Vibalogics, a global contract development and manufacturing organization (CDMO) and recognized leader in the virotherapy services market, has announced the first appointments to its Scientific Advisory Board.
Supporting Vibalogics’ early-to-late phase global cGMP manufacturing business, the board is comprised of leading scientists, physicians, and company executives in the fields of oncolytic virus and viral vector gene therapy. Members have extensive experience across academic, clinical, and commercial product development.
Dr. Guangping Gao, Ph.D., Dr. Alain Pralong Ph.D., Dr. Stephen Russell, M.D., Ph.D. and Dr. Kai Lipinski, Ph.D., will join as the first phase of the board’s establishment, with additional appointments to be announced in the future.
Dr. Guangping Gao, Ph.D., Co-Director, Li Weibo Institute for Rare Diseases Research, Director, Horae Gene Therapy Center and Viral Vector Core, Professor of Microbiology and Physiological Systems, Penelope Booth Rockwell Professor in Biomedical Research, University of Massachusetts Medical School
Dr. Alain Pralong, Ph.D., CEO, Pharma-Consulting ENABLE GmbH; Associate Professor Bioprocess Industrialization and Quality at the University Marseille, France
Dr. Stephen Russell, M.D., Ph.D., CEO, Vyriad Inc.; Professor of Molecular Medicine at Mayo Clinic; President (Immediate Past) of the American Society of Gene and Cell Therapy (ASGCT)
Dr. Kai Lipinski, Ph.D., CSO, Vibalogics GmbH
Dr. Lipinski who will lead the board through its launch and future development shares, “The experience of Dr. Gao, Dr. Pralong, Dr. Russell and future appointees will be instrumental in steering the direction of Vibalogics in alignment with the best interest and rapid growth of the virotherapy market. The members will advise the company on a range of topics including current and future market direction, advances in scientific technology, and global clinical and commercial regulatory paradigms for viral products.”
“We believe the development of Vibalogics’ Scientific Advisory Board will complement our current Global Leadership Team and Board of Directors to position the company with added industry expertise critical to our ongoing global expansion in the United States and Germany.” added Tom Hochuli, CEO.
The announcement is a part of Vibalogics’ multi-year strategic build of its business offering virotherapy process development, manufacturing, quality control testing and fill-finish services for industry partners.
The company is in the middle of a three-year investment plan, which includes construction of a 140,000 ft2 (13,000 m2) clinical to commercial-stage facility and new global headquarters in Boxborough, MA, and further development of the 100,000 ft2 (9,400 m2) clinical facility in Cuxhaven, Germany. The global projects will total over $200 million in planned investment, including redevelopment of the sites, procurement of innovative new equipment, the recruitment of expert personnel, and development of next-generation production processes for the virotherapy market. Both sites are set to open the first phases of their expansion projects by Q4 of 2021.
Advisory Board Biographies:
Dr. Kai Lipinski, Ph.D.
Dr. Kai Lipinski joined Vibalogics in 2010 as Head of Cell Culture and Virus Production. Dr. Lipinski was named Head of Process Development in 2013, then promoted to Chief Scientific Officer (CSO) in 2020. Dr. Lipinski has a wealth of experience in viral vector manufacturing stemming from a career working within industry. Prior to Vibalogics, he was Principal Scientist at Cobra Biologics, focusing on upstream process development for virus and mammalian protein expression projects. Prior to Cobra Biologics, Dr. Lipinski worked as Senior & Principal Scientist at ML Laboratories, where he was responsible for the development of targeted adenoviral vectors for gene therapy approaches to cancer. At Vibalogics, Dr. Lipinski is central to the establishment of process development and manufacturing capabilities, technology evaluations, and the oversight of client technical relationships. Dr. Lipinski has a Ph.D. in Transcriptional Regulation by Adenoviral E1A Proteins, and a Post-Doc, also on Transcriptional Regulation, from the University of Duisburg- Essen.
Dr. Guangping Gao, Ph.D.
