Temperature Control & LogisticsNorth American Summit

and opportunities for cross-industry collaboration and exchange.

Medium-Large Enterprise Stream

• Understand & achieve the true value of real-time monitoring & end-to-end network visibility

Join us at the Temperature Control & Logistics North American Summit, taking place 19 - 21 September in Falls Church, VA, as we cut through the complexity to identify which approaches will work for you, bringing genuine value to your supply chain, your business, and your patients. Key Speakers Include:

• Bill Mcgillian, Associate Director, Supply Chain Management, Merck

• Victoria Wilmore, Global Temperature Control Support Director, Johnson & Johnson

• Tonino Antonetti, Executive Director, Regulatory, Affairs & Quality, Roche Diagnostics

What to Expect

The temperature-controlled supply chain is a hotbed of innovation, with pharmaceutical and biotechnology companies continuously finding new ways to mitigate the threat posed by potential temperature excursions and supply chain disruption. New visibility tools, packaging technologies and logistics services are redefining what is possible, allowing the industry to confidently protect and transport life-saving products.

It is crucial we discover how to demonstrate both reliability and true business value of any given technology and/or approach. That is why we have built a program built around the unique needs of medium-to-large pharmaceutical manufacturing and small-to-medium biotechnology companies, with bespoke learning outcomes

• Drive environmental sustainability across your supply chain without increasing risk & cost

• Enhance your logistics network design & forecasting to bolster resilience, security & ensure success

• Partner across the network to confront an increasingly complex operating & regulatory environment

• Discover the implications for your logistics network of disruptive technologies & new therapies

• Small-Medium Size Enterprise Stream

• Discover the logistics strategies that will allow you to navigate the path from clinical to commercial

• Identify & partner with the vendors capable of delivering the service your products require

• Implement best GDP practice to achieve & demonstrate long-term regulatory compliance

• Scale the size of your operations to put supply chain & logistics at the heart of your growth strategy

• Build your supply chain & logistics strategy around the unique requirements of your products

Temperature Control & Logistics

Date: September 19 - 21, 2023

Location: Falls Church, Virginia, USA

Website: https://www.pharma-iq.com/events-temperature-control-and-logistics/agenda-mc

Email: enquire@iqpc.co.uk

Accelerate Assay Development and Reduce Cycle Times for AAV Quantification in Complex Biological Samples

This webinar was presented by Yoann Saucereau, Ph.D. from Excellgene.

Recombinant Adeno-associated viruses (rAAVs) are vital for gene therapy, with over 255 clinical trials conducted in the past 25 years. However, assessing the titers and quality of AAV vectors during manufacturing is challenging. ExcellGene, in developing its AAV platform, faced the need for a rapid and robust assessment method. They turned to a label-free approach, which reduced matrix effects and enabled high-throughput, automated analysis of up to 96 samples in under 30 minutes. This innovative solution revolutionized QC workflows in AAV development and manufacturing, offering a reliable and efficient method for evaluating viral particle titers and quality attributes, propelling advancements in gene therapy.

Yoann Saucereau, PhD

Designation: Research Associate Analytics

Organization: ExcellGene

Yoann Saucereau obtained his Ph.D. in microorganism interactions and infection at the Claude Bernard University in Lyon in 2016, where he explored the molecular and immune mechanisms of microbial interference in mosquitoes before completing a post-doc at the Department of Biochemistry at the University of Cambridge, UK, where he continued to study this topic using biophysical approaches to characterize these interactions. With this experience in studying interaction models and using state-of-the-art techniques such as BLI and SPR, he joined Excellgene as an Analytical Research Associate to bring his experience to integrate and develop new innovative analytical methods.

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CPHI South East Asia

July 12 - 14, 2023

Bangkok, Thailand https://www.cphi.com/sea/en/home.html

About Event: CPHI South East Asia will be your one-stop shop to source cost-effective pharma solutions under one roof. More than an exhibition, the event also facilitates finding the right partners with its online matchmaking tool, and encourages knowledge gathering and sharing with its online conference.

Listed Under: Manufacturing

CPHI Korea

August 30 - 01 September 2023

Seoul, South Korea https://www.cphi.com/korea/en/home.html

About Event: CPHI Korea is a dynamic meeting place where pharmaceutical suppliers, purchasers and decision makers get together for three days of uninterrupted business. Exhibiting companies showcase products from across the entire pharma supply chain: from ingredients and contract services, through to machinery and biopharmaceuticals.

Listed Under: Manufacturing

Pharmaconex

September 3 - 5, 2023

Cairo, Egypt https://www.pharmaconex-exhibition.com/en/home.html

About Event: Pharmaconex is Africa’s pharmaceutical manufacturing hub, connecting the entire supply chain in Egypt, the largest producer of the pharmaceutical market in the MENA region. Offering a comprehensive experience for the pharma community to network and build knowledge around the latest industry trends.

Listed Under: Manufacturing

The Pharma CI Conference

September 20 - 21, 2023

Newark, New Jersey, United States http://pharmaciconference.com/usa/

About Event: The Pharma CI Conference & Exhibition is THE INDUSTRY’S GOLD STANDARD for senior level pharma, biotech, and device professionals seeking the latest news and the rare chance to network with all the industry’s luminaries. If you’re interested in where your company is headed this year and beyond, you can’t miss this big event of the year!

