In the pharmaceutical world, Canada is falling lower on the totem pole due to major drug shortages. RAPS (Regulatory Affairs Professionals Society) reports that the manufacturing plant that produces nearly 90% of all injectable drugs used in Canada, owned by Sandoz Canda, recently caught fire. These injectable drugs ranged from anesthetics to painkillers to antibiotics.
So, what now?
Canadians are calling for Prime Minister Stephen Harper’s help and to propose regulations targeted at mending these issues. Harper responded that Health Canada is working on solutions to fixing this crisis, including finding multiple sources for vital medication.
What is foreseen for Canada’s drug and pharmaceutical future? Will drug prices drastically increase due to this shortage of medications? How will the US be involved? Let us know your thoughts on this major issue that Canada is facing!
What would you do with a billion dollars? Some would buy 371 Super Bowl ads, others may buy an island, but in the pharmaceutical world, a billion dollars is just a sliver of how much it costs to invent a new drug. According to the Forbes article, “The Truly Staggering Cost Of Inventing New Drugs”, the average drug developed by a major pharmaceutical company can cost as much as $11 billion!
The skyrocketing cost of inventing new drugs implies that medicine should be pricey. After all, countless hours of research and testing new drugs in laboratories across the world account for much of the hefty cost of inventing new drugs. However, what happens when the drugs fail to be approved and plummet in the medical market? Currently, less than 1 in 10 drugs that are tested in human clinical trials succeed. What does this say about the pharmaceutical industry? How about the billions of dollars being invested every year into new drugs? About the people who need and rely on new drug development?
What do you think about the skyrocketing cost of drug development? Will prices only get higher from here? Let us know your thoughts!
This past week was ENET’s (Boston’s IEEE Entrepreneurs’ Network) monthly meeting on legal and tax issues. I guess there’s no big reason to learn about those when starting a company. Who likes keeping their hard earned money anyways? Did you catch that?
Decisions made in the early stages of forming a company are critical to the company’s future. From forming as an LLC, C corp or S corp, there are pros and cons that must be fully understood to prevent things such as double-taxation (don’t we pay enough?), unnecessary liabilities, and future investments. Now all of these can’t be laid out in a single article, and even so I’m not qualified to do so. I happen to know a few people that would be qualified and ENET is the place to meet them. It’s good food for thought.
The next meeting will be January 3rd from 7:00 – 10:00PM at the Foley Hoag Emerging Enterprise Center, 1000 Winter Street, Suite 4000 (north entrance), Waltham, MA and will be on Creating a Technology Services Company. The meeting is sure to be an exciting one and will feature none other than Valentina Rosa, founder & CEO of TRA360, and a panel of seasoned entrepreneurs. If you’re interested in the topic or just in networking with the best group of professionals in Boston, ENET is the place to be.
A technical writer in the Greater Boston area sent me the following email.
Hi,
I am interested in a career move, to the field of regulatory writing for medical devices. I feel that my software development experience, attention to detail and technical skills would transition well to this endeavor.
I am looking for suggestions for training or certificates that would prepare me for this field. What type of training do people look for when they are hiring for regulatory writing? I appreciate any suggestions you can provide.
Signed, Career Move
I’ve been working in the regulatory writing field since 1992 and TRA360 has had a regulatory writing practice since 1997 so I had some ideas to share. Here they are: