New Business Development & Business Strategy

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Contact: Edward A. Narke Title: New Business Development & Business Strategy Email: solutions@dsinpharmatics.com Telephone: 855-805-8402 Website: http://www.dsinpharmatics.com   FOR IMMEDIATE RELEASE   DESIGN SPACE INPHARMATICS (DSI) NAMES ROB RIGNEY VICE PRESIDENT OF BUSINESS DEVELOPMENT AND BUSINESS STRATEGY   Harleysville, PA., May 10, 2017 – Design Space InPharmatics (DSI), a full-service CMC consulting firm specializing in regulatory affairs, drug development consulting services, and operations management for the life sciences industry, announced today the appointment of Rob Rigney to the position of Vice President of Business Development and Business Strategy. “Rob’s extensive experience in CMC and regulatory drug development will be extremely Read More

What The SUPERBOWL Can Teach Us About CMC Strategy?

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EVER CHANGE YOUR PLAYBOOK IN A CROWDED HUDDLE?   “Clinical Phase Appropriate” assignment of CMC activities can serve as relief from the pressure of limited resources for carrying out your CMC regulatory compliance strategy. Phase Appropriate is defined as “matching the extent of completion for a CMC activity, as well as its timing for completion, to the patient safety risk associated with each clinical development phase.”   What are you trying to accomplish? You may not be trying to win a game, but it’s likely you’re considering how to make decisions to drive development, satisfy commitments with increasing expectations, appease Read More

Let Your Creativity Bubble Up

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The Primer… For the purposes of my practical explanation, it is necessary to produce an admittedly unbalanced discussion that shortchanges some sections of the Quality modules but that includes considerable discussion of other sections that can largely influence the ultimate success or failure of an application. The Quality Modules 2 and 3 are well defined components of the Common Technical Document (CTD) containing both drug substance (active ingredient) and drug product sections, each containing required presentations of Chemistry, Manufacturing and Controls (CMC) information, covering processes and key control parameters, and various justifications supported by qualification and validation studies. The information Read More

Does Your Program Need A CMC Or CMC Regulatory Expert? Don’t Wait Too Long!

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When a CMC emergency crops up, you grit your teeth, your blood pressure spikes and you pledge to bear down and make the right decision. And that’s exactly why you might make the wrong decision. In today’s biotech industry, (where MONEY and, TIME, can make you or break you) it can be harder to bounce back. When you get subjective about a tough choice, you’re more likely to make a mistake. An independent CMC expert or team of experts can help take emotion out of your decision-making. They can help you create a budget so you have a better understanding Read More

Traversing the Regulatory Landscape of Combination Products

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An ice cream shop offers customers the choice of a cup or a cone. It offers a choice of three different flavors: chocolate, vanilla, or strawberry. It also offers three different toppings: sprinkles, nuts, or hot fudge. How many different combinations result from choosing a cone or a cup, one kind of ice cream, and one topping? The concept of the combination product is simple and straightforward. In short, it is a single product consisting of two or more regulated parts, which can be either drugs, devices, or even biological parts. However, it is important to remember that simple concepts Read More

How a falling apple inspired the understanding of gravitational force.

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Challenges of CMC Development for Emerging Biotech Companies It is one of the most famous anecdotes in the history of science. The young Isaac Newton is sitting in his garden when an apple falls on his head and, in a stroke of brilliant insight, he suddenly comes up with his theory of gravity. The story is almost certainly embellished, both by Newton and the generations of storytellers who came after him. But from today anyone with access to the internet can see for themselves the first-hand account of how a falling apple inspired the understanding of gravitational force. Today, in Read More

Developing the Appropriate CMC Matrix. Part 1: The Role of Time?

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The Reasoning With venture capitalists and other investors looking to put money into an industry that is unceasingly seeking innovative new products and where small to mid-sized companies compete for their share of the financial pie, the race to show positive clinical results is intense. In an intensely competitive environment, sponsors from small biotech to large pharma are continuously seeking resourceful ways of fast-tracking their development process. Timelines to begin clinical trials are becoming shorter as companies seek conclusive results that would demonstrate or contradict their product’s potential. In order to gain a competitive clinical edge, these companies may look Read More

The Importance of Living Development Reports

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The most important approach to maximize the chance that the NDA or BLA is received favorably is to strive for clarity, to avoid exaggerations, and to discuss rather than hide negative findings and deficiencies. Avoid claims that cannot be substantiated, and keep in mind the advice that if something is not documented it is rumor. When submitting the marketing application for your drug product, the CMC section must show that your product can be manufactured consistently and to quality standards.  Having a  pharmaceutical development report of the project provides a single go to reference for explanation of processing methods, information Read More

Who is Keeping Track of ISO Changes for Controlled Environments? – Why is this Critical?

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First introduced in 1999, the ISO Standard 14644 has become the de facto guidance for cleanrooms and controlled environments for aseptic filling and biologics manufacturing. Offering more detail than FDA regulations, the ISO 14644-1 and 14644-2 provide acceptable particle levels for air cleanliness, creating a cleanroom classification model and an outline for practices and procedures for managing the risk of contamination. In 2015, ISO made notable updates to the standards to incorporate best practices for contamination control by enhancing sampling plans and classification requirements in ISO 14644-1, and monitoring guidelines in ISO 14644-2. David Ensor, chairperson for ISO Technical Committee Read More

The necessary regulatory compliance information to assure that informed decisions are made regarding the potential in/out-licensing of a development compound.

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You are an emerging Biotech company, have just begun development of a compound or in-licensed a product and received funding. Now the fun starts as you sort through what development has been done, how to cope with establishing or taking over various contractors who have parts of the project and get a clinical trial started or keep one going all this while trying to cope with coming up with a concise CMC development and regulatory strategy and plan as well as a budget for your Board of Directors throughout out-licensing. As you dig in and get going you realize that Read More