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- BIO TALK - BIO with Story
- Eun-Ki KIM
- BIO TALK - BIO with Venture
- Partnership among Investros and Entrepreneurs in BIO Industry
- CSIRO Health & Biosecurity – An Introduction
- Working with our partners, we're assembling strong multidisciplinary research teams to tackle major national and international health and biosecurity challenges. In doing so we're protecting the health of our farming sector, environment, people, and our way of life. more We help protect our Australia's productive industries, environment and human health from pests and diseases by assessing the risks they pose, prioritising the pathways of entry and providing new technologies for surveillance and early response through sensor networks and autonomous platforms. We deliver research-based solutions to reduce the impact they pose to Australia’s industries, biodiversity, ecosystem services and urban environments. Our scientists are providing the knowledge, tools and countermeasures to help control and mitigate outbreaks of emerging diseases and are working to underpin national security preparedness against pandemic and bioterrorist threats. We deliver innovation to Australia's food, health and wellness industries, resulting in significant health and economic benefits
- Introduction of George Clinical
- George Clinical is a leading independent Asia-Pacific and US-based clinical research organization (CRO) with global capabilities differentiated by scientific leadership, innovation and extensive investigator networks. more With staff operating in 15 countries, and with significant operations in the USA, China, India and the broader Asia-Pacific region, George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trials.
- Application of DNA Encoded Library for Drug Discovery
- Novel drug discovery research and activities are characterized with large investment, high risk and long development time, etc as well as facing more challenges. more Lead generation is the starting point and one of the most important steps during the early phase of drug discovery R&D, which requires compound library and advanced screening technology and can only be accomplished by some big international pharmaceutical companies with abundance of capital and cutting-edge technology. The emergence of vast DNA Encoded Library has gradually filled the gap in this field and decreased the technological barriers for drug companies at home in the hit identification. As the perfect fusion of Combinatorial Chemicals and High Throughput Sequencing, it not only improves small molecule library to 100Mn even 10Bn, but also makes compound screening more convenient and effective. In this talk, some examples of DEL in drug discovery and technological development will be presented.
- Gene to GMP Manufacturing in 9 Months for Therapeutic Antibodies
- KBI Biopharma is pleased to offer the shortest development time in the industry from gene to cGMP manufacturing for therapeutic antibodies. more Cell line development is performed by KBI's affileate, Selexis SA, in Switzerland using their proprietary CHO-M cell line platform. KBI begins process development using drug substance produced at the early stable pool stage. Selexis continues the clone selection process and KBI uses our analytical expertise to choose the final clone by product quality and titer. KBI completes the cell culture/purification development as well as the analytical and formulation development using the final clone. KBI produces tox material in the pilot plant. KBI prepares the master batch record and produces clinical material in the GMP suite. Selexis and KBI can complete the process from gene to cGMP drug substance in 9 months using this accelerated approach.
- eClinical in Eastern Europe: dissolving myths
- Is it the right time to enter the Eastern European market? How to cut a study budget by 4 times? What made a CRO switch from a US vendor to Data MATRIX? more Оne of the leading eClinical providers in Eastern Europe, Data MATRIX team will combine their knowledge and competence on the global trends and match it against local specifics and practices based on real-life cases.
- A Road Map To A Successful IND Program
- Drug discovery and development is a long journey, which involves many regulatory requirements for characterizations of a new molecule in terms of drug disposition and safety profile. more This presentation will share our experience on IND-enabling programs for global submissions in terms of general considerations of conducting animal studies and projecting human safety by using animal data. Also the presentation will introduce WIND, WuXi’s IND-enabling services to audience. WIND is a truly one-stop shopping for IND-enabling program. The presentation will detail how WIND program works, and share some successful stories.
- Leveraging Non-Invasive Approaches in NAFLD/NASH Clinical Research
- Proteina's newly developed biomarker called "PPI (Protein-Protein Interaction)", at least 2-3 times accurate than NGS, has an unprecedented predictive power for companion diagnostics and prognosis. more Proteina has validated the predictive power of the new biomarker and is currently expanding its bio realm through R&D in drug discovery as well as immuno-oncology. In BIO KOREA 2019, our Chief Technology Officer is proudly presenting our recently achieved breakthrough clinical results on breast cancer as well as our drug discovery strategies.
- Successful outsourcing strategies for the development and manufacturing of biologics
- More and more companies are looking for a CDMO partner to advance their molecule into Phase I clinical trials as quickly as possible. Patheon’s Quick to Clinic program can deliver released drug substance (IgG1 or IgG4) starting from DNA in just 14 months. more This is 6 months faster than most other standard timelines and includes a cell line documentation package, non-GMP drug substance for toxicology studies, released GMP drug substance for First-in-Human studies, viral clearance data and at least one month of stability data. Although speed is important, a strong quality track record, flexibility and technical expertise should also be key attributes of your selected CDMO. Molecule formats such as Fc-fusions, bispecific antibodies and non-antibody recombinant proteins are becoming more popular but can be challenging to develop. Patheon has expertise with these molecule types and can apply many of the Quick to Clinic strategies to identify suitable manufacturing processes ASAP.