Newsletter | August 14, 2019

08.14.19 -- Bury The Hatch-Waxman: Generics Were Not The Answer

From The Editor
Bury The Hatch-Waxman: Generics Were Not The Answer
By Louis Garguilo, Chief Editor, Outsourced Pharma

The hypothesis is bold: Our emphasis on generics is a detriment to U.S. patients and the entire healthcare system. Instead, these past decades we should have focused intently on increasing the life cycle and distribution of innovator drugs.

The Next Generation Appreciates Our Outsourcing Industry
By Louis Garguilo, Chief Editor, Outsourced Pharma

Our future appears to be in good hands after all. Following on our earlier editorial, here’s a broader measure of the motivations and modus operandi of the youth inhabiting our drug development industry as we head into the 2020s … a decade they can conquer utilizing our outsourcing industry.

Featured Editorial
Equipment Change Control For GMP Production Facilities: Proving It All Works
By Greg Weilersbacher, Eastlake Quality Consulting

The first article in this two-part series outlined the six primary stages of equipment change control and discussed the first two stages. Part 2 describes the final four stages of this process: evaluating the impact of new equipment installation on previously validated utilities, executing validations for new equipment, review of equipment turnover packages and validation reports, and performing change control effectiveness checks.

4 Trends In Recent FDA Warning Letters To OTC Drugmakers: And How To Avoid Them
By Alan D. Greathouse, The FDA Group, LLC

A recent flurry of warning letters issued to manufacturers of over-the-counter drug and health products has revealed similar deficiencies related to GMP and quality management expectations. Areas of enforcement focus include ineffective quality units, poor testing of incoming materials and components, poor product testing, poor analytical and microbial testing and validation methodology, and inadequate nonconformance management.

Industry Insights
How To Design Cell-Based Potency Assays
Article | By Aryo Nikopour and Ming Li, Ph.D., Nitto Avecia Pharma Services

Not seen on HGTV: method design for cell assays. The many decisions when designing cell-based potency assays make home remodeling look easy.

The Evolution Of Public Health Research: The Next Frontier
Article | By Abdul Ally, Thermo Fisher Scientific

Public health and medical research occasionally take unexpected turns that allow us to glimpse new wonders in the world we inhabit. After the scientific community had accepted Pasteur’s germ theory of disease, discoveries in microbiology increased exponentially, including Robert Koch’s use of agar in 1876 as a culture medium to isolate specific microorganisms.

Scale Matters: A Flexible Approach To Demand Uncertainty
Article | By Bruce McCafferty and Mark Santos, Lonza Pharma & Biotech

Mid-volume capacity bioreactors offer agility in an unpredictable industry and balance the cost of goods as a program prepares to launch.

Why Invest In Emerging Markets Now
Article | By Günter Jagschies, GE Healthcare Life Sciences

Unexplored and emerging markets are an attractive prospect for biopharma companies looking to expand. But when it comes to ensuring success, what’s the wisest way to invest?

Business And Cultural Considerations When Managing Clinical Supplies For Asia-Pacific Studies
Article | By Michele Stokes, Catalent

In addition to careful adherence with all applicable regulatory and customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.

Don’t Let Insufficient Data Undermine Your CMO And CRO Selection Processes
Article | By Kevin Olson, ISR Reports

Selecting a partner is challenging, but with the right information you can simplify your efforts and increase your likelihood of making the best decision. 

Services And Equipment
Pharmaceutics International
Contract Development And Manufacturing: A CDMO Beyond Measure
Samsung BioLogics
Sterile Injectables Fill-Finish
Pfizer CentreOne Contract Manufacturing
Small Molecule API
Thermo Fisher Scientific



ISR Reports is a full-service market research company and sister company of Pharmaceutical Online. Operating exclusively in the pharmaceutical and pharmaceutical services industry, their syndicated and custom market research capabilities enable their customers to make smarter, more informed business decisions.


Topics include: Manufacturing practices and models, trends and technology, commercialization, dosage forms, excipients, outsourcing strategies, and more.


Check Out ISR's Syndicated Pharmaceutical Market Research Reports


Connect With Outsourced Pharma: