– Enable Injections, Inc. (“Enable”), a leader in wearable drug delivery technology, today announced an expanded partnership with Roche. 

– The collaboration leverages Enable’s expertise in the enFuse® platform to accelerate the development and commercialization of innovative treatment options.

EnFuse Technology: Revolutionizing Drug Delivery

The enFuse platform is a groundbreaking wearable device designed for:

• Subcutaneous Delivery of Large Volumes: Unlike traditional methods, enFuse delivers large volumes of medication subcutaneously, eliminating the need for intravenous (IV) administration.
• Simplified Treatment Experience: enFuse offers a simpler and potentially more comfortable injection experience for patients compared to IV treatments.

Roche Gains Exclusive Rights to Combine enFuse with Specific Molecules

Under the terms of the agreement, Roche receives a worldwide, exclusive license to develop and commercialize combinations of the enFuse technology with specific drugs from their portfolio. Enable will take responsibility for the clinical and commercial manufacturing and supply of the enFuse system.

“IV infusions can be inconvenient and time-consuming for both patients and providers. This is especially true when treating chronic disorders, which require longer-term treatment and frequent trips to the clinic,” said Mike Hooven, Chairman and CEO of Enable Injections. “enFuse was designed to overcome IV infusion shortcomings through fast, simple and convenient delivery, bringing efficiency and value to the entire spectrum of healthcare, including patients, providers, and payers, with the ability for at home self-administration.”

What You Should Know; 

– Boston Micro Fabrication (BMF) today announced the launch of BMF Biotechnology Inc., a dedicated subsidiary focused on developing and commercializing innovative BioChips – advanced microfluidic platforms that mimic human organs. 

– By leveraging BioChip technology, BMF Biotechnology aims to accelerate breakthroughs in drug development, improve cosmetic safety and efficacy testing, and ultimately, contribute to the development of more effective treatments for patients.

BMF: A Legacy of Precision Microfabrication

BMF has established itself as a leader in high-precision micro-printing solutions for various industries, including medical devices, electronics, and life sciences. Their expertise in creating features with exceptional resolution and dimensional tolerance is a cornerstone of their success.

Expanding Beyond Printing: The Rise of BMF Biotechnology

In late 2022, BMF embarked on a strategic expansion. This initiative included the establishment of the San Diego Research Institute, dedicated to pioneering microfluidic BioChip technology for drug discovery and cosmetic testing. The initial phase of research has yielded highly promising results.

BioChips: A Powerful Platform for Advanced Research

BMF Biotechnology’s BioChips offer a revolutionary approach to studying human health and disease. By meticulously replicating the body’s physiological conditions, these platforms enable researchers to:

• Investigate biological mechanisms of health and disease
• Evaluate the safety and efficacy of drugs and cosmetics
• Predict patient responses to treatment

A key advantage of BioChips is their integrated “vascular-mimetic” network. This intricate system mimics the human body’s blood vessels, allowing for the delivery of nutrients, removal of waste products, and distribution of compounds throughout the entire tissue sample. This innovation has the potential to yield:

• More precise testing results
• Enhanced prediction of compound sensitivity compared to traditional 2D cell cultures and animal models

BMF Biotechnology Partner Program: Fostering Collaboration and Innovation

To fully unlock the potential of BioChips, BMF Biotechnology is actively recruiting collaboration partners. The BMF Biotechnology Partner Program provides a framework for joint development and validation of innovative devices and biological models. Industry, research institutions, and academia are all encouraged to reach out and explore potential partnerships.

“Building on success that BMF has had with other self-driven innovations such as the UltraThineer veneers, the launch of BMF Biotechnology Inc. represents a significant leap forward in our ability to harness the potential of 3D BioChip technology,” remarked Dr. Jennifer Sun, Chief Scientific Officer of BMF Biotechnology Inc. “With our innovative technology and approach, we aim to empower researchers with the tools they need to translate scientific discoveries into tangible therapeutic solutions that improve patient outcomes.”

What You Should Know: 

– ARTBIO, Inc., a leader in developing targeted alpha radioligand therapies (ARTs) for cancer, and Nucleus RadioPharma Inc., a pioneer in radiopharmaceutical development and manufacturing, announced today a strategic collaboration to propel ARTBIO’s clinical trials forward.

