THERAPEUTIC AREAS OF PRECLINICAL AND CLINICAL RESEARCH

Cardiology

Move your cardiology compound from preclinical to early clinical efficiently, with a CRO that has worked on 30 different cardiology compounds across more than 70 studies. We can quickly de-risk your molecule with preclinical cardiovascular studies and with early cardiac safety assessment in early clinical studies.

Our preclinical and clinical experience spans a wide range of cardiology indications, including arrhythmias, hypertension, dyslipidemias, and congestive heart failure. Preclinical programs can be conducted across different species with robust safety pharmacology cardiovascular studies. Our preclinical facility has a specially designed room for ECG monitoring by telemetry. Our clinics are equipped with telemetry and staffed by a trained cardiac team.

Dermatology

Working with a dermatology expert from preclinical to proof of concept can help to speed up your development program. As one of our therapeutic specialties, Altasciences conducts specific safety assessments for locally acting dermatology therapies and proof of concept in locally or centrally acting therapies, including both small and large molecules.

We assess toxicology of topical therapies, including edema/erythema measurement and Draize scoring, using mini pigs or NHPs. In the clinic, we collaborate closely with our consulting dermatologists who perform specialized assessments, such as biopsies or scoring lesion severity. If your locally acting product requires irritation and sensitization studies, our dedicated clinic areas can offer different climates, and can enroll up to 200 participants in one day.

Consult our Topical Clinical Trials Fact Sheet and our Nonclinical Dermal Safety Assessment Fact Sheet.

Gastroenterology

We offer extensive preclinical and clinical expertise in the gastrointestinal therapeutic area, with over 100 Phase I/II PK or PD studies involving drugs acting systemically or locally in the GI tract. This includes general toxicology studies in a number of different species, as well as examining preclinical colitis and proctitis models. Our clinical pharmacology capabilities cover all study types, supported by a gastroenterologist Principal Investigator with experience in over 1,000 clinical studies.

Safety or efficacy monitoring is done via endoscopy, colonoscopy, intragastric pH monitoring, and X-ray imaging with barium. Additionally, we have experience with barostat model of colon pain and with PK sampling from ileostomy pouch.

Case Studies

• A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy
• An Interaction Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy
• A Study to Evaluate Safety, Tolerability and Pharmacokinetics of trimebutine 3-Thiocarbamoylbenzenesulfonate (GIC-1001) in a Randomized Phase I Integrated Design Study: Single and Multiple Ascending Doses and Effect of Food in Healthy Volunteers
• A Phase Ib Clinical Study on the Analgesic Effect of NCE on Visceral Pain under Rectal Distension and Rectal Sensory Threshold using the Barostat Method in Male and Female Healthy Volunteers

Consult our Gastroenterology Trials Fact Sheet

Hematology

Support your early phase hematology program by partnering with a CRO that has relevant nonclinical and clinical expertise, aided by efficacy measures using flow cytometry or coagulation measures, including thromboelastography (TEG) and bioanalytical methods for a number of biomarkers.

Both our preclinical and clinical facilities perform flow cytometry, including when methods require samples to be analyzed within four hours of collection. We investigate coagulation directly or look for changes in different components of the coagulation cascade. If the focus is on the immune system, we have validated methods for a number of steps in the complement pathway.

Immunology

Support the development of your immunology compound by working with a CRO that has the relevant therapeutic area expertise — and the flexible, collaborative approach — you need. With over 250,000 square feet of analytical laboratories spanning both our preclinical and clinical sites, Altasciences’ experience in analyzing immune endpoints is best positioned to meet your molecule’s development needs. Our biomarker panels, including the complement pathway and flow cytometry assessments, will allow you to seamlessly translate your preclinical findings to the clinical phase. Whether small or large molecules, we have the experience in conducting many types of programs, with scientific and technical expertise in the preclinical setting, and clinics that are set up and staffed with expert teams to ensure the safety in first-in-human studies for immune modulators.

Vaccines

With a comprehensive understanding of FDA regulations and requirements for vaccine approval, and access to a large database of participants, we are uniquely positioned to streamline the clinical development of new vaccines and delivery systems. We have conducted vaccine trials for the following conditions:

• Seasonal influenza
• Pandemic influenza
• Norovirus
• Hepatitis B
• HPV
• HSV

In-house vaccine development supported by:

• CAP-accredited and CLIA-certified (accreditations in Los Angeles only) reference laboratories with the following features relevant to vaccine testing:
  • Respiratory panel testing through the multiplex PCR BIOFIRE® FILMARRAY® system to evaluate the presence of an infection in the respiratory tract of immuno-compromised patients
  • Ability to isolate peripheral blood mononuclear cells (PBMCs) through multiple collection methods
  • Biosafety Level 2 (BSL-2) laboratories with limited badge access, biosafety cabinets, biohazard-trained staff, cleaning protocols, and all required containment procedures
  • Long-term sample storage
• Dedicated large molecule bioanalytical laboratory with capabilities and state of the art equipment for flow cytometry, cell-based functional assays, immunogenticity expertise, etc. to support all clinical activities.

