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Digital Adrenaline: Can An App Be Effective in Drug Delivery Training?
Adele Graham-King 5/22/2013 7 comments
An app has been developed that simulates the adrenaline injection process to ensure that patients use devices correctly. Simulation can go only so far, but could this be a good way to handle drug delivery instruction?

Electronic Batch Records: Are Your Systems Ready for Inspection?
Jim Cahill 5/21/2013 3 comments
Electronic batch records call for the automation of "negative paths," but remember, you can't possibly define every single thing that could possibly go wrong during manufacturing. However, you can predefine mitigation and resolution activities.

In-Silico Drug Development: A Must-Read Paper
Agnes Shanley 5/20/2013 2 comments
A paper sketching a new, in-silico approach to new drug development has been published by Swiss Pharma. Authors verified the process in the lab. It seems like science fiction, but authors argue it would save money in the long term. What do you think?

Can Simulation Take Drug Development Into the Future?
Agnes Shanley 5/20/2013 5 comments
How can more advanced formulation development technologies be made more accessible for generic drug manufacturers and smaller pharma? A conference in Cambridge next month will discuss knowledge gained from academic and industrial simulation studies.

A Spoonful of Sugar
Adele Graham-King 5/17/2013 10 comments
Isn't it time that we developed better oral liquid drug delivery alternatives for children?

Making New Drugs, Not Patients, the Guinea Pigs
Agnes Shanley 5/16/2013 3 comments
The second in our "Outliers: Roads Less Travelled" series looks at mytomorrows.com, a new startup based in Amsterdam, which aims to turn the clinical paradigm on its head, making investigational drugs the guinea pigs of patients with terminal illnesses and unmet medical needs.

PharmaEvolution Case Files 4
Agnes Shanley 5/15/2013 4 comments
A look at pharma's recent smart and not-so-smart moves (and movers).

Are You Smarter Than an FDA, EMEA, or PIC/S Inspector?
Barry A. Friedman 5/15/2013 4 comments
Barry Friedman has cooked up this little quiz to see how well you understand those portions of the FDA's cGMPs that are most often cited in 483's involving contamination issues: 21 CFR 211.192 and 21 CFR 211.113(b).

Are Regulators Missing Opportunities for Greater Clarity on Aseptic Requirements?
Barry A. Friedman 5/14/2013 6 comments
Industry watchers have noted an increase in regulatory actions based on contamination. Are opportunities for greater clarity and improvement being missed?

Improving APIs & Formulation: Are You Harnessing the Power of Liquids?
Girish Malhotra 5/14/2013 3 comments
Failing to take advantage of material properties, especially those of liquids, can mean losing out on opportunities to improve process productivity and sustainability. Long term, this will only lead to loss of competitive advantage and profit.

Biosafety Cabinets & Laminar Flow Hoods Are Not Interchangeable
James Agalloco 5/13/2013 4 comments
Let's remember the key difference between the two: Laminar flow hoods operate with a net flow of air out, while biological safety cabinets operate with a net flow of air in. Using the two as if they were interchangeable puts patients at risk!

Where Did the Term 'Design Space' Come From Anyway?
Ron Snee 5/12/2013 10 comments
A look at the origins of a much debated and contested term reveals some interesting facts, and lessons on change.

Outliers: Taking the Road Less Traveled
Agnes Shanley 5/10/2013 7 comments
A new regular feature will look at pharma professionals who are enhancing the industry's image through interesting and altruistic ventures. We start with Maryellen Ruvolo, whose new project aims to fund job creation by helping companies save money on recruitment.

Who Has Won Our Cartoon Caption Writing Contests So Far?
Agnes Shanley 5/9/2013 3 comments
Here are the winners of our cartoon caption writing contests so far! We'll be getting in touch with each of you soon.

Slideshow: How to Get in Trouble With [INSERT REGULATORY AUTHORITY HERE]
Agnes Shanley 5/8/2013 5 comments
The FDA's CDER recently summarized the top 15 inspection findings that lead to 483s. Turns out the patterns transcend international boundaries. Here, a pictorial look at errors of commission, or most likely, omission, from cartoonist Jerry King.

Slideshow: The Rogues Gallery of Pharmaceutical Counterfeiting
Agnes Shanley 5/8/2013 3 comments
It's important to remember that pharmaceutical counterfeiting is not limited to developing nations -- or to Internet sources. The Partnership for Safe Medicines recently put human faces on a global problem.

