Jobs
View more job listings or post a job
Jazz Pharmaceuticals Senior Manager, Clinical Pharmacology
Nektar Therapeutics Research Associate III
Nektar Therapeutics Sr. Scientist, Bioanalytical
Genentech, Inc. Associate Scientist/Scientist, Drug Metabolism and Pharmacokinetics
Jubilant Discovery Services Senior Manager Business Development
Aimmune Therapeutics The Associate Director, Quality Control will be a key member of the analytical team and he/she will support activities associated with quality control activities of Aimmune’s APIs and drug products conducted at CTL/CMO.  
Precision for Medicine Senior Manager, Quality Assurance
Denali Therapeutics Bioanalytical Research Scientist, DMPK (SM/Biomarker)
Arena Pharmaceuticals The Principal Scientist will report to the Head of Analytical Sciences and will serve as the analytical lead in cross-functional product development tea
Genentech Associate Scientist/Scientist, Process Analytical Technology, Small Molecule Analytical Chemistry  
Post a job

Workshop

Considerations for Successful Clinical Development: Fundamentals and Best Practices for Clinical Trial Design, Biostatistics, and Data Management


Speakers: Masoud Makhtarani, Douglas A Milikien, Hajime Arnold
Organizers:
Date: 2020-01-21
Time: 8:45-17:00 Pacific Time
Registration fee (USD): Regular: $195; Academic: $125; For unemployed or students: $30; For vendor-show rep: $35; For major-sponsor rep (incl lunch): $0
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2019-10-18  (it will close sooner if the seating cap is reached)

About the Topic

This full-day workshop offers an overview of the important steps and considerations when planning clinical trials for pharmaceutical or biologic products in the domains of 1) Clinical Development, 2) Statistics, and 3) Data Management. Throughout this very practical course, attention will be paid to recent scientific developments in the field, new regulations, best practices, and common pitfalls. The use of case studies throughout will illustrate the proper implementation of key concepts and design choices. Upon course completion, participants will have a solid understanding of key steps in the strategic product development, study design, data collection, and data analysis processes of clinical trials.

This workshop is intended for researchers who are either interested in designing a clinical trial, or who want to be better informed about clinical trials in order to improve communication with and understanding of clinical research colleagues, contract research organizations, investigators, members of the scientific and life science business communities, patients and other stakeholders.

 

Topics To be covered:

Clinical Development Considerations in Clinical Trials

  • Drug development process from bench to bedside
  • Objectives of different phases of the clinical program; safety, efficacy, approval
  • Basics of clinical trials designs: objectives, endpoints, assessments, outcomes
  • Good clinical practice: safety reporting, the role of investigators and sponsors

Statistical Considerations in Clinical Trials

  • Design considerations: framing the comparisons and choice of control group
  • Sample Size estimation
  • Planning for interim analyses : sequential studies, adaptive studies, seamless designs
  • Analysis Types:  continuous, binary, time-to-event, counts
  • Special handling necessary: multiple comparisons, missing data, and pooling

 Data Management Considerations in Clinical Trials

  • Data sources and structures: clinical visits, questionnaires, labs, PK/PD/PG, biomarkers, CDISC
  • Database build, documentation, and data transfers
  • Discrepancy management, query management, and reconciliations
  • Planning for ongoing and active data review during the study
  • Paradigm shift in data management: GDPR, privacy protections, third party data


2019-11-12, Antibody Drug Discovery and Development: Hit Generation, Engineering, Cell-line Development, IND enabling studies, and Biosimilars
2019-12-10, In Vitro Diagnostics (IVD), Companion Diagnostics (CDx) and Precision Medicine
2020-01-10, All about half-life: which one should I use? (tentative title)
2020-02-11, Development of Drug/Device Combinations
2020-02-24, MS Courses by Dr. Jack Henion: Advanced LC-MS/MS (Day1) & Interpretation of MS/MS CID Spectra (Day2)
2020-03-16, Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions)
2020-04-10, Biopolymer-based conjugation of therapeutic proteins and antibodies for improving drug properties (tentative title)
2020-05-12, Regulated Large Molecule Bioanalysis: Fundamentals, the New FDA Guidance and Beyond
2020-05-22, No More Undruggables: Unconventional Approaches for Drug Discovery and Design - prodrugs, PROTACS, fragment-based design, directed evolution and beyond
2020-06-23, Advances in Immuno-Oncology (A Joint Symposium by PBSS and BioScience Forum)
┬ęPharmaceutical & BioScience Society, International; Last Modified: 10/20/2019; Admin Logon
Ads (in random order)
Submit a Text Ad
($250 for 2 months)

Origin Bioanalytical Laboratory Sacramento-based CRO for bioanalytical method development, validation, and consulting of LC-MS/MS analysis, specializing in ocular matrices
BIOTECH WEEK BOSTON - Sept. 9-12 Access over 5,000 of the most innovative scientific minds & business leaders in Boston and around the world. Learn More.
XCELERATE at Biotech Week Boston Driving the Future of the Life Science Industry. Sept. 11 at BCEC. Learn more.
UC Davis UC Davis LC/MS Confirmation Supervisor (Lab Rsch Supv 2) Apply Online: http://50.73.55.13/counter.php?id=165482 UC Davis is an AA/EOE
Adesis Inc. Adesis provides expertise in custom synthesis, process dev, R&D, and specialty mfg. to pharma, chemical, biomaterials, and catalysts companies
Alturas Analytics, Inc. Expert GLP & non-GLP LC-MS/MS & GC-MS/MS bioanalytical quantitation services of small & large molecules in any matrix. Discovery through phase IV.
Submit a Text Ad