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Catherine Hanley

Recent Posts by Catherine Hanley:

SCIENTIST SPOTLIGHT: November 2018

Name: Jasmine Mace
Alcami Site: Germantown, WI

How long have you been with Alcami?
I have been with Alcami since March 2014.

What is your role? 
I am an Analytical Scientist II.

What is the most rewarding part of your job?
It is very rewarding when I am presented with a difficult analytical method development and I find a way to deliver a solution to the client. Sometimes it takes some “thinking outside of the box” to arrive at a solution which satisfies the client’s needs for an analysis. The key for me is always asking the right questions:

  • Is this testing needed, or are there adequate tests being done to satisfy the quality attributes of the process/compound?
  • Are there any historical examples of how a similar problem was handled in the past?
  • Which techniques could potentially be used?
  • Did I think of what the test method could potentially affect downstream?
Topics: Alcami Voices

Case Study: Medicines Development for Global Health

In 2016, the not-for-profit Australian biopharmaceutical company Medicines Development for Global Health (MDGH) came to Alcami to initiate work on moxidectin, a novel new drug for the treatment of river blindness (onchocerciasis). The project utilized Alcami’s advanced analytical testing services and industry-leading accelerated turnaround time offering to meet critical New Drug Application (NDA) filing timelines. Now, the two companies are exploring new opportunities to help eliminate neglected tropical diseases that affect over 2 billion of the world’s most disadvantaged people.

Read this case study to learn more about how Alcami’s advanced analytical testing technology center supported MDGH's moxidectin’s US Food and Drug Administration (FDA) approval.

Topics: Resource Center Analytical Development

White Paper: Insight into Orphan Drug Formulations and Regulations

The US Orphan Drug Act of 1983 characterizes an orphan disease as a rare medical condition that affects a population of fewer than 200,000 people. Rare diseases have various causes— most notably, genetics. However, the National Institutes of Health (NIH) states, “many rare diseases, including infections, some rare cancers, and some autoimmune diseases, are not inherited. While researchers are learning more each year, the exact cause of many rare diseases is still unknown” (NIH, 2017).

The term “orphan disease” resulted from pharmaceutical companies not having the resources to design and scale up formulations to treat these diseases, due to the lack of financial support for such highly specialized programs. The Orphan Drug Act (ODA) allows for the necessary financial backing of pharmaceutical companies to develop treatments for rare diseases (NIH, 2017), giving special status to a drug or biological product (drug) upon request of a sponsor. This status is referred to as orphan designation or orphan status.

Topics: Resource Center Oral Solid Dose Formulations Regulatory Compliance Orphan Drugs

Alcami President & CEO Elected as 1st Vice President of the Board of Directors of the Drug, Chemical & Associated Technologies Association

Stephan Kutzer, Ph.D., President & CEO of Alcami Corporation, has been elected to serve as 1st Vice President of the Board of Directors of the Drug, Chemical & Associated Technologies Association (DCAT) beginning November 1, 2018. Together with the ten other members of DCAT’s Board of Directors, Dr. Kutzer will help develop and guide the organization’s strategic plan in a manner to best serve the organization’s 500+ member companies.

Topics: Company News

Beyond the Label: Four Challenges to Serialization

Many pharmaceutical manufacturers are concerned about label design and placement to accommodate a serialized label. These are, of course, very legitimate concerns. However, there are much more complex issues at hand, including the importance of standardization, scaling information technology infrastructure, agility to accommodate regulatory changes, and data security.

Why Serialization Matters
The first objective of any pharmaceutical company is to deliver safe and effective medicines to patients. While historically there have been methods to provide product visibility and control along the supply chain, the processes have been highly manual, with paper-based record keeping being the prevalent modality.

Topics: Regulatory Compliance Serialization Supply Chain

ON-DEMAND WEBINAR: Submitting Samples through Alcami OnDemand™

Join Alcami for a webinar to learn more about submitting samples through Alcami OnDemand, a customer portal that provides clients unprecedented and rapid access and visualization into ongoing projects. 

Using Alcami OnDemand to submit Analytical Testing projects is a simple process that will save you time and streamline project tracking. This webinar will detail the finer points of online sample submission. We will show you how to build a sample submission project in Alcami OnDemand and walk you through the following processes:

Topics: Webinars Analytical Development Analytical Testing Alcami OnDemand

SCIENTIST SPOTLIGHT: October 2018

Name: Zach Dubey
Alcami Site: Germantown, WI

How long have you been with Alcami?
I have been with Alcami for two years.

What is your role? 
I am a Process Chemist in the Kilo Labs Manufacturing department, which manufactures APIs, normally generics, on a smaller scale (gram to kilogram scale).

What is the most rewarding part of your job?
The most rewarding part of my job is training new personnel and collaborating with the Technical Services department on the Kilo Labs processes with which I have become intimately familiar. I also enjoy learning about these processes beyond the executional level (i.e. the sequence of steps in the batch record); understanding the underlying chemistry within these processes provides a greater respect for the chemistry and answers “the why question,” or why I am executing a step—or sequence of steps—a certain way. This has also been beneficial when writing complicated deviations that require a sophisticated understanding of these processes.

Topics: Alcami Voices

Alcami Launches New Features and Enhancements to Alcami OnDemand

Alcami OnDemand™ is a customer-focused portal giving you the power to know where your results are at all times. Alcami OnDemand (AOD) features quoting tools, project tracking, material and test reference libraries, a progressive messaging center, and central file repository. AOD provides you with the ability to build a custom sample submission quote quickly and track major milestones within your project.

Alcami’s new features and enhancements to the platform allow for a more user-friendly and intuitive system. Our mission is to continuously bring first-to-market initiatives to the pharmaceutical and biotechnology industries— further increasing our commitment to our clients and their patients. Improved features include:

Topics: Alcami OnDemand Analytical Testing

Editorial: Aligning with Sponsors for Strategic Growth

As published in Pharma's Almanac Q3 2018.

In the current climate, the success of innovative small and medium-sized drug companies is increasingly important to the success of the industry as a whole. Alcami is focused on enabling the growth of these firms and, in the process, changing the structure of the market. Having demonstrated the feasibility of our integrated business model and educational strategy, we are taking these efforts to the next level through our partnership with Madison Dearborn Partners (MDP).

Topics: Thought Leadership Editorials

Case Study: Stability When You Need it Most

The top pharmaceutical developers and manufacturers pride themselves on their ability to successfully manage and mitigate risk. Some implement dual sourcing strategies to secure their supply chain, like Alcami’s Protect Your Brand® program. Others invest in infrastructure to minimize project disruptions, but even the most meticulously-planned backup strategies can fail and emergencies can still disable sophisticated protection measures. What happens when critical analytical testing timelines are threatened?

In this case study, Alcami’s laboratory services experts quickly stepped in to save a new client’s key stability study, and in the process became their trusted solution provider.

Topics: Resource Center Stability