Fwd: WSGR Alert: FDA Target of Executive Order on Agricultural Biotechnology

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FDA Target of Executive Order on Agricultural Biotechnology               June 24, 2019 In response to concerns expressed by livestock groups and some in the biotechnology industry over the Food and Drug Administration's (FDA's) approval process for gene editing in animals, the Trump administration issued an executive order recently to address this matter. The executive order was titled, "Modernizing the Regulatory Framework for Agricultural Biotechnology Products," but if an informal subtitle had been included, it could have read: "The FDA should modify its regulatory framework for the gene editing approval process." Background The federal system for evaluating products developed through modern biotechnology is guided by the Coordinated Framework for the Regulation of Biotechnology. Developed in 1986 and updated most recently in 2017, the coordinated framework clarifies regulatory roles with respect to agricultural biotechnology. The Animal and Plant Health Inspection Service (APHIS) at the U.S. Department of Agriculture (USDA) regulates organisms and products that are known or suspected to be plant pests or to pose a plant pest risk, including those that have been altered or produced through genetic engineering. The Environmental Protection Agency (EPA) regulates pesticides that are produced through biotechnology. The FDA is responsible for ensuring the safety of all plant-derived food and feed, including those developed through genetic engineering. In January 2018, an Interagency Task Force on Agriculture and Rural Prosperity, established by the Trump administration the year before, issued a set of recommendations for improving life in rural America. As part of this list, the task force recommended that additional steps be taken to further modernize the regulatory framework for agricultural biotechnology products to facilitate innovation and ensure coordination across regulatory agencies. Based on the task force recommendation, the executive order directs the USDA, the EPA, and the FDA to identify and streamline relevant regulations and guidance documents within their respective jurisdictions to ensure that products of agricultural biotechnology are regulated based on the risks such products pose. Under the executive order, the agencies also are directed to "avoid arbitrary or unjustifiable distinctions across like products developed through different technologies" and exempt low-risk products from undue regulation. It seems clear that the language in the executive order is directed at the FDA, specifically the agency's guidance for industry (GFI) on Regulation of Intentionally Altered Genomic DNA in Animals. GFI #187 The debate over the gene editing approval process at FDA has been simmering for years. The FDA's GFI #187, first released in 2008, was updated in 2017 to confirm the agency's conclusion that intentional gene-editing would be subject to a mandatory new animal drug evaluation. This determination was made to the consternation of livestock groups and the biotechnology industry, which lamented that such a regulatory framework would be more burdensome and costly. Livestock groups, particularly the National Pork Producers Council (NPPC), have argued that the FDA has jurisdiction over gene-editing in food-producing animals, despite the lack of any statutory requirements. They also contend that the FDA process would treat any gene-edited animal as an animal drug, and any livestock operation as a drug manufacturing facility, which ultimately would harm U.S. competitiveness in foreign markets. The NPPC lauded the Executive Order in a press release declaring, "The United States is falling behind countries such as Canada, Brazil, and China that have established regulatory frameworks conducive to investment in the development of gene editing." The group added that they are hopeful that the executive order "breaks the FDA's current grip on gene editing" so a regulatory framework can be established at the USDA to ensure that American farmers realize its potential. The NPPC also complained in its statement that, through GFI #187, the FDA continues to advance a regulatory framework for gene edited livestock that counters the executive order. Greater USDA Role in Gene Editing APHIS has long been viewed by livestock groups and the biotechnology industry as the more appropriate federal agency to conduct oversight of gene editing in food-producing animals. Perceived as being more responsive to industry concerns compared to their FDA counterparts, APHIS issued a statement in 2018 providing clarification that, under its biotechnology regulations, the agency does not regulate or have any plans to regulate plants gene-edited plants as long as they are not plant pests or developed using plant pests. A similar approach by the FDA for gene editing in food-producing animals would represent the best case scenario for livestock groups and the biotechnology industry. Will FDA Slow-Walk Matters? Whether the rank-and-file FDA personnel accede to the administration's position will be a situation worth monitoring as the executive order is implemented. Just as those at the USDA revere the 'mark of inspection' that gets affixed to labels of meat and poultry products, FDA scientists firmly believe in the sanctity of the agency's product approval process and resist any efforts that they feel would compromise that process. It is conceivable that career FDA experts may use subtle administrative methods to delay any attempts to minimize the agency's oversight of gene editing in food-producing animals, and engage with public health allies in Congress for assistance. While the executive order imposes a six-month deadline for the relevant agencies to identify regulations that could be streamlined, there is an inconsistent record of these deadlines actually being met. Wilson Sonsini Goodrich & Rosati's FDA group is actively following developments on regulations impacting agricultural biotechnology. For more information, please contact Brian Ronholm, David Hoffmeister, Georgia Ravitz, Jamie Ravitz, or any member of WSGR's FDA group.

