by Sheri Farsakh on 7/14/15
Integrium would like to thank everyone who attended "Alternative Financing Solutions for Biotechs: Finance Your Next Clinical Inflection Point." As trusted advisors and clinical proof of concept experts, we hope you have gained a better understanding of the essential necessity for POC Trials when strategizing for safety, efficacy, and capital-raising in your clinical approach.
by Sheri Farsakh on 4/22/15
Request a Type B meeting for pre-IND guidance and start building that good rapport with the FDA. Acquire maximum benefit for your strategic plan by engaging the FDA to help facilitate the development process. Although the meeting is not required by the FDA, it is highly recommended and has become more common of a researcher to take this proactive approach prior to undergoing the long and expensive pathway through to regulatory approval.
by Sheri Farsakh on 4/20/15
In order to create the best environment for a successful biotechnology event to take place, we think 3 key essentials must be met:
The Right Speakers And Topics
Tap into your network of Mavens and construct topics of discussion with specific audience interest in mind
Appropriate Audience
Target your contact list separately by identifying Hot Prospects, Current Customers, and Influencers
Powerful Marketing
Position your event digitally with visual appeal to consider, using all appropriate medium platforms
by Sheri Farsakh on 4/1/15
Discussing the invigorating field of regenerative medicine created quite the atmosphere last week when you consider the tremendous potential at hand for investors and patients. Key opinion leaders and life science investment experts and analysts shared their view on the topics at hand:
Gene Therapy Delivery: What can be accomplished with existing vector technology & how should we expect it to evolve?
Adoptive T-Cell Therapies: Considering key upcoming clinical & commercial milestones
The experience took a reviving turn as we spotted some of Integrium's very own clients pitching in front of the various biotech funding groups.
by Sheri Farsakh on 3/30/15
Highlights of the two day event must be given credit in large part to keynote speakers who have made their mark in the crowd. Mark Levin gave a particularly exciting and moving speech as Innovative Leadership Award Honoree.
by Sheri Farsakh on 3/25/15
Mike Loftus spoke to an audience of 30 people last week, addressing one of small virtual biotechs' most stringent concerns. How do you gain the trust and interest of these funding sources? I bet the investors in the room agreed with Mike as he revealed the benefits and 4 key standards to a successful proof of concept study.
by Sheri Farsakh on 3/18/15
Why run a Proof of Concept clinical trial? Well, it's just about the best solution to mitigate risk, minimize cost, and still gain solid safety and efficacy data all before late-stage clinical development. Early drug development challenges raise a lot of risk in which many experts in the industry have realized can be alleviated rather strategically.
February 18th, 2014
Medical monitoring
Protocol waiver and compliance assessment
Serious adverse events (SAEs) surveillance (24-hour coverage)
Lab safety review
Medical data review
Endpoint adjudication
February 18th, 2014
Our Medical Affairs team has monitored international outcomes trials with more than 6,000 subjects located at investigator sites around the world. Our trial-tested expertise is why many clients have such confidence in our abilities and why we have provided these services to clients on a stand-alone basis.
February 18th, 2014
Integrium understands that patient safety is the greatest priority when conducting clinical trials. Under the expert guidance of our Chief Medical Officer, Dr. David Smith, the Medical Affairs team at Integrium operates with the highest levels of accuracy, responsiveness and ethics.
