Jodi Cook, Ph.D., is President and Chief Executive Officer of Skylark Bio, Inc. She is an operationally focused business leader with experience across public and private biotechnology and medical device organizations. She brings to Skylark a unique combination of expertise across science, clinical development, operations and commercialization in both therapeutics and device companies including gene therapy modality and hearing indications. Prior to leading Skylark, Dr. Cook was Senior Vice President, Gene Therapy Strategy at PTC Therapeutics. Before PTC, Dr. Cook served as the Chief Operating Officer of Agilis Biotherapeutics where she oversaw its sale worth over $1 billion to PTC. Earlier in her career, she served as Vice President, Clinical Research & Professional Relations at InSound Medical, a company that developed, manufactured and sold extended wear hearing devices. Dr. Cook also held the role of Director, Hearing Aid Center, and Assistant Professor at the Mayo Clinic and before that was the Director of Audiology and Business Development at Songbird Hearing, and Clinical Assistant Professor at Arizona State University.
She earned her Ph.D. from Arizona State University, a Master’s of Audiology at University of South Carolina and her Bachelor of Arts from Loyola University of Maryland. She did a fellowship at Johns Hopkins Medical School in Baltimore, Maryland. She currently serves as a Board member of Fennec Pharmaceuticals and was previously Board Chair of STRM.BIO.
Shawn Harriman, Ph.D., is Chief Development Officer, Head of Translational Sciences at Skylark Bio. He brings over 27 years of experience working in cross-functional teams bridging clinical, pre-clinical and drug discovery. Dr. Harriman has worked across multiple therapeutic areas and has been involved in over 30 IND filings and four drug approvals. He has extensive experience with a diverse set of modalities, including gene therapy, and interacting with global regulatory bodies including, the CBER and CDER divisions of the FDA, EMA, MHRA, PMDA, and most recently with the Chinese regulatory agency, NMPA.
Prior to joining Skylark he was Chief Development Officer, Head of Research and Development, for Frontera Therapeutics responsible for the development of AAV based gene therapies for Ophthalmology, Hematology, Neuromuscular and Metabolic Disease indications. He served as Senior Vice President for Pyxis Oncology, Head of Nonclinical Development, where he was responsible for the advancement of immuno-oncology and antibody-drug conjugate-based oncology programs through preclinical development to IND stage and into clinic. Lastly, he served as Vice President at Sarepta Therapeutics, Head of Translational Sciences, where he was a key contributor in the company obtaining accelerated FDA approval of two medicinal products, Vyondys and Amondys for Duchenne muscular dystrophy (DMD), and for the advancement of AAV based gene therapies for DMD and other rare neuromuscular diseases.
Dr. Harriman received a B.S. in Zoology and an M.S. in Pharmaceutical Sciences from the University of Rhode Island. Dr. Harriman received his Ph.D. in Medicinal Chemistry from the University of Kansas and completed his postdoctoral research at the Massachusetts Institute of Technology.
Anne Marie Conway, M.H.A., R.N. is Senior Vice President of Clinical Development and Program Management at Skylark Bio. Anne Marie brings 30+ years of experience in clinical drug development with demonstrated success through optimizing clinical program outcomes through all phases of product lifecycle management. Her career trajectory has taken her from academia to industry where she has held roles of increasing responsibility in clinical development, clinical operations, and program management.
Most recently, Anne Marie was a consultant to Myrtelle Gene Therapies where she was Acting Head of Clinical Operations. Other roles in gene therapy have included Clinical Head of Biologics at PTC Therapeutics and Vice President of Clinical Operations at Agilis Biotherapeutics. While at Agilis and then at PTC, Anne Marie was the Clinical Lead for the AADC AAV gene therapy program resulting in the approval of Upstaza™ in the UK and Europe.
Her other roles have included Vice President and Program Executive for Autism Spectrum Disorder and Vice President of Clinical Operations at Finch Therapeutics. Prior to that she was Vice President Clinical Development Operations at Shire Human Genetic Therapies. While at Shire HGT, Anne Marie led a global organization of 80+ people and was involved in 4 product approvals, including elaprase™ for the treatment of Hunter syndrome.
Prior to making the transition to the biotech industry, Anne Marie was the Research Manager for the Gastroenterology Division at Tufts Medical Center in Boston.
Anne Marie is currently a Senior Lecturer (Adjunct) in Healthcare Administration at Suffolk University in the Sawyer Business School where she teaches graduate level courses in Innovation and Strategic Management.
Anne Marie received her Bachelor of Science with a major in Nursing from Boston University and a Master of Health Administration from Suffolk University.
