Introduction to elluminate® Clinical Analytics

8:00am PST - 8:30am PST
Achilleas Zaras , Sales Engineer, eClinical Solutions , Achilleas has 12+ years of experience in software industry involving software demonstrations, managing a team of 15+ developers, hands-on coding in Microsoft .Net platform and Business Intelligence Suites like QlikSense. He has enjoyed a progressive career in diverse roles including responsibilities of a Sales Engineer, Team Manager, Software Engineer and Business Intelligence Analyst in various industries like Banking, Retail and now the Pharmaceutical industry with eClinical Solutions. ,

In a 2019 Tufts CSDD survey, 90% of respondents from over 140 life sciences companies rated self-service analytics as important for managing multiple data sources and growing volume of data. However, just 46% of respondents had analytics dashboards currently available. To effectively manage trials, resources, timelines and oversee vendors according to regulatory requirements, clinical teams need on-demand access to their clinical and operational data for decision making. The elluminate clinical data platform was designed to provide an end to end comprehensive platform that delivers access to governed clinical data to clinical teams. elluminate Analytics includes more than 50 out of the box visualizations designed to support data review objectives and provide new insights to medical monitors, data managers, clinical operations and biostatisticians.

elluminate Analytics helps clinical teams visualize data to see outliers and trends that are not possible to detect in line listings and supports cross study analyses for deeper insights.

More than 50 Life Sciences companies rely on Clinical Analytics from elluminate to improve the clinical data review process and enhance operational oversight.

COVID-19 Preclinical Disease Modeling and Vaccine Development

Dr. Terina Martinez , Field Application Scientist , ,

Taconic Biosciences' webinar presented by Dr. Terina Martinez, Field Application Scientist, will present a high-level overview of the animal models suitable for COVID-19 research along with a deeper dive into specific mouse models for studies of SARS-CoV-2 disease pathogenesis and screening of therapeutics and vaccines.

OC LIFe (Lifesciences Innovators Forum) – featuring Vivek Mutalik & Chang Liu

3:00 PM - 4:30 PM PST
Vivek Mutalik , Research Scientist, Berkley Lab / Innovative Genomics Institute , Vivek Mutalik is a staff scientist at the Environmental Genomics and Systems Biology Division and Biological Systems and Engineering Division at the Lawrence Berkeley National Laboratory. Previously Dr. Mutalik was a team leader at the BIOFAB, the first biological design-build-test facility, which focuses on developing extensively tested standard biological parts to facilitate easier engineering of biology. Currently, his work focuses on developing standardized genetic tools for industrially important microorganisms, a robust functional genomics platform and study of regulatory design principles in microbial stress responses. Vivek’s recent research is based on exploring how to engineer bacteriophages to precisely control microorganisms important to human and environmental health. , Chang Liu , Associate Professor, Liu Lab UCI , Professor Liu’s research is in the fields of synthetic biology, chemical biology, and directed evolution. He is particularly interested in engineering specialized genetic systems for rapid evolution and creating synthetic organisms that use new building blocks for their informational and functional macromolecules. For example, his group is known for their construction of an orthogonal DNA replication (OrthoRep) system capable of driving the rapid, scalable, and deep evolution of desired genes in vivo. These systems can be widely applied for the engineering, discovery, and understanding of biological function. ,

OC LIFe aims to connect industry with entrepreneurs and strengthen the life sciences and medical technology communities.

Create connections that could last a lifetime.
The OC LIFe (Life Science Innovators Forum) is a monthly free event series focused on creating a collaborative environment that fosters connections between innovators in the life sciences and medtech industry.

Exploring emerging technologies and innovative methods to advance genomic research.
Searching beyond the core set of genomic editing tools and next-generation sequencing to design therapeutics and solve environmental problems.

1. What emerging technologies and methods can improve genomic research
outcomes for developing therapeutics?
2. What are the challenges of synthetic biology and how can we move closer
to solving these problems?

