Meeting temperature requirements in a changing environment

Transcription

1 Meeting temperature requirements in a changing environment After an extremely successful launch in 2017 and great growth for the 2018 edition, Temperature Controlled Logistics in Biopharmaceuticals will be back once more in Princeton for April 2019! The conference once more will provide you with highly informative content about shipping products that need to be kept at given temperatures, clinical and commercial operations overviews and real life case studies. You will enjoy meeting and hearing from industry leaders to gain insights into new trends for the biopharmaceutical industry and hear opinions and strategies to incorporate into existing processes within your organization alongside the opportunity to network and find solutions to your packaging technology challenges! Confirmed speakers: Rupa Vadodaria, Associate Director, Merck Edward Lelina, Supply Chain Operation Leader, Torrent Pharma Kimberly Mulvaney, Senior Compliance Project Manager, CLS Global Operations, Johnson & Johnson Dave Malenfant, Executive Vice-President, Industry Liaison Director, Center for Supply Chain Innovation, BSMA (Biotech Supply Management Alliance) Neeley School of Business, TCU (Texas Christian University) Sara de la Rosa, UAS Coordinator, Interagency Supply Chain Group (ISG) Oscar Riaño, Director, Sales Analytics and National Accounts, Mallinckrodt Pharmaceuticals Brian Files, Government Affairs, Strategic Policy Executive, Drug Supply Chain Security Act (DSCSA) Pravada Pendse, Senior Manager, CMC, SK Life Science Carl Accettura, Vice President, PharmoRx Therapeutics Kevin Otto, Senior Director, GS1 Anthony Zuccarello, Associate Director, Global Clinical Supply, Amicus Therapeutics Robert Celeste, Founder, Center for Supply Chain Studies Stavros Evangelakakis, Chairman, Cool Chain Association Derrick Kearney, Supervisory Import Specialist, US Customs & Borders Protection Mary Zhang, CBP National Account Manager, US Customs & Borders Protection Donnie Weissberg, Head of Warehousing, Logistics and Last Mile Americas, Bayer Jeremy Cress, Director of Operations, Fibrocell Helen Cocuzza, Sr. Manager, Regulatory Affairs, Foamix Pharmaceuticals Day One Tuesday 2 nd April :15 Registration and refreshments 08:50 Chair s opening remarks 09:00 OPENING KEYNOTE: Preparing for the future are block chain and artificial intelligence taking over? Better than the human eye how AI can pick out hot spots in the supply chain Achieving digital transformation of your clinical supply trial Forecasting for the future: understanding how block chain augments your supply chain Highlighting the advantages block chain and AI bring to your business

2 Dave Malenfant, Executive Vice-President, Industry Liaison Director, Center for Supply Chain Innovation, BSMA (Biotech Supply Management Alliance) Neeley School of Business, TCU (Texas Christian University) 09:30 Sensitech Adding value to cold chain product launches with the Enabling Technologies of cold chain temperature monitoring & verification with serialization, GPS tracking & traceability Why a combination of serialization, cold chain, and Mobile App/GPS apps and technologies will be needed to stand on a four-legged stool to enhance commercial Rx brand value, from time of launch! 10:00 Why item-level enabling technologies for real-time monitoring, such as temperature monitoring, serialization, GPS and brand protection can help differentiate product launches and secure patient health Why some pharmaceutical products can be enhanced and differentiated in their delivery to patients by being identifiable, trackable, and verifiable with serialization at the sub-dscsa saleable unit level Carl Accettura, Vice President, PharmoRx Therapeutics 10:30 Morning refreshments and networking 11:00 Controlant INTERACTIVE ROUNDTABLE DISCUSSIONS 11:30 Facilitated by industry experts, this is your chance to discuss key topics and challenges in smaller, interactive groups. You will be able to share your own experiences and hear from others; benchmark; exchange ideas and get clear answers to specific questions RT1 RT2 RT3 RT4 Blockchain: harnessing blockchains power to improve transportation Kevin Otto, Senior Director, GS1 Global update on the DSCSA Brian Files, Government Affairs, Strategic Policy Executive, Drug Supply Chain Security Act (DSCSA) Sustainability: innovative ideas in packaging materials Pravada Pendse, Senior Manager, CMC, SK Life Science Direct to patient clinical supply transportation

