PharmaTalkRadio

Design Thinking is a human centered approach to innovation that helps uncover the sweet spot of opportunity where the needs of people, the possibilities of technology and the requirements for business success all converge. The application of the Design Thinking methodology (originating out of Stanford’s d.School) as a new approach to looking at solutions can lead to disruptive innovation in clinical trials for drug development. It allows for designing new ways of working, including the needs, challenges and insights about the complex world we work in.  

In this discussion, we introduce the basic principals of Design Thinking and an understanding of how the methodology teaches empathy for the end user (the patients). We explore its ability to reframe questions and unleash innovative thinking as well as the "downside" of creative tension. Most importantly, we address how Design Thinking can drive more successful trials.  

Hosted by Valerie Bowling, Executive Director of the Conference Forum, guests include:

Kate Helber

President at Infidea Agency, Past Co-Founder, The Helber Group

Jen Reichuber

Co-Founder & Principal at Altani Associates, Past Co-Founder, The Helber Group

Komathi Stem

Strategic Innovation Leader, Genentech/Roche

Kate, Jen and Komathi Presented a in-person program in May 2015 in Boston. For more information on the next program, plase contact us at [email protected]

In September 2012, TransCelerate Biopharma launched with the aim of simplifying and accelerating the delivery of innovative medicines to patients.  What progress has really been made and what are the realistic goals for 2015? In our 2015 kick off radio show, Clinical Air Episode #13, host Craig Lipset, Head of Clinical Innovation, R&D, Pfizer talks with Dalvir Gill, PhD, CEO of Transcelerate and Andy Lee, MD, SVP, Head of Global Clinical Trial Operations at Merck. In this frank discussion, we learn:

What’s working well and changes for 2015?Is Tanscelerate performing better or differently from other collaborations?How have engagements with outside organizations advanced?  Where do gaps remain?How are new areas selected and scope defined?Thoughts on implementing new ideasNew role for CROsWhat deliverables does Tanscelerate anticipate for 2015?

Since the FDA and EMA published their current thinking on clinical oversight and risk-based monitoring (RBM) strategies, the topic has received a magnitude of attention, commanding column inches, webinar discussions and industry conferences. With so much discussion going on, it is unsurprising that many sponsors are feeling out in the cold when it comes to identifying how to practically implement RBM strategies within study designs. As data quality matters most in determining study success and ensuring patient safety, the latest recommendations have created growing demand for solutions that simplify the transition to risk-based techniques.

In this program, our guests discuss how emerging technologies and Central Statistical Monitoring (CSM) now present more practical means of implementing successful RBM strategies. Both Sanofi and Novartis will provide a large pharma perspective on making the move to RBM.

Host: Valerie Bowling, Executive Director, The Conference Forum

Guests:

Marc Buyse, Founder, International Drug Development Institute & CluePoints

Eric Genevois-Marlin, VP, Biostatistics & Programming, Sanofi

Thomas Haag, Data Integrity Process Expert, eClinical Quality Assurance, Novartis Pharmaceuticals

In Clinical Air Episode #12, Craig Lipset, Head of Clinical Innovation, R&D, Pfizer talks with Marc Sluijs, Director Life Science Business Development at Oracle Health Sciences. 

Marc shares his thoughts on the digital health space and where technology is heading in clinical trials. In this informal discussion, Craig and Marc also cover how digital technologies can better serve patients as well as tips on keeping tabs on this rapidly moving space and what can disrupt pharma? 

Host

Craig Lipset

Head of Clinical Innovation, R&D

Pfizer

Guest

Marc Sluijs

Director Life Science Business Development

Oracle Health Sciences

Producer

Valerie Bowling

Executive Director

The Conference Forum

Donald Jones, Chief Digital Officer, Scripps Translational Science Institute talks with host Craig Lipset, Head of Clinical Innovation, R&D, Pfizer on what's happening with digital in drug development. Don discusses his thoughts on the evolution of new products with digital and the “digitazation” of tools for clinical trials. He also shares his thoughts on the biggest disruptors in pharma. 

Don and Craig will be featured in an interview as well at DPharm: Disruptive Innovations to Advance Clinical Trials on September 11, 2014 in Boston.

