AXIS is supporting clinical research for NDA, 505(b)(2)

1. Pharmacology Enabling Clinical Projects
2. Ophthalmology, Oncology, Dermatology & Others
3. Encompassing full-service CRO support

Phase 1 Early Stage Capabilities:

• First in Human/Proof-of-concept
• Pharmacokinetic/Pharmacodynamics
• Single Ascending Dose (SAD)
• Multiple Ascending Dose (MAD)
• Drug-Drug Interaction (DDI)
• Food Effect (FE)
• Gender and Age Effect
• Renal Impaired Studies
• Hepatic Impaired Studies
• Cardiac Safety Studies

US Patient Trials Therapeutic Areas:

Ophthalmology

Glaucoma, Cataracts, Contact Lens, Cornea, Refractive Indications, Retinal conditions, POC, AMRD, RP, Uveitis

Oncology

Breast cancer, Solid tumors, Hematological malignancies, PTCL

Dermatology

Acne, Actinic keratosis, Age spots, Atopic dermatitis, Bullous pemphigoid, Canker store, Chronic hives, Contact dermatitis, Cutaneous lupus, Dermatitis, Dermatomyositis, Genetic skin disorders, Graft-versus-host disease, Hair loss, Hemangioma, Hyperhidrosis, Keloid scar, Moles, Psoriasis, Rosacea, Spider veins, Sun allergy, Vasculitis, Vitiligo, Wrinkles

Our Therapeutics Experts:

Dr. Sai Chavala (Ophthalmology)

Dr. Chavala is a clinician-surgeon-scientist, dedicated to innovation and development of novel treatments that improve the quality of life of patients. After obtaining his MD, he completed residency/fellowship at Weill Medical College of Cornell University and Duke University. His research has been funded by NIH. He is a Professor of Surgery at TCU/UNTHSC School of Medicine in Fort Worth.

Indications:

Glaucoma, Cataracts, Contact Lens, Cornea, Refractive Indications, POC, ARMD, RP, Uveitis

 

Dr. Michael J. Blankinship (Dermatology)

Board-certified dermatologist, Dr. Blankinship provides comprehensive care to patients with various types of skin conditions and diseases. He lives in Fargo with his wife, Sunny and their three children. He and his family enjoy traveling and spending time at their lake cabin. He is originally from the Upper Peninsula of Michigan and enjoys hunting and fishing. He was a Big Ten bass fishing champion in 1999.

Indications:

Acne, Actinic keratosis, Age spots, Atopic dermatitis, Bullous pemphigoid, Canker sore, Chronic hives, Contact dermatitis, Cutaneous lupus, Dermatitis, Dermatomyositis, Genetic skin disorders, Graft-versus-host disease, Hair loss, Hemangioma, Hyperhidrosis, Keloid scar, Moles, Psoriasis, Rosacea, Spider veins, Sun allergy, Vasculitis, Vitiligo, Wrinkles

 

Dr. Erard M. Gilles (Oncology)

20 years’ experience in the pharmaceutical industry covering: R&D experience in large and small companies, creation and development of Invivis Pharmaceuticals Inc., Medical Affairs and Marketing

Indications:

Breast Cancer, Solid Tumors, Hematological Malignancies, PTCL

 

For further information, please feel free to contact John Pottier, Senior Vice President Business Development 913-314-6755 j.pottier@axisclinicals.com

AXIS Clinicals US Patient trials Expansion: Ophthalmology, Dermatology, Oncology

AXIS Clinicals, a CRO offering clinical pharmacology services addressing needs of the evolving clinical research industry, and our clients, AXIS Clinicals has established as an extension of our organization the following therapeutic experts to advance our services bringing targeted patients into trials earlier within the drug development process.

In addition to performing First-in-Human, Single Ascending Dose/Multiple Ascending dose pharmacology projects, AXIS can offer patient overnight confinement at our Minnesota CPU to support Phase Ia/2b studies. Sequentially we offer multi-center Phase 2/3 trials within oncology, ophthalmology, and dermatology drug development announcing the appointments of:

 

Dr. Sai Chavala (Ophthalmology)

Dr. Chavala is a clinician-surgeon-scientist, dedicated to innovation and development of novel treatments that improve the quality of life of patients. After obtaining his MD, he completed residency/fellowship at Weill Medical College of Cornell University and Duke University. His research has been funded by NIH. He is a Professor of Surgery at TCU/UNTHSC School of Medicine in Fort Worth.

Indications:

Glaucoma, Cataracts, Contact Lens, Cornea, Refractive Indications, POC, ARMD, RP, Uveitis

 

Dr. Michael J. Blankinship (Dermatology)

Board-certified dermatologist, Dr. Blankinship provides comprehensive care to patients with various types of skin conditions and diseases. He lives in Fargo with his wife, Sunny and their three children. He and his family enjoy traveling and spending time at their lake cabin. He is originally from the Upper Peninsula of Michigan and enjoys hunting and fishing. He was a Big Ten bass fishing champion in 1999.