3 Ambient: handling room temperature products RT5 Kimberly Mulvaney, Senior Compliance Project Manager, CLS Global Operations, Johnson & Johnson 12:30 Lunch and networking 13:30 14:00 14:30 Overcoming challenges within the air cargo community Ensuring products are delivered to hard to reach countries The last mil: efforts to be taken to ensure final destination Stavros Evangelakakis, Chairman, Cool Chain Association SmartCAE Controlling temperature excursions during shipment and warehouse storage Exploring different methods into monitoring a controlled chain of custody Ensuring expedited shipping to resupply clinical sites quickly Assessing your current supply chain and leveraging technologies to enhance the supply chain Allowing flexibility in your processes to meet guidelines and deadlines Edward Lelina, Supply Chain Operation Leader, Torrent Pharma 15:00 Zenatech 15:30 Afternoon refreshments and networking PANEL: Real-time monitoring the pros and cons Evaluating traceability technologies Understand how real-time data can improve your business 16:00 Overcoming challenges of real-time tracking Demonstrating the benefits Oscar Riaño, Director, Sales Analytics and National Accounts, Mallinckrodt Pharmaceuticals 17:00 Chair s summary and close of day one Day Two Wednesday 3 rd April :15 Registration and refreshments 08:50 Chair s opening remarks 09:00 KEYNOTE: Customs and Borders International borders overcoming delays and complications Centers of Excellence and Expertise - focus on industry-specific efficiencies to

4 09.30 facilitate legitimate trade and enhance the effectiveness of enforcement efforts Partnership programs - CBP and the trade community have collaborated to make international trade easier, cheaper and more secure by promoting the efficient and secure movement of legitimate goods and by fostering a global supply chain system and encouraging internal control Derrick Kearney, Supervisory Import Specialist, US Customs & Borders Protection Mary Zhang, CBP National Account Manager, US Customs & Borders Protection Preparing for the future are block chain and artificial intelligence taking over? Better than the human eye how AI can pick out hot spots in the supply chain Achieving digital transformation of your clinical supply trial Forecasting for the future: understanding how block chain augments your supply chain Highlighting the advantages block chain and AI bring to your business Robert Celeste, Founder, Center for Supply Chain Studies AGENDA HIGHLIGHT: Integration of Unmanned Cargo Aircraft as part of supply chain transport networks Infrastructure and HR (ie. the need for drone ports, drone cargo handling 10:00 standards, drone repairs, new skilled personnel), Airspace Regulations (ATM and Unmanned Traffic Management system integration) and Multi-modal supply chain data and asset management (how to improve tracking cold chain commodities transported via multiple vehicles over land and over air) Sara de la Rosa, UAS Coordinator, Interagency Supply Chain Group (ISG) 10:30 Morning refreshments and networking 11:00 Jeremy Cress, Director of Operations, Fibrocell Re-usable packaging: understanding the value, environment, value to customer, value proposition and product integrity Going green: why sustainability in packaging is imminent 11:30 Understanding how sustainable packaging can improve your business Aligning your business goals with respect for the environment The advantages of going green and available materials in the market Rupa Vadodaria, Associate Director, Merck PANEL DISCUSSION: Challenges and solutions on successfully running international clinical trials through enhanced transport methods Understanding the roles of all parties involved and overcoming regulatory hurdles 12:00 Creating a balance between cost and optimizing efficiency Managing your timeline to overcome complexities with different guidelines Gaining a clear vision of global trends and regulation Donnie Weissberg, Head of Warehousing, Logistics and Last Mile Americas, Bayer 13:00 Lunch and networking

5 14:00 REFLECTION ZONE: If you re just starting up or an expert in this field, there is a roundtable for you! Choose from one of the following roundtables to suit your needs: 1. GDP compliance implementing standards 2. Artificial intelligence and block chain HANDS ON! 3. Reducing the cost of packaging: what alternatives do we have? 4. Direct-to-patient overcoming challenges 5. International borders understanding cultures and regulations 15:30 Chair s summary and close of conference