Blog News
Blog News - A Dose of Drug Development is a web publication produced by Integrium. The blog post content included conveys subjects of discussion and practice in the drug development process along with real-time Integrium activity.
"Alternative Financing Solutions for Biotechs" Breakfast Seminar: A Thank You to our Attendees & Speakers
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.
A special thank you to our speakers Miguel de los Rios, Daron Evans and Mark Powers. Thank you for sharing your valuable time, insight and expertise with us.
We had many requests for a copy of the PowerPoint Presentation. For those who have attended, it will be in your inbox by the end of the week! If you were unable to attend and would like a copy of the presentation, send your request via email to Mike.Loftus@integrium.com.
JLabs Took It From A - Z: Drug Development At The Core
by Randa Wahid on 5/12/15
Yet another successful and educational event was held yesterday at the JLabs in San Diego, "From Chemical to Drug: The Path to a Small Molecule IND." The Janssen R&D team of experts covered in their program the processes and best practices when filing a small molecule investigational new drug (IND) application.
Beginning with a history overview of Janssen Labs and before handing the microphone off, Dr. Anders Brunmark referenced the audience back in time to something Dr. Paul Janssen would say, "...the patients are waiting."
The Senior Director of Preclinical Development & Safety, Sandra Snook, shook up a number of questions from the audience as she explained the stages of discovery and development in preclinical studies, focusing on the strategies for pharmacokinetics, drug metabolism, and toxicology.
As Dr. Mark Krook took the stage to walk us through CMC nuances and guidelines, I found a familiar understanding in his message, from a CRO point of view. Many of our studies are delayed due to manufacturing. Mark's presentation outlined the scope of CMC, factors to consider when choosing a partner, and why the stability and synthetic complexity of certain molecules may make manufacturing development run longer than expected.
Dr. Kenneth Turner is the Senior Scientific Director of Quantitative Sciences in Cardiovascular and Metabolism. Ken's objective during his presentation outlined understanding the safety, tolerability, pharmacokinetics, and pharmacodynamics in First-in-Human Trials. He reviewed the different designs to consider when running a FIH trial and reasons for choosing one over the other, a conversation we as a company discuss with our potential clients on the daily.
Katherine Tsokas, J.D., head of Global Regulatory Affairs, ended the event with her synopsis on IND requirements, the importance of pre-IND Meetings, and the entire regulatory strategy. "Start with the end in mind," she emphasized to ensure biotechs have a well-defined development plan, and understand why their products bring value to the patient.
Complete a Successful Pre-IND Meeting With The FDA
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. In an effort to ease the drug approval process, the FDA must be delivered an accurate understanding of what the sponsor hopes to obtain from the meeting. Be honest and forthcoming with your concerns. Your proposed study may contain potential issues you are unaware of yet can be identified in a pre-IND meeting, which in turn can decrease your encounter of costly delays. Position yourself with the ability to gain such valuable feedback by forming a pre-planned agenda based on specific scientific or regulatory issues. Focused and specific questions are what the FDA expects. It is never too early to seek the help you need in order to plan your meeting accordingly, while building a strong relationship with the FDA for a successful drug program. Integrium recommends scheduling your pre-IND meeting 6-8 months prior to IND submission.
3 Key Essentials For An Outstanding Biotech Event
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:
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The Right Speakers And Topics
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Tap into your network of Mavens and construct topics of discussion with specific audience interest in mind
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Appropriate Audience
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Target your contact list separately by identifying Hot Prospects, Current Customers, and Influencers
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Powerful Marketing
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Position your event digitally with visual appeal to consider, using all appropriate medium platforms
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Regen Med Investor Day - New York
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:
1. Gene Therapy Delivery: What can be accomplished with existing vector technology & how should we expect it to evolve?
2. 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. The Alliance for Regenerative Medicine put on a great event alongside Piper Jaffray, their supporting bank, Maxim Group, and industry sponsors including CIRM and PCG Advisory Group.
MassBio Annual Meeting 2015 - Massachusetts
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. He was recognized for his leadership in the industry as Partner and Co-Founder of Third Rock Ventures. Another great speech was given by Andrew Lo as he discussed the potential for financially engineering the biotech world. Lo is a Yale and Harvard graduate, author of several academic articles on Finance and Financial Economics, and Charles E. and Susan T. Harris Professor and Director at the MIT Laboratory for Financial Engineering. A lasting impression was left on the last day with a panel discussion on innovative ways to fund your early stage company, a topic Integrium consistently discusses with potential clients.