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Protecting Your Startup

– Contributed content –

Open sign

(Unsplash)

14 Nov. 2018. Starting your own business is a fantastic achievement. It’s exciting, nerve-wracking, daunting and stressful. It’s challenging and exhilarating. It’s your chance to create the company that you’ve always wanted. To do things your way, to make a difference and to work doing something that you love. Many people dream of starting up on their own, and in today’s world, more people than ever before are able to turn that dream into a reality.

Starting your own business takes an awful lot of time and effort. You might find yourself working six or seven day weeks for months. You might be unable to take holidays or even clock off at a sensible hour. Your to-do lists might be pages and pages long for the first few months of your business, and you might feel as though it has completely taken over your life.

Wouldn’t it be terrible if all of that hard work, time and money, was for nothing? If your business fell at the first hurdle because you failed to take the appropriate steps to protect it from the offset? Because you failed to do your research, to spend time reading advice from LegalZoom or seeking help elsewhere?

Unfortunately, many new businesses make exactly these mistakes. They get caught up in the excitement of starting up, and they neglect to offer themselves and their business the protection that it needs to grow and flourish. Here are some of the steps that you should take to ensure that you are not one of them.

Insurance

Getting the right insurance is an absolute must for all business. No matter how big or small. What you need, however, will vary. If you run a small business from home, you might simply need to add the value of the equipment that you use to your home insurance policy. If you have any contact with the public at all, liability insurance can be a good idea, and small business insurance is often a wise investment. Learn more about the different types of coverage available to a small business in your field, and take out any premiums that you need.

Online security

You’ve probably taken care of offline security with actions like installing quality locks and CCTV cameras. But, what about online security? Even if your business is brick and mortar based, you probably still use social media, have a website and bank online. This means that you need to be worried about cybercrime and hacking. Install the relevant security plugins on your site, update all of your software and be vigilant with passwords.

Trademarks

If you are unfamiliar with trademarks, copyrights, and patents, it can all be very confusing, and it’s often hard to know what you need. But, all of these documents exist to protect your business, your products, and even your ideas. Research the law to find out which documents you should be applying for and make sure you do it as soon as possible to offer your business, and it’s future key protection.

Discretion

Starting a business is terribly exciting, and you might want to shout it to the world. But, be careful about what you say and who you say it to. Certainly, before you’ve got other legal protections in place. Discretion and common sense can go a long way to protecting a new business.

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Biotechs to Develop Personal Cancer-Killing Virus Vaccines

Adenovirus illustration

Adenovirus illustration (Richard Feldmann, National Cancer Institute)

13 Nov. 2018. Two biotechnology companies developing engineered viruses as cancer therapies plan to create personalized treatments for solid tumors with viruses that harness the immune system. Financial and intellectual property aspects of the agreement between DNAtrix in Houston and Valo Therapeutics in Helsinki, Finland were not disclosed.

Both DNAtrix and Valo Therapeutics use adenoviruses as therapeutic devices to treat cancer. To most people, adenoviruses are benign, but they can cause symptoms similar to the common cold or other viral diseases. DNAtrix develops what it calls “armed viruses,” adenoviruses engineered to enhance and invoke immune-system responses to attack tumor cells. The armed viruses attack tumors directly, but also stimulate T-cells in the immune system to kill tumor cells.

The company, a spin-off enterprise from MD Anderson Cancer Center, currently designs adenovirus treatments for tumors expressing proteins known as tumor necrosis factor receptors, associated with breast, melanoma, brain, and lung cancer. DNAtrix says it successfully tested these treatments in lab animals and has one therapy called tasadenoturev, or DNX-2401, in a clinical trial among patients with the deadly brain cancer glioblastoma. As reported by Science & Enterprise in February, the trial reported mixed results, with dramatic efficacy among some patients, but limited results for others. The company is recruiting participants for other clinical studies of DNX-2401 in patients with brain cancer both alone and with other cancer drugs.