Dr. Guangping Gao is the Co-Director, Li Weibo Institute for Rare Diseases Research, Director, Horae Gene Therapy Center and Viral Vector Core, Professor of Microbiology and Physiological Systems, Penelope Booth Rockwell Professor in Biomedical Research, University of Massachusetts Medical School; Elected fellows, both the US National Academy of Inventors (NAI) and American Academy of Microbiology. Dr. Gao is an internationally well-recognized gene therapy researcher who has played a key role in the discovery and characterization of new family of adeno-associated virus (AAV) serotypes, which was instrumental in reviving the gene therapy field, hugely impacting many currently untreatable human diseases. For 30 years of his scientific research career, Dr. Gao has primarily focused on molecular genetics and viral vector gene therapy of rare genetic diseases, encompassing disease gene cloning, causative mutation identification, patho-mechanism investigation, animal modeling, novel viral vector discovery and engineering for in vivo gene delivery, vector biology, preclinical and clinical gene therapy product development, viral vector manufacturing for preclinical and clinical gene therapy applications as well as technology platforms development as novel approaches for human gene therapy. Dr. Gao has published more than 300 research papers, 6 book chapters, and 5 edited books. Dr. Gao holds 191 patents with 401 more patent applications pending. He serves as Executive Editor-In-Chief of Human Gene Therapy, Senior Editor of the Gene and Cell Therapy book series, Associate Editor of Signal Transduction and Targeted Therapy, and on Editorial Boards of several other gene therapy and virology journals. Dr. Gao was ranked as the World’s Top 20 Translational Researchers in 2017 and 2019 by Nature Biotechnology. Dr. Gao co-founded Voyager Therapeutics, Adrenas Therapeutics, and Aspa Therapeutics, focusing on developing recombinant AAV gene therapeutics for treating a variety of devastating rare diseases. He served as Vice President, President-elect, and President of the American Society of Gene and Cell Therapy from 2017 to 2020.
Dr. Alain Pralong, Ph.D.
Dr. Alain Pralong obtained his doctorate in molecular and cellular biology in apoptosis research at the University of Berne in 2000. Until 2004, he worked at Schering-Plough on Adenoviruses for a gene therapy clinical trial. Following a move to Roche, he managed the transfer of the Avastin manufacturing process from Genentech. From 2007 to 2008, he led at Merck-Serono the commercial manufacturing of human hormones. Dr. Pralong served as Vice President at Crucell leading the Global Process Development Department working on mAbs and vaccines until the acquisition of Crucell by J&J in 2011. At GSK 2011, Alain served as Vice President New Product Introduction & Technical Life Cycle Management. From 2015 to 2018, Alain was SVP Manufacturing Operations for Cell Medica. In 2018, Dr. Pralong has worked for AMAL Therapeutics before joining AgenTus Therapeutics where he worked as VP for Process Development, Manufacturing and Quality Assurance in Belgium and the US. Since 2020, Dr. Pralong is working as CEO of Pharma-Consulting ENABLE GmbH assisting various clients in the Cell & Gene Therapy, mAb and Vaccines field. Dr. Pralong has been listed among the 100 most influential people in biopharmaceutical industry issued by The Medicine Maker in 2015 and works as Associate Professor at the Polytech of the University Aix-Marseille.
Dr. Stephen Russell, M.D., Ph.D.
Dr. Stephen Russell is the CEO of Vyriad. He is also the Richard O Jacobson Professor of Molecular Medicine at Mayo Clinic and President of the American Society of Gene and Cell Therapy. Dr. Russell obtained his M.D. from the University of Edinburgh in 1982 and since that time has relentlessly pursued the goal of effective oncolytic virotherapy. He specialized clinically in hematology, then undertook his Ph.D. training at the Royal Marsden hospital where he was the first to engineer both retroviral and parvoviral vectors to deliver interleukin genes for cancer immunotherapy. He then moved to Cambridge, England where he led a research team in the MRC Laboratory for Molecular Biology, developed a novel method for antibody affinity maturation using phage display libraries, pioneered the display antibody domains on retroviral vector particles and on recombinant measles viruses, and founded Cambridge Genetics, a biotechnology/drug discovery company. In 1998 Dr. Russell moved to Mayo Clinic where he founded the Department of Molecular Medicine, built a comprehensive oncolytic virotherapy program, developed innovative engineering approaches for targeting, arming and noninvasively monitoring OV infections, and orchestrated the GMP manufacture, preclinical pharmacological/toxicological testing, IND filing and clinical translation of a number of oncolytic Measles and Vesicular Stomatitis Viruses for several different cancer indications. He co-founded two oncolytic virotherapy companies which merged in 2015, thereby establishing Vyriad as the first multi-platform OV company.