Expert Details

Expert in Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization

Expert ID: 729349 Michigan, USA

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Technological / Scientific Infrastructures Speed to Markets
• Advising and Strategically Coordinating with the Following Agencies:
 World Health Organization COVID-19 Accelerator Cure Project
 Linking Collaboration Platforms for Best in Class Teams around the world
 The Directorate for Global Health Security and Biodefense - Coronavirus Task Force
 Pandemic & All-Hazards Preparedness Joint Command: DoD BARDA, CDC, DHL, BSL-4


RELEVANT EXPERIENCE
Executive Leadership:
 Advisor to Health Security
 COVID-19 Economic Impact
 KOL to Board of Directors
 Harmonizing Governance
Functional:
 Rapid Infrastructure Scaling
 Digital & Genomic Strategy
 Accelerating cures to markets
 Health Emergency Response
International:
 US, Europe, Asia, Lat Am
 Private / Public Partnerships


*** Expert is willing to travel both nationally as well as internationally!!***

• Thought partner with and confidant to CEO, CFO, CTO, COO, CMO on the following deliverable:
• Reshaping the process and outcomes acceleration for technology enabled scientific Discovery
• Setting next generation product development: Virtual Trials, Real World Evidence, IoT studies
• Restructuring global manufacturing and supply chain with new Industry 4.0 emerging standards
• Create Marketing Channels from Edge to Core to Cloud
• Influencing billions of dollars in R&D through vendor evaluation and Strategic alliance
• Managing a budget of $1.2 billion that impacts $15 billion in revenues annually
• Direct report from 9 cross functional teams across US, Europe, Asia and Latin America
• Creating Risk Management Indicators that fulfills Governance, Risk, Compliance, Cyber-security

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 a 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.

Key Consultant Clients
• Creating 7x playbooks on behalf of Private Equity and Venture Capital Groups
• Largest Companies: Blackstone, Pfizer, Oracle, SAP, GE
• Industries: Pharmaceutical, High Tech, Manufacturing
• Governments: United States, China, The Emirates

Specific Projects:

Research and Development
• Clinical trials in Oncology, Cardiovascular, Diabetes, Central Nervous System, Respiratory and others
• Clinical Research Organization M&A and competitive landscape differentiation
• Specialty Pharmaceutical
• Biotech / Medical Device
• Multibillion dollar procurement process, evaluation and decision making across product lifecycles.
• National Institute of Health Project Funding & Research Focus
• Oncology research using multiple compounds and nanomedical delivery systems
• Generic industry changes: Teva, Mylan and others
• Generic product and devices
• Predictive algorithms
• Open Innovation
• Experimental Designs
• Product Partnership Development: Academic and private sector agreements
• Changes in R&D models
• Trends of R&D costs
• Computational modeling in R&D and its vendors
• Clinical trial registries
• Clinical trial enrollment solutions
• Clinical trial design and its predictive model
• Designing clinical trial for the aging population
• Trends of CROs in emerging market vis a vis the ones in the U.S. and Europe
• CROs in China, in particular WuXi and ShangPharma
• CROs in India
• Case process service
• Toxicology outsourcing
• CROs in Latin America: Mexico, Brazil, Argentina, others
• Bioanalytic outsourcing: Pharmacokinetics and other services
• Trends on biobanks / biospecimens and its IT sourcing models
• Trends in central labs outsourcing
• DNA Genome sequencing players
• Understanding Phase I-IV clinical trial development cycles
• Selection process of Phase I-IV outsourcing
• Companion Diagnostics
• Life Science Tools
• Liquid Chromatography
• Chemoinformatic Services

Technology
• Mobile Health: Wearable / Internet of Things
• Real World Evidence / Deep Learning
• Nanomedical delivery protocols
• Growth of Diagnostics
• Clinical Data Management
• Clinical Trial Software
• Hospital IT Infrastructure
• WebMD
• Direct to Patient Advertising Trends
• Patient Adherence / Patient Engagement
• SAP / HANA / ERP $1.6 billion solution
• New model with Academic Partnerships
• Sponsor Research Agreements
• IT Process management players such as Accenture, IBM, InfoSys, SAP, Oracle
• Electronic Data Capture players among others: Phase Forward (Oracle), Medidata, ERP
• ePRO: Patient Reported Outcomes
• Solutions for Pharmacy Buyer Organizations
• Key CRO Players: Icon, Parexcel, Quintile, PPD, etc.
• Lab information systems
• Electronic Medical Records (EMR) and Electronic Health Records (EHR) game changer
• Integration of Clinical Data Management Systems and Electronic Medical Records