Nucleus to Manufacture ARTBIO’s Lead Therapy Candidate

This agreement signifies a significant step for ARTBIO. Nucleus will manufacture ARTBIO’s 212Pb-radiolabeled therapies for its planned Phase I and II clinical trials. The key focus will be on AB001, ARTBIO’s lead program targeting prostate cancer. ARTBIO’s proprietary AlphaDirectTM technology will be utilized for the isolation of 212Pb during this manufacturing process.

Nucleus Facility to Serve Northern and Midwestern US Patients

The agreement facilitates the production and supply of ARTs from Nucleus’ state-of-the-art facility in Rochester, Minnesota. This strategic location will ensure efficient treatment access for patients residing in the Northern and Midwestern regions of the United States.

AlphaDirectTM: A Pioneering Approach to 212Pb Isolation

ARTBIO’s AlphaDirectTM technology represents a groundbreaking advancement in radiopharmaceutical production. This first-of-its-kind system offers a reliable and efficient method for isolating highly pure 212Pb, a radioisotope with promising therapeutic potential. 212Pb’s unique properties, particularly its short half-life, make it an attractive candidate for targeted alpha radioligand therapy. Early studies suggest 212Pb-based radiopharmaceuticals hold significant promise in addressing unmet needs in cancer treatment.

“As we continue building our distributed manufacturing capabilities in the U.S. and globally, selecting partners who share our patient-centric vision is critical,” said Emanuele Ostuni, Ph.D., Chief Executive Officer of ARTBIO. “The Nucleus team shares our passion to make targeted radiopharmaceutical therapies accessible, and together, we commit to bringing a new class of alpha radioligand therapies to hospitals across greater Minnesota and beyond.

What You Should Know:

– BioPhy, an AI drug development company, and Every Cure, a non-profit dedicated to unlocking the potential of existing drugs for new uses, today announced a strategic partnership to revolutionize drug repurposing through artificial intelligence (AI).

– The partnership follows Every Cure’s recent funding from the Advanced Research Projects Agency for Health (ARPA-H). A successful pilot using AI led to the identification of potential treatments for diseases like sickle cell disease, ALS, and autism spectrum disorder.

Unlocking Hidden Cures on the Pharmacy Shelf

Every Cure aims to identify new uses for existing medications, potentially saving patients from suffering while effective treatments remain undiscovered. This partnership will leverage BioPhy’s BioLogicAI platform to:

• Identify Promising Drug-Disease Matches: BioLogicAI’s AI engine will help Every Cure evaluate potential repurposing opportunities with high value.
• Optimize Clinical Trials: The partnership will focus on simulating and optimizing clinical trials for these potential new uses, maximizing success rates and reducing costs.

BioLogicAI: A Powerful Tool for Drug Development

BioLogicAI is a comprehensive AI engine that offers a range of benefits for life science companies:

• Clinical Trial Endpoint Predictability: BioLogicAI predicts successful clinical trial endpoints, a critical factor in drug development.
• Informed Decision-Making: The platform provides data-driven insights for various stages of drug development, including indication selection, licensing, and asset management.
• Benchmarking Preclinical Assets: BioLogicAI compares preclinical drug candidates to existing drugs and FDA-approved medications, informing development strategies.

Enhancing Drug Repurposing with AI

This collaboration will focus on several key areas to advance drug repurposing with AI:

• Building AI Infrastructure: The partnership will establish public and private benchmark datasets and knowledge graphs, crucial for AI development.
• Data Integration: Proprietary and novel data will be incorporated into the AI platform to enhance its capabilities.
• Refining Drug-Disease Matching: Ranking algorithms for drug-disease queries will be further optimized.
• Simulated Clinical Trials: AI will be used to simulate and optimize clinical trials for potential drug repurposing candidates.

“At BioPhy, we’re committed to creating a world where pharmaceutical companies won’t be forced to waste billions of dollars as a result of failed clinical trials. Every Cure shares that mission, while also unlocking new ways FDA-approved drugs can be used to accelerate treatment to patients suffering from diseases,” said Dave Latshaw II, CEO and Co-Founder of BioPhy. “We look forward to partnering with Every Cure to uncover even more diseases that all existing drugs can treat.”

What You Should Know:

·      Yseop, a world-leading Artificial Intelligence (AI) software company and pioneer in Generative AI, has announced today the development of an enhanced Generative AI application tailored for the Biopharma industry, with support from Amazon Web Services (AWS).

