Archives: Speakers

Research & Development Scientist and Leader with 20+ years experience in multiple phases of drug discovery and early development.

Specialties: Oncology and Fibrosis research and development, drug discovery, translational research, early clinical development, collaboration with academic centers and major Pharmaceutical companies

1. Career
   • Vice President, Clinical Operations, Nitto BioPharma, 2016-present
   • Senior Director, Oncology, Regulus Therapeutics , 2012-2015
   • Senior Director, Oncology, Pfizer, 2010-2011
   • Associate Director, Oncology,  AstraZeneca, 2001-2010
   • Principal Scientist, Oncology, Novartis, 1997-2001
2. Education
   • Post-Doctoral Fellow, California Institute of Technology
   • Ph.D., Molecular and Cellular Biology, The Johns Hopkins University
   • B.S., Biology, University of Rochester

Sarjan Shah is the Chief Operating Officer at Auritec Pharmaceuticals, a rapidly growing drug delivery company. In this role, he oversees all product development, business development, intellectual property development, and regulatory affairs activities. Sarjan has co-authored award-winning federal grants and INDs for first-in-human clinical trials across a broad range of disease indications, including but not limited to, women’s health, infectious diseases (HIV, HSV), opioid addiction, and organ transplantation. In collaboration with the CEO, Sarjan leads Auritec’s initiatives from product ideation through proof-of-concept clinical studies.

On a day-to-day basis, Sarjan is responsible for directing the company’s laboratory staff and administrative personnel along with conceptualizing and executing his own projects that span across target product profile design, nonclinical studies, regulatory submissions, grant writing, and serving as the central point of contact for vendors, collaborators, partners, and regulatory agencies. Through his 8+ years of work experience and resulting accomplishments, Sarjan has developed unique expertise in early-stage development of 505(b)(2) sustained release drug products.

Prior to joining Auritec, he worked as a Business Analyst/Consultant for multiple life science advisory firms where he collaborated with senior consultants to co-develop actionable reimbursement, market access and business development strategies/tactics for Fortune 500 and Mid-sized pharma, biotech and medical device/diagnostic clients.

Sarjan graduated with a Master of Business and Science degree from the Keck Graduate Institute and has a Bachelor’s degree in biotechnology engineering at the University of Mumbai.

Dr. Lei Zhang has over25 years of experience spanning across the biotech/biopharma, medical device, diagnostic, and CRO industries. Her unique drug development lifecycle expertise includes global clinical development & operations, scientific innovation, and regulatory interactions with the FDA (CDER, CBER, CDRH). Dr. Zhang engaged various therapeutic indications in oncology, cardiology, endocrinology, dermatology, OB/GYN, gastroenterology, urology, and infectious diseases. Her track record includes contributions to development strategy, corporate partnership, clinical trial design and execution (Phase I-III, 510(k), PMA) as well as regulatory submissions. Lei provides leadership overseeing functional teams in clinical/regulatory affairs, program management, Biostat, data management, medical writing, CRO/vender selection.

Dr. Zhang received her M.S. from Beijing Medical Univ. and Ph.D from Germany; performed postdoc research at MIT. Lei is an active speaker at biotech & biopharma forums on clinical/regulatory topics.

Dr. Gal has over 30 years of medical device experience as a practicing veterinarian, academician at Tufts University School of Medicine and subsequently in industry. Dov held R&D, clinical marketing and clinical affairs positions with increasing responsibilities in private start-up, and medium to large public medical device companies.

Most recently, Dov led the clinical organization for the Heart Valve Therapy business at Edwards Lifesciences, overseeing clinical trials of Class III implantable devices. Prior to Edwards Lifesciences, he led the clinical organization at Broncus Technologies, a start-up with an investigational, minimally invasive device-drug combination product for the treatment of patients with severe COPD. The system was evaluated in an international clinical trial under an IDE. Prior to Broncus, Dov was a director of clinical research at Medtronic Vascular responsible for the AAA stent graft product line

Raj is the founder of the Gastric Vest Technology System (GVS), which was acquired in 2017.  The GVS has several issued patents involving weight loss technologies, including – gastric restriction, intra-gastric technology, bio-electronics for type II diabetes, and spine surgery.

• Focusing on key role of participants in clinical studies with opportunities for healthcare access and contributions to diversity in clinical trials
• Current and former role as VP, Clinical Operations (SiteBridge Research, Takeda, Revance); VP Clinical Development (Meitheal/Xentria, AnaptysBio) and Head of Strategic Operations/Clinical Research Operations (Pfizer, Avexis, Astellas) leveraging early and late stage Drug Development and global clinical trials experience toward creating a high-performance teams and outsourcing plans for clinical trials
• Experience in Global Development, Clinical Operations, Scientific Strategy and Clinical Affairs over the last 20+ years from bench to commercial; mergers, licensing and acquisitions and organizational evolution
• Global experience including reports both within NA and outside US (including Canada, Eu, Jpn)
• Former Astella’s Board member on AVOCA, Operations Committee member with Transcelerate, scientific development liaison for IFPMA/WHO Clinical Fellowship program.
• Key driver — business case as part of Takeda strategy for Asia development operations in Singapore
• Therapy areas of experience: Women’s Health, Musculo-skeletal Disorders, Oncology, Immunology/Inflammation, InfDiseases, Urology/Nephrology, CKD, Metabolic Diseases, CNS/Pain/Movement Disorders

Notable career achievements:

• Contributions to development, regulatory submissions and/or approval of DaxibotulinumtoxinA, ZolgenSMA, Myrbetriq, Xtandi, Rozerem, Cresemba, ACTOS, Lipitor, Lyrica, Actonel; numerous INDs/ODAs including mabs for rare diseases, pivotal trials for dermatologic and respiratory diseases
• Developing global strategy for Astellas’ Global Operating Model/Global Project Team, including implementation in US, EU and Jpn ; this model remains in place for some 2000+ colleagues in Astellas Medical/Development.
• Globalizing Clinical Operations at Takeda, establishing ‘business units’ with Clinical Program Managers/Study Manager in alignment with key TAs for which Takeda was developing compounds and having high stds/global processes to run projects from Phase I – IV, including internal processes and those for overseeing outsourced study management activities.
• Recognized leader and mentor Pfizer, Takeda and Astellas as a leader and mentor.