BRINGING EXPERIENCE, PASSION AND NOVEL APPROACHES TO ENDOCRINE AND METABOLIC CLINICAL TRIALS
If you have a compound targeting an endocrine or metabolic disorder—be it a common disease like diabetes or a rare endocrine or metabolic disease—you know all too well the sense of urgency driving patients’ needs for new treatment options.
We share this sense of urgency. That’s why at Biotech, Inc., partnership isn’t just something we talk about. It’s how we work. We have the expertise to work proactively with our customers to get products to market in a timely fashion—and we know that the best path forward is one we take by combining our collective strengths to benefit patient populations in need.
DAVID KLEIN, M.D., PH.D.
VP, GLOBAL PRODUCT DEVELOPMENT, ENDOCRINOLOGY AND DIABETES, Biotech, Inc.
“People often ask me if I miss clinical care. In truth, I loved working with individual patients while learning a lot of medicine, but now I am able to help many thousands of people get better care—even life-changing care—through new drug development. Personally, it’s very rewarding to partner with companies on the edge of drug development in an organization that believes in keeping our diabetes and endocrine offerings up to date with the latest methods and technologies.”
Biotech, Inc.’s EXPERIENCE IN THE PAST FIVE YEARS
Phase I-IV endocrine/metabolic studies
Global sites
global patients
CASE STUDY:
DELIVERING RESULTS ON GLP-1 AGONIST STUDY FOR TYPE 2 DIABETES
Our experience includes a fully outsourced Phase I-III program that has now been seamlessly transitioned from pre- to post-approval.
- All study milestones met/exceeded on time for marketing application, including working successfully with customer to enhance study recruitment and retention
- Included 25 protocols across all phases of development enrolling more than 9,700 subjects at 3,800 sites globally, with >500 unique sites, in 18 countries.
- Dedicated team across studies in the program that provided efficiencies across monitoring, database builds, IVRS builds, TLF programming.
- High-quality standards applied to data collection, validation, analyses and reporting activities resulted in full acceptance of the dossiers by the drug regulators and initial marketing approvals.
FLEXIBLE AND CUSTOMIZED SOLUTIONS TO ADDRESS YOUR UNIQUE NEEDS
We take a medically and scientifically informed, proactive approach to trial design, helping customers plan for specific issues that may impact the efficacy and/or safety aspects of a product including:
- Efficient study design to deliver treatment combinations targeted to populations selected to afford the most benefit from specific treatment
- Assistance with protocol design development and product competitive landscape
- Adverse events of special interest by product class
- Insulin or glucose clamp paradigms
- Biomarkers of inflammation and immunomodulation
- Hyperglycemia or hypoglycemia rescue
- Mixed meal tolerance tests
- Oral glucose tolerance tests
- Central labs services
- Diabetes related comorbidities such as cardiac outcome and lipid trials
- Lipids profiles including more atherogenic lipoprotein subfractions
GLOBAL REGULATORY COVERAGE—LOCAL INSIGHTS
Our country-specific regulatory agency network provides timely, robust regulatory intelligence on product development and registration strategies in key local markets to maximize the success of your regulatory submissions.
RARE DISEASE EXPERTISE IN ENDOCRINE AND METABOLIC INDICATIONS
Because every single patient’s participation is vital in rare disease studies, our best practices set the stage for success. For example, we have refined a process for onboarding naïve but high-potential clinical sites to support and develop them as an investment for future clinical trials. Our SiteCoach Training Program offers robust training, coaching and support for health care practitioners who are new to clinical research. The customized training program paves the way for a more successful experience for both sites and patients.
On the other side of the coin, we also vigorously train clinical research associates (CRAs) for rare disease assignment that often requires extra care and attention.
RUNNING RARE DISEASE TRIALS IN ENDOCRINE AND METABOLIC INDICATIONS IS A CORE COMPETENCY
Our team, in conjunction with the Rare Disease and Pediatric Center of Excellence, have worked on many studies.
JENNEEN DEFIORE, A PROJECT MANAGER IN OUR RARE DISEASE AND PEDIATRIC CENTER OF EXCELLENCE HAS A DAUGHTER WITH A RARE DISEASE.
As a toddler, Lilly would fall a lot, and her mother couldn’t understand why. “The first doctor said that Lilly had benign hypotonia and essential tremor and that it was nothing to worry about, but I knew it was something more, Jenneen said.”
