Author Archive

Grad Student Innovation

Angie DrakulichWant to know what the future of pharma science looks like? AAPS knows. They recently awarded several graduate students for their work in research and development, pharma analysis, drug delivery, bio- and nano-technology, and more. PharmTech had the chance to talk with some of the winners and their stories appear in the December issue of PharmTech. You can get a sneak preview of the students’ winning research via a video podcast on and the PharmTech Player.

When Disaster Strikes at Home

Angie DrakulichThe editorial offices of PharmTech are based in New Jersey, so when Hurricane Sandy hit last month, we were all affected. Flooding and high winds destroyed many coastline homes along with well-known destinations across Atlantic City, the Jersey Shore, and the neighboring Manhattan boroughs. Suburban communities and businesses (including many US biopharma manufacturing headquarters) across the state were without power for days and schools were shutdown for a week or more in several counties. President Obama declared the state, along with New York, a major disaster area. The entire ordeal was quite surreal, and our team considers ourselves to be lucky that we made it through unscathed. Our thoughts go out to those who are still recovering from the storm and trying to get back to normal. Read more »

Changing Trends in Laboratory Compliance

Laboratory best practices for meeting regulatory and compendial requirements are changing. FDA’s emerging expectations on data integrity, operational qualification report generation, along with the ISPE GAMP Good Practice Guide for Validation of Computerized Systems have provided the industry with new ways to approach laboratory compliance. In addition, the status of USP Informational Chapter <1058> on analytical instrument qualification is being discussed across the industry and the pharmacopeial body. A stimulus paper is being written on this chapter, offering some revision proposals.

Paul Smith, EMEA and India Compliance Program Manager at Agilent, spoke about these issues and offered some best practices for moving forward in an educational webcast. You can watch the webcast for free on demand here.

FDA 483 Issued in the Calm before the Storm

The East Coast, including PharmTech’s offices, is largely boarding up and shutting down in preparation for Hurricane Sandy.  But the FDA is still keeping vigilant. Just before the weekend, on Friday, Oct. 26, 2012, FDA released a copy of a Form 483 issued to the New England Compounding Center (NECC), which has been under investigation for violating the Federal Food, Drug, and Cosmetic Act.

“The inspection report for NECC has not been completed and is not being shared at this time,” says the release. FDA is still working with the US Centers for Disease Control and Prevention and Massachusetts partners regarding fungal meningitis outbreak and those patients who received NECC’s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid, according to the release.

For back story, see the video on regarding the compounding center and its connection to the recent fungal meningitis outbreak.

FDA Reg Science Initiative Moving Along with Academic Help

Angie DrakulichDr. Lei Zhang of CDER’s Office of Translational Sciences gave an update at the AAPS Annual Meeting in Chicago yesterday regarding the agency’s regulatory science initiative, which was rolled out in August 2011. She noted that some of the same challenges facing regulators a few years ago continue to plague FDA drug reviewers, namely:

-products are being developed more quickly using evolving sciences and technologies
-unmet medical needs are growing
-industry is shifting from a treatment focus towards a focus on disease prevention and long-term clinical outcomes
-global drug development is leading to increased responsibilities for all.

The agency is trying to address these challenges not only with increased regulatory collaboration, which we’ve been hearing about for a few years (e.g., EMA, TGA, overseas offices) but also with grant programs to encourage academic research into how drugs and devices are reviewed and evaluated at FDA. Read more »

Grad Student Research Sparks Innovation through AAPS Awards

Angie DrakulichAt this week’s AAPS 2012 Annual Meeting in Chicago, graduate students across the country are being honored for their research and work in bio/pharmaceutical innovation. Pharmaceutical Technology had the chance to talk with a few of the recipients. Read more »

AAPS 2012 Annual Meeting and Exposition Next Week

Angie DrakulichI’ll be in Chicago next week for the 2012 annual AAPS meeting and hope to see you there. Looking forward to this year’s hot topic conversations on the changing pharma sciences career, drug development at small companies, FDA’s regulatory science initiative, and drug shortages in the United States. These sessions are being led by key industry representatives and offer insight into key challenges facing bio/pharmaceutical developers and manufacturers. Plus, AAPS will be announcing the recipients of its graduate student awards, among other recognitions. If you can’t make it to the show, be sure to follow my tweets @PharmTechAngie. And if you are there, stop by our booth #5011.

How to Handle an FDA-483 Observation When You Don’t Agree

The best approach to deal with an observation with which a company does not agree is to prevent an FDA-483 observation in the first place. During the course of an FDA inspection, there will be many opportunities to ascertain the areas of interest and potential areas of concern of the investigator. The clearest opportunity to understand the true concerns of the investigator will be during the periodic wrap-up sessions, which should occur on a daily basis per Investigations Operations Manual (IOM) Section 5.2.3, writes Parexel’s David Elder and Richard Wright, former FDA officials, in the current PharmTech issue.

FDA investigators are human beings just like the rest of us and mistakes or misunderstanding can happen. The agency encourages the industry to use these communication opportunities to ask questions or request clarification, and if during the course of these communication opportunities it becomes apparent that there is an area of misinterpretation or misunderstanding, additional information or documentation should be presented quickly and clearly, they state. Read more of this answer in the October issue of PharmTech

How to Reach First-in-Man Studies Successfully

What’s the best way to reach first-in-man studies when you have little to no information?   Bioavailability issues, financial constraints, and pressure to meet accelerated deadlines can affect development, so having a firm plan in place is key. PharmTech is hosting a free educational webinar on this topic next week, Oct. 3. Check it out for insight into the signs to look for when finalizing a plan and how to achieve the best outcomes. A detailed case study about a molecule that has successfully navigated through development to commercial success will be presented.

CMC Troubles? Send Us Your Questions

Pharmaceutical Technology and Patheon are partnering to provide you—our readers—with CMC advice from some of the leading formulation scientists and pharmaceutical manufacturing experts in the world. To get started, we need to know what plagues your CMC strategies and daily work. Email your questions directly to Editorial Director Angie Drakulich at (*Note: We will keep your name and company affiliation anonymous.)

Answers will be provided by the Patheon Certified Consultants team beginning in the January 2013 print and online editions of PharmTech. These experts have collectively brought more than 200 pharmaceutical products to market, including some of the world’s largest blockbusters.

Sample questions:

• I have a BCS Class II compound for which amorphous solubility is easily sustained, but I can’t get the compound to rapidly dissolve. What are some solutions, particularly with respect to excipient selection?
• I have a compound that is non-ionizable and does not form a stable salt. Are co-crystals my best option and what are the key criteria in identifying a suitable co-crystal?
• I am having trouble maintaining product stability when scaling up a lyophilization process. What are the likely factors causing the problem?

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