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On October 27, Dr. Kush Dhody, Senior Vice President of Clinical Operations, conducted the webinar Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design. The recording of this webinar is now available.
Cancer treatments are fulfilling the promises of personalized medicine. One aspect is the use of biomarkers detectable in blood such as circulating tumor cells. This webinar reviews several newer clinical trial strategies such as combining adaptive trial designs with innovative endpoints; and umbrella or basket designs that allow multiple drugs to be tested against a cancer in a single trial, or a single drug to be tested against multiple cancer types in a single trial. Dr. Dhody also discusses the challenges of interpreting traditional survival analysis methods in this era of personalized cancer immunotherapies.
View the webinar recording on our YouTube channel.
(September 16, 2020) – Amarex Taiwan, LLC, an NSF International company, will exhibit and present at the 2020 Bio Innovation Conference hosted by the Maryland Technology Council and held October 5-6.
The conference anticipates participation by 300 bioscience industry leaders involved in clinical product development and business success. Speakers will share experiences and information about best practices for clinical product business start-ups. Significant participation by international companies is expected. The two-day conference will be conducted online and includes presentations, panel discussions, live Q&A, and a one-on-one partnering program.
Amarex President & CEO, Dr. Kazem Kazempour, will present at Session C: Entrepreneurship Track, ‘Business Resiliency for the Unexpected and Expected’
Business resiliency implies ability to handle unexpected, difficult situations: lack of funding, a failed clinical trial, a surprise FDA audit, loss of a key employee, a lawsuit, stagnant sales, etc.; but it also means preparedness for achieving expected goals: licensing a product, raising funds, advancing the product, selling the product or business, etc. In this session a panel of entrepreneurs will share advice on business resiliency based on their business experiences.
Register for this conference at https://www.marylandlifesciences.com/conference/.
(September 04, 2020) – Amarex Taiwan, LLC, an NSF International company, is pleased to announce exhibiting at 2020 Korea National Enterprise for Clinical Trials (KoNECT) Ministry of Health and Welfare (MOHW) Ministry of Food and Drug Safety (MFDS) International Conference Virtual, held September 09-11. This year, the conference will be live-streamed online and offers presentations and workshops on new technologies and approaches to clinical trials in Asia, with a special focus on advanced regenerative medicine, biopharmaceuticals, and medical devices.
Register for this conference (and sign up for virtual partnering with us) at https://www.konectintconference.org/.
Visit us at virtual booth #2: http://www.kic-exhibition.or.kr/contents/company02.php.
Taipei, Taiwan (August 14, 2020) – On 24 July 2020, Amarex Taiwan, LLC President & CEO, Dr. Kazem Kazempour, keynoted at BioAsia-Taiwan 2020 on Clinical Trials for Advanced Therapies.
Clinical trial design for advanced therapies differs from clinical trial design for other pharmaceutical products. Dr. Kazempour discusses the challenges at the design and analysis stages of clinical development for these products, including sample size and power calculations for efficacy. Strategies for successful design are covered and special programs, such as Expedited Programs, are suggested when applicable.
Amarex Clinical Research, LLC, an NSF International company, is pleased to announce that Amarex Taiwan, LLC will keynote at BioAsia-Taiwan 2020 Online + Live. BioAsia-Taiwan 2020 will be held digitally on July 22-26. This conference brings together biotechnology and pharmaceutical leaders from around the globe to explore biotech developments and business opportunities with a focus on activities and companies in Asia.
On Friday, July 24, President & CEO of Amarex Taiwan, Dr. Kazem Kazempour, will keynote at Workshop 2 on the topic of Clinical Trials for Advances Therapies.
The design of clinical trials for advanced therapies often differs from the design of clinical trials for other types of pharmaceutical products. In this talk, Dr. Kazempour will focus on the challenges at the design and analysis stages of clinical development for advanced therapy products, including sample size and power calculations needed to establish efficacy. By identifying the challenges of these innovative and complicated clinical trial designs, we can offer strategies from different perspectives to overcome them. There are also multiple opportunities to take advantage of special programs at different stages of clinical development, including the utilization of Expedited Programs.
Additional presentations in this workshop will cover advanced immunotherapy, oncology trial design and regulatory considerations for evaluation of regenerative medicine products.
To view the agenda or to register for BIO Asia-Taiwan 2020, visit https://bioasiataiwan.com/.
The full recording of our complimentary webinar, reviewing clinical trial design, is available here.
This webinar is presented by Amarex President & CEO, Dr. Kazem Kazempour. He addresses aspects of before study and after study clinical trial design. Physicians focus groups, KOL thoughts, selecting endpoints, IP management and distribution, site selection and patient recruitment are discussed. This webinar focuses specifically on the advantages and disadvantages of adapting a clinical trial.