Archives: Speakers

With over 25 years of comprehensive clinical development expertise spanning biotech companies, CROs, and academic research sites, I have contributed to advance novel therapies across diverse therapeutic areas such as oncology, immunology, virology, etc. in global Phase 1-4 programs, driving regulatory submissions, and achieving approvals for significant HIV therapies at Gilead Sciences.  I’ve held various Clinical Operations leadership roles at Amgen, Gilead, and currently at Profound Bio as Executive Director heading Clinical Operations department.

Liza Melchor-Khan is a Senior Director of Clinical Operations at NGM Biopharmaceuticals, Inc. with over 25 years of experience in the biotech and pharmaceutical industry. Liza has extensive experience in managing and overseeing phase I-IV clinical trials globally as well as building and growing clinical operations teams in oncology, cardiovascular, metabolic and liver diseases, HIV and trials in gene therapy.

Experienced Clinical Operations and Clinical Data Management professional with over 25 yrs of Biotech/ Pharma industry, and Study Site experience. Phase I through Phase IV clinical studies experience in various therapeutic areas, (e.g. infectious diseases, GI, hepatitis, pain, and HIV AIDS), and formulations (oral, IV, injectables, skin patch).

Evaluated and managed CROs for both Clinical and CDM activities. Led implementation of, and worked with various software systems like DFNet, Medidata, Oracle Clinical, ClinTrial, Clinical Trial Management system, and Document Management. Monitored and co-monitored national and international study sites (India and Thailand). Experienced in managing clinical trial process from inception to reporting and submission.

Specialties: Vendor and CRO management, oversight or study sites (US, Thailand, India). Collaboration with international teams. Establish Data Management Dept., implementation of software systems and processes that are well integrated with Clinical, Biostat/Programming, QA/QC, and Research.

Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. Solution-oriented professional, with strong problem solving capabilities.

Sandy Mohan is the VP of Quality at Iovance Biotherapeutics. Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck. She has worked at several companies in positions of increasing responsibility including VP of Quality at InterMune (acquired by Roche) and Director of Quality at CV Therapeutics (acquired by Gilead). She has over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules. She has extensive experience in building quality organizations, overseeing Phase 3 global clinical trials, supporting marketing authorization applications in the US and EU, and managing pre-approval inspections leading to multiple product approvals and launches. She received her MS and PhD in Microbiology from New York University and did a postdoctoral research at Merck Research Laboratories.

I am the CEO at OrPro Therapeutics, a biotechnology company in San Diego, CA developing biologic drug solutions to unmet needs in serious epithelial diseases including cystic fibrosis. My training is in genetics (Ph.D.) and mechanical/biochemical engineering (M.S.), both from Duke University where I was also an undergraduate. I went into industry for post-doctoral studies at the biotechnology research center at Ciba-Geigy Corp. (Novartis) and have over three decades of academic and industrial research and senior management experience in protein and metabolic engineering, bio-based manufacturing, and drug discovery / development. I am passionate about the life sciences and the clinical and commercial potential of novel therapeutics and applications of synthetic biology.

Hang Nguyen brings over 20 years of medical device clinical research and is currently the Sr. Director of Clinical Affairs at Materna Medical, a novel OBGYN platform company defining a $6B market in the most common pelvic conditions women face. She has executed a variety of clinical trials involving therapeutic areas including autologous breast reconstruction, heart failure, hypertension, arrhythmia management and erectile dysfunction. She also has worked within the clinical department at several reputable companies like Axogen, Medtronic, Coloplast and CR Bard.