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 Mike Todd, M.A., M.S., President
and CEO, brings over 25 years of clinical trials experience with an
extensive background in statistical analysis and clinical trial
programming. Mike is actively involved in project management and
strategic planning for Nth Analytics. He began his pharmaceutical career
in 1981 at Hoechst-Roussel Pharmaceutics (now Aventis), where he
established a standard macro library of statistical procedures and
streamlined report processes. Subsequently Mike acquired extensive
experience as a statistician, project manager, and application
developer, at Merck, Covance, and Janssen. Therapeutic areas of
expertise include oncology, CNS, and vaccines. He was a member of
the Merck-wide task force that established standards for clinical data
structures based on the FDA Guidance for Electronic Submissions. As a
recognized CDISC expert, he has been an invited speaker at the
last 3 CDISC Interchange conferences.
Career Highlights
Merck - Varicella Vaccine
One of my proudest moments came in
December 1994 at Merck helping get the Varicella vaccine approved. In December I
was at Covance working on another project. The FDA reviewer requested
all 8 years-worth of Varicella data on breakthrough rates in a
spreadsheet ... by the end of the year - less than 2 weeks away. The vaccine was getting tremendous scrutiny because it was a
live virus and millions of children would be vaccinated.
Merck had made two previous
submissions. This was the third try - and if this failed there were no
plans to try again. The business rules had changed over
the years, plus the data were in all different formats. Nonetheless, we
pulled it together accurately and on time. My client at Merck, Debbie Wilson, wrote me a nice
"thank you" which I saved all these years because it meant a lot to me
Click here
to read it
Today, this would be a legacy SDTM
conversion project. The challenges of integrating legacy we faced in
1994 would still remain, but the job would be easier today because the
target data structure (SDTM) is well-defined, and we have tools
available to automate the programming and documentation.
Merck - SAS Transport Task Force
The FDA mandated that after August
31, 1999 all sponsors must submit all their data as SAS Transport files
instead of the traditional data listings in PDF format. This was a huge
change. Merck set up a company-wide SAS Transport Task Force to
implement the new requirements. This was a precursor to CDISC SDS team,
back in the days when each company developed their own standards.
I was the representative for the
standard reporting group. We reviewed the Guidance line by line and
implemented standard SAS Transport file definitions for all Merck
submissions. Much like the situation with SDTM today, every clinical
team we met was in denial and didn't believe the FDA guidance applied to
them. Of course, they all had to comply. I received another thank you from
the chairman, Dan Orfe and the co-chair, Anita Zubak, for my
contributions
Click
here.
Challenges as President of Nth Analytics
My experience is mostly on the technical end. Transitioning into the role of company president has been a
challenge. I’m most interested in implementing the latest technology,
and designing processes to ensure quality, or at least maximize the
chance of getting the accurate results I insist on.
My main responsibilities are:
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Setting strategic direction
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Ensuring quality standards are enforced.
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Allocating resources, particularly, making sure the right people are
assigned to the right projects.
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Recruiting staff
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Final decisions on contracts
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Legal strategy
Other duties that I would like to avoid, but can’t, are:
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