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Regulatory Affairs Support for Success

Arciel's Colleagues*


Grace Furman

Grace M. Furman, PhD, DABT

Nonclinical Toxicology Expert

Paracelsus, Inc

As CEO/President of Paracelsus, Inc., Grace provides professional toxicology services to the pharmaceutical industry as an independent consultant. She made the decision to become independent in mid 2006, at which time she was Senior Director of Regulatory Safety Assessment in Pfizer’s Drug Safety Research and Development department. Paracelsus commenced conducting business as a corporate entity in January 2007. Grace’s area of professional expertise relates to regulatory toxicology as applied to development of novel small molecule therapeutics.

Fred R. Kohn, PhD

Nonclinical Pharm/PK Expert

Kohn Consulting, Inc

Fred has 25+ years of experience in the biotechnology and pharmaceutical industry designing and directing preclinical programs for product development (small molecules, proteins, peptides, monoclonal antibodies, drug delivery systems, cell-based therapies). Additional experience includes writing of US and international regulatory documents and interaction with regulatory agencies, research collaborations with academic laboratories, analytical methods development and setup of QA/QC/documentation systems, clinical trial design, monitoring of preclinical and analytical studies at contract facilities, and project management. Knowledge of GLP regulations. Biomedical areas of experience include diabetes, autoimmune diseases, inflammation, infectious diseases, pain management and cancer. Excellent written and oral communication skills.

Mark Staples

Mark A. Staples, PhD

CMC Expert

Cusp Pharmatech Consulting, LLC

Cusp PharmaTech Consulting LLC (CUSP) was founded in 2007 and is based in Cambridge, MA. Mark has worked in drug development for over 25 years and has broad-based experience with technical operations concerning development of drugs, biologics, and combination products. The CUSP name and logo reference the radical transformation of the pharmaceutical industry due to the advent of biotechnology. CUSP enables the efficient translation of a promising drug from the discovery laboratory to the marketplace.

Neil Edwards

European Regulatory Affairs Expert

Sirius Regulatory Consulting Ltd

Niel is Managing Director at Sirius Regulatory Consulting, a progressive Regulatory Affairs and Drug Development Consultancy supporting the global pharmaceutical industry to achieve product development and regulatory approval in Europe.

ProPharma Services Corp

Nonclinical Pharm/PK Experts

ProPharma Services Corp

ProPharma Services supports and partners with small to mid-sized biotechnology and pharmaceutical companies. Our expertise can assist in preclinical as well as clinical stages of drug development. We have broad experience in both small and large molecule drugs.

Brad Fox, BSME, MSML

FDA Regulatory Expert, Medical Devices

Brad Fox

Brad has over 30 years of experience in the development, testing and Regulatory process with medical devices. His background includes multiple small business start-ups; completing strategic technology planning and evaluations as well as over 20+ years of direct FDA and CE process. Brad works as a liaison between the client and the FDA and has expertise in the preparation of medical device submissions including Request for Designations, Q-submissions, pre-IDE, IDE and De Novo. He also has special expertise in Combination Products, Companion Diagnostics and 3D Printing of medical devices.

Christine Smith

Christine M.N. Smith, Ph.D.

Pharmaceutical Development (CMC) Expert

Pharmalytical Consulting LLC

Christine provides professional expertise on CMC from the pre-clinical stage through commercialization. She has had hands-on experience in the areas of API, formulation, process, analytical methods, regulatory strategy, quality, and technical writing, working with peptides, small-molecules, parenterals, orals, non-conventional formulations, and drug-device combination products. Prior to consulting, Christine served as Executive Director, Product Development at Amylin Pharmaceuticals where she led the CMC department.

David Essayan

ONCORD, Inc.

Clinical Development and Regulatory Affairs

ONCORD, Inc.

Susan Jerian, MD and David Essayan, MD are co-principal consultants at ONCORD, Inc., a consulting firm providing clinical development and regulatory affairs expertise. They have worked with numerous pharmaceutical and biotechnology companies and academic researchers in North America, Europe, Australia and Asia. They specialize in challenging and complex development programs. Susan and David have a proven track record of bringing products through the development process, including pre-IND, IND and NDA/BLA/MAA approval.

Forsythe and Bear, LLC

Forsythe and Bear, LLC

Statistical Consulting

mbear.fbllc@gmail.com

Forsythe and Bear, LLC provides statistical consulting for the BioPharma Industry specializing in the design, analysis, and interpretation of clinical trials. Both Dr. Forsythe and Ms. Bear bring numerous years of clinical development experience including early, late phase, and post-marketing development.

Jeffrey Clarkson

Jeffrey L. Clarkson, JD, LLM

Attorney

jlclarkson@me.com

Jeff is a corporate transactional attorney with 30+ years of experience working for large and small law firms, Fortune 500 companies and the Federal Government.

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Aaron Roberts

Web Design & IT Services

Sigilware LLC

Aaron founded Sigilware, LLC to help small businesses create a modern web presence. He's worked as a software developer for more than 20 years focusing on clean, engaging web sites.

Kevin Rotenberry

Kevin B. Rotenberry, CPA

Certified Public Accountant

Padgett Business Services of Palm Springs

Kevin is a CPA with over 28 years of experience. He helps Individuals and Small Businesses pay the least amount of tax legally possible, and providing peace of mind that their returns are prepared accurately.

* The colleagues listed here are available under separate contract directly with the consultant.