·      A member of the AWS Partner Network (APN), Yseop has strategically utilized AWS since its inception, leveraging its robust security and scalability to enhance its Large Language Model (LLM) ecosystem, infrastructure, and technological expertise. With AWS’s backing, Yseop aims to empower leading Biopharma companies globally, facilitating the expedited delivery of pharmaceuticals and vaccines to market.

Yseop and AWS Revolutionize Biopharma with Enhanced Generative AI Application

By harnessing the capabilities of AWS, Yseop now seamlessly embeds LLM models, facilitating the generation of comprehensive scientific content while ensuring compliance with the stringent security standards of the pharmaceutical sector. This collaborative effort between AWS and Yseop enables scientific and medical writers within prominent pharmaceutical corporations to significantly augment their productivity, thereby accelerating the dissemination of therapeutics to those in need.

Miguel Alava, AWS Managing Director, Software Companies EMEA, emphasized the joint initiative between Yseop and AWS, stating, “Yseop and AWS are collaborating to democratize access to generative AI, delivering unparalleled business value to the life sciences sector while navigating challenges such as scalability and trust. Leveraging capabilities like Amazon SageMaker and Amazon Bedrock, Yseop can effectively address the rigorous AI software and data requirements prevalent across Biopharma.”

In the Biopharma domain, Yseop’s collaboration with AWS offers a multitude of advantages, including accelerating time-to-value through a pre-configured SaaS enterprise platform powered by AWS, securely scaling content generation across organizations via AWS managed services and tools such as Amazon EKS, Amazon RDS, and Infrastructure as Code CDK, managing end-to-end data and document flows with enhanced security features, and harnessing the latest AI capabilities through a model-agnostic SaaS powered by AWS SageMaker, AWS Inferentia, and AWS EC2.

Crucially, AWS provides Yseop and its clientele with a fully managed, private cloud environment, crucial for compliance within the regulated life science industry.

Yseop stands at the forefront of Generative AI for life science and pharmaceutical enterprises, revolutionizing content automation solutions with a human-centric, AI platform. Serving as a trailblazer in Natural Language Processing (NLP) technology, Yseop acts as a “Copilot” for medical writers, enhancing their efficiency and accuracy in generating pivotal reports essential for drug development and approval processes. By integrating cutting-edge language models, Yseop ensures that pharmaceutical firms effectively tackle the most demanding content tasks with ease, scalability, and utmost application security.

What You Should Know: 

– Quest Diagnostics today announced it will acquire key assets of PathAI Diagnostics, including its state-of-the-art digital pathology laboratory in Memphis, Tennessee. 

– As part of the acquisition, this facility will become Quest’s AI and digital R&D center, supporting its pathology businesses, AmeriPath, and Dermpath Diagnostics.

Digital Pathology and AI Integration

Quest will license PathAI’s AISight™ digital pathology system and AI algorithms. This will empower Quest to integrate digital pathology and AI into its existing pathology laboratories across the US. PathAI will continue to operate its independent biopharma lab, providing end-to-end clinical trial services. Quest will become a preferred provider for these services.

Unlocking the Power of Digital Pathology

Traditional cancer diagnosis relies on visual examination of tissue samples under a microscope. Digital pathology offers numerous advantages:

• Faster turnaround times: Digital slides can be shared electronically, eliminating the need for physical transportation of samples.
• Improved access to expertise: Digital slides can be reviewed by specialists remotely, regardless of location.
• Reduced workload for pathologists: AI can assist pathologists by identifying areas of concern within digital images.

“This transaction will enable Quest to dramatically ramp our capabilities in AI and digital pathology, building on our leadership in oncology and subspecialized pathology services,” said Kristie Dolan, Senior Vice President, Oncology, Quest Diagnostics. “AI and digital technologies have tremendous potential to improve cancer care, and Quest has the know-how to scale and deliver innovations that are high quality, efficient and broadly accessible. PathAI has industry-leading expertise in AI pathology innovation, and their state-of-the-art digitized laboratory in Memphis provides a platform for future growth.”

What You Should Know:

–       G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, and Pepper Bio, the world’s first transomics drug discovery and development company, announced a global licensing agreement (excluding the Asia-Pacific region) for lerociclib for all indications outside acute radiation syndrome (ARS).

