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.read more
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.read more
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:read more
On November 2, 2017, I had the pleasure and opportunity to represent LifeSciences BC board, together with Nancy Harrison, Chair, Board of Directors, Dr. Lesley Esford, President & CEO, along with other board members, Dr. Pieter Cullis and Scott Phillips. Our visit included breakfast with the NDP caucus and lunch with the Liberal caucus, where Dr. Esford presented an overview of the life sciences sector in B.C.
What we shared with government were several impressive and enlightening facts:read more
We were delighted to host Karl Handelsman, Partner at Roche Venture Fund in Vancouver last week.
Over 100 participants came to his talk at BC Cancer Agency where he talked about “Winning Strategies for Biotech Startups”. Afterwards, we held a private dinner where he met several companies he had expressed interest in connecting with. The following day we went on a fishing trip with where Karl had an opportunity to connect with the biotech entrepreneurs one on one for several hours.
Why did we invite Karl?read more
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?read more
I have had a successful career in pharmaceutical development and operations and I was about to retire but decided not to. So why am I an Advisor at Novateur Ventures?
I just saw a quote from astrophysicist Neil Degrasse Tyson and this answers part of the reason for my motivation.
“When I think of science and scientists, I think of kids who never lost their curiosity and wonder, and then woke up one day as adults with the same sense of search for what is and what is not true in the world.”read more
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
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