Host

Craig Lipset

Head of Clinical Innovation, R&D

Pfizer

Guest

Donald Jones

Chief Digital Officer

Scripps Translational Science Institute

&

Founder & Chairman, Wireless Life Sciences Alliance

Producer

Valerie Bowling

Executive Director

The Conference Forum

Join host, Craig H. Lipset, Head of Clinical Innovation, R&D, Pfizer lead a discussion on what it really means to partner with patients in clinical trials.

Guests include:

Jeri Burtchell, Founder, Partners in Research

Regina Holliday, Artist and Medical Advocate

For more information on Jeri's new launch, visit: Healthivibe.com and for Regina walking gallary, google Regina Holliday, walking gallary.

For more information on the topic of Patients as Partners, visit www.theconferenceforum.org. The Conference Forum presented a program in March 2014 fully dedicated to understanding the journey a patient takes in clinical trials. Also take a look at Disruptive Innovations to Advance Clinical Trials scheduled for September 11-12, 2014 in Boston. This event addresses significant innovation to help improve a patients experience in a clinical trial.

Join host, Craig Lipset, Head of Clinical Innovation, R&D, Pfizer lead a discussion onInvesting in the future of clinical research.

Guests include:

Todd Pietri, Co-Founder, Milestone Ventures

Jeremy Sohn, Managing Director, MPM Capital 

VC views on:

Disruption in the clinical trial spaceEntrepreneursFinding opportunities (incubators and accelerators)Good sources of deal flowsInvesting in technology or people?MobileBig dataBeyond the pilland more....

Craig, Todd and Jeremy will also be speaking at Mobile@Dpharm on September 10th at the Farimont Copley Plaza hotel in Boston. This event helps drug developers get their arms around the mobile/digital clinical trial landscape and figure out:

How mobile is innovating clinical trialsWhat parts of clinical trials mobile/digital technology is currently impactingHow mobile technology is making clinical trials cheaper, easier and more accurateHow mobile/digital is increasing the efficacy of drugsWhat the true value is to clinical trialsOpportunities

There is an opportunity to participate in creating a clinical trial app. Mobile@Dpharm will also be of interest to investors and app developers. Following this one day event is DPharm:Disruptive Innovations to Advance Clinical Trials. For more information, visit www.theconferenceforum.org or call 646 350 2580.

In Clinical Air episode # 8, host Craig Lipset, Head of Clinical Innovation, R&D, Pfizer hosts a show discussing investigators as partners in clinical research. Guests include:

Christine Pierre, President, Society of Clinical Research

Jacalyn Kent, Director, Clinical Development Information & Optimization, Eli Lilly

Key topics include: 

Misunderstandings around Remote Based Monitoring Training and communication challenges for remote site managersTranscelerate updateWhat are the real cost savings around RBM...are we just shifting costs?Real time data and how this should affect sites and paymentsReducing burdens to the sitesInvestigator turn over rate, making sites sustainable

In 2013 Pfizer launched the Pfizer Blue Button Project, a first-of-it’s-kind initiative enabling patients who have participated in clinical trials the opportunity to download their individual clinical data.  Using the Blue Button standard launched by the White House, patients will be empowered to use the data to improve their overall health and wellness, from sharing with healthcare providers to powering clinical risk assessments.  In this show, our host Craig Lipset, Head of Clinical Innovation, R&D, Pfizer speaks to the leaders behind these initiatives to find out why they launched, initial learnings, and where the projects may go if successful. Also joining Craig is Thomas Krohn, Business Lead for the Lilly Clinical Open Innovation Team. 

Host:  

Craig Lipset, Head of Clinical Innovation, R&D, Pfizer 

Guests:

Adam Dole, Presidential Innovation Fellow, The White House

Thomas Krohn, Business Lead for the Lilly Clinical Open Innovation Team

Jennifer Wulff, Director, Clinical Innovation, Pfizer

How a patient experiences a clinical trial is changing. Access, ease, efficiencey, safety and better quality data collection are the target goals. This episode features some of the emerging technologies together with a discussion on the opportunities and challenges to include patient access, recruitment and retention. Predictions for 2014 are shared by our guests.

Host:

Craig H. Lipset, MBA

Head of Clinical Innovation, Worldwide Research and Development, Pfizer Inc.

Guests:

Tomasz Sablinski, MD, PhD

Founder & CEO, Transparency Life Sciences

Komathi Stem

Senior Director, Product Development, Innovation Lead, Genentech, A Member of the Roche Group, United States