ROUNDTABLE | Getting the most out of your CRO partnerships

ROUNDTABLE | Getting the most out of your CRO partnerships

31 Jul 2023|Healthcare
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Helen PoliviouHelen PoliviouManaging Director at PureCDM

Helen is a seasoned expert in the realm of clinical research and data management, with an extensive career spanning over two decades. As the Founder and Managing Director of Pure CDMA, her visionary leadership has shaped the company into a trusted partner for organizations seeking strategic solutions in the complex world of clinical data.

Con KonstantopoulosCon KonstantopoulosDirector at Akesa Pty Ltd

Con’s experience in commercial pharmaceutical sourcing and wholesale distribution helps provide customized solutions for Akesa’s client and supplier network. Prior to founding Akesa, Con has been in the life sciences industry for over 20 years. During his tenure at Symbion (Australia’s largest pharmaceutical wholesaler), he significantly increased sales revenue and market share within the hospital and community pharmacy wholesale sector. In his last role as Group Business Development Manager, Con was heavily involved with pharmaceutical manufacturers offering strategic third-party logistics solutions. Business development has always been a passion for Con, providing the focus required to help Akesa become the APAC supplier of choice for registered pharmaceutical products used in clinical trials.

Dr Babaji YadevDr Babaji YadevSenior Consultant at Novotech Drug Development Consulting

Babaji Yadav is an Associate director and Principal consultant with over eight years of academic experience in pre-clinical oncology drug development and ten years of industry experience in drug development. Babaji has a strong background in pharmaceutical sciences with a PhD in Pharmacology and Toxicology from University of Otago, New Zealand. Previously he has worked as a Research Project Manager to oversee IND enabling toxicological studies for lead oncology drugs and, prior to joining NOVOTECH, was a Clinical Project Manager for early phase oncology trials. Babaji is a EU/UK Registered Toxicologist and at NOVOTECH he is focussed on providing technical toxicology advice and product development strategies to facilitate entry of client’s compounds into clinical trials. Babaji has experience in small molecules, combination products, and biologicals including vaccines, proteins, monoclonal antibodies, and advanced cell and gene therapies.Babaji is also an independent reviewer on Bellberry Human Research Ethics Committee, Australia.

Dr Angela DrewDr Angela DrewVP, Regulatory Strategy at Premier Research

Dr. Angela Drew is a US regulatory expert with Premier Consulting, a Global CRO that is Built for Biotech. Angela has expertise in the FDA’s 505(b)(2) approval pathway and US Regulatory Strategy, and is based in Melbourne, Australia. Prior to joining Premier, Angela worked at Camargo. Her regulatory knowledge is backed up by an earlier academic career in nonclinical models of inflammation, cancer and coagulation. Her roles include providing drug development advice, preparing meeting packages and submissions for FDA, and conducting meetings with CDER Review Divisions. Angela loves challenging regulatory projects that require custom solutions

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Description

This session will include a series of short briefings followed by a breakout to more intimate roundtables hosted by a range of different CROs. These roundtables offer the opportunity for a deeper dive discussion with CROs who can talk you through the various clinical services, solutions and strategies which will be most advantageous to your business.

This session will bring together a variety of different vendors specialising in a range of areas, enabling biotech’s to arm themselves with the right information to make informed decisions and get the most out of their partnerships with CRO’s.

Some of the areas we may cover in these briefings include: • Reducing start-up times, and how to position product/project to end customer • How to improve & help on recruitment • Take control of your clinical data • What are you looking for in a partner? • Designing with the end in mind – reimbursement in line with your clinical trial design • What are some of the pre-clinical program considerations to support a successful clinical trial? • How do you develop an effective safety & efficacy program through a rigorous nonclinical strategy? • Identifying clinical trial supply challenges in the early stage of trial design • Is my product eligible for approval vie the US 505(b)(2) pathway?

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