| Page 87 | Kisaco Research

1. Regulatory workflows are complex but structured.

The presentation highlights that regulatory processes—spanning data management, authoring, reviewing, publishing, and health authority queries—are intricate yet follow consistent patterns. They are highly collaborative, interdependent, and mission-critical to bringing therapies from candidate nomination to market

2. AI is powerful but needs context and precision.

While AI excels at understanding and summarizing information, it struggles with reasoning and lacks domain-specific (drug development) context. Effective use of AI in regulatory work requires clear task definition—large enough to matter, but small enough to manage

3. Human-AI collaboration transforms regulatory efficiency.

When applied thoughtfully, AI can make regulatory work up to 100× faster without compromising quality—reducing months of effort to hours. Studies with Takeda and partnerships with Parexel demonstrate how AI can accelerate timelines, elevate human expertise, and make portfolio knowledge computable across programs

 

Author:

Lindsay Mateo

CCO
Weave Bio
... read more

Lindsay Mateo

CCO
Weave Bio
  • Learn how real-world data is transformed into structured, usable intelligence through PRISM (Patient Record Inference & Structuring Module), an AI-enabled engine that converts fragmented, multi-modal patient data into inference-ready patient journeys supporting scalable clinical insights and model validation.

  • Explore how Zephyr’s AI-enabled multi-modal models (AIM Suite) predict drug response and reconstruct gene expression from clinically available inputs, such as NGS data from commercial LDTs and whole-slide images, enabling retrospective and prospective evaluation of treatment predictions across oncologic therapeutic classes.

  • Discover how Zephyr’s AI-driven software accelerates co-development and clinical integration, enabling fine-tuned foundation models to embed directly into R&D workflows while supporting rapid clinical intelligence queries, cohorting, and data-driven decision-making.

Author:

Anshu Jain, MD

Chief Business and Clinical Officer
Zephyr AI

Dr. Anshu Jain is Zephyr AI’s Chief Business and Clinical Officer. A double board-certified radiation oncologist and clinical informatician, he leads business development, clinical strategy, medical affairs, and partner collaborations—translating Zephyr’s AI and large-scale real-world data into solutions that help biopharma and diagnostic partners advance precision medicine for patients. Prior to Zephyr, Dr. Jain served as Chief Medical Officer at Aster Insights.

Dr. Jain has authored peer-reviewed publications in Nature Communications, Journal of Clinical Oncology (JCO), and JCO Clinical Cancer Informatics, and has served as a principal investigator for early- and late-phase oncology trials. He has advised the FDA Office of the Commissioner and the Oncology Center of Excellence, and provided clinical leadership to large-scale data initiatives including the NCI SEER program.

He serves on the Board of Directors of the Community Oncology Alliance, the Board of Advisors for the Duke Cancer Institute, and is an Assistant Professor at the Yale School of Medicine.

Dr. Jain trained in internal medicine and radiation oncology at the Massachusetts General Hospital and Columbia New York Presbyterian Hospital. He earned his M.D. with Highest Distinction from the University of Kentucky College of Medicine and a degree in Economics from Duke University.

... read more

Anshu Jain, MD

Chief Business and Clinical Officer
Zephyr AI

Dr. Anshu Jain is Zephyr AI’s Chief Business and Clinical Officer. A double board-certified radiation oncologist and clinical informatician, he leads business development, clinical strategy, medical affairs, and partner collaborations—translating Zephyr’s AI and large-scale real-world data into solutions that help biopharma and diagnostic partners advance precision medicine for patients. Prior to Zephyr, Dr. Jain served as Chief Medical Officer at Aster Insights.

Dr. Jain has authored peer-reviewed publications in Nature Communications, Journal of Clinical Oncology (JCO), and JCO Clinical Cancer Informatics, and has served as a principal investigator for early- and late-phase oncology trials. He has advised the FDA Office of the Commissioner and the Oncology Center of Excellence, and provided clinical leadership to large-scale data initiatives including the NCI SEER program.

He serves on the Board of Directors of the Community Oncology Alliance, the Board of Advisors for the Duke Cancer Institute, and is an Assistant Professor at the Yale School of Medicine.

Dr. Jain trained in internal medicine and radiation oncology at the Massachusetts General Hospital and Columbia New York Presbyterian Hospital. He earned his M.D. with Highest Distinction from the University of Kentucky College of Medicine and a degree in Economics from Duke University.

Data powers the engine of artificial intelligence (AI), but not all data is created equal. While software capabilities are rapidly accelerating, the biopharma industry still largely lacks the intelligent hardware needed to generate clean, contextualized, and high-quality data that AI and machine learning (ML) models require to deliver on their promise.

Explore how today’s in silico process development tools for bioreactor scaling and mechanistic modeling of chromatography can help you get it right the first time now, and why the next generation of intelligent hardware will be critical to unlocking the full potential of AI/ML in biopharma.