Reformulating to a More Convenient Tablet for Patients With Dementia
Agnes Shanley 5/7/2013 8 comments
Close control of particle size and other key factors allowed one team to reformulate a challenging drug into a convenient form that is likely to improve patient compliance.

Pharma Evolution Case Files 3
Agnes Shanley 5/6/2013 10 comments
A look at pharma's recent smart and not-so-smart moves.

Approaching Formulation Like a Materials Scientist
Agnes Shanley 5/6/2013 11 comments
A recent webcast emphasized the importance of risk management and materials science in developing a more scientific approach to pharmaceutical formulation.

Will US Senate Track & Trace Proposal Really Protect the Supply Chain?
Ed Silverman 5/3/2013 18 comments
Finally, US lawmakers have proposed legislation to require tracking and tracing of pharmaceuticals. But some advocates such as the Pew Group wonder if it goes far enough.

Why Face Time With Regulators Is Critical to PAT/QbD Success
Agnes Shanley 5/2/2013 16 comments
Speakers on an Interphex 2013 panel on PAT and QbD noted ongoing issues with acceptance and understanding of these concepts. However, a BMS project suggests that regulators are or will be receptive if you address their questions face-to-face.

Product Volume & API Process Optimization: Connecting the Dots
Girish Malhotra 5/2/2013 8 comments
API manufacturing processes can be complex and complicated. Our job is to make them as simple and environmentally friendly as we can and produce things that meet quality targets all the time without interference. Volume targets must guide these efforts.

Winning the Stem Cell Race: Could Inducible Stem Cells Level the Playing Field Between the US & Asia?
James Netterwald 4/29/2013 10 comments
Inducible techniques allow stem cells to be collected without damage to human embryos. The technique ends ethical dilemmas involved in this research, and could level the competitive playing field, allowing US research to catch up with that in Asia.

Ajaz Hussain Challenges Indian Generics Firms
Agnes Shanley 4/29/2013 13 comments
At a recent Indian Pharmaceutical Alliance meeting, Wockhardt's chief scientific officer asked whether the country's generics manufacturers can win a Baldrige Award by 2020.

Illicit Designer Drugs: The 'Other' Biosimilars
Emil W. Ciurczak 4/25/2013 9 comments
If the FDA were also given oversight of illegal drugs, couldn't that bring the collective power of the FDA, DEA, ATF and FBI to assist in seizures and arrests?

FDA Crackdown on Compounders: Too Little, Too Late
Ed Silverman 4/25/2013 12 comments
The FDA now admits that it could have done more to prevent the compounding safety disaster.

Changing Pharma’s Negative Public Image
Agnes Shanley 4/22/2013 29 comments
Former Pfizer R&D chief John Lamattina proposes some interesting solutions to improving pharma's poor public image in his blog on Forbes.com. Unfortunately they don't address core quality, compliance, and development/manufacturing issues.

ICH Q11 & Stealth QbD for Drug Substances
Bikash Chatterjee 4/18/2013 6 comments
Last May, ICH Q11 came on the scene without much hoopla, but the new guidance aims to clarify and apply principles outlined in ICH Q8-10, to drug substances. It represents the future for our industry.

Cancer Drug Delivery Goes Nano
James Netterwald 4/17/2013 8 comments
Finally, breakthroughs are being made in the area of nanoparticle delivery of cancer treatments.

Question-Based Review, APIs & the Importance of Being Biosimilar
Emil W. Ciurczak 4/17/2013 6 comments
Question-Based Review could be a way to help ensure the safety of biosimilars.

So You Think You Know Lean?
William Botha 4/15/2013 6 comments
Do you understand Toyota Production System concepts and how they connect, or might connect, to pharma? Take William Botha's quick quiz and find out.

The Michelin Chef Approach to QbD: Developing the QTPP
Line Lundsberg 4/15/2013 9 comments
I asked an award-winning Michelin Chef to summarize his approach to cuisine and was surprised to learn how relevant his approach is for pharmaceutical Quality by Design.

Accountability & Ending the 'Us' vs. 'Them' Impasse Between Quality & Manufacturing
William Botha 4/12/2013 9 comments
21 CFR Part 211.22 calls for a separation between quality and manufacturing departments, which often leads to a dysfunctional relationship between the two. In the end, manufacturing must still lead the charge to continuous improvement.

