By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    improving patient experience
    6 Ways to Improve Patient Satisfaction Within Hospitals
    December 1, 2021
    degree for healthcare job
    What Are The Health Benefits Of Having A Degree?
    March 9, 2022
    custom software development is changing healthcare
    Digital Customer Journey Mapping and its Importance for Healthcare
    July 21, 2022
    Latest News
    Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
    May 16, 2025
    Learn how to Renew your Medical Card in West Virginia
    May 16, 2025
    Choosing the Right Supplement Manufacturer for Your Brand
    May 1, 2025
    Engineering Temporary Hospitals for Extreme Weather
    April 24, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    Can Thinking Younger Make You Live Longer?
    April 20, 2011
    Image
    Obesity’s Outlook Unchanged
    June 13, 2011
    When It’s An Emergency Elderly Not Treated As Well in Hospitals
    July 16, 2011
    Latest News
    Building Smarter Care Teams: Aligning Roles, Structure, and Clinical Expertise
    May 18, 2025
    The Critical Role of Healthcare in Personal Injury Recovery: A Comprehensive Guide for Victims
    May 14, 2025
    The Backbone of Successful Trials: Clinical Data Management
    April 28, 2025
    Advancing Your Healthcare Career through Education and Specialization
    April 16, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: Crowd-Sourcing in Clinical Development
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Technology > Medical Innovations > Crowd-Sourcing in Clinical Development
BusinessMedical InnovationsTechnology

Crowd-Sourcing in Clinical Development

BioPharm Physicians
Last updated: July 25, 2011 8:12 am
BioPharm Physicians
Share
11 Min Read
SHARE

Guest Post from Tomasz Sablinski, MD, PhD

 

FDA’s Janet Woodcock recently testified to a subcommittee of the House of Representatives that drug approvals in 2011 may be headed for a 20 year high.  However, most of the news in the industry lately has been negative.

As noted in Fierce Biotech:

More Read

Blogging vs. Other Social Channels
Guidelines for Using Wi-Fi for Medical Devices
Study: Liposuction’s Benefits Are Only Temporary
Why Are Hospitals Still Using Pagers?
Virtual Reality Visual Field Test Device in Healthcare

Guest Post from Tomasz Sablinski, MD, PhD

 

FDA’s Janet Woodcock recently testified to a subcommittee of the House of Representatives that drug approvals in 2011 may be headed for a 20 year high.  However, most of the news in the industry lately has been negative.

As noted in Fierce Biotech:

“A recent Thompson Reuters report found that the number of experimental drugs moving in to Phase III trials plunged 55 percent in 2010. The stats weren’t much better in earlier stages either: new Phase I studies dropped by 47 percent and while new Phase II trials fell over 50 percent. That high failure rate partially explains why only 21 new drugs got the green light in 2010–fewer than both 2009 and 2008, when 25 and 24 were approved, respectively.”

A long-time drug developer in the industry, Tomasz Sablinski, MD, believes the industry needs new and novel approaches in drug development.  In addition to his role as Head of Development at Celtic Therapeutics he recently founded Transparency Life Sciences, and is inviting a diverse audience of patients, providers and scientists  “to help create the world’s first open-source, completely transparent drug development organization”.

 

Dr. Sablinski sat down with BioPharm Physicians to talk about innovation in drug development.

BioPharm Physicians: Dr. Sablinski, you’re involved in two organizations, Celtic Therapeutics and Transparency Life Sciences. Both are using novel approaches to drug development.  Can you begin by telling us a little about Celtic?

Dr. Sablinski: Celtic Therapeutics is a limited partnership private equity fund focused on drug development.  Unlike a classic venture capital or private equity partnership, we focus on acquiring and developing promising new therapeutics using a small team of experts and a virtual drug development model.  The goal of the partnership is not to build new companies.  Rather, the goal is to build value in new products through smart, cost-effective development and then sell or out-license those products to pharmaceutical companies for downstream commercialization.

We are building and developing a diversified portfolio of products in quite diverse areas including ophthalmology, Amyloid A (AA) amyloidosis and variety of cancer indications.  Our approach is novel, since we avoid the costs and overhead associated with building individual companies.  We focus only on building value in individual products.

BioPharm Physicians: What have been some of the biggest challenges in the virtual drug development model?

Dr. Sablinski: Traditionally, many have viewed “virtual” development, as inferior to a “bricks and mortar” approach. Thus, the first challenge is to convince external audiences (development partners, investors) that the main reason to be virtual is not the shortage of money, but rather the superiority of the approach versus one that calls for using resources to build a stagnant “built to last” organization.

The second challenge is to find the right people.  There is no room for free-riders in a super-dynamic, content–centered and transparent development environment. The engagement of contributors starts and ends with an enthusiasm for the content, and from applying one’s expertise to contribute to moving a project forward.  It is increasingly easier to identify people who share such a mindset, and knowledge networks such as LinkedIn and your community of physicians are great enablers.

Another interesting challenge is to appropriately reward contributors who will often meet in the “cloud” only – different models exist and are successful in other industries.

Drug development in our industry has not yet embraced and faced these challenges. It is not surprising, as in my estimate this industry is about a decade behind other industries in effective use of computers  and new information technologies.  Unfortunately, this decade-gap is widening rapidly, and I do not think it can be bridged without a radical re-engineering of the entire model.

BioPharm Physicians: You’ve recently launched Transparency Life Sciences.  Can you describe for us what you hope this new initiative can accomplish?

