Harmonization of qPCR
June 15-16, 2021
Virtual Workshop
qPCR has increasingly been used in many bioanalytical laboratories to support pharmacokinetic evaluation of nucleic-acid based therapies and to support quantitation of biomarkers. Bioanalytical laboratories ten years ago were primarily LC/MS/MS and immunoassay focused. Drug development has grown more challenging with higher complexity therapies. The emergence of RNA biomarker assays and the evolution of cell and gene therapy has led to many bioanalytical laboratories implementing qPCR and/or ddPCR. While there are existing papers and recommendations available on how to approach the development and validation of qPCR/ddPCR assays, there has not been any consensus paper that is based on a dialogue amongst bioanalytical scientists. This workshop includes a series of presentations with case studies from CROs who have implemented qPCR/ddPCR in a regulated environment. A critical aspect of the workshop will be open discussion that comprises as much discussion as presentation. The workshop outcomes will be shared through publication.
Agenda
Tuesday, June 15, 2021
10:30 am - 12:00 pm
Session 1: Extraction of DNA/RNA (Katie Matys, PPD)
Session 2: Method Development Considerations (Rafiq Islam, Ph.D., Smithers)
Wednesday, June 16, 2021
10:30 am - 12:00 pm
Session 3: Validation of PCR Methods (Amanda Hays, Ph.D., PRA)
Session 4: Considerations for ddPCR Method Development and Validation (Dave Williams, Ph.D., BioAgilytix)
22nd Annual Bioanalytical Conference
In partnership with
July 12-14, 2021
Virtual Event
Stronger in the Future: What we Learned and How we are Applying the Experiences of the COVID Years to be Better Bioanalytical Scientists
The Land O’ Lakes 22nd Annual Bioanalytical Conference will present a unique look at what we had to learn very quickly in 2020 and 2021 in order to rise to the scientific and logistical challenges brought to us by the COVID-19 pandemic. The pharmaceutical industry rose to the challenge of producing vaccines and treatments at a pace we never thought possible. Bioanalytical laboratories worldwide played a significant role in developing these therapies to fight COVID-19 while also continuing to efficiently operate and bring new life saving therapies for the many other diseases of the world. In the three-day conference we will look at how many of the key advancements occurred, how they are being applied and what we see in the future of Bioanalysis beyond the pandemic. The way we think and operate has forever been changed and we will take a look at these changes to reflect and learn and look forward.
Learning Objectives:
- Understand the major accomplishments of the last year in the context of the challenges that we faced as Bioanalytical Scientists.
- Learn of major advancements in bioanalytical science that enabled the success of pharmaceutical development in 2020.
- Evaluate the changes in logistics and infrastructure such as patient-centric clinical trials and remote working in our laboratories and how we will apply them to be better beyond the pandemic.
- Learn about the most recent breakthroughs in bioanalytical science in 2021.
- Take a look at the horizon of bioanalysis: where will be beyond the pandemic?
View the agenda, register, and submit a poster abstract
Tuesday, July 12
Part 1: How Do You Operate a Lab in Pandemic Conditions?
Part 2: What Have We Learned/Accomplished Analytically?
Wednesday, July 13
Part 3: What’s Next? What New Technologies are in the Pipeline?
Part 4: What’s Next? New Modalities and Applications
Thursday, July 14
Part 5: Regulatory Learnings for a Post-Pandemic World
Group Registration
Bring four or more paid full conference attendees from the same company and receive a 15% discount per full conference registration. This offer cannot be used with other discounted offers (e.g. speaker rate, complimentary sponsor passes, student rates, etc.). Please email meetings@aaps.org for your discount code. The deadline to redeem is July 8, 2021. If your group does not meet the minimum requirement, AAPS reserves the right to alter your registration fee.
61st Annual Land O'Lakes Pharmaceutical Analysis Conference
August 9-11, 2021
Virtual Event
The purpose of this 2.5 day conference us to provide an educational forum to discuss issues and applications
related to pharmaceutical analysis. The conference connects leaders together to share new scientific and regulatory developments in the areas related to or with direct application for pharmaceutical analysis, product development, product quality, and the analytical method lifecycle applications.
The Land O’ Lakes Pharmaceutical Analysis Conference is well-recognized as one of the premier teaching conferences for colleagues in the pharmaceutical industry. Attendees are primarily from the pharmaceutical industry but also include those affiliated with governmental agencies as well as academia.
Call for Papers
Now accepting abstracts for poster presentation. The abstract submission deadline is June 2, 2021 at 5pm ET. Start your submission today.
View the agenda, register, and submit a poster abstract