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CNS Summit Conference 2021

The CNS Summit, a year-round community with an annual in-person Summit was held at the Encore Resort Boston Harbor. It was very well-attended with over nine hundred registered. There was a feeling of pent-up need for networking and reconnecting. It is quite apparent that participants at this meeting are enthusiastic to be attending in person. The joy and happiness of seeing friends, colleagues (past and current) and being able to freely move about and make new connections was palpable. There is such a willingness to hear about what each other is up to, has learned and is doing different since the last time we gathered in person.

Rapid antigen testing was conducted rapidly for Covid-19, and  a negative test result (within about 15 minutes) indicated by a wristband provided, allowing access to the Summit.  The testing was provided by CNS Summit in partnership with Care Access. The process went off flawlessly, a great testament to the Care Access and CNS Summit staff involved.

There were many exhibitors, patrons and sponsors. To see which companies participated, I recommend you go to the website: https://cnssummit.org/

Digital Biomarkers, Artificial Intelligence, Machine Learning, Big Data, Patient Diversity, Real World Data were among many Spotlight topics. As an example, Sharecare and UCB presented real-world data on patients with Myasthenia Gravis. The insights learned, the new endpoints discovered and the capabilities of the smartphone in such trials was impressive.

Below is the expanding list of companies that define themselves as DCT clinical trial service providers.  Go to https://www.dtra.org/  Decentralized Trials & Research Alliance to fully appreciate the expansion of companies and organizations in and/or getting into the decentralized research segment of our industry.

Curebase Circuit Clinical
Medable Science 37
TrialBee Thread
CaptureProof Care Access
Clinical Ink DataCubed Health
Medocity Medidata
ShareCare (SmartOmix) Science 37
SiteRx

If you are interested in the CNS Summit community and the opportunity for interacting within it year round, you can apply at the organization website, which is listed above in  paragraph 3.

And on a sad note, Medidata co-founder, Glenn DeVries who attended and presented at the conference passed away November 11 in a private plane crash in New Jersey.

 

Technology changes so quickly

Maybe the title of this should be “the pace of change”.  Recently while starting a company with people much younger than me, I felt like I had missed several years of involvement in the world.

With the accelerating pace of technological change, many of us find ourselves behind in keeping up with new software, programs, and technological processes implemented in the workplace.

A critical part of adapting to the digital advancements is learning and training. Implementing various types of training systems, such as written instructions and live video training to accommodate different work styles and preferences may be helpful.
In order to be effective, we need to identify the technological changes that will enable us to attain the goals of our future projects and avoid those that could jeopardize their completion.

How can we adapt to the rapid, sometimes unpredictable digital advancements? How do we prepare ourselves for the new technology processes? How do you know if you indirectly resist the changes and how can you solve that?

The Uncertainty about future or current technologies might have nothing to do with the technology itself, but instead with how we respond to the changes.

I don’t know if kids still read Washington Irving’s story of Rip Van Winkle.  https://en.wikipedia.org/wiki/Rip_Van_Winkle  It’s about a man who fell asleep and woke up 20 years later and it was hard to accept all that had changed.  Well, lately, I feel like I’ve been asleep for 10 years and have completely missed some of the digital advances and even the more mundane.

Let’s address the mundane one first, so tonight I stop in at Staples because I’m all out of “business” envelopes – you know  the type, the long envelope that if you wanted to mail an 8.5 x 11 inch letter to someone, you’d fold it in thirds-ish and put it in this envelope. So I confidently stride to the aisle labeled Envelopes and begin looking for business envelopes.  No such thing to be found.  They had boxes of an envelope with the wording Number 10.  So I look at the dimensions and it seems that they would work.  At check out, to confirm I was buying what I needed, I ask the two 20-30 year olds – one was a manager –  at check out, “are these envelopes the same as what I know as “business envelopes”? They, of course, had never heard that term.  So I explained that I was looking for what I know as business envelopes, they said, well, yeah it looks like that would fit as this is 9 and a half inches wide.

