Life Science Leader Magazine Supplements

CMO 2015

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 17 NANTONG, CHINA Founded 2014 with doors open in 2015; Siegfried Nantong offers complete life cycle management of API's before, after and throughout patent protection phase(s). Site Scope – Development – Pilot & Launch – Commercial Manufacturing Site Capabilities – Hydrogenation up to 40 bar – Temperature range from minus 100 °C – 250 °C – Handling of hazardous materials – Chlorination & Bromination – Reactor sizes from 0.1 – 10 m 3 – Total reactor capacity of 350 m 3 Offers full-fledged compliancy FDA; EMA and SFDA (thermal oxidizer, waste treatment plant) HAMELN, GERMANY Founded in 1950; a Siegfried company since December 2014; site awarded "Facility of the Year" in 2009. Site Scope – Development and Scale up of Sterile Forms – Clinical Manufacturing – Commercial Manufacturing and Packaging Site Capabilities – Vials (from 2 to 100 mL) – Ampoules (from 1 to 30 mL) – 8 filling lines – 2 product autoclaves – Automatic and semiautomatic visual inspection machines – Crack detection machines – Automatic labeling and packaging equipment Main Regulatory Certifications EMA, FDA, Japan, ANVISA, MFDS S. Korea, Turkey Siegfried offers more integrated capability in 2015 with new facilities in both West and East Europe. Hameln, Germany Nantong, China Siegfried has worldwide presence with chemical manufacturing multi-purpose cGMP sites located in: Zofingen, Switzerland; Pennsville, New Jersey (USA) and Nantong (China), and drug product manufacturing sites in Zofingen, Switzerland (Pilot), Malta, Irvine (USA) and Hameln (Germany). seeking investment is not 100 percent pre- pared in our first meeting, we start thinking of scheduling multiple sets of meet- ings. At that first meeting, if we believe the product is differentiated and there is potential for it, we will start a conversation about who else the entrepre- neur might want on his or her team. We also try to make sure the right individu- als, such as executives and consultants, are involved at different stages along the way. To help those entrepreneurs who are less prepared, we like to ask a lot of ques- tions to better understand the product. If we are meeting with a smart chem- ist or biologist, we will say, "Help me understand what you want to do. Help me understand how this asset, drug, or pathway will meet an unmet need." You need to start with the science. JAISIM SHAH, Semnur Pharmaceuticals: When you are at the stage where you are talking to investors, there are several areas that you must be prepared to cover. One is a clear understanding of the unmet need you are trying to address. Not just the scientific or medical need, but also the business need. You also need to discuss how your idea, concept, technology, or product com- pares to existing therapies. You should address the potential for superiority, not just one or two, but five years down the road. Having a clear understanding of your development path and what the FDA expectations may be for developing your product are keys. IP is also a key area that a lot of inves- tors focus on. They want to ensure the product they are investing in will have multiple levels of protection. It basically comes down to summarizing the benefits of investing in your venture versus other ventures. MAHENDRA SHAH, Vivo Capital: We do late-stage investing, so the companies that come to us have a proof of concept in humans for the target indication they want to develop. The first thing we would do is make sure the IP for the product has been taken care of. Second, we would look at whether the formulation is there to manufacture a commercial product and if the necessary resources are available, all the way down to the required APIs. A third thing we look at is the marketing plan and whether the company will be able to market the product on their own. If they can't, we would want to know how they might go about partnering the prod- uct, and at what stage of development that should happen. Finally, we make sure the Phase 3 clinical end points are no different than in Phase 2, to make sure there are no surprises during the study and that the company is not trying to cut corners. At

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