Indications:

Acne, Actinic keratosis, Age spots, Atopic dermatitis, Bullous pemphigoid, Canker sore, Chronic hives, Contact dermatitis, Cutaneous lupus, Dermatitis, Dermatomyositis, Genetic skin disorders, Graft-versus-host disease, Hair loss, Hemangioma, Hyperhidrosis, Keloid scar, Moles, Psoriasis, Rosacea, Spider veins, Sun allergy, Vasculitis, Vitiligo, Wrinkles

 

Dr. Erard M. Gilles (Oncology)

20 years’ experience in the pharmaceutical industry covering: R&D experience in large and small companies, creation and development of Invivis Pharmaceuticals Inc., Medical Affairs and Marketing

Indications:

Breast Cancer, Solid Tumors, Hematological Malignancies, PTCL

 

“I am excited for the growth of our clinic to be able to support overnight confinement for patient populations. We have a strong history of performing complex healthy volunteer studies, and feel we are ideally positioned to support the research needs for Phase 1a/2b studies.”, said Dr. Pete Boldingh, the Vice President of Clinical Operations at AXIS Clinicals USA.

 

For further information, please feel free to contact John Pottier, Senior Vice President Business Development 913-314-6755 j.pottier@axisclinicals.com

AXIS Clinicals, a Clinical Research Organization, welcomes Dr. Keith Gallicano as a consultant as the Senior Advisor in Clinical & Scientific Affairs.

DILWORTH, MN, 1^st March, 2021 – AXIS Clinicals added another member as part of the consultation team with the welcoming of Dr. Keith Gallicano as the Senior Advisor in Clinical and Scientific Affairs.

Keith Gallicano, Ph.D. (Chemistry) is a consultant in clinical pharmacology and biopharmaceutics with expertise in the areas of bioequivalence, drug-drug interactions, and pharmacokinetic, pharmacodynamic and clinical endpoint trial design and data analysis/interpretation.

“As part of the AXIS consultation team, Dr. Gallicano will be assisting our teams with study design and Phase 1 trials. His extensive and diverse background in clinical research will be essential for AXIS to continue to provide excellent solutions for sponsor needs.”, said Senior Vice President of Business Development – John Pottier

Dr. Gallicano brings over 32 years of experience in the pharmaceutical industry and an exceptionally diverse background including various positions in government (Senior Research Scientist, Health Canada), academia (Assistant Professor of Medicine, University of Ottawa; Adjunct Professor of Pharmacology and Therapeutics, University of British Columbia), the pharmaceutical manufacturing industry (Head, Clinical and Regulatory Affairs, Axar Laboratories, Inc.; Director, Biopharmaceutics, Watson Laboratories, Inc.) and the CRO service industry (Chief Scientific Officer, Novum Pharmaceutical Research Services; Vice President, Research and Development, Axelson Biopharma Research, Inc.; Scientific Director, CroMedica Prime and Prime Trials).

https://axisclinicalsusa.com/14436-2/

Dilworth, MN – Clinical and bioanalytical studies supporting pharmacology projects and multi-site patient trials continue at AXIS. Various projects supporting research to address the Coronavirus pandemic and other critical research for oncology, neurology, women’s health, and other key therapeutic areas are ongoing.

We have placed critical polices for safety and sanitization protocols for staff and participants. Daily reviews are being undertaken to ensure that our facilities and overall operations continue to be a clean and safe environment for all. We believe these steps will be appropriate and allow healthy volunteer studies with in-house stays to be conducted safely as well as overseeing clinical trials given the current SARS-Cov2 outbreak restrictions.

Dilworth, MN – Axis Clinicals USA announces they have received ERT Certification. The Certification program ensures sites are proficient in collecting the highest quality ECG data. This is done by conducting Phase I QT assessments using ERT’s proprietary Expert Precision QT approach.

With Axis Clinicals being ERT certified, we are able to work with biopharmaceutical clients making recommendations on the design, conduct, analysis, and interpretation of continuous Holter recordings to assess the cardiac safety profile of a drug during various pharmacology studies. AXIS’ encompassing clinical and bioanalytical operations at our purposed built facility in Dilworth, Minnesota allows expedited results with bioanalysis samples walked to an adjacent laboratory to the clinic, ideal for First-In-Human, Single Ascending Dose/Multiple Ascending Dose and Cardiac Safety pharmacology studies conducted at any time of a drug developments’ program.

About AXIS Clinicals USA
Our Dilworth, Minnesota (Fargo, ND area) Clinical/bioanalytical operations is centrally located in the US with a proven history of enrolling large panels of compliant healthy volunteers and targeted patient populations for complex studies.

For more information
John Pottier – Vice President, Business Development
j.pottier@axisclinicals.com