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7th - 8th May 2019 | Boston, MA

13th Clinical
Trials Conference

Thought Leaders & Visionaries

Charles Makin

Charles Makin

Global Head, Real World Evidence Strategy

Biogen

Balazs Flink

Balazs Flink

Head of Clinical Trial Analytics, Business Insights & Analytics

BMS

Sharon Klier

Sharon Klier

VP Ophthalmology

Quark Pharmaceuticals Inc

Tracy Vanderslice

Nicole Powell

Director, Business & Development

SDC

13th Clinical Trials is a unique experience where top notch attendees can discover, learn and shape the future of Clinical Trials together.

As the premier event for Pharmaceutical, Biotechnology and CROs, CTIP reflects the very nature of Science – seamlessly blending inspiration with practical application.

With Interactive Workshops, Panel Discussions, Roundtables, Ignite Sessions and Technology Tracks brimming with ideas and solutions to your challenges, you will be a part of experience like no other.

It is one of the leading conferences focusing on all aspects of Clinical Trials and its integration with Digitization covering Artificial Intelligence, Machine Learning, Internet of Medical Things, Big Data and Blockchain.

Whether your company’s goal is to meet the Latest Technological Advancements on Data Integrations, Site Selection, Mobile Tech, Patient Recruitment, Outsourcing or Developing new strategies to manage Clinical Trials.


With 13th CTIP, you are at the right place to drive collaboration with greater efficiency!

Begin The Journey With A Call

Canada: + (1) 647 849 3326

UK: + 44 (0) 20 3129 8222

13th CTIP Expert Interview

I have been working in the industry for 16 years, in various roles and capacities, and have been strongly rooted in the data world for clinical research. Over the years, while expanding my own knowledge and scope into clinical development operations, my latest roles have brought me to be highly engaged with customers and colleagues from a development perspective in getting small to medium size biotech/device companies to the clinical development stage and their programs moving.

I think the greatest challenge is to see beyond the high level of competition and embrace our strengths as a provider. Building collaborations with not only other CROs but more so, creating a unified team for the customers. For smaller biotech and device companies this holds the most value for them and for us in being able to apply our experience and knowledge to successfully execute.

There are so many moving pieces in the industry, though I think obviously there is a lot of momentum behind further personalizing medicine – whether it be through ATMPs or application of AI to the way we treat patients. Application of what we already know as well as utilizing that knowledge to advance the way we innovate will remain a huge driver and constant game changer.

There are obvious intricacies to each trial, however when thinking of cross authority compliance, we need to keep in mind the highest level of requirements applicable as well as the way collect and interpret results. Standards which have been put in place for data is certainly a huge consideration for any company and should be implemented at the earliest stage possible.

Since our industry doesn’t allow for a lot of, “artistic flavor”, I think we need to stay on point with what is required and expected, however as a service provider I always have liked thinking outside the box as much possible. I don’t like to think of CRO services as a shopping trip for the customer where they just purchase ready products – there is always a level of customer level uniqueness and that must be considered.

Design of the trial and considerations for the safety aspects as well as the approach for the (depending on the type of device) usability, functionality, etc.

Our level of involvement, from very early in our relationships with customers, seeks to assess the precise needs and thereby how we can apply our own knowledge (local or general) to meet regulatory deadlines. It is often the case that though a timeline has been set, there can be many opportunities for efficiency increase, however that always involves knowing exactly where we are in the big picture.

I am looking forward to engaging with companies on not only areas of where Crown CRO may be able to assist, but also to have exchanges of ideas, understand further the challenges that we are all facing in the industry as well as brainstorming ways, new or reinvented, on how to solve those challenges.

Strategikon Pharma is an expert-led, innovation-driven, agile, emerging new leader in the clinical trial business management space. We are a Woman-Owned Small Business, and cloud-based technology platform company funded by Silicon Valley and made up of industry veterans with experience on both the Sponsor and CRO side. Clinical Maestro is our flagship product; it is a fully digital system for clinical trial planning, budgeting, sourcing, vendor management and financial performance metrics management.

Our Clinical Maestro solution is absolutely unique in the industry – there are just no substitute products out there with the same breadth of novel solutions and collaborative infrastructure that have the potential to transform the industry.
This is largely because we are not trying to build a product to sell to pharma companies or CROs, rather we are trying to solve an age-old problem that has plagued the industry with inefficiency since the introduction of computers and email.
Our vision incorporates moving away from traditional Excel-driven manual methods of budgeting, sourcing and vendor management and metrics and into the age of workflow automation and artificial intelligence.
Clinical Maestro brings order to the RFP process by assembling and organizing inputs from all stakeholders to create a shared digital standard.
A good visualization of the current state of the industry is that each Sponsor and each CRO is playing their own musical instrument, their own song, in their own style, alone, in a corner. Clinical Maestro brings all these players together in unison to create a beautiful symphony.
Together, with the right technology and tools, we believe we can get there.