Now  to the digital world – so a client of ours texts us to say he’ll be texting us an image that we’re to take a picture of and save for later use in demo’ing his product at a conference. Those simple 6 words: “take a picture of and save”. So that I know what I’m to do I reply with: “just to confirm – by take a picture of and save – do you mean that I’m to use my iPhone and when I see the image I’m to do that iphone thing where I push a button on the side of the phone and at the same time push the round home button such that it takes a screen shot and then once that’s done I click on the screen shot and select “save to pictures”?  He replied, “yes”.  So you see what’s happening here? 59 words of explanation are needed for me to understand, interpret and act on his 6 words.

You should pray for my colleagues, this type of thing happens nearly weekly. You should pray for my colleagues, this type of thing happens nearly weekly.    Quite simple really isn’t it: “take a picture and save it.” *%$”(#*%4”@$(*$*(#@$*(@#)

Drug Development Industry Networking Event

One of the things I thoroughly enjoy about networking is meeting such interesting people with different perspectives. This helps us understand and appreciate those differences and helps us re-consider our approach to certain things.

On October 20, the Global Life Sciences Alliance along with FOCM Networking held its monthly pharmaceutical/biotech/clinical research/medical device/drug development industry online networking event (that’s a sentence-full). I know I wrote that in last month’s minutes too, so I promise to acronymize/shorten/bitly it next month, maybe to Pharma/Bio/CRO/Med & DrugDev or PBCMD? Is there a broader term one of you readers can suggest?

While people were arriving into the Zoom room, the first arrivers greeted each other and got their headsets, earphones, etc ready and connected. We started with the acknowledgement that October is National Breast Cancer Awareness Month. The advances in cancer therapies over the past dozen years or so is truly remarkable. With genotyping advances, new drugs are designed/created that work very well.  This allows testing to be done prior to drug administration and know ahead of time that certain patients will respond well.  So instead of having to enroll 300 cancer patients in a study to get enough with the defect in order to show statistical significance, the study can be done with fewer patients and to show significance and speed up the time to FDA approval.

We then moved to our featured speaker, Heather Hollick, a friend of mine for several years and the author of “Helpful, A Guide to Life, Careers and the Art of Networking”. Heather focused the discussion on best practices for using LinkedIn. It is an invaluable tool for networking. There are 8 ways that LinkedIn is beneficial.

  1. LinkedIn is how you present yourself to the industry. At a minimum it is your online resume.
  2. Enhances introductions – you know so much more about who you’re being introduced to.
  3. Refreshes your memory on who a person is, where you know them from and how long you’ve been connected.
  4. It helps you prepare for meetings – review who will be in the meeting and find items of commonality.
  5. Find companies that are hiring
  6. Provides links to other websites aiding in your research
  7. Keep track of who is in your network.
  8. Engage in groups and discussions with others that you share interest with.

I like to include how I met people, as a demonstration of the power and benefits of networking. I was connected to Heather via Tanyss Mason. I admit I’m having a difficult time remembering how Tanyss and I first became connections. Heather was in the midst of writing the book when we first met over the phone. When the book was released and Heather was in the RTP, NC area at a book premier and signing event we got to meet in person. Heather co-presented at the 2021 DIA Annual meeting (virtual) with me on a Networking workshop. We’ll collaborate again on this session for the DIA 2022 meeting being held in Chicago.

We typically go into several breakout sessions of 3-4 attendees for about 12 minutes each but this time, there was so much good discussion about LinkedIn and maintaining, nurturing and freshening one’s network that we showed our flexibility and kept rolling with the topic of interest.

Please join us next month on November 17.

