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.)

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 , He 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