Author:

Tobias Hahn, PhD

R&D Director, GoSilico
Cytiva

Tobias Hahn is R&D Director of chromatography mechanistic modeling activities at Cytiva. As former co-founder and CEO of GoSilico, now part of Cytiva, Tobias is responsible for delivering simulation software and workflows for in silico process development. He received his undergraduate education in computational mathematics and technical physics in Karlsruhe and Stockholm, earning his PhD in chemical engineering from Karlsruhe Institute of Technology (KIT). During his doctoral studies, he utilized his background in mathematics and software engineering to create the simulation software now known as GoSilico™ chromatography modeling software.

... read more

Tobias Hahn, PhD

R&D Director, GoSilico
Cytiva

Tobias Hahn is R&D Director of chromatography mechanistic modeling activities at Cytiva. As former co-founder and CEO of GoSilico, now part of Cytiva, Tobias is responsible for delivering simulation software and workflows for in silico process development. He received his undergraduate education in computational mathematics and technical physics in Karlsruhe and Stockholm, earning his PhD in chemical engineering from Karlsruhe Institute of Technology (KIT). During his doctoral studies, he utilized his background in mathematics and software engineering to create the simulation software now known as GoSilico™ chromatography modeling software.

Author:

Cilon Li

Sr. Director of Engineering, Digital Products Development
Cytiva

Cilon Li is a digital and IT executive with over 15 years of experience in healthcare and biopharma. He is a strategic leader with a proven track record in driving digital transformation across supply chain management, product management, and R&D. At Cytiva, Cilon drives the company’s digital strategy and expanding product portfolio, encompassing Internet of Things (IoT), data analytics, AI/ML, software as a service (SaaS) and enterprise applications to help customers progress their digital biomanufacturing journeys. 

... read more

Cilon Li

Sr. Director of Engineering, Digital Products Development
Cytiva

Cilon Li is a digital and IT executive with over 15 years of experience in healthcare and biopharma. He is a strategic leader with a proven track record in driving digital transformation across supply chain management, product management, and R&D. At Cytiva, Cilon drives the company’s digital strategy and expanding product portfolio, encompassing Internet of Things (IoT), data analytics, AI/ML, software as a service (SaaS) and enterprise applications to help customers progress their digital biomanufacturing journeys. 

Review how decision intelligence is transforming the way organisations plan and execute complex projects. Apply decision intelligence to high-stakes environments such as clinical trials and learn how AI can dramatically reduce trial-planning timelines, optimise trial execution, and improve portfolio-level decision-making. Explore how leading enterprises are using Decision Intelligence platform to bring greater clarity, speed, and confidence to their most critical operational and strategic decisions.

Author:

Andrew Brookes

Chief Technical Officer & Co-Founder
Faculty

Andrew leads Faculty’s technical teams and developed the backbone of Faculty’s AI operating system, Frontier. His accomplishments span building the NHS Covid Early Warning System and mission critical projects for the UK Ministry of Defence. Before Faculty, Andrew led an engineering team at investment management firm BlackRock. He holds a Master’s degree in Computer Science from the University of Warwick.

 

... read more

Andrew Brookes

Chief Technical Officer & Co-Founder
Faculty

Andrew leads Faculty’s technical teams and developed the backbone of Faculty’s AI operating system, Frontier. His accomplishments span building the NHS Covid Early Warning System and mission critical projects for the UK Ministry of Defence. Before Faculty, Andrew led an engineering team at investment management firm BlackRock. He holds a Master’s degree in Computer Science from the University of Warwick.

 

This session explores how hybrid AI infrastructure is transforming drug discovery by integrating on-premises, private cloud, and public cloud resources for optimal data control, computational power, scalability, and security. Attendees will learn how pharmaceutical organizations use cutting-edge AI and machine learning tools for target identification and molecular design, while maintaining compliance with strict regulatory standards. The presentation will cover the architecture and core components of hybrid infrastructure, including high-performance computing, data management, MLOps, and compliance frameworks. Key benefits such as accelerated R&D, cost reduction, improved collaboration, and flexible scalability will be discussed, alongside real-world case studies. The session will also address challenges like data integration, interoperability, regulatory complexity, and AI interpretability, offering practical strategies to overcome these obstacles.

