Join the PDA West Coast Chapter in Las Vegas, Nevada for a day-and-a-half: Artificial Intelligence (AI) in Biopharmaceutical Development and Manufacturing Conference. This is a content-rich program offering a variety of industry expert presentations, interactive roundtables, and engaging panel discussions on artificial intelligence in: Manufacturing, upstream processes in Process Development, and downstream testing from a Quality view.

This 1.5-day event will provide insights on applications of AI in biotech/biopharma from industry experts, unique perspectives on implementation and tools to build out AI capabilities on your own teams, and similarities and challenges from adjacent industries. Come learn from our esteemed speakers and panelists on topics including:

• Advances in AI and Integrated Process Modeling for Commercial Molecules
• AI Implementation: Adoption, Tools, Roadmap
• Current and Future State of AI in Manufacturing
• Generative AI and Real-World Case Studies
• Impact of AI on Quality, Documentation, and SOPs
• Regulatory Considerations for AI
• Robust Manufacturing: AI Automation in Process Design, Risk Assessment, and Knowledge Management
• More to Come!

Room block information for discounted accommodations at Caesars Palace in Las Vegas from March 19–21, 2025 will be provided upon registering for the conference in the confirmation email.

Visitor and Vendor Policy:

Due to security measures, all attendees must be pre-registered on Eventbrite prior to attending.

Please Note: Everyone attending must have a ticket registered under their own name.

Speakers:

*Subject to change based on speaker availability.

Taylor Chartier, PhD

CEO | Modicus Prime

Taylor Chartier is a data scientist and engineer from the pharmaceutical industry. She has supported FDA Biologics License Applications by advancing Quality by Design initiatives in Process Development, Manufacturing Sciences and Technology, and Commercial Manufacturing operations. She has also applied machine learning and artificial intelligence for multivariate modeling to optimize pharmaceutical production and perform root cause analysis, most recently at Bayer Pharmaceuticals.

Chartier is CEO of the AI software company, Modicus Prime, to provide pharma with compliant AI computational techniques and apply them in a vigorous way to help safely and more efficiently produce drugs for patients. She has implemented AI software in biologics and cell and gene therapy manufacturing. In addition, she is a contributing member to the ISPE Software Automation & Artificial Intelligence Special Interest Group, BioPhorum AI Validation Worksteam, and the Texas PDA Chapter.

Rashed Harun, PhD

Senior Data Scientist | Genentech

Rashed has been a data scientist in Genentech for 5 years and is currently supporting allogeneic CAR-T therapy development. He has a strong expertise in applying explainable machine learning methods across various functions throughout the company, and in particular, clinical pharmacology. He received his Ph.D. in Neurobiology from the University of Pittsburgh, followed by a postdoctoral fellowship in Computational Neuroscience from UC Davis and an Insight Data Science fellowship in San Francisco.

Joshua Kim

CEO, Co-Founder | Artos

Josh is the CEO and co-founder of Artos, a Y Combinator-backed company providing the most scalable AI platform for document creation and management in the life sciences.

Josh’s journey began in regulatory, clinical, and commercial strategy roles at leading precision oncology companies, including Ignyta (acquired by Roche in 2017) and Erasca (backed by a16z and ARCH Ventures). At Ignyta, he focused on executing late-stage trials and securing marketing approvals while at Erasca, he worked on early-stage IND strategy and trial design.

Inspired by his experiences in biotech and personal interactions with healthcare systems, Josh transitioned to academic research at the University of Chicago where his work centered on developing AI for clinical workflows and drug development, including time-series machine learning techniques to monitor neurodegenerative conditions like Alzheimer’s. His work earned him recognition as the youngest NIH-funded Principal Investigator at the National Institute on Aging, leading collaborations to deploy AI in clinical trials and improve trial site selection and patient recruitment through NLP techniques.

Josh graduated summa cum laude from the University of Chicago.

