Societal CDMO

Maintaining a Strong Company Culture Through Difficult Times

Change, particularly during difficult economic seasons, is inevitable and can pose a threat to the values that define an organization’s culture. A strong culture supports the organization’s mission and goals while keeping team members aligned, engaged, and motivated. Ensuring your company’s culture remains strong during difficult times starts with a few fundamentals.

In this video, sponsored by Societal™ CDMO and presented by 

, J. David Enloe, President and CEO, and Erica Raether, Senior Vice President and Chief People Officer, both at Societal™ CDMO, share their insights surrounding how companies can ensure their values are being represented in daily interactions and communications.

Videos

Societal™ CDMO's J. David Enloe and Erica Raether discuss the fundamentals of maintaining a strong company culture during times of change.

Join us for a presentation as we share real-world experiences as a Pharmaceutical CDMO with a well-established history of formulation development and commercial manufacturing.

https://www.pharmtech.com/pt_w/avoiding-clinical-hold

This webinar highlights the advantages associated with a pre-IND meeting request and briefing document submission for a drug development program. Learn more about what topics should be addressed and learn how to successfully prepare CMC and eCTD activities in accordance with regulatory requirements to increase the chance of a successful IND submission and avoid clinical hold.

Significance of pre-IND meeting requests, briefing packages, and ongoing FDA correspondence

Successful preparation of CMC and eCTD activities in accordance with regulatory requirements

Understanding regulatory expectations and avoiding issues

Heads of Pharmaceutical Development, Analytical and Clinical Activities

Pharmaceutical Business Development Professionals


Vice President, Regulatory Affairs and Pharmacovigilance
Societal™ CDMO



 brings over 35 years of experience in pharmaceutical regulatory affairs to Societal™ CDMO, serving as the site’s vice president of regulatory affairs and pharmacovigilance. Wayne is an experienced manager with broad experience and success, supporting regulatory agency meetings in addition to IND, NDA, ANDA, DMF, and ROW filings and approvals. Wayne has a strong understanding of regulatory, clinical, development, and life cycle management filing requirements, including post-approval support for phase IV, pharmacovigilance, and supplemental approvals. Prior to joining Societal™ CDMO, Wayne held various positions of increasing responsibility at Alkermes, Elan Drug Technologies, and Solvay Pharmaceuticals.

Wayne is a registered pharmacist graduating from the Mercer University School of Pharmacy. He has delivered lectures in regulatory affairs and pharmacovigilance for the University of Georgia School of Pharmacy: Master of Science in Regulatory Affairs program and serves as an adjunct professor. He has also supported the Mercer School of Pharmacy: Doctor of Pharmacy Preceptor training program. He is a member of RAPS, DIA, and AAPS.




Director of Regulatory Affairs
Societal™ CDMO

 brings 20 years of experience in pharmaceutical regulatory affairs and quality to Societal™ CDMO. She is currently the director of regulatory affairs. Karen’s experience includes CMC, electronic submissions (eCTD), drug safety reporting, and labeling in NDA and ANDA filings. Prior to joining Societal, Karen held various positions of increasing responsibility at Par Pharmaceuticals (formerly Qualitest). Karen holds a BS in Chemistry from San Diego State University. She is a member of RAPS.



 has more than 30 years of experience in the pharmaceutical contract manufacturing industry, specializing in the areas of regulatory compliance and new drug applications. Sharon currently works for Societal™ CDMO, serving as the associate director of regulatory affairs. Prior to joining Societal™ CDMO, Sharon held various positions of increasing responsibility at Mikart, LLC.

Sharon’s career experience includes eCTD drafting and submissions for various IND, NDA, ANDA, DMF, and ROW filings. Sharon has a strong background in the overall drug development process and in providing teams with regulatory support throughout the entire product lifecycle.

Sharon received her BS from the University of Georgia. She also holds a Regulatory Affairs Certification and is a current member of RAPS.



Webcasts

Webinar Date/Time: Wed, Nov 3, 2023 11:00 AM EDT

Pre-IND Meeting Requests and Avoiding CMC Related Clinical Hold

Articles

Technology Transfer and Commercial Manufacturing of Tablets and Capsules

Societal™ CDMO Tech Transfer Capabilities Fact Sheet

Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. Because of their high-profile importance in development, clinical needs get the emphasis, while the many CMC needs and risks may seem less critical. Unfortunately, as time passes, there is an increased risk of CMC issues becoming more complicated, time-consuming, and expensive to fix. Learn how to avoid these roadblocks by reading this white paper from Societal™ CDMO.

How to Avoid Last-Minute CMC Roadblocks to Approval (Oct 2023)

The relationship you build with your executive sponsor (ES) is the most critical relationship you will build with your CDMO partner and will serve as the foundation for long-term commercial success. At the core of vendor selection activities, it is vital to understand the CDMO’s flexibility and culture, models and scale of equipment, technical and analytical capabilities, regulatory support, quality system, and audit inspection history – and it is equally as vital to understand its executive sponsorship model. Learn more about why this is a vital component of your process.

The Value of An Executive Sponsor with Tech Transfers

Do you want to develop an oral controlled release (OCR) product? If so, you’ll quickly realize there are a lot of questions to answer. What do you want the final dosage form to do? What formulation and process approach are you going to use? What traps and roadblocks might you encounter? Understanding the options and their ramifications is the first step toward devising a plan.