Quality to the Nth Degree

 


Company

Contact us

Services

Nth News

Servers

eBrochure

Capabilities

Pharma News

Top Pharma News

Twitter Pharma

Pharma Blogs

FDA News

PharmAsia

SAS Blogs

Services

Biostat

CDISC SDTM

Validation

PK/PD

Contractors

Key Staff

President

Corp. Development

Links

DIA

CDISC

AmStat

ClinicalTrials.gov

PhilaSUG

Reference

ICH

E1

E2A

E2B

E2BQ&A

E2C

E2D

E2E

E3

E4

E5

E5Q&A

E6

E7

E8

E9

E10

E11

E12

E14

E15

eCTD  
 

Mike Todd View resume info@nthanalytics.com 908 672 5649

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. Iím 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:

  • Setting strategic direction

  • Ensuring quality standards are enforced.

  • Allocating resources, particularly, making sure the right people are assigned to the right projects.

  • Recruiting staff

  • Final decisions on contracts

  • Legal strategy

Other duties that I would like to avoid, but canít, are:

  • Programmer of last resort. 

  • Dispute resolution.

  • Rescuing projects in trouble. Fortunately, this very rarely happens.