This communication is provided as a service to our clients and friends and is for informational purposes only. It is not intended to create an attorney-client relationship or constitute an advertisement, a solicitation, or professional advice as to any particular situation. To update your preferences for the kinds of materials you'd like to receive from us, please click here to visit the WSGR Subscription Center. You also can quickly unsubscribe from all WSGR mailings by clicking here. Wilson Sonsini Goodrich & Rosati 650 Page Mill Road Palo Alto, California 94304

 

Sender notified by Mailtrack 06/24/19, 01:53:51 PM

An open letter on behalf of all my strong, determined, and experienced coach and consultant friends...

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Dear Nightmare-Client-From-Hell,

I'll put up with your whining...

I'll put up with your arguing...

I'll put up with your stubbornness...

I'll put up with your fear...

I'll put up with your resistance...

I'll put up with your procrastination...

I'll put up with your uncertainty...

I'll put up with your impostor syndrome...

I'll put up with your fleeing to your comfort zone...

=======

I will NOT put up with your disrespect...

I will NOT put up with your self-righteousness...

I will NOT put up with your comforting self-delusions...

I will NOT put up with your arrogance...

I will NOT put up with your complacency...

I will NOT put up with your lack of coachability...

I will NOT put up with your ego...

I will NOT put up with your posturing...

I will NOT put up with your petulance...

I will NOT put up with your self-sabotage...

========

YOU ARE FIRED!!

Goodbye.

Good luck.

Good riddance.

Fwd: Selling ... made as simple as humanly possible

C'mon guys, let's get the easy things right

Life is so random, and business so competitive ... Are you getting the the easy things right? For example, I've found there is one very simple reason why smart, successful, even famous people don't close the deals they really should close. I've seen it with big-name celebrities, like Axl Rose. I've seen it with legendary silicon valley types, like the inventor of MP3. I've even seen this happen with New York Times best-selling authors. These kinds of brilliant people should be listened to because even their worst ideas are usually worth buying into. But what these big names and successful people don't realize ... Brilliant insights don't sell. Facts and figures, even when perfectly accurate, don't sell.  A new and better product doesn't sell automatically. And the promise of huge profits might attract attention ... but still doesn't sell. And I can tell you exactly why. As someone who has written over a thousand sales and investor presentations, as well as shown 1000+ entrepreneurs, investors, and companies how to sell products and big ideas - I've learned what it takes to get someone to "pay attention" ... and to buy. Here's the big secret:  You can have a brilliant idea, a great product, you can offer the best value the world has ever seen, and you can promise to cure cancer, bring Tupac back and have the Dallas Cowboys win the 2020 Superbowl, but this is the only thing that matters:  Creating CERTAINTY. Let me give you an example of this in the field of investing: Yes, of course I WOULD LIKE to double my money by investing in you. But you're offering me stock your bitcoin startup.  Since I'm only 1% certain I'll get my money back, sorry, I'm "OUT." Oh, now you want me to invest in your plan to renovate and flip three houses in your neighborhood and make $20,000 in 4-weeks for my trouble. And, hey, you've already done this same thing five times successfully, and I'm 90% certain you can pull it off again.  Great! I'm "IN". In other words, in what universe would you find yourself investing your retirement funds in bitcoin over "flipping a house"? You wouldn't. In fact, even the wealthiest and craziest and most out-there investors won't do it. Because the "certainty" in cybercurrency is too low. Certainty creates sales, or kills them. Why you should trust me on this: I've been going to pitch meetings for a long time. When I was 31, I got 5 million dollars for an "idea" on 1-sheet of paper. I once flew to Moscow, pitched a Russian Oligarch for 10 million, and got it. I've done the same thing, asked for money, and got it, hundreds of times. So  I can tell you that there is no more valuable skill in today's digital age than understanding the science behind creating the feeling of certainty. One of the more useful insights that emerged for me from five years of studying ways to create certainty is how a buyer craves certainty in a similar way to how he craves food, sex, and other primary rewards. Uncertainty matters too. A sense of uncertainty generates a strong threat or 'alert' response. Uncertainty is a type of pain, something to be avoided. Certainty, on the other hand, feels rewarding, and we tend to steer toward it. Everyone is anxious about the future.  Since buyers are so anxious,  it doesn't help the buyer to hear you promise how your great product will work perfectly. Or your great company will be a huge success. This does nothing because you are self-motivated to say these things. Instead, here's one way to quickly create certainty. First, think how much your market is changing. Products. Competitors. Regulation. Technology. So instead of promising this-or-that about your product, show people how well you understand The Most Important Changes going on. Interpret what The Changes mean, and what will likely happen.  iPhones have become boring. Why? Because Steve Jobs died? Tesla doesn't make money. Will Ford and Mercedes kill them off? Social Responsibility is now critical to making money. What changed? Copper pipes are no longer a first choice in home construction. WHY? (note: copper mining and manufacturing are so environmentally damaging that despite its longevity and recyclability, copper plumbing pipe is nowhere close to a green product.) When you speak with authority about changes in your market ... You create a feeling of certainty.  You make people feel that FINALLY, someone around here knows what's going on. Knows how things work. And knows what's going to happen next, and what will and won't work. How good are you at this? Well, let's see. Just send me your "Big Changes in the Market" scripts. I'll read yours on my podcast and give credit to the best ones. Finally, a quick question for you:   Is your revenue more than 10 million? Are you working to grow the company? Do you need a better "win-rate" on sales? If YES, your revenue > $10M, I'd like to hear about your company.   Tell me about yourself using this quick form  or if you're more of an email type, drop your details to oren@pitchanything.com If your revenue is less than $10M, nothing wrong with that, I'd suggest you watch my free training program here and then join my weekly LIVE call. Click here to get my free training I'm an investor and I help buy & sell companies. If you're selling (or raising money) you can reach me here. My observations about people and how they buy from each other led to the book   Pitch Anything. I take the time to share these stories with you in recognition that it may give us a reason to connect. To receive my weekly email, click the link at right.  SUBSCRIBE TO THIS NEWSLETTER

