Experienced Leaders. Proven Results
Vadim Klyushnichenko, Ph.D.
Founder and Principal Consultant
Fractional VP CMC • Quality • Regulatory • Technical Operations
Executive CMC leader with 30+ years of experience guiding biotechnology and pharmaceutical programs from discovery through commercialization. Former leadership positions at Pfizer, Sanofi, Baxter, Piramal (CSL), Catalent (Paragon BioServices), Terapio Corp., and The Scripps Research Institute. Expertise includes CMC strategy, Quality Systems, global CDMO oversight, regulatory submissions, and AI-enabled pharmaceutical development.
Expertise
- CMC Strategy
- Regulatory Affairs
- Quality Systems
- CDMO Oversight
- GMP Audits
- AI in CMC
Advisory Team
Ramgopal (Ram) Nadimpalli, Ph.D., M.B.A.
What's something exciting your business
With about 18 years of experience, Ram is a seasoned professional in drug development program management, demonstrating extensive expertise in research and development as well as program and alliance management across multiple therapeutic areas. His areas of specialty include oncology, immuno-oncology, infectious diseases, respiratory, autoimmune, and inflammatory disorders. Ram’s technical and program management expertise covers different drug modalities, including monoclonal antibodies, recombinant proteins, vaccines, and advanced cell therapies. Ram earned a Ph.D. in Pharmacy from the University of Georgia, and an MBA from the University of Maryland. He holds certifications as a Project Management Professional (PMP) and a Six Sigma Black Belt. Throughout his career, he has held pivotal roles in research, product development, and program management at leading pharmaceutical and biotech firms, including Dupont Pioneer, Roche, Gene Logic, AstraZeneca, TSRI, and Mnemo Therapeutics.
Irene Klyushnichenko, M.B.A.
Irene Klyushnichenko has over 20 years of experience in financial analysis and accounting in midsize and large companies across multiple industries.
Her passion is financial analysis and modeling in clinical trials to improve company success in drug development, as well as assure patients’ safety and better health. Experienced in improving processes related to data consolidation and reporting as well as turning that data into usable business insight. Project leader with advanced analytical and organizational skills as well as the ability to work on cross-functional teams and with all levels of management.
Irene holds MBA degree in Finance from Boston University and BA degree in Economics from University of Massachusetts (Boston)
Specialties:
• Financial analysis and reporting
• Financial modelling
• Budgeting and forecasting
• Accounting support
• Key performance indicators (KPI) trending and reporting
• Business process analysis and improvement implementation
• Market research and competitive intelligence
• Pricing strategy
• Project management
Val Bunchak, M.S.
Val Bunchak is a mechanical engineer with over 30 years of experience in civil engineering, warehouse management, and logistics. Also, he has a good expertise in the maintenance and repair of biotech equipment, as well as its calibration, qualification, and validation.
Extended Team of Experts
Our extended team consists of the network of experts with advances degrees and 15-25 years of hands-on experience in bio/pharaceutical industry. Our experts can help you in the following areas:
- Development of mAb, Fab, Recombinant Proteins, and Enzymes for therapeutic use
- Development of conjugated proteins for early and late stage
- PEGylation
- ADC
- Bispecifics
- Cell and gene therapy
- Process Development, MSAT, Validation, Quality, and Manufacturing
- External Manufacturing, Risk Management, Downstream Development, and Process Characterization
- Project, Program, and Portfolio Management
- Supply chain/cold chain
- Quality Management Systems
- GMP/Quality Audits and Due Diligence
Industry experience
Ready to Accelerate Your Development Program?
Schedule a complimentary consultation to discuss your CMC, Quality, Regulatory, or CDMO strategy.
email: vadim@keypharma.com
Tel#: 1 (858) Eight 58-281-971 Zero