Dr. Sablinski: Transparency Life Sciences (TLS) is a web-enabled biopharmaceutical company whose mission is to develop medicines for significant unmet medical needs, using a fundamentally superior approach compared to current industry standards. Initially, TLS will focus on acquiring and re-directing the development of compounds that have demonstrated a signal of efficacy, and a clean safety profile, but are “on the shelf” as a result of poor alignment with the owner’s corporate strategy, unsuitable properties for the current indications of interest, or financial reasons.

Transparency Life Sciences will develop products using a game-changing approach based on three pillars:

  1. Collaborative intelligence (cIQ), a.k.a crowd-sourcing, open source
  2. Transparency of data
  3. Convergence of modern health information technology with drug development know-how

 

As a result we hope to develop much less expensive medications, much faster and with relevance and quality of data exceeding today’s standards.

 

BioPharm Physicians: Can you discuss the importance of an open-sourced approach and the value of transparency in drug development?

Dr. Sablinski: The value of this approach to product design has been well proven in software (Linux), and many other industries. It is increasingly recognized as a valuable method in basic research, and drug discovery (references available on request). However, no company has adopted cIQ as a way to design, execute, and analyze clinical studies – the crucial, most expensive and most time-consuming part of the development of new treatments.

With open-sourced development, anyone anywhere will be able to contribute to the planning and design of TLS compound development strategies and tactics in real-time. By granting full data access to a broad expertise, the TLS open source approach will add substantial value to its pipeline of products, benefiting TLS stakeholders, partners, and product acquirers. Algorithms and filters to manage crowd input will be implemented to enable efficient processing of information. A reward system will provide incentives to users offering high quality, high impact contributions. Based on the open source approach, TLS can cover a wide range of therapeutic areas and diversify overall business risk.

In contrast to the historical approach taken by Pharma companies in most aspects of their business, TLS believes that the benefits of working in a transparent environment far outweigh the risks. Pfizer, Merck, Lilly and others have recognized this value, and launched “open source” efforts in early research to supplement and improved the productivity of their internal discovery efforts. TLS however believes that transparency should facilitate every step of its business process, from evaluating and selecting compounds for acquisition; developing the clinical plan and study protocols; recruiting and executing studies; processing, analyzing and interpreting data; regulatory and reimbursement discussions; and ultimately making decisions related to potential asset sales.

BioPharm Physicians: The industry faces tremendous challenges in improving its research productivity and reducing the cost of late stage failures in development.  What are your thoughts on some of the things that industry physicians need to consider to improve R&D productivity?

Dr. Sablinski: I have a very clear and blunt message here:

1. Do not waste time attempting to improve existing model(s) of clinical stages of drug development, as these are based on mid – twentieth century principles and completely ignore the fact that we live and operate in the world driven by technology. Consequently, these approaches are, in fact, trying to adjust the world around you to fit the glacial pace of change in the industry.  They will fail.

2. Look for successful models in other industries, particularly in computer sciences and information technology.  Adopt and try them in drug development.

Dr. Tomasz Sablinski is the Head of Clinical Development and a member of the Executive Committee of Celtic Therapeutics Development (CTD).  He is Founder of Transparency Life Sciences. Prior to joining CTD, Dr. Sablinski served as Vice President at Novartis in charge of US Clinical Development and Medical Affairs. Prior to this, Dr. Sablinski held several leadership positions at Novartis headquarters including Vice President of Clinical Research and Development and Head of Global-Japanese Coordination. He also held multiple leadership positions in Novartis’ Transplantation Business Unit. He participated in, and supervised numerous NDA and IND submissions in the US, Europe and Japan.

Dr. Sablinski joined the Pharmaceutical Industry with Parexel in the mid-nineties as  Medical Director. Prior to joining the pharmaceutical industry he conducted basic research while appointed as Instructor of Surgery at Harvard Medical School, Massachusetts General Hospital, and Fellow at the Brigham and Women’s Hospital in Boston. His other clinical appointments include Lahey Clinic, Burlington, MA, and Central Clinical Hospital in Warsaw, Poland.

Dr. Sablinski earned his MD and his Ph.D. in transplant immunology at Warsaw Medical School.

TAGGED:crowd-sourcingmedical technologypharmaceuticalsTransparency Life Sciences
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

Clinical Expertise
Building Smarter Care Teams: Aligning Roles, Structure, and Clinical Expertise
Health care
May 18, 2025
Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
Health
May 15, 2025
Learn how to Renew your Medical Card in West Virginia
Learn how to Renew your Medical Card in West Virginia
Health
May 15, 2025
Dr. Klaus Rentrop Shares Acute Myocardial Infarction heart treatment
Dr. Klaus Rentrop Shares Acute Myocardial Infarction
Cardiology
May 13, 2025

You Might also Like

BusinessGlobal HealthcareMedical EducationNews

James Huang, China Forum II Co-Chair, Investigates the Big Trends in Chinese Healthcare

December 21, 2011
king for a day
BusinessHealth ReformPolicy & LawPublic Health

Healthcare Executives – Keep Calm and Be A King for A Day

August 14, 2015

Technology Migration in Global Wound Closure Markets

November 15, 2014
baby pictures
BusinessHospital AdministrationMedical EthicsMedical RecordsPolicy & LawSocial Media

Are Those Cute Baby Pictures in the Doctor’s Office Offending HIPAA?

September 18, 2014
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?