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Follow on Google News | Selecting The Right Business Partner In Today’s Generics ClimateInterview with Richard DiCicco, Chairman with Harvest Moon Pharmaceuticals, on key topics to be discussed at the upcoming marcus evans 7th Product & Pipeline Enhancement for Generics Conference, on July 30-31, 2014 in Alexandria, VA
By: marcus evans How could cultivating quality business partnerships add value to an organization’ Partnerships make every task easier. Each party has a list of tasks to execute, provided both parties are in agreement. The result is increased value to the generic portfolio, with a “go to” partner for future products. However, partnerships can be challenged by unexpected events, and this is why partnerships are relevant for generic companies right now. In October 2013, FDA’s Office of Generic Drugs (OGD) changed its operational model as a result of GDUFA. There is no communication on a submitted ANDA until OGD issues a complete response letter, a tentative approval or a final approval. It is important to involve the partnership in creation of the ANDA’s documentation, and avoid a “refuse to receive” letter upon submission, or a very difficult-to- What are the must-have qualities of a business partner? · Understanding the business · Ability to evaluate quality · Respect for specific expertise and quality · Leadership attributes to manage and control the partnership · Sharing information and goals · Team building for trust · Create a sense of belonging through mutual respect Are there any best practices when drafting a contract between an organization and its business partner? Licensees of generics prefer to pay milestones later rather than up front. We have found it mutually agreeable to pay an extra milestone on the back end by specifying the last milestone is due 90 days after launch. How would you see this interest in developing partnerships impacting or shaping how generics companies might do business in the future? Partnerships are absolutely necessary to cope with the new OGD, so it is here to stay. For more information, please contact Tyler Kelch, Marketing Coordinator, Media & PR, marcus evans at 312-894-6310 or tylerke@marcusevansch.com About Richard DiCicco Chairman, Harvest Moon Pharmaceuticals. Richard DiCicco co-founded Harvest Moon Pharmaceuticals USA, Inc. in 2007 with a proven pipeline of products developed since 1984. Harvest Moon Pharma develops, manufactures, markets and exports worldwide, complex generic drug products and biosimilars. Small molecule generics include a complete line of transplant drug products; complex hospital injectables such as enoxaparin, glatiramer, octreotide LAR, risperidone depot, lanreotide depot, paliperidone palmitate depot; complex oral solids such as dronedarone and mesalamines; Biosimilar products include adalimumab, rituximab and trastuzumab entering phase I clinical trials in Europe. These mAbs are manufactured in the USA and comply with the EMA mAb revised guidelines. There are 15 additional biosimilar mAbs and two fusion proteins which will be registered by 2017 in various countries. Mr. DiCicco is a member of the Editorial Board of the Journal of Generic Medicines, a member of the Licensing Executives Society, speaks often and is widely published in generics and biosimilars. About marcus evans Marcus evans conferences annually produce over 2,000 high quality events designed to provide key strategic business information, best practice and networking opportunities for senior industry decision-makers. Our global reach is utilized to attract over 30,000 speakers annually; ensuring niche focused subject matter presented directly by practitioners and a diversity of information to assist our clients in adopting best practice in all business disciplines. End
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