–       As Pepper Bio’s first in-licensed therapeutic, lerociclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). The therapeutic has previously demonstrated impressive efficacy in clinical studies across various cancer types, including two completed Phase 3 clinical trials in HR+/Her2- metastatic breast cancer. 

Pepper Bio Advances Liver Cancer Treatment with Lerociclib: A Breakthrough in Precision Medicine

Pepper Bio’s revolutionary transomics platform, COMPASS, is reshaping the landscape of drug discovery by offering a comprehensive view of disease biology. By translating biological maps encompassing genomics, transcriptomics, proteomics, and phosphoproteomics, COMPASS provides researchers with unprecedented insights into the real-time function of proteins, revolutionizing drug development methodologies. Leveraging COMPASS, Pepper Bio identified CDK4 and CDK6 as promising targets in hepatocellular carcinoma (HCC), the most prevalent form of liver cancer and the third leading cause of cancer-related deaths.

In a significant milestone, Pepper Bio conducted preclinical testing of lerociclib, a potential therapeutic for HCC, demonstrating superior efficacy compared to standard care both during and after dosing. This success led to an in-licensing agreement, marking lerociclib as Pepper Bio’s inaugural therapeutic slated for Phase 2 clinical trials.

Under this partnership, Pepper Bio gains exclusive rights to develop, manufacture, and commercialize lerociclib for non-ARS indications across major global markets, excluding the Asia-Pacific region licensed to Genor Biopharma. Collaborating closely with G1 Therapeutics, Pepper Bio aims to seamlessly transition lerociclib through clinical trials and regulatory approval processes.

This development follows Pepper Bio’s oversubscribed seed funding round, supported by notable investors such as NFX, Silverton Partners, and Merck Digital Sciences Studio. With these resources, Pepper Bio is poised to initiate clinical development programs for lerociclib, with the overarching objective of expediting regulatory approvals and bringing this innovative therapy to patients worldwide.

The agreement outlines upfront payments to G1 totaling mid-single-digit millions, with potential milestone payments reaching up to $135M across three indications, alongside double-digit royalties on lerociclib’s annual net sales. This collaboration underscores the commitment of both parties to advancing precision medicine and addressing unmet medical needs in liver cancer treatment.

“Liver cancer is a real and devastating diagnosis for hundreds of thousands of patients each year. Adding lerociclib into our pipeline is a significant step forward in our mission to find treatments for untreatable diseases,” said Jon Hu, Chief Executive Officer and co-founder of Pepper Bio. “Lerociclib holds tremendous promise as a cornerstone of our oncology portfolio, and we are excited to leverage its potential to bring life-saving treatments to those in need.” 

What You Should Know: 

– Genomics plc, a leader in polygenic risk score (PRS) technology, and pharmaceutical giant GSK inks a new collaboration to explore the potential of PRS for optimizing clinical trial design. 

– The innovative approach could revolutionize the way researchers select patients and ultimately lead to faster development of new treatments.

Unlocking the Power of Genetics for Clinical Trials

Genomics plc brings its expertise in PRS technology to the table. PRS is a score that combines an individual’s genetic data to assess their risk of developing a specific disease. GSK, with its extensive experience in drug development, aims to leverage this technology to improve the efficiency and effectiveness of clinical trials.

Benefits of PRS-powered Clinical Trials

The collaboration will explore several applications of PRS, potentially leading to:

• Reduced Number of Trial Participants: By identifying individuals with a higher risk of developing the disease under study, PRS could help researchers recruit more targeted participants, potentially reducing the overall number needed.
• Shorter Trial Timescales: With a more focused patient pool, trials could be completed more quickly, accelerating the development of new therapies.
• Improved Trial Outcomes: Selecting participants with a higher risk of the disease may lead to clearer results and a more efficient evaluation of new drugs.

Understanding the Genetic Influence on Disease

The project builds on the established knowledge that genetic factors play a significant role in disease susceptibility, progression, and response to medications. PRS offers a way to capture these complex genetic influences into a single score, aiding in patient selection for clinical trials.

“We could not be more excited to be collaborating with GSK on this programme. PRS-based approaches have the potential to support clinical trial design. Using PRS to get the right people into studies could have a potential positive impact, including in the reduction of trial size and timescale, leading to efficiencies in drug development,” said Professor Sir Peter Donnelly FRS, FMedSci, Founder and Chief Executive Officer, Genomics plc.

