Newsletters

Shortcuts to Receiving Market Approval

13Think waaaaaaaaaaaaay (haha) back…growing up, did you ever try and take shortcuts when doing your homework? Perhaps reading the cliff notes for a book instead of the actual book you were assigned?!? Sound familiar? Eh…hem…we all took shortcuts at some point! The problem was…those shortcuts typically didn’t work…we probably ended up in a situation where our developing minds were missing important information that was needed for question number 1 on a final exam! Sweaty palms for the rest of the exam…

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What is it to be overwhelmed?

I would like to welcome back, Heather S. Duffy, JD PhD, a career scientist of over 20 years, who’s been a fabulous member of the MLC team!

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“GSP” – Good Submission Practices!

I’d like to introduce Lisa D’Attanasio, part of our McCormick LifeScience family for the last 3 years!  Lisa has over 20 years of experience working in the pharmaceutical industry.  Her career started in Quality Assurance before moving into Regulatory Affairs.  For the last 15 years she’s worked in Regulatory Project/Submission Management for both small and large companies in the Cambridge area.  To date she’s notched 1 eNDA, 2 NDAs, 1 BLA, and 1 MAA on her CTD Submission Tool Belt.

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Preparing for Meetings with the Food and Drug Administration (FDA)

So really, how do you prepare for meetings with the FDA? They can be quite intimidating, especially for new companies developing a relationship with the FDA for the first time.  Who knows what they need to hear?  Who knows what they will ask?  Do we wing it or do we prepare? Can we prepare?  How would we prepare?

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Yes, Virginia, you ARE ready for eCTD!

Yes, Virginia, you ARE ready for eCTD!

It is my pleasure to introduce you to one of our “newest” members of the McCormick LifeScience team!  Nannette Hayes, RAC, has 12 years of Regulatory experience and holds her RAC certification.  She has operations and strategy experience working on trials conducted in the US and OUS (Canada, UK, Bulgaria, Czech Republic, Australia, Brazil, Colombia, Argentina, etc.) in Phases 1-3 with a special interest in working with controlled substances in clinical studies. Nannette also has experience with the preparation of several NDAs and post-market requirements. Always a team player, Nannette possesses a great work ethic, sense of humor and dynamic personality!

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Presentation Skills That Take You to the Top!

Presentation Skills That Take You to the Top!

I would love to welcome and introduce one of the newest members to our McCormick LifeScience team, Heather S. Duffy, JD, PhD!  We are so lucky to have her with us!  Heather is a career scientist working in biotechnology, who has spent the last two decades helping people develop their careers to the fullest.

Take it away!

Congratulations! You’ve been awarded a talk at the major conference in your scientific area.

You look at the list of speakers who will be speaking and you realize with horror that you have to go right before the top thought leader in your field! This means that everyone in your field will be there and will listen to your talk first. You suddenly have knots in your stomach and you wonder how are you could ever have agreed to do this! You know the science is great but you are not so sure how to stand up at the podium with confidence and deliver your message.

That’s okay, great speakers were not born great at speaking, they had to start somewhere too. The first step is to listen to lectures given by people that you think give great presentations. Write down some of the things that they do that make the talk great.

This could be that they speak clearly and loudly enough or it could be that they have a great way of explaining difficult material. This gives you a list of “what to do” when presenting. Also watch people that are not doing so well at it, what is it you find so hard to listen to? It is likely that others find these traits difficult to listen to as well.

This gives you a list of “what not to do” when presenting. Don’t worry great presentations are like great anything else, all it takes is to know the basic rules for a great presentation and stick with them! There are five basic rules of presentations that, if you follow them, will always insure a great presentation!

Rule number 1

Know who is in the audience. Okay, you won’t know exactly who is there but you can know if they are basic scientists, clinicians, business people or lawyers. Direct your talk at what they will be interested in about your work. You were invited because your work fit in with the theme of the session so just remembering what they are there for will help make your talk interesting to them. Interested people don’t sleep through talks.

Rule number 2

Memorize your talk, do not read the slides to the audience. In fact, one good thing to do is minimize the amount of text you use. Just show the figures and talk the audience through the data. The presentation should feel like a conversation with the audience, not like a lecture from Cell Bio 101.

Rule number 3

Do not go over your time slot. People are very aware of the time at these talks and if you start to go over your time they will not have a great impression of you even if the science is great. Generally you want to stick to one slide per minute of talk, excluding the title and acknowledgements. This means that a ten minute talk should have no more than 12 slides with the title and acknowledgement slides. If you end early, you just made a whole room full of new friends!

Rule number 4

Dress for success. While the science environment is often thought to be a “casual” environment don’t be fooled in to showing up in jeans and sneakers. The audience will be more likely to consider you a professional if you dress like one. This means a suit and dress shoes for many conferences that have clinical components. Got invited to give a talk at Keystone in the winter? Don’t be the guy that shows up in ski pants to speak…….

Rule number 5

Practice, practice, practice! Starting to prepare your talk well in advance of the conference will give you time to present to an audience before your big day. Find lab mates, friends, and even family members (remember, Mom will always want to hear you speak!) that are willing to listen to your talk and make suggestions as to how to make it better. Make corrections based on comments. Be open to changing things around if they are not clear.

In the end you will do just fine. The first big talk is always the hardest but don’t shy away from giving talks. Remember, the more talks you give, the more everyone in the industry will know you and this is how you grow a career.


toto-white

  • Remember that confidence comes from knowledge so make sure you really know your stuff, which is easy because it is YOUR stuff and no one knows it like you do.
  • Professional is as professional does, when you look the part of a Professional you get automatic kudos.
  • The more you practice the easier speaking in public becomes.
  • When you walk on that stage remember that this is your ticket to the top!

Documentation… the Basis of our “Packaging?!”

Once again I welcome back one of my favorite members of the McCormick LifeScience Consultants, LLC team, Jacob Cooper, Quality Systems and Regulatory Operations Consultant. He loved writing last month’s issue so much that he came back begging to do it again! (right Jake?!?!?!)

Take it away!

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Yes, Virginia, you ARE ready for eCTD!

Yes, Virginia, you ARE ready for eCTD!

It is my pleasure to introduce you to one of our “newest” members of the McCormick LifeScience team!  Nannette Hayes, RAC, has 12 years of Regulatory experience and holds her RAC certification.  She has operations and strategy experience working on trials conducted in the US and OUS (Canada, UK, Bulgaria, Czech Republic, Australia, Brazil, Colombia, Argentina, etc.) in Phases 1-3 with a special interest in working with controlled substances in clinical studies. Nannette also has experience with the preparation of several NDAs and post-market requirements. Always a team player, Nannette possesses a great work ethic, sense of humor and dynamic personality!

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GLPs… Assuring Data Quality

Can you remember back in our good ole’ school days (no, I’m not implying you’re old!) doing those long, drawn out math problems where we had to show every step prior to getting the answer?! The pain, the pain, the pain.

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Never Giving Up After Failure Will Lead to Success

You have to work through the “wrong” ones to get to the “right” one. What does that make you think of? It makes me think of 2 things: 1) Relationships, and 2) Drug Development. I know, you’re thinking, “huh?”

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