Cambridge Healthtech Institute's Inaugural

Clinical Supply Management
( 臨床試験のためのサプライチェーンマネジメント )

Effective Tracking, Managing and Distributing Clinical Supplies

2018年2月14-15日 | Hyatt Regency Orlando | フロリダ州オーランド




Wednesday, February 14

11:30 am Registration Open

12:10 pm Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:50 Coffee and Dessert Break in the Exhibit Hall

1:30 Plenary Keynotes

3:00 Valentine's Day Celebration in the Exhibit Hall, Last Chance for Exhibit Viewing


4:00 Chairperson's Remarks

Doug Meyer, MBA, RPh, Associate Director, Clinical Drug Supply, Biogen, Inc.

4:05 Building an Effective End-to-End Cold Chain Supply Management Process

Doug_MeyerDoug Meyer, MBA, RPh, Associate Director, Clinical Drug Supply, Biogen, Inc.

This presentation will discuss: 1. What tools and technologies can you leverage to protect the product and avoid costly temp excursions? 2. How can you build efficient processes that ensure drug is always available for patient dosing? 3. What strategies should you adopt in your stability program to enable an efficient and scalable supply chain for temperature sensitive products?

4:30 Clinical Trial Supply Chain Strategy - Minimizing Risk and Cost

Ajay Gupta, Associate Director, Clinical Supplies, Merck

This presentation will discuss strategies and techniques that can be used to minimize risk and cost along the clinical trial supply chain. Issues related to oversight, tracking, and waste will be addressed.

4:55 Sponsored Presentation (Opportunity Available)

5:25 The Near-Term Viability and Benefits of eLabels for Clinical, Sites and Patients

Jodi_Smith-GickJodi Smith-Gick, RPh, Senior Advisor, Product Delivery and Supply, Eli Lilly and Company

This session will speak to the options and benefits of utilizing eLabeling to enhance site efficiency and enhance patient centricity. Specifically discussed will be approaches, considerations when planning a study, and potential add-on technologies which can further improve productivity at sites. Specific feedback received from patients and sites on these concepts will be shared. In addition, this session will de-bunk some of the misconceptions around the near-term viability for an eLabel solution.

5:50 Close of Day

5:50 - 7:00 pm Track Reception (Sponsorship Opportunity Available)

Thursday, February 15

7:15 am Registration Open

Accenture7:45 Breakfast Presentation to be Announced


8:30 Chairperson's Remarks

8:35 Supply Chain Integrity; Technology Tools for Tracking and Tracing Clinical Supplies

Tom_SkiendzielewskiTom Skiendzielewski, Associate Director, Clinical Supply, Shire

This presentation will discuss: 1. Benefits of ERP system application in Clinical Supply Management (in-source vs. out-source), 2. Scoping your IRT to optimize benefit, reduce risk, and increase compliance, 3. Comprehensive Technology-Based Time Out of Environment (TOE) Management, 4. Analyzing RFID utilization in the Clinical Supply Chain, and 5. The Last Link of the Clinical Supply Chain - Site Level Management

9:00 IRT Considerations for Managing Clinical Supplies

Carol Lee, Associate Director, Clinical Drug Supply, Logistics, & IRT, Regeneron

This presentation will discuss: 1. Exploring methods through which IRT technology can improve clinical supply logistics, 2. Pinpointing how IRT technology can be set up to improve your logistical planning, 3. Exploring the benefits of creating your own in-house IRT system versus using a base-line vendor model, 4. Recognizing the value of IRT in clinical supply ordering and distribution, and 5. Emphasizing ways through which IRT systems can become more effective for your different trials.

9:25 IRT Data Integration Provides Big Benefits

Jackie_KentJackie Kent, Senior Director, Product Delivery, Supply Planning & Systems, Eli Lilly

It's obvious an IRT makes conducting a clinical trial more efficient and secure; from study drug forecasting and distribution to treatment group assignment and blinding. But using an IRT can provide benefits in many other aspects of trial execution. IRT allows near real-time data capture that can seamlessly integrate with multiple systems and functions while safeguarding sensitive data through automation. And combining data from an IRT with patient data from other systems can allow information alignment and facilitate reconciliation. And sharing a consistent data flow from an IRT can reduce vendor cost and play a critical role in bringing an asset to market in less time.

9:50 Sponsored Presentation (Opportunity Available)

10:15 Networking Coffee Break


10:30 Chairperson's Remarks

10:35 FEATURED PRESENTATION: Patient Centered Clinical Trial Material Design and Delivery

Janelle_SaboJanelle Sabo, Pharm.D., RPh, MBA, Senior Group Director, Product Delivery, Eli Lilly

We will explore areas for patient-centered design and delivery in CT material, including formulation/drug product, kitting, delivery and technology. Practical current examples and inspirational goals will both be discussed to frame where we are today but where the future opportunities lies within clinical supplies.

11:00 Sponsored Presentation (Opportunity Available)

11:25 Brief Session Break

11:35 Direct-to-Patient Distribution: One Company's Journey

Speaker to be Announced

12:00 pm PANEL DISCUSSION: Direct-to-Patient Distribution: Meeting the Patient's Needs

Moderator: Sascha Sonnenberg, MBA, Vice President, Commercial Operations Americas & EMEA, Marken

Panelists: Gerald Finken, CSO/Founder and Innovator, Clinical Supplies Management

Janelle_SaboJanelle Sabo, Pharm.D., RPh, MBA, Senior Group Director, Product Delivery, Eli Lilly

As the pharma industry moves towards more patient-centric initiatives for clinical trials, direct-to-patient distribution is growing in popularity, but many challenges still remain. Topics discussed in this panel include: 1. Investigator and site buy-in and support for direct-to-patient initiatives, 2. Logistical, cost and regulatory considerations; and 3. Challenges with patient handling of IMPs.

12:50 Closing Remarks

1:00 SCOPE Summit 2018 Adjourns

Melissa DolenGroup Discounts Are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts, contact us.


2018 SCOPE Conference at a Glance

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In Memory of Gerald "Jerry" Matczak
Matczak Jerry

Gerald "Jerry" Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world, someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.

- Cambridge Healthtech Institute (CHI)