Consultants Expertise

Our success lies in the experience, values and innovative thinking of our consultants. Our Senior Consultants, along with our deep network of Product Development and Regulatory Affairs consultants, stay ahead of the curve, and provide you the expertise required to negotiate Pharmaceutical, Biotech, Generic and Medical Device approvals, and also develop product development and regulatory strategies for these products. A summary of some of our senior consultants expertise is listed below.

 

Senior Consultants

Nasser Hassan, Founder and Principal Consultant:  Over 30 years' experience working in regulatory affairs, drug development and medical research.  He has extensive experience in drug development, including managment and submission of major regulatory dossiers (CTD's,/BLA's/NDA's/IND's/eCTD/s) to worldwide regulatory agencies.

 

email: info@regsourceconsulting.com

 

Ross Lobell, Prinicipal Consultant, Regulatory Affairs: Over 30 years' experience in regulatory affairs, drug development and submission management processes for NDA's and BLA's.  He has a broad experience across both small and large molecules, including gene therapy and therapeutic areas such as oncology, rheumatology, respiratory, women's health, and cardiology/lipid metabolism.

 

email: rlobell@regsourceconsulting.com

 

Dave Silberstein Ph.D., MPH, Principal Consultant, Translational Sciences: Over 29 years' experience in NIH-funded research within the Biochemistry and Immunology  industry.  He has led drug discovery projects and various R&D functions, including target discovery, genomics, lead identification, biomarker development, translational science studies in patients with respiratory and autoimmune diseases, and post-marketing scientific suppport.

 

email: dsilberstein@regsourceconsulting.com

 

Don Cilla, Pharm.D, MBA, Principal Consultant, Program and Project Management: Over 25 years' of experience in clinical development, clinical pharmacology, clinical operations and program/project management.  Significant experience with small molecules and large molecules in the endocrine, cardiology, pain, antiviral/anti-infective, pulmonary and oncology supportive-care space, in addition to regulatory interactions for submissions of NDA's, BLA's, sNDA's, ANDA's, 510(k)'s and IND's.

 

email: dcilla@regsourceconsulting.com

 

Lisa Erickson, Principal Consultant, CMC: Senior regulatory affairs professional with over 20 years experience specializing in Chemistry, Manufacturing & Controls (CMC), including Quality Systems.  She has managed complete lifecycle development (preclinical through to post-approval) of CMC data for large molecule protein therapeutic, and small molecule drug products.

 

email: lerickson@regsourceconsulting.com

 

Coreen Oei, Ph.D. Principal Consultant, Clinical Strategy and Execution: Over 14 years' of drug development and clinical research experience.  She has overseen the execution of clinical trials, and the development of budgets and project timelines.  In previous roles she has lead a global clinical team of over 145 clinical scientists accountable for the delivery of early phase studies for the Center of Excellence in Drug Discovery across all therapeutic areas.

 

email: coei@regsourceconsulting.com

Neal Siegel, Ph.D., Principal Consultant, Medical Devices:  Over 25 years' hands-on experience working in the clinical diagnostics, pharmaceutical and medical device industry.  Neal has numerous patents, awards and publications, and has expertise specifically in quality systems and regulatory compliance, medical device quality and regulatory issues, corrective and preventative actions (CAPA),  product development and submissions of 510(k)'s, and product and process validation. Neal also developed and taught the Quality of Science course for undergraduates, and helped create the Masters in Quality and Regulatory Science program at Northwestern University.

email: nsiegel@regsourceconsulting.com

 

Jonathon Holt, Ph.D., Principal Consultant, Preclinical Strategy & Execution: Over 10 years' experience working on and leading discovery programs, and the development of early stage compounds through clinical POC.  In addition to providing support for various therapeutic areas, including Parkinson's, urological indications, hemostasis, depression, pain, premature ejaculation, psychosis, cardioprotection, and Phase III experience in HIV-prevention. 

email: jholt@regsourceconsulting.com

 

 

Thank you for reviewing the page.  We only have highlighted a few of our senior team of consultants.  If you are looking for any additional skills not highlighted in the consultants listed above, please don't hesitate to contact us, as we have a significant number of senior consultants in our database.

 

Look forward to talking to you soon.