• A Glimpse Into Thailand’s Ongoing Life Sciences Transformation
    A Glimpse Into Thailand’s Ongoing Life Sciences Transformation

    During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.

What Thailand Revealed About U.S. Pharma R&D

A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.

Top 5 Biosimilar Developments Of 2016

In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.

Are You The Future of Pharmaceutical Development?

Pfizer's Bernie Huyghe and ADC Therapeutics' Michael Mulkerrin get bushwhacked with this question in a public forum. Their open replies will help each one of you to your own personal assessment. Be prepared for some soul searching.

The Case For Moving The EMA To Ireland

Relocating an organization as large as the EMA, which employs upwards of 1,000 people in London, will be no easy feat. As such, IDA Ireland, an agency that supports companies in Ireland and promotes foreign direct investments in the country, is working to compile information on why Ireland would be a good location for the EMA.

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  • An Introduction To Analytical Instrument Qualification & Validation — Meeting FDA Expectations
    An Introduction To Analytical Instrument Qualification & Validation — Meeting FDA Expectations

    According to the FDA and other regulatory agencies, analytical instruments should be under the same strict control as manufacturing equipment. Analytical instruments provide critical scientific data about a manufactured product. This data ensures confidence that a quality product has been manufactured and is appropriate and safe for sale to the public. Therefore, as manufacturers, we are bound to ensuring all of our equipment is strictly controlled. Analytical instruments must be qualified, just as manufacturing equipment. We have to show consistency, reliability, and repeatability to ensure the quality of the drugs we produce. The FDA's findings of deficiencies concerning analytical instrument qualification indicate it expects definitive evidence that instrument qualification schedules satisfactorily control manufacturing processes as well as testing processes.

  • Rapid Growth In Life Science Sector Constrains Capital Projects Supply Chain
    Rapid Growth In Life Science Sector Constrains Capital Projects Supply Chain

    According to the latest PharmSource Trend Report, Bio/Pharma CapEx Trends 2016, biopharma companies have invested over $150 billion in new plants and equipment in the past five years. As this sector continues on an upward trend, it is placing significant pressure on the supply chain. Mother Nature in California, Texas, Puerto Rico, Mexico, and Southeast Asia and Amazon’s much-anticipated HQ2 serve as further reminders to plan for mitigating cost and schedule project impact.

  • How To Build A Value-Added GMP Supplier Management Program
    How To Build A Value-Added GMP Supplier Management Program

    Typically, supplier management programs use a supplier survey or an on-site audit to verify if a supplier is compliant with the requirements of a standard or regulation. However, for a supplier management program to provide added value to an organization, the supplier evaluation should look beyond the requirements of a standard or regulation. A value-added supplier management program should also consider items such as supplier capability, capacity, and contingency planning.

  • Reviewing FY2017 FDA 483s: Training Failures Or A Learning Paradigm?

    I find it interesting to evaluate the FDA 483 data, year after year, and see the same pattern of non-compliance. An interesting response can be observed at conferences when this data is presented: Everyone begins to frantically write down the numbers.

  • Why You Should Engage With Regulatory Early In Product Development

    The transition from research to product development is a bit more involved than simply adding “&D” to “R.” Involving regulatory affairs early in the development process facilitates definition and execution of the development pathway while considering both regulatory requirements and the company’s business needs.

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  • Excipients: The Unsung Heroes Of Pharmaceuticals

    Excipients have a much larger influence on final product performance than the term “inactive ingredient” suggests. Choosing the right excipients is a key determinant of the quality.

  • Manufacturing Process Scale-Up For Phase III

    The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process may be.

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