How to Organize a Virtual Data Room for Biopharma Partnering
But successful biopharma partnerships don't happen by chance and negotiating an out-licensing deal can be complex—especially when the company may also be progressing the clinical portfolio.
New Gene Therapies for Rare Disorders
Recent cutting-edge advances in genetic therapies are likely to provide game-changing treatments, if not cures, for many patients with rare inherited disorders.
Why Clinical Trials Fail - Know It All
GlaxoSmithKline CEO Andrew Witty once commented on the high cost of drug development, saying, “If you stop failing so often, you massively reduce the cost of drug development.” So, why do clinical trials fail, and what can be done about it?
How to Submit an ECTD to the FDA With Ease
As of May 5, 2017 submission of NDAs, ANDAs and BLAs to the Center for Drug Evaluation and Research (CDER) using the eCTD format became mandatory. For commercial INDs and Master Files the deadline is May 5, 2018.
Choosing a Contract Research Organization
Selecting the right CRO to manage a clinical trial can be a critical decision in the program’s successful outcome. With so many CROs to choose from, what kind of evaluation criteria should be used?
Patient Engagement—The Benefits Without the Risks
Everything you need to know about the Federal Anti-Kickback Statute and the Beneficiary Inducement Statute and how it affects your patient engagement program.
Adoptive Cell Therapy — Hope or Hype?
The therapeutic field of adoptive cell therapy (ACT) in cancer has expanded dramatically in recent years, both in investment activity and technology proliferation. Tune in to our web panel discussion to find out what experts think is in store for this exciting field.
Best Practices for Maintaining a Trial Master File
We recently sat with the experts at LMK Clinical Research Consulting to get their perspective on electronic Trial Master File (eTMF) challenges and best practices.
Microbiomes — Hope OR Hype?
In light of our March 2017 web panel discussion, we sat down with Dr. Ravi Kiron, Managing Partner at Biopharm Strategy Advisors and moderator of the webinar, to find out whether this area could revolutionize the healthcare industry of the future or whether we are treading on dangerous ground that we know little about.
Why Life Science Companies Fail + The Fix
In this webinar, our speaker, Lucia Mokres, the Founder and Principal of Araneae Biotech Consulting, will examine the complexities of this scientific founder knowledge gap and explore why even when aware of this knowledge gap many founders are overwhelmed, resistant, unfamiliar, unaware, and unable to...