Getting Life Sciences Back to Better

11:00 AM PT - 12:00 PM PT
Raj Indupuri, MBA , CEO & Co-Founder, eClinical Solutions , Raj has spent the majority of his career supporting clinical data management and programming objectives by introducing and implementing solutions and technologies to accelerate clinical research development. , Joseph Panetta , President & CEO, Biocom Board of Directors , Biocom is the California association that advocates for 1300 companies, service sector firms, universities and research institutes working in the biotechnology and biomedical device arena. Joe guides Biocom by setting strategic direction, guiding policy priorities, and championing the biopharmaceutical industry at the local, state, national, and international level. , John Reites , President & CEO, Thread Research , Thread enables virtual visits +eCOA to conduct decentralized trials. John’s career includes 17+ years leading global drug development and healthcare innovation. He was named one of the Top 100 Influencers in Digital Health. ,

The COVID-19 pandemic has and will have far reaching impact across the life sciences industry that present numerous opportunities and challenges. How organizations adapt to the changing environment impacts both the shape of the current industry and the future of medicine and drug development. This panel discussion will share a variety of perspectives and strategies on how the biopharmaceutical industry can emerge from this period stronger than ever and how drug development is transforming based on trends, technology, processes and resources.

Topics Covered
What trends have developed during the pandemic that have long-lasting impact on the industry? And are there any “fads” that are not as likely to have lasting impact?
With the focus on therapies for COVID-19, how can other types of therapies come back into focus for companies developing new methods of treating disease?
How does the industry need to change to adapt to this new environment across people, process, technology and mindsets?
How does organization size impact strategy and how can emerging organizations thrive in this environment?
What opportunities have been created by the pandemic and how can companies take advantage of them?

DRIVE™ : Brothers in Arms to support small molecule drug discovery from Hit to IND

11:00 a.m. - 12:00 p.m. EDT
Fabrice Viviani, Ph.D , Senior Executive VP, Head of Oncodesign Service Business Unit, Oncodesign and director of at the François Hyafil research center , Fabrice Viviani holds a PhD in organic chemistry and an MA in biology from Pierre-and-Marie-Curie University (UPMC). He started his career as a biologist and was responsible for research project and clinical teams in infectiology, before turning his attention to oncology research at Aventis’ oncology therapy department. He was then appointed Sanofi-Aventis’ Vice President for R&D, having managed several departments (medicinal chemistry and biology for exploratory research and internal medicine, early-to-candidate DPU). At GSK he took charge of the discovery biology group at the François Hyafil research center. To date, he has been involved in discovering and developing over 20 preclinical and clinical drug candidates. Since January 2020, Fabrice is overseeing and leading all the services activities of Oncodesign Service Business unit. , Christophe Parsy, Ph.D , MBA, Head of Medicinal Chemistry, Oncodesign Service Business Unit and Senior Leader Integrated Drug Discovery Services , Christophe has acquired a broad knowledge of the pharmaceutical industry by working in various R&D environments from Research Services Provider to Biotech and large Pharma. Over the past 20 years, he has lead major drug discovery projects from Hit to IND in Anti-infective (HIV, HCV) and Oncology. These resulted in clinical candidates IDX320, Samatasvir and Uprifosbuvir. He has a proven ability to lead and deliver clinical candidates in a cross-functional and multi-cultural environment with a track record of delivering high quality candidate in a fast-paced environment. Proactive leadership with a high degree of priority setting, he recently completed is training by obtaining an Executive MBA with specialization in Lean 6 Sigma, Strategy and Leadership. Christophe is author and co-inventor of 30 + patents and peer review publications. , Barry A. Morgan, PH.D , CSO HitGen , Barry Morgan has broad experience in drug discovery and development. He is Professor and Director of Discovery in the Center for Drug Discovery at Baylor College of Medicine, Houston Texas, and has 40 years of experience in drug discovery and development in the Pharmaceutical and Biotechnology industries in the United Kingdom, France and the USA. He was Vice President, Molecular Discovery, and Site Head at GSK, Boston 2007-2012. He was previously Senior Vice President for Chemistry and Discovery Sciences at Praecis Pharmaceuticals Inc., where he was a primary inventor of DNA Encoded Library Technology. PRAECIS was acquired by GSK in February 2007. inventor of DNA Encoded Library Technology. PRAECIS was acquired by GSK in February 2007. , Yann Gaston-Mathe, MSc , Founder and CEO Iktos , Yann Gaston-Mathe is a senior Life Science professional with extensive experience in Pharma R&D and in Data Analytics for Life Science and Healthcare. Yann is the co-founder and CEO of Iktos, a start-up company specializing in artificial intelligence technology for chemical optimization in drug discovery, and he is also engaged in start-up projects in oncology. , Thomas Schubert, Ph.D , CEO 2bind GmbH , Dr. Thomas Schubert received his PhD in Biochemistry in the area of Epigenetics from the University of Regensburg; Germany. In 2012, Thomas joined 2bind and became CEO in 2013. Dr. Schubert holds a degree in economy/commerce (Betriebswirt IWW). , Laura Sailor , President Icaria Life Sciences , Icaria cares! Laura Sailor, a serial entrepreneur, builds teams to innovate and deepen expertise in structure based drug design. Icaria’s “the structure people” have deep institutional knowledge of “the undruggable”protein targets and most comprehensive suite of Instrumentation for protein production, structural biology, biophysics To support early stage hit- finding programs. ,

