Agile Research Informatics for Nimble Organizations: From Experiment to Decision

Speaker(s): David Lowis
Date: May 9, 2018
Time: 11 am EDT
Duration: 1 hour

David Lowis, Sr. Director from Certara, will describe how data access and analysis of any experiment through Certara’s D360, can be quickly deployed as a first research informatics system, used to supplement existing partial solutions or used to replace high-overhead systems. D360 provides an efficient scientist-driven system that delivers both standard data views and exploratory data query and analysis. This allows scientists to move from experiment to research decision with the agility that is so vital for smaller research organization. He will describe a case study where D360 was used to replace older technologies at a biotechnology company.

Dr. Lowis will also show D360’s new visualization tools and share the future roadmap as D360 advances its support of biologics in addition to small molecules.

Key Themes

1. Research informatics environment must match the agility of your organization

a. Capture any experiment, ask any question, close to real-time decision making
b. Informatics environment must have low overhead without heavy IT needs

2. Follow your train of thought from experimental measurement to research decision in a matter of minutes

3. It’s never too early to introduce your first research informatics system

a. Replacing manual processes in Excel
b. Adding capability to existing, specialized, systems
c. Replacing older technologies that require significant overhead or are end of life

About Our Speakers

David R. Lowis, D. Phil., Senior Director, Product Management | Dr. David Lowis leads Certara’s scientific informatics group and has responsibility for the D360 scientific informatics platform. For the last 7 years, he has led the design and development of D360 data access, analysis, and collaboration software, expanding from small molecule discovery into biologics and pre-clinical research domains. Dr. Lowis gained his Doctor of Philosophy degree from Oxford University under the supervision of Professor W. G. Richards studying computation of physical properties of small molecules in solution utilizing large scale MD and MC simulations. He holds a 1st class honors degree in chemistry from Oxford University (The Queen’s College).


A House Divided—The Interplay of Bioanalysis and Pharmacokinetics

Speaker(s): Stephanie Pasas-Farmer, Frank Engler
Date: May 23, 2018
Time: 11:30 am EDT
Duration: 1 hour

Drug discovery and development is key to meeting the world’s unmet medical needs. However, bringing a drug to market is a risky, labor intensive, time exhaustive, and expensive endeavor. And for every single drug that reaches the market, over 10,000 have failed (success rate of 0.01% or less).

A key piece to understand during a drug’s development is not only the drug concentration in the body but also how this concentration impacts safety and efficacy. Bioanalysis is the science of measuring both exogenous (drugs) and endogenous (biomarkers) molecules in biological samples.

The clinical pharmacologist is responsible for getting the right drug into the right patient at the right time. Accurate and precise measurement of drug and biomarkers are key for the correct interpretation of drug pharmacokinetics, drug safety, and drug effect. Proper bioanalysis and efficient communication of results enables the clinical pharmacology group to provide timely and thorough data interpretation.

To overcome limited resources, limited capacity, or a gap in the capabilities of the in-house scientific staff, bioanalysis is often outsourced by companies of all sizes: from large global pharma companies to virtual biotech. But, treating a key compound of your clinical pharmacology deliverable as a commodity has led to a disconnect between these two functional areas. This disconnect can often result in delays, clinical holds, loss of potential revenue, expensive requirements to repeat clinical trials, and unnecessary risk to patients.

This webinar will introduce the importance of bioanalysis and its downstream effects on clinical development and clinical pharmacology. By attending this webinar, you will gain an appreciation of the following:

  • The importance of bioanalysis in the drug discovery and drug development process
  • The interdependence of robust bioanalytical data and clinical pharmacology
  • An in-depth case study illustrating where bioanalysis went awry:
    • how this effected the clinical program
    • key warning signs that went undetected
    • strategies to overcome these challenges
    • ways this could have been avoided from the beginning
    • examples where things went right

About Our Speakers

Dr. Stephanie Pasas-Farmer is the President and Founder of BioData Solutions, LLC, a consulting firm that offers R & D, regulatory, and commercial consulting services to early stage pharmaceutical and biological drug development organizations in the field of bioanalysis. With more than 14 years of industry experience, Dr. Pasas‐Farmer specializes in discovery and regulated bioanalysis of pharmaceutical, biologics, and biosimilars. Dr. Pasas-Farmer is a frequent contributor to industry conferences and peer-reviewed publications on current bioanalytical and pharmaceutical industry topics. She also is an adjunct Professor as well as a member for Board of Advisors for the Division of Pharmacy Professional Development (DPPD) of the University of Wisconsin’s School of Pharmacy.

