Patrick R. Ayd - ClinPharm Network

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Patrick R. Ayd
1012 Milching Drive Bel Air, Maryland 21015
Phone: 410.420.3603  Mobile: 443.386.8771  E-Mail: Patrick@clinpharmnetwork.com
CPN
Objective
To continue expansion of the successful consultative practice known as ClinPharm Networks (CPN) that is dedicated to building and promoting world‐class Phase I clinical trial units to optimize capital investment, improve process efficiencies, and increase each unit’s marketability to the pharmaceutical and biotech companies. CPN will continue to grow and expand its network of experienced and approved clinical trial sites to assist pharmaceutical and biotech companies to accelerate the site identification and selection process, improve quality and speed of data collection across all aspects of operations related to the inpatient early phase clinical drug development process. Experience
ClinPharm Network, Inc President & CEO Bel Air, MD 5/2007 – Present Founder and chief executive officer responsible for growing consulting services practice for clinical research facilities as well as pharmaceutical and biotech firms involved in the inpatient early phase drug development process. CPN works to identify, evaluate, implement and promote long‐range best practices across the clinical trial enterprise. Responsibilities vary by engagement but most often include: 
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Phase I business development process and management Capital resource planning Evaluation and/or overhaul of financial forecasting and budget design processes, evaluation of overall clinical operations design and efficiency and re‐design” of staff positions Real estate development, design and renovation Review and revision of existing Standard Operating Procedures along with introduction of new SOP methodologies Management and Operation of new facility Pricing strategies and presentation formats Human Resource Management Omnicare Clinical Research Project Director King of Prussia, PA 10/07‐ 03/09 Responsible for primary management and oversight of multi‐site Phase III & IV clinical research projects for global contract research organization (CRO). Role included the management and motivation of a cross‐functional project team to fulfill their responsibilities in accordance with project contracts, contract amendments and Omnicare Clinical Research policies, procedures and SOPs. Primary achievements included: 
Direct strategic aspects of projects including oversight of day‐to‐day project operations and third party vendor activities
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Manage project resource needs and utilization according to project contract and contract amendments
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Conduct GCP audits for physician based clinical research sites
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Participate and present at investigator meetings, as required.
BioKinetic Clinical Applications Vice President of Operations Springfield, MO 01/07‐05/07 Responsible for transforming existing 30‐bed BCA clinical trial facility with simple trial capabilities into a fully functional Phase I unit that could conduct complex trials. Project scope included overhaul and expansion of existing Phase I site, consultation for new site design as well as full integration of old and new operations. Also responsible for managing primary operations for clinical pharmacology services firm whose services include protocol development, clinical pharmacology, safety and tolerance studies, bioequivalence/bioavailability, pharmacokinetic/pharmacodynamic, drug/drug interaction, food effect, QTC intervals, rising dose tolerance, data management, and dedicated institutional review board. Primary accomplishments included:  Introduction of new service offerings, new pricing strategies and presentation formats  Full assessment and “re‐design” of staff positions  Completely updated financial forecasting and budget design processes  Addition of new and revision of existing Standard Operating Procedures  Improved organizational structure including department specific accountabilities, job descriptions and performance evaluation processes  Launched formal staff education program related to GCP clinical procedures Bio‐analytical Systems Inc. (BASi) Executive Director of Clinical Research Baltimore, MD 05/06‐01/07 Assumed primary responsibility for managing clinical research operations (Phase I – Phase IV) for leading firm that provides various services, including screening and pharmacological testing, preclinical safety testing, formulation development, regulatory compliance, and quality control testing as well as ongoing responsibilities for clinical research business unit management. Project scope included oversight of mergers and acquisitions, expansion of the Baltimore operation, and the integration of clinical research into BASi’s entire U.S. based operations. Project highlights included:  Incorporated Phase I unit into corporation (prior seen as a separate business due to location, type of service, etc. Generated revenue in excess of $5 million to provide the company their first two profitable quarters in 13 years  Introduced “First in Man” clinical research capabilities to expand full suite of services provided by the organization  Led business development and client services activities  Developed training specific to the corporate business development department related to Phase I clinical research as well as introduced enterprise‐wide learning that incorporated GCP and ICH guidelines  Hired, developed, and mentored new senior management team  Redesigned and restructured all employee positions to meet new organizational requirements and adhere to new enterprise performance metrics  Guided external vendor relationships including those for all general services (food, laundry, medical supplies) from initial contract negotiation through service deliverable. 2
SNBL Baltimore, MD Vice President of Operations 11/04‐05/06 Senior level executive for subsidiary for one of the world’s largest CROs focused on complex clinical pharmacology research with projects that included support for a full range of drug development services, including: safety research, clinical pharmacology, and clinical Phase I, Phase II, and Phase III trials. Accountabilities included:  Development and execution of overall business plan  Vendor management and contract negotiation  Initial launch and ongoing management of multiple strategic partnerships  Architectural Design of 2—24,000 feet2 floors in a new building  Creation and management of strategic partners in drug development process  Hiring of the Executive and Director level management team  Responsible for evaluation and training of Phase I operations at Japanese parent corporate offices  Design of all internal systems including Accounting And Finance, Business Development, Clinical Operation, Human resources, Security, strategic Alliances and Volunteer/Participant Recruitment Parexel Vice President of Operations Springfield, MO 12/00 – 03/04 Led all major operations of Clinical Pharmacology Research Unit (CPRU). Responsible for the move of a small operation in Washington D.C. Responsible for the design, construction of the inpatient Phase I facility and subsequent expansion from a 24‐bed unit to a 52‐bed unit. Designed and hired all department directors and physicians. Grew operational revenue from $.75 million/yr to $5.3 million/year over a three‐year period. Organizational accomplishments included:  Provided direction for the administrative and operational aspects of all departments within the organization  Developed and implemented strategic business plan  Developed, submitted, and monitored the annual operating and capital improvement budgets  Communicated with other PRXL CPRU Unit Directors to create the harmonization of processes and functions of all Worldwide Parexel Clinical Pharmacology Units  Consultation and approval of internal SOPs and workflows for all areas within the CPRU.  Coordinated the process of proposal preparation, presentations, and contract negotiations with potential clients.  Represented PAREXEL‐Baltimore at tradeshow and other industry meetings.  Maintained collaborative relationships with the leasing hospital.  Negotiated terms/conditions with external and internal providers of services.  Actively involved in the monitoring and improvement of all unit wide quality initiatives. 3
Education
Wharton Executive Education, University of Pennsylvania. 1994 – 1995 Wharton School of Business, Leonard Davis Institute of Health Care Economics Philadelphia, Pennsylvania Strategies I and II: Clinical Design & Change Management Loyola University, The Sellinger School Masters in Business Administration (MBA) 1994 University of Maryland School of Nursing Bachelor of Science in Nursing (B.S.N.), Magna Cum Laude 1985 Essex Community College Associate of Arts Degree in Nursing 1983 Sample Collateral
Presentations (Not all Inclusive)  "Preparing for an FDA GCP Audit" Advanced GCP Course sponsored by the South Africa MCC (South Africa’s version of the FDA), Capetown, South Africa, October, 2002  "Executives Practice of GCPs," Advanced GCP Course sponsored by the South Africa MCC (South Africa’s version of the FDA), Capetown, South Africa, October, 2002 Thought Leadership  Katona BG, Ayd PR, Caspi M, Walters JK. High Dose Labetalol Infusion in Hypertensive Emergency. Drug Intell Clin Pharm.  Katona BG, Ayd PR, Britt J. Massive Methanol Overdose in a Morbidly Obese Male. Ann Emerg Med.
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