Pharmacy 1980 – 1983

Indiana University, Bloomington, IN BA, Biology and Chemistry 1975 – 1979

Fellow, American Heart Association and Council on Arteriosclerosis, Thrombosis & Vascular Biology 2001

LUNDBECK U.S. / OVATION PHARMACEUTICALS Deerfield, IL 2007 – May, 2012

A U.S. affiliate of H. Lundbeck A/S, a Denmark-based pharmaceutical company. Lundbeck U.S. formed from the 2009 acquisition of private equity-owned Ovation Pharmaceuticals.

Clinical Lead, Clinical Research U.S. 2010-2012

• Stepped in to re-invigorate and salvage US site enrollment for global phase 3 pivotal registration study for NCE in acute ischemic stroke by implementing independently associated national stroke networks. Lundbeck discharged a major CRO from the US responsibilities due to inadequate performance. This was the first effort for a US person to be fully integrated in a Lundbeck initiated global and late stage registration/development project

• Identified a key lead national stroke director with ties to established regional key investigator research directors in order to develop a stroke clinical trial hub-and-spoke network resulting in over 70 initiated recruitment which was an increased by 4-fold within one year. Enrollment increased 5-fold and held a steady, consecutively monthly pace for the first time after the site network was fully established.

• Directly supervised a cross-functional operations team to qualify and initiate sites, monitor trial conduct and managed US Medical Affairs physicians/medical monitor to assure consistency of study enrollment criteria including key imaging components using CT/MRI based technologies.

VP, U.S. Processes and Systems, Drug Development 2009 – 2010

• Nominated to manage cross-company teams responsible for the integration of SOPs, processes and standardized systems/tools for clinical development and regulatory affairs departments between Ovation and Lundbeck which was successfully completed ahead of schedule over a 6 month period.

• Implemented integrated processes across US teams and shared learnings with the Lundbeck functional leads to drive best processes going forward including optimizing clinical trial contract reviews and negotiations with average cycle time reduction of 6 weeks

• Co-authored revised new company global clinical development code of conduct reflecting behaviors, accountabilities and deliverables of key senior leadership and functional lead teams.

Vice President, Clinical Operations - Ovation 2007 – 2009

• Managed development of timelines, budgets and outsourcing strategy for clinical programs for a mid-size clinical operations group (n=15) for 3 compounds in late stage development for epilepsy disorders including orphan drug candidates. Lead Project Manager for integrated Sponsor/CRO teams.

• Accelerated enrollment effort on complex registration study of an acute IV compound with CRO restructuring and result to end study conduct and complete reporting to meet timely critical path to submission of results to FDA that would have been delayed initially by over 6 months.

• Assisted in finalizing presentation and compiling data files with independent experts for presentation of drug at a Peripheral and Central Nervous System Drugs Advisory Committee meeting 2009 for infantile spasm indication that was subsequently approved unanimously by the FDA advisory committee.

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• Key contributor to REMS document and designed post-commitment REMS safety trial in collaboration with Regulatory Affairs.

• Served as business lead for matrix based evaluation of eDM, eCTD and CTMS system requirements, including gap analysis, review of vendors and implementation.

• Delegated responsibility and provided mentoring to integrated team for evaluation of budget software system that was eventually approved by senior management to be licensed and implemented.

deCODE GENETICS, INC. Woodridge, IL/Reykjavik, Iceland 2004 – 2007

A biopharmaceutical company formed to discover key genetic targets for the development of new compounds for treatment of high risk individuals through their unique genotype and translational molecular risk factors.

Vice President, Clinical Operations

• Established clinical development plans, operational budgets and timelines for NCE for the treatment of intermittent claudication in patients with peripheral arterial disease (PAD) and two NCEs for prevention of recurrent MI, stroke and cardiovascular related events.

• Implemented and completed phase I dosing and food effect programs 1 NCE to establish dose and safety margins for phase 2 after successful IND meeting with FDA.

• Developed phase 3 protocol, IVRS and supply strategy and selected CRO for implementation of genomic based registration trial in high risk, minority based patient population in collaboration with major cardiovascular academic network prior to program being cancelled.

NEOPHARM, INC. Lake Forest, IL 2003 – 2004

An early stage biological products manufacturer specializing in oncological diseases.

Executive Director, Clinical Research Management - Clinical Development, Oncology

• Managed clinical operations for the implementation/execution of a pivotal phase III (n=300 patients) and globally outsourced trial for a NCE combined with an infusion device for the treatment of first recurrent malignant gliomas (GBM) across the US and Europe. Enrollment trajectory maintained a steady slope upward upon initiation of all global study centers.

• Supervised the development of phase I/II clinical protocols for newly diagnosed malignant GBM) program including collaboration on study designs with oncology and NIH research network leaders.

