DIVERSE

course topics, from R&D and clinical trials to manufacturing, global regulatory, and post-market concerns.

QUALITY

instruction from the best Subject Matter Experts in pharma, biotech, and med device.

ACTIONABLE

content that provides you with practical solutions to the toughest challenges.

INTERACTIVE

features for the adult learner including polling, break-outs, and assessments.

UPCOMING LIVE COURSES

STAY TUNED WITH US

Subscribe for the latest pharmaceutical, biotechnology, and medical device training courses and special offers.

LIFE SCIENCE TRAINING INSTITUTE

Get to know us (by the numbers).

Life Sciences Industries Covered
Expert Instructors
Courses Run
Past participants

INDUSTRY RESOURCES

biocontainment
11
Aug
Biocontainment: Understanding Biosafety Levels

This two-part article on biocontainment is a companion to our discussion of potent compounds, which focused primarily on chemically derived drug substances and drug components. While analogous to chemical potent compounds, biologically derived ingredients, intermediates, and products are produced by human manipulation of naturally occurring lifeforms and their byproducts.

Posted in: FDA, Manufacturing,
Tags: biocontainment, biological processes, containment,
DNA
10
Aug
Genome Editing & The Future Of Drug Discovery

The genome editing market is estimated to reach $3.5 billion in 2019 — an increase from $2 billion in 2014 — with a CAGR of 13 to 14 percent. The factors driving this market include increased R&D funding for genomic research, a growing demand for synthetic genes, new technologies in genome editing, and high utilization in plant breeding. However, high regulatory stringencies, lengthy approval processes, and ethical issues associated with the fear of genetic research hamper market growth. This article examines the utilization of genome editing tools and technology and their impact across the drug discovery industry.

Posted in: R&D,
Tags: CRISPR, DNA, drug, genetic research, genome, R&D,
teamwork
04
Aug
Establishing a “Voluntary Quality Assurance” (VQA) Culture Through Training – Improving Quality and Accountability With Staff

Training provides an opportunity to lay the groundwork for a Voluntary Quality Assurance (VQA) culture, which is a culture that involves trust, collaboration, and ownership among many people and departments.

Posted in: Training,
Tags: assessment, quality assurance, standard operating procedures, training program,
Biosimilar
03
Aug
How Can Biosimilar Companies Emerge As Leaders In The Biosimilar Space?

We recently reached out to biosimilar experts from several prominent management consulting firms to ask for their perspectives on biosimilar company archetypes, emerging biosimilar development and business strategies (as well as mistakes to avoid), and the market’s future. First up is Mark W. Ginestro, principal in KPMG’s Healthcare and Life Sciences strategy team.

Posted in: Manufacturing,
Tags: biosimilar development,
China
02
Aug
What China’s New Two-Invoices Policy Means For Pharmaceutical Manufacturers

Regulators in China have long been concerned that this multitiered network inflates drug prices. A 2017 pilot program, known as the “two-invoices” system, aims to address this issue by changing the way manufacturers, distributors, and healthcare facilities operate in the procurement process.

Posted in: Manufacturing,
Tags: distribution, distributor, drug, supply chain,
supreme court building
31
Jul
The Supreme Court’s Upcoming Review Of IPR Constitutionality — A Biopharma Perspective

IPR provides an adversarial process for challenging patents at the U.S. Patent Office. As of earlier this year, there were over 50 IPR petitions reportedly on file challenging patents relating to the large molecule biopharma space.

Posted in: Clinical, Manufacturing,
Tags: biopharmaceutical, biosimilar,

WHAT'S YOUR DISCIPLINE?

TESTIMONIALS