Clinical Research Topics | Matheus BD Connections, LLC

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.

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 3^rd or 4^th 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.

Branding Presentation

March 23 – 25 is the DIA Medical Affairs & Scientific Communications Forum. I’ll be presenting on the importance of having a self brand and the role of social media in creating it.

Get involved through Mentoring

Sharing with you a mentorship program I’ve gotten involved with at the University of North Carolina Wilmington. FuseCR (Center for Clinical Research Workforce Development) is a collaborative designed to connect UNCW with the field of clinical research. FuseCR is providing local clinical research talent with powerful career and industry enhancing services. One such program is MentorCR which pairs undergraduate students majoring in clinical research with experienced industry professionals in a formal, structured partnership.

My mentee is Keith Reid, https://www.linkedin.com/in/keithtreidjr/ . Keith is a Junior in the Bachelor’s Degree in Clinical Research program. While going to UNCW, Keith works as an Advanced EMT at New Hanover Regional Medical Center. Like many others in the clinical research industry, Keith feels drawn to this as a career having lost both his grandfather and father to heart disease at the age of 50.

Keith and I will meet monthly or more often as needed. Given my passion for connecting people, some of you can expect to hear from me requesting some of your time to talk with Keith on career path options and to share your experience and perspective.

The UNCW Clinical Research degree program is impressive in preparing students for entering into the clinical research industry. Keith has already completed the following certifications:

Medidata Classic Rave EDC Essentials for clinical research coordinators | March 2019
TransCelerate Essential Documents | February 2019
TransCelerate IRB/IEC Responsibilities & Informed Consent | February 2019
TransCelerate Facilities & Equipment | November 2018
TransCelerate Investigator Oversight Informational Program | November 2018
TransCelerate Delegation & Training | October 2018
Medidata EDC Inspection Readiness for Clinical Sites | June 2018
CITI Biomedical Research Certification | 2018

For more information on UNCW FuseCR and the MentorCR program, read on or go to the links shown.

FuseCR (Center for Clinical Research Workforce Development) is a collaborative designed to ignite a new synergy between UNCW and the field of clinical research. By fusing resources and knowledge from academia and industry, FuseCR is energizing the local clinical research talent with powerful career and industry enhancing services.

https://uncw.edu/chhs/community/fusecr/index.html

Build Connections between Academia and Industry
Enhance Our Existing Workforce
Prepare Students for the Workplace
Educate the Next Generation of Talent

The general objectives of these programs and services are as follows:

FuseCR was formed by UNCW faculty from the School of Nursing’s Clinical Research Program and the Math and Statistics Department, in partnership with the NC Biotechnology Center Southeastern Office and the NC Coast Clinical Research Initiative. This project was partially funded by a grant from the Duke Energy Foundation to strengthen the workforce for the local clinical research industry.

MentorCR for Industry Professionals: FuseCR Mentoring ProgramMentorCR pairs undergraduate students majoring in clinical research with experienced industry professionals in a formal, structured partnership. Engagement opportunities and leadership seminars are offered to further the student’s careers and the industry professional’s mentorship skills, while building professional relationships within the clinical research industry.

https://uncw.edu/chhs/community/fusecr/mentor.html

Mentors meet with their students 2-3 times per month and have opportunities to attend leadership seminars to further their careers while building networks within the industry. This program advances UNCW’s goal of workforce development in health-related fields for our regional community and provides crucial applied learning opportunities for our clinical research students.

Mentors have the opportunity to:

Support UNCW students by orienting them to the industry and helping them to build networks
Help the local economy by preparing better trained students
Experience the personal and professional benefits of being a mentor

Essential Skills Training

On March 23, 2019 at UNC-Wilmington (UNCW) Fuse CR site, a 6 hour workshop on Essential Skills was held. I’d gotten involved with this initiative through my desire to use my network to help others.

Working with Tiffany Erichsen and Susan Sinclair, we put on a program for the students in the Bachelor’s and Master’s Degrees in Clinical Research.

The first topic was Effective Leadership Styles presented by Michael Williams. Michael is the Chief Executive Director of the Executive Service Corps of the Triangle. I’ve known Michael for over 30 years. We were room-mates while in training for our first jobs out of college with Burroughs Wellcome Co. He is an excellent presenter. Students learned the DISC profile and its role in leadership and communications.

The second topic was Collaborative Negotiating presented by Jim Sheegog. Jim is a founder of Rowhill Consulting Group. Jim and I have known each other around 20 years. Jim also worked at Burroughs Wellcome Co which is where we met and then by chance I ran into him at a local restaurant about 7 years ago. Jim is well known in the corporate training and leadership development industry with significant work at global organizations.

A representative from the UNCW Career center spoke over lunch regarding professionalism, conference attendance, image and how to navigate a buffet lunch.

The final speaker was Danielle Baxter and she spoke on Branding. Danielle is Director of Business Development for Paragon Global CRS. I’ve known Danielle for 2 years and she is a very impressive speaker.

I was able to help because I keep in touch with people I’ve met from across the spectrum of my career and I put in effort to maintain the relationship – networking.

