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April 28, 2011

Optimizing Early Clinical Research to Accelerate Drug Development Timelines:  Value of Early Safety Assessments

Presentation:

William Wheeler, MD, FACC, Therapeutic Area Lead-Cardiovascular  Learn More
Value of Early Safety Assessments

Panel Discussion:

William Wheeler, MD, FACC, Therapeutic Area Lead-Cardiovascular (Chair) 
Cardiovascular

Sandra Connolly, MD, Principal Investigator, Neptune, NJ USA  Learn More
Neuropsychiatric

Johnston Stewart, MB, MRCGP, MFPM, Principal Investigator, Belfast, Northern Ireland UK  Learn More 
Pulmonary

Scott Rasmussen, MD, Principal Investigator, Lincoln, NE USA  Learn More
Liver Toxicity

Stephen P. Youngberg, MD, Principal Investigator, Lincoln, NE USA  Learn More
Renal Biomarkers

Dennis Swearingen, MD, CPI, Principal Investigator, Phoenix, AZ USA  Learn More 
Ophthalmologic

The primary focus of early phase studies is to assess the relative safety of new drug candidates in humans. However, the emphasis is not solely on identifying acute organ toxicity, but also to identify potential toxicity issues that may become a concern later in clinical development or when the drug is marketed. Early clinical safety assessment is being facilitated by the development of new safety biomarkers of organ-specific effects, changing study designs that incorporate learnings from prior experiences, and technologies that allow faster, better and efficient capture of more data.

In this webinar, Celerion's experienced physicians will describe their approaches and experience in making the early assessments of safety and tolerability of new drug candidates. Through brief case studies, the audience will learn about changing tools, approaches and considerations for identifying hepatic, renal, pulmonary, neuropsychiatric and cardiovascular adverse effects as well as assessing risk for ocular toxicity in humans.

To request this webinar archive contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com
April 28/11
Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Value of Early Safety Assessments
Archive available - click on the link for more information
May 17/11
Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Adaptive Study Design
Archive available - click on the link for more information
June 8/11
Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Microtracer Studies
THIS PROGRAM IS INTENDED FOR:

VPs, Directors, and Managers in the following areas:

  • Clinical Research or Clinical Development
  • Clinical Operations
  • Medical Director
  • Drug Development
  • Clinical Pharmacology or PK/PD or DMPK
  • Research & Development
  • Outsourcing

Plus Presidents, CEOs, Chief Medical Officers and Chief Scientific Officers for pharmaceutical and biotech companies worldwide

ABOUT OUR SPEAKERS

William Wheeler, MD, FACC, Therapeutic Area Lead-Cardiovascular

William Wheeler, MD, FACC, is a board-certified cardiologist and industry expert with 30 years’ experience in clinical medicine, drug development research, business and academia. He is the Therapeutic Area Lead-Cardiovascular at Celerion. Dr. Wheeler was instrumental in the development and launch of the new Hybrid Phase I/ ECG Core Lab. The highly-automated system integrates ECG functions within Celerion’s clinic network, providing improved speed, quality and lower costs for the execution of Thorough QT studies and ECG assessments in SAD and MAD programs. He received his medical degree from UCLA, completed internship and residency at the Los Angeles County/USC Medical Center and cardiology fellowship at Cedars-Sinai in Los Angeles.

Sandra Connolly, MD, Principal Investigator, Neptune, NJ USA

Sandra Connolly, MD, is the Principal Investigator at Celerion’s Neptune, New Jersey facility. She has worked on almost 100 studies over the past six years, including Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) and studies necessitating specific procedures (skin biopsies, gastric pH probe inserts, etc.) Dr. Connolly is board certified in Family Medicine. She earned her medical degree from Robert Wood Johnson Medical School in Piscataway, New Jersey. She completed her residency in Family Medicine at Lancaster General Hospital in Pennsylvania. Dr Connolly practiced emergency medicine for 15 years before becoming a part of the Celerion team.

Johnston Stewart, MB, MRCGP, MFPM, Principal Investigator, Belfast, Northern Ireland UK

Johnston Stewart, MB, MRCGP, MFPM, is the Principal Investigator for Celerion’s Belfast, Northern Ireland UK facility, where he has worked since 1992. He has acted as the Principal Investigator on the majority of the studies conducted at the facility and has experience with over 500 studies, including First-In-Human, BA/BE, PK/PD, food effect and drug-drug interaction. Dr. Stewart has a Diploma in Pharmaceutical Medicine and is a member of the Faculty of Pharmaceutical Medicine (UK).

Scott Rasmussen, MD, Principal Investigator, Lincoln, NE USA

Scott Rasmussen, MD, is a Principal Investigator at Celerion’s Lincoln, Nebraska facility. Dr. Rasmussen has been the Principal Investigator for over 70 trials, with special focus on First-In-Human, drug-drug interaction and ADME studies. He completed his residency in Internal Medicine at the University of Minnesota Hospital and Clinic in Minneapolis, Minnesota. Dr. Rasmussen worked as an Internal Medicine Physician at Lincoln Internal Medicine prior to joining the Celerion team.

Stephen P. Youngberg, MD, Principal Investigator, Lincoln, NE USA

Stephen P. Youngberg, MD, is a Principal Investigator at Celerion’s facility in Lincoln, Nebraska and in the past 18 months has worked on over 40 studies at Celerion. His career in clinical medicine/nephrology extends back to 1977. Dr. Youngberg is Board Certified in Internal Medicine and Nephrology and he received his medical degree from the University of Iowa, College of Medicine. He completed an internship and residency in Internal Medicine at the Mayo Graduate School of Medicine in Rochester, Minnesota. Thereafter, he completed a fellowship in the subspecialty of Nephrology and was a Research Fellow in renal physiology at the Mayo Division of Physiology and Biophysics.

Dennis Swearingen, MD, CPI, Principal Investigator, Phoenix, AZ USA

Dennis Swearingen, MD, CPI, is the Principal Investigator at Celerion’s clinical research facility in Phoenix, Arizona. During the past eight years as a Principal Investigator, he has served on approximately 500 early stage clinical trials; including First-In-Human, dose escalation, drug-drug Interaction, Thorough QT, BA/BE pharmacokinetic, dermatologic, ophthalmic, platelet aggregation, and reproductive toxicity studies. He received his medical degree from Loyola University Chicago Stritch School of Medicine and completed a Family Medicine residency at Mayo Clinic Arizona. Dr. Swearingen has been a Certified Physician Investigator through the APPI/ACRP since 2005.

OUR XTALKS PARTNER FOR THIS EVENT

Celerion is the premier provider of innovative early stage clinical research solutions. Formed through the acquisition of the early stage development operations of MDS Pharma Services, Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds in Phase 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. For more information, visit www.celerion.com

 
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