Life Science Stability Testing and Validation Conference

March 19-20, 2018 | Herndon, VA

Hilton Washington Dulles Airport Hotel

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DAY ONE | MONDAY, MARCH 19

7:45 REGISTRATION & WELCOME COFFEE

8:45 CHAIRPERSON OPENING REMARKS

9:00 CASE STUDY: ALIGNING STABILITY TESTING & VALIDATION THROUGHOUT THE PRODUCT LIFECYCLE
Forward thinking life sciences corporations are considering comprehensive, longterm product lifecycle approaches to stability testing to validate the long-term stability and shelf-life of products through testing at routine intervals and utilizing data from early clinical phases in later product phases to reduce duplicative testing and operational expenditure. This type of lifecycle approach to stability testing has many benefits for corporations and products, creating assurance of product stability through longer-term testing and data analysis, as well as statistical benefits of routine long-term testing. At the same time, lifecycle approaches can be difficult to implement and carry out over long periods of time, and requires thoughtful planning in order to execute correctly.

  • Early stability testing pre-clinical through Phase 2
  • Testing stability ahead of pivotal Phase 3 trials
  • Post-market stability testing & annual review

Peju Odunusi, Group Leader, Stability, ABBOTT VASCULAR

 

9:45 PANEL DISCUSSION: ACCURACY OF STABILITY TESTING IN SHELFLIFE PREDICTION
A core area of importance for stability testing executives is ensuring that shelf-life predictions are accurate and take a risk-based approach to ensuring the safety of medicinal products, though it can be difficult to consider all factors involved in the real-life utilization of therapies. Varied approaches to shelf-life determination can result in differing outcomes, a cause for considerable concern for both manufacturers as well as regulators. Discussion surrounding shelf-life prediction and the differing routes to determination will provide participants with insights into the activities and best practices in accurate shelf-life testing.

  • Development of accurate specification protocols
  • Comparison of real-time and accelerating testing
  • Regulatory acceptance of shelf-life estimation

Emily Jameson, VERTEX PHARMACEUTICALS INCORPORATED

Cheryl Collier, B. BRAUN MEDICAL

Kim Huynh-Ba, PHARMALYTIK

 

10:30 COFFEE & NETWORKING BREAK

 

11:00 BUILDING A STABILITY TESTING DEPARTMENT FROM THE GROUND UP
Whether initiating internal stability testing at a smaller organization for the first time, or breaking away from a larger group to become a free-standing stability testing department, many stability executives are being called upon to build standard operating procedures, laboratory equipment and technology set-up, and comprehensive teams of scientists from the ground up. The opportunity to develop such a function provides executives with a clean slate but at the same time requires thoughtful consideration for the resources required, budgets needed and requisite personnel to fully equip an internal stability group. Analysis of one organizations journey towards a free-standing stability testing function will provide insights into best practices that can be applied to a variety of scenarios, whether rebuilding or restructuring an existing team, or initiating stability testing internally for the first time.

  • Securing internal support for stability testing
  • Resources required for effective internal testing
  • Lessons learned in internal stability testing

Heather Egland, Stability Supervisor, FRESENIUS KABI

 

11:45 CASE STUDY: TEST SPECIFICATION METHOD & PARAMETER SELECTION
In order to comply with complex regulatory guidance from FDA, other national regulatory authorities as well as in-line with ICH guidance documents, stability testing executives must thoughtfully consider test specification methods and parameters to ensure results meet appropriate criteria. While regulatory authorities increasingly seek a wider range of test specification parameters, it is important to consider the real-life utilization of products, potential storage methods by patients and healthcare professionals, to set realistic parameters. As parameter and method specification establish the framework for submission data, it is critical that stability executives select and set the most appropriate parameters possible.

Jian Liu, Ph.D., Manager, Stability R&D Analytical Chemistry, ABBOTT VASCULAR

 

12:30 LUNCHEON FOR ALL CONFERENCE GUESTS

 

1:45 USE OF LIMS TECHNOLOGY FOR EFFECTIVE VALIDATION OF STABILITY TEST RESULTS
With the necessity of digitization in stability testing, managers responsible for overseeing stability validation utilize Laboratory Information Management Systems for ensuring comprehensive documentation, efficacy and quality of stability testing. These systems are able to provide efficient, real time data with audit trails, and include modern features with increased storage capability. By providing a better understanding of LIMS features and benefits, stability teams can streamline testing documentation across the board, while maintaining compliance with regulatory authorities.

  • Features of LIMS upgrades
  • Analyzing data of non-routine stability studies with varied outcomes
  • Collaboration of stability LIMS data to outside vendor systems

Chris Latoz, Stability Manager, HOLLISTER INCORPORATED

 

2:30 COFFEE & NETWORKING BREAK

TESTING TECH TALKS
To provide exposure and insight into various stability testing software and chamber technologies being utilized across the Life Science industry, presenters are asked to provide a brief 10-15 minute presentation highlighting the software or chamber integrated, providing a background on why these platforms were selected, features and core benefits. Following all presentations, presenters will facilitate small group discussions to provide further insights into the technology and chambers used, answering questions and engaging in dialogue with industry participants.

3:00 HUMIDITY CHAMBER
Chris Latoz, Stability Manager, HOLLISTER INCORPORATED

3:15 LABORATORY SOFTWARE
Cheryl Collier, Sr. Drug Stability Manager, B. BRAUN MEDICAL

3:30 STABILITY SAP MODULE
Madhavi Mahavadi, Sr. Manager, Quality Control Stability, Standards and Controls, BAYER

 

3:45 BREAKOUT GROUP DISCUSSIONS
Group 1: Humidity Chambers
Group 2: Chromatography Chambers
Group 3: Refrigeration Chambers
Group 4: Heat Chambers
Group 5: Laboratory Software

 

4:15 LEVERAGE OF STATISTICAL ANALYSIS IN TRENDING & VALIDATING STABILITY DATA

  • Analysis of proven and expected testing results
    • Identifying out-of-trend results
    • Utilization linear vs non-linear regression
  • Review of relevant ICH Q1E guidance
    • Data required for statistical extrapolation
    • Variables affecting retest period and shelf life
  • FDA audit statistic guidelines and expectations
  • Effects of batch variables in accelerated and long-term studies

Junghae Scott, Director, Quality Control, RELYPSA, INC

 

5:00 CONCLUSION OF DAY ONE PRESENTATIONS

 

6:30 FACILITATED GROUP DINNERS
Q1 Productions will make arrangements for dinner reservations at local restaurants near the conference venue for those interested in joining a group of fellow participants for dinner on Monday, March 19th. Keep an eye out for details on the restaurant choices in the weeks prior to the meeting dates to make your selection and be added to a group.