Insights

16
Jul
2019

The Pharmaceutical Supply Chain: How Repackers Are Affecting Public Health

The pharmaceutical supply chain process involves many safeguards to protect the public. While other manufacturers can distribute products directly to consumers, our market pathway is through a pharmacy or wholesale distributor. Before this step happens, registered repackers may be manipulating your API for packaging.
Continue Reading ?
09
Jul
2019

Proposed Rule to Open Biosimilar Competition

The FDA does not allow pharmaceutical companies with licensed biologics and biosimilars to reference the drug master files for any information regarding drug substances. Recently, this has resulted in a lack of supply and declining biosimilar competition. The FDA has realized that this act has put a damper on the ability to access various health treatment options, not to mention the skyrocketing costs of drugs like insulin
Continue Reading ?
25
Jun
2019

Life Sciences Startups Attract Talent to Boston and Cambridge

Boston and Cambridge have long been the center of intellectual advancement in the U.S., with some of the top universities in the country and the world.
Continue Reading ?
18
Jun
2019

Scared to Jump on the Biosimilars Bandwagon? You’re Not Alone

As of March of this year, only 17 biosimilars had been approved for sale in the US by the FDA. Of these, only one has been commercially successful. Yet we know that biosimilars do very well in Canadian and European markets. It’s well publicized that in 2020, $100 billion worth of biologics will be off-patent and ready for biosimilar development.
Continue Reading ?
11
Jun
2019

The Reproducibility Question: How Better Data Access Fosters Good Laboratory Practice

Of the many issues that encompass good laboratory practice regulations, the thorniest is probably ensuring reproducibility. Recent research from the Global Biological Standards Institute (GBSI) showed that a staggering 50% of published preclinical trial results cannot be reproduced by another research team. As any professional knows, a trial that can’t be reproduced was better not done at all. This problem accounts for $28 billion per year in wasted funds in our country alone.
Continue Reading ?
04
Jun
2019

Continuous Manufacturing: The FDA’s Pet Project

In February of this year, the FDA released new draft guidelines on Quality Considerations for Continuous Manufacturing, an area the agency has shown increasing interest in, despite the fact that only 20 pharmaceutical manufacturers in this country are currently invested in continuous manufacturing or are considering it as an option for their business.
Continue Reading ?
28
May
2019

Medical Device Recalls: New FDA Data is Not What You’d Expect!

A new report from Northeastern University has shed some light on the top reasons for medical device recalls in the last five years. Previously, the FDA had been working from a report covering the fiscal years 2003-2012, but this new report that covers 2013-2018 suggests that updating is in order.
Continue Reading ?
21
May
2019

New Course Offering: Developability Assessment – The Logical Approach to Discovery Lead Selection

If you work in drug discovery, you know the disheartening statistics: Only 0.4% of compounds in development ever reach the market, and companies can spend $1.4 billion on average to get a single pharmaceutical on the market.
Continue Reading ?
14
May
2019

Establishing CMC Regulatory Compliance Readiness: When Research Outpaces Regulation

Compliance strategies for biopharmaceuticals and biosimilars are based on five pillars of excellence: The first, that the strategy takes into account the full scope of Chemistry, Manufacturing and Controls activities.
Continue Reading ?
07
May
2019

Optimize Your Process, Optimize Your Career: Become a Quality by Design (QbD) Certified Professional

QbD is a comprehensive system for designing experiments that focuses on quality and reliability from the beginning of drug development. Ensuring your processes receive FDA Certification requires careful planning and stewardship. Pharmaceutical professionals who are certified in QbD are in well-placed for career advancement in both domestic, international and emerging markets.
Continue Reading ?
23
Apr
2019

Data Integrity: The Next Step in Computer System Validation

In our Computer System Validation course, offered May 20-21 in London, our instructors will discuss key concepts in computer system validation including FDA regulations, non-compliance issues that can result in warning letters, and implementing a practical-but- defensible computer validation system for your development programs. While these foundational topics are excellent for those who are new to data validation and equipment regulations, it’s important in this industry to stay abreast of new technological developments that can ensure the success of your drug development projects.
Continue Reading ?
16
Apr
2019

Fast-track to a Great Career: Earn Biotechnology Certification

A recent report from the IMARC Group showed that the market for testing pharmaceutical products has seen steady growth and will continue to growth through 2024. Where there is market growth, there are great careers to be had for eager professionals, whether new grads or those already working in the pharmaceutical and biotech industries. Adding a biotechnology certificate to your credentials sets you apart in the job market, and ensures your skills are in high demand.
Continue Reading ?
09
Apr
2019

Stability Test Chambers Market Forecasted to Grow as Regulations for Accurate Product Shelf Life Testing Tighten

An essential component of good manufacturing practices, stability testing can be the make-or-break step in the manufacturing process. FDA guidelines determine which standards for shelf life a drug must meet, including humidity and temperature controls, but all testing must happen in a controlled environment for valid results.
Continue Reading ?
02
Apr
2019

How the GDPR Affects the Medical Device Industry

Like many industries, the medical field is becoming more and more reliant on information and analytics to improve their services and find better ways to serve the public. But complying with data protection means more than just passwords and virtual locks, especially for an industry that intends to take care of the physical and mental well-being of humans.
Continue Reading ?
26
Mar
2019

Preparing for Annual Product Quality Reviews: Good Manufacturing Practices Training

One of the most important times of the year for professionals engaged in Good Manufacturing Practices quality assurance, the annual product quality review as mandated by the FDA allows your business to ensure not only compliance with FDA regulations, but also ensure the best quality products that carry your brand name are on the market.
Continue Reading ?
19
Mar
2019

Creating GMP-Grade CBD: Drug Developers Eyeing Synthetic Cannabinoids

The cannabis industry is already making big waves and big money in the U.S. in spite of being legally available in only a few markets. In 2016, the U.S. industry alone was estimated to be worth $7.06 billion and is forecasted to grow rapidly by 2025.
Continue Reading ?
12
Mar
2019

CMC Certification: Staying on Top of New Developments in Gene Therapy

For CMC certified professionals, the importance of being up-to-date in your field cannot be underestimated. New drug and biologic developments occur at a rapid pace, and lack of awareness could be costly for decision-makers with compounds under development or in review.
Continue Reading ?
05
Mar
2019

Changing eCTD Submission Requirements: What You Need to Know

Since 2015, the FDA has required certain types of submissions to follow the eCTD format, and has slowly rolled out the requirement to other channels. Even though the deadline for conversion to eCTD for Type III Drug Master Files (DMF) applications has been extended to May 5, 2020, it is still very much in progress, and pharmaceutical professionals must be aware of the constantly changing requirements and evolution of the document format itself.
Continue Reading ?
26
Feb
2019

Report: The Contract Biomanufacturing Services Global Market

Released in December of last year, a new report forecasts the global CMO market to 2027 and discusses the impacts of increased partnering with contract organizations, the risks and potential opportunities that biopharma companies need to know now in order to be a key player in this $13.3 billion market.
Continue Reading ?