Listed Under: Manufacturing

iPharma Expo

September 21 - 22, 2023

San Francisco, USA https://www.ipharmaexpo.com/

About Event: The expo will showcase the latest trends and technologies in pharmaceuticals, drugs, and formulations. The expo is expected to witness approx. 150 exhibitors and 1500- 2000 visitors footfall from pharma industry & management. Direct access to highly targeted senior pharma executives, buyers, procurement managers, contract manufacturers, hospital administration, and many more Meetings with manager and business development managers who are looking for new supplies, building strategic partnerships, or entering into new ventures.

Listed Under: Research & Development

CPHI Barcelona

October 24 - 26, 2023

Barcelona, Spain https://europe.cphi.com/europe/en/home.html

About Event: CPHI Barcelona unites industry leaders, pharma professionals and businesses of all sizes under one roof for three days of powerful connection and collaboration. This is the event to witness emerging pharma trends, discover innovative solutions and products to stay in front of the marketplace and drive your business forward!

Listed Under: Manufacturing

Pharmapack Europe 2024

Lab Asia 2023

October 10 - 12, 2023

Kuala Lumpur, Malaysia https://www.lab-asia.com/

About Event: LabAsia is Southeast Asia’s leading laboratory exhibition, serving as the region’s trade platform for laboratory equipment & services suppliers to engage with trade buyers from across the ASEAN region.

Listed Under: Research and development

January 24 - 25, 2024

Paris, France https://www.pharmapackeurope.com/en/contentprogramme/call-for-speakers-2024.html

About Event: Pharmapack is the European hub for the pharma packaging and drug delivery device industry. Taking place annually in Paris, the event unites over 5,000 attendees and more than 300 exhibitors for two days of innovation, networking, and education.

Listed Under: Manufacturing

Fda Approval Fda Approval

ADvantage Therapeutics' Lead Drug Approved for Alzheimer's Clinical Trial

ADvantage Therapeutics, Inc. has received regulatory approval in Poland, Bulgaria, and Slovakia to commence a clinical trial for its primary candidate, AD04™, designed to treat mild Alzheimer's disease (AD) in each country.

The authorized Phase 2b study in these countries will be a 12-month randomized, double-blind, placebo-controlled trial, with the goal of confirming proof-of-concept and establishing the safety and effectiveness of AD04™ in patients with mild AD.

The study will assess various outcomes, including hippocampal volume as the primary objective and biomarker endpoint.

The primary endpoint will be a composite score that integrates ADAScog and ADCSADL, while other measured outcomes include CDR-sb, the Neuropsychiatric Inventory (NPI), ADAScog13, ADCS-ADL, and the patient Quality of Life-Alzheimer's disease. These measures will be reported by either the study subjects or their caregivers.

ADvantage Therapeutics plans to expand the study to include additional European sites, incorporating countries like France, Germany, and Austria.

In a previous study, the control arm receiving a 2mg dose of AD04™ showed significant cognitive and quality of life improvements. The AD04™ group also demonstrated a slower decline in MRI-measured hippocampal volume, a biomarker of AD progression.

FDA Approves Argenx's SC Injection for Effective gMG Treatment

The FDA has granted approval to VYVGART® Hytrulo, an Argenx-developed treatment, for generalized myasthenia gravis (gMG) in adults with anti-acetylcholine receptor (AChR) antibodies. Halozyme Therapeutics, Inc. confirmed the news.

VYVGART® Hytrulo is a novel subcutaneous (SC) injection that combines efgartigimod alfa (formerly marketed as VYVGART® for IV usage) with hyaluronidase PH20 (rHuPH20) via Halozyme's ENHANZE® drug delivery technology.

VYVGART® Hytrulo is administered by healthcare professionals as a weekly SC injection at a set dose of 1,008 mg over 30-90 seconds for four weeks.

Positive results from the Phase 3 ADAPT-SC research, which revealed the efficiency of VYVGART® Hytrulo in decreasing anti-AChR antibody levels comparable to the IV formulation of VYVGART® in adult gMG patients, supported the FDA approval. The ADAPT-SC research acted as a bridge to the Phase 3 ADAPT trial, which formed the basis for the FDA's December 2021 approval of the IV VYVGART®.

This milestone approval represents a substantial development in the treatment of gMG, providing a simple subcutaneous therapy option to adult patients who are positive for anti-AChR antibodies. The use of Halozyme's ENHANZE® technology allows for the successful delivery of biologics by subcutaneous administration, providing an advantageous alternative to IV administration.

The approval of VYVGART® Hytrulo demonstrates the potential of combining the therapeutic benefits of efgartigimod alfa with the increased convenience and accessibility of subcutaneous delivery, thereby improving management and quality of life for people with generalized myasthenia gravis.

Roche's Columvi® Receives FDA Approval for DLBCL and LBCL

Roche has discovered the first and only bispecific antibody Columvi® (glofitamabgxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or follicular lymphoma (LBCL) recurring after two or more systemic therapies.