Valo Therapeutics, a spin-off enterprise from University of Helsinki founded in January 2017, also develops cancer immunotherapies with adenoviruses, but modifies the viruses with cancer-killing peptides, short chains of amino acids resembling simple proteins. In the company’s technology known as Pepticrad, the capsid, or viral shell, absorbs the peptides into the virus, turning the virus into a antigen that provokes an immune response specific to the targeted tumor. Valo advanced the technology so multiple peptides can be included into a single virus, including neoantigens, peptides expressed by individual cancer patients’ tumors.

DNAtrix and Valo are collaborating on development of adenovirus cancer vaccines that combine the armed viruses from DNAtrix with Valo’s personalized neoantigen peptides, to provide cancer therapies addressing the precise molecular composition of a patient’s tumor. Frank Tufaro, CEO of DNAtrix, notes in a joint statement, “For the first time, we can combine the potent tumor killing and immune stimulation triggered by viruses along with a patient specific anti-tumor vaccine for generating effective anti-tumor immunity. Perhaps most importantly, the process eliminates the need to manufacture new viruses for each patient.” Tufaro adds, “We are moving swiftly into the clinic to evaluate this exciting technology.”

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RNA Therapeutics Company Raises $30M in First Venture Round

Kevin Weeks

Kevin Weeks (Lars Sahl, Univ of North Carolina – Chapel Hill)

13 Nov. 2018. A company spun-off from a university biochemistry lab is raising $30 million to fund discovery of treatments targeting RNA, genetic material instructing protein production in cells. Ribometrix, a 3 year-old enterprise in Durham, North Carolina, is co-founded by University of North Carolina chemistry professor Kevin Weeks in Chapel Hill, on whose research the company’s technology is based.

Weeks’s lab studies the chemical structure of ribonucleic acid, or RNA molecules, the genetic material transcribed from genetic codes in DNA that provide instructions for protein production in cells. The lab’s researchers look particularly at the three-dimensional folding of RNA in cells, bringing together a range of disciplines including organic chemistry, biophysics, bioinformatics, and computational biology. Weeks is a pioneer in organizing and applying this branch of chemistry — known as selective 2?-hydroxyl acylation analyzed by primer extension, or SHAPE — that measures the structure and dynamics of RNA in assembling proteins.

Research by Weeks and colleagues shows the 3-D structure of RNA reveals identifiable targets for small molecule, or low molecular weight, chemicals that can harness RNA to create therapies for disease. Weeks and Ribometrix co-founder Katherine Warner describe targeting these RNA pockets in a July 2018 article in the journal Nature Reviews Drug Discovery (paid subscription required). Weeks and Warner say these binding targets offer a way to address diseases resulting from so-called undruggable proteins, which is the core of Ribometrix’s corporate strategy. Warner is the company’s research director, while Weeks is an adviser and stockholder. Christine Hajdin, Ribometrix’s screening director, is a co-author of the article.

Michael Solomon, also a Ribometrix co-founder and current CEO, says in a company statement, “A huge medical opportunity awaits RNA-targeting small molecules that can be designed in a systematic fashion, analogous to discovery methods currently employed for protein targets.” While Solomon adds that ” we are well positioned to advance a broad pipeline of compelling drug programs,”

Ribometrix has so far not revealed its current product pipeline, although the Dementia Discovery Fund is an early and continuing investor. A story about the company on the university’s web site in March 2018, quotes Weeks and Warner that Huntington’s disease, a fatal genetic disorder, is a condition the company plans to address. In addition, Weeks is on the faculty at the UNC-Chapel Hill medical school’s cancer center.

The company’s first venture funding round is raising $30 million, led by M Ventures, based in Amsterdam and a subsidiary of drug maker Merck, with participation by the venture investment arms of biopharmaceutical company Amgen and genomics technology developer Illumina, as well as venture investor Pappas Capital, all new investors. Also joining the financing round are Ribometrix’s seed-round funders SV Health Investors, AbbVie Ventures, Hatteras Venture Partners, MP Healthcare Venture Management, the Dementia Discovery Fund, and Alexandria Venture Investments. The company’s seed round raised $7.5 million.

