Archives: Speakers

Wendi Carroll received her Pharm D from the University of the Pacific. She has 20+ years of diverse global experience in the biotechnology industry including roles within Clinical Development, Medical Affairs, and Risk Management. During her career she has advocated for critical partnerships with vendors supporting integration with internal stakeholders. Wendi is currently the Executive Director, Global Medical Affairs Evidence Generation COE at BioMarin Inc. where she oversees global operational strategy and execution for programs in the post-approval setting.

Vast experience of nearly 25 years in Quality, Regulatory, Processes Improvements, leading clinical studies and cross organization projects VP Quality Assurance, Regulatory Affairs and Clinical at IceCure Medical, since September 2020, leading the company compliance and clinical affairs. Prior to joining IceCure Medical, held a position of Director of Quality, Regulatory and Customer Support at Applied Spectral Imaging (ASI) and Several positions at Carestream Health (formerly Kodak medical division)

Alton Sartor completed a combined MD/MBA from Tulane University. Subsequently completed a Neurology Residency at Columbia University with additional Fellowship training in Neuro-Oncology at the Mass General Brigham program. Practiced Neuro-Oncology and General Neurology at the VA and Boston Medical Center. Joined industry with a goal of developing digital and devices to improve patient care. Currently a Medical Director/Patient Safety Physician Digital & Devices at Astrazeneca.

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.

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.