Saturday, 31 October 2020



Watch On Demand


How 'ClinicReady' by Avance Clinical Gets Biotechs into Clinic Faster

Watch On Demand video

In this webinar you will hear from the leading Australian CRO for biotechs, and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner, Avance Clinical about ClinicReady a dedicated scientific and regulatory advice service that gets biotechs into clinic faster.

The highly regarded Avance Clinical scientific and regulatory team has been advising biotech clients on their drug development for more than 20 years and is now the dedicated ClinicReady service under the Avance Clinical banner.

Why Biotechs Need ClinicReady
"With our two decades of CRO experience we have become acutely aware of the importance of advising clients earlier in the development process, prior to them commencing preclinical safety and toxicology activities, so they conduct an appropriately balanced set of preclinical studies to get the right data for approval of their first-in-human study in Australia," said Dr Gabriel Kremmidiotis, Avance Clinical's Chief Scientific Officer.

The ClinicReady team has also expanded with the appointment of Dr Jorgen Mould as Scientific Affairs Specialist.

"Dr Mould has over 20 years of experience in the medical industry specialising in drug discovery and clinical development. He was appointed to further expand our range of services to cater for the preclinical research management needs of small biotechnology enterprises and assist them in bringing their products to clinic," said Yvonne Lungershausen, Avance Clinical’s CEO.

"Having spent several years taking biotech products to the clinic, I am really looking forward to the opportunity of sharing my experience with Avance Clinical’s clients in a way that expedites access to the clinical trial testing for their preclinical assets," said Dr Mould.

ClinicReady has been formed in response to increased demand from biotechs for dedicated expertise in preclinical study management and scientific and regulatory advice to take their products to first-in-human trials.

The ClinicReady team of scientific and medical affairs specialists comprises PhD qualified individuals with decades of experience in industry and academic research. They provide clients with scientific, regulatory and medical writing services, preparation of investigator brochures, clinical trial designs and study protocols, and patient information and consent forms as well as clinical trial data and clinical study reports.

ClinicReady by Avance offers the following services:

  • Gap Analysis
  • Preparation of Drug Development Plans
  • Preclinical vendor selection and management
  • Scientific Advice
  • Therapeutic Area Advice
  • Chemistry Manufacturing Controls (CMC) Advice
  • Preparation of Investigator's Brochure
  • Regulatory agency submission support

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services fit for global regulatory standards to the local and international drug development industry for 20 years.

Watch On Demand video


Speaker:


Jorgen Mould PhD,
BSc (Hons) Avance Clinical's Scientific Affairs Specialist

About:

Jorgen has over 23 years of experience in medical research and drug development. With a passion for developing new treatments for human diseases, Jorgen has worked in positions that span the full spectrum of a drug lifecycle from bench side discovery to post market approval.

Prior to joining Avance Clinical, Jorgen worked in the Neurology Medical team at Merck Healthcare where his background in neuroimmunology and neuroinflammatory disorders was used to build strong scientific partnerships with key external stakeholders. During this time, Jorgen also gained considerable knowledge of late phase clinical development and regulatory submission.

Prior to this, Jorgen was Director of Ion Channel Biology at Bionomics Limited, where he was responsible for leading the pre-clinical development of small molecule therapeutics for Multiple Sclerosis and Chronic pain. Other notable career highlights include 5 years postdoctoral work in the department of Neurobiology at Northwestern University, Chicago working on Influenza Virus and a 3-year appointment at the Institute for Molecular Biosciences at the University of Queensland identifying novel peptides as pain therapeutics.

Jorgen has a PhD in medical sciences from the John Curtin School of Medical Research at the Australian National University and a Bachelor of Science (Hons) majoring in Biochemistry from the University of Queensland. Jorgen has published several peer reviewed articles in prominent scientific journals and has contributed to numerous patents relating to small molecule therapeutics for the treatment of multiple sclerosis and chronic pain.



Gabriel Kremmidiotis
PhD, BSC Hon Avance Clinical's
Chief Scientific Officer

About Gabriel :

Gabriel has 26 years’ experience in medical research and drug development. He has devoted most of his career to the biotechnology industry, managing drug development programs from early discovery to completion of phase II proof of concept clinical trials and subsequent commercial drug licensing deals.
He has been part of the CPR Pharma Services team since 2015 managing the department of clinical operations and offering drug development advice to biotechnology companies seeking to enter clinical trials in Australia.

In 2019, Gabriel was appointed Chief Scientific Officer of Avance Clinical where he currently leads the Department of Scientific and Medical affairs offering Medical Writing, Drug safety monitoring and reporting and early phase clinical drug development and regulatory advice services.

Prior to joining CPR Pharma Services, Gabriel was the Vice President Research & Development of the Australian ASX listed company Bionomics limited where over several years led teams in discovery and progression of cancer therapeutics through to completion of several phase I and Phase II clinical trials in Australia and the US.
Gabriel’s 26 years in medical research also includes appointments with the Cancer Therapeutics CRC, Flinders University of South Australia, Adelaide University, the Los Alamos National Laboratories and the Adelaide Women’s and Children’s Hospital.
With primary expertise in oncology, Gabriel has a diverse scientific background spanning the fields of Clinical Development, Drug Discovery, Cancer Biology, Molecular Genetics, Bioinformatics and Immunology. He has a PhD and a Bachelor of Science (Honours) from Flinders University and a Bachelor of Science from The University of Melbourne. He has published research findings in 29 international scientific papers and has several patent inventions on cancer genes and small molecule anti-cancer therapeutics. Gabriel is a member of the American Association for Cancer Research, the American Society of Clinical Oncology and ARCS Australia.