As drug candidates move closer to final approval, the role of contract research organizations (CROs) becomes more than just a support function—it is a key driver of success.
Beyond bioanalysis and early-phase research, CROs play a crucial role in ensuring regulatory alignment, smoothing the transition to manufacturing and keeping commercialization on track. The right CRO strategy can be the difference between a streamlined approval process and costly delays.
In this webinar, the expert speakers will have a practical, insightful discussion on how strong CRO partnerships can:
- Speed up regulatory approvals by strengthening data integrity and compliance
- Ensure seamless knowledge transfer between development and manufacturing teams
- Identify and prevent late-stage risks that could derail commercialization
No matter where you are in the approval process, this webinar will give you the tools to optimize your CRO relationships and keep your drug development moving forward.
Register for this webinar to gain insights into how effective CRO partnerships can accelerate regulatory approvals, streamline bioanalysis and safeguard against commercialization risks.
Speakers
Jennifer Zimmer, PhD, Laboratory Director, Alturas Analytics
Dr. Jennifer Zimmer is the Laboratory Director at Alturas Analytics, Inc. and has been working in the field of bioanalysis for over 20 years. She received her BA in English and Zoology from the University of Idaho and her PhD in Pharmacology from the University of Colorado Health Sciences Center, working in Dr. Robert Murphy’s laboratory on the leukotriene lipid mediator pathway. Her post-doctoral experience in Dr. Richard Smith’s laboratory focused on using metabolomics to elucidate disease pathways and to discover novel biomarker targets.
Dr. Zimmer is responsible for the overall operation of the Alturas Analytics laboratory. She has experience with FTICR, TOF, ion trap and quadrupole instrumentation. She has utilized these instruments for quantitation as well as structure elucidation using HPLC-MS/MS and HPLC-MSn. She oversees the scientific staff and ensures that client deliverables are met while working laterally with the Alturas Analytics, Inc. QAU in order to maintain laboratory compliance with all procedures and regulations. Dr. Zimmer is an active participant in the Global CRO Council (GCC) and a member of the American Society for Mass Spectrometry.
Message Presenter
Jeanne Taylor Hecht, MBA, CEO and Executive Chairwoman, Lexitas Pharma Services, Inc.
Jeanne Taylor Hecht is Lexitas’ Chief Executive Officer and Chairwoman of the Board of Directors. Her industry career spanned over twenty-five years as Board member and Chief Executive Officer of multiple companies, including Ora, Median Technologies, IQVIA, Decision Biomarkers and the UNC Oncology Protocol Office.
Jeanne also launched and expanded a Life Sciences consulting practice that supported companies with sales, marketing and market growth strategies as well as advisory and board work. She is primarily motivated by helping to bring relief to patients.
Jeanne is an active Advisory Board Member for the University of North Carolina Chapel Hill Kenan-Flagler’s Business School and lecturer at the business school. She contributed to the creation of Wake Forest University’s master’s in clinical research program and remains an active industry advisor to the school. She holds a Bachelor of Science from the University of Michigan and a Master of Business Administration from that university’s Ross School of Business.
Message PresenterWho Should Attend?
This webinar will appeal to those working in the following areas or having the following job titles:
- Regulatory & Compliance:
- VP / Director / Head of Regulatory Affairs
- VP / Director / Head of Quality Assurance
- VP / Director / Head of Compliance
- Clinical & R&D Leadership:
- Chief Medical Officer (CMO)
- VP / Director / Head of Clinical Development
- VP / Director / Head of Research & Development
- VP / Director / Head of Drug Development
- Clinical Operations Director / Manager
- Manufacturing & Commercialization:
- VP / Director / Head of CMC (Chemistry, Manufacturing & Controls)
- VP / Director / Head of Supply Chain Management
- VP / Director / Head of Technology Transfer
What You Will Learn
Attendees will learn about:
- How to speed up regulatory approvals by strengthening data integrity and compliance
- How to ensure seamless knowledge transfer between development and manufacturing teams
- How to identify and prevent late-stage risks that could derail commercialization
Xtalks Partner
Alturas Analytics
Alturas Analytics is a GLP compliant bioanalytical CRO specializing in LC-MS/MS solutions supporting preclinical and clinical research, IND submissions, and New Drug Applications. In addition to providing PK support services to pharmaceutical companies worldwide, Alturas maintains an intensive research effort to apply new technologies toward scientific advancement. Our success is built on developing long-term relationships with clients by delivering high-quality bioanalytical results in a timely manner.
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