Engage Health's affiliates are leaders in the comprehensive array of specialty services required to maximize the commercial success of your orphan or specialty medical product. Affiliates are comprised of an impressive accumulation of industry experts, with real and pragmatic experience. Affiliates blend their collective experience and wisdom on behalf of your project, making the whole greater than the sum of its parts.
MARKET DEVELOPMENT, RESEARCH AND STRATEGY
Patti A. Engel, R.N., BSN
Founder, President and CEO, Engage Health, Inc.
Ms. Engel has worked extensively in the areas of strategic and infrastructure planning, patient identification and quantification, market research, market valuation, clinical trial recruitment, risk management and managed distribution for orphan drugs and specialty medical products. Ms. Engel's experience includes significant policy and governmental affairs work at both the federal and state level, and extensive involvement rallying patient support groups around important policy issues.A frequent presenter on complex issues related to commercializing therapies for rare diseases, Ms. Engel held the position of Vice President of Marketing and Sales at Orphan Medical, Inc., and spent over 10 years in various sales and marketing management roles at 3M Pharmaceuticals. She sits on the Advisory Board for Raptor Pharmaceuticals, Kakkis EveryLife Foundation, and is a member of the National Organization for Rare Disorder�s Corporate Council Advisory Group. Ms. Engel is an R.N. with a background in pediatric oncology nursing and earned her Bachelor of Science in nursing and Bachelor of Arts in sociology from the College of St. Catherine, St. Paul, Minnesota.
REGULATORY AFFAIRS
Marie DeGayner Kuker, RPh, RAC, FRAPS
Founder and President, Kuker Regulatory Consulting, LLC
Ms. Kuker has more than 25 years of experience in the medical products industry with a particular emphasis in orphan drugs, pre- and post-marketing pharmaceutical regulatory affairs, compliance and regulatory strategy. Marie has worked in regulatory affairs at Orphan Medical, Upsher-Smith Laboratories and 3M, most recently as the head of regulatory affairs worldwide for 3M Pharmaceuticals before founding her consulting business. Marie received her Bachelor of Science degree in Pharmacy from the University of Minnesota. She is an adjunct faculty member in the Center for Orphan Drug Research of the University of Minnesota College of Pharmacy Department of Experimental and Clinical Pharmacology, and a faculty member of the Masters of Science program in Regulatory Affairs and Services at St. Cloud State University in Minnesota.
EPIDEMIOLOGY
Ann Hale, PhD, MBA
Dr Hale brings over 25 years experience in
medical science research, biotech, public and private UK healthcare
and non-profit sectors. Ann has extensive experience of diagnostic product
development and clinical product/service development. As Head of Research at
BUPA Medical Research, she led a non-profit organisation specialising in
epidemiological research. She has also been Head of Public Health for the UK
Alzheimer’s Society. As Executive Director of GOLD, Global Organisation for
Lysosomal Diseases she developed a network of over 155 organisations,
comprising patient advocates, scientists, clinicians and pharma/biotech
companies in 37 countries. Ann graduated in Biochemistry from the University of
Hull, UK and gained her PhD at the Medical College of St Bartholomew’s
Hospital, London UK. She also holds an MBA from
Cranfield University School of Management, UK
DATA ANALYTICS AND MODELING
David Lapidus
Founder, Lapidus Data
Mr. Lapidus brings practical experience in analytics, modeling and forecasting. His company specializes in complex markets with atypical dynamics, such as rare diseases. As part of cross-functional teams at both Decision Resources and Genzyme, Mr. Lapidus has analyzed many types of market data to develop tools which achieve strategic objectives. His propriety models and data collection systems serve as the backbone of commercial infrastructure throughout the product cycle. David received his Bachelor of Arts in Social Studies from Harvard University and has completed extensive coursework in epidemiology at Tufts University.
MEDICAL WRITING
Carl S. Hornfeldt, PhD, RPh, DABAT
Founder, Apothekon Inc.
Dr. Hornfeldt brings over 30 years of clinical and scientific experience to generate accurate and concisely-written documents to advance your goals and objectives. Dr. Hornfeldt's portfolio includes an impressive variety of publications with an emphasis on specialty diseases for the pharmaceutical and biotechnology industries.
Dr. Hornfeldt received his Bachelor of Science degree in Pharmacy and Doctoral degree in Pharmacology from the University of Minnesota and is a diplomate of the American Board of Applied Toxicology. He is the former Clinical Director of the Hennepin Regional Poison Center and Director of Medical Information and Drug Safety at Orphan Medical, Inc.
BUSINESS DEVELOPMENT
Michelle Boelter
Founder, Boelter Sales
Ms. Boelter brings 25 years of sales and business development experience in relationship-intensive industries. Michelle spent 21 years with a leading consumer goods packager as a Business Development Manager where she worked with Fortune 500 customers regarding new product development and product launches. As a National Account Manager for a leading express logistics company Michelle was responsible for developing sales infrastructure and field presence. Experienced in business and client development, Ms. Boelter brings a thorough understanding of tools and infrastructure required for companies of all sizes.
BUSINESS OPERATIONS AND LOGISTICS
Connie Ring
Logistics Manager, Engage Health, Inc.
Ms. Ring brings over 25 years of business operations and logistics experience to support your specialty or rare disease product. Ms. Ring was with the University of Minnesota Administrative Information Services where she worked in project management, IT training and IT support. She was with SuperAmerica Corporation where she supervised the data management function. Ms. Ring�s expertise in information technology, along with her significant skills in customer service makes her an excellent fit to develop and provide logistics support for your project. Experienced in numerous information technology platforms, her experience includes development of standard operating procedures, investigators meetings, clinical trial recruitment, database and registry development, and patient advocacy activities.