Scott Kobayashi

SVP of Sales | BioPhy

Scott Kobayashi is currently SVP of Sales at BioPhy, an AI drug development company that specializes in clinical trial prediction, automated SOP gap analysis, and other use cases designed to deliver drugs to market faster. In this role, Scott works with Life Science companies of all sizes on implementing BioPhy’s AI solutions to meet their business needs. Prior to BioPhy, Scott was co-founder and CEO of Delta Project Management (acquired by Verista), a CQV and Project Management consulting firm based in the Bay Area and Boston. Scott has over 20 years of experience in the Life Sciences industries.

Julie Kong

Data Scientist, Cell and Gene Therapies | Genentech

Julie Kong is a data scientist in Cell and Gene Therapies at Genentech with a B.S. in Chemical and Biomolecular Engineering from UC Berkeley. She has extensive experience in pharmaceutical manufacturing, spanning process engineering, supply chain, downstream process development, and procurement. Julie specializes in leveraging AI and data-driven insights to optimize manufacturing processes, enhance clinical outcomes, and drive digital innovation. She plays a key role in creating and executing a program-level FAIR data strategy for cell therapies, ensuring high-quality, accessible data to advance therapeutic development.

Passionate about the intersection of biopharma, data science and AI, Julie is committed to accelerating the robust delivery of life-saving therapies. She is also dedicated to mentoring and upskilling young talent, fostering the next generation of innovators in the field.

Don Low, PhD

Senior Director, PT Cell and Gene Therapies – PTC | Genentech

Don Low, PhD, is a Senior Director in the Cell and Gene Therapy group at Genentech, based in South San Francisco, California. With over 14 years of experience at Genentech, Don leads a team specializing in bioinformatics, data, and analytics to support process development and manufacturing for cell and gene therapies. He plays a key role in advancing individualized mRNA,T-cell, and regenerative medicine collaborations through the integration of computational methods into drug development. Don’s expertise spans small molecule, peptide, and biologics programs. His early career included an NIH postdoctoral fellowship and a successful role as Principal Investigator for an NIST Advanced Technology Program, where he managed interdisciplinary teams and fostered international collaborations. Don holds a PhD in Chemistry from the California Institute of Technology and a Bachelor’s degree in Chemistry from the University of California, Berkeley. A native Californian, Don is an avid cyclist and loves cooking food with his family.

Ramon Mendoza, PhD

Scientific Director, Analytical Development – Cell & Gene Therapies, Vaccines, BioTherapeutics Development & Supply, Discovery, Product Development & Supply | Johnson & Johnson

Ramon is the Scientific Director within the Cell and Gene Therapy Analytical Development group at Johnson and Johnson Innovative Medicine where he supporting the cell & gene therapy portfolio, leveraging his ATMP expertise. Prior to joining Janssen, Ramon worked for Bristol Myers Squibb (Celgene), Orchard Therapeutics, Rocket Pharma, Bayer Pharma and Analytical Lab Group now part of Element Materials Technology. During this time, Ramon had the responsibilities of leading analytical and commercial GMP quality teams, developing process and analytical control strategies for AAV, LV, RNP’s and CAR-T drug products. He has experience supporting Cell & Gene Therapy programs from early /late-stage development, well into the commercial lifecycle. He has authored many submissions and participated in agency inspection and meetings, leading to successful commercial approvals of new CAR-T drug products. Ramon has a PhD in Cell & Molecular Biology from the University of Washington, MS and BS in Biochemistry from San Francisco State University. He also held postdoctoral positions at the Fred Hutchinson Cancer Research Center in Seattle WA.

Thomas Mistretta, MS

Director Data Science | Amgen

Tom is a highly experienced transformational technology leader within the biopharmaceutical industry. Through opportunities to work with many digital technologies, Tom’s career path has focused on driving advancement in digital capabilities and analytics across the operations value chain. Tom has also served in many roles in process development throughout his career including process design, technology transfer, and continuous process verification.

Tom has an MS in Engineering Management from Northeastern University and a BS in chemical engineering from RPI.

Sandeep Mora, PhD

Director, Innovation Management & Data Science | Boehringer Ingelheim

Sandeep Mora is a seasoned biotechnology leader with over 10 years of industry experience and a Ph.D. in Chemical and Biomolecular Engineering. Currently serving as the Director of Process Technologies and Data Sciences at Boehringer Ingelheim, he spearheads drug substance development, technology transfer, and digital innovation initiatives. Dr. Mora has a proven track record in leading multidisciplinary teams, driving AI and machine learning applications in biopharma, and contributing to regulatory submissions. His expertise spans process development, data sciences, and the implementation of cutting-edge technologies to solve complex technical challenges.