Infectious Diseases 

Maximize the efficiency of your infectious disease program by leveraging our significant preclinical, clinical, and bioanalytical therapeutic area expertise. We support the streamlined development of new vaccines, anti-viral therapies, delivery systems, and antimicrobial agents with our integrated, multi-disciplinary services. Partner with a leader that has a proven track record in infectious diseases and vaccine development.

Our preclinical site has the advantage of BSL-2 designation because of its NHP population. Our experts in infectious disease have conducted more than 220 clinical studies for acute or chronic infections, performed in healthy participants and patient populations.

Indications include:

• Bacterial infection
• Common cold
• MERS
• HBV
• HCV
• HIV
• RSV
• Complicated skin infections
• Fungal infections
• Herpes zoster
• Influenza

We have performed clinical immune monitoring to establish proof-of-concept in diseases such as hepatitis C and influenza. Our experience in healthy participants includes antivirals, antifungals, antibiotics, and antiparasitics.

Infectious Diseases Case Studies

• A Phase Ib Study Evaluating GS-7340 in Treatment-Naive Adults with Chronic Hepatitis B (CHB) Infection
• A Phase Ib Study Evaluating GS-9620 in Virologically Suppressed Subjects with Chronic Hepatitis B Virus Infection
• A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging, Adaptive Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS 9620 in Treatment-Naive Subjects with Chronic Hepatitis B Virus Infection
• A Single and Multiple Dose Study of MK-3682 (IDX21437) in Healthy and Hepatitis C Virus (HCV)-Infected participants (MK-3682-001)

Consult our Hepatitis Trials Fact Sheet
Consult our Infectious Diseases Trials Fact Sheet

Metabolism and Endocrinology

Beyond the standard clinical chemistry and lipid panels to assess disorders in this therapeutic specialty, our preclinical services include specialized assays such as A1C, and specialized tests such as glucose tolerance to further evaluate molecules in this area. In the clinic, we have conducted over 75 early stage trials involving antidiabetic and hypoglycemic agents in patients who are diabetic (Type I and II), obese, or have metabolic syndrome or NASH. These include a large number of proof-of-concept studies investigating different measures of glucose tolerance, including clamping studies using state-of-the-art YSI-2900 that can analyze multiple glucose samples per run.

Consult our Dyslipidemia Trials Fact Sheet
Consult our Metabolic Disorders Trials Fact Sheet
Consult our issue of The Altascientist on Metabolic Disorders

Read the results of a Phase I study conducted by Altasciences combining obesity medications with different mechanisms of actions to provide more efficient treatment options for weight management. 

Neurology

Neurology is one of the key therapeutic areas of research conducted at Altasciences. Recognized globally as a CNS Center of Excellence, our scientific team has completed more than 200 preclinical and clinical neurology studies, in addition to providing formulation, manufacturing, and analytical testing services, as well as bioanalytical support. Whether large or small molecule, we can help move your compound through early development seamlessly and efficiently, from prototype formulation through commercialization.

Discover how working with a single partner for your end-to-end CNS drug development program can lead up to 40% in time savings.

Oncology

Our preclinical oncology expertise can move your compound into patients, and we have clinical expertise with a number of non-cytotoxic oncology compounds. Drawing on a broad range of preclinical experience in oncology, we are accustomed to fast-tracking development so that you can proceed to patient studies as rapidly as possible. Our experience in oncology extends to the clinic, with experience testing nine different tyrosine kinase inhibitors in healthy participants.

Ophthalmology

As a leading partner in ocular therapy, our integrated CRO/CDMO solutions can support your ophthalmic drug development program from lead candidate selection to market. You will benefit from working with a single partner as your compound advances through each phase of drug development—from prototype formulation through preclinical testing, to early phase clinical trials, and manufacturing.

Discover our end-to-end ophthalmic drug development solutions that can lead up to 40% in time savings.

Orthopedics

Altasciences brings your orthopedics and musculoskeletal molecule through preclinical to proof of concept. Our experience with proof-of-concept studies in healthy participants and patient populations, such as those with osteoarthritis, includes models such as the 6-minute walk test or stair challenge, and imaging using X-ray, MRI, CT, or DEXA at our preclinical and clinical sites. Finally, our panels include a number of inflammatory biomarkers.

