Showing posts with label Eli Lilly. Show all posts
Showing posts with label Eli Lilly. Show all posts

Tuesday, September 1, 2015

Top Scientists Address Downstream Processing

Characterization of Host-Cell Proteins Using Mass Spectrometry Enables Effective Purification Optimization

Lin Zang, Senior Scientist, Analytical Development, Biogen describes the mass spectrometry workflow for host cell protein identification that she will be presenting on at the BioProcess International Conference & Exposition, and discusses the implications of HCPs on downstream process development.

Hear more from Lin at 4:00 pm on Wednesday, October 28, 2015 at BPI.

Listen to her interview here: http://bit.ly/1VucXxR



A Novel Approach to Monitor Clearance of Host Cell Proteins Associated with Monoclonal Antibodies 

The big challenge in downstream process development concerning host cell proteins is that the amount of HCPs in the purified product is often so low that it is hard to determine the identity of the HCP. Min Zhu, Senior Scientist, Purification Process Sciences, MedImmune LLC, describes how the approach she will be presenting at the conference overcomes this challenge.

Hear more from Min at 4:30 pm on Wednesday, October 28, 2015 at BPI.

Listen to her interview here: http://bit.ly/1VucXxR



Implementing Multi-Attribute LC/MS Methods for More Informed Process Development 

Matthew Traylor, Analytical Scientist, Process Development, Shire, discusses how he gets a deep characterization a specific protein out of a mixture, using LC/MS software packages that automate the process. He shares how this technology can be used at laboratory, pilot and production scale process development.

Hear more from Matthew at 9:20 am on Tuesday, October 27, 2015 at BPI.

Listen to his interview here: http://bit.ly/1NKYZWY



Continued Process Verification (CPV) Informatics Systems and Validation 

Carly Cox, Senior Process Engineer, Pfizer, describes what a CPV informatics system is and how it’s used in product manufacturing. She’ll be presenting at the BioProcess International Conference on how multiple source systems can pull data on product manufacturing processing and be collected into a CPV informatics system, and some of the important areas to consider for validation and configuration for regulatory reporting and process monitoring.  

Hear more from Carly at 9:20 am on Wednesday, October 28, 2015 at BPI.



Rapid Microbiological Methods for Real-Time Release of Autologous Cell Therapy Products 

Hear about how a risk based approach to autologous cell therapy products used at Vericel. In this podcast, John Duguid, Principal Scientist, Vericel Corporation, describes how rapid microbiological methods are used in product release of autologous cell therapy products, and discusses the areas of contamination risk. Audio Player

Hear more from John at 2:00 pm on Thursday, October 29, 2015 at BPI.

Listen to his interview here: http://bit.ly/1IFdZ0I

If you haven’t already, register for BPI 2015 taking place this fall in Boston. BPI is engineered to be exactly what YOU need it to be. Formal and informal networking experiences connect you to peers, prospects, and customers. Parallel tracks give you the option to dive deep or take a big picture approach to learn about industry trends, challenges, and benchmark against the latest research developments. Big pharma and large, mid-size and emerging biotechs collaborating with solution providers featuring proven and next generation technologies make BPI a one-of-a-kind meeting place.As a valued reader of our blog, you get an exclusive $100 off the current rate when you use code XB15171BLOG. Register here: http://bit.ly/1JA9EQe




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Tuesday, August 19, 2014

FDA Tentatively Approves Lilly's New Diabetes Medication

The FDA has granted Eli Lilly “tentative” approval for a diabetes medication akin to Sanofi’s Lantus.  The drug, to be marketed as Basaglar, is a long-lasting insulin injection that helps to control blood-sugar levels and is essentially a knockoff of the Sanofi version.

The new medication, however, won’t reach shelves for at least 30 months as Sanofi has filed a suit claiming patent infringement.  The drug could hit the market earlier if the court rules in favor of Eli Lilly but is in a holding pattern until then.  Lantus is scheduled to come off of patent February of next year.  This news comes months after Merck divulged plans to develop its own knockoff of the diabetes medication. 

Basaglar has the same amino acid sequence as Sanofi’s drug but for technical reasons is not considered a biosimilar—although for all intents and purposes, it is one.  By European standards, the drug does actually fall under the biosimilar classification and goes by the name Abasria.    

Said Christophe Arbet-Engels, Vice President, Metabolic-clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc., "Because of the combined diabetes, development and commercialization experience of Lilly and Boehringer Ingelheim, we are confident that Basaglar, upon final approval, will become a valuable treatment choice for people who need a basal insulin to manage their type 1 or type 2 diabetes."


The biosimilars news is going to keep coming. We’ll have the breakdown of the latest industry updates and trends at the Business of Biosimilars conference. Join us October 20-22 in Boston, MA. Download the agenda here to see what’s on tap.

SAVE $100. Register here and use code XP1986BLOG.

Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
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Friday, January 21, 2011

Biorepositories Asia Session Spotlight: Biobanks in China: Resources and Harmonization

Leading up to Biorepositories Asia, we'll be highlighting a session from the upcoming conference. It will take place April 11-13, 2011, in San Francisco, California. For more information, download the brochure.

