14th CTIP Expert Interview
I am an Epidemiologist and Biostatistician by trade.I have over ten years of clinical research experience and 7+ years of business development and strategic partnership know-how. I have been fortunate enough to participate in the deal making process through in-licensing and preferred provider opportunities. Studying at different universities and in various countries for my post-graduate work, along with my certifications, has given me the scientific expertise to be successful in understanding client needs. I live in the beautiful city of Montreal and am home-based. Some of my hobbies and interests include dancing, singing, cooking, working out and reading.
Retaining clients and ensuring client satisfaction is the most challenging part for any service organization and for a full-service CRO like Cliantha, it is no different. However, we combat this challenge by ensuring synergies, mutual benefits and collaborative efforts. When a client decides to work with Cliantha Research, we are their ‘Research Partner”. They are not our “Client” but a “Collaborator” that cares about providing important and effective drugs, devices and/or alternatives to patients, just as much we do. Due to our passion, expertise, experience and responsiveness, we are able to create an environment that provides exceptional results, high-quality studies, ensures patient safety and timeliness.
The next 5-10 years will be a time of excitement and revolution for the pharma, biotech and generic industries.Biosimilars are going to make their mark where patients, clinicians and law makers will see that they are necessary alternatives, are safe and cost effective. Pharmacogenomics and Epigenetics will play a huge role as we move towards “Precision Medicine” and “Personalized Medicine” for the pharmas and biotechs. Leading generic companies are shifting their focus from “solid orals” to drug products requiring alternate routes of administration including topical, pulmonary and long-acting injectables. Places like India and China will become important clinical trial hubs because of their population diversity, especially as they ease their regulatory requirements. Lastly, artificial intelligence will change the landscape of how medicine is viewed and I think those changes are beyond our imagination!
When designing trials that comply with the requirements for ANY regulatory agency from the FDA, EMA, Health Canada, MENA or DCGI, it is important to ensure strategies that can evaluate risk and mitigate those risks as well. Trials need to ensure safety parameters, scientific validity, clinical relevance and authenticity. Our purpose as researchers, regardless if you are from the side of the sponsor or CRO, is to be responsible and accountable to the study subjects and subsequent populations who will have access to these therapies and choices for the particular disease burden.
Cliantha Research’s aim is to have the best technological inventions and improvements available right now. Our organization has always believed in organic growth that focuses on expertise and experience, rather than size. We want to ensure that we are competitive, are moving forward and are ready for the new adaptations entering the market place. We strive to always remain curious and learning new things!
Technological integration is an absolute necessity for the successful execution and completion of clinical trials. It ensures timely delivery with decreased manual intervention that may lead to errors. It increases efficiency and we are able to practice the principle of ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) for the data collected. Lastly, it also decreases the clinical trial costs and produces high-quality data.
As a meeting sponsor for The Clinical Trial Innovation Programme (CTIP) conference, my colleague, Cynthia Day O’Brien and I are looking forward to interacting with pharma, biotech and generic companies to learn of ground-breaking work they are currently conducting. We want to demonstrate how Cliantha Research can become a true research partner to these organizations. Our goal at this conference is, to determine if there are synergies between these companies and Cliantha as a service provider, so we can aid these industry leaders in bringing pioneering and vital drugs or devices to market in the shortest amount of time and cost effectively, while maintaining safety, quality and efficacy. We are very excited to be part of such an event that fosters alliances, sharing of ideas and advancement of mutual research collaboration.
CDO: I have 20+ years of experience in Business Development, with the last 10+ years at Cliantha Research, supporting services such as Central Lab, CRO and ECG Core Lab for both large and small companies. I have a passion for customer service and supporting the unique needs of each and every client. I am home-based in Rochester, MN and enjoy a variety of outdoor activities such as horseback riding, gardening and motorcycling.
CDO: The most challenging, yet the most exciting and rewarding, is the customization of clinical trials to meet the needs of advancing our clients’ clinical development programs. We strive to combine trials to give our clients cost and time efficiencies -- for example, combining Phase I and Proof of Concept studies. These are complex trials that require experienced staff and clinical conduct according to tight timelines. As well, we must work closely with regulators, which can give our sponsors a quick assessment of their molecule’s efficacy. We can also incorporate testing a comparator product early on, to give our sponsors an idea of market positioning. This approach can help large pharma quickly decide which molecule to advance or to stop investment. For smaller biotechs, this can help give them solid data, early on, to share with potential investors.
CDO: I believe the advancement of wireless and AI technologies, as well as an increase in patient advocacy and involvement, will take our industry to the next level. Identification of new drug targets and indications using machine learning and AI technologies will breathe new life into old medications. Integration of e-tools in clinical trials will help to streamline data flow and improve the quality of endpoints, especially e-PRO tools.
CDO: Obviously, sponsors need to be aware of any and all guidances that are available/applicable for certain types of trials and receive appropriate advice from regulatory experts. That being said, sponsors who are able to demonstrate novel approaches, with sound data backing, can save time and cost with innovative approaches. We see this at Cliantha Research when sponsors will utilize the Environmental Exposure Chamber (EEC) to conduct allergy-related studies in a controlled environment (thereby reducing variability). We routinely attend sponsors’ meetings with the FDA for pre-IND discussions re: study designs and new approaches. This is unique in the respiratory space.
CDO: We are very open to new methods and cutting-edge science. Our CRO has, on staff, a team of Research Scientists who routinely assist with the development of novel technologies. We have validated highly-technical techniques such as acoustic rhinometry (nasal ultrasound), nasal ciliary motility, impression cytology, sputum collection, and many other novel techniques. At Cliantha, we are technologically agile and have integrated new technologies and even developed in-house technologies to improve clinical trial outcomes. For example, we developed an electronic tablet system for collecting sign and symptoms of allergy in real time in our specialized facilities as well as at-home and are able to apply geo-fencing technology to ensure good pollen exposure. This system can be customized easily and validated quickly.
CDO: As stated above, we have the technical resources in house to evaluate and implement these technologies quickly and efficiently. In addition, our network of KOL’s and research scientists are readily available to us to consultation and scientific advisement. In order to make these technologies work for both our patients and our sponsors, we also develop training tools to ensure that there i standardization of all data collected. These have included video training modules (so that patients can understand better how to interpret questions and answer accordingly). For example, in perennial allergy, patients may have had chronic allergy symptoms for many years, such as nasal congestion, and they do not have a frame of reference. This leads to accommodation of symptoms -- they do not remember what life is like without nasal congestion. For this reason, training and framing their responses into context is vitally important to good outcomes.
CDO: As a mid-size, full-service CRO, we are able to track each project closely and adjust our support quickly to address study-specific issues that may arise. The management at Cliantha are very involved with each study from inception to close-out. We can expedite data flow from the clinic to regulatory-ready submission. We also offer “fast-to-file” services. In the generics industry, we can apply these to first-to-file services to give our clients opportunity for market exclusivity. This is only possible through our global integration such that our teams can literally work around the clock on one project to completion.
CDO: CTIP will offer us insights into current sponsor needs and gaps/challenges that they are facing with respect to CRO service providers. This conference will also allow for Cliantha Research to have a broader reach/better exposure across North American pharma and biotech industries.
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.