Anjil Giri, Ph.D. is the Head of Technical Operations at Skylark Bio, with responsibilities spanning internal and external vector manufacturing, process and analytical development, supply chain, as well as quality control activities. Dr. Giri is an accomplished technical operations leader with experience in bioprocessing and CMC development for gene therapies and traditional biologics.
Most recently, Dr. Giri was the Head of CMC Development at PTC Therapeutics, where he oversaw CMC strategy and development of PTC’s portfolio of AAV gene therapy candidates for CNS and ocular indications, including EU and UK approval of Upstaza, the first AAV gene therapy molecule delivered directly to the brain. Prior to PTC, Dr. Giri held TechOps roles of increasing responsibilities at Tesaro-GSK and Alexion Pharmaceuticals, where he contributed to the development and commercialization of monoclonal and bispecific antibodies, including Ultomiris and Jemperli.
Dr. Giri’s work in academia and industry has resulted in 10 peer-reviewed publications with over 900 citations, and a patent. He received a Ph.D. in Chemical Engineering from Johns Hopkins University and a Bachelor’s in Biological Systems Engineering from the University of Idaho.
Nilay Thakar, Ph.D. is the co-founder of Skylark Bio and serves as its Head of Business Development. Dr. Thakar is also a Principal with ARCH Venture Partners and focuses on company creation, identifying and evaluating new life sciences technologies, and providing operating assistance to early-stage portfolio companies. He also supported investments in, and serves as board observer or member at, Skylark Bio, Lifordi Immunotherapeutics, Doppler Bio, hC Bio, Arbor Bio, Volastra Tx, and Sonothera.
He has authored eight peer-reviewed publications with greater than 250 citations in the areas of neuroscience, stem cell biology, intracellular signalling, and epigenetics. Prior to ARCH, Dr. Thakar led the turnaround of an Australian biotech start-up Stem Cells Limited and out-licensed their assets to Evotec GmbH, served as a Think Tank Advisor at the Australian Academy of Sciences, and worked as an Analyst at Dendright, a biotech start-up developing personalized immunotherapy. Dr. Thakar also conceived an app to help blind Australians use public transport and was selected a Finalist for Queensland Government Open Data Award.
Dr. Thakar holds a B.S. in Biochemistry (High-Distinction honors) and a Ph.D. in Cell Biology from the University of Queensland in Australia. He also completed his M.B.A. at the University of Chicago Booth School of Business.
Dr. Gillis joined ARCH Venture Partners as a Venture Partner in 2005 and became a Managing Director in 2006. He is focused on the evaluation of new life science technologies and on the development and growth of ARCH’s biotechnology portfolio companies. He serves as a Director and/or Chairman of multiple companies within the ARCH ecosystem.
Dr. Gillis was a founder and director of Corixa Corporation and served as CEO from its inception and as its Chairman from 1999 until its acquisition in 2005 by GlaxoSmithKline. Prior to Corixa, Dr. Gillis was a founder and director of Immunex Corporation. From 1981 until his departure in 1994, he served as Immunex’s Director of Research and Development, Chief Scientific Officer, and as CEO of Immunex’s R&D subsidiary. Dr. Gillis was interim CEO of Immunex Corp. following its majority purchase by American Cyanamid Co. and remained a member of the board until 1997. Amgen, Inc. acquired Immunex in 2002.
Dr. Gillis is an immunologist by training with over 300 peer-reviewed publications in the areas of molecular and tumor immunology. He is credited as being a pioneer in the field of cytokines and cytokine receptors, directing the development of multiple marketed products including Leukine, (GM-CSF), Prokine (IL-2) and Enbrel (soluble TNF receptor-Fc fusion protein) as well as the regulatory approval of Bexxar (radiolabeled anti-CD20) and the vaccine adjuvant MPL. Dr. Gillis received a B.A. from Williams College and a Ph.D. from Dartmouth College.
Dr. Giampiero De Luca is Head of Intellectual Property at B-FLEXION (formerly Waypoint Capital).
Prior to his appointment with B-FLEXION, Dr. Giampiero De Luca was Vice President Licensing and Intellectual Property of Merck-Serono and Chief Intellectual Property Counsel of Serono International S.A. His responsibilities included management of Serono’s patent portfolio, oversight of patent-related litigation, and coordinating the Intellectual Property Department’s support of the company’s licensing activities.
Dr. De Luca began his career at the European Patent Office before joining Serono where he held a variety of positions and responsibilities including the management and coordination of research and development activities, and the establishment of the Corporate Intellectual Property Department in Geneva. Dr. De Luca was also a member of Serono’s Executive Management Board.
He holds a doctoral degree in industrial chemistry from the University of Milan, a Diploma in General Microbiology from Institut Pasteur and is a chartered European Patent Attorney, Swiss and Italian Patent Attorney and authorized representative before the Office of Harmonization in the Internal Market (OHIM).
