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Manufacturing Focus

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How Cellino’s Cassette Technology Will Impact Regenerative Medicine

Co-founder and CEO of Cellino Biotech, Nabiha Saklayen, discusses the company’s innovative platform which uses automated technologies to overcome challenges in the development of regenerative medicine.

Rising Leaders Regenerative Medicine

Agnė Vaitkevičienė: The Versatile CEO Driving Memel Biotech

Rising star Agnė Vaitkevičienė is juggling roles as the CEO of an emerging Lithuanian biotech, with work for a partner company, the national biotech trade association and much more. 

Manufacturing Regenerative Medicine

China VBP, Localization And Other Strategies - How Far And Which Way?

Could health sector players encounter issues similar to those facing Tesla in China, a country which virtually saved the electric vehicle maker but where it is now facing challenges? Are there any lessons to be learned from a success story under China's volume-based procurement scheme? A partner at EY looks at these and other issues. 

China Business Strategies

Key Considerations When Acquiring A Cell And Gene Biotech

Stakeholders looking to gain deeper insights into potential cell and gene therapy candidates and optimize R&D strategies can employ several strategies to inform portfolio management decisions.

Growth Gene Therapy

Generics CEOs Unplug At AAM Conference

The AAM’s annual Access! 2024 conference brought its much-enjoyed CEOs Unplugged panel to Tampa again for another engaging discussion on critical issues, challenges and opportunities for generics and biosimilars in the US.

US States AAM

COVID To GLP-1: Catalent Plants Ride With Novo To Next Public Health Crisis

A complex transformation is underway as client proposes to acquire CDMO facilities that vaccinated the world against the COVID-19 pandemic for pivot to the obesity epidemic.

Manufacturing Supply Chain

Why Advanced Manufacturing Technologies Haven’t Prevented Drug Shortages – And How They Could

A decade later, another MIT retreat explores factors behind slow adoption of technologies touted in the first – and how the barriers could be overcome to deliver higher-quality, more shortage-proof generic drugs.

Generic Drugs Manufacturing

Why Did The European Commission Decide All Antimicrobials Should Be Rx-Only?

The European Commission responds to questions regarding its decision to include OTC antivirals and antifungals, including commonly used products like thrush and cold sore creams, in the expanded prescription-only requirements for antimicrobials, as part of proposed measures to combat antimicrobial resistance. 

Europe EU Legislative Reform

Rentschler’s New CEO On 2024 Expectations For CDMOs

In Vivo caught up with Benedikt von Braunmühl at the recent BIO-Europe conference in Munich, Germany, to discuss his first six weeks as CEO at Rentschler Biopharma and the biggest trends impacting contract development and manufacturing organizations (CDMO).

Manufacturing C-Suite Speaks

The Long Learning Curve For Artificially Intelligent Drug Manufacturing Begins Now

Drugmakers quickly adopt low-impact AI/ML models in quest to eventually automate manufacturing processes. Already, they are learning a lot about how these models can support their operations. One finding: innovative change management approaches may be required to unlock their full potential.

Artificial Intelligence Manufacturing

Outlook 2024: Shaping A Medtech Environment Where Technology Leads The Way

Environmental demands, the evolution of care models, new delivery technologies and AI tools are influencing how medtechs must approach innovation.

Commercial Strategies Outlook 2024

Syngene Eyes Sweet Spot As New Modalities Hog Limelight

Syngene’s CEO discusses its work in ADC development and trends in the CRDMO space as US biotechs navigate a funding squeeze and manufacturing opportunities loom in areas like GLP- 1 receptor agonists.

Leadership Manufacturing

Manufacturing Devices In The Rollercoaster UK Market

A scale-up strategy is the missing link in the UK devices industry, claims business research organization CPI. Own brand and contract medical manufacturer and packaging company Pennine Healthcare and longstanding medical device CDMO Renfrew Group International give their take on the environment for manufacturers and the opportunities for strengthening the industry base.

Manufacturing Outlook 2024

CGT Development Is Booming, But Manufacturing Workforce Must Keep Up

Due to the unprecedented growth in the development of cell and gene therapies over the past decade, there is now high demand for certain workforce roles, especially in highly specialized areas and entry-level manufacturing positions.

Gene Therapy Leadership

A Decade At The Top: Lupin MD On Listing Adjacencies, Creating Health Care Continuum

As family-led firms go through a churn in India, Lupin’s MD Nilesh Gupta speaks about adding value via adjacencies to the legacy business, building digital interfaces and a healthcare continuum for patients. In an interview with Scrip, he also emphasized Lupin promoters are neither interested in selling their own stake nor in acquiring that of Cipla’s promoters.

C-Suite Speaks Commercial

Explaining The Unexplainable: How To Win US FDA’s Trust In Artificially Intelligent Drug Manufacturing

One issue that has surfaced as the pharmaceutical industry responds to the US FDA’s recent discussion paper on manufacturing with AI machine learning models is the question of how to explain what the models are doing.

Artificial Intelligence Drug Approval Standards
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