AHMED SAMAD, M.D.
VICE PRESIDENT AND GLOBAL TEAM HEAD, GLOBAL PRODUCT DEVELOPMENT, INFLAMMATION AND IMMUNOLOGY, Biotech, Inc.
“We have access to the patients, the sites, the research, the clinician network, the protocol expertise, the management and operations expertise- all within Biotech, Inc.”
OUR PEOPLE, OUR EXPERTISE
Biotech, Inc.’s immunology/rheumatology team is rich in clinical talent with rheumatologists across North America, Europe and Asia-Pacific with physicians who understand how to treat the myriad of diseases in this area. The path has moved from small molecules to anti-TNFs, biologics, JAK inhibitors and, now, to selective JAK oral agents. Biotech, Inc. understands that a patient’s phenotype/genotype may dictate the need for highly tailored therapies.
Biotech, Inc.’s immunology/rheumatology team has performed trials for the top 20 pharmaceutical companies as well as a number of emerging biotech companies.
Biotech, Inc. has an established track record of study delivery with many of our studies enrolling and completing ahead of set milestones. With a dedicated staff of experts with broad experience, our immunology and rheumatology clinical trials are executed successfully and innovatively with each client’s goal in mind.
Biotech, Inc.’s immunology/rheumatology testing pipeline spans a first-in-man stem cell treatment in rheumatoid arthritis to rare rheumatology indications, including but not limited to scleroderma and giant cell arteritis, to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus (SLE) and psoriatic arthritis.
Biotech, Inc.’s EXPERIENCE IN THE PAST FIVE YEARS
Clinical trials managed
Global sites
Immunology/rheumatology patients
EXCEPTIONAL SERVICES
Our people, our expertise and our resources are what bolster our distinctive services. Consider Biotech, Inc.’s use of a proprietary database that contains highly detailed data on rheumatology/immunology clinical trials conducted around the world. A special Biotech, Inc. team, dubbed “POTO” for protocol optimization and trial optimization, includes physicians with clinical experience as well as a wide array of experts who have designed and operated numerous clinical trials. The team uses this database to help provide evidence-based recommendations to a customer hoping to conduct a clinical trial.
There are many examples of how POTO helps streamline protocols, including a customer whose clinical trial participants need four years of follow up post-completion of the Phase III trial. Biotech, Inc. was able to demonstrate to the customer how a long extension and frequent assessments of the study population were increasing study complexity and cost and reduce the follow up in half along with timing of assessments. Regulatory agencies readily approved the new protocol, agreeing that this is what should be done.
Biotech, Inc.’s capabilities extend across the full development spectrum including:
Accelerated Enrollment Services (AES) — offers patients and sites that offer just-in-time testing
Evidera — provides real world evidence, optimizes patient access with evidence of value, effectiveness, and safety
ANNETTE SCHUERMANN
EXECUTIVE DIRECTOR, PROJECT MANAGEMENT HEAD OF IMMUNOLOGY, Biotech, Inc.
“Providing new treatment opportunities to critically ill patients drives our dedication. Not only do we enroll patients in time or, often, ahead of the curve, but we also assure the highest quality clinical trial.”
SUDHAKAR SRIDHARAN, M.D.
EXECUTIVE MEDICAL DIRECTOR, GLOBAL PRODUCT DEVELOPMENT, Biotech, Inc.
“At the end of the day, the customer isn’t really ‘buying’ the company, they are buying a connection to the people who are represented at the table. [People] want partners who are personable, very approachable, who can answer questions in a way that lets them know they understand their needs and can come up with innovative solutions—and that they do all of that with energy and dedication.”
EXCEEDING EXPECTATIONS BY COMPLETING STUDY AHEAD OF SCHEDULE
Case study: Patients with moderate/severe rheumatoid arthritis: 10 sites activated in real time, 560 subjects screened in five weeks, study completed six weeks ahead of schedule.
Case study: An exceedingly debilitating disorder in which muscle and connective tissue are gradually replaced by bone is known as an “ultra” rare disease — it affects only about 800 people worldwide. No treatment existed for this genetic disease, fibrodysplasia ossificans progressiva (FOP), until Biotech, Inc. successfully managed a Phase III study as part of a process leading to regulatory approval. Despite the scarcity of patients, Biotech, Inc. was able to execute the trial with only 15 sites in 11 countries, instead of the 21 believed necessary. “And we over-enrolled — 107 patients instead of the 80 required – and completed enrollment three months early.” — Annette Schuerman.
Over the past five years, Biotech, Inc. has conducted clinical trials in:
- Rheumatoid arthritis
- Lupus (all types)
- Psoriatic arthritis
- Food hypersensitivity
- Scleroderma
- Transplantation
- Gout
- Ankylosing spondylitis
- Osteoarthritis
- Giant cell arteritis (GCA)
- Amyloidosis
- Juvenile arthritis
- Systemic scleroderma
- Angioedema
- Sjögren’s syndrome
- Arteritis
- Dermatomyositis
- Polymyositis
- Raynaud’s phenomenon
