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.read more
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.read more
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.read more
Dr. Carol Stephens delivered a speech at the LifeSciences BC McCarthy Spotlight Speaking Series event on November 17, 2016 in Vancouver, BC.
The speech was focused on the trends at the Food and Drug Administration regarding medical device approvals.
View and download the full presentation:read more
Dr. Thomas Stephens delivered a speech at the LifeSciences BC McCarthy Spotlight Speaking Series event on November 17, 2016 in Vancouver, BC.
The speech was focused on the trends at the Food and Drug Administration regarding drug approvals.
View and download the full presentation:read more
As members of the life science community and organizations lobbying for our sector, we ought to do a better job educating the public on a tall task we have chosen for our careers. No other sector is as risky as the life science sector and many of us as life science entrepreneurs end up risking our savings and spend our careers trying to bring new medicines to patients. Many of these ventures do not ever make it. The true value of the drug, the expense and risk that takes to bring a medicine to patients, needs to be better communicated.read more
The FDA Guidance describing the pathway for development and approval of a 505(b)(2) application covers a lot of ground, but as with any Guidance, it serves only as a general outline.
A key element of this Guidance is described in Section II.B.2.read more
The annual Biotechnology Industry Organization (BIO) Convention is around the corner, and several of our clients are extremely excited as several of the large pharmas have requested to meet with them at BIO. These clients are in different therapeutic areas, but all are developing novel small molecules or biologics with targets that are of interest to large pharma. However, in several cases their lead molecules are in very early preclinical stages.
How does one decipher large pharma’s interest? Is it that they are truly interested to partner with assets at this stage in development?read more
Like every story, a drug development success story isn’t one where 2 + 2 = 4. We hear about the headlines and the end results once victory is achieved over the acquisition end line, however the backstory is seldom given the right amount of air time. This story is one with many twists and turns. It is in this story where the real lessons lie.
The common ingredients in successful drug development are a confluence of timing, knowledge, experience, hard work, access to capital and sheer luck. But how these come together is the real story.read more
As it relates to the biotech industry, there are two themes to be mindful of as we enter the new year. The first theme is correction. Biotech indices have gone and continue to go through a significant correction since September 2015. According to a recent Forbes article out of 142 VC backed biotech IPOs that were completed between 2013 to 2016, 74% are trading below their IPO price. However, the total value of all the companies is higher than original IPO, meaning that 26% of high quality companies still balance out the rest.read more
- Entrepreneurial Pharma: Confronting the Adage, “Experience is something you get just after you need it.”
- How Trump Presidency and BREXIT Are Creating the Perfect Storm for Reversing Canada’s Brain Drain
- Conquering the South Pole and Lessons for Biotechs
- Trends at the FDA in Medical Device Approvals
- Trends at the FDA in Drug Approvals