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Hat tip: Endpoints News

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Becoming a Well-Rounded Entrepreneur Right Now

– Contributed content –

Meeting around a laptop

(Brooke Cagle, Unsplash)

13 Nov. 2018. Your goal in life is to become a widely respected and well-rounded entrepreneur, so that you can grow your small business into an empire one day. You are willing to learn about everything and anything there is to know about your industry so that you can become the best business owner there can possibly be. You want to speed up your career progression so that you have a clear pathway for your future.

Instead of feeling lost and unfocused you will have huge opportunities ahead of you because you are thrusting yourself right into the center of everything that matters in your career. Use the following pointers and you will have a much brighter future ahead of you.

Open up your mind

It’s time to start opening up your mind and exploring all of the opportunities available to you. You can start by using the internet to your advantage, by reading articles, listening to podcasts and watching videos. You will be able to discover all sorts of informative videos from Tully Rinckey here on their channel. Use other people’s experience and knowledge to get you on step ahead in your career. You would be surprised at how much you can learn from other people’s business ventures and real life experiences, so apply this to your own life and see where it takes you.

Try something new

You might have your ideal career set in stone in your mind, but what’s the harm in trying something a little bit different for a change? You might discover an underlying passion for another domain or industry that you might be perfect for. You will never know unless you try, so step out of your comfort zone and into something a little more challenging. Every budding entrepreneur should be willing to get their hands dirty and get stuck into something completely alien to them, so take this opportunity to advance your skills right now.

Listen to advice

Sometimes you just need to become a better listener and understand that others might know more than you. Don’t close your mind and retreat into your shell when you are trying something new; listen to other people and take their advice on board at all times. You might just be able to learn from their mistakes so that you don’t have a rocky and troubled path ahead. People who have been in your industry for a long time will be able to provide you with worthwhile advice, so open up your ears and be prepared to listen.

Never stop learning

Even when you have reached your career goals, you need to understand that your journey isn’t over. There will always be new facts to learn and updates within your industry to get a grasp of. If you have the ability to keep your mind open and never stop learning, you will always be in a much better place to progress.

All of these ideas will help you to become a well-rounded entrepreneur right from the very beginning of your business venture.

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NIH Funds Support for Point-of-Care Device Entrepreneurs

Medical care

(Pexels.com)

12 Nov. 2018. Two institutions in Massachusetts are starting a program to help inventors and new enterprises anywhere in the U.S. bring their point-of-care medical devices to market. The Center for Advancing Point-of-Care Technologies, or Capcat, is a joint venture of University of Massachusetts in Lowell and University of Massachusetts Medical School in Worcester, and funded by a 5-year, $7.9 million award from National Heart, Lung and Blood Institute, or NHLBI, part of National Institutes of Health.

Capcat aims to encourage designers of medical devices addressing heart, lung, blood, and sleep disorders to create point-of-care technologies, and help device developers bring their inventions to market. The founders of the center at UMass-Lowell and UMass medical school cite data from NHLBI showing these conditions account for 41 percent of deaths in the U.S., and impose a direct $400 billion burden on the U.S. health care system.

In addition, say Capcat’s creators, a growing emphasis on accountability and transparency in health care delivery, such as bundled payments based on performance and accountable care organizations, are creating a greater need for faster delivery of diagnostics and better documentation. These needs are enhanced, and in some cases complicated by more involvement of patients in their health care decisions, calling for new evidence-based, user-friendly, and patient-centric, point-of-care technologies.

Among the devices Capcat plans to support are systems to measure blood components, record heart and respiratory rates, and alert patients to changes in disease conditions. “The new center,” says UMass-Lowell biomedical engineering professor Stephen McCarthy in a university statement, “will address the urgent need to bring to market medical technologies and devices that can be used to provide fast, accurate information to patients anywhere they are, empowering them to better monitor their conditions and get on with their daily lives.” McCarthy is co-director of Capcat.

McCarthy is also founder of the Massachusetts Medical Device Development Center that will operate Capcat. The project is expected to identify the most promising point-of-care technologies to address unmet medical needs, and help their inventors navigate technical and business pathways to bring their ideas to fruition. Capcat plans to provide training and mentoring, from fellow scientists and engineers, business developers, and legal experts from the two institutions.