Author:

Alex Madama

Distinguished Technologist
Hewlett Packard Enterprise

Alex Madama is a Distinguished Technologist at Hewlett Packard Enterprise, specializing in strategic technology integration for life sciences organizations, including healthcare, pharmaceutical, biotech, and medical device companies. He leads initiatives combining high-performance computing, Hybrid Cloud, IoT, big data, and AI to advance drug discovery, pharmaceutical R&D, and biologics manufacturing, aiming to optimize patient outcomes and reduce costs. Before re-joining HPE, Alex served as Vice President of Product at UnitedHealth Group R&D, where he drove innovation in healthcare research and development. He holds a bachelor’s degree in life science and a Doctor of Osteopathic Medicine from New York Institute of Technology, with additional clinical training at Good Samaritan Hospital Medical Center, and lectures as an Adjunct Professor of Health Information Technology at Hofstra University. Previously, Alex founded Onyx CCS and held leadership roles at Nook.com, Barnes & Noble, AIG, Cravath Swaine & Moore, and as founder of seekPhysician.com.

... read more

Alex Madama

Distinguished Technologist
Hewlett Packard Enterprise

Alex Madama is a Distinguished Technologist at Hewlett Packard Enterprise, specializing in strategic technology integration for life sciences organizations, including healthcare, pharmaceutical, biotech, and medical device companies. He leads initiatives combining high-performance computing, Hybrid Cloud, IoT, big data, and AI to advance drug discovery, pharmaceutical R&D, and biologics manufacturing, aiming to optimize patient outcomes and reduce costs. Before re-joining HPE, Alex served as Vice President of Product at UnitedHealth Group R&D, where he drove innovation in healthcare research and development. He holds a bachelor’s degree in life science and a Doctor of Osteopathic Medicine from New York Institute of Technology, with additional clinical training at Good Samaritan Hospital Medical Center, and lectures as an Adjunct Professor of Health Information Technology at Hofstra University. Previously, Alex founded Onyx CCS and held leadership roles at Nook.com, Barnes & Noble, AIG, Cravath Swaine & Moore, and as founder of seekPhysician.com.

Advanced computing is a strategic imperative for pharmaceutical innovation. The industry is at a point where traditional computational methods are no longer sufficient to solve the increasingly complex problems in R&D and operations. Embracing technologies like quantum computing and HPC is critical for maintaining a competitive edge and driving breakthroughs.

A hybrid approach is essential for a complete solution. No single technology is the silver bullet. The most effective solutions come from using the right tools—be it classical, quantum, or quantum-inspired—and combining them into a single, powerful workflow to maximize efficiency and impact. This approach allows companies to apply the best technology to a wide range of problems across the business, not just in drug discovery.

Strategic partnerships are key to capability building. For a large enterprise like J&J, the path to adopting these advanced technologies is best navigated through collaboration. Working with a specialist like Strangeworks bridges the knowledge gap, provides access to powerful platforms, and helps overcome organizational hurdles. The ultimate goal of this collaborations like these is to be able to empower J&J's internal teams to become self-sufficient pioneers of innovation.

Author:

Steve Gibson

Chief Commercial Officer
Strangeworks

Steve has held a range of C-Suite positions in technology companies ranging from financial technology services, to data science consulting. Currently he serves as Chief Commercial Officer at Strangeworks; an advanced compute platform as a service (PaaS) company based in Austin, Texas. Prior to Strangeworks, Steve helped build several startups from the ground up, the most successful being Honest Dollar which was the first startup acquired by Goldman Sachs in their 147 year history. Prior to Honest Dollar, Steve worked for a number of large multinational corporations in the European aerospace sector delivering platforms for military, civil and space applications. Steve holds a Bachelor’s degree in Aerospace Systems Engineering from the University of Coventry in the UK.

... read more

Steve Gibson

Chief Commercial Officer
Strangeworks

Steve has held a range of C-Suite positions in technology companies ranging from financial technology services, to data science consulting. Currently he serves as Chief Commercial Officer at Strangeworks; an advanced compute platform as a service (PaaS) company based in Austin, Texas. Prior to Strangeworks, Steve helped build several startups from the ground up, the most successful being Honest Dollar which was the first startup acquired by Goldman Sachs in their 147 year history. Prior to Honest Dollar, Steve worked for a number of large multinational corporations in the European aerospace sector delivering platforms for military, civil and space applications. Steve holds a Bachelor’s degree in Aerospace Systems Engineering from the University of Coventry in the UK.

Author:

Selene Sass

Technology Product Manager
Johnson and Johnson

Selene is a technology product manager at Johnson & Johnson with nearly five years supporting the Advanced Computing and Analytics team. Her primary focus is to empower R&D scientists with emerging and innovative technologies in the advanced computing space, including the integration of quantum computing within J&J. Currently, she supports groups working in AI/ML and is exploring how quantum computing techniques can further enhance these capabilities. 

... read more

Selene Sass

Technology Product Manager
Johnson and Johnson

Selene is a technology product manager at Johnson & Johnson with nearly five years supporting the Advanced Computing and Analytics team. Her primary focus is to empower R&D scientists with emerging and innovative technologies in the advanced computing space, including the integration of quantum computing within J&J. Currently, she supports groups working in AI/ML and is exploring how quantum computing techniques can further enhance these capabilities. 

