smjStrategies Operates on the Cutting Edge of Drug Development.  Check out 

some of our Interesting Content and Projects here...

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June 2024
smjStrategies is thrilled to announce original research on the participation of drug development professionals as clinical trial subjects.  Pharma companies spend millions each year asking third parties to explain and predict the patient journey, when in fact all drug development professionals are free to learn first hand what participating in a clinical trial is like. Those that have participated have reported high impact insights and learnings that are directly related to their job performance and company missions.  

Pharma as Patients, a collaboration with Brenner Insights, seeks to establish a baseline metric of drug development professional participation in clinical trials.  This is the first of its kind.  We believe direct participation in clinical trials, by the professionals who are empowered to design them, could be a significant innovation accelerator in clinical research and the pharmaceutical industry.  
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November 2023
This final PHUSE and ASA webinar on Interdisciplinary Safety Evaluation for Learning and Decision Making:  Education for Executives summarized the four prior in the series, specifically to help executives hear it all fast, because executives don’t have an extra six hours to learn the nitty gritty like transitioning from SAS to R, understanding how best to prepare for FMQs (FDA Medical Queries) and SMQs (Standardized MedDRA Queries), and how industry is learning how to stop analyzing safety data using efficacy-oriented statistical methodologies. 

In this executive summary, smjStrategies addressed the other item that is of great interest to executives:  impact to revenue stream.  Yes, the primary value of safety data is to protect patients.  However what this Working Group has shown is that using non-efficacy statistical methods for safety data, earlier in the program, can and does have a positive impact on revenue.  Check it out here!

80-100 Drug Development Professionals.
1.5 hrs.
"One of the most useful skills development trainings I've ever had"
...is what most attendees walk away saying.  If you have a team of 80-100 people and you need to gamify skills development in a fantastic, fun, and extremely memorable way, The Negotiation Game is for you.  Also called The Collaboration Game, we break out into 12 teams and each team is given a secret assets.  Over the course of 1.5 hours and two rounds of negotiation, each team seeks to increase its assets value by trading with other teams.  Game players are subject to sudden changes in market valuations, and other uncertainties that simulate real-life corporate and project conditions.  

"The Negotiation Game improved my negotiation and collaboration skills, for sure.  It gave me immediate take aways for my work, and was thought provoking for a long time to come.  It was also one of the most fun activities I've done at a corporate event in a very long time"- Galyna G, Biometrics professional, mid sized US based pharmaceutical company.

To find out more about the Negotiation Game and if it might be a good fit for your next on-site corporate event, please email smj@smjstrategies.com.
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July 2023

Regulatory Information Management Reference Model

At the DIA Regulatory Submissions, Information and Document Management Conference in 2014, together with my colleague Peter Terbeek of Astellas, we formed the DIA Regulatory Information Management Working Group.  Our primary objective was to address the growing crisis of organically-grown taxonomy appearing throughout the regulatory landscape, sowing unnecessary confusion due to a lack of industry-wide strategy and coordination.  Today I am thrilled to see these efforts manifest in the form of a nascent Regulatory Information Management Reference Model, published in the DIA Global Forum this month.  Although I'm no longer actively involved in the working group on a monthly basis, my successors, specifically V. Balasubramanian who has been the Co-Chair since I stepped down, have done an incredible job manifesting this original vision.  The value to industry is immense, and more to come.  To read about the RIM Reference Model see the article here.  An e-Book published by the Drug Information Association is underway, watch this space!

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June 2022

RWE Thought Experiment: Could RWE Have Prevented Today's Opioid Epidemic? Lessons from 19th Century China

The application of Real Word Data/Evidence discovered remarkable patient experience parallels between today and 1800's China. thanks to research collaborators Duke Medical School's  William John, PhD and librarian Lou Zhao.  Together with Sheila Mahoney of smjStrategies, we discovered fascinating parallels between current opioid abuse and 19th century China's opium epidemic. Poster evidence presented shows positive-predictive value regarding opioid availability and consumption by the general population.  Furthermore, the question of data collection is addressed.  If we, as a society at any point in time, dismiss the patient experience from earlier time periods due to data collection standards that don't meet present-day, are we not dooming ourselves to, as they say, repeat history?  To see this poster, please email smj@smjstrategies.com or listen to our session on The Real World Data-Real World Evidence Club podcast, here.
 December 2021

Pharmacovigilance innovation:  FDA's June 2021 Draft Guidance, Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies, encourages industry to take unprecedented approaches to drug safety.  Several techniques are addressed.   MedAssessment, led by drug safety expert Dr. Peg Fletcher, delivers astounding capabilities at a particularly difficult drug development focal point:  early drug development, when sample sizes are small and statistical methods are not as sure as the post marketing experiential dataset of hundreds, thousands, possibly millions of patient experiences. 