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Pitch Industries, 5825 Avenida Encinas #110, Carlsbad, CA 92008

Sender notified by Mailtrack 06/11/19, 12:17:04 PM

Fwd: Take a summer vacation this year

 

Take a Summer Vacation this Year

By Jeff Wolf

Originally published June 2015 in the American Management Association Playbook

Time to read: 2 minutes

How many times have you heard your boss tell you that? In fact, how many times have you told your employees that?

Come on, fess up. Either case is as rare as a drenching rain in the Sahara. Let's face it. Too many bosses discourage employees from taking more than a day off or a weekend here and there. And even then they don't discourage a barrage of phone calls from work and many will expect employees to check their email several times a day. A two-week getaway to the Far East? Not a chance.

Every year, the media reports on surveys showing that large chunks of U.S. workers don't plan on taking all their vacation time. Why does this happen, when it's part of a worker's compensation package? Large percentages of workers wouldn't pass on a company-sponsored life insurance plan, or forgo a paycheck for all of December, so why are so many people willingly (or perhaps not so willingly) giving their paid time off back to their employers?

Forbes Magazine contributor Kristi Hedges nails the explanation: "The idea of a skimpy vacation as a worthy sacrifice or badge of honor is culturally embedded. The U.S. is the only rich country to not have legally mandated paid vacation and holidays." She goes on, "science tells us that this is a very bad idea. Increasingly, studies are showing that breaks of any kind are not only good for you; they can actually increase productivity and well-being."

Long Vacations Benefit Both Company and Employee

To create a lasting change in their organization, and maybe even greater society at large, leaders must fully embrace the practical benefits of vacations. Good leaders will be more inclined to not only grant, but also encourage employees to take not just a couple of long weekends here and there-and maybe a week off in the summer-but longer vacation time. Employees come back from a full week (or two or three) of time off when they were able to truly disconnect from work energized and recharged, with better ideas, a fresh perspective, lower stress-levels, and genuine excitement to tackle work challenges that can become overwhelming without time to recharge. Truly effective leaders recognize the value of paid time off, and understand it's key to a productive and engaged workforce. 

Here are specific steps leaders can take to make sure this happens:

• Issue specific company policies that encourage all employees of the organization to take all vacation days due them, and in any increments they prefer. 
• Be clear the time off must not interfere with mission critical work, but also be clear that one person's week off shouldn't incapacitate a well-run department, and that while every department has busier times on the calendar, it is normal and expected that departments will experience slower times periodically throughout the year.
• Require that all managers and supervisors conduct short meetings with their employees explaining the vacation policy.
• Ask employees for feedback regarding perceived problems with the vacation policy. Since many employees may feel constrained to speak up, use a suggestion box where they can offer suggestions or voice complaints.
• Assure that all complaints and suggestions are answered by a third-party, such as Human Resources.
• Follow-up yearly to make sure the new vacation policy is working.