Screen shot of Zoom networking

ATTENDEES (bolded names were first time attendees, I think):

Heather Hollick, Rizers, LLC; Author of “Helpful, A guide to life, careers and the art of networking”
Mike Burrows, Burrows Life Science Associates, LLC
Lacey Clements, IMA Clinical Research
Nadia Bracken, Medidata
Christine Narro, Medical Device Co.
Lewis Kelly, Gunvatta
Chris Bergey, Humphries Insurance Agency
Michael O’Gorman, Life Science Marketplace
Patrick McCarthy, ValidCare
Joe Dustin, Transcelerate Biopharma
Janie St. Pierre, Accellacare
Ellen Bedenko, IQVia
Patrick Champoux, SkillPad
Andrew Mulchinski, Symbio Research
Chris Matheus, Global Life Sciences Alliance & FOCM
Denise McNerney, Global Life Sciences Alliance
Joe Buser, Global Life Sciences Alliance
Daryl Oberg, Global Life Sciences Alliance
Brandon Huffman, Global Life Sciences Alliance
Holly Cliffe, Global Life Sciences Alliance
Zulma Varela, Global Life Sciences Alliance
Sally Haller, Global Life Sciences Alliance

Supporting a MatheusBD Connection

I am excited to announce that, Alicia Kelley Schifano, a connection of mine for over 10 years is hitting the big time!!  Alicia will be a contestant on a new TV show airing Thursday, October 14th on the USA Network.  The show is America’s Big Deal.  It was created by Joy Mangano (from the movie Joy) and it will be hosted by Scott Evans from Access Hollywood!  It will be a bit like Shark Tank but live and “shoppable” so people can buy the products in real time while watching the show.  Alicia will be on the first episode, competing for a retail deal for the Mr. Big Curling Irons!  Here is a link to the video promo: https://youtu.be/t3xJYFU8ugc

Here’s a link to the contestant page:

Please tune in at 9pm, October 14th and watch Alicia shine! And check out the product being offered at a $20 discount at the above link. For any of the FOCM members with long hair, this curling iron is a must in your beauty supplies inventory.  https://www.mrbigcurlingirons.com/

I have known Alicia for more than 10 years, having been introduced to her via TommiLynn Baker.  At our first meeting we talked for hours.  Alicia is energizing to be around; so much energy, passion and enthusiasm.

Networking Stories

When I do presentations and/or workshops on networking it’s been pointed out to me that some of the best “aha” moments or learnings that people take away come from the stories that I share.  So, I plan to to write up these stories in the hopes that they’re helpful or illustrative.

I use fictitious names when I have not asked for or not been given permission to use real names, yet the stories are real.

During the financial crisis of 2008, an acquaintance of mine (I’ll refer to him as John) worked in IT and became laid off.  I do not know for certain (no personality test was given) that John’s personality leans toward introversion, but I’d bet $100 that he is. He’d been unemployed for close to 10 months and was complaining about having applied to hundreds of openings, getting rejection letters, hearing nothing or getting some interviews but no job offers.  After many interviews and never getting the job, he explained that he was being interviewed by people 10-20 years younger than him that had no where near his experience and talents. Over time he was becoming embittered.

I asked for his resume and said I had connections in several of the local companies in my industry and would be happy to send his resume in to them.  His response was something like this: oh the networking approach, well I think that’s cheating.  In an idealized world, I see the point, and it would be nice if everyone were unbiasedly judged/evaluated on their resume.  But we’ve all seen good and bad resumes, which is one way in which recruiters judge/evaluate candidates. Recruiters and hiring managers use a variety of criteria to evaluate candidates: resume content and layout, experience, personality, references, etc.

Networking is most definitely not cheating; it’s a requirement.  I explained to John that networking isn’t cheating – I do not get him the job because I sent his resume to someone I know.  Me, sending his resume to someone I know just gets his resume lifted out of the pile and gets it a second or maybe third look.  Now the resume carries a reference an additional factor giving it more credence.  Chris Matheus or whoever sent the resume to their friend acts like a background check. Getting the resume lifted out of the pile does not get John the job – it gives him a better shot at getting an interview.  He still has to “get” the job, still has to interview (without the embittered chip on his shoulder) and interview well.