What You Should Know: 

– Deciphex, a leading digital pathology company based in Dublin, Ireland, has announced a collaborative effort with Novartis, a prominent multinational pharmaceutical corporation. 

– The strategic partnership focuses on developing innovative artificial intelligence (AI) solutions aimed at revolutionizing preclinical pathology assessments within the drug discovery and development process.

Optimizing Preclinical Pathology with AI

The collaboration centers on creating a suite of AI-powered tools designed to streamline and enhance the evaluation of pathology data in toxicology and efficacy studies, critical phases of drug development.  

Here’s how this partnership will function:

• Leveraging Expertise: The collaboration combines Deciphex’s proficiency in unsupervised AI model development with Novartis’s extensive experience in AI models, digital pathology databases, and related tools.
• Building on Existing Assets: The project will utilize Deciphex’s existing intellectual property alongside Novartis’s resources to create potentially groundbreaking algorithms for accurate lesion identification and quantification within drug discovery applications.

Combining Expertise for Innovation

The collaboration will prioritize several key objectives:

• AI-powered Lesion Detection Tools: Developing a comprehensive suite of AI tools specifically designed to detect lesions across various tissue types and species, applicable to both Good Laboratory Practice (GLP) and non-GLP studies.
• Regulatory Compliance: Ensuring the developed AI tools meet the most recent regulations and guidelines governing AI development processes, paving the way for wider adoption.
• Digital Pathology Archive Creation: Deciphex will leverage its next-generation scanning services to digitize Novartis’s vast collection of tissue slides, creating a valuable digital library for future research and analysis.

“This partnership underscores our commitment to advancing healthcare through the development of cutting-edge solutions that address critical challenges in drug development lifecycles.Novartis is committed to innovating AI-based approaches with potential to accelerate drug discovery and development and bring life-changing medicines to patients faster,” said  Dr. Donal O’Shea,” CEO of Deciphex.

What You Should Know: 

– COTA, a leading real-world data (RWD) and analytics company in oncology, has announced a new collaboration with Sanofi. 

– The strategic partnership aims to leverage RWD and artificial intelligence (AI) to accelerate clinical trials specifically focused on multiple myeloma, a cancer affecting white blood cells. The findings from this partnership have the potential to significantly impact future clinical trial designs for multiple myeloma.

Unlocking Insights with Real-World Data

COTA’s expertise in RWD analysis will be instrumental in this initiative. Their comprehensive datasets offer valuable insights into real-world treatment pathways for cancer patients. This data will provide Sanofi with crucial context about key patient populations battling multiple myeloma.

Focus on Multiple Myeloma

The initial project will center around multiple myeloma, a complex blood cancer. By analyzing RWD, the collaborators aim to:

• Unravel the Treatment Landscape: Gain a clearer understanding of the evolving treatment options for multiple myeloma.
• Inform Future Trials: The insights gleaned from RWD analysis will be used to design more efficient and targeted clinical studies in the future.
• Interpret Ongoing Trials: RWD can provide valuable context for interpreting the results of ongoing and future multiple myeloma trials, ensuring their relevance to real-world treatment practices.

Guiding Trial Interpretation

Additionally, the collaboration’s insights can aid in interpreting the results of ongoing and future clinical trials. By understanding how new treatments compare to existing standards of care for multiple myeloma patients, researchers can make more informed decisions about their therapeutic potential.

“Our collaboration with Sanofi has the potential to enable more patients and their families to benefit from breakthrough treatments in an expedited time frame,” said Dr. C.K. Wang, an oncologist and COTA’s chief medical officer. “We are providing high-quality RWD enabled by new AI-based tools to accelerate pharmaceutical research and improve patient care.”

What You Should Know:

–              When developing new drugs, nutritional products, or pesticides, it’s critical that unknown molecules are identified correctly. But accurate identification is a lengthy process and all too often unsuccessful, leading to failed regulatory processes, or worse, consumer health being put in danger.

–              Isospec Analytics has raised $1.9M to commercialize new technologies for molecular analysis that rapidly identify unknown molecules in minutes, helping pharmaceuticals, nutrition and agritech companies develop safer products and enabling researchers to discover new biomarkers.

Isospec: Redefining Molecular Analysis for Breakthroughs in Biotech

Founderful (formerly Wingman Ventures) leads Isospec’s $1.9M pre-seed round, joined by specialized investors Tiny.vc, another.vc, and Venture Kick.

