Advisory Team

Dr.Klyushnichenko has over 20 years of experience in Bio/Pharmaceutical Project Management, Process Development, Engineering and Scale up to clinical and commercial Manufacturing, International Tech-Transfer and Regulatory Filing for oral, injectable, implantable, and pulmonary drugs and drug/device combinations.  His Drug Delivery experience includes formulation of proteins and small molecules in micro-crystals, micro- and nano-particles, liposomes, and bio-degradable matrices, for  controlled-release systems. 

Vadim has developed his growing managerial and scientific responsibilities working as Vice President of Pharmaceutical Development and Quality at Calibr/Scripps Research (La Jolla, CA), Paragon BioServices (Baltimore MD), Terapio Corporation (Austin TX), and Coldstream Laboratories Inc. (Lexington, KY), Lab Head/Principal Scientist  at Wyeth BioPharma, Sr.Scientist at Epic Therapeutics (Baxter), Altus Biologics (Boston, MA) and Aventis (Sanofi Pasteur, Toronto ON Canada).

Vadim has received his B.S. in Physics from Moscow Institute of Physics and Technology (Fiztech), and Ph.D. in Chemistry from Shemyakin & Ovchinnikov Institute of Bioorganic Chemistry (Moscow, Russian Academy of Sciences). Dr.Klyushnichenko continued his academic research in Analytical Biochemistry and Process Development in Germany and Canada.

Vadim is a Certified Professional Project Manager (PMP/PMI), Professional Supply Chain Manager, and holds a Certificate in Administration and Management from Harvard University. 

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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.

• 25 years Biopharmaceutical Development

• Experienced in development of mAb, Fab, Recombinant Proteins, and Enzymes for therapeutic use

• Experienced in development of conjugated proteins for early and late stage

• PEGylation

• ADC

• Bispecifics

• Roles in Process Development, MSAT, Validation, Quality, and Manufacturing

• Skilled in External Manufacturing, Risk Management, Downstream Development, and Process Characterization

   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

  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