  • Learn how AI analyzes patent and R&D data to identify chemical trends, aiding in compound optimization.
  • Discover how integrating diverse data sources streamlines the optimization of drug candidates, enhancing decision-making.

Author:

Sam Winders

Account Director
Patsnap

Sam is the lead representative for the healthcare and life sciences team at Patsnap. One of the organization’s longest serving employees, Sam works closely with our leading customers and the Patsnap product development team to ensure that our customers’ needs our met and that Patsnap continues to rapidly expand the technical frontier within the evolving drug discovery space. 

... read more

Sam Winders

Account Director
Patsnap

Sam is the lead representative for the healthcare and life sciences team at Patsnap. One of the organization’s longest serving employees, Sam works closely with our leading customers and the Patsnap product development team to ensure that our customers’ needs our met and that Patsnap continues to rapidly expand the technical frontier within the evolving drug discovery space. 

Author:

Christina V. McDonough

Principal
Fish & Richardson P.C.

Christina McDonough helps clients with patent prosecution, portfolio management, reexamination, counseling, and due diligence for clients ranging from small start-ups to large companies and academic institutions. She co-leads the firm’s standard essential patent (SEP) practice. 

Christina has particular expertise in the areas of artificial intelligence, digital therapeutics, bioinformatics and medical systems (e.g., telehealth, medical registries, readmission reductions, modeling and predictive analysis of biological data, genetic codes, and immunotherapy response), computational fluid dynamics (e.g., simulation of acoustic and fluid flow properties), complex data processing (e.g., big data and complex events), and financial algorithms (e.g., predictive modeling and forecasting of real-time security trades).

... read more

Christina V. McDonough

Principal
Fish & Richardson P.C.

Christina McDonough helps clients with patent prosecution, portfolio management, reexamination, counseling, and due diligence for clients ranging from small start-ups to large companies and academic institutions. She co-leads the firm’s standard essential patent (SEP) practice. 

Christina has particular expertise in the areas of artificial intelligence, digital therapeutics, bioinformatics and medical systems (e.g., telehealth, medical registries, readmission reductions, modeling and predictive analysis of biological data, genetic codes, and immunotherapy response), computational fluid dynamics (e.g., simulation of acoustic and fluid flow properties), complex data processing (e.g., big data and complex events), and financial algorithms (e.g., predictive modeling and forecasting of real-time security trades).

Author:

Crystal Culhane Ph.D.

Principal
Fish & Richardson P.C.

Crystal Culhane, Ph.D., applies her extensive academic background in organic chemistry to help life sciences organization protect their products and innovations through U.S. and foreign patent prosecution, client counseling, due diligence, patentability and freedom to operate opinions, patent opinions, and post-grant proceedings.

Known as a responsive communicator with a strong depth of knowledge, Crystal works with clients ranging from universities to start-ups and growing companies to multinational organizations to prepare intellectual property strategies that suit their business goals.

In recent years, Crystal has worked with a number of pharmaceutical clients in high-impact patent prosecution. Her clients include a large pharmaceutical company for which she has helped develop and manage a portfolio of several hundred patent families and another which in 2021 received its first-ever FDA approval for a new drug that treats a rare liver disease.

Crystal earned her doctorate in chemistry at Johns Hopkins University, where her research focused on the design, synthesis, and evaluation of novel optical and radioactive small molecule prostate cancer imaging agents. She has significant experience in various scientific disciplines, including synthetic organic chemistry, radiochemistry, biology, radiobiology, and small animal imaging.

... read more

Crystal Culhane Ph.D.

Principal
Fish & Richardson P.C.

Crystal Culhane, Ph.D., applies her extensive academic background in organic chemistry to help life sciences organization protect their products and innovations through U.S. and foreign patent prosecution, client counseling, due diligence, patentability and freedom to operate opinions, patent opinions, and post-grant proceedings.

Known as a responsive communicator with a strong depth of knowledge, Crystal works with clients ranging from universities to start-ups and growing companies to multinational organizations to prepare intellectual property strategies that suit their business goals.

In recent years, Crystal has worked with a number of pharmaceutical clients in high-impact patent prosecution. Her clients include a large pharmaceutical company for which she has helped develop and manage a portfolio of several hundred patent families and another which in 2021 received its first-ever FDA approval for a new drug that treats a rare liver disease.

Crystal earned her doctorate in chemistry at Johns Hopkins University, where her research focused on the design, synthesis, and evaluation of novel optical and radioactive small molecule prostate cancer imaging agents. She has significant experience in various scientific disciplines, including synthetic organic chemistry, radiochemistry, biology, radiobiology, and small animal imaging.

 

Jeremy Hill

VP, Payer Solutions
Optum

Jeremy Hill

VP, Payer Solutions
Optum

Jeremy Hill

VP, Payer Solutions
Optum