Webinar Description:

Outsourcing drug discovery has become an overwhelmingly accepted approaches across the pharmaceutical industry from virtual biotech to large pharmaceutical companies as part of the globalization process. It does represent a cost-effective opportunity to access specialized technologies and expert scientist resources having a broad knowledge of pharmaceutical drug discovery development. Oncodesign’s objective with DRIVE™ offer is to provide its customers with the best possible options and state-of-the-art technologies to progress their drug discovery in the shortest possible time with the highest quality. Oncodesign is doing so by setting up under a single leadership, privileged partnering with selected and trusted companies sharing the same values of innovation and quality as its own. Hits finding and validation are important phases in early drug discovery. With DRIVE™ Program, Oncodesign is providing DNA encoded libraries, fragments screening along with Hit validation using NanoDSF, MST, SPR, ITC and Structural Biology (Cryo-EM and X-Ray crystallography) supported by artificial intelligence.

Learning Objectives:

Introduction to a solution provider from hits finding to IND filling
Advantages of Drug discovery integrated provider vs silos approach
Special focus on Hits identification and validation across DNA encoded libraries, Artificial Intelligence, Biophsysics and Biostructures

How to assess the interplay between tumor, microbiota and therapies?

8:00AM - 9:00AM PDT
Sylvie Maubant, PhD , Study Director , Sylvie Maubant has more than 15 years of experience in preclinical research in oncology field. She obtained a Ph.D in Biology, Medicine and Health from the University of Caen in France then she continued her career as a postdoctoral researcher at several institutes to work on projects related to the identification of new therapeutic targets, drug development and/or validation of therapeutic tools in collaboration with industry. In 2014, Sylvie joined Oncodesign in vivo department as a study director. Since 2018, she has been mainly involved in bacteria-oriented programs for clients ,

A comprehensive platform to investigate bacteria as immuno-modulating vectors or agents.

Preclinical and clinical studies have shed light on the beneficial role of bacteria for cancer therapy. Indeed, these works have demonstrated that these microorganisms have properties that allow them to selectively colonize tumor tissue and that they could also be considered as predictive drug efficacy biomarkers.
Based on these results, bacteria are now used 1) for delivering therapeutic proteins into tumor cells or antigens into body, 2) for shaping gut microbiota. Ultimately these approaches lead to the activation of an immune response against the tumor.
Owing to our scientific and technological expertise at manipulating microbes, Oncodesign proposes tailor-made strategies to clients for investigating the efficacy of their bacteria-based treatments and/or the effect of their therapies on microbiota in vitro and in vivo.