Dr. Frank Engler is a Clinical Pharmacologist and Consultant at Certara with both preclinical and clinical drug development experience. Dr. Engler obtained his PhD from the University at Buffalo, followed by working in the pharmaceutical industry as a clinical pharmacologist. In addition to constructing clinical pharmacology development plans and designing studies, he has authored study reports, Investigator’s Brochures, protocols, SOPs, and INDs. His areas of expertise include pharmacokinetics (PK) and pharmacodynamics (PD), population-based, and physiologically-based PK/PD modeling and simulation. Dr. Engler’s work has focused mainly in oncology, where he has experience with multiple therapeutic drug platforms, including monoclonal antibodies, antibody-drug conjugates, and small molecules.


Accomplish More with Phoenix—New Phoenix 8.1 Release in June 2018!

Speaker(s): Nathan Teuscher, Kevin Trimm
Date: June 6, 2018
Time: 11 am EDT
Duration: 1 hour

As the gold standard for pharmacokinetic and pharmacodynamic (PK/PD) software, our upcoming Phoenix 8.1 release delivers new capabilities to automate processes, reduce errors, and save you time. Dr. Nathan Teuscher, VP of Pharmacometric Consulting, and Kevin Trimm, Director of Phoenix Technology Services, will share our latest innovations in WinNonlin and NLME and conduct a live demo.

Join this webinar today to learn how to get the most out of Phoenix.

  • New NCA Ratios Plugin delivers one-step calculation of renal clearance, accumulation ratio, linearity index, parent to metabolite exposure ratios and more
  • Descriptive Statistics will include additional automated statistical calculations geometric SD, user-specified percentiles, and an option to select statistics for outputs
  • More Charting Capabilities allow chart controls by sort or group variable, order profiles in legend, error bars for bar/column plots, offset for any overlaid plot, and more
  • Enhanced WinNonlin Validation Suite provides full software validation in under 30 minutes with locked PDF reports containing links to results and updated validation template documents aligned with latest regulatory guidance documents
  • Improved Visual Predictive Check in Phoenix NLME offers separate analyses for different types of data such as continuous data with BQLs, categorical data, and time to event data

Furthermore, we are adding charting capabilities that enable users to order the presentation of categorical axes, utilize the offset function, change font style and size, and more. These enhancements will provide more flexibility for customization of charts and plots.

About Our Speakers

Nathan Teuscher is the Vice President of Pharmacometric Solutions at Certara. He is a leader in the pharmaceutical industry as a scientist, consultant, and teacher. Nathan has been teaching and training for over 15 years in the pharmaceutical industry, providing lectures in general pharmacokinetics to non-scientists, and specialized training in population pharmacokinetics and drug development to industry experts.

Kevin Trimm, Director of Phoenix Technology Services, leads the services team at Certara, implementing Phoenix software and providing customized solutions. Prior to joining Certara, Kevin worked for 14 years in pharmaceutical contract research, primarily at Charles River Laboratories, where he was the global head of the Pharmacokinetics and Statistics departments. Kevin also co-founded Montreal Pharmacokinetics Inc., a GLP accredited contract research organization specializing in pharmacokinetic analysis, reporting, and consultation. Kevin’s bachelor and master’s degrees were focused on cognitive and neurological sciences. He continued his graduate education in pharmacology and biostatistics at McGill University.


