Importance of Women’s Leadership in Life Sciences

It wasn’t very long ago when, at the JP Morgan Healthcare Conference, presenters named Michael outnumbered female CEOs giving company presentations. Of the presenters, there were 22 men named Michael, overshadowing the total number of 20 female CEOs. With 4 out of 9 panels including no women at all, as either moderators or panelist. This was only a year ago. JPM this January saw a slight shift in its presenter line-up, but 90% were still men, reported STAT. It is interesting to note though, J.P. Morgan’s Executive Leadership Team itself is a good example of gender diversity, with 43.8% women. As JPM is one of the largest annual gatherings in the world for biopharmaceutical executives, it serves as a window to the biotech and biopharma landscape as a whole.

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Tips for Raising Venture Capital

One of the most mystifying processes in the start-up community is how to get to a ‘yes’ from a venture capitalist. Between the often-opaque internal timeline and the seemingly ever-shifting criteria for investing, it’s an understandably frustrating process for entrepreneurs. In addition, the numbers can be daunting, with VCs touting sub 1% rates of funding companies that they see. Although every firm has a different process, most venture firms do share a few commonalities in the way they evaluate investments. 

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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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