Founded in 2022 by Ahmed Ben Faleh, Stephan Warnke, and Thomas Rizzo, Isospec aims to redefine molecular analysis, unlocking new biological insights for diagnostics, therapeutics, and nutrition. Leveraging over 20 years of research, the founders merged technologies from analytical chemistry, photonics, and cryogenic materials originally developed for space applications. This fusion resulted in a groundbreaking tool capable of unveiling previously unknown molecular structures.

Traditional methods of identifying molecules, primarily relying on mass analysis, often fall short. Mass alone cannot definitively determine a molecule’s structure, leading to a time-consuming process of purification and synthesis. Isospec’s technology overcomes this limitation by generating comprehensive metrics that rapidly identify unknown molecules, revolutionizing molecular identification with scalability and speed.

By integrating infrared analysis directly into mass spectrometry, Isospec enhances molecule identification, enabling swift and precise analysis in minutes rather than months. Originating from EPFL’s Laboratory of Molecular Physical Chemistry, their technology is already revolutionizing quality control and R&D in the food and agritech industries.

Currently focused on platform scalability, Isospec is introducing automation and machine learning tools for enhanced data analysis. Positioned within the competitive landscape of sugar and metabolite analytics, Isospec aims to lead the way in molecular analysis and biomarker discovery for therapeutics and diagnostics.

The biopharmaceutical market within the Japan and Asia-Pacific (JAPAC) region has grown consistently since 2010, specifically for emerging biopharmas (EBPs). In fact, in 2018, 80% of all biopharma pipeline projects in JAPAC were EBPs, accounting for 75% of the total clinical trial volume in the region. This growth benefits contract research organizations, pharma organizations and patients alike, but several factors must be considered for drug development safety and regulatory operations in JAPAC countries.

Global health authorities in differing regions have varying requirements, so successfully launching a drug program requires in-depth knowledge and expertise of each authority’s specifications. For the JAPAC region, this includes particular quality and compliance standards, as well as cultural nuances. In this context, the key to navigating safety and regulatory requirements lies in understanding the areas that set JAPAC countries apart.

The distinguishing factors

JAPAC countries have unique safety and regulatory distinctions compared to the typical standards of the rest of the world. Unlike most other countries that accept English language resources, Japan and China, for example, require bilingual language proficiency to process adverse event reports, provide updates to global counterparts and submit regulatory reports to the local health authorities. As adverse events are processed within a bilingual database, operational staff within the organization must be proficient in reading and writing. Management staff must share updates with global counterparts, so speaking proficiency is required on their part. 

While all regulatory authorities have high standards for quality and compliance, Japan’s health authority, the Pharmaceuticals and Medical Devices Agency (PMDA), and China’s health authority, the National Medical Products Administration, are especially stringent. Both authorities expect 100% compliance from organizations operating within their boundaries

The JAPAC landscape: Requirements in Japan and China

Across the countries in JAPAC, Japan and China are countries with more rigorous compliance requirements. We will dive into some of their processes to illustrate how in the same region the steps taken for compliance differ. 

Japan’s PMDA has many safety and regulatory distinctions. In terms of good pharmacovigilance practices, there are three designated roles for the marketing authorization holder (MAH): Souseki, Anseki and Hinseki. This team works together to maintain quality and compliance for an organization. Their main responsibilities include training, self-inspection, detailed recordkeeping and early post-marketing pharmacovigilance, which is required for all newly approved products. 

In fact, for six months post-launch, appropriate usage information is shared with medical institutions and any adverse drug reactions are monitored closely. It is the responsibility of the MAH, and the Souseki, Anseki and Hinseki, to ensure work is performed in compliance with both the pharmaceutical company’s procedures as well as regulatory standards. In terms of outsourcing, the service provider is expected to complete annual self-inspections at every operations site. 

Furthermore, an in-country clinical caretaker (ICCC) is appointed if the MAH does not have a presence in Japan. The ICCC is responsible for reporting safety information from global clinical trials and post-marketing adverse events to the PMDA. They are also in communication with the sponsor, who is the MAH of the active pharmaceutical ingredient. 