PFIZER / PHARMACIA / SEARLE 1991 – 2003

Leading global pharmaceutical companies (now part of Pfizer) formed through a series of mergers and acquisitions (Monsanto/Searle Pharmacia and Upjohn).

Clinical Drug Development 2002 – 2003

Senior Director, Arthritis and Inflammation, Clinical Program Director, Clinical Development – Pfizer

• Executed clinical studies outlined in the clinical development plan as Global Clinical Program Director in Inflammation/Pain/Arthritis for registration trials in acute pain with novel injectable cox-2 inhibitor including 5 phase III clinical studies (total operating budget: $70 million) with extensive outsourcing activities for on time completion.

• Implemented new global Phase III 1700 patient trial in patients undergoing coronary artery bypass surgery (CABG).

Senior Director, Experimental Medicine, Cardiovascular/Metabolic and Oncologic Diseases - Pharmacia

• Lead clinical expert for integrated technology and discovery team established for development of biomarkers, assays in pre-clinical and clinical studies including non-invasive imaging for non-drug and intervention Proof of Concept protocols in inflammation and vulnerable plaque assessment.

• Managed a diverse matrix arranged team for the development of Proof of Concept (POC) studies and strategies. Clinical development lead for the design and implementation of proof of concept DMOAD studies using new imaging modalities for assessing joint disease progression.

• Managed 29 person operations group responsible for conducting trials in chemoprevention and treatment. Mentored and directed highly qualified project managers for execution of clinical programs.

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Cardiovascular/Metabolic Diseases - Pharmacia

Senior Director, Medical Development 1997 – 2002

• Global Clinical Program Director in Cardiovascular disorders in Clinical Development in R&D.

• As Clinical Lead, presented to Regulatory agencies, including the US (FDA), Canada, and agencies in France (MRA) and Germany (BfArM) for pre-phase 3 registration discussions.

• Program director lead of clinical teams for preparing development strategies for novel compounds for cholesterol lowering, post-MI remodeling, inflammation (plaque rupture) and CHF therapeutic areas of research

• Participated in merger integration teams for merging processes related to: clinical study operations, clinical development and outsourcing strategies with CRO partners.

Director, Clinical Research; Searle Pharmaceuticals 1993 – 1997

• Prepared clinical development plans for 2 NCEs as first in class oral anti-platelet agents.

• Managed clinical operations team for a successful enrollment of a 7,200 and 10,000 patient phase III clinical trial for each of the aforementioned compounds. Managed clinical budgets of $80 and 95 million, respectively with worldwide outsourcing management. Accelerated enrollment by 4 months with re-organization of CRO team support and re-engineering of CRO project management and milestone payment structure. Set up key opinion leaders along with a major, key academic coordinating center in worldwide recruitment effort.

• Represented the sponsor on Independent Data Safety Monitoring Boards for global, multi-center, registration studies. Recruited for IDMC/DSMB and Clinical Endpoint Committees and assisted in the development of appropriate charters

• Lead Clinical Representative on project teams for cardiovascular products for thrombosis, inflammation and ventricular remodeling.

• Clinical lead on due diligence activities with Japan based Sankyo Pharmaceuticals to successfully finalize a co-development deal on one of the NCE candidates.

• Key contributor on task forces evaluating bridging activities for Japan/Asia (2000- present). Drafted a bridging strategy for PK/PD and early phase 2 studies for a CV compound developed for ventricular remodeling.

Corporate Medical / Scientific Affairs, U.S. - Searle/Lorex Pharmaceuticals

Associate Director Cardiovascular Drug Development 1991 – 1993

• Designed protocols and managed operation teams to coordinate 4 pivotal phase III trials comprising hypertension and angina patients for regulatory submissions.

• Coordinated preparation of medical summary documents for verapamil GITS NDA (Covera HS) which was subsequently approved.

Additional experience includes Assistant Director, Cardiovascular; Medical Operations with PRINCETON PHARMACEUTICAL PRODUCTS / SQUIBB PHARMACEUTICALS (1987-1991).

• Developed Phase III and IV clinical study phase 3B programs for Cardiovascular Drug Products (Squibb: beta blocker, ACE inhibitor) that comprised a 3-year clinical plan in hypertension, diabetes and renal disease totaling over $17 million and including 12 protocols.

Project Management Summary

• Led integrated clinical project teams for preparing and submitting reports, briefs and tables for INDs and NDAs. Responsible for tracking and maintaining milestones for clinical activities of six IND submissions and one NDA cardiovascular submission for two indications.

INVITED LECTURES / PANEL DISCUSSION PARTICIPANT

Invited Panelist Invited Industry Expert, Lecturer

REMS “Veterans” Share Their Battlefront Tales University of Washington

Third Annual Risk Management and Drug Safety Summit Gen. Pharmaceutics II (Winter 2010/2011/2012)

The National Press Club, Washington, D.C. Clinical Drug Developmen

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