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. Some issues recently seen with clients include: R&D staff found a second supplier for a key active ingredient for use in a drug device but the supplier was not audited and qualified. The material received was later found to be sub-potent which delayed the start of a clinical trial. R&D staff faced a tight timeline to produce clinical material for a Phase 2 trial and agreed to batch record changes without QA review that jeopardized a link to a completed Phase 1 study. A company chose a well-known API supplier and did not conduct an audit or complete supplier qualifications. Since the API supplier has supplied many companies worldwide and has many regulatory approvals, qualification was not considered...

Why Did We Go Fishing with Roche Venture Fund?

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? We live in a geography where there is a dearth of Venture Capital funding. Most funds are located in San Francisco and Boston and unless our Canadian clients are visiting those cities on a regular basis, they would not have exposure to many VCs and family funds. We are spearheading an effort to create awareness on our innovators. If we can not all go down south, let’s bring up serious VCs to connect with our companies. Specifically, we liked Roche Venture Fund and Karl as they are interested in investing in companies that are developing early stage ground-breaking ideas. We have many of those in Canada. In addition, Karl in his previous life was involved in building a company that was sold to Amgen. We find VCs that were entrepreneurs in the past to be better investors or at least more understanding of the challenges of biotech entrepreneurship. Why did we go fishing with Karl? Investors invest in people with ideas, not just ideas. They need to meet you, feel comfortable with you and know that they can trust you. They need to...

Forgoing Retirement: Why I Became an Advisor at Novateur Ventures

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.” As a adolescent one has to select a direction for study and a potential career. Hopefully, the choice is something that ignites a spark inside rather than just a means to make a living but everyone makes individual decisions based on many factors. As a child, I helped my Dad take apart and fix just about every thing around the house that needed to be repaired. Starting out as “curious observer”, advancing to “assistant and helper” handing over tools and finally to “repair partner”. My curiosity caused me to often forgo typical childhood pursuits and yes, it had my mother concerned. Later I became fascinated with nature and biology and how living organisims work, and how they interact with the world around them. I remember being intrigued by how some cells in plant seeds turn into stems that grow upwards and other cells become root hairs and grow downwards. Also, how can you swallow an aspirin and your headache goes away? This got me hooked on medicine and the human body. Working in the pharmaceutical science field for over thirty years, I know...