We have seen amazing innovation start to flourish in the business processes around clinical development. I call it the Administrative Revolution of clinical trials. These include simplified, digitized and automated solutions for vendor discovery and payment, site and patient compensation, and whole process evolution for planning, sourcing, financial performance metrics and engaging with vendors such as Clinical Maestro’s digital Transaction Room and Governance dashboards.
Furthermore, artificial intelligence has a mega role to play in our ability to use predictive analytics to better mine one’s own data sets and collective, anonymized data sets such as Clinical Maestro’s Intelligence Bank and Data Trove.
Other areas that will change the game include using AI for at-home dosing, patient access and patient engagement. I am personally very excited by the use of video communication technology and localized contract staffing models to reach patients in remote areas. Lots of exciting things are happening that should propel our ability to deliver life-saving and life-improving therapies to patients in need.

Early adoption; with any new technology solution there tends to be a hockey-stick pattern of adoption – no one wants to be first and no one wants to be last.
Having been founded in 2016, Strategikon Pharma is still a young company in a very conservative, slow-moving, and highly regulated industry. Our solution is so novel, so mind-blowing in its ability to disrupt current highly manual processes and deliver efficiencies that we are finding clients need time to digest the potential impacts. These include politicized corporate challenges such as replacing old, underutilized, embedded legacy applications, and even threatening existing low-productivity empires.
We are addressing major industry pain points and are confident that our product is the absolute best on the market. Therefore, we are highly focused on Advocacy and Thought-Leadership to help educate the market, engaging the most open-minded and technology-savvy movers and shakers in the industry to champion our system, and of course building ongoing strong investor backing to help us weather the long sales cycles.
In short - we aren’t going anywhere and are committed to bringing the future forward!

1. Inertia – there are many numerous new technologies available on the market that could really help solve industry problems but most are being brought forth by small, innovative companies that need to survive in order to move the dial. Many larger drug companies are taking a passive approach and expecting vendors to solve their internal issues with very broad, customized solutions that will require M&A activity. I worry that by waiting for these small players to consolidate into larger-scale providers, the industry to lose some of the innovation edge and nimble service benefits that small organizations can deliver today.
2. Conservatism – similarly, as much as we like to think of the pharmaceutical industry as being “high-tech”, we really haven’t changed that much in the past 40 years or even 20 years. In fact, much of the advances in communication have created more busywork and distractions. Each of us industry professionals need to look within at how our own daily behaviors and working practices could be improved to drive greater productivity and impact. We believe without a return of focus to analysis, strategy, action, performance and change, drug development will continue to elongate which drives up cost and risk. We owe it to patients to innovate and evolve.
3. Balance of Power – in my prior role at a Top CRO, I experienced the integration of commercial services into clinical solution strategies. This was a mega eye opener for me to start to appreciate this completely other world, and I will never forget the words of our CEO who led the assembly of this model back in 2011. He talked about the future being one in which drug companies are paid not for supplying drugs, but for achieving Health Outcomes. This, along with the introduction of greater efforts to hear the voice of the patient and the growth of formal patient advocacy groups, will finally start to change the dynamic towards one where the real customers of our industry achieve a greater balance of power. I believe this connection to the communities we serve and the accomplishments we deliver is essential for our industry to remain relevant and thrive.

It is important for us to attend CTIP because we have an excellent message to share and are eager to seek out other like-minded professionals who are thirsty for innovation. We hope that CTIP will help us expand minds while making new friends and partners in the process.

I have been in the pharma industry for 26 years and have touched all aspects of commercial product life cycles from sale, marketing, managed care, manufacturing, licensing and acquisitions, and clinical development. I have been a part of six successfully exited start up pharma companies. Contributing to patient wellness and healing is important to me.

The RxStudy Card is innovative. It saves clinical trial study teams and their colleagues significant time and money. Most importantly it, like UBER or Amazon, cuts time consuming and painful steps of acquiring and managing clinical trial supplies. To be exact, RxStudy Cards eliminates or dramatically reduces 20 steps in the supply process to 5 steps.

The biggest game changers will likely come in more automated processes that save costs of medications and therapies, both clinically and commercially. In addition, quality manufacturers will look for cost savings in every area of their business to become more efficient within our highly regulated and archaic systems. The pharma leaders will address excessive costs, primarily PBM rebates, but also distribution fees, as both will come under greater scrutiny. Lastly, the rise in direct to patient specialty pharmacies services will erode the market share of retail convenience stores which have a pharmacy in the back of the store.

The RxStudy Card is innovative, we have participated in nearly 200 clinical trials for large pharma and CRO’s to date but gaining traction in a logistics heavy market is a process of chipping away at the block. With cost savings north of 40% per study through reduction in waste of medications, and shifting logistic risks to the pharmacies, not including the heavy burden on human capital, the uptake is here. Once a company uses the service, they rarely revert back to the old traditions of pick, pack, ship, manage and throw away.

For the clinical trial space we serve, the challenges are: 1) competing for the available subjects, 2) making direct to patient clinical trials easy of subjects to comply with the trial, 3) while lowering spend or keeping costs in check.

We are excited about learning from peers, witnessing the challenges that are present, and formulating partnerships to overcome the challenges to running successful clinical trials. The focused education from thought leaders is enriching. Bringing minds together to solve problems at the root cause is our primary focus.

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What Makes 13th CTIP Unique?

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    Pitch Sessions

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    CEO's Panel Discussion

    WorldBI's 13TH CTIP Breakout Networking Sessions

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    WorldBI's 13TH CTIP Oxford Style Debates

    Oxford Style Debates

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    Fireside Chats

    WorldBI's 13TH CTIP Quick Recap

    Quick Recap

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