40+ years studying inner ear biology 30 years HHMI
David P. Corey, Ph.D. is the Bertarelli Professor of Translational Medical Science in the Department of Neurobiology. For over 40 years, Dr. Corey has studied proteins of the hair-cell mechanotransduction complex with methods ranging from single-cell electrophysiology to single-molecule force spectroscopy to biochemistry to cryo-EM. His laboratory is now focused on how mutations in some of these proteins lead to hereditary deafness, and how gene therapy can treat deafness. With Casey Maquire (Massachusetts General Hospital), he has also developed methods for gene therapy in the inner ear, developing more efficient vectors and restoring hearing in five different mouse models with either gene addition or Cas9 disruption of a dominant mutation. With Cynthia Morton (Brigham and Women’s Hospital), he heads the Harvard Medical School Center for Hereditary Deafness. He has received many awards, including the Young Investigator Award from the Biophysical Society and the Award of Merit from the Association for Research in Otolaryngology, the Association’s highest award. He is an elected member of the American Academy of Arts & Sciences.
20+ years engineering vectors/gene therapies
Casey Maguire is a scientific co-founder and consultant of Skylark Bio. He obtained his Ph.D. in Microbiology and Immunology from the University of Rochester School of Medicine and Dentistry in 2006. Dr. Maguire is a virus vector bioengineer by training, with over 23 years of experience, first working with adenoviruses for his doctoral work and with adeno-associated virus (AAV) vectors. He is an Associate Professor Neurology at Harvard Medical School and Principal Investigator at the Massachusetts General Hospital.
He has published over 50 peer-reviewed papers, mainly in the field of vector gene delivery and therapy and has 5 issued US patents related to biotechnology, including novel AAV-based gene delivery systems. Together with collaborator and neurobiologist, Dr. David Corey at HMS, they have developed and tested novel AAV systems for gene delivery and therapy in mouse models of deafness and in 2018 demonstrated that AAV could efficiently transduce the inner ear of non-human primates.
25+ years audiology/hearing science; 20 years NIH-funded research
Titles:
René Gifford, Ph.D., CCC-A is a Professor in the Department of Hearing and Speech Sciences and holds the Fred H. Bess Chair in Audiology. She is the Director of the Implantables, Hearing Enhancement, & Amplification Research (I HEAR) Laboratory and Co-Director of research for the National Center for Childhood Deafness and Family Communication (NCCDFC) at the Vanderbilt Bill Wilkerson Center. Her research focuses on the study of auditory perception, spatial hearing, and binaural development for children and adults using combined electric and acoustic stimulation (EAS) via hearing aid and cochlear implant technology. Her primary professional goal is centered on improving auditory-based outcomes and ensuring that we are using data-driven recommendations for hearing and speech/language intervention for our patients. Dr. Gifford’s research has been NIH funded for over 20 years, she has published over 140 peer-reviewed articles, multiple book chapters, and she authored a book, now in its second edition, entitled “Cochlear Implant Patient Assessment: Evaluation of Candidacy, Performance, and Outcomes.” Dr. Gifford was a featured scientist on the National Public Radio, Science Friday broadcast entitled Breakthrough: Portraits of Women in Science—Hearing a Whole New World. Additionally, Dr. Gifford was awarded the 2015 Louis M. DiCarlo Award for Recent Clinical Achievement from the American Speech-Language-Hearing Association, the 2017 Vanderbilt University Chancellor’s Award for Research, as well as the 2021 Jerger Career Award for Research in Audiology from the American Academy of Audiology.
Dr. Gregory Robinson is Chief Scientific Officer at Tevard Bio, a biotechnology company pioneering tRNA-based therapies for a broad range of genetic diseases. Dr. Robinson has more than 30 years of experience helping advance scientific discoveries into the clinic, including more than a decade developing gene therapies using adeno-associated virus (AAV) vectors and non-viral approaches to target different tissues for a variety of diseases. Before joining Tevard, Dr. Robinson held CSO roles at several gene therapy companies including Summation Bio, a non-viral approach to treating ophthalmologic disorders; Akouos, developing treatments for hearing disorders (acquired by Lilly); Nightstar Therapeutics, targeting inherited retinal diseases (acquired by Biogen); and Agilis, focused on rare central nervous system disorders (acquired by PTC Therapeutics). Prior to his experience in gene therapy, Dr. Robinson held leadership roles at Shire Plc. and Eyetech Pharmaceuticals. He has co-authored more than 40 peer-reviewed publications and has 13 issued patents. Dr. Robinson holds a Ph.D. in Biochemistry from Boston University, completed postdoctoral studies at the Dana Farber Cancer Institute, Harvard Medical School, and received his B.S. in Biology from Macalester College.