BUSINESS MODEL

HCE provides consulting services for contract manufacturing, technology transfers, joint ventures, and portfolio management for small and large molecule development and commercialization.  These products and services are placed with small, medium and large manufacturers keen to enter and expand within the biotech and pharmaceutical markets.  HCE will link FDA and EMA approved manufacturers of both bulk and finished pharmaceuticals with business partners in search of these products to commercialize and capture market share.

It has been universally understood and agreed that developing counties will fuel future growth opportunities and market expansion.  Many first world manufacturers are keen to enter new and developing markets with their product offerings and many second and third world FDA and EMA approved manufacturers are eager to enter the first world markets but find it difficult to exploit these opportunities.

HCE will leverage its extensive network to assist firms to meet their objectives.  Additionally, our talented consultants will also provide business development, market access and reimbursement, contracting services, team building, and diversity training development to biotech and pharmaceutical firms and further downstream to wholesalers, retailers and government entities requesting such services.  This virtual business model ensures successful cooperation, application, and proven results.

TEAM

James Harris III, MBA CEO:James is a dynamic, highly-skilled, results-oriented entrepreneur and senior-level executive with extensive experience within biotech, pharmaceuticals, and medical devices with small start-ups, mid-sized and large firms.

He is the founder of Healthcare Economics LLC, co-founder of AS Biotech AG, and a highly experienced business expert, board member, lecturer, and author specializing in commercialization, business development, pharmacoeconomics, market access, and reimbursement. Successful deal structures include but are not limited to multimillion-dollar in-licensing and out-licensing deals, merger and acquisition partnerships within various disease states such as oncology, neurology, infectious disease, nephrology, and combination products, tech transfers with contract development manufacturing organizations (CDMO’s), clinical development with clinical resource organizations (CRO’s) and raising venture capital for start-ups.

James participates on the board of directors as well as advisory boards for various firms. Before this, he served as General Manager and Vice President at Dragon Pharmaceuticals, Inc. where he was instrumental in the launch and successful market penetration of rh-Erythropoietin (“EPO") internationally, in-licensing Granulocyte Colony Stimulation Factor and guiding Dragon Pharma to be recognized as a top 100 firm in British Columbia, Canada.

His publications include “Biosimilars landscape and FDA regulatory expectations”, “Generic Drugs: World Market Outlook 2011-2021”, “Patient Empowerment and Compliance: The Role of Direct to Consumer (DTC) Advertising”, “Marketing and Globalizing Biosimilars”, “How to Establish Comparability for a faster route to Market", and “GCSF and Bioequivalence: The Emergence of Healthcare Economics”. James has an MBA in Finance from Long Island University, a Bachelor of Arts degree in Urban Studies from Wright State University, and participates extensively as a featured business expert either chairing or speaking at medical meetings globally.

Dr. Peter Kalinka: Senior Consultant: Dr. Kalinka possesses in-depth knowledge of drug development and has directed a large number of development projects which include(d) Therapeutic Proteins, Monoclonal Antibodies and Fusion Proteins. Several of these (Human Growth Hormones (2), Filgrastim, Peg-Filgrastim, EPO) were approved by the EMA, FDA, many were managed by him from inception to submission.  His knowledge in overall development spans cloning, cell line development, process development, scale up, analytical development, bioassays, pre-clinical, clinical Phases I - IV, to manufacturing and regulatory affairs.  Dr. Kalinka looks back on a large number of meetings with FDA, EMA, Health Canada as well as other jurisdictions and has dealt with these regulators during the scientific advice, pre-submission and submission phases.  He is a pioneer in the biosimilars arena.  He set up the Biopharmaceuticals Division at Sandoz and was responsible for the development of Omnitrope, the very first biosimilar to be approved in the EU, Australia and the US. He was then involved in the development of the second biosimilar to be approved, Valtropin when working at BioPartners in Switzerland.  This was followed by many other biosimilars, bio-betters and novel biologics largely as an independent consultant.  His most recent approval was the first biosimilar of Neulasta, Peg-Filgrastim, by Health Canada.

Dr. René Fricker: Senior Consultant: Dr. Fricker has served as a CEO in multinational companies such as CIBA GEIGY, Alusuisse – lonza and Dynamit-Nobel Germany. He is also a member of the board in several companies in Switzerland as well as a business development (BD) consultant for industrial activities. Dr. Fricker holds a PhD in Economics and is fluent in four languages (English, German, French and Italian).

Anil Kumar, MS: Senior Consultant: Anil is an entrepreneur who has built a number of successful enterprises and is the Managing Director of The Targeting Group.

He is known in the industry as 'The Super Connector’ because he makes sure his clients get to the right person, with the money at the right time, and are first to market. Having started his career in science as an immunologist, he felt the pull of the commercial side was too strong for him, a people’s person at heart he felt the best way to give back and build was helping scientists concentrate on the science whilst he took care of everything else. This background gave him the ability to speak to the right people in their language and for him to build a client base who trusted him to look after their interests.

CAREERS

If you are interested in working for Healthcare Economics LLC, please send a Curriculum Vitae and specific career interests to: info@healthcare-economics-llc.com.  We look forward to hearing from you.

NEWS and EVENTS

The Patent Cliff Threatens Billions of Global Pharmaceutical Sales

The patent cliff is real.  During 2010 -2017 and during 2019-2024 approximately USD $150B and $198B respectively either have been and or are at risk of losing patent protection.  Worldwide prescription drug sales are expected to grow at a CAGR of 6.9 percent to $842 billion during the 2019-2024 time period. This is triple the CAGR seen for 2010-2019 and is driven by an increase in FDA approvals for novel drugs and growth in the oncology therapies and orphan drugs markets.

Healthcare Economics (HCE) has developed extensive contacts with manufacturers, technology clusters, and academia to supply the needed link into each sector with its proven experience and globally developed extensive network.  Therefore, the opportunity is immense for HCE to partner with firms to supplement their pipelines to ensure future success.

USA Biosimilar Approval and Launch Dates