LEADERSHIP

Our integrated leadership team, comprised of several seasoned Biopharmaceutical industry experts, has a shared purpose and vision to address many of the challenges associated with vaccine development.  The Team has a proven track record of "Concept to Clinic" stewardship, for a diverse portfolio of Vaccine Products and clinical candidates.

A. Krishna Prasad, Ph. D.
​Founder

Dr. Krishna Prasad, the founder of Citranvi™, is a recognized industry leader in Vaccine Development.  He joined Wyeth-Lederle Vaccines and Pediatrics in 1998, which later became Pfizer.  He has been named as an inventor or co-inventor in more than 150 granted patents, world-wide, which played a significant role towards the development and protection of Pfizer’s diverse conjugate vaccine intellectual property portfolio.  Dr. Prasad functioned as the Director of Vaccine Research and Development, at Pfizer. His responsibilities included managing and directing large teams with expertise in key technical functions and methods for vaccine candidate identification, production, characterization, assay development and testing of clinical trial materials. 
During his 20 years tenure at Wyeth/Pfizer, he successfully led many innovative and complex multi-component vaccine candidates through all stages of pre-clinical and clinical development through commercial licensure, notably Pneumococcal conjugate vaccine (Prevnar-13®), meningococcal (Meningitec®); and many clinical candidates such as staphylococcal, Group B Streptococcus, GBS, Respiratory Syncytial Virus (RSV) and A-β-Peptide-CRM197 conjugate immunotherapeutic against Alzheimer's Disease.  Dr. Prasad is an expert in design, research, early and late phase clinical development, scale-up, technology transfer, clinical trial material manufacturing under cGMP, trouble-shooting and commercialization of vaccines.  This includes handling CMC regulatory issues directly with various boards of health, including FDA.

James Cowell, Ph. D.
Advisor, Vaccines R & D

Dr. James Cowell has 40 years of professional experience in the non-clinical aspects of biological product development including technology assessment, business development, research, product & process development, technology transfer, quality control, and regulatory affairs.  This experience includes the 8 years at the FDA (CBER), 16 years in industry at both small (Praxis Biologics) and large companies (Lederle-Praxis, Wyeth-Lederle and Wyeth), 5 years as a consultant with the Biologics Consulting Group, and 11 years as an independent consultant. While at the FDA and in the biotech/vaccine industry much of the work was with purified capsular polysaccharide-protein conjugates, purified LOS-protein conjugates, peptide-protein conjugates, purified native and recombinant proteins, live attenuated viral and bacterial organisms and with vectors such as attenuated Salmonella.  
 
Dr. Cowell functioned as the Assistant VP of Bacterial and Viral Vaccine Development, where he had the responsibility for managing and directing departments with expertise in all the technical functions and methods for vaccine candidate identification and for GMP biological product production, characterization, formulation, and assay development and QC testing of clinical trial materials. 
 
Dr. Cowell was actively involved in the development of acellular pertussis vaccines, bacterial conjugate vaccines for Haemophilus influenzae type b (HibTiter), Neisseria meningitidis type C (Meningitec), and Streptococcus pneumoniae (7v and 13v)..  All of these vaccines became successful commercial products with the licensure of HibTiter in 1988, Acel-Immune (DTaP) in 1991, Meningitec in 1999, Prevnar 7v in 2000 and Prevnar 13v in 2010.  All have been very important for the control of the infectious diseases caused by these bacteria and have made major contributions to improving global public health.
 
As an independent consultant Dr. Cowell has continued to provide product development and CMC advice to companies pursuing new conjugate vaccines and cancer vaccine development issues and small drug-protein conjugate vaccines for drug addiction. He provided product development and CMC advice for the development of methamphetamine-protein conjugate vaccines to University of Arkansas. He provided technology transfer, manufacturing (CMC), and general regulatory advice to Heat Biologics, Chapel Hill, NC  for the development of an allogeneic whole cell cancer vaccine for NSCLC. 
 
Dr. Cowell has a broad range of experience across many scientific areas and technologies and regulatory fields that he can utilize to provide  sound advice for product development of many different types of biotech and vaccine products.  

Robert Corder, Ph. D.
​Advisor, Process Development and Quality

​Dr. Robert Corder has over 30 years of vaccine experience with specific expertise in the development of new vaccine processes, designing scale up, and developing cGMP manufacture practices for the production of clinical trial materials and commercial vaccines.   Most recently, Dr. Corder was Senior Director of Quality at Lederle/Wyeth/Pfizer Vaccines. During his 23 years at Lederle/Wyeth/Pfizer, he developed the upstream, manufacturing processes for four licensed products including pnuemococcal (Prevnar®) and meningococcal conjugate vaccines.   He is experienced in technology transfer from lab scale to full scale manufacturing, leading development of fermentation and recovery processes from bench scale to full-scale production for Prevnar®, Streptococcus pneumoniae conjugate vaccine, Neisseria meningitidis serogroup C conjugate vaccine (Meningitec®), and Meningococcal serogroup B vaccine (Trumenba®).  Dr. Corder received his PhD in microbiology from The Ohio State University.