Key learning objectives:
- Introduction to bacteria-mediated cancer therapy.
- How can Oncodesign support your evaluation of bacterial therapies and/or the impact of your treatments on microbiota?
- Case study examples.

How to accelerate drug development and reduce costs with in-human data before phase I.

9:00am - 10:30am
Prof. Go van Dam , CEO and Co-Founder at TRACER , He published the 1st in-human application of targeted fluorescence imaging in 2011 (Nature Medicine) and published more than 140 papers predominantly on the subject of clinical translation of innovative-targeted optical molecular imaging. He is considered an expert in his field and strives to make in-human microdosing and molecular imaging a standard in drug development. , Dr. Yalia Jayalakshmi , Vice President and head of Clinical Development at OncoNano Medicine , She has been leading the development of their diagnostic and therapeutic portfolio, based on pH activated polymeric micelle nanoparticle platform. In a span of 3 years, she has built the clinical team from ground up and progressed the lead candidate, an intraoperative imaging agent for cancer surgery through CTA and IND filings, FDA meetings and Phase 1 and Phase 2 clinical studies in US and Europe. Dr. Jayalakshmi brings over 25 years of industry experience in developing drugs, medical devices and nanotechnology products. She received her Ph.D. in Physics from the Indian Institute of Science, Bangalore and postdoctoral training at ENS, Paris and University of Delaware, Newark. ,

Today, developing a new drug can cost an average of $1.4billion and take 10+ years to reach the market. With lower R&D productivity and higher R&D costs the pressure to achieve return on investment for new innovative drugs is higher than ever before.

The FDA approved microdosing technique offers a solution that provides up to 50% faster time-to-market and up to 50% less development costs. In short, microdosing shows whether the tested compound reaches the target tissue in humans before Phase I.

Why attend? In this in-human microdosing workshop you will learn how to employ a microdosing strategy to accelerate your drug development and enjoy benefits, such as:
• Generate in-human data before Phase I
• Make early go/no-go decision making on MNEs
• Skip costly large animal toxicity studies by having in-human data
• Monitor progression of diseases or results of treatment over time
• Boost company valuations with positive in-human data even before phase 1

Who should attend? In-human microdosing can be applied in small to large organizations that are developing new drugs for the market. Therefore, TRACER and BIOCOM invite:
• All organizations that are actively developing a new drug to the market
• R&D scientist that would like to broaden their horizon
• Business Development Managers that look to optimize their business
• Biotech start-ups wanting to increase company valuation from an early stage
• Life Sciences investors that want to learn how to increase asset value and decrease investment risk through microdosing

One-Way Ticket to Commercial Launch: Regulatory Considerations for Clinical to Commercial Launch

10AM PT / 1PM ET
A Webinar Trilogy
Todd Phillips, PharmD, RAC , Director, Global Regulatory Affairs Cardinal Health Regulatory Sciences , Regulatory Considerations for Clinical to Commercial Launch ,
Moderator: Marisa Reinoso , Marketing Manager, PCI Pharma Services

Preparing for a successful commercial launch starts long before FDA approval.
Join AMRI, PCI Pharma Services, and Cardinal Health Regulatory Sciences for this three-part webinar series as we review this complex process and identify common challenges to commercialization. We will focus on what drug synthesis, clinical logistics, packaging design, and regulatory considerations should be thoroughly planned and checked for a successful commercial drug launch.

Regulatory Considerations for Clinical to Commercial Launch
A review of the Investigational New Drug (IND) application and the FDA’s marketing authorization process, including common areas that are underestimated
Expedited FDA programs (i.e. Fast Track, Breakthrough, Accelerated Approval, etc.)