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. Novateur has a history of attracting world-class advisors. Only the very best join our team and work diligently to solve our client’s issues. Several of these world-class experts have become full time executives at Novateur and have relocated to Canada from the United States. We are pleased to contribute our part to reverse the Canadian “brain-drain”. With over 120 active advisors and over 1,000 global advisors in our network, we can solve any life science problem effectively and efficiently. Novateur is a very active and global group: Our advisors are part of many new start-ups and serve in active executive roles for our clients and partners. Our advisors attended over 200 conferences and seminars throughout the year and were speakers at several. I attended over 20 conferences and spoke at or chaired 6 conferences. Several of us participated in...

Companion Diagnostics: A Guide to Cure?

There is an obsession by biotechs, pharma, investors and payers to pre-select responders to a therapy before they are treated. How did we end up here and how is this going to impact medicine in the long term? In certain diseases where the biology landscape is understood better, like oncology, there has been tremendous impact. However, in most other target areas we still cannot isolate the responders and use “all comers” to try treatments and hope the safety and efficacy of a drug can be shown to be statistically significant. What happens to target areas where specific responders cannot be identified? What happens to companies that have an effective treatment but cannot get funding because they cannot find their “targeted population”? By “targeted” we mean a sub-population that expresses a specific genetic mutation or biomarker. At Novateur we are often approached by creative scientists that have discovered a biomarker diagnostic or in some cases can analyze hundreds of your markers to show that you may potentially have various disorders. Would the doctors be interested to tell you that you may have early Alzheimer’s when there is no treatment available for it? And would the payers pay for it? In our experience, diagnostics will have a challenging time getting funded and partnered, unless they can be paired with an effective therapeutic. The ultimate goal is to be able to utilize the diagnostic to change the clinical outcome in a meaningful way. In a similar fashion, biotech companies developing treatments need to think how to incorporate potential diagnostics to pre-select responders. After decades of experience at large pharma, our advisors believe...

Entrepreneurial Pharma: Confronting the Adage, “Experience Is Something You Get Just After You Need It.”

During my 23 years working in the entrepreneurial pharma environment I have witnessed many lessons learned and I continue to see many companies focusing primarily on reaching key funding milestones while neglecting good drug development practices. This is a mindset that can cost them dearly and deliver experience after it’s needed! It is crucial for entrepreneurs to focus on creating a strong value proposition for the company, attracting the top investors and scientific advisors and moving quickly to key milestones and the additional funding they provide. It’s the nature of the environment. However, at the same time, pharma development requires early and consistent compliance with regulatory guidelines and quality assurance standards and exemplary collaboration skills to enable critical preclinical and clinical trials. The paradox is the need to move quickly AND carefully comply with regulatory requirements and solve technical challenges. This can create confusion when weighing the “must haves” and the “nice to haves”. Often, many important elements are considered “nice to have”. Many entrepreneurs have trouble discerning which is which. Usually, a lack of time or staff or cash is reason for projects moving ahead without the “must haves” like proper documentation or quality checks. In addition, the outsourcing environment is something that is both art and science, something not fully appreciated by all entrepreneurs. Staffing at outsourcing firms varies in expertise, especially in the areas of regulatory strategy and documentation. This requires experienced oversight by the sponsor company.   Here are some real-world examples of my observations of companies that failed to focus on the fundamentals and paid the price: When I was working as and independent...

How Trump Presidency and BREXIT Are Creating the Perfect Storm for Reversing Canada’s Brain Drain

Historically Canada has faced a significant challenge in attracting top talent compared to the United States and retaining top talent already in Canada. Until recently, top entrepreneurs would often choose to start their next big idea in the US, for several reasons, including: Better access to capital Better access to talent Lower income taxes The results of the 2016 presidential election and BREXIT have changed this. For the first time, some of the top US, UK and international executives and entrepreneurs are considering relocation to Canada. Canada offers the following first class resources: Friendly and easy business regulation Top notch basic science from world class universities Lower corporate income tax Significant government R&D incentives designed for start ups such as SRED, IRAP and Mitacs Provincial incentives for investors (Angels and Venture Capitals) to invest in early stage companies and most importantly, a progressive open minded government that is in tune with the need for change in the 21st century. This January 28, 2017 article from Globe & Mail quoted several global technology leaders including Google, Netflix and Uber CEO expressing concern about top talent leaving US. At Novateur, we have been addressing the shortage of experienced pharma talent by matching the best global advisors to Canadian biotech and pharma Companies. Since the US election, several of our most sought after US based advisors have expressed genuine interest in relocating to Canada. We are delighted to announce that as of April 1, Dr. Gina Stetsko, a world-class biotechnology expert in CMC Manufacturing and process scale up has relocated from San Diego to Vancouver and joined Novateur as a full time...

Conquering the South Pole and Lessons for Biotechs

How the Norwegians conquered the South Pole while the well funded and well resourced British all died on the way back & how that applies to biotech   December 14th, 2016 marked the 105th anniversary of the first expedition to the South Pole by the Norwegian Roald Amundsen, trained by the Inuit in Canada. Famously, the second place finishers, a British team led by Robert Scott, showed up at the South Pole 34 days later. Despite starting the race much earlier with significantly more men and resources, the Brits not only faced defeat, but also died on the return journey. This race in many ways reflects two different business models. What we can learn from it is especially applicable to biotechs and pharma. Why would the underdog end in triumph and the other well-stocked team in tragedy?     The Nordics Were Coached by the Inuit – Experience Matters Amundsen had just completed a 3 year journey successfully crossing the Northwest Passage. During that period he spent many months stuck in ice, so he had a lot of downtime to learn from the Inuit how they kept alive in extreme conditions. Thus, the Norwegian came to the southern hemisphere with what was then the cutting-edge in polar technology: Dog sleds, igloo-building techniques and loose-fitting fur parkas. Amundsen’s subject matter experts (the Inuit) were like a team of experienced pharma drug developers who know the latest drug development techniques and the regulatory/business development/reimbursement landscape. Trekking to the South Pole is like trying to get a new drug or device to approval; it is not something you want to learn “along the...

Trends at the FDA in Medical Device Approvals

Dr. Carol Stephens delivered a speech at the LifeSciences BC McCarthy Spotlight Speaking Series event in Vancouver, BC on November 17, 2016. The speech was focused on the trends at the Food and Drug Administration regarding medical device approvals.   View and download the full presentation View and download the full presentation About the Author Dr. Carol Stephens has 28 years of experience in drug development and support with focus on regulatory planning, negotiation, execution, and compliance. In her spare time she likes to design new gardens, spoil her dog Moxie, and travel with her...