With BioEurope Around the Corner: Are Your Meeting Requests Getting Rejected or Never Answered?

Any business development executive on the out-licensing or sell side will be familiar with the phenomenon. You’ve carefully crafted your messaging, detailing what you can offer, your science is sound, the demand is there you hear time and again, but after sending out 20 meeting requests to potential partners, you remain with 19 out of 20 meeting requests being declined or unanswered.

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Rewarding Summer for Novateur and Its Clients and Portfolio Investment Companies

It has been a rewarding summer for Novateur and its clients and portfolio investment companies!

Despite the heat and the vacation season, this summer has seen a flurry of notable activities across the Life Sciences.

We are excited to announce new Novateur Services as well as to celebrate the success of Novateur clients and our investment portfolio companies in closing deals, partnerships, and investments.

Congratulations to IRICoR, Feldan Therapeutics, Navigo Proteins, MetaOptima, Vasomune, Immune BioSolutions and AIT Therapeutics.

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Clinical Evaluation Reports for EU-Marketed Medical Devices – A Summary of the Regulatory Guidance

Following the June 2016 release of the new MEDDEV 2.7/1, revision 4 guidance (Rev 4), manufacturers of CE-marked medical devices are scrambling to maintain compliance. Clinical evaluation is necessary for the initial CE-marking of new devices, as well as for devices that have been marketed for years. Manufacturers are required to provide sufficient evidence to show conformity of the medical device to the Essential Requirements, and its performance and safety when used clinically according to the instructions for use. Clinical Evaluation Reports (CERs) must be created during device development and updated periodically throughout the marketed lifetime of the device in the EU. This summary outlines the major aspects of this regulatory requirement.

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Go Luke! Luke Timmerman Is Hiking to the Top of Mt. Everest for Cancer Research

When I found out Luke Timmerman is raising funds for cancer research by hiking the tallest mountain in the world, admittedly I was both excited and jealous!

I met Luke Timmerman when he gave an ever-engaging talk at a biotechnology investment conference in Toronto a few years ago and I have been subscribing to his newsletter, Timmerman Report, since. He is one of the most respected biotech journalists who has been writing — and in some cases predicting — many key trends and challenges about our space.

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Winding Down 2017 With Tremendous Gratitude

As we approach the end of 2017, we look back with tremendous gratitude for the many friends and supporters of Novateur, especially for our valued clients, whom we consider our partners.

We had a great year and grew our practice in substantial ways in every possible metric. We worked with over 30 companies and investment groups conducting due diligence and providing product and project development advisory. We completed over 120 projects. Our clients raised over $100 M in capital, including one that successfully became public on a US stock exchange. Several companies also completed partnerships with larger pharma clients.

We believe Novateur is the solution for the “talent” challenge in Canada and other geographies where there is dearth of seasoned development and execution expertise and lack of a track record.

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Quality Assurance: An Important Contributor to Value Creation

For most start-up pharma companies the drive to the next fundraising milestone and value inflection point consumes most of their planning. Sometimes, however, some of the details “behind the scenes” can be deprioritized, such as a designated person responsible for quality assurance, a preliminary quality system and quality procedures.

From a regulatory perspective a quality assurance function ensures compliance with regulatory guidances and the integrity of the data generated by all parties involved so it is suitable for regulatory submission or for review by potential future partners.

Quality Assurance clearly needs to ensure compliance with GLP, GMP and GCP requirements (collectively GXP). Studies conducted under these guidelines are inextricably linked, so all need to be addressed in a similar manner.

However, compliance goes beyond just meeting regulatory requirements since it can also serve to prevent wasted time and money on delays or repeating GXP activities and also supports informed business decision-making.

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Cannabis In Canada – Sweeping Changes

Yesterday, Health Canada announced their proposed new legalization framework for cannabis in Canada – full proposal is found here – and which is now launching Canada to the forefront of the global cannabis market. I’ve seen many regulatory adjustments and changes to cannabis in the last decade, but nothing quite like this. Most of us are still waking up with a “regulatory hangover” and trying to process all of the changes. As the founder and CEO of the world’s largest and most professional cannabis compliance firm, I’m writing this article to provide my insights on where cannabis is headed. Because this is a game changer.

Many of us knew the changes were coming, but none of us predicted in full how far the government would take this. In short, Canada is creating a whole new framework for cannabis production and sales, which will immediately spill into these established industries: health products, food, cosmetics, pharmaceuticals, medical devices and agriculture.

Overnight, cannabis became an ingredient, not a product. Let me explain.

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Diagnostics: The Good, the Bad & the Ugly

On October 26-27, I co-chaired an International Conference on “Companion Diagnostics & Biomarkers” in Porto, Portugal.

The presenters included global experts in diagnostics including market leaders such as Unilabs, Agilent, Qiagen, ThermoFisher and Gurdant.

The Conference was initiated by the other Co-chair, Harry Glorikian, the author of Moneyball Medicine who delivered an engaging presentation predicting the future of medicine and digital health.

Throughout the two days, impressive and informative presentations described the current status and the predicted future of diagnostics and digital health technology including the anticipated tsunami of future changes.

I initiated the second day of the conference with an overview of  the past, present and future of diagnostics, encompassing the best (and worst) examples of companion diagnostics (“The Good, the Bad and Ugly”). Click here to link to the presentation.

Here are some summarized highlights from the conference:

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