Supply Chain, Manufacturing and Operations
• Decision making criteria for vendor selection
• Impact of Business Process Outsourcing
• Contract Manufacturing Organizations
• Comparison and contrast among the top CMOs in the market
• Contract Manufacturing: American vs. Asian competitors
• The API current and future global market dynamics
• Formulation and clinical manufacturing
• eGMP: Good Manufacturing Practices – Protocols and compliance
• Generic market growth and its manufacturing tech transfer implications
• Middle Eastern and African Markets
• Bio Defense space key players
• Pharmaceutical Logistics: Key players and game changers
• Clinical trial distribution
• Cold supply chain in biologics main players
• Compassionate Use – Market access programs
• Reagents
• Lab supplies
• Over the counter drug markets
• API, Excipients and other drug components for manufacturing and its global market
• Optimization tools for manufacturing, supply chain, lab workflow.
• Asia and South Pacific markets
• Role of emerging markets

Governance, Risk Management, Regulatory
• Regulatory Affairs, QA, QC
• Government Affair Teams: Lobbying and Policy Making
• EMA regulatory approval process in Europe
• Regulatory agencies in China, Japan, Latin America and Eastern Europe
• How to lead clinical, medical affairs, and regulatory teams in Market Access strategy
• Pharmacovigilance, Post Market Launch Surveillance, EHS
• Stress testing technology, process and teams so that they can operate under crisis
• Governance, Risk, Compliance tools: MetricStream, Compliance 360, SAP, Pilgrim
• Industry impact on FDA initiative: REMS, RMPs, RiskMAPS, the Sentinel Program
• Risk management, Governance and Compliance
• Best practice on Government and Public Affairs
• Corporate Integrity Agreements and regulations
• Compliance software in life science

Finance
• Pricing
• HEOR, Market Access
• Private / Public Payors
• Government Affairs – Impact on pricing
• Generic pricing markets
• New breed of generic and bio superior drugs
• Changing dynamic of drug portfolio management
• Life Science & Pharma Co M&A
• Acquisition strategy in the pharmaceutical space
• Market dynamic of private and public payers
• Reimbursement mechanics and markets
• Channels of wholesales, distribution and pharmacies
• Relation between Health Economic Teams (Pharmacoeconomics) / Medical Affairs and Payers

• Drug qualification for Medicare / Medicaid
• Clinical Trials Payment Management Space
• Pharmacoeconomics trends in Europe and the U.S.
• Medicare reimbursement
• Reimbursement in Europe
• Valuation of product pipelines
• Big pharmaceutical merger trends
• Healthcare reform impact on the pharmaceutical industry
• M&A opportunities in biotech, pharmaceutical, CRO space
• Valuating licensing potential
• Challenges of cross border M&A in biopharma
• FDA regulatory and approval process impact on pricing
• M&A synergies between US and Indian Private Equity Syndication

Expert may consult nationally and internationally, and is also local to the following cities: New York City, New York - Silicon Valley, California - San Francisco, California - San Bernardino, California - Princeton, New Jersey - Berlin, Germany - Beijing, China - London, United Kingdom

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Education

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

Work History

Years Employer Title Department Responsibilities
Years: 2019 to Present Employer: Undisclosed Title: Global Leader to COVID-19 Solution – Organizing Teams, Process, Technologies Department: Responsibilities: Establishing Collaboration protocols with Pandemic Distributed Teams across the Globe

• $100 billion, 62 countries, 2,300 research labs, over 200,000 scientist, 7,200 tech companies
 Mission: Finding prevention and treatment in 1 year versus the typical 7-9 years
 Current collaboration: 9 clinical trials and the over 93 preclinical developments
 Building governance accountability through performance based outcomes
 Creating transparent frameworks and end to end transactional visibility
 FDA-EMA-PMDA Harmonizing for COVID-19 simultaneous vaccine approval

• Linking efforts from mega research and development efforts from the following

 US, EU, Japan, C.E.P.I. led R&D $37 Billion
 May 4, 2020 $8 Billion Launch of U.N. Health Organization COVID-19 Accelerator
 $55 Billion from private, NGOs e.g. Bill & Melinda Gates Foundation and others
 US Codename Operation Warp Speed:
 93 potential vaccines from 80 pharmaceutical companies and
 14 promising treatments under testing and development

• All technologies on deck: Artificial Intelligence, Track & Trace, Genomics, Automation, IoT

• Organizing AI researchers in tech and academia with U.S. CTO Michael Kratsio to support:
 The launch of effective treatments, diagnostic prevention treatments
 Global automated surveillance risk assessment, spread, containment effectiveness
 COVID-19 mission to use Real World Evidence Data from development to production

• Mapping full Automation Internet of Things (IoT) continuous 4.0 manufacturing / distribution:

