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 Expert  729349

Expert in Pharmaceutical/Biotech Clinical Trials, Regulatory, R&D, Mergers & Acquisitions, Trends, Outsourcing


Available for your Consulting and Expert Witness Needs

Michigan (MI)
MICHIGAN
USA
Education Work History Career Accomplishments Consulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Expert is Director of Regulatory Affairs and Clinical Trials managing $3.6 billion at at a pharmaceutical company in New York, NY. His expertise is in managing and deploying outsource/insource teams worldwide for multiple clinical trials and regulatory approvals. Previously, he was Director of Research and Development at the same organization. During his career there, which began in 2000, Expert has contributed to seven major acquisitions including Warner-Lambert/ Parke-Davis/ Agouron, Pharmacia, and Wyeth. He was previously at GE Medical: Imaging Diagnostics as Product Development, Research & Development and Launch Manager where he created over $2 Billion in yearly revenues by securing projects, acquisitions, and patents of devices and pharmaceutical system. Expert received his Ph.D. in Clinical and Biomedical Sciences from Oxford, MBA from Hamburg, Germany and BS in Biology from Andrews University in Berrien Springs, MI.

Expert has comprehensive firsthand knowledge of global CRO outsourcing trends, the future of R&D development and the necessary requirements for a biotech or pharmaceutical company to be successful.

R&D Skills: New Multi Release Dosage Development | Scale-up | ANDAs' Manuf.| Support CMC Regulatory & Compliance | eGMP | Multi-site Tech Transfer| Process Improvement | Project Validation | New product Development | Production Approval Process| Implementation on technologically innovative approach.

Merger & Acquisition Skills: Prior to merger analyzing pipelines of medical drugs and device in development, their strength towards regulatory approval and valuation of revenues after its launch. Post merger: Business process re-engineering that aligns and integrates clinical, regulatory and R&D teams, real time alpha model through live data links, risk management, SAP, portfolio management, cross functional team leadership and training, Quantitative Strategy, P&L management, auditing and compliance, cash flow management, business valuations, data warehouse reporting, audits and compliance, A/P, A/R, strategic validation.

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21 CFR Part 11

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510(k) document

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advanced product quality planning

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Advanced Research Projects Agency

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advertising claim substantiation

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biomedical device

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biomedical research and development

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brand valuation

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business process management

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business process re-engineering

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business valuation

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competitive intelligence

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competitive intelligence countermeasures

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continuous quality improvement

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Cooperative Research and Development Agreement

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Current Good Manufacturing Practice

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drug labeling requirement

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drug product approval

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drug regulation

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enterprise resource planning

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Food and Drug Administration compliance

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Food and Drug Administration drug registration

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FDA medical device regulation

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Food and Drug Administration validation

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global regulatory procedure

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Good Laboratory Practice

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Good Manufacturing Practice

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international investment

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investment value

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market access, pharmacoeconomics

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mergers and acquisitions

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pharmaceutical industry

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pharmaceutical manufacturing

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pharmaceutical manufacturing facility auditing

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pharmaceutical quality assurance

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pharmacoeconomics

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pre-approval inspection

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product approval

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productivity measurement

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productivity measurement (quantity)

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project management

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quality auditing

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quality control

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quality evaluation

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quality improvement

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regulatory compliance auditing

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research and development management

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research and development organization

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research and development planning

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research and development productivity

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return on investment

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strategic market planning

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suitability of investments

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team building

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technology management

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technology transfer

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total quality managment in research and development

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world-class manufacturing


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Grand Rapids, Michigan;  Flint, Michigan;  Lansing, Michigan;  Ann Arbor, Michigan;  Kalamazoo, Michigan;  Wyoming, Michigan;  Saginaw, Michigan;  Battle Creek, Michigan;  South Bend, Indiana;  and Elkhart, Indiana.

