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

Date
11:00 a.m. - 12:00 p.m. EDT
Location
Webinar
Speakers:
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?

Date
8:00AM - 9:00AM PDT
Location
Webinar
Speakers:
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.

Date
9:00am - 10:30am
Location
Webinar
Speakers:
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

Date
10AM PT / 1PM ET
Location
A Webinar Trilogy
Speakers:
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.)

One-Way Ticket to Commercial Launch: Supply Chain & Packaging Design Considerations for Clinical to Commercial Launch

Date
10AM PT / 1PM ET
Location
A Webinar Trilogy
Speakers:
Greig Ross, PCI Pharma Services , Director of Business Development , Supply Chain & Packaging Design 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.

Supply Chain & Packaging Design Considerations for Clinical to Commercial Launch
Transitioning from clinical to commercial: safety, packaging design, and materials
Transitioning from clinical to commercial: distribution supply chain considerations including biologics and cell therapies

Understanding the Importance of Crystallization Processes to Avoid Unnecessary Cost, Risk and Development Delays

Date
10am EST / 7am PST - 11am EST / 8am PST
Location
Webinar
Speakers:
Dr. Craig Callahan , Project Scientist, Cambrex Edinburgh , ,

Crystallization is often the ultimate step of a drug substance manufacturing process prior to isolation and drying. A robust crystallization process can allow many benefits, such as isolation of a desired polymorphic form, optimization of purity through exclusion of impurities, and enhanced yield. Additionally, a crystallization process can allow physical properties of a batch of particles to be optimized. An API’s particle size distribution, particle morphology and flow properties can also have a significant impact on the downstream processing that it will have to endure en-route to a formulated drug product. Filtration, washing, drying and formulation can all be enhanced, and product consistency improved, by adopting a suitable, well developed crystallization process that targets suitable particles by design.

This webinar will:

-Provide an introduction and overview of the importance of crystallization in the pharmaceutical industry
-Discuss the workflow of a crystallization process development program at Cambrex Edinburgh
-Consider examples of typical issues faced during the crystallization process development of an API
-Discuss case studies where careful control of the crystallization has allowed processing problems to be overcome
-Cambrex’s Edinburgh site is a world-leader in providing solid form development services for drug substance and drug product.

One-Way Ticket to Commercial Launch: Drug Synthesis Considerations for Commercial Launch

Date
10AM PT/ 1PM ET
Location
A Webinar Trilogy
Speakers:
Ravi Rai, Ph.D., AMRI , Senior Research Scientist III , Drug Synthesis Considerations for 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.

Drug Synthesis Considerations for Commercial Launch
The importance of route scouting and development while getting the drug registered and validated
Defining the edge of failure in the drug synthesis process and avoiding it

Preclinical Oncology Seminar

Date
8:00 AM - 10:00 AM
Location
Biocom – McGraw Conference Room 10996 Torreyana Road Suite 200 San Diego, California 92121
Speakers:
Tiina Kähkönen, Ph.D., , Chief Scientific Office, Pharmatest Services , , Patrick McConville, Ph.D. , VP, Non-Clinical Research Services, Invicro , ,

Pharmatest Services, Invicro and Taconic Biosciences welcome everyone to a seminar discussing human immune system engrafted mouse models and their use in preclinical metastasis models, and preclinical imaging in oncology studies.

Humanized Immune System Mice: how a first-generation model paved the immuno-oncology path and where the next-generation models are leading us, by Janell Richardson, Field Application Scientist at Taconic Bioscience