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...

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 Drug Approvals

Dr. Thomas 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 drug approvals.   View and download the full presentation View and download the full presentation   About the Author Thomas W. Stephens, Ph.D. has 28 years of pharmaceutical development preceded by 12 years of in vitro diagnostic experience with emphasis in research, regulatory, project management and administration. In his spare time Tom pursue various interests including astrophotography, underwater photography, swimming, gardening and...

How Would the Biotech Landscape Change After the Election?

This is the 10th US Election I am following personally. I remember US elections going back to 1980 (Carter vs Reagan) at a time when I was attending a kindergarten in Charlotte, North Carolina and Iran hostage crisis was unfolding. The last time I remember a contested and controversial US election was between George W. Bush and Al Gore of Election 2000. This year’s Election has taken everything to a new level (high or low) depending on what you’d be measuring. Besides all the rhetoric and unbelievable factoids we are learning about candidates everyday, we wonder how this election would impact the FDA, reimbursement and generally the life sciences sector. As many of you know, the head the the FDA (the Commissioner) reports to the Secretary of Health and Human Services who reports to the President and is part of the President’s cabinet. Both are appointed by the President and confirmed (or not) by the Senate. So the choice Americans make on the president impacts who he or she chooses for the head of the FDA and the direction FDA would take. Also, we are entering unchartered waters in the US regarding the reimbursement debate. There has not been another time in the US history where drug pricing and the value of new medicines have been so controversial and debated. In my opinion, the few bad apples (Martin Shkreli, Mylan and others) are giving the whole industry a bad reputation. At a BIO CEO/Investor Forum last week in San Francisco, a number of protestors interrupted the plenary lunch session and prevented many of us from attending the session. Drug...

How to Decipher Large Pharma’s Dating Game?

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? The Novateur team’s several decades of experience from both the buy side of large pharma and the sell side at biotech tells us that in such cases large pharma is mainly gathering competitive intelligence – and “just in case” they might lose out to the other large pharmas. Some signs are: The large pharma will ask questions but is only interested in non-confidential information and is not willing to sign a confidentiality agreement. Your primary contact at the large pharma throughout is junior business development staff (i.e. managers and associates). The primary jobs of these titles is gathering and strategizing competitive intelligence. This information helps large pharma understand the landscape of the disease, target and the who’s who. Generally if large pharma is truly interested, you would see senior executives getting engaged and confidentiality agreements being signed. So when does large pharma become seriously interested to partner? In our experience, with the exception of certain “hot” fields, large pharma is generally not willing to risk large amounts of upfront cash or their own resources for...

The Serendipity of Drug Development

  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. This story takes on epic proportions in a biotech setting, which is not cushioned and protected like in large pharma. The news feeds give us the story line of the scientific creativity, the wonder of it all and the successes. What they usually don’t tell is what really creates this: the herculean amount of hard work, the painful process of raising the needed capital, the incredible patience and perseverance needed when the idealized projections don’t pan out, the countless sleepless nights, the huge sacrifices made personally by those leading the process and by their families who endure their absence and stress, and perhaps most illusive of all: the need for luck. For instance, many people know Millennium Pharmaceuticals (now part of Takeda Pharmaceutical Co.) as a biotech success story. Millennium is known by its flagship multiple myeloma drug, Velcade® ($2.6 B global sales in 2013). However few state that Velcade® did not come from Millennium’s research platform – a platform that used up hundreds of millions of investor dollars and never panned out....