Massachusetts Medical Device Development Center has operated labs and R&D work spaces at UMass-Lowell and UMass Medical School since 2007. The organization says it helped more than 100 companies and offers an annual challenge awarding $200,000 in seed funds to promising new ideas in medical device, diagnostics, and biotechnology companies.

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Phone App Shown to Detect Serious Heart Attack

KardiaMobile

KardiaMobile device and app (AliveCor Inc.)

12 November 2018. A smartphone app that monitors heart functions like an electrocardiogram, or EKG, can detect a dangerous form of heart attack, according to results of a clinical trial. Findings from the study were presented on Saturday at the annual Scientific Sessions meeting of American Heart Association in Chicago.

A research team from several sites in the U.S. and Argentina tested the EKG device and app developed by AliveCor, a medical device company in Mountain View, California. The system, known as KardiaMobile, attaches to Apple or Android phones to measure electrical impulses traveling through the heart as it beats. This information, like that from an EKG, is usually collected by a non-invasive test given at a doctor’s office or hospital with 12 electrodes attached to the patient’s body.

For KardiaMobile, the information is captured with two fingers of each hand placed on pads in a small panel attached to a smartphone for 30 seconds. The phone displays and analyzes the readings with a built-in algorithm for signs of irregular heart beats and sends the results to a physician. FDA cleared the KardiaMobile system to monitor heart signals for irregular heart rhythms, such as atrial fibrillation.

In this case, researchers led by cardiologist J. Brent Muhlestein at Intermountain Medical Center Heart Institute in Utah are testing KardiaMobile as a device to detect ST-elevation myocardial infarction, or Stemi, a heart attack where the artery is completely blocked. Stemi is considered a dangerous, life-threatening, and time-sensitive emergency that needs to be quickly diagnosed and treated.

Muhlestein and colleagues are investigating KardiaMobile as a way of saving precious time if Stemi occurs. “The sooner you can get the artery open,” says Muhlestein in an Intermountain statement, “the better the patient is going to do. We found this app may dramatically speed things up and save your life.”

The clinical trial tested KardiaMobile along with standard EKG systems among 204 individuals, with an average of 60, reported chest pains at Intermountain Health Care in Utah, Mayo Clinic in Rochester, Minnesota, and 3 other locations. Patients admitted for chest pains were checked by both types of devices, and 3 independent clinicians interpreted the results as Stemi attacks, non-Stemi conditions, or unable to interpret, without knowing if the readings were made by a conventional EKG or KardiaMobile. For this study, the MobileKardia attachment was used to check heart signals from several angles on the body, simulating a conventional EKG.

The results show the KardiaMobile system and EKG machines accurately agreed on a Stemi diagnosis 89 percent of the time, while agreeing on a non-Stemi condition 84 percent. The results also show positive and negative predictive values of 70 and 95 percent respectively. Qualitative judgements by the review panel likewise show a good correlation, 79%, between the two detection systems.

The findings suggest the smartphone-connected device can serve a useful screening function for serious heart diseases, such as Stemi. The team envisions a scenario where an individual experiencing chest pains uses a mobile device to report the condition, with the results sent to the cloud and interpreted by clinicians. If the data show a possible heart attack, the person would be told to get to a hospital immediately.

“If somebody gets chest pain and they haven’t ever had chest pain before, they might think it’s just a bug or it’s gas and they won’t go to the emergency room,” notes Muhlestein. “That’s dangerous, because the faster we open the blocked artery, the better the patient’s outcome will be.”

More from Science & Enterprise:

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Importance Of Quality Materials For Construction

– Contributed content –

Modern skyscraper

(Free-Photos, Pixabay)

12 Nov. 2018. Construction is among the largest industries in the world, and one that contributes a massive amount to GDP. However, for entrepreneurs in the field, the reality of running a construction business can be incredibly challenging. While construction is undeniably essential, entrepreneurs find themselves hampered by one particularly problematic issue: profit margins.