"It has been beyond an honor to observe and support Dr. Fletcher and her team's digestion, analysis and communication of this innovative FDA Draft Guidance for Industry"
-Sheila Mahoney
  
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February 2020

Panelist, DIA Regulatory Submissions, Information and Document Management Forum:  Artificial Intelligence Panel:  Regulatory Affairs in the Age of Artificial Intelligence 

In this panel discussion, we explored how the Regulatory function is positioned in the age of Artificial Intelligence and emerging technologies. From exploring whether it is hype or reality, to evaluating potential use cases, to building business cases, and evaluating organizational readiness for a change of this magnitude; this session brought together industry leaders to share insight into how Artificial Intelligence will impact Regulatory. As more and more use cases are defined and practical implementation is realized, how will we see the application and impact play out over the next few years?
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Q2 2019

LifeSciHub Goes Live!

After over a year of working closely with a software development team located in eastern Europe, the LifeSciHub platform went live!  In June of 2019 LifeSciHub became revenue generating as its own separate entity.  Originally designed to be what other verticals refer to as an "open talent online marketplace" LifeSciHub seeks to adapt to the particular needs and conditions of the life sciences market.  

"Developing LifeSciHub has helped me understand my consulting clients on a more profound level.  Ownership means risk, and risk means making much heavier, more complicated decisions than ever before" -Sheila Mahoney.  
Nov 2018

S.Mahoney presents Sisyphus' Rock: An Analysis of Risk as Experienced (suffered?) by Life Sciences R&D, DIA Electronic Document Management Conference, Barcelona Spain
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Regulatory agencies are calling on industry to take risk-based approaches.  For subject matter experts who have spent long careers dedicated to total quality management, this can be deeply disconcerting.  And yet, life sciences R&D is impacted by risk at every level.  Every decision, every project, every budget, and every outcome is heavily impacted by risk.  But "risk" itself often goes unchallenged with respect to differentiating between perceived vs. real risk.  This presentation provides  techniques to raise awareness of risk, the impact of uncertainty on critical decision making and clinical research budgets, and tools to diagnose true risk in a quantifiable way.   Watch now!  
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Q4 2017

smjStrategies Embarks on v2 of the Framework for Paper Destruction



Managing paper is both a tremendous expense and significant risk for Sponsors.  And yet, so is destroying paper in a compliant manner.  Sheila Mahoney named as Team Lead- Regulatory Team as the Framework Working Group begins research on the second version of the Framework for Paper Destruction.  Download the Framework here.
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Q4 2017

A Remarkable Reason to Consider Win Loss Reviews- smjStrategies Case Study

Sheila Mahoney has over 20 years of conducting Win Loss Reviews (WLRs), in roles such as Head of Global Business Development and Corporate Strategy, and for the last 5 years as an independent consultant.  Much of this 10 minute video will sound familiar to any life sciences R&D vendor, such as the long sell cycles and challenging information flows.  However hopefully you won't relate to this startling discovery Sheila made while conducting a WLR.  The truly concerning thing is, this could happen to any vendor and probably does more often than we'd like to think.   Watch now!
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Q2 2017

smjStrategies- Seed Stage Investor in LifeSciHub

Online resource marketplaces are projected to be the "Future of Work" and no where is an innovation in talent more relevant than life sciences R&D.  Seed stage investor Sheila Mahoney:  "This is a space that already relies heavily on temporary engagements with experts, because there is a permanent uncertainty impacting any projections of clinical trial workloads.  There is also already a robust independent workforce, it just hasn't been tech-enabled yet.  LifeSciHub will adapt lessons learned from other verticals that have already adopted online resource marketplaces, and deliver this technology innovation in a way that is highly contextualized to this niche market.  This is an incredibly exciting investment and development opportunity!"  Learn more here!
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DIA Annual Meeting Philadelphia PA
June 26-30, 2016    

As usual, lots of exciting stuff happening at the DIA Annual this year in Philadelphia.  
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May 18, 2016

Corporate Strategy Webinar Series:  So you Want to Have  a User Group?

This webinar covers User Group Best Practices developed over 20 years of building, participating in, and observing multiple vendor user group meetings.  Before diving in, or if you'd like to benchmark what you're already doing against accumulated best practices, view this recorded webinar here

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February 10, 2016

DIA Regulatory Submissions, Information, and Document Management Forum, Bethesda MD


Sheila Mahoney, Co-Chair of the newly formed DIA's Regulatory Affairs Community RIM (Regulatory Information Management) Working Group, chaired a session introducing this important thought leadership group.  For more information, contact us.  Session abstract, click here.
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March 16, 2016

Corporate Strategy Webinar Series:  Win-Loss Reviews:  Why, How, now Do!

There are few, if any, actions that are so small and relatively easy, that combat uncertainty so effectively, and that yield such immensely powerful results.  A formal Win Loss Review program, if conducted properly, produces nothing short of strategic information gold. To view this in-depth webinar on Win-Loss Review Best Practices  Click here
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June 2015

Glass Ceiling or Stinkin’ Thinking?  An Application of Lean In in Life Sciences R&D

"Bravado" as a career skill?  Do women lack it or have it?  Should they even care?  A timely, compelling subject.  Sheila Mahoney speaks at the Drug Information Association Annual Conference, June 2015 in DC as a representative and co-founder of Women in Life Sciences. Watch now!
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