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

We’ll close out the two-day conference with a dynamic half-day workshop designed to turn insights into action. Attendees can expect interactive sessions exploring advanced risk modeling approaches as well as practical perspectives on transformational quality programs and implementation best practices, featuring industry and technology partner insights. Additional sessions are being finalized—stay tuned as we shape an engaging, hands-on finale to the event.

Hotel Room Block:

Room block information for discounted accommodations at MGM Grand in Las Vegas from April 8-10, 2026 will be provided upon registering for the conference in the confirmation email.

Speakers:

Nikoo Arasteh, Former Sr. Director of Quality Assurance | Jaguar Health
Nikoo Arasteh, PhD, MBA is a Quality Assurance leader with over 25 years of experience in pharmaceutical and biotechnology environments. She has led quality organizations across biologics, small molecules, orphan drugs and rare disease therapies. Nikoo has driven digital transformation initiatives including eQMS implementation, data integrity programs, Analytical method lifecycle validation, and inspection readiness strategies supporting global quality oversight. She most recently served as Senior Director of Quality Assurance in Jaguar Health and is a Board Member of the Parenteral Drug Association – West Coast Chapter (PDA WCC) actively contributing to advancing industry collaboration and innovation.

Melika Ashtiani, Data Scientist | Former FDA

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, Director of Automation Engineering | Gilead Sciences

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, Founder | Biolygon

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.

Clare Elser, Quality and Regulatory Consultant | Ex-Genentech
Clare Elser is a strategic quality and regulatory executive with more than 30 years of experience leading enterprise-wide transformation across life sciences and highly regulated industries. When at Genentech, she led global quality, compliance, and risk governance initiatives across R&D, manufacturing, and commercial operations. She has extensive experience integrating digital health platforms, AI-enabled analytics, and eQMS technologies to strengthen inspection readiness, data integrity, and risk-based decision-making. Dr. Elser holds a Doctorate in Regulatory Science from the University of Southern California.

David Florez, VP of Sales | Peer AI
David Florez is a strategic leader in life sciences technology, currently spearheading the adoption of Agentic AI at Peer AI. With over a decade of experience partnering with pharmaceutical and biotech organizations, Peer AI focuses on transitioning the industry to “Systems of Intelligence” that automate complex regulatory and medical writing processes.

Prior to joining Peer AI, David spent six years at Veeva Systems, where he helped organizations optimize their clinical, regulatory, quality, and commercial operations through cloud-based solutions. His expertise in life sciences digital transformation makes him a frequent contributor to discussions on how emerging technologies can accelerate the drug development lifecycle and ensure global compliance. David looks forward to meeting with fellow PDA members in Las Vegas to discuss the evolving landscape of regulatory document automation and the future of AI-driven systems.

Haik Gazarian, Director, QMS Strategy | Veeva Systems
Haik Gazarian is a Quality Strategist, leader, and IT systems expert with a distinguished career spanning team leadership, IT quality compliance, operational excellence, transformative program design and delivery, and the implementation of enterprise-grade Quality Management Systems. His work supports a broad range of quality business use cases while ensuring full GxP compliance and maintaining the agility required for continuous enhancement. His areas of expertise include process improvement, complex program leadership, best-practice implementation methodologies, and delivering impactful solutions to organizations within the pharmaceutical, medical device, and consumer packaged goods industries. Haik has been directly responsible for the successful rollout of multiple new products to key customers, helping global market-leading software providers establish a strong presence in new industries.

Bo Henry, Senior Director, Enterprise Quality Systems and Lab Operations | Catalent
Bo Henry is the Senior Director of Enterprise Quality Systems and Lab Operations at Catalent, a global pharmaceutical, biotech, and consumer health CDMO with more than 40 sites worldwide. With over 24 years of experience in pharmaceutical contract manufacturing, Bo has held key Quality leadership roles across Catalent’s Maryland operations and the former Bloomington, Indiana site. He brings a strong foundation of Quality and IT experience from his prior work at Cook Pharmica and Baxter Healthcare.

Bo holds a Bachelor of Science in Biology from North Dakota State University and a Master of Business Administration from Indiana Wesleyan University. He currently oversees compliance and validation for all Catalent Enterprise Systems and serves as Application Owner for the company’s trademarked suite of Quality-focused artificial intelligence tools.

Professional Affiliations: Parenteral Drug Association (PDA)

Oliver Hesse, VP of CMC Digital Transformation and Data Science | Bayer
Oliver Hesse is a senior digital and AI leader with 25 years of experience driving automation, advanced analytics, and AI-enabled transformation in the pharmaceutical industry. He currently leads CMC Digital Transformation and Data Science at Bayer, heading global teams that apply advanced analytics and AI to accelerate development, strengthen decision-making, and improve productivity across CMC.

Recently, Oliver has been contributing to Bayer’s broader rAIvolution—the company-wide transformation to embed AI into everyday work—by shaping and executing Reality 2030, a CMC-focused vision that reimagines how human expertise and AI work together in a data-centric, end-to-end operating model. He brings a pragmatic, end-to-end perspective on how digital transformation and AI can be translated from vision into real impact in pharma organizations.

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.

Sebastian Scheler, Co-Founder and Managing Director | Innerspace
As the co-founder and leader of a multidisciplinary team of life science professionals and software developers at Innerspace, Sebastian is passionate about driving innovation through our Frame-by-Frame Technology—an automated solution for process modelling, risk assessment, and knowledge management. This technology empowers organizations to automate and design processes, streamline operations, improve scalability, and mitigate risks in life science manufacturing processes.

In his role as Managing Director at Innerspace, he oversees the continuous development and optimization of this groundbreaking approach, ensuring it remains at the forefront of industry innovation.

Additionally, as a trainer, he delivers expert-led courses that enhance industry standards. His involvement in the PDA/Innerspace partnership allows him to actively shape the design and delivery of training programs, ensuring they meet the evolving needs of the life sciences sector.

Apurva Shah, Founder and CEO | Global Compliance Partners
Apurva Shah is the Founder and CEO of Global Compliance Partners. Over the past decade, he has built and scaled high performing teams across the full spectrum of GxP consulting, including supply chain, validation, automation, process validation, data integrity, and quality systems, supporting biologics, small molecules, and advanced therapy programs, with a core focus on cell and gene therapy. He is known for weaving strong team culture and disciplined execution into complex biotech environments, helping organizations move from clinical stage through commercial readiness with confidence. Apurva has also broken barriers in advancing automated document workflows, introducing regulatory intelligence and practical AI into traditionally manual compliance systems. Outside of work, he is a dedicated ping pong coach, a committed food and fitness enthusiast, and values time above all with his wife and daughter.

Scott Sherrill, SVP of Regulatory Intelligence | Redica
Scott Sherrill is SVP of Regulatory Intelligence at Redica, where he leads product strategy, AI integration, and partnerships with one goal in mind: making sure customers genuinely love the product.

Over the past several years at Redica, he’s helped shape how pharmaceutical companies use regulatory intelligence to work smarter, move faster, and stay ahead of a constantly shifting compliance landscape.

Before joining Redica, Scott built his career at customer-focused data and technology companies.

Exhibitors:

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://www.koerber.com/en

more info at https://sterile.com/

more info at lonza.com

more info at https://ntint.com/

FAQs

How can I contact the organizer with any questions?

You can contact the event organizer by sending an email to [email protected]. 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.