The trouble with construction profit margins

The profit margins in the construction industry are notoriously low. In some years, profit margins can be below 3 percent. This is problematic enough in and of itself, but the matter is further complicated by the fact that profit margins are also unstable. Some years will be far above 3 percent, others may dip below it.

This variety is undeniably problematic for construction business owners. Profit margins dictate the overall viability of a company; while they are always subject to change, the swing that construction companies experience tends to be notably severe. This, combined with the fact profit margins are already low, is incredibly difficult to manage – and tends to lead construction entrepreneurs to the natural conclusion…

Construction businesses have to keep control of their costs

This conclusion is understandable. With profit margins so low, and so variable, cost control is vital in construction.

Inevitably, this pressing need for cost control causes construction entrepreneurs to be extremely cautious about every cent they spend. If you run a construction business, you’ll likely be familiar with this scenario – you scrutinize every price point, keep a firm eye on your margins, and do all you can to ensure expenditure is as managed as possible. This is all good practice – but it’s not without its downsides.

The temptation of low-cost materials

Materials are a huge budgetary demand for construction companies, so it naturally follows that you will want to ensure your expenditure in this area is as low as possible. The less you spend, the more controlled your costs are, and thus you are well equipped to deal with the problematic issue of profit margin – problem solved, surely?

Not quite. Unfortunately, as tempting as low costs can be on paper, in practice, they tend to be anything but beneficial. Low-cost materials cost less because they are of inferior quality, and the consequences of using low-quality materials can be substantial.

The true cost of poor quality materials

  • Poor performance
  • Higher level of breakage
  • Compromised safety of the finished work

The problems above are difficult enough, but they can also combine to cause a secondary issue: a poor business reputation. If your construction company continually produces inferior work due to low-quality materials, the impacts of this can be severe – and could lead to fewer contracts in future.

Why quality materials are the better deal

The truth is that construction businesses owners such as yourself are always better investing in materials they can rely on; from finding quality steel piping to seeking out the most durable nuts and bolts on the market, good materials are always worth the extra effort. Not only do quality materials allow a smoother building process, with less wastage, but they also prevent issues that could negatively affect your business’s reputation in future.

Final thoughts

Yes, construction business owners need to keep a firm eye on their costs – but materials are not an area that can be compromised. Instead, focus on the pace of work, seeking to do more within a normal expenditure by increasing overall productivity. These measures are far preferable to spending as little as possible on materials, and allow you to effectively manage costs without harming your business’ operations and reputation.

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Infographic – Superbugs Annually Kill 33,000 in Europe

Chart: Superbug deaths n Europe

Click on image for full-size view. (The Lancet, Statista)

10 Nov. 2018. We’ve reported at Science & Enterprise on the problem of antibiotic resistance for several years. Bacteria and viruses evolve into new strains resistant to current antibiotics, also known as “superbugs,” causing health authorities and drug developers to scramble for stronger or alternative options. In some cases, authorities are concerned the development of new antibiotics can’t keep up with new superbug strains, with ominous implications for public health.

Our friends at Statista posted a chart this week that underscores this problem, showing the median number of deaths by country in Europe from microbes resistant to antibiotics, this weekend’s infographic. The data from 2015 first appeared in a paper earlier this month in the medical journal The Lancet, showing some 33,000 died from antibiotic-resistant infections that year. About one-third of those deaths, nearly 11,000, occurred in Italy, with another 5,500 in France.

Researchers on both sides of the Atlantic seem to be taking this threat seriously, and we’ve reported in Science & Enterprise on advances in academic and industry labs to develop new or more powerful diagnostics and antibiotics. A few of the most recent stories are listed below.

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Tasks Your Start-Up Should Outsource

– Contributed content –

Drawing on a whiteboard

(Rawpixel, Pixabay)

10 Nov. 2018. When you start out in business and working for yourself, it can be a large juggling act. There are so many different aspects that you have to look at, from the finances, to the marketing, employment, and so on. And when it is your business idea and your dream, it is so tempting to want to do all of it yourself. When you have the plan and want to get the ball rolling with it, you can be really hands-on, especially in the early days.