Featured Session: Biobanks in China: Resources and Harmonization

Presented by:
Ti He, NATIONAL ENGINEERING CENTER FOR BIOCHIP, SHANGHAI

About the Session:
China has the largest population of patients, and the latest health reform encourages even more admissions to hospitals, however, potential resources for clinical research have been ignored for a long time. The boom of the pharmaceutical industry and the progress of biomedical studies in China necessitate the use of the clinical samples. In recent years, biobanks have emerged from various hospitals across China. While such biobanks provide access to clinical samples, there remain problems to solve down the road, especially the harmonization of procurement standards. Gain insights on increasing procurement opportunities, including how to:
• Establish key partnerships within the industry to facilitate clinical research
• Gain access to unique samples and cell lines
• Address procurement standardization challenges


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Friday, January 14, 2011

Biorepositories Asia Session Spotlight: Understand and Overcome Global Ethical Concerns to Obtain Approval from Ethics Committee

Leading up to Biorepositories Asia, we'll be highlighting a session from the upcoming conference. It will take place April 11-13, 2011, in San Francisco, California. For more information, download the brochure.

Featured Session: Understand and Overcome Global Ethical Concerns to Obtain Approval from Ethics Committee
Panelists: Rajeev Shrivastava, PhD, Senior Manager, Clinical Research, ELI LILLY AND COMPANY, INDIA

Amelia Wall Warner, PharmD, RPh, Head, Clinical Pharmacogenomics and Clinical Specimen Management Director, Experimental Medicine, MERCK RESEARCH LABORATORIES

Anita Nelsen, Manager, Genetics Sample Acquisition & R&D Human Sample BioRepository, GLAXOSMITHKLINE

Ethical issues and data privacy considerations can be a problematic barrier to global sample collection in Asia. Join this interactive discussion as industry leaders from multiple perspectives share open dialogue on some of the toughest issues surrounding sample management. Legal, regulatory, policy and ethical factors are addressed to help the industry manage patient privacy, while simultaneously pursuing the future potential of biospecimen research.

Discussion addresses how to:
• Manage variation with global ethics committees
• Understand protected health information and data confi dentiality laws and regulations
• Address concerns around collection for unspecific use
• Effectively communicate with global investigators and sites participating in clinical trials



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Wednesday, March 24, 2010

Immunogenicity for Biotherapeutics 2010: Hear Case Studies from Amgen, Eli Lilly, & Pfizer

The 11th Annual Immunogenicity for Biotherapeutics convenes the industry’s leading experts and scientists to discuss updates on emerging regulatory updates, new assay development and validation strategies, novel and advanced case studies, and more to help your company conserve time and money so you weather the storm in today’s economy. Join 100+ colleagues to hear the latest immunogenicity techniques and learn how to accelerate approvals through the adoption of innovative scientific methods that deliver validated immunogenicity data.

→ Are you confident you are managing drug interference effectively?
Many consider drug interference as one of the toughest challenges in immunogenicity testing. Hear case studies from Amgen, Merrimack Pharmaceuticals, and Human Genome Sciences as these scientists share method validation techniques and lessons learned for handling drug interference with the diversity of therapeutic products in development.

→ Can you accurately evaluate the downstream impact of your immunogenicity data and establish clinical relevance for overall study interpretation?
Hear case studies from Eli Lilly and Biogen Idec on how to handle complicated immunogenicity assessments and the overall impact of these results upon clinical studies. Be ready to share your own lessons learned and ask questions of industry colleagues regarding strategies and solutions for data interpretation and establishing clinical relevance.

→ Do you need clarity on the induction of immunological tolerance to proteins?
To achieve the full potential of biologicals as therapeutic products, alternative approaches for eliminating immunogenicity are essential. Spend an afternoon with experts from Pfizer, State University of NY at Buffalo, Genzyme, and the University School of Medicine to discuss the details and challenges for tolerance induction to therapeutic proteins.

Join these sessions and many more at the longest running and the largest Immunogenicity event of the year. Visit our website to view the finalized agenda and to place your registration.



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Tuesday, November 3, 2009

Lilly Opens Biotech Center in San Diego

Eli Lilly and Company has opened a multi-faceted biotech center in San Diego aiming to discover and develop more biotechnology medications.

Laboratory Equipment reports that Lilly is moving its ImClone research headquarters (which specializes in developing cancer biologics) into a new biopharmaceutical research cluster in New York, and just one year after Lilly completed construction of its biotechnology R&D complex at its headquarters in Indianapolis.

"We're moving full speed ahead toward building a biotechnology powerhouse," says John Lechleiter, Lilly chairman/CEO. "The science, technology and talent at our new center in San Diego will help bring novel biotech medicines to patients faster and more efficiently, and reinforces Lilly's commitment and contributions to San Diego's burgeoning bioscience industry."

What do you think of Lilly's move out West? Will it be a step in the right direction for their bio offerings?


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Thursday, July 23, 2009

2nd Annual Bioanalytical Method Development

What’s new in 2009 for Bioanalytical Method Development?
• Tackle biomarker assay issues with Biomarin, Human Genome Sciences, and Genentech – bring back to your lab new approaches for including biomarkers in your PK/tox program, using biomarker assays as a trigger for treatment, and strategies to resolve heterophilic interference
• Half-day dedicated to all new Fc Functionality data
• Improve your developmental strategies for free and/or total antibody drug at the half-day workshop dedicated to case studies and open dialogue on the challenges, pros, and cons of developing free and total assays with Eli Lilly and Amgen
• Industry experts share strategies to generate meaningful data on molecular interactions to support biotherapeutic development
• Pfizer presents data on interference generated in different assay formats, using modeling as a predictive tool, and how to generate significant savings by reducing the number of assays requiring GLP validation.

Why IIR’s BAMD?
• Shorten development timelines to improve speed to market
• Network with colleagues to solve your biggest challenges
• Reduce costs by improving efficiencies in your lab

This is a unique opportunity to mingle with such an esteemed group of scientists all focusing on the advancement of bioanalytical method development! Register now and save $400 when mentioning code FVFVSBF.


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