Building a network of contacts is a key element in managing your career. It needs to be nurtured, maintained and expanded.  Remember networking is a reciprocal endeavor, you must be helpful to those in your network if you are going to ask for their help.

Summary of GLSA FOCM Event

Minutes of the GLSA – FOCM Meeting of May 20, 2021

So, it finally happened, on that glorious day which shall long be remembered, these minutes will be heretofore submitted to the USA Library of Congress, the Smithsonian Institute and for reasons unknown, to the Sydney Opera House on the northside bulletin board for public postings.

On May the 20, in the year 2021 of the Gregorian calendar, it was noted that the GLSA (Global Life Sciences Alliance) and FOCM (Friends of Chris Matheus) Networking organization did hold an online (virtual) networking event. The meticulously planned event went terribly awry when but half of the positive RSVPs failed to show up.  That said, it was a resounding success for the initial such event.  A total of 21 attended.

The meeting started off with an acknowledgement that it was Global Clinical Trials Day and a toast was given to the clinical research industry for saving the world from Covid-19 and to James Lind, the Scottish doctor who initiated the first controlled randomized clinical trial on May 20, 1747 aboard a sailing ship. Dr. Lind divided twelve sailors sick with scurvy into six groups of two. They all received the same diet but, in addition, each group was given a different treatment. Only the two sailors who received citrus fruits improved and returned to work.

Chris then introduced the GLSA members to the FOCM community.  After a bit of general discussion, several polls were taken. About half of the group is reluctant to resume conference travel immediately, preferring to wait a few more months. Slightly more than half have been vaccinated or acquired immunity through catching the virus. An interesting opinion was voiced that perhaps as members of the clinical research industry, we should set the example by all being vaccinated.  I, for one and I believe I speak for many of the others have the utmost confidence that not a step was missed, not a shortcut taken in the development of the available vaccines.  Given the prioritization and urgency of vaccine development, we were able to speed up the data review process. The one thing that the sped up development lacked is longer term safety and side effect data.  However, vaccine side effects rarely (I can’t think of any) change the longer from the time of injection.

Then it was time for speed networking!  The assertion has been made by Chris that each of us in the clinical research industry are within 2 degrees of separation from each other. We had 4 different sessions.  Attendees were randomly put into different “rooms” with the assignment to each introduce themselves to the group, sharing where they’d worked the previous 10-20 years and what they’re doing now to see if they could identify who they knew in common.  Good information was exchanged and several new connections were made which can improve the management of clinical trials.

Join us next month – June 16.

Attendees:
David Holland, Cmed Research
Jon Matheus, Pancrazi Real Estate
Sheila Mahoney-Jewels, Life Science Hub
Eric Nier, Block Clinical
Lynne Becker, Power of Patients
Nadia Bracken, Medidata
Christine Ver Straate, GLSA
Mitchell Efros, Verified Clinical Trials
Cassandra Hui, HealMary
Denise McNerney, GLSA
Joe Buser, GLSA
Tom Ryan, GLSA
Kalyan Ghosh, Inference Inc
Marty Frazier, GLSA
Tanusree Bhattacharyya, Inference Inc
Zulma Varela, GLSA
Mike O’gorman, Life Science Marketplace
David Gibboni, DJGibboni Consulting
Eric Mayer, EDP Biotech
Craig Fernandes, EDP Biotech
Maria Frane, C3 Research

Selling clinical trial services

One of my sales principles is this: be wherever the users/decision makers/decision influencers of what you’re selling gather.  By “gather” I mean the conferences they attend; be they large (national) or small (regional). I have had fellow sales people tell me these small, local/regional meetings are a waste of time.
I should have put this disclaimer at the start, but it’s my website, so I’ll put it here. Disclaimer: It is acknowledged that I’m not the stereotypical salesperson.  Type A personality I am not; highly competitive I am not.  When selling services, I believe that people buy/purchase/select services and solutions from someone they know and trust;  also known as relationship selling.
So all that is to demonstrate through this short story:
I recently attended a virtual and regional conference on managing clinical supplies for clinical trials.  There were ~80 people in attendance.  I noticed one or two salespeople for manufacturing and packaging companies, none from drug supply management software companies.  At the end of the meeting, a request is made of the attendees for topics they’d like to hear about at the fall meeting. A specific request was made on the topic of managing study drug pooling by the drug management software.  The leader then asked if anyone had recommendations on who could speak to this.
Posted in the chat window was this: the name of one of the software companies followed by the names of two of that companies’ project managers. 
I trust the moral of this story is obvious.