As we head in to the height of the summer, when friends and family frequently plan reunions, couples get married, families with children have the freedom to travel, as leaders it's our job to help facilitate these getaways. Your employees will thank you for it, and ultimately, your bottom line will thank you for it too.

Jeff Wolf is the author of the international best-seller Seven Disciplines of a Leader.

A dynamic speaker and highly sought after executive coach, Jeff was named one of the country's top 100 thought leaders for his accomplishments in leadership development and managerial effectiveness.

Get in touch with Jeff at 858-638-8260 or jeff@wolfmotivation.com.

Wolf Management Consultants
www.wolfmotivation.com

Wolf Management Consultants, 4225 Executive Square, Suite 600, La Jolla, CA 92037, United States
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Sender notified by Mailtrack 06/05/19, 10:12:45 AM

Fwd: Radio broadcasts vs. email?

---------- Forwarded message ---------
From: Matt Wolfe <info@evergreenprofits.com>
Date: Fri, May 17, 2019 at 11:40 AM
Subject: Radio broadcasts vs. email?
To: <stevescott@techacq.com>

Something that we've been hearing a lot lately is that people really enjoy the emails I write. You'll probably think it's BS and I'm just tootin' my own horn but, quite honestly, we get a compliment about once per week. Some of you receiving this know it's true because those compliments come from you guys. So I thought I'd quickly breakdown my approach to email marketing... I treat email in a similar fashion to how radio broadcasts treat radio programs. I believe the analogy came from email marketing expert, Ben Settle, and it's something that's really stuck with me. (His approach is wildly different but the analogy was spot on for me) A radio host is going to spend their time on the air entertaining you and informing you. In between that entertainment and information, they're going to endorse and recommend products. Listeners of that radio personality are more likely to purchase things from the person they've built a bond with (by listening to them daily). We take the same approach to email... Every Tuesday and Thursday we entertain and inform via our podcast episodes. Every Saturday we give you a quick recap of the week and share other cool things we've found (more entertaining and informing). And Monday, Wednesday, and Friday, we share info that also mentions offers that we endorse. These come in the form of blog posts, educational emails (like this one), videos about tools we use, and sometimes (full transparency) we'll send you an email that flat out makes an offer to purchase something. I leave Sundays free. Basically just as a break for me from writing emails. (I have been known to mail on Sundays sometime when I have something I really want to share) That's it. That's how we treat email. I know what style of email I'm writing every day. I know we're providing insane amounts of value to the people that follow us. And I know that we're going to be able to keep the lights on over here because we've built enough trust with people that, when we recommend stuff, many of them buy. This could be a good philosophy to test in your business? Anyway... I thought I'd share that with you while it was fresh in my head. If you want to get all sorts of tips, tactics, strategies, and resources mailed to your home every month, definitely become and Evergreen Profits Member. It's only $15 and promises to blow your mind month over month. We appreciate ya, Matt Wolfe P.S. I'll often use the PS in emails to mentioned a secondary thing in an email. I don't want to take the focus off the main thing (the podcast, the newsletter, the offer) but I do want to draw attention to one other thing. For instance, I'll mention our print newsletter in the PS portion of emails on podcast release days. Other Interesting Stuff: Latest Podcast Episode (Subscribe on iTunes) Download The Podcast Episode Guide (Updated Monthly) Learn Our Unique Traffic Strategy (Free Book) Whitelist Us Want out of the loop? Unsubscribe. Our postal address: 771 Jamacha Road #505, El Cajon, CA 92019

Sender notified by Mailtrack 05/17/19, 11:59:27 AM

Fwd: From stranger to my first $125,000 VIP Day client...

