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Quality Assurance (QA) in Pharma Tech has undergone substantial transformation, with a strong focus on regulatory compliance, data integrity, and risk management. Tony Johnson, Senior Director, Global Clinical Quality Assurance, Mallinckrodt Pharmaceuticals, discusses how emerging technologies like blockchain, AI-powered analytics, and automated validation are becoming integral to quality systems. Global Clinical QA for Innovation and Compliance With the understanding that the objective of emerging technologies such as blockchain and AI-powered analytics is to gain a suitable assessment of activities promptly, Global Clinical Quality Assurance can use the technologies to prioritize assessments in those areas where the risks can compromise patient safety or data integrity. For example, there may be a dependence on clinical site personnel and CRAs to ensure the investigational product (IP) is always stored within the appropriate temperatures. Blockchain technology can provide tempe
Dr. John Lin, President
Across laboratories and research facilities worldwide, the race to develop life-changing drugs and therapies is in full swing. Frontage Labs, a global contract research organization (CRO), stands as a pillar of support to the leading players in the field of drug discovery and development. It offers essential services—from identifying promising drug candidates to navigating the complex web of regulatory requirements—that are pivotal in bringing these innovative treatments from the lab to the market. The company provides a comprehensive solution for pharmaceutical-based biotech companies, particularly medium-sized companies. It covers all stages of drug development from discovery to early-stage clinical services. Some of the core services areas include chemistry, drug metabolism and pharmacokinetics (DMPK), bioanalytical and preclinical services and expertise in antibody-drug conjugate (ADC) development. These services propel pharmaceutical innovation forward, paving the way for groundbreaking treatments to become a reality. “We aim to be the one-stop shop for our clients, offering holistic support from drug discovery to clinical trials,” says Dr. John Lin, president at Frontage Labs. Its services are indispensable to biotech and pharma companies venturing into diverse therapeutic areas to usher in a multitude of drug candidates into the development pipeline. From small molecules and peptides to fusion proteins and biologics drugs including ADC, Frontage plays a crucial role in supporting these advancements.
Pharma Manufacturing
Sherene Min, VP, Head of Clinical Development, ViiV Healthcare
Pharmacy Management
Safwan Kezbor, M.D., Global Medical Lead, (Senior Medical Director), Clinical Development, Shionogi Inc
Pharma Manufacturing
Diane Paskiet, Director of Scientific Affairs, West Pharmaceutical Services
Pharma Platform
Haichen Yang, MD, MA, MBA, Vice President, Clinical Research, Amicus Therapeutics Inc
Pharma Manufacturing
Alexis Bossie, Head of Media R&D, Lonza
Employing robust data validation and cleaning processes helps to identify and correct errors early.
Pharmaceutical organizations are reaping significant rewards from the rapid advancement of technology.
AI-Driven Evolution of the Pharma Industry
At the core of this evolution, laboratory information management systems (LIMS) are revolutionizing lab operations by integrating cloud computing and advanced cybersecurity. With industries like pharmaceuticals, healthcare and environmental testing demanding realtime data management and seamless automation, LIMS is evolving to meet these needs. Trends such as cloud-based LIMS, AI-driven data analytics and enhanced cybersecurity measures are reshaping the industry, enabling laboratories to operate with greater precision and agility.
Cloud-based LIMS are upgrading laboratory operations by enabling remote data access, seamless scalability and automated updates while reducing IT maintenance burdens. AI-driven analytics transform data processing, automate workflows and uncover patterns that enhance decisionmaking and predictive capabilities. Meanwhile, enhanced cybersecurity measures—such as advanced encryption and multi-factor authentication— ensure data integrity and regulatory compliance, addressing growing concerns around sensitive information protection. These advancements are allowing laboratories to operate more accurately and with agility.
Driven by these trends, the global LIMS market is poised to reach $1.63 billion from 2025 to 2029, growing at a CAGR of 12 percent.
This edition provides insights into recent developments in the pharmaceutical industry, especially in LIMS and how companies offer services that are aligned with the latest trends.
The magazine features a thought leadership article by Haichen Yang, MD, MA, MBA, Vice President of Clinical Research at Amicus Therapeutics Inc., highlighting the challenges and opportunities in gene therapy. It also includes insights from Diane Paskiet, Director of Scientific Affairs at West Pharmaceutical Services, who sheds light on data quality and integrity in driving the digital transformation of the pharmaceutical industry.
In this edition of Pharma Tech Outlook, we hope you find the right partner to meet your organization’s needs.