In comparison to Japan, China has fewer distinctions. While the country adheres to the guidelines provided by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, there are some additional requirements. The MAH, in this case, must have a designated safety point of contact, and if outsourcing, the requirements for the pharmacovigilance system master file (PSMF) should be fulfilled. Though there is no language requirement for a PSMF, the document is required to be written in Chinese if the product is only marketed in China. For global distribution, a PSMF in English is necessary to avoid repeated translation.

China also requires a local person for pharmacovigilance (LPPV) to ensure consistency at a local level as well as a regional level. As per the LPPV requirements, within the first 30 days of receiving the initial drug approval certificate, the MAH is expected to complete registration in the National Adverse Drug Reaction monitoring systems. Subsequent updates are required to be provided within 30 days of the change date.

Understanding the requirements 

For organizations starting in the JAPAC region as an EBP, creating a structure aligned with all local requirements is critical. A staff with bilingual language proficiency will also be extremely beneficial, particularly if the organization plans to move into Japan, as this will eliminate silos and communication gaps between Japanese and global PV counterparts. 

It is also key to rely on technology that can handle, manage and analyze large data sets. This enables organizations to bring fully compliant products to market more efficiently. The applications of technology for JAPAC safety and regulatory operations are vast, and these may include:

• Bilingual safety databases support case processing efforts in Chinese and Japanese
• Artificial intelligence-empowered translation tools reduce the time and effort required for manual translation
• Robotic process automation is an asset for foreign case assessment and entry for PMDA reporting 
• Workflow management tools improve case allocation, monitoring and compliance 
• Narrative automation customizes and creates templates

Technology can be one crucial component for operating in the JAPAC region. By relying on advanced solutions, organizations can successfully launch a drug program with efficiency and accuracy. 

Ensuring patient safety and product efficacy while maintaining compliance with regulatory standards is critical, and the right technology and human knowledge of regional nuances can help ease the transition into the JAPAC region. 

As the region’s biopharma market continues to rapidly expand, organizations must understand the challenges and different needs of the countries they operate. EBPs will need to plan for success and build strategies that map the unique requirements of the countries in which they are developing different initiatives.  

About Hye Jin Choi, R. Ph., Senior Director of Regulatory Affairs and Drug Development Solutions, IQVIA Asia Pacific

Hye Jin Choi joined IQVIA in 2018 and provides regional leadership of Regulatory Affairs and Drug Development Solutions for business expansion across JAPAC. Hye Jin leads the efforts of client engagement and integrated solutions. She interacts with various JAPAC biopharma companies with global drug development ambitions. She also offers regional and global regulatory advisory for proposal strategy development and closely collaborates with IQVIA’s regulatory and drug development leaders to help customers who require regulatory expertise for business in the global markets.  Located in South Korea, Hye Jin has over 29 years of experience across the various healthcare industry sectors, including biomedical research institutes, R&D-based biotechs, and global CROs.

About Dr. Jayawant Fuke, Senior Director of Lifecycle Safety, IQVI
Dr. Jayawant Fuke joined IQVIA in 2019 and provides leadership for the JAPAC regions for Safety Operations, Medical Information and Project Management. Jay provides operational and strategic oversight for safety projects in the JAPAC region and works closely to develop JAPAC centric solutions and operational delivery plans. Located in India, Jay has over 16 years experience managing large global deals in pharmacovigilance.

What You Should Know: 

– Nucleai, a leader in spatial biology and AI, and GoPath Diagnostics, a leading provider of digital pathology and molecular diagnostics, announced a strategic collaboration today. 

– The partnership aims to revolutionize clinical trials, diagnostics, and research in oncology and immunology by combining their strengths in AI and real-world data.

Unlocking the Power of Spatial AI Biomarkers

Nucleai specializes in “spatial AI biomarkers.” This technology analyzes tissue samples to understand the complex communication and interaction between cells. By deciphering these “cellular conversations,” Nucleai’s AI can predict how patients will respond to specific treatments.

GoPath’s Expertise in Real-World Data and Diagnostics

GoPath Diagnostics brings extensive experience in digital pathology and molecular diagnostics to the table. They offer a full suite of services, including:

• Digital Pathology: GoPath offers advanced digital tools for analyzing tissue samples.
• Molecular Diagnostics: Their services include cutting-edge molecular testing for a deeper understanding of diseases.
• Real-World Data: GoPath possesses a rich dataset of real-world patient information.

