Mark Rohlfing. Vice President of Operations Almac Clinical Services Souderton, Pennsylvania

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2 Mark Rohlfing Vice President of Operations Almac Clinical Services Souderton, Pennsylvania Confidential Almac Group 2014

3 Who We Are Almac is a global drug development services provider. Our mission is to be the partner of choice, providing an expanding array of innovative Clinical Solutions worldwide employees globally in Clinical Services DISCOVERY DEVELOPMENT DELIVERY Biomarker Discovery & Development API Services & Chemical Development Pharmaceutical Development Clinical Trial Supply Clinical Technologies Analytical Services Commercial Services Confidential Almac Group 2014

4 Global Reach DEPOTS 48 ON CONTINENTS 6 250,000 SHIPMENTS ANNUALLY TO OVER 80 COUNTRIES Integrated Operations Centers Global Depot Network Confidential Almac Group 2014

5 Global Distribution What have been our most significant challenges? Ever growing demand for cold chain solutions to support development of biological medicines Greater threat from counterfeit drugs entering the global supply chain Client need for real time visibility of product inventory and shipping data across global network of depots Staying ahead of evolving global regulations and Good Distribution Practices Growing trend in industry to reduce packaging waste MHRA APPROVED MORE OF SHIPMENTS ARE WITHIN THAN 99% SPECIFICATIONS Ambient C 2-8 C -20 C -70 C Confidential Almac Group 2014

6 Confidential Almac Group 2014

7 Herr Foods Inc. Dan Sifer V.P. Supply Chain / Contract Manufacturing Nottingham, Pa 7

8 Supply Chain Innovation Regional Snack Food Manufacturer Family Owned & Operated Since ,000 sq. ft. here in Nottingham 50,000 sq. ft. in Chillicothe, OH DSD Distribution 520 Company Owned Routes & 20 Distribution Centers Distributors and Vending sales Channel National Sales Direct Distribution Over 1,400 Employees 500 SKU s SQF Level III Certified 8

9 Supply Chain Innovation 9

10 Supply Chain Innovation 10

11 Supply Chain Innovation The Most Significant Challenges for Herr s Increased demand for cost efficient packaging that withstands extreme altitudes. Heightened need for shipping logistic efficiency across all three sales channels Live visibility to orders in the que to co-ordinate materials from raw materials delivery through finished goods shipment. Streamlined communication to allow for visibility to Inventories and upcoming demand so suppliers can gain scheduling efficiencies to improve product delivery 11

12 Click to edit Master title style Click to edit Master text styles Second level Third level Blue Fin Group Ron Krawczyk Managing Partner Proprietary and Confidential

13 Click Who We to edit Are Master title style As Click the premier to edit Master management text styles and technology consulting firm for the healthcare Second industry, level Blue Fin Group has been providing clients with market-shaping solutions since 2001 Third level Keen Industry Insight Cutting-Edge Strategies Unparalleled Experience With consultants located across the United States who average 20+ years of deep industry experience, we are proud to serve over 170 healthcare clients Manufacturers National provider networks Service providers From start-ups through top 40 industry leaders, and many others Proprietary and Confidential 13

14 Click Our Clients to edit Master title style Click to edit Master text styles Second level Third level Leading Pharma Emerging Generic BIO and device HC and Service Providers Proprietary and Confidential 14

15 Click An Example to edit Master of Our Client s title style Critical Issues Blue Click Fin to Group edit Master works text with styles clients to develop and recommend solutions to their Second most level difficult business problems. The following two, are examples Third that level have not been solved or solutions are present and not yet fully embraced. 1) Supply Chain Integrity Protecting the Asset Temperature Transparency/Data 2) Inventory Management Physician Office Site of Care/Dispensing/Administration/Billing Reimbursement Proprietary and Confidential 15

16 The Last Mile: Its not just a package, it s a patient Click to edit Master title style Click to edit Master text styles Second level Third level Proprietary and Confidential 16

17 Click Product to edit Director Master - Protecting title style the Asset Objective: Pharmaceutical/Biotech/Vaccine manufacturers MUST consider the Click to edit Master text styles capabilities of the supply chain and distribution channels when configuring a solution, connecting Second the level product to the patient Third level Product Director must ensure that any solution chosen will - Ensure product availability - Product is at the right place at the right time (Access) - Transparency - where the product is being used, inventory in channel - Product Integrity/Safe and Secure Temperature, Ambient, frozen, refrigeration 2-8 Degrees C - PROTECT THE ASSET We do know that: Temperature does have an effect on many drugs, MAB, liquid, Lyophylized powder Returned Goods? Patient safety what is that? Adverse events Proprietary and Confidential 17

18 Example: Technologies Applied to Address Unmet Market Needs Core Products Freeze Cumulative Heat Delayed Heat Threshold Instant Heat Threshold 18

19 Click Beyond to edit Track Master and Trace title style Click Specialty to edit Drugs Master are predicted text styles to account for 40-45% of U.S. drug sales by 2016 Second level Third level About half of all Specialty Drugs are utilized in doctor s offices and outpatient centers Inventory management and payment reconciliation are critical for doctor s offices engaged in Specialty Drug buy and bill With a tight margin and expensive products there is NO room for error Browser technology and widespread availability of broad band internet access has allowed many business systems, formally managed with inhouse, server client software products to be managed with a cloudbased software product An example of this fusion of the needs of buy and bill practices and modern technology is PODIS Proprietary and Confidential 19

20 Innovation What is PODIS? Cloud based Internet program that automates all aspects of product tracking, from ordering through payment Payment is by subscription; Software as a Service (SaaS) Ability to respond to changing environment and to our practices Critical distinguishing features System generated barcode labels allows tracking of each dose of medication Interfaces with all brands of Practice Management Systems (PMS) Billing Accuracy Report reconciles billing to actual inventory utilization Manages all aspects of drug inventory Orders, inventory tracking, office location transfers, dose assignment, billing accuracy Automated alerts include: low inventory, diagnosis, orders/transfers not received, do not administer and product expiration Proprietary & Confidential 20

21 Click to edit Master title style Click to edit Master text styles Second level Third level Ron Krawczyk Managing Partner The content within this presentation is subject to the confidentiality agreement between Blue Fin Group, Inc. (BFG) and Client. Client is entitled to use content within this presentation solely for its own internal business purposes and is prohibited from modifying, translating, or otherwise creating derivative works based on the content of this presentation. Client is further prohibited from licensing, selling, leasing, distributing, lending or otherwise transferring the content within this presentation to any third party regardless of the relationship between third party and Client. Client may not make any copies of any BFG presentations and related content except for internal distribution purposes as described and agreed to in the confidentiality agreement, provided that all such copies are reproduced with and incorporate all of BFG s protective notices, including this and all copyright notices. Nothing in the content within this presentation and/or any agreement applicable thereto between Client and BFG constitutes a waiver of BFG s rights under United States copyright law or any other law. This information has been obtained from sources which BFG believes to be reliable but we do not guarantee the accuracy or completeness of this information. Proprietary & Confidential 21