
Please join the PDA West Coast Chapter in Las Vegas, Nevada for a 1.5-day conference: Digital Transformation in Biopharma.
This content-rich program features expert presentations, interactive roundtables, and engaging panel discussions focused on modernizing legacy operations into digitally enabled environments.
Key discussion areas include:
- AI tools and integration
-Intelligent engineering and CMC/regulatory strategy
- Maintaining compliance during digital transitions
- Strategies for enhancing efficiency and managing system transformations
- Management of change
- Annex 11 considerations
- QA and regulatory alignment
- Human element and training
Melika Ashtiani is a data scientist with a background in chemical engineering and biochemistry, specializing in machine learning and data-driven risk assessment. At the FDA’s Center for Drug Evaluation and Research (CDER), she developed analytics tools to enhance inspection readiness and post-market surveillance by integrating diverse data sources and identifying emerging risk signals.
Previously at Merck, she served as product owner of a deep learning initiative and contributed to advanced analytics projects.
Melika holds a Master of Engineering from the University of Toronto and dual bachelor’s degrees from the University of Colorado. She is AWS Machine Learning Specialty certified.
Andy Chong is an accomplished automation engineer with more than 20 years of experience in biopharmaceutical industry. He is currently serving as the Director of Automation Engineering at Gilead Sciences, a leading research-based biopharmaceutical company.
In his role at Gilead Sciences, Andy leads a team responsible for overseeing and maintaining automation-based systems and solutions that provide a flexible, innovative, highly efficient, compliant, and quality-focused environment for research and development and manufacturing. He is instrumental in developing, planning, and implementing projects and solutions in collaboration with cross-functional teams, ensuring successful programs and customer satisfaction.
Andy has been a key driver in Gilead's Corporate Pharma 4.0 Digital Transformation initiative, leading the evaluation and introduction of new Pharma 4.0 tools. He also plays a pivotal role in developing automation technical standards and procedures to ensure the highest level of efficiency and quality within the organization. Prior to his current role, Andy served as the Principal Automation Engineer at Gilead Sciences for a span of seven years. During this time, he was responsible for overseeing all capital automation projects in Gilead's Foster City location, including the design, installation, commissioning, and qualification of the Building Management System (BMS) and Process Control System (PCS).
Fabio De Martino is a seasoned life sciences executive, educator, and project management consultant with over 15 years of experience leading cross-functional teams in the biotechnology and pharmaceutical sectors. He has held leadership roles at industry-leading organizations, including Gilead Sciences, Genentech, and Novartis, where he drove key initiatives across quality systems, operational excellence, and global program management. Fabio specializes in project and program management, organizational readiness, and regulatory compliance, with deep expertise in cGMP, Lean Six Sigma, and quality improvement frameworks. He is the founder of Biolygon LLC, a business service platform that connects professionals with life sciences companies seeking expert project support.
Nikolai Makaranka, Founder & CEO | Daikon
Nikolai Makaranka is the founder and CEO of Daikon, an AI-native platform for quality and operations in life sciences. He brings over 15 years of experience across pharmaceutical and medical device organizations, including Bristol Myers Squibb and Philips, where he led enterprise-scale implementations of AI and data solutions in regulated environments. His work focuses on applying high-fidelity, compliant AI to quality, manufacturing, and operational workflows. Prior to founding Daikon, he worked closely with quality and operations teams to modernize legacy processes and systems using data and automation. Nikolai is a frequent speaker and writer on practical, production-grade AI in life sciences, with a focus on what actually works in regulated settings. He is passionate about bridging deep domain expertise with real-world AI deployment.
more info at www.bayer.com
more info at www.biomerieux-usa.com
more info at https://bionovascientific.com/
more info at www.element.com
more info at https://www.gene.com
more info at www.gilead.com
more info at www.globalcompliancepartners.com
more info at https://sterile.com/
more info at lonza.com
How can I contact the organizer with any questions?
You can contact the event organizer by sending an email to rsvp@wccpda.org. Please allow a few days for the response, emails will not be monitored on the day of the event.
Is my registration fee or ticket transferable?
Tickets are not reimbursable, however you can transfer your ticket by 01APR26 to whomever would like to attend on your behalf.
Cancellation & Refund Policy:
Tickets are non-refundable. Seating is confirmed and reserved in advance. All sales are final and no refunds will be provided, including but not limited to non-attendance at the event. If a registrant cannot attend, substitutions are welcome no later than 10 days before the event (01APR26). The Chapter reserves the right to cancel an event if the minimum number of attendees is not met by the Monday prior to the event. The Chapter reserves the right to not answer emails or phone calls on the day of the event.
Privacy Policy:
We manage your personal data responsibly and align with PDA Privacy Policy.
REGISTRATION AGREEMENT: By registering to this event, I consent to the WCC PDA recording and/or photographing me and using those recording(s) and/or photograph(s) in the future WCC PDA promotional and marketing material, and to send me promotional information via email.
more info at https://ntint.com/