Matheus BD Connections 2020 Person of the Year

Without a doubt the work done by the pharmaceutical, biotech, clinical research, drug development industry and the Food and Drug Administration is worthy of this distinction for 2020. What was accomplished is just short of miraculous.

The federal government (FDA) and the corporations cut no corners. I have no doubt that everything was done according to established good clinical principles. What was done was the speeding up of the regulatory processes; decreasing the workflow processing time. Turn around time on data review and decision making was the focus. The researchers and the reviewers of the data had Covid-19 treatments and vaccines at the forefront of their priorities.

The typical time for vaccine development to get approved is 4 years. The first two approved were done within 12 months!! There are several more in development.

We are now beginning to see the impact the vaccine is having in the US in terms of the decline of daily new cases. Many people have had their second dose.  The United Kingdom began vaccinating their population one week earlier than the US and you can see the impact to their daily new cases as well. This has me very encouraged. I’m hopeful that by Memorial Day, we’ll be back to dining out and meeting in person, traveling to conferences, vacations, etc.

US Daily New Cases Jan 18, 2021

 

 

 

 

 

 

 

UK Daily New Cases, Jan 18, 2021

Virtual Conference Observations

Observations on Virtual DIA 2020

2020, the year of the COVID-19/Protests/Riots/Presidential Election and the year the clinical research industry’s annual convention went virtual.

The noteworthiness of this made me think to jot down my observations.

I have been attending DIA since 1997. That year it was held in Montreal. Last year was in San Diego, which is probably the best place to have it in terms of weather.  The conference is always in the 3rd or 4th week of June.  The heat and humidity in Chicago, Philadelphia, Baltimore, and Boston has often been close to unbearable.

The biggest differences for me were:

  • I didn’t get to co-host the FOCM Networking event with my friends from Zymewire
  • I missed seeing everyone! Not seeing friends in person (this event is very much an industry reunion) and not getting to socialize with them makes it more difficult to maintain relationships
  • Seeing so few friends in the virtual exhibit hall (Thanks Adriana Grado and Amy Zastawney for taking time to meet with me). Every year I make a point to walk the entire exhibit hall to make sure I see and catch up with as many people as I can and to see what new and innovative products and services are available
  • I didn’t stay out too late (there was no virtual Transperfect party or vendor parties of any kind)
  • I didn’t drink too much.
  • I didn’t have a Fireball shot at the Barrington James exhibit.
  • I didn’t welcome any new FOCM members and hold any card ceremonies (I’ll have to re-write the card ceremony SOPs – the handshake may have to be eliminated)
  • Here it is the last day and I’m not exhausted.

As I have often told people younger and/or with less conference experience than me, at DIA – you will stay out too late and drink too much.  I point out that you HAVE to do this (it might even be in the SOP binder), because if you don’t, it wouldn’t be the tradition that it is.

A couple months ago I held a virtual FOCM Networking event with about 10 industry friends. I asked them if DIA were to be held in person, who would travel to DC for it.  The answer was no one.  Comments made were: it’s too risky, I don’t want to get on a plane, stay in a hotel, take a cab or Uber and go to a conference with 5000+ people.

We in this industry are proud of the role we’re playing and demonstrating to the world the value, the need and the method for discovering treatments for COVID-19. The need to utilize recent innovations in big data, AI, high throughput screening, lighten cumbersome regulatory hurdles will serve the world well for developing new treatments for all diseases.