Real Patients & Their Virtual Twins: A New Paradigm for Personalized Drug Safety Assessment

Speaker(s): Mark Holbrook, Nikunj Patel, Sebastian Polak
Date: June 19, 2018
Time: 11 am EDT
Duration: 1 hour

A major challenge in developing efficacious and safe drugs is the ability to understand and effectively predict adverse effects of xenobiotic substances on complex biological systems early in the drug discovery process. An alarming fact is that thirty percent of adverse drug reactions (ADRs) cannot be predicted by current pre-clinical animal testing and existing modeling methodologies. Quantitative systems toxicology and safety (QSTS) modeling is an approach that can inform understanding of the mechanistic basis of ADRs and achieve more predictive and accurate risk assessments.

QSTS is a multidisciplinary approach which, at the juncture of Systems Biology with Toxicology and Chemistry, integrates classical toxicology with quantitative analysis of the molecular and functional changes that occur across multiple levels of biological organization. QSTS aims to characterize ADRs by describing modes of action as adverse outcomes pathways and perturbed networks versus conventional empirical end points and animal-based testing.

In this webinar, Sebastian Polak, Nikunj Patel, and Mark Holbrook will introduce the Cardiac Safety Simulator (CSS) platform and explain how they developed a QSTS model for citalopram to serve as a “virtual twin” and help predict the likely occurrence of cardiotoxic events in real patients under different clinical conditions. Citalopram is a widely prescribed antidepressant drug, which has been linked with cardiac toxicity especially at higher doses.

By attending this webinar, you will learn:

  • About the latest version of CSS platform
  • How QSTS models, with the appropriate drug and systems parameters, can bridge the gap between preclinical cardiac safety assessments and clinical toxicology results
  • How QSTS models, in combination with appropriate drug and systems parameters, can pave the way towards personalized safety assessments
  • How such an approach can be leveraged to inform predicting likelihood of drug-mediated renal, hepatic, and CNS toxicities in individual patients

About Our Speakers

Dr. Mark Holbrook is Certara’s Acting Vice President of Quantitative Systems Toxicology and Safety. Mark has extensive and broad experience of drug discovery and development gained from more than 28 years working for a range of companies across the biopharma spectrum; from small biotech (Celltech) and large pharma (AstraZeneca, Pfizer) to CROs (Covance) and consultancy. He has led projects from early target selection delivering molecules into development, through to proof of concept and regulatory filing. For the last 15 years, he has focused on non-clinical drug safety as the Global Head of Safety Pharmacology for Pfizer and more recently Covance where he was also the Chief Scientific Officer for Early Development. At Certara, Mark is leading Quantitative Systems Toxicology (QSTS) with the clear vision that it will significantly aid drug discovery and development helping projects be more efficient, make better decisions, and be more successful.

Nikunj Patel is a senior research scientist in Certara’s modeling and simulations group where he is leading oral and dermal absorption projects and is a member of the Cardiac Safety Simulator development team. He joined Certara in August 2011 and led the development of the physiologically-based IVIVC (PB-IVIVC) module of the Simcyp Simulator and the Pharmaceutics module of SIVA (Simcyp In Vitro (data) Analysis) platform. Before joining Certara, he spent three years at the life science innovation labs of Tata Consultancy Services as a research scientist, mainly working on pharmacokinetic/pharmacodynamic modeling and QSAR development for various ADMET properties. During his graduate studies, he used computer aided drug design (CADD) and molecular modeling to identify safe and potent novel anti-diabetic ligands.

Dr. Sebastian Polak is a Senior Principal Scientist at Certara where he is a member of the modeling and simulation group. He leads the development of cardiac safety modeling and simulation systems based on the biophysical models of human cardiac myocytes operating at the population level (CSS – Cardiac Safety Simulator). Dr. Polak is also a tenured Associate Professor in Biopharmaceutics at the Faculty of Pharmacy at Jagiellonian University in Krakow, Poland. Dr. Polak serves as a reviewer for multiple professional scientific journals and scientific book publishers. He has published over 40 peer-reviewed articles. He earned a DSc Degree in Biopharmacy from the Faculty of Pharmacy at Jagiellonian University Medical College in 2013. He earned a PhD from the Department of Toxicology, Unit of Pharmacoepidemiology and Pharmacoeconomics at Jagiellonian University Medical College in 2006. Dr. Polak earned a Master’s Degree in Pharmacy in 2000 from the Faculty of Pharmacy at Jagiellonian University Medical College.

 


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