Ed Ergenzinger, Ph. D., J. D.
Intellectual Property Counsel

Ed Ergenzinger is a patent attorney with more than twenty years of in-house and private practice experience. He is currently a partner with FisherBroyles, LLP, a full-service law firm with over 200 partners across the United States.  Over the course of his career he has represented a range of clients, from Fortune 500 companies and world-class research universities to early stage companies and independent inventors.  A substantial portion of Dr. Ergenzinger’s practice involves the provision of patent services, including the preparation and prosecution of patent applications, strategic planning and management of worldwide patent portfolios, and the preparation of patent-related opinions.  His experience encompasses a wide array of technologies, including biologics, vaccines, and related biomanufacturing processes; pharmaceuticals and small molecule formulations; diagnostics, next-generation sequencing methods, and related microfluidic systems and devices; animal models, cell culture systems, and genetic and chemical engineering; and agricultural biotechnology. Representative matters include serving as virtual in-house counsel for Wyeth Vaccines, where he provided seminal patent prosecution and worldwide portfolio management services for Prevnar 13, and serving as Director of Intellectual Property and Legal Affairs for the Duke Human Vaccine Institute, where he managed a worldwide patent portfolio of over 300 patent cases while also drafting and negotiating over 200 contracts per year for matters arising from over $50 million dollars per year of extramural funding.  Dr. Ergenzinger also regularly serves as an Adjunct Professor of Law teaching patent and intellectual property classes at institutions such as Wake Forest University, Campbell University, and the University of North Carolina at Chapel Hill.   Dr. Ergenzinger is admitted to practice before the United States Patent & Trademark Office, the courts of the State of North Carolina and the Supreme Court of the United States.

Luke Handke, Ph. D.
Advisor, Molecular Biology

Dr. Luke Handke holds a Ph.D. in Pathology and Microbiology from the University of Nebraska Medical Center.  Following postdoctoral studies in Molecular Biology and Microbiology at Tufts University, he joined the Vaccine Research and Development Department at Wyeth.  During his 10 years at Wyeth/Pfizer, Dr. Handke was involved in discovery and pre-clinical research activities for several of the company’s innovative vaccine candidates, including the S. aureus, S. agalactiae, N. meningitidis, and respiratory syncytial virus vaccine programs.  During this time, he also led and coordinated the research activities of a team of molecular biologists.  Dr. Handke brings his substantial well-rounded cross-disciplinary skills and expertise comprising molecular biology, microbial genetics, cell culture, protein expression and purification, fermentation, and assay development to Citranvi.    

George Makhatadze, Ph. D.
​Advisor, Structural Biology

Dr. George Makhatadze holds a PhD in Biophysical Chemistry from Moscow Physico-Technical Institute.  Following Postdoctoral work at the Department of Biology at Johns Hopkins University, he continued his independent academic carrier first at the Department of Chemistry and Biochemistry at Texas Tech University (1996-1999).  In 1999 he joined the Department of Biochemistry and Molecular Biology at Penn State College of Medicine.  In 2007, he moved to the Rensselaer Polytechnic Institute as a Constellation Chaired Professor of Biocomputation and Bioinformatics, Professor of Biology, Chemistry and Chemical Biology.  His expertise includes development of experimental and computational tools to study protein functional dynamics, conformational stability, protein folding, protein engineering, and protein-ligand interactions.

Phil Fernsten, Ph. D.
Advisor, Immunology

Dr. Philip Fernsten served as Senior Director, Vaccine Research and Early Development at Wyeth Vaccines Research and Pfizer and Pfizer Vaccine Research, after joining Wyeth-Lederle Vaccines and Pediatrics in 1998.  He has a very broad background in vaccine research and early clinical development and contributed to a number of bacterial and viral vaccine programs, five of which (Prevnar®, Meningitec®, FluMist®, Prevnar 13®, and Trumenba®) resulted in successful product launches. 
 
Dr. Fernsten participated extensively in discovery and preclinical research and in the development of scientific and commercial strategies for a number of other vaccine programs, including S. aureus, A-β-peptide conjugate, and pediatric combination vaccines; led early clinical science subteams; and served as the technical interface with external scientific leaders and collaborators for serological assay-related issues.  He developed and evaluated preclinical models of immunogenicity and protection and oversaw evaluation and development of new platform technologies and strategies to increase the quality and efficiency of serological assessments of vaccine antigen immunogenicity in preclinical and clinical vaccine trials, and spearheaded the discovery and development of leading edge assay technologies that were accepted by world health thought leaders in vaccines and biologics..  He was responsible for assay development, documentation, validation, transfer to compliant internal throughput teams and external contract laboratories, and high-throughput of clinical assays. 
 
Dr. Fernsten has extensive experience with regulatory compliance and documentation and with regulatory writing, including preclinical sections of IND/CTA filings and BLA submission dossiers for the US, Europe, and Japan, as well as drafting responses to questions from regulatory authorities and Boards of Health from these countries.  He was a key member of the team responsible for the successful launch of Prevnar in Japan.  He has overseen laboratory operations and documentation programs in internal laboratories and monitored the performance of external contracted facilities to ensure compliance with internal and external regulatory expectations (GLP, GCP, etc.) and safety guidelines.  He provides key experience with quality and regulatory requirements associated with successful agency submissions. 
 
Prior to joining Wyeth-Lederle Vaccines, Dr. Fernsten carried out basic research in cancer and autoimmunity at the Scripps Research Institute, The National Cancer Institute, and the University of North Carolina and holds a PhD in immunology from Duke University.  

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