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Impressive improvements in study start-up time

A report issued in July of this year, featured the use of a Just-in-Time (JIT) approach to speed up patient enrollment in oncology clinical trials. Collaboration between Cancer Treatment Centers of America and a division of PPD has been able to shorten site activation from a typical 8 months down to 2 weeks! This improves patient access to potentially life-changing therapies while speeding up the ability to evaluate treatments to conquer cancer.

https://www.ppdi.com/news-and-events/news/2019/july-16-optimal-cancer-trials

The JIT approach is based on establishing a community of sites with prenegotiated contracts and terms, which provides immediate engagement by sites to search for patients. Patients are identified first, triggering the activation of sites, enabling patients to be enrolled within two weeks. As a result of the efficiencies of this process, there are zero non-enrolling sites.

This is a huge improvement. Faster startup will allow the pharma/biotech companies to more quickly assess if a drug candidate is working or not. This is a better and more efficient use of everyone involved in conducting a clinical trial, vastly improving productivity of the process.

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.

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.

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.

Branding – Danielle Baxter

Collaborative Negotiation – Jim Sheegog

Leadership – Michael Williams

Leadership Workshop

Leadership Workshop

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).

LaunchBio_August_2018_Web-10

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?

Matheus BD Announcement

Matheus BD Connections and DSG

Matheus BD Connections, LLC is pleased to announce that it has added DSG’s eClinical suite of products including IRT, edc, eCOA, Safety, Risk-Based Monitoring, CTMS and full Clinical Data Management services  http://dsg-us.com/index.html to its portfolio of customers.  DSG, Inc. is a leading global eClinical provider with a fully unified suite of innovative technology solutions and data management services for the global clinical research community. DSG’s eClinical software platform provides competitive advantage that is cost-effective with on-time project delivery. DSG solutions have been used in thousands of clinical trials around the globe with our award-winning eCaseLink™ platform and eCaseLink Designer for enterprise licensing. Founded in 1992, the company is proud of its record of adding products and services in response to their customers’ needs.

Matheus BD will be acting as an independent consultant providing business development and sales services for DSG’s product and service lines.

Matheus BD Connections and Global Clinical Trials (GCT)

Matheus BD Connections, LLC is pleased to announce that it will be representing GCT –  Global Clinical Trials – a very well positioned CRO with on-the-ground coverage in Europe and India, performing clinical development services for drugs and medical devices since 2001.

GCT supports clinical research across the breadth of USA, Europe and Asia, operating in Russia, Ukraine, Bulgaria, Romania, Republic of Moldova, Poland, Hungary, Czechia, Slovak Republic and India.

Matheus BD will be acting as an independent consultant providing business development, sales and promotional services to enhance GCT brand recognition.