Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.
- Create The Correct Checklist To Land The Best CDMO
- Venture Philanthropy Launches Biotech From Within
- The Fruits Of Synthetic Biology
- A Methodology To Support Particle Investigations In Biopharma Products
- 1 Year Out, Where Do We Stand On DSCSA Implementation?
- FDA Releases Guidance On Drug Products Containing Nanomaterials
- Computational Biology Speeds The Path To Clinical Studies
Where Biotech Business Nuance Isn’t Lost
You read, you watch, you listen, you travel to conferences and events, and you learn from all of it, but none of those are the leading source of information for those who seek it. What medium do most biopharma leaders actively seek when it’s learning they’re yearning? Conversation.
Vaxxinity, small as it may be on the greater pharma landscape, is carving out positions as innovator, disruptor, and leader in what CEO Mei Mei Hu, J.D. refers to as the third biologic revolution. Here, she shares Vaxxinity's position on immunotherapeutic vaccines in the context of traditional vaccines and biologics and offers insight into the company's unique culture.
Sarah Howell, Ph.D. joined Arecor as COO back in 2011. She brought drug development experience—and commercial success—honed at big pharmas including GSK, UCB, and BTG. What she didn’t bring with her was experience in the C-suite. Hers had had been spent on another C-level: CMC. Here's what Dr. Howell, now CEO, learned about the transition.
Turning academic interest in biology into careers in biopharma: A look at NIIMBL's commitment to nurturing the skilled workforce the industry desperately needs now—and will need even more as it moves into the development and production of increasingly complex ATMPs and multi-modal therapeutics.
NIIMBL Director Kelvin H. Lee, Ph.D. illustrated the power of consortia and public/private partnerships in advancing next-generation approaches to ATMP manufacturing, and demonstrated how the Institute isn’t just talking — it’s building.
Create The Correct Checklist To Land The Best CDMO
When considering outsourcing strategies, develop the right kind of checklist that considers human dynamics. This is not a script, nor is it static. Flexible enough to meet the needs of the project and the personnel, this spec will help you create frameworks, master service agreements, and quality agreements for best oversight of your supplier.
The Fruits Of Synthetic Biology
Can cell and gene therapies be programmed with sophisticated behaviors, to sense, make decisions, and treat important diseases effectively? Synthetic gene circuits may hold the key.
A Methodology To Support Particle Investigations In Biopharma Products
Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.
1 Year Out, Where Do We Stand On DSCSA Implementation?
This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts, before examining where implementation currently stands and what gaps and challenges remain.
FDA Releases Guidance On Drug Products Containing Nanomaterials
In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.
The Expanding Patent Landscape For RNA-Based Therapeutics
The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.
Biology Meets Computer Science For Next-Gen Biologics Drug Discovery
We have entered a new age in biologics development, which is undergoing a technological revolution with an increasing focus on software-dependent and data-driven results. Integrating the biological and the computational creates a need for specialists working together in parallel.
Frequent Deficiencies In GMP Inspections, Part 1
It is sometimes astonishing how often pharmas and biotechs "commit" similar or even the same GMP mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.
BIOPROCESSING WHITE PAPERS
Continuing The Conversation: The Future Of Reimbursement For Cell And Gene Therapies
Cell and gene therapies were expected to pose significant payer challenges however, several high-cost cell and gene therapies have achieved rapid and broad reimbursement to date across major payer bodies.
What Every Clinical Team Should Consider Before The Next Protocol6/3/2022
Even though everyone applauds the renewed focus on patients as a positive development, some say it is time for biopharma companies to turn their attention to another audience: clinical trial participants.
Patient-Centric Oral Solid Dose Formulation5/17/2022
Gain insight into the systematic application of patient centricity to the design of OSD products.
The Roles Of Operational Readiness, Capital Projects In Drug Manufacturing8/31/2022
Read more about what a facility needs to achieve operational readiness and the necessary steps to take to be at full scale production when the “go” button is hit.
Ensuring Resilience: How Life Science Is Reshaping Supply Chains In Response To COVID-191/24/2022
Understand how the supply chain experience, severely affected by COVID-19, involving global workforce disruption, surging demand, and drug shortage notices, is shaping attitudes toward resilience.
Accelerate CHO Cell Characterization With The Blazar® Rodent Panel2/24/2021
The Blazar Rodent Panel allows biopharma to move away from traditional in vivo antibody production assays when characterizing cell banks of rodent origin used in the production of biologicals.
BIOPROCESS ONLINE CONTENT COLLECTIONS
From setting up and implementing a QRM program to objectively measuring your risk appetite and risk tolerances to proving sound risk management through factory and site acceptance testing (FAT and SAT), this e-book offers a collection of fresh insights from biopharma risk mitigation experts to help guide your risk management strategy.More Content Collections