Join advanced therapies stakeholders for the free virtual Advanced Therapies Manufacturing Strategy Summit, July 14-15, to take stock of the first half of 2020 and the short and long term implications of the ongoing COVID-19 pandemic. Registration is free (vendors and solution providers, please note your registration is not free). . 

Hear an update on FDA regulatory guidance for manufacturers, take part in a virtual Q&A, and gain insight on current consortia initiatives and priorities for cell and gene therapy manufacturing and commercial development. Some industry leaders joining us include: 

• Peter Marks MD, PhD, Director, Center for Biologics Evaluation and Research (CBER) FDA
• Michael Lehmicke, Director, Science and Industry Affairs, Alliance for Regenerative Medicine (ARM) 
• Kelvin H. Lee, Institute Director, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
• Steven Goodman, Head of Drug Product Manufacturing, Bluebird Bio
• Vlad Hogenhuis, Chief Operating Officer (fmr.), Ultragenyx
  
  

Fill out the form to download the full event program to see what we have in store for you, and don't forget to secure your registration.

If you are interested in sponsoring or want additional information about the event, email enquiry@unitelifesciences.com.

The field of gene therapy is growing exponentially, with The first gene therapy study was carried out in 1989 and since then, around 2600 clinical trials have been conducted. To help companies overcome issues surrounding the development and commercialization of gene therapies, the FDA directs considerable effort toward the development of regulatory frameworks and policies that provide necessary guidance to the industry. On January 28, 2020, the FDA issued Chemistry, Manufacturing, and Control (CMC) information for human gene therapy Investigational New Drug applications (INDs). The FDA's guidance document provides recommendations to sponsors of human gene therapy INDs on how to include sufficient CMC information to delineate the safety, quality, strength, and purity of the investigational product in an original IND application.

Download this exclusive report to get a break down of what you need to know regarding the FDA's new guidance document. We'll cover:

• Manufacturing changes during drug placement
• Standardization guidelines (Labels)
• Manufacturer information
• Manufacturing process
• Autologous and allogeneic cells and tissues
• Manufacturing process development 

Review the Current Attendee Snapshot for Advanced Therapies Manufacturing Strategy Digital to get an idea of the companies and industry executives you can expect to meet and network with through our virtual, interactive summit.  

For questions or details pertaining to sponsorship/exhibition, contact us at enquiry@unitelifesciences.com

Event details: July 14 - 15, 2020 | Online Event

In an industry as complex and highly regulated as life sciences, how does one get started on their company’s intelligent automation journey? With help from industry experts from companies like Pfizer, MilliporeSigma, and Johnson and Johnson, we put together this industry-specific, step-by-step guide for effectively:

1. Planning & Piloting a new intelligent automation project
2. Rolling out and measuring the success of a new IA tool
3. Fully leveraging and optimizing IA investments for years to come
4. Balancing cost-effectiveness with compliance with user experience

This handbook draws on the discussions of leading experts and real-life experiences to serve as a guide to navigating the challenges of Pharma/CMO relationships and best practices for building long-lasting partnerships.

Download this handbook to learn the following: 

• Effectively managing communication with CMOs
• Handling complex external supplier footprints
• Defining strategic partnerships
• When to move on from your CMO roundtable
• Discussion summaries overcoming scenarios in managing CMO relationships
  

In a time where the possibility for face-to-face interaction is limited, Unite Life Sciences understands it’s more important than ever to help you engage qualified decision makers and generate fresh new leads.

Ahead of our fall event in Boston, leverage the digital event summit, Advanced Therapies Manufacturing Strategy Digital, July 14-15.

Offer content without having to leave your home to raise your profile and reinforce your thought leadership status – all while generating highly qualified leads!

Download the digital sponsorship opportunities brochure to see how to get involved. To have a copy sent to your inbox, or to discuss sponsorship opportunities, email us at enquiry@unitelifesciences.com.

The outsourcing biologics industry is expected to grow to $87.5 billion by 2027.

With the approval of the first recombinant DNA product, Humulin, biologics has brought great enthusiasm and excitement to doctors, patients and others in the pharma field. Utilizing human life tissues, the practice of biologics can ultimately pave the way for personalized treatments to specific cures based on your DNA and live tissues. With so much promise, small pharma companies are outsourcing R&D to CMOs, but this process continues to show some bumps in the road. For example, how do pharma companies go from clinical to commercial working in partnership with CMOs? How do they increase speed to market? 

To continue reading, please fill out the download form.........

The efficient onboarding and management of CMO networks is crucial to ensure that drugs get to market on time and within budget given the increasingly complex factors being applied by sponsors to supplier selection. If Sponsor/CMO partnerships are not managed effectively and are not mutually beneficial, drug development timelines and market access can be affected.

This report contains insights from over 50 individuals within the Pharma industry, and is accompanied by commentary from Ulrich Ruemenapp, Head of Launch Preparation at Bayer. Download now to take an in-depth look at the most important components when selecting a CMO, the greatest risks when choosing to outsource and best practises for managing CMO networks.

Given that unexpected challenges in CMO relationships can arise anywhere, it is important to devise a crisis management strategy that ensures production suffers as little interruption as possible, whilst protecting the necessary high quality levels. Ensuring that a CMO-related crisis is effectively managed can help save time and money for both parties. 

This report was put together using insights from individuals working directly on Pharma/CMO relationships. In each case, we asked individuals how they would tackle a particular CMO crisis; we have compiled their insights into this handy guide.