EDITOR'S DESK

  • Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations
    Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations

    I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.

Samsung Bioepis: Applying The "Hunger" For Biosimilars To Novel Drugs

Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.

New U.S And Canadian Facilities Boosting Biologics Capacity

Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.

Why Biosimilars Won’t Be “A Stake In The Heart Of Innovation”

There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"

2018 Outlook: Biosimilar Trends To Watch

Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.

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GUEST CONTRIBUTORS

  • Cybersecurity Among Biggest Challenges For Pharma Firms Incorporating Digital Health Technologies
    Cybersecurity Among Biggest Challenges For Pharma Firms Incorporating Digital Health Technologies

    This is the second of two articles focusing on the issues that pharma companies face when moving into the digital health space. In the first installment, the development process, agency guidance, and the type of quality oversight needed for software incorporated into medical device and combination products were explored. This part focuses on the importance of cybersecurity and software maintenance, how time scales and methods of execution differ from those in traditional pharma, how agile software development works, and how to avoid potential pitfalls.

  • Cardiac Stem Cell Controversy — 3 Important Lessons Learned
    Cardiac Stem Cell Controversy — 3 Important Lessons Learned

    Heart problems have touched many of our lives, or the lives of those we care about. Heart attacks and heart failure are leading killers in the U.S.,1 with limited treatment options available today. Typically, a heart attack is followed by significant heart muscle cell death, leaving the organ in a weakened state and the patient at risk of cardiovascular dysfunction and eventual heart failure. This leads to many of the deaths attributed to cardiovascular disease.

  • Data Integrity, Startups, & Cloud Storage: Don’t Let This Happen To You!
    Data Integrity, Startups, & Cloud Storage: Don’t Let This Happen To You!

    Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.

  • Continued Process Verification And The Validation Of Informatics Systems For Pharmaceutical Processing

    This article, written by members of the BioPhorum Operations Group (BPOG) Continued Process Verification (CPV) Informatics team, summarizes their collective experience in validating the informatics components of their CPV programs, to shed light on common issues and provide recommendations and best practices.

  • The Brexit Deal And Its Impact On The Pharmaceutical Industry

    According to trade groups, approximately 45 million packs of medicines leave the U.K. for Europe every month, and 37 million go in the opposite direction. In a year, that’s almost 1 billion packs of medicines. What those borders would look like after a Brexit deal would significantly impact major industries in the U.K. and EU economies.

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BIOPROCESSING WHITE PAPERS

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • Tips For Preparing Process-Scale Chromatography Columns
    Tips For Preparing Process-Scale Chromatography Columns

    Scaling up from laboratory-scale to process-scale purification is one of the most important manufacturing activities for the pharmaceutical industry. However, many challenges exist in this activity.

  • How Biopharma Is Capitalizing On The Antibody Boom
    How Biopharma Is Capitalizing On The Antibody Boom

    Antibodies continue to dominate. Analyzing the strategies employed by successful players in the field could provide invaluable lessons for those hoping to enter it.

  • Top Five Tips For Chromatography Sample Preparation
    Top Five Tips For Chromatography Sample Preparation

    Discover the steps you can take to improve the quality of your chromatography sample prior to performing your column separation, to ensure optimal isolation of your target protein.

  • Staying Flexible In Biomanufacturing
    Staying Flexible In Biomanufacturing

    The concept of optionality is key to staying flexible in biomanufacturing by keeping your options open and having multiple pathways to take while navigating through this highly uncertain environment. Using a combination of financial options analysis and decision analytics to quantify your options helps to embrace the uncertainty equation.  

  • 7 Key Areas Of Risk In Single Use Bioprocessing — Is Your Process Protected?
    7 Key Areas Of Risk In Single Use Bioprocessing — Is Your Process Protected?

    Is your bioprocess adequately protected against the risks associated with single use technology (SUT)? Discover the seven key areas of risk in SUT and learn the strategies to protect against each risk.

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LIFE SCIENCE INDUSTRY EVENTS

Trade and Channel Strategies 2018 December 11 - 12, 2018
Philadelphia, PA
Adverse Event Reporting: Avoiding Common Pitfalls December 11 - 11, 2018
1pm-2:30pm EST, Online Training
Specialty Product Data Strategies December 12, 2018
Philadelpia, PA
Copay Accumulator Summit December 13, 2018
Philadelphia, PA
Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
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TRAINING COURSES

Adverse Event Reporting: Avoiding Common Pitfalls December 11 - 11, 2018
1pm-2:30pm EST, Online Training
More Upcoming Courses