Dear Sir or Madam, My name is Rob Shaffer, PhD, and I am a biotechnology entrepreneur with a passion for developing therapeutics for underserved patient populations, especially those with rare diseases. I write today to express the reasoning behind my deep dismay with the recent decision by the Biden administration to support waiving patent protection for Covid vaccines. The current argument is that waiving intellectual property, IP, rights will allow foreign nations to understand how to produce these crucial, life-saving vaccines to bring the pandemic to an end sooner. Of course, this is a no ..read more

Congrats! You just found out that your SBIR/STTR proposal will be funded. Now what? There are many many resources to get assistance with small business proposal writing, including from the NIH, individual bloggers, and companies that can be contracted to help complete applications. But when I found out that one of my proposals was set to be awarded, I had very little idea of what to expect and what to do. Fortunately, I was able to lean on a grad school friend who had success in this area, so I didn’t go in totally blind; but there’s a real lack of good information out there, so I will try to ..read more

It’s been awhile since my last post because, fortunately, I’ve been swamped on two fronts: setting up operations and BD activities for my startup, and doing some part-time consulting (i.e., getting paid to learn about things). But I have some time so I’d like to lay out some learnings on external legal considerations that seem trivial and dry, but are essential for external interactions for any biotech newco. I’ll touch on confidentiality/nondisclosure agreements (CDA), material transfer agreements (MTA), option agreements (OA), and right of first negotiation / right of participation (ROFN) ag ..read more

One of the very first tasks that must be accomplished when starting a new biotech is figuring out its legal structure and completing the myriad government registrations required, especially for grant applications. Let’s first go into an overview of the concepts and considerations behind incorporation and I will go through some of my decisions for my recently created company, Enable Therapeutics LLC. For rookies like myself, I recommend The Entrepreneur’s Guide to Business Law by Constance E. Bagley and Craig E. Dauchy. Why would I want to incorporate, rather than just conduct business on my ow ..read more

My current company is winding down operations because they had a really hard time getting funding for the next step in the clinical development of their lead asset, despite a positive Phase 1/2 readout that showed we beat standard of care. The funds required to enter a registrational phase 3 trial in this particular rare disease would likely be over $100M, and the board and business development team could not close a deal to fund that work. Despite the terrifying nature of not having a steady paycheck, I find myself to be at a really exciting point in my career. After breaking the bad news to ..read more

There are a good number of biotech companies that have little to no actual lab space, meaning they are effectively virtual companies. My current company was virtual before they hired me, their first employee, and we’re still partially virtual. One question I had entering the industry after grad school was: How do companies advance their pipeline candidates without their own labs? The answer is through outsourcing research, development, and/or manufacturing to one of the many CRO, CMO, and CDMO businesses worldwide. In this post, I will discuss a high-level overview of contracting out R&D a ..read more

This is not the first article written about how biotech startups can weather the current pandemic storm (for one of the better examples see here). With stay-at-home orders and supply chain disruptions, clinical trial disruptions are well documented (example article in STAT here), but preclinical work at Chinese CRO’s is starting to ramp back up so there is reason to be optimistic. Thanks to biotech companies being deemed “essential” in places like Massachusetts, companies can keep lab work going, but we all know we should be staying home as much as possible. But clearly the situation is not no ..read more

In this post I’ll share two interesting brainteasers I recently discussed with some colleagues. What other possible answers or situations can you think of? First brainteaser: why would a biotech investment fund not only be content, but in fact happy, if a public holding declines by 90%? And, their shareholders would in fact appreciate this as well? This is a really interesting brainteaser. My first thought was that if this decline was due to a trial failure, then the fund could be happy for two reasons: 1) a “clearing event” so they could purchase a larger percent of the company for more p ..read more

­­­My wife and I are new parents, with an 8-month old adorable, smiley, chatty baby at home. I am incredibly thankful every single day that she is thriving and healthy, and I know that fortunes can take unexpected turns; I try desperately not to think about that. My heart breaks for all the parents whose children have devastating rare genetic diseases, especially for those without effective treatment or who cannot afford treatment because of a lack of insurance coverage. New innovations are being developed into commercial therapeutics at a faster pace than ever. Especially now with recent a ..read more

Say you’re an entrepreneur who has a promising preclinical drug candidate that modulates a target that is a validated in multiple disease areas. How do you pick the right one on which to focus your IND? Say you’re a venture firm and you’re looking to invest in two otherwise equal startups approaching the clinic, and you can only choose one. One is in oncology, and the other is in autoimmunology. How do you choose which therapeutic area will break the tie? Say you’re a biotech investor and you are an expert in immunology, so you want to take advantage of your expertise in immunology and ..read more