But try as you might, it is going to be very difficult for you to do absolutely everything yourself. There may be some things that you are really experienced in and it would make a difference to you if you were able to do them. But there will be many tasks that can easily be outsourced to others.

Why outsource? One of the reasons why outsourcing can be good for your small business is that you are hiring professionals or experts within their own industry. You might have an idea when it comes to creating a website,for example. But when you’re not entirely sure, you could spend a whole day trying to get it looking as you want it, and that is precious time for your business.

So instead, you could hire a professional and they’d be able to meet your requirements but do it in nearly half the time. Saves you time and in the long term, that will save you money. Outsourcing can be cheaper too, as you don’t have to pay someone full-time. You simply pay them for the work that they do, rather than fo just turning up as you’d do with a full-time (or even part-time) employee.

Web design was mentioned there, and is definitely something that can be outsourced quite easily. But what else? If you are starting out in business, or will be shortly, then making a plan of who will do what, and the kind of timeline that you are looking at is going to make a difference. So with that in mind, here are some of the things that can be easily outsourced. It can lighten the load and leave you time to do all of the things that only you will be best at, to help your business and vision come to fruition.

Money and accounts

When you’re someone starting out in small business, you are never expected to be able to do everything that the business needs. And one thing that only some people will have experience of is accounting and all things relating to the small business and money. When it comes to tax forms, tax returns, refunds, expenses, payroll, and anything else accounting related, it can be quite easily outsourced to someone else. They just need your information and the receipts and so on, and they will be able to organize and arrange it all for you, as they know exactly what they will be doing.

Video content

For your advertising or marketing, and even your social media channels these days, video can be really good to capture the attention of your potential customers. In fact, it is often listed as one of the top things that can be done to help your digital marketing effort, as mentioned in an article here: https://digitalmarketinginstitute.com/video-marketing. And if you have no real experience of video, especially for these kinds of channels, then it can really pay off to use professional help.

You will want to create a brand that is professional looking, and not just like you filmed something on your phone and threw it all together on your laptop and uploaded it. Someone who does this for a living, or as a hobby that they have really honed their skills in, is going to make something that looks much better. So it is worth hiring the, to get the video content looking exactly how you want it, and as professional looking as you want it.

Marketing

Video content is part of your digital marketing, but there are so many other aspects when it comes to marketing, as well as advertising, and other promotions. For small businesses, they can rarely afford to do all of this themselves (financially and on a practical level). It can be full on for someone doing that each day, which you might not have scope to do at the moment. So look to hire agencies to handle this kind of thing for you. You can call on them when you have a launch or a specific campaign that you’re working on. It will save time, effort, and will mean that all work is done to a good standard. Even if you have experience of this, your time can be better spent doing things elsewhere.

Transport and logistics

If you have products that need to be moved from a warehouse or storage and off to different locations, then managing it all yourself can be tricky, as well as time-consuming. Which is why outsourcing for the transport and logistics side of things can be a wise decision. Look at sites like https://www.jayde.com.au/ to see the kind of things that someone else could offer to you, and then you could go from there. When you outsource in this way, it can also help you to make the business larger and deliver to a wider region. So it is definitely something that has the potential to help the business to grow.

Content creation

All small businesses need a website. And as such, will need someone to help to create the content for the website. Not to mention that as part of the website, it helps to have a blog for the business. This can help your site to be found in online searches, as well as increasing traffic to your site when you have exciting, interesting, or relevant content for people to read. But who is the person that is going to create that content?

It can be expensive and not the best use of an employee’s time to do this. Which is why hiring a writer, copywriter, or social media content creator, to write this kind of thing for you. You could pay per article, or perhaps just ask them to create ten pieces of content all at once for a set fee. They could create the content for your business’ blog, as well as social media channels. It is all important for the growth of your business, but isn’t something that the top people should be doing.

Admin and time planning

The admin side of running a business can be pretty difficult. As there are is a lot to organize and arrange. Plus, in the early days of the business, and as it grows and progresses, there are plenty of people that you need to meet with and arranging it all, although important, can be such a time-sucker.

