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Catherine Hanley

Recent Posts by Catherine Hanley:

Alcami Attending DCAT Week 2019

Alcami will be attending DCAT Week 2019, to be held March 18 - 21 in New York, NY.

Schedule a Meeting with Alcami

Topics: Events

SCIENTIST SPOTLIGHT: January 2019

Name: Marilyn Heidbrink
Alcami Site: St. Louis, MO

How long have you been with Alcami?
I joined the Alcami team in August 2016.

What is your role? 
My title is Technical Specialist. I interact with sales and clients to understand the scope of the client’s project in order to draft protocols and reports for client projects. I also execute the validation and transfer activities. Additionally, I assist project managers and analysts with their technical questions. 

What is the most rewarding part of your job?
It is very rewarding when we execute analytical validations and issue reports which are then used to launch new products. It’s so inspiring to see a project from its beginning with validation to clinical use in patients.

Topics: Alcami Voices

SCIENTIST SPOTLIGHT: December 2018

Name: Matthew Collmeyer
Alcami Site: St. Louis, MO

How long have you been with Alcami?
I have been with Alcami since March 2018.

What is your role? 
I am the Sr. Manager of the Chemistry Laboratory Operations at Alcami's St. Louis, MO site.

What is the most rewarding part of your job?
The most rewarding part of my job is working with the chemistry team to tackle testing challenges and to see their dedication to ensuring we are doing as much as we can for our clients. Developing personnel through coaching and training is especially rewarding as well.

Topics: Alcami Voices

Video: Alcami's Oral Solid Dose Manufacturing

Your Manufacturing Milestones Matter.
Specialized to manufacture oral solid dose (OSD) forms, Alcami’s Wilmington, North Carolina site supports preclinical production through commercial launch and supply. Our cGMP manufacturing technologies, including low/high shear granulation and fluid bed drying capabilities, are arranged in flexible suites to support novel, advanced, and complex projects. 

In addition to OSD development and manufacturing, Alcami’s in-house analytical, stability, and packaging services provide an integrated and custom-tailored offering to help your product reach patients sooner.

Topics: Company News Oral Solid Dose Drug Product Videos

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