Have you ever wondered... What are the key considerations and who are the key stakeholders in regulatory and reimbursement strategies? How to decide which market to target for regulatory approvals and reimbursement pathways: TGA, FDA, PBS, U.S. payers? How do regulatory or reimbursement strategies differ between startups and big pharma?

Then join us for this Masterclass where we will explore how Start Ups can consider Regulatory & Reimbursement strategies, through the lens of Market Access strategy.

Key areas we'll explore for Regulatory include:

Which Market do you want to work in first? Which impacts where you seek your Regulatory Affairs approval first
How to use Regulatory Affairs as your secret weapon in gaining rapid market access and scale
Should you seek Regulatory Affairs approval in series or parallel?
Should you use the same data package?

Key areas we'll explore for Reimbursement include:

Ecosystem (The clinical need)
Health Economics aspects
Payer Archetypes in Public Healthcare
Commercial & Private Pay Market considerations
Market Access strategy as a start up
Evidence Generation for Regulatory Success and Reimbursement

Brief agenda:

8am: Registration and passing through security

8:30am: Breakfast

9am: Masterclass begins

9:30am: Audience Q&A

10am onwards: Networking

Meet your Speakers:

Grace Gowda, Program Director of the International Biomedical Regulatory Sciences Program and an Associate Professor in the College of Pharmacy
Grace has more than 25 years of experience in the pharmaceutical industry. Her areas of experience include product development, basic research in the field of neuroscience, clinical research and trials in mental health, targeted drug delivery in immunology, clinical and quality strategy for registration and maintenance of products and regulatory policy. In her position within the college of Pharmacy, she is responsible for overseeing the Masters of Science program in International Biomedical Regulatory Sciences as well as the multiple graduate certificate programs. She also is part of the Regulatory Knowledge and Support program within the Georgia Clinical and Translational Science Alliance GA CTSA) and sits on the Association for Graduate Regulatory Educators. Grace has held leadership positions in national and international trade associations and has represented the U.S. animal health industry in Veterinary International Conference of Harmonization (VICH). She also represented the animal health industry in four animal health user fee negotiations with the FDA. Her commitment and service in leadership roles with Healthcare Business Women Association (HBA) and American Association of Pharmaceutical Scientists (AAPS) were recognized with the HBA Chapter Leadership Award and AAPS Regulatory Sciences Section Service Awards, respectively.

Orin Chisholm, Program director for the postgraduate programs in Pharmaceutical and Medical Device Development at the University of Sydney.
Orin has academic appointments with UNSW and Arizona State University, USA. Orin has spent many years in industry and as a consultant in regulatory affairs. She is on the Board of the Association of Graduate Regulatory Educators (USA) and is a founding member of the Regulatory Affairs Education Alliance. Orin received the TOPRA (the organisation for professionals in regulatory affairs), UK award for excellence in regulatory education in 2017; became a Senior Fellow of the Higher Education Academy (UK) in 2018 and was elected a Fellow of the Regulatory Affairs Professionals Society in the USA in 2021. Her research focuses on regulatory science, workforce development and pharmaceutical policy.

Kylie Earle, Market Access Lead at Sanofi
Kylie Earle is a Market Access Lead for Sanofi Australia and New Zealand, with close to 20 years’ experience developing and implementing successful reimbursement strategies which have helped to support affordable access for patients to a broad range of treatments. With a Bachelor of Medical Science (Honours) and a PhD in Neuroscience from the University of Sydney, she commenced her career in Regulatory Affairs in Australia. She continued her career in London where she worked in a global Regulatory Affairs roll. On her return to Australia, Kylie transitioned to Market Access upon which she completed a Master’s in Public Health at the University of Sydney. At Sanofi we chase the miracles of science to improve people’s lives and as a Market Access Lead, Kylie is committed to working collaboratively with Government, Academia, Healthcare professionals and patients to support timely and affordable access to innovative medicines and vaccines for Australians and New Zealanders.

Nicholette Conway, Board Chair of Genetic Alliance Australia and Co- Founder and Director of AxisHealthCo
With over 25 years of experience, Nicholette has worked across the pharmaceutical, medical device, and diagnostic industries. Her expertise spans clinical development (Phase 1-3), Health Technology Assessment (HTA) new product planning (NPP), market access, and reimbursement (MSAC & PBAC) and commercialisation, and is committed to delivering timely access to life changing treatments and improving health outcomes for patients through cross-disciplinary collaboration, building strong relationships and embracing new technologies. Nicholette has led many multi-disciplinary/cross-functional teams both internally and externally to organisations, to set strategic goals or commercialise products and delivered on these goals to support commercial outcomes. Fundamental to the success of these projects has been building broad and deep stakeholder understanding both internally and externally, including with healthcare providers, allied health practitioners, service providers (including digital, data science (AI/ML) and engineering), regulators, payers and patients as well as patient advocates and working with stakeholders to build the evidence needed to deliver regulatory, reimbursement and commercial outcomes.

Meet your Facilitator:

Christopher Boyer, Chief Business Officer & Director of Tessara Therapetuics
Christopher brings 20 years of experience in the discovery, development and commercialisation of biotechnology, and combines his technical and commercial insights to build the value of emerging biotech companies. His R&D roles have included small molecule drug discovery and molecular neuroscience, attained at Novartis and the Howard Hughes Medical Institute, respectively, and his progressive roles in business development have included NewBiotics and Halozyme Therapeutics in San Diego; and Cryptome Pharmaceuticals in Melbourne.

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NOTE: You may be photographed or videod while attending this event for marketing purposes: please approach the organiser if you have questions, concerns, or do not wish this to happen.

The masterclass will be followed by an optional tour of Jumar Bioincubator. Let us know in the registration form if you're interested in participating.

About

Jumar Bioincubator acts as a first home for biotech startups, providing affordable lab and office space, practical support, and community activities to unlock the potential in early scientific discoveries.

Jumar Bioincubator was established by CSL, WEHI and the University of Melbourne. Together, with backing from innovation investor Breakthrough Victoria and operator Cicada Innovations, the mission is to connect early-stage and scaling biotech ventures with the support they need to progress discoveries towards real-world treatments and therapies and build a critical mass of scientists with the knowledge and confidence to run successful biomedical ventures.