So to save your time for the more important things like prepping for the meetings and planning pitches and so on, it can be worth outsourcing to an assistant to arrange these kinds of thing got you. A VA (or virtual assistant) can set your schedule for you, and deal with the admin side of things like arranging transport such as taxis, airport bookings, and flights. This can be done remotely, and you’ll just need to email and call them with details for them to then set up and arrange. So it is something that can be really worth doing. Plus, it is something that can be paid hourly, and at a pretty low rate. As they’re unlikely to be needed each day, it can make a difference to your budget, and give you plenty of time (and sanity) back.

Your weaknesses

As the business owner, director, or CEO, there are plenty of things that you can be doing for the business (and it can be tempting to want to do it all yourself). And there will be some of the tasks that you quite easily can do yourself. But when you own a business, it is important to be humble and make sure that you are getting help where your weaknesses lie. You can’t do everything as the business owner, and it takes someone special to accept what they’re not as good at and then do something about it.

So the best things to outsource for you, can be those things that you’re just not as good at. Even if you could physically do it, it is going to be better in the long term when you outsource for the things that you are not as good at. It can be hard to do but needs to be done.

Is there anything else that you would add to the list? Outsourcing really can be one of the best things that a small business or startup can do. It gives you the time that you need to grow it, all until you need or are able to hire employees. It would be great to hear what you think.

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FDA Updating Expanded Access to Investigational Drugs, Devices

Scott Gottlieb

Scott Gottlieb, FDA Commissioner, in November 2017 (A. Kotok)

9 Nov. 2018. The Food and Drug Administration says it’s streamlining policies for making drugs and medical devices in clinical trials or under review available for people in the U.S. with life-threatening conditions. The changes to FDA’s Expanded Access program were announced yesterday in a statement by FDA Commissioner Scott Gottlieb.

FDA’s Expanded Access — also known as compassionate use — program makes available drugs, biologics, or medical devices being tested in clinical studies or under review by the agency for people with immediately life-threatening or serious medical conditions. In addition, to use Expanded Access, a patient’s needs cannot be met with comparable alternatives to diagnose or treat the disorder. Moreover, enrollment in a clinical trial of that therapy is not possible, and benefits from the proposed treatment outweigh the risks. And all stakeholders in the process, including developers of the proposed treatment, must concur.

Gottlieb says FDA received more than 9,000 requests for early access to treatments under review through the program, and authorized virtually all (99%) of them. Nonetheless, the agency conducted an independent evaluation of Expanded Access that highlighted confusion encountered in understanding the requirements, such as administrative burdens, and navigating the program’s web pages. Gottlieb says in addition to updating the web pages, the agency’s Patient Affairs Staff that reports to the Commissioner is now the first point of contact for Expanded Access for patients and physicians.

The Commissioner says FDA made other changes in the program, separately from the formal evaluation, as a result of feedback from individuals and Congress. The agency, says Gottlieb, reduced administrative requirements to request use of a drug or device being tested or under review that now take about 45 minutes for physicians to complete. FDA also simplified Institutional Review Board processes, where only the chair of the board — the group looking out for patient welfare in clinical trials — or a designee can approve a patient’s request, rather than the entire board. And the agency clarified reporting of safety data under Early Access to meet concerns of developers that the reports may affect subsequent FDA review.

In the statement, Gottlieb also said FDA is implementing its Right to Try program, a parallel pathway created by legislation signed in May 2018. Under Right to Try, patients with life-threatening conditions can request access to drugs or biologics not yet approved by FDA, but have at least completed early-stage clinical trials that usually test for safety. Gottlieb says FDA established a working group to consider steps needed to implement the law, but Expanded Access is still the main avenue for patients to gain access to unapproved therapies.

Gottlieb notes that these programs have more than a professional interest to him. “As a cancer survivor,” he says, “I understand, on a very personal level, that patients who are fighting serious or life-threatening diseases want the flexibility to try new therapeutic approaches, including investigational medical products. This is especially relevant when there’s no other FDA-approved treatment option available to a patient.”

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