Education:
Year   Degree   Subject   Institution  
1990   PhD   Biomedical & Clinical Science   University of Oxford  
2000   MBA   Added Value Global Supply Chain   Hamburg University - Germany  
1984   BS   Biology and Business Double Major   Andrews University  

Work History:
Years   Employer   Department   Title   Responsibilities

2000 to

 

(Undisclosed)

 

Regulatory

 

Director of Clinical and Regulatory Affairs

 

Revenue projections of $5.3 Billion based on 7 current trials he is supervising of phase I-IV oncology programs when approved and launched to market according to DDMAC guidelines. These trials involve three different compounds: Sutent, Axitinib and CP-751 that will focus on 4 types of cancers: hepatocelluar (HCC), non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) and prostate cancer.

Progressive and successful filing of IND, ANDA, NDA, BLA and CMC approval through CBER, CDRH and CDER, EMEA other global agencies.

Member of Merger and Acquisition Strategic Team: Among 7 other acquisitions the $68 Billion Wyeth Merger: Prior to merger analyzing pipelines of medical drugs and device in development, their strength towards regulatory approval and valuation of revenues after its launch. Business process re-engineering that aligns and integrates clinical, regulatory and R&D teams; risk management, SAP, portfolio management, cross functional team leadership and training, Quantitative Strategy, auditing and compliance, cash flow management, business valuations, data warehouse reporting, audits and compliance, strategic validation.

Chose CRO partners worldwide for best in breed and functional service model. Also their integrated approach in clinical trials, analytics and regulatory compliance based on their track record and data management for real time collaboration across different platforms and international team projects. Utilizing cost efficiencies from India and China as well as other partners across the globe.

Outsourcing: Aligning function / country and integrated SOP towards metric fulfillment that reduced project management costs. Streamlining contracting and improving resource forecasting. Doing technology transfer and partners in Europe and the U.S. and process outsourcing with Accenture, CSC, IMB, Infosys, SAIC and Tata.

1984 to 2000

 

Ge Healthcare

 

Medical Imaging

 

Project Manager

 

Evaluating investment and acquisition opportunities, ranging from biotechnology companies to the value of licensing strategic technologies that contributed from $2.5 to $5 billion growth for the division.

 Product Development, Research & Development and Launch Manager creating over $2 Billion in yearly revenues by securing projects, acquisitions, and patents of devices and pharmaceutical system.

 Coordinated Investigational Imaging Device Exceptions as well as Pre Marketing Approval for devices both in the U.S. as well as overseas.

 Supervising registration to meet individual country authorization. Submitting technical data, testing, labels to the proper authorities in Latin America and Asia synchronized with Sales and Marketing efforts.


Career Accomplishments:
Associations/Societies

MIT-Harvard Nanomedical Consortium

Nanohealth Alliance

Strategic Adviser to Doctors without Borders


Consulting Services:
Selected Consulting Examples:
  • For the last 5 years he has consulted with private equity fund managers, investment bankers and industry players wanting to know trends and the impact of major changes still ongoing in the industry.
Recent Client Requests:
  • Statistics market research expert for consulting on Software for the design and executio of adaptive clinical trials.
  • 21 cfr 11 expert for consulting on Clinical Trial Pharmaceutical/ Biotech.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • FDA expert witnesses for consulting on FDA medical device and supply chain/distribution.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
1984 to   South America   Conducting product registry, clinical trials and market expansion
1985 to   Europe   Working with regulatory agencies such as the EMEA, also clinical trials throughout the region.
2000 to   Asia   R&D as well as all the above.

Language Skills:
Foreign Language   Description
Spanish   100% fluent
French   Moderate to fluent

Market Research:
Comprehensive firsthand knowledge of global CRO outsourcing trends, the future of R&D development and the necessary requirements for a biotech or pharmaceutical company to be successful.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Training/Seminars

Training multinational teams on optimizing cross functional team progression towards fulfillment of goals and mission.

Developed courses on: Leadership, Global Compliance, Quantitative Strategy.

Supplier and Vendor Location and Selection

Selecting CRO and other outsourcing partners worldwide.


 

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