California's E-Pedigree Requirements Could Have Global Impact
Douglas Stockdale 4/11/2013 5 comments
California's new E-Pedigree law poses major packaging challenges. Are you ready for them?

And We'll Name the Baby... Apotex? Using Technology to Prevent Packaging Errors
Emil W. Ciurczak 4/11/2013 8 comments
Yet another birth control pill recall reminds us of the need to harness preventive technology. Too expensive, you say? How about the costs of a major class action or huge ethical issues?

India Gives Pharma a Reality Check on Drug Patent 'Evergreening'
Agnes Shanley 4/10/2013 16 comments
We can expect other nations to follow India's lead in rejecting lame patent extension attempts. Isn't it time for pharma to wake up? And for patent law to change?

Biopharmaceutical Facilities: Modular Does Not Always Mean Flexible
Maik W. Jornitz 4/9/2013 10 comments
A number of modular and flexible choices are available for new biopharma facility designs. All are valid. However, modular plants are not always flexible.

Data Mining Can Be Dangerous Work
Emil W. Ciurczak 4/8/2013 16 comments
When done correctly, data mining can yield great benefits. But never assume anything about the way the data was collected. Establish best-practices for operators and equipment calibration, or it's safe to assume the worst.

Justifying New Tech Investment When the Plant Is Running Full Out
Jim Cahill 4/5/2013 10 comments
It's often easier to prove the return on investment of a new project or technology when a manufacturing facility is running at or close to capacity.

The FDA May Determine What We 'Like'
Sherry Yanez-Gregor 4/4/2013 9 comments
In the absence of any concrete guidance from regulators, a recent FDA Warning Letter offers pharma some clear guidance on social media policy.

The Secret Life of APIs: The Importance of Sociochemicology
Girish Malhotra 4/4/2013 8 comments
Optimizing API development requires a close understanding of each functional chemical or chemical group's individual and collective behavior. I call this "sociochemicology." Without it, you can't apply QbD to active ingredient manufacturing.

An Effective, Flexible Framework for More Effective Drug Development
Robert Dream 4/2/2013 6 comments
Personalized medicine, more proactive healthcare, and focused "nichebuster" drugs can only be envisioned today because of new tools and technologies, as well as changes in manufacturing and facilities.

Sterilizing Grade Filter Integrity Testing: Let Process Risk Dictate Practice
Maik W. Jornitz 4/2/2013 4 comments
Requirements for testing the integrity of sterilizing grade filters are unclear. Practice should depend on the level of risk within the process.

You're Optimistic About FDA Restructuring
Agnes Shanley 3/29/2013 5 comments
Most respondents to our last poll believe restructuring will lead to a more efficient FDA.

Coming Soon: A Michelin Guide to QbD
Line Lundsberg 3/28/2013 5 comments
At this point, the jury is still out on whether the concept of QbD has been useful to the industry. Patients cannot judge quality until after they've taken a drug for a long time. Perhaps the best insights will come from those experienced in drug development.

How Well Do You Understand Supply-Chain Management?
Hedley Rees 3/28/2013 8 comments
The right approach to supply-chain management involves QbD thinking, and developing this approach should start as early as possible in the value chain, during pre-formulation, says consultant Hedley Rees, who offers a quiz on the topic of supply-chain management.

No Nonsense Computer Systems Validation: Covering All Bases
Michael J. Gregor 3/26/2013 7 comments
ISPE's GAMP is a useful guide, but may not be practical for smaller companies. In addition, it calls for some steps that are not required. Here is a quick rundown of what is legally required under 21 CFR Part 11.

I Don't Mean to Be Critical, But...
Bikash Chatterjee 3/26/2013 10 comments
New interpretations of process validation, and concepts like quality by design, have failed to gain traction. Until the pharmaceutical industry can embrace good science, positive change will remain elusive.

Better Capsules Through PAT
Emil W. Ciurczak 3/22/2013 3 comments
A quick review of how NIR-based PAT can help optimize capsule production.

Form-Fill-Seal as an Aid for Patient Compliance, Lean Operations
Douglas Stockdale 3/22/2013 8 comments
FFS technology, aided by robotics and more efficient, lower-cost production, is particularly useful for patients who require infrequent dosages of pharmaceuticals, particularly over-the-counter drugs. It can also contribute to leaner operations.

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