AI-powered Digital Pathology Solutions

By combining these strengths, Nucleai and GoPath aim to:

• Develop AI-powered Digital Pathology Solutions: Nucleai’s AI will be integrated with GoPath’s digital pathology platform, creating a powerful solution for clinical trials and diagnostics.
• Centralized, Secure Environment: The AI analysis will occur within a secure environment meeting the highest regulatory standards. This ensures data privacy and compliance.
• Actionable Insights for Clinicians: The AI will provide clinicians with valuable insights to support patient care decisions throughout the treatment journey.
• Biopharma Partner Support: The collaboration will streamline research for pharmaceutical companies by providing access to real-world data, AI capabilities, and comprehensive lab services.

Focus on Actionable Results

The partnership will initially focus on developing AI-powered pathology analysis tools that deliver practical, clinically relevant insights for multiple clinical trials and research studies in oncology and immunology. This includes areas like prostate cancer and inflammatory bowel disease.

What You Should Know: 

– Synchron, a company pioneering brain-computer interface (BCI) technology unveils a community registry that aims to bring together patients with motor impairments, their caregivers, and medical professionals to explore the potential of BCI in restoring lost functionality.

– By uniting patients, caregivers, and medical professionals, this initiative has the potential to revolutionize the way we treat motor impairments and empower individuals to regain control of their lives.

Minimally Invasive Brain Interface

Unlike traditional BCI methods requiring open-brain surgery, Synchron’s technology utilizes a minimally invasive approach:

• Endovascular Implantation: The BCI device is strategically placed within a blood vessel near the brain’s motor cortex via the jugular vein.
• Wireless Communication: The implanted device wirelessly transmits the user’s motor intent signals for external use.

The Power of Community Collaboration

The Synchron BCI registry serves as a platform for:

• Patient and Caregiver Education: Providing patients and caregivers with valuable information on BCI technology and its potential applications.
• Clinician Engagement: Facilitating collaboration between clinicians, researchers, and developers to accelerate BCI advancements.
• Shared Experiences: Enabling patients and caregivers to connect and share their experiences with BCI technology.

“BCI technology enables individuals with motor impairment to regain independence,” said David Lacomis, M.D., principal investigator and Chief of the Neuromuscular Division at UPMC and Professor of Neurology and Pathology at the University of Pittsburgh. “By controlling digital devices through one’s own thoughts, BCI offers a transformative path towards performing daily tasks with greater ease and efficiency. From communication to accessing essential services online, BCI technology represents a ground-breaking frontier for individuals and their families.”

What You Should Know: 

– Hartwig Medical Foundation, a provider in using comprehensive genetic profiling to improve cancer treatment, and Ultima Genomics, a developer of groundbreaking next-generation sequencing (NGS) technology, announce a groundbreaking collaboration. 

– The strategic partnership aims to make whole genome sequencing, the most detailed form of genetic analysis, a more accessible and affordable tool in the fight against cancer.

The Challenge: High Costs Limit Testing

Despite advancements in NGS technology, the high cost often restricts its use in cancer testing, particularly whole genome sequencing. This limits the depth and frequency of testing, hindering the development of personalized treatment plans for cancer patients.

Introducing Ultima’s UG 100 System and ppmSeq Technology

Ultima Genomics addresses this challenge with the UG 100 sequencing system and ppmSeq technology.

• UG 100 System: This innovative platform offers significantly lower sequencing costs compared to traditional technologies.
• ppmSeq Technology: This unique technology delivers ultra-high accuracy for detecting single nucleotide variants (SNVs) in a patient’s genetic makeup.

Benefits of the Collaboration

By combining these advancements, Hartwig and Ultima aim to:

• Increase Accessibility: Make whole genome-based cancer diagnostics more affordable for patients, enabling more informed treatment decisions.
• Enhanced Monitoring: Enable more frequent monitoring of a patient’s cancer, allowing for timely adjustments to treatment plans.
• Minimal Residual Disease Detection: Explore the potential for using the UG 100 system to detect minimal residual disease (MRD) in a patient’s blood. MRD refers to the presence of a small number of cancer cells remaining after treatment.

Collaboration for Future Advancements

Hartwig Medical Foundation plans to integrate the UG 100 system and ppmSeq technology into their routine diagnostic procedures, working with partner hospitals. Data from consenting patients will be added to their existing database of over 7,000 samples. This enriched resource will be used for scientific research, ultimately leading to better cancer care for future patients.