Webinars

Serialization is Behind You – Now What?

09.18.19

Wednesday, September 18th, 2019 | 10:00 AM ET

Compliance Alone Can’t Solve Your Drug Diversion and Counterfeiting Problems

Serialization is a great achievement for the pharmaceutical industry, however, executives now realize it is not the best answer to protect people from the dangers of drug counterfeiting and diversion. Global pharmaceutical companies are reassessing how to truly keep products authentic, safe and connected across the supply chain—from manufacturing to the patient’s hands. What if you could leverage what you’ve already invested in your serialization compliance efforts? It already exists and you can use it to fight counterfeiting and diversion. But how?

Join Systech and Fareva as we discuss the future of the pharmaceutical supply chain and review innovative technologies that are changing the landscape for brand, product, and consumer protection.

In this webinar we will discuss a CMO’s perspective:

Going beyond serialization and understanding why compliance alone isn’t enough
The need to stay innovative and add value and protection to your current serialization solutions
How to leverage existing package labeling to fight the threats that impact your supply chain
Cost-effective solutions to prevent counterfeiting and diversion that are being used by industry leaders today
How to digitally connect your product and gain real-time insight as it moves across the supply chain, without adding anything to your existing package labeling

Speakers:

David DeJean
SVP Strategic Initiatives, Systech

Pierre Laissy
Operational Excellence Director
Project Management & Continuous Improvement
FAREVA CORPORATE France

Designing an End-to-End Sterility Assurance Program

07.25.19

NOW AVAILABLE ON-DEMAND

Sterility assurance for a pharmaceutical product is critical, and includes many aspects outside of the actual sterilization cycle or aseptic process. There is some recent movement in the health care industry regarding the term End-to-End Sterility Assurance, along with a document being written through AAMI to provide guidance on the topic. Effective sterility assurance includes extensive collaboration with parties across the product life cycle. In the webinar we will address the various aspects of sterility assurance and provide guidance on establishing a complete program.

Speakers:
Martell Winters - Director of Scientific Competency, Nelson Labs
Wendy Wangsgard, PhD - Senior Scientist, Nelson Labs

Stability Testing as a Quality Control Measure

06.25.19

NOW AVAILABLE ON-DEMAND

Optimizing the Process throughout the Product Lifecycle

Assessing a compound’s stability is a complex and lengthy process with objectives varying by the development phase. A poorly designed stability study can cause delays that extend to years, create significant budget overruns and even result in product failure. Thus, stability testing requires scientific expertise and very specialized experience in order to minimize development costs and avoid severe consequences. This webinar will discuss the purpose, scope, and type of stability testing required at each phase of product development. With this understanding, sponsors can aim to optimize the process and ensure that the right data are gathered at the right time.

SPEAKER:
Guoqiang (Gary) Dong, PhD
Executive Director of Analytical Services of CMC
Frontage Laboratories

Terminal Sterilization or Aseptic Assembly? Consider all options for your Pharma product.

05.21.19

NOW AVAILABLE ON-DEMAND

Regulation is clear that, whenever possible, products intended to be sterile should be terminally sterilized in their final container. Only if terminal sterilization is not possible, filtration or aseptic assembly should be applied. This webinar will focus on elements to evaluate prior to selecting aseptic assembly for the manufacturing of sterile drug products. Participants will learn about various mitigation possibilities for the use of terminal sterilization with gamma radiation or ethylene oxide. Understanding the fundamental differences between aseptic assembly and terminal sterilization is a critical factor in overall patient safety.

SPEAKER:
Annick Gillet, Technical Director EO Pharma

3DP Dosage Forms and the Future of Drug Lifecycle Management

10.25.18

NOW AVAILABLE ON-DEMAND

Pharmaceutical companies and their drugs face numerous challenges in the brief window between launch and patent expiration. This makes it extremely important to plan lifecycle management (LCM) strategies well in advance of patent expiry. One way to address this is with advanced manufacturing techniques that make it much more difficult for competitors to genericize.

For pharmaceutical companies that seek market enhancement strategies beyond the capabilities of existing fast melt technologies, join Contract Pharma for this webinar as we hear from Don Wetherhold, the senior executive advisor and senior vice president of Aprecia Pharmaceuticals. He will talk about the company’s innovative ZipDose technology and why it offers an exclusive opportunity to address patient demand and create products not easily genericized.

See how Aprecia’s 3DP for pharmaceutical manufacturing can help you expand your drug’s market reach into new therapeutic areas and patient populations by unlocking entirely new dosage forms—with formulation opportunities that can only be achieved using 3DP for Pharma technology.

SPEAKER:

Don Wetherhold, SVP, Business Development, Aprecia Pharmaceuticals

Mr. Don Wetherhold serves as the head of business development at Aprecia Pharmaceuticals where he also serves as a key strategist and advisor to the senior executive team. Mr. Wetherhold previously served as the company’s Chief Executive Officer (2013 – 2017) prior to which he served as Senior Vice President, long-term care at Omnicare, Inc. Mr. Wetherhold was Aprecia's Corporate Commercialization Officer previous to his time at Omnicare.

Mr. Wetherhold’s career spans 30 years of experience in the healthcare industry, including key leadership roles and management positions at Omnicare, Prasco Laboratories, Hampton Lane, Cardinal Health, Snyder Healthcare Sales and Solvay Pharmaceuticals.