Hey Steve,   I remember it very well...   It was the final session of Day 1 of my High End Selling Secrets event a few weeks ago.   Everyone was a little tired from a full day of learning, including me (I had to eat a banana to keep my energy up).   But I decided to sell my first $125,000 VIP day live on stage to demonstrate the Free Sessions That Sell process.   I had sold many $100,000 VIP days, but I decided to raise my price right there on the spot.   (I know, it was a little nerve-wracking for sure. Especially after a long day of teaching and standing up on stage!)   So here's what happened…   Everyone started to stroll back into the room after a satisfying dinner.   I then asked if anyone would like to undergo the Free Sessions That Sell process live on stage.   Almost everyone raised their hand and using my intuition, I picked Brad.   I pulled up a couple of chairs, gave Brad a big hug, and got started with the intro session.   Fast forward to the end of the session, Brad signed up for a $125,000 VIP day after taking him through the Free Sessions That Sell process.   Here are the highlights of how I worked with Brad on stage so you can implement for your own intro sessions:   1. I didn't try to "sell" Brad on my coaching.   The truth is I don't need any more clients.   And even though you may be growing your business, that's the mindset you should have when doing your intro sessions.   The mindset you should have is:   "I am offering coaching. If anybody decides to go for it, I'm excited for them."   This conversation wasn't trying to sell Brad on anything.   I was trying to find out what he needs and see if what I have to offer can help him.   If Brad was interested, then I'll tell him what I have and how it works.   If he wasn't interested, then I wasn't going to tell him about it.   It's a lot tougher to get on an intro session call with the mindset of, "Gosh, I need to pay my mortgage next month and my car payment, etc."   I should know, because I've been there!   The money from the clients is great, but you don't want to be in a place where you're needy for it.   Even if you do need the money, you want to shift your mindset from a place of neediness to a place of "I don't need any more clients" when you're on an intro session.   You want your prospects to get the coaching for what it can do for them far more than what they're going to pay you.   2. I made sure Brad got value on the intro session.   I asked Brad what kind of an income he wants to make with his coaching business.   I also asked what his dream coaching business and life would look like if he could push a magic button.   I could tell Brad never really thought about these questions because I had to dig a little deeper.   He finally told me he wanted to work 4 hours per day and only work 4 days per week.   He also told me he wanted to travel all over the world with his wife.   In other words, Brad got massive clarity during his intro session regarding what he wanted in his coaching business.   He even told me after he eventually signed up for coaching that he got a lot of value out of that intro session, which is why he decided to sign up for a VIP day with me.   Remember, a prospect can still get a lot of value out of an intro session,  even if they don't end up working with you…   …especially if you follow my Free Sessions That Sell process.   3. I asked Brad what would hold him back from his dream coaching business.   Brad told me not knowing how to approach potential high end clients could hold him back from having the business he wants.   He also told me he had his own blocks (shyness, fear, doubts) that could sabotage his goals.   In other words, Brad quickly saw the gap between where he is now, and where he wanted to be in his coaching business.   I then told him he could achieve the business of his dreams by himself, but those doubts and fears could come up and hold him back.   He quickly nodded his head and recognized he needed help.   Finally, I told Brad we could work through those doubts and fears during our VIP day.   I also told him we could create a plan for finding high end clients that would support the business and income he desires.   It was a quick decision for Brad because he immediately saw the value in hiring me for a VIP day.   He saw how working with me would help him close the gap between where he currently is in his business, and what he wanted to achieve.   So that's a snapshot of how I took Brad from a stranger at one of our events, and turned him into my first $125,000 VIP client.   If you want to sign up high end clients (whether high end for you means $5K or $125K), I hope this helps you sign up more of them.   Big Love, Christian   ps. Whenever you're ready... here are 3 ways I can help you grow your business:    1. Grab a free copy of my #1 best selling book Get Clients Today   You'll discover what to say and do to get potential clients to sign up and work with you — Click Here   2. Join the "Get Clients Today" community and connect with coaches, consultants, and healers who are getting clients too   It's our Facebook community where you receive valuable content and tips about how to get clients and grow your business and you'll get to interact with me — Click Here   3. Work with us privately   If you'd like to work directly with me and my team to finally get all the clients you want... just reply to this message and put "Private" in the subject line... tell me a little about your business and what you'd like to work on together, and I'll get you all the details!                 ------------------------------------   C Mickelsen  CEO, Future Force, Inc  936 SE 1st Ave #943 Miami, FL  33130  USA  www.CoachesWithClients.com (800) 492-7152   Discover More Business Secrets, Plus See My Personal Side By Following Me On... Facebook: christianmickelsen.com/facebook Instagram: christianmickelsen.com/instagram YouTube: christianmickelsen.com/youtube             Click to  manage your subscription ,  view our disclaimer and privacy policy , or to  unsubscribe .     Future Force Inc. 936 SE 1st Ave #943 Miami, Florida 33130 United States (800) 492-7152

Sender notified by Mailtrack 04/28/19, 9:58:39 AM