by Susan Hsiong, PhD
You’ve been submitting resumes like nobody’s business. And contacted everyone you know asking if they know of any job opportunities. You’ve attended all the local networking events and career fairs. After what seems like forever, you get called in for an interview. Congrats! Continue reading
You have to hand it to Tengion, they are trying to tackle one of the largest challenges I can think of: producing tissue engineered organs and tissues from a patients own cells in unrelated indications (bladder, blood vessel, and kidney). While moving through clinical trials Tengion will surely be transforming patients lives with these technologies. They have already had early-stage clinical success with their tissue engineered bladder (highlighted at CNN), but there are several challenges to overcome in creating a business from autologous tissue engineered products. Continue reading
Posted in autologous, Biomaterials, Bioprocessing, Clinical Trials, combination products, Company Profiles, JNJ, patient specific cell therapy, personalized medicine, Regenerative Medicine, Tengion, tissue engineered product, vascular regeneration
Tagged autologous therapies, company prifile, tissue engineering company
When looking for a job, a good fit is very important. You want to be able to get as much out of a job as possible, as well as feel like you are making an impact on the direction of the company. What your own wants and needs are will be dictated by your personality. However, what you can can expect from a company is mostly (not always) dictated by whether it is a large, well funded company, or a small company where profits aren’t expected for years. This post will generally outline the biggest differences in these two very different work environments, and will be followed by individual posts outlining what it is like to work in each type of environment. Continue reading
Pervasis Therapeutics announced that they have raised $9.75M to further develop their allogenic tissue engineered endothelial cell (EC) product for vascular health indications. Their Vascugel product is comprised of ECs grown in 3D collagen sponges that are implanted externally on blood vessels to prevent them from occluding. Pervasis has proven safety in a Phase I study concluded in 2006, and they have recently finished enrollment of two end stage renal disease (ESRD) Phase II studies in 2007. Continue reading
Posted in Biomaterials, Bioprocessing, cell delivery, Clinical Trials, combination products, Company Profiles, Manufacturing, Pervasis, Regenerative Medicine, tissue engineered product, vascular regeneration
Tagged end stage renal disease, endothelial cells, ESRD, gelfoam, tissue engineering, vascular health
When we have a cold or a headache, we pop a pill. We get sick, we go to the doctor and get a shot. Taking medication orally via a pill or getting drugs injected via a syringe are some of the oldest forms of delivering therapeutic molecules. In the past, “drug delivery” simply meant getting the therapeutic inside the patient,whereas now it has evolved to include “controlled release,” allowing control over the timing, dosage and also location of drug release.
A transformation in the field of controlled release is being pioneered by Mimetics Solutions, LLC (Austin, TX), with the development of their proprietary Affinimer™ technology. This technology shifts the current controlled release paradigm from one of Continue reading
Posted in Biomaterials, biomimetics therapeutics, combination products, controlled release, diabetes, Mimetic Solutions, Regenerative Medicine, Smart materials
Tagged controlled release, diabetes, drug delivery, mimetics, Mimetics Solutions
Osiris Therapeutics announced that they won a DoD contract worth up to $224.7 million for developing their adult mesenchymal stem cell (MSC)-based therapeutic for treating acute radiation exposure. The contract allows for reimbursement of up to $24.7 million for continued development of their Prochymal product, and then, once the product is FDA approved for acute radiation syndrome (ARS), 20,000 doses will be purchased in 5,000 dose increments at $10,000 per dose . This contract provides Osiris with much needed cash to cover clinical development while they complete their various other clinical trials.
Importantly, Osiris has partnered with Genzyme, a niche-disease development expert Continue reading
Posted in adult stem cell, business models, Clinical Trials, DoD, MSCs, Osiris, Regenerative Medicine, stem cells
Tagged Acute Radiation Therapy, DoD contract, Mesenchymal Stem Cell product, near term revenue, Prochymal, Type 1 diabetes
Just a quick note on a topic that keeps catching my attention: China. Three interesting things have come up in the last month:
- Organogenesis signs a distribution deal with China’s National Tissue Engineering Center, with the potential to expand into manufacturing and joint product development activities.
- WuXi Pharmatech purchases contract organization Apptec to gain a US footprint and expertise in biologics.
- Regenerative Medicine venture capital firm Toucan Capital has two positions open that require both an advanced life science degree and fluency in Chinese – I wonder where they are looking to invest their next round of funding?
With the US dollar so low and the Chinese markets so hot, it is highly possible we see even more investment from Chinese firms in US regenerative medicine companies as we are seeing in other industries. But I wonder how much more US-based capital will make it into China?