Carl Ning

Senior Director, Vault Quality Strategy, QMS | Veeva Systems

Carl Ning heads up product strategy for Veeva QMS application. With over 25 years of experience delivering transformative solutions in the life sciences, consumer products, discrete manufacturing, and financial services industries, Carl has dedicated over 20 of those years to quality management/quality systems. With experience in over 200 quality and regulatory system design and implementation projects, he is dedicated to driving innovation in quality solutions. His work focuses on helping organizations meet regulatory requirements, address business challenges, and enhance efficiency and value for both customers and the industry – with his primary objective to support the life sciences sector in achieving optimal product quality and ensuring patient safety.

Remus Osan, PhD

Director of Data Science | Gilead Sciences

Remus Osan is the Director of Data Science at Gilead, specializing in Computer Vision solutions for pharma manufacturing. His work focuses on the characterization of particles, 3D structures for long-acting injectables and tablets, and additional computational modeling. In this role, his graduate training in Physics from University of Pittsburgh and his faculty experience in Math&Stats from Georgia State University comes in handy sometimes to fend off GenAI hallucinations (or is part of the process without knowing it).

Mike Salem, MA

Associate Director of Data Science – Quality Assurance | Gilead Sciences

Mike Salem is the Associate Director of Data Science – Quality Assurance at Gilead Sciences in Foster City, CA. He has worked in data science and technology for more than 15 years developing AI/ML solutions and products across multiple domains including robotics, finance, education, and healthcare. Mike has a BS and MA in mathematics from Arizona State University and attended Georgia Institute of Technology specializing in AI, Machine Learning and computational perception / robotics.

Sebastian Scheler

Co-Founder & 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 Innerspace’s Frame-by-Frame Technology—an automated solution for process modelling, risk assessment, and knowledge management. Innerspace’s technology aims to empower organizations to automate and design processes, streamline operations, improve scalability, and mitigate risks in life science manufacturing processes.

As Managing Director at Innerspace, Sebastian oversees the continuous development and optimization of the Frame-by-Frame Technology to ensure it remains at the forefront of industry innovation. Additionally, Sebastian is proud to contribute as a trainer, delivering expert-led courses that enhance industry standards.

Apurva Shah, MBA

Founder & CEO | Global Compliance Partners & Co-Founder | Nexdox

With over 17 years of experience in the biotech industry, Apurva is the founder and CEO of Global Compliance Partners, a leading biotech consulting company for cell and gene therapy, and the co-founder of Nexdox, an AI platform for documentation services in life sciences.

Apurva received his MBA from the Fuqua School of Business at Duke University and completed his Masters in Electrical Engineering at Syracuse University. In his free time, Apurva is a food and fitness enthusiast who plays golf and coaches ping pong. He also enjoys spending time with his wife and newborn baby.

Sponsors:

more info at www.bayer.com

more info at https://www.biomerieux.com/

more info at https://bionovascientific.com/

more info at https://www.boehringer-ingelheim.com/

more info at https://www.element.com/

more info at https://www.emerypharma.com/

more info at https://www.eurofins.com/

more info at https://www.gene.com

more info at www.gilead.com

more info at https://globalcompliancepartners.com/

more info at www.nelsonlabs.com

more info at https://www.ntint.com/

more info at www.thermofisher.com

more info at https://www.sterile.com/

FAQs

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 10MAR25 to whomever would like to attend on your behalf.

My company would like to become a PDA WCC Sponsor, do you have a sponsorship program?

Yes, our PDA WCC Sponsorship Program offers a unique opportunity for companies that want to strengthen brand image, increase visibility, and gain access to leaders of the San Francisco Bay Life Science Community.

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 (10MAR25). 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.

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REGISTRATION AGREEMENT: By registering to this event, I consent to PDA WCC recording and/or photographing me and using those recording(s) and/or photograph(s) in the future PDA WCC promotional and marketing material, and to send me promotional information via email.