Consult our Pain Models Fact Sheet

Psychiatry

Altasciences has therapeutic specialty expertise in psychiatric research, conducting studies from preclinical to clinical proof of concept in patients. Our preclinical expertise covers the complete range of general toxicology and safety pharmacology studies, and includes 24-hour video monitoring and performing functional observation battery tests to assess behavioral changes.

Our clinical expertise is augmented by two Principal Investigators who are psychiatrists, and our experience covers substance abuse, epilepsy, anxiety disorder, panic disorder, depression, ADHD, and sleep disorders. As your clinical development proceeds, we can conduct the human abuse potential testing and driving simulator studies that will likely be required, two areas where we have extensive expertise.

Consult our Central Nervous System Trials Fact Sheet

Respirology

You can count on an efficient development of your compound to treat respiratory/pulmonary disorders, leveraging our preclinical and clinical experience with investigating both systemic and locally acting therapies. Our clinics have units with specialized air handling systems that quickly exchange air to minimize cross-contamination between dosed participants. Our staff consistently trains patients on using different pulmonary devices to ensure consistent dosing. We are adept at pulmonary function testing, and have pulmonologists and respiratory technicians on site to assist in study design or with assessments.

Consult our Pulmonary Trials Fact Sheet

Rheumatology

Altasciences can help support you in the development of your rheumatology compound, delivering the preclinical, clinical, and bioanalytical expertise and experience you need. We have extensive preclinical and clinical experience testing immune modulators backed up by a battery of biomarkers, including components of the complement pathway and cytokines.

Substance Abuse

Altasciences offers leading preclinical and clinical sites for substance use disorders, one of our key therapeutic areas of clinical trials, including expertise across a wide variety of mechanisms of action. Our experience in general toxicology, safety pharmacology, and clinical pharmacology covers a wide range of compounds, including oral, IM, IV, and implanted products. We also analyze a number of biomarkers and efficacy outcomes using visual analogue scales (VAS) and questionnaires.

Our robust database of patients combined with our upscale facilities enable us to deliver rapid enrolment and excellent retention rates. Our sites have controlled substance licenses, including a DEA Schedule I license to conduct research with tetrahydrocannabinol and cannabidiol in Kansas City. Cannabis study start times at our Montreal site have been positively impacted by the legalization of cannabis in Canada.

Urology

Leverage our preclinical and clinical expertise to help you tackle the development needs of your urology compound. Having conducted almost 30 studies, we are skilled in general toxicology, safety pharmacology, and clinical pharmacology of a wide range of compounds. Our experience covers treatments for urinary incontinence, erectile dysfunction, benign prostate hyperplasia, and prostate cancer. We can also analyze a number of different biomarkers. With our extensive patient database and outreach, we can help you establish proof of concept by recruiting patients across a range of urological conditions.

Women’s Health Clinical Trials

With extensive expertise, experience, and a multitude of solutions for sponsors developing therapeutic products and diagnostics in the area of women’s health, Altasciences is ideally positioned to attain your drug development goals.

Altasciences has conducted preclinical and clinical studies with products for breast cancer, oral contraception, fertility treatment, hot flashes, and hypoactive sexual disorder. Our experience includes a wide range of compounds delivered orally, vaginally, or by implant, and we have validated methods for the majority of marketed contraceptives, fertility treatments, and hormone replacement therapies.

Consult our women’s health fact sheet for more information on the specific therapeutic areas we have experience in.

Our clinical pharmacology units are located in densely populated areas, allowing access to a wide variety of ages, ethnicities, lifestyles, and health conditions. We have a diverse participant database of over 100,000 healthy pre- and postmenopausal women who are actively interested in participating in our clinical trials, as well as access to a number of patient populations through our own database and partnerships with local fertility clinics. This enables us to tailor your study and obtain the data you need to move your project forward.

We work closely with a network of local gynecologists for specialized exams and biopsies, and offer imaging service like transvaginal ultrasounds and DEXA.

Some of the study types we offer include:

• Alcohol interaction
• Comparative BA/BE
• Drug-drug interaction
• Driving impairment
• Proof of concept, efficacy
• Transdermal adhesion/HRIPT
• FIH (SAD/MAD)
• Food effect
• Genotyping PK
• Renal impairment
• Safety, PK, tolerability

In addition, Altasciences’ large and small molecule bioanalytical expertise and comprehensive research support services ensure an integrated, efficient, and holistic solution for your women’s health studies.