Novel clinical supply strategies and technology to deliver a patient centric supply chain

The Almac team cordially invites you to our complimentary upcoming workshop:

Novel clinical supply strategies and technology to deliver a patient centric supply chain

This workshop will provide you with an understanding of key milestones that directly impact clinical trial supply and will explore current and projected shifts in the clinical trial landscape which require sponsors to be more adaptive and responsive to change.

Throughout the workshop our subject matter experts will guide you through best strategies for your clinical trials to support speed, agility and patient centricity, whilst translating supply concepts into a plan that can be delivered.

When conducting clinical studies within the EU all Investigational Medicinal Products (IMPs) must be certified by a Qualified Person (QP) prior to release for use in a Clinical Trial. Our QP will explain the release process which can be daunting for Sponsors who are unfamiliar with EU requirements.

We will also cover industry changes and best practices to ensure that the supply chain is prepared for the changes expected in the clinical research arena in the future.

The workshop will run from 1pm until 5pm followed by a complimentary networking reception until 7pm.

Date: Wednesday 28 June 2023
Reception desk opens at 12.30pm
Seminar: 1.00pm – 5.00pm
Reception: 5pm – 7pm

Venue: JW Marriott Hotel Seoul
Address: 176, Sinbanpo-ro, Seocho-gu, Seoul, South Korea, 06546
Directions:https://www.marriott.com/en-us/hotels/seljw-jw-marriott-hotel-seoul/overview/

Registration has been closed on Wednesday, June 14th. If you have any questions, please contact our sales representative.

Time Topic What you will learn
12.30 – 1.00 Registration
1.00 – 1.20 Welcome
  • Almac company overview
  • Positive changes and outcomes of the post-pandemic world
  • Digitalisation, patient centricity and the future for clinical supplies
1.20 – 2.00 Choosing the best strategy for your trials to support speed, agility and patient centricity
  • Planning, Forecasting and Supply Chain Management models
  • Consideration of therapeutic area, patients and regions involved - building flexibility into the design of your study
  • What strategy best fits your clinical trial – decentralized, site/patient model or hybrid approach
  • Building IRT development into your plan
2.00 – 2.20 Coffee beak
2.20 – 3.00 Translating your supply concepts into a plan that can be delivered
  • Implementing your supply plan
  • Removing label text and translations from the critical path
  • What strategy best fits your clinical trial – decentralized, site/patient model or hybrid approach
  • Manufacturing and logistics models to deliver your strategy
    • Bulk manufacturing
    • Just in Time Manufacturing
    • Direct to Patient solutions
  • The importance of temperature management, control and tracking solutions throughout the supply lifecycle
3.00 – 3.20 Coffee beak
3.20 - 4.20 Quality release to facilitate the implementation of new supply chain strategies
  • QP Release requirements for the EU
  • Putting your patient at the centre of the supply chain
  • Impact of the EU Clinical Trial Regulation
  • Maintaining and enhancing quality
4.20 – 4.50 Open Panel Forum Almac experts will take questions provided in advance or raised during the workshop and will provide answers and insight to support you and your clinical projects. Almac experts will be available to discuss:
  • Decentralised Clinical Trials
  • Demand Led Supply Chain Management
  • Make best use of Interactive Response Technology (IRT)
  • Just in