 Over 200 medicine manufacturers connected to real time on demand data
 Real time / simultaneous prototyping, testing, validation of tech, process, teams
 Over 23, distribution points on integrated KPI dashboards for quality and compliance
 Distributed sensors from batch production to health care delivery for quality / compliance
 Contextual Intelligence from global, to region, to individual stakeholders and patients
Years: 2000 to Present Employer: Undisclosed Title: Leadership Council Adviser for Accelerating Product Values to Markets Department: Responsibilities: • Achieving greater transformation in 7 weeks after Emergency Quarantine than the prior 5 years
 Based on 12+ years of managing virtual teams: Virtualizing all possible functions
 60 countries of operations, 125 countries of sales and distribution
• Infrastructure transformation with current and incoming tech next generation systems
• Reassessing and evaluating all partners, vendors and solutions providers for new environment
• Addressing C-Suite and Board of Director Leadership on accelerating products values to markets
• Precompetitive collaboration across private / public researchers for faster treatment delivery
• Fast tracking Pharma 4.0: End-to-end Machine Learning AI enabled Analytics in a frictionless IoT
Years: 1984 to 2000 Employer: Ge Healthcare Title: Project Manager Department: Medical Imaging Responsibilities: 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.

• Sourcing at scale on count down between medical device approval and market launch
• Integrating Six Sigma verification and validation protocols for regulatory compliance
• Diagnostic Imaging leader in emerging markets: Latin America, India, China
• Managing key resources of capital balance sheet, project funding and liquidity
• Liaise upstream / downstream with domestic, regional, global partners and stakeholders
• Value stream mapping medical imaging solutions to increase value for clients worldwide

International Experience

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

Career Accomplishments

Associations / Societies
Board of Directors- Doctors Without Borders- Addressing refugees and conflict zone Trauma Medical Emergency Logistics (Paris, France)
Special Operations Training Group Kinetic Precision Leadership Under Fire, Chula Vista CA
MIT Machine Health IoT Consortium - Member

Additional Experience

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.

Education Overview:
Business, Cognitive Sciences, Life Sciences, Technology
MBA, Managing Global Strategy University of Hamburg, Germany
PhD, Systems Approach to Biomedical Science Research University of Oxford, UK
Bachelor’s of Science Andrews University, Berrien Springs MI
System Design Digital Strategy (Innovation) Executive Program MIT University, Cambridge MA
Erickson Institute, Mindset Disciplines for High Performance Phoenix, AZ
Vendor Selection
Selecting CRO and other outsourcing partners worldwide.
Marketing Experience
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.
Other Relevant Experience
Interests: Blockchain, 3D Printing / Supply Chain, Filmmaking
Book Collection Code --A personal library with over 12,000 volumes of textbooks across all disciplines including
• Risk Management, Strategy, Innovation / Production / Launch
• Global Manufacturing, Systems Engineering, Artificial Intelligence and more

Language Skills

Language Proficiency
Spanish 100% fluent
French Moderate to fluent

Fields of Expertise

21 CFR Part 11, 510(k) document, advanced product quality planning, Advanced Research Projects Agency, advertising claim substantiation, biomedical device, biomedical research and development, brand valuation, business process management, business process re-engineering, business valuation, competitive intelligence, competitive intelligence countermeasures, continuous quality improvement, Cooperative Research and Development Agreement, Current Good Manufacturing Practice, drug labeling requirement, drug product approval, drug regulation, enterprise resource planning, Food and Drug Administration compliance, Food and Drug Administration drug registration, FDA medical device regulation, Food and Drug Administration validation, global regulatory procedure, Good Laboratory Practice, Good Manufacturing Practice, international investment, investment value, market access, pharmacoeconomics, mergers and acquisitions, pharmaceutical industry, pharmaceutical manufacturing, pharmaceutical manufacturing facility auditing, pharmaceutical quality assurance, pharmacoeconomics, pre-approval inspection, product approval, productivity measurement, productivity measurement (quantity), project management, quality auditing, quality control, quality evaluation, quality improvement, regulatory compliance auditing, research and development management, research and development organization, research and development planning, research and development productivity, return on investment, strategic market planning, suitability of investments, team building, technology management, technology transfer, total quality managment in research and development, world-class manufacturing, pharmaceutical scale-up, business acquisition, medical procedure, leadership development, intangible assets valuation, manufacturing process design, compliance, economic appraisal, investigational drug procedures, Good Clinical Practice, medication risk assessment survey, vaccine development, business operations, pharmacodynamics, market trend, Food and Drug Administration National Drug Code, business management, clinical study, medical statistics, enterprise resource planning software, clinical trial design, pharmaceutical product development, action analysis, biomedical application, investigational medical device exemption regulation, drug validation, drug clinical trial, medical device clinical research, drug toxicology, chemotherapeutic drug, drug safety testing, clinical toxicology, pharmaceutical design, Food and Drug Administration CFR-21 part 175, clinical research management, clinical research, pharmaceutical research, clinical protocol, drug development, new technology business value measurement, drug dosage form development, business system design, new drug, prolonged-action drug, waste reduction, Food and Drug Administration new drug code, investigational drug, clinical trial

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