With International Guest Speaker: Dr Patrick Smith, Chief Scientific Officer, Consulting Services, Certara (US) and a panel of local experts
In July this year, FDA Commissioner Scott Gottlieb, M.D., outlined a new ‘Innovation Initiative’ to advance the speed of drug development. Part of this plan is the use of in silico tools in clincial trials, such as modelling and simulation, to inform study design and de-risk clinical development, and one of the first areas of interest for the application of these new approaches is in paediatric trial design.
Dr Patrick Smith recently spoke at an FDA workshop Paediatric Trial Design and Modeling: Moving into the Next Decade and we are delighted to host him in Melbourne for this BioBriefing event on the challenge of thinking differently about the development of medicines in the 21st century.
This will be followed by a panel discussion on strategies to enhance the co-operation of industry sponsors, the paediatric clinical community and regulatory bodies to drive innovation, reduce paediatric drug development timelines and costs and to provide greater access to new and emerging therapies for all patients. Who should attend this event: Biotech and pharmaceutical executives, clinical trials and regulatory affairs professionals, and anyone with an interest in novel approaches to drug development.
Date: Friday 17th November Time: Registration from 2:45pm for 3.00pm presentations and discussion, followed by networking until 5.00pm Venue: Phillips Ormonde Fitzpatrick – Level 16, 333 Collins St, Melbourne
BioMelbourne Network Members: $65
Non Members: $130
(Prices include GST.)
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About Patrick Smith
Dr. Smith has over 17 years of global drug development experience. Working across all phases of development, he has particular expertise in infectious diseases, oncology, and inflammation, including significant experience with novel early development program design, and applying modeling and simulation to solve critical development problems. As a co-founder of d3 Medicine (now Certara), Dr. Smith has led many development and due diligence projects for clients ranging from pre-clinical development/IND strategy, design and execution of entry-into-human and proof of concept studies, design and implementation of modeling and simulation strategies, and crafting clinical pharmacology and clinical development plans. He has extensive clinical development experience globally, and has interacted with all major health authorities.
Dr. Smith was the US Site Head for Clinical Pharmacology for Roche, and a member of key corporate governance committees defining disease area and portfolio strategy. He served as an Associate Professor at the University at Buffalo School of Pharmacy and Roswell Park Cancer Institute. He obtained his PharmD degree from UCSF, and completed a clinical residency at Duke University Medical Center. Dr. Smith currently holds a Research Professor appointment at the University at Buffalo School of Pharmacy, and has authored more than 100 peer reviewed publications in journals including The Lancet and New England Journal of Medicine.
Dr Jayesh Desai, Medical Oncologist
Jayesh Desai is based at the Victorian Comprehensive Cancer Centre in Parkville. He practices as a Medical Oncologist at the Peter MacCallum Cancer Centre in Melbourne, and is a Senior Clinic Research Fellow at the Walter and Eliza Hall Institute in Parkville. Dr Desai has a strong interest in Phase I Cancer Trials/Early Drug Development. He has been Chair of the Cancer Trials Australia (CTA) Phase I Drug Development Group, the largest such network in this region; and is Head of Early Drug Development Trials at Peter Mac.
His clinical and research interests focus on rationally developing new anticancer therapeutics, and exploring predictive markers of response to these agents. Dr Desai has been Principal Investigator on more than 40+ oncology trials, including 20 first-in-human Phase 1 oncology trials with a broad array of compounds. These have included a number of investigator-initiated trials, as well as trials sponsored by small academically-focused groups to biotechs and large pharmaceutical companies.
A/Prof Craig Rayner, President, d3 Medicine (A Certara Company), Adjunct Associate Professor, Monash University – Monash Institute of Pharmaceutical Sciences
Dr. Rayner has more than 15 years of drug development experience. His past appointments include leadership roles in Clinical Pharmacology and Early development (Roche), Clinical development (CSL-Behring), in Business Development/Licensing as Global Due Diligence Director (Roche) and as an academic researcher in clinical pharmacology and infectious disease research (Monash University). Dr. Rayner was also co-founder and CEO of d3 Medicine – a global advisory company providing strategy and stewardship of complex drug development programs, until Its acquisition by Certara in 2016.
Dr. Rayner has extensive experience in early and late development of therapeutics, regulatory interaction experience with all major global health authorities, multiple filings and accountability for numerous due diligences, active support of negotiations, deal making and integration activities. He holds an Adjunct Associate Professorship in Pharmaceutical Science (Monash University), and is broadly published in clinical pharmacology and also infectious diseases.
Joanna Waugh, Independent Regulatory Consultant and Consultant to Roche Products Pty Ltd
Joanna Waugh is a regulatory professional with over 20 years of global regulatory experience from positions based in Australia, the US and Europe. She has experience with submission of multiple NDA and line extension filings, extensive experience interacting with global health authorities and special expertise in regulatory management of marketed products. Joanna currently assumes a US regulatory leadership role for a major multinational pharmaceutical Company overseeing part of their marketed products portfolio. She is also the co-founder of Stratopharm, an Australian-based regulatory and marketing consultancy.
Previously Joanna was Vice President of Regulatory Affairs at Noven Pharmaceuticals in New York and a Group Director at Hoffmann La Roche.
Joanna is motivated by the challenges associated with meeting the needs of multiple regulatory authorities with one development program for the benefit of patients globally.
Dr Warwick Tong, MB, ChB, MPP, GAICD, Chief Executive Officer, Cancer Therapeutics CRC (CTx)
Dr Tong brings more than 24 years experience of senior leadership in medical, clinical, commercial and business development in the major pharmaceutical and biotechnology sectors. He has been CEO of CTx for 6 years. As part of its activities CTx is working in a close partnership with the Children’s Cancer Institute (CCI) in Sydney in the area of developing new drugs for paediatric cancer as well as supporting the CCI led Zero Childhood Cancer project.
From 2005 to 2011 he was SVP, Development, for Surface Logix Inc, Boston USA. Previously he held positions of increasing seniority at GlaxoSmithKline (GSK), including country, regional and global roles as Medical Director, Business Development Director and VP Commercial Strategy for Infectious Disease. Before his pharmaceutical industry career he worked in primary care medicine for 14 years, founding two medical clinics in New Zealand.
He graduated as Senior Scholar in Medicine from Auckland University, New Zealand and has a postgraduate qualification in Public Policy from Victoria University, Wellington New Zealand.