DIA 2019 Call for Abstracts

The Drug Information Association (DIA) 2019 Call-for-Abstracts is now OPEN!! DIA 2019 will be in San Diego, getting an abstract approved is a great way to get to attend. The registration fee is significantly reduced for those who present content. At the site is also the abstract guidelines and categories.

The submission period is open from August 1 – September 12.

DIA 2019 Call for Abstracts

LaunchBio NC Networking

LaunchBio (LaunchBio) holds events on the first Thursday of the month in Durham, NC. They are held in the Chesterfield Building in the downtown area. The building was formerly a cigarette manufacturing building. It has now been converted and there is incubator lab space for drug discovery and development.

It is a great opportunity for networking with people involved in the clinical research industry. Here I am enjoying conversation with Peter Weiman with MedNet Solutions (MedNet Solutions) and David Holland with Cmed (Cmed Research).

Matheus BD Connections and Array Biostatistics

Matheus BD Connections, LLC is pleased to announce that we have added Array Biostatistics ( arraybiostat.com) as a customer. Array is a full-service biostatistical and statistical programming CRO for the biopharmaceutical industry. Array is committed to providing individualized, adaptable and dedicated services to all of our customers with a team of highly experienced biostatisticians and statistical programmers.

Matheus BD will be acting as an independent consultant providing business development, sales and promotional services to enhance Array’s market recognition and secure additional projects.

“I’ve known several of Array’s leadership team for many years. They have a wealth of experience across many therapeutic areas and deliver high quality service,” Chris Matheus, President, Matheus BD Connections.

“Array Biostatistics is excited to be working with Matheus BD Connections. Together, we look forward to growing Array’s business and developing relationships with additional sponsors and partners.” – Sandy Ferber, CEO, Array Biostatistics

Matheus BD Connections and Investigator Support Services

Matheus BD Connections, LLC is pleased to announce that it has added Investigator Support Services (ISS) (www.isstrials.com) as a customer.

Investigator Support Services streamlines site selection and optimizes consumer and provider communications. Our depth of experience, geographic reach and technological infrastructure have allowed us to quickly and effectively respond to the needs of the biopharmaceutical industry for over 20 years.

Services include:

Site Selection
Mitigate risk with fully vetted sites across North America.
Longstanding partnerships of 10+ years.
Hand-selected and matched to study parameters.
Direct connection to sites for contracting and payment.
No cost to sponsors and CROs.

Global Healthcare Contact Center

Communications in over 35 languages to support your product development, promotion and safety programs.
24/7/365 live agents, interactive voice response, web solutions, social media and a range of other solutions tailored to your program needs.
600+ call center seats and trained lay and licensed healthcare professional agents.
Support clinical trials and post-approval programs with our knowledge of and sensitivity to a wide range of medical communication needs.

Matheus BD will be acting as an independent consultant providing business development, sales and promotional services to enhance ISS’ brand recognition and secure trials for the sites in their network.

“I’ve known the executive management at ISS for several years and am thrilled to be working with them,” Chris Matheus, President, Matheus BD Connections.

Excesses in Patient Recruitment?

Recall the excesses in pharmaceutical sales and marketing activities of the 1990’s – paying to send doctors to major sporting events (Super Bowl, Masters, World Series, etc), handing out pre-ordered take home dinners on street corners, sales representatives were catering lunches daily, providing examining table covers with product advertising, pricey dinners and entertainment, etc.

Recently a few industry veterans met over coffee and the topic of some activities being seen in patient recruitment came up. There has been a surge in companies that provide supportive logistics for clinical trials. The logistical support includes: transportation to and from doctor appointments, temporary housing at hotels or apartments while in the clinical trial or for pre and post study visit. Lyft and Uber are being contracted to provide some of the transportation as well as “black car” limo companies.

Getting and keeping patients in a clinical trial, increases the speed at which the trial can be conducted, speeding up discovery of which drugs work and thereby reducing pain, disease and suffering. While we acknowledge how important recruiting and retaining a patient in the trial is, there’s a sense that the pendulum may be swinging too far. Typically, when that happens for too long, the government steps in and well-intentioned but burdensome regulations are added. That was done to pharmaceutical sales and marketing activities, now, pharmaceutical companies are not even allowed to give out pens and notepads. It would be better to improve our own oversight than to have something forced upon us.

Others may feel we’re over-reacting. Let us share some of the things we’ve seen and we invite you to respond with your thoughts.

Automobile transportation: Uber Black including a uniformed driver.
Patients being put up at Five Star hotels, after they complain about lower priced ones.
Accommodations for extended family members are being included (for moral support).
The current regulations allow for reimbursement of “necessary and practical” items. To accomplish this, debit/credit cards are given out and when the money runs out, more is requested and more is put back on the card. It’s been reported that a patient in one trial bought a car with their card, asked for more money and more was put on.
Patients and families are being brought to the US from all over the globe for extended periods of time. When the study is over, do we think these families are going to want to leave?
For their time in clinical trials, the patient and/or patient family’s financial lifestyle is being augmented and made potentially made better.

Is this excessive or necessary?