Meet our consultants

NGT BioPharma Consultants: Innovative Minds for Transformative Results

Michael K. O’Brien, PhD
President & CEO
  • API/drug product research, development, commercialization
  • Organizational and operational excellence
  • Innovative technology platform design and implementation
  • Collaborative, expert-network building
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Ed Herpel, MA
Vice President, Operations
  • Biopharmaceutical & vaccines R&D
  • HR leadership
  • Mergers & acquisitions
  • Organizational effectiveness
  • Talent management
  • Business development
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Jean Schaefer, M.S.
VP Program Management
  • Program and project management
  • Strategic business transformation
  • Vendor oversight
  • GCP process, compliance and inspection readiness
  • Target validation and drug discovery
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Rachel Franckowiak, BA
Senior Executive Coordinator
  • Executive/C-suite office management
  • Research and reporting
  • Website content development
  • CRM/database development and maintenance
  • Bookkeeping
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Mark Zettler, PhD
API and Formulation R&D
  • Technology scouting, open Innovation, investment processes
  • Route ideation and API process development
  • Technology transfer and operational production
  • Process analytical techniques and product characterization
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Alton Johnson, PhD
Manufacturing Operations, Drug Development
  • Digital transformation of manufacturing processes
  • Drug product development
  • Advanced process control
  • Continuous processing
  • Global product/process knowledge and risk assessment management
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Joshua Daniel
Digital Strategist
Joshua Daniel
  • Strategic development and implementation of data protection for intellectual property
  • Safeguarding privacy and anonymity
  • Optimizing local and cloud storage, including virtualization
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Malcolm Berry, PhD
Multi-Stage Continuous Processing for APIs
  • Continuous process design, integration and implementation
  • Operational and material management
  • PAT application and integration
  • Regulatory preparation
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Nancy C. Motola, PhD, RAC
Regulatory, Compliance, Quality Assurance
  • Compliance strategies and organizational development
  • Regulatory activities and submissions for INDs, NDAs and BLAs
  • FDA regulatory liaison
  • Discovery through product lifecycle regulatory strategies
  • Advertising/promotional review
  • CMC manufacturing processes
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Robert Perks, MSc
Process and Manufacturing Automation
  • Global manufacturing and process automation
  • Digital transformation
  • Industry/Pharma 4.0
  • Data analytics
  • Manufacturing intelligence
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Michael Placke, PhD, DABT
Nonclinical Development and Drug Safety
  • Nonclinical development, drug safety
  • Pharmacokinetics, drug Metabolism
  • Exploratory research, discovery biology
  • Bio-analytical and biomarker Support
  • Toxicology and pathology
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Sandy Farmer, PhD
Digital Innovation and Discovery R&D
  • Transformative discovery through data innovation and AI
  • Strategic leadership in data utilization and discovery research
  • Next-generation target validation utilizing human genetic, real-world and exploratory data
  • Drug discovery and precision medicine R&D processes
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Frederick ‘Simon’ Golec Jr., PhD, RAC
API and Drug Product CMC Regulatory Sciences
  • API/drug product CMC regulatory sciences
  • CMC regulatory project management for agency meetings, submissions, review and approval processes
  • Regulations, guidelines, agency policies, procedures, practices and case studies
  • Chemical, pharmaceutical, analytical and CMC regulatory development
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David Lowenschuss, JD
Biotech and Life Sciences Legal Counsel
  • Negotiating and drafting R&D agreements
  • SEC filings
  • Sarbanes Oxley compliance
  • Mergers and acquisitions
  • In-license and out-licensing contractual deals
  • Lease negotiations and construction agreements
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Frank P. Orlowski, MBA
Biotech and Life Sciences Global Finance
  • Biopharmaceutical acquisition, divestiture and joint ventures
  • Budgeting, forecasting and operations planning and analysis
  • Financial modeling for localization and commercialization
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Steve Hammond
Process Analytics and PAT Innovation
  • Process based analytics
  • Technology innovator/inventor
  • PAT sensor technologies and custom interfaces
  • Material sciences and forensic analysis
  • Invited speaker at global biopharmaceutical conferences
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Karl Bratin, PhD
Novel Drug Program Management
  • Novel drug development
  • Regulatory submission, approval, commercialization
  • Analytical R&D
  • Clinical trial manufacturing, packaging and supply
  • Pharmaceutical Sciences portfolio & resource operations
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George Karam, PhD
NBE and NCE Expert and Strategist
  • Drug R&D guidance and management
  • Biotherapeutics and small molecule discovery and CMC support
  • Protein and antibody drug development/generation
  • Drug and drug target analysis and assay development
  • Biopharma market analysis
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John Dillon, PhD
API Process R&D, Synthetic Organic Chemistry
  • Synthetic organic chemistry
  • Process development
  • API manufacturing and validation
  • Compliance (Consent Decree)
  • Technology transfer
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Patricia Richards, MD, PhD
Clinical Development, Pain Management
  • Central nervous system (CNS) drug development
  • Clinical studies due diligence
  • US, EU and Asia clinical trial design
  • Regulatory strategies and communications
  • Protocol development, clinical strategy and IND/NDA preparation
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