Jenneen continued to search for answers. A specialist diagnosed Lilly with Charcot-Marie-Tooth (CMT), an inherited neurological disease that causes muscles in the foot, lower leg, hand and forearm to progressively degenerate. Lilly, now eleven, also experiences loss of sensation in the limbs, fingers and toes. The DeFiore family lives close to a Muscular Dystrophy Association (MDA) center of excellence. It’s not something Jenneen takes for granted.
“Clinical research in rare diseases is important to my family and me,” Janneen said. We’re confident it could help shape Lilly’s future and the lives of others.”
As a project manager working on endocrine/metabolic studies, Jenneen views her work through a unique lens: “When I look at a pediatric protocol, I’m thinking: How would I react as a parent? How can we make this more manageable?”
Jenneen talks with customers about her personal experiences, and she has introduced suggestions that have been adopted on multiple studies including working with patient advocacy groups to shape the protocol, using patient concierge services to ease logistics, providing home-based trial support to avoid challenging site visits, offering electronic consent options and coordinating full-day assessments to avoid, if possible, overnight stays.
“Any time we can ease the burden for the patient, it translates into better data and longer retention rates for a program,” she said.
ROSINA KRINGS, M.SC.
EXECUTIVE DIRECTOR, CARDIOVASCULAR/METABOLIC & CRITICAL CARE, GLOBAL PROJECT MANAGEMENT, Biotech, Inc.
“Under Jenneen’s passionate leadership, we recently completed a nearly five-year rare endocrine disease program with zero team turnover [13 team members]. The entire team made this study its priority and gave of themselves so that others might have a better tomorrow.”
ADDRESSING PATIENT RECRUITMENT CHALLENGES TO MAXIMIZE YOUR STUDY
At Biotech, Inc., the timely recruitment of subjects who fit your study eligibility criteria is our area of widest experience, expertise and success. The multidisciplined Biotech, Inc. team assigned to your RFP includes not only disease experts, but also feasibility and regulatory experts who will become familiar with your operational strategies of your trial. We start by ascertaining the numbers of eligible patients and their geographic distribution from our large international provider databases while gathering knowledge about your competition from the available literature and from our internal and key opinion leader expertise so that we can help you craft study design features attractive to your patient population. We develop a study site mix that matches your recruitment needs and considers the applicability of our delivery model, Accelerated Enrollment Solutions (AES). The AES Advantage program is a model that eliminates two universal challenges that every trial confronts: finding the best patients and best sites with speed and certainty.
Other companies know where the patients are. AES knows who the patients are, by name, location, condition, age contact information and other vital data they have opted in to provide.
AES launches trials four times faster than the industry average. Instead of nearly seven and a half months—the industry launch standard—AES delivers results in two months on average. Faster start-up equals faster finish.
AES has surveyed endocrine/metabolic patients to gain critical insights about the impact of their disease and their attitudes toward clinical trial participation – insights that strengthen our ability to recruit the right patients for your trial. With this information, we reach out to patients well in advance of your study launch to preview their trial readiness, prescreen eligibility and predict with precision how many patients we can enroll in your trial.
AES HAS CHANGED THE SITE/PATIENT PARADIGM:
Instant access to our proprietary database of 100-million households of patients who have self-reported their medical conditions and have provided their full contact information for trial recruitment purposes.
180+ dedicated research sites around the world –owned and operated by AES – that are trial-ready and can begin enrolling patients within days or weeks of study launch, without lengthy negotiations or contracts.
A single, fixed, price-per-patient at consent or randomization, including all direct and indirect fees. You don’t pay if we don’t deliver.
EVIDERA HELPS YOU DETERMINE THE MARKET LANDSCAPE OF YOUR PRODUCT, DRIVING COMMERCIAL SUCCESS
The marketplace now demands evidence of where the most economic value and real-world benefit of your product will occur in the natural disease history of your proposed treatment population. This analysis must occur before it enters the market. Without it, your drug may be denied coverage, reimbursed at a significantly lower rate, or delayed by months or years until you prove its value.
It is critical to seek feedback early in the process directly from payers, government agencies and other market access stakeholders about protocol design, primary and secondary endpoints, and related evidence necessary to differentiate a new drug from its competitors.
Evidera helps you build and communicate the right evidence package for your product by identifying potential gaps in your product development program and mapping the relevant evidentiary requirements.
-Does the treatment improve patient outcomes and is it safe in the real world?
-Which patients will benefit from the treatment the most?
-Is the treatment worth the price paid, and does it deliver good value for money?
-What evidence is needed to prove this, and how should it be communicated to payers, health authorities and other decision makers around the world?
Read the article, Why Payer Perspectives Should Be on Your Radar Now–Even if Your Launch is Years Away