The approval for this indication is granted under accelerated approval, taking into consideration the response rate and durability observed in phase I/II NP30179 study. Further approval for this specific use will be dependent on the confirmation and description of clinical benefits through a confirmatory trial. Columvi is expected to be made available in the United States in the upcoming weeks.

Diffuse large B-cell lymphoma (DLBCL) is a prevalent and challenging disease, representing the most common type of nonHodgkin lymphoma in the United States. Although initial treatment response is favorable for many DLBCL patients, a significant portion experience relapse or become refractory to subsequent therapies, leading to unfavorable prognoses.

FDA accelerated approval of Columvi® is backed by positive outcomes from phase I/II NP30179 study. 132 relapsed/refractory DLBCL patients, including prior CAR T-cell therapy recipients, received Columvi. Notably, 83% were refractory to their last treatment. Results showed fixed-duration Columvi led to durable remission, with 56% overall response rate and 43% complete response rate.

ACROBiosystems Revolutionizes Neuroscience Discovery with Electrophysiology Solutions

ACROBiosystems, in collaboration with Diagnostic Biochips, introduces ACRO Certify's Aneuro brand, unveiling in vivo electrophysiology solutions for neuroscience research. This partnership aims to accelerate drug discovery and commercialization in the field of neurology.

Electrophysiology plays a vital role in neuroscience research, offering insights into the intricate neural network. By monitoring field potential and neuron-level electrical signals in various brain regions, researchers gain valuable information about neural network function and the underlying biological mechanisms of neurological diseases.

In vivo electrophysiology poses challenges due to the complex nature of the neural network. These challenges include data acquisition and the use of animal models, primarily rodents. ACROBiosystems addresses these challenges by offering probes designed to work without a headstage, minimizing the physical burden on animal heads while maintaining optimal signal channels. Additionally, their deeparray electrodes provide a recording depth of 90mm across 128 channels, enabling comprehensive neural activity analysis.

To enhance the capabilities of the probes, ACROBiosystems offers data acquisition systems and AI/Cloud-based data analysis software. These tools facilitate structural and functional analysis of neural circuits, biomarker discovery through electrophysiology, and drug screening. Additionally, ACROBiosystems provides beginner's guides and training for researchers venturing into the field of neurosciences, ensuring a smooth start to their experiments.

FDA Approves Alentis Therapeutics' IND for HNSCC Treatment

Alentis Therapeutics, a clinical-stage biotechnology firm focused on developing treatments for Claudin-1 positive (CLDN1+) tumours and organ fibrosis, has gained FDA approval for ALE.C04 as an Investigational New Drug (IND).

The approval enables for the testing of ALE.C04 in a first-in-human clinical trial as a monotherapy and in combination with pembrolizumab.

The trial, which will begin in the second half of 2023, will particularly target recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

FDA's IND approval is a major milestone for Alentis Therapeutics in developing innovative therapies for CLDN1+ tumors and organ fibrosis. It enables clinical trials to evaluate ALE. C04's safety and efficacy for HNSCC treatment, as monotherapy and in combination with pembrolizumab. This advancement signifies a critical step in improving treatment options and advancing novel medications for patients.

ALE.C04 is a novel monoclonal antibody that targets cancer cells expressing CLDN1. It acts by remodeling the extracellular matrix to enhance immune cell trafficking and directly kill tumor cells. ALE.C04 shows promise as a monotherapy and in combination with checkpoint inhibitors.

HNSCC is the sixth most frequent type of cancer in the world, and its prevalence is increasing. In addition to surgery, chemotherapy, and/or radiation therapy, authorized therapies include cetuximab and pembrolizumab.

Novo Nordisk Invests US$2.3million in Denmark Facility Expansion

Novo Nordisk has recently announced a significant investment of 15.9 billion Danish kroner to expand its existing Active Pharmaceutical Ingredient (API) production facility in Denmark. This expansion aims to cater to the growing demand for medications in the field of serious chronic diseases. Coinciding with the company's 100th anniversary, this investment demonstrates Novo Nordisk's commitment to its Danish roots, as more than half of its global workforce of 21,000-plus employees are based in Denmark.

The expansion in Hillerød, Denmark, will create additional production capacity and enhance Novo Nordisk's ability to meet future market demands. It will serve as a key enabler for the company to develop its future clinical late-phase product portfolio. Henrik Wulff, the executive vice president of Product Supply, Quality & IT, emphasized the importance of this investment in delivering essential medicines to patients worldwide. He also expressed gratitude to the Danish Government and Parliament for their support in ensuring good infrastructure and supplies, enabling the company's production capacity expansion.

The new facility will cover an area of approximately 65,000m2 and will be designed as a multi-product facility, allowing for flexibility and accommodating new processes. It will incorporate state-of-the-art technology and provide a modern and efficient working environment. The construction will prioritize high-quality production while focusing on reducing water and energy consumption in an environmentally sustainable manner.

Construction has already begun, and the facility is expected to commence API production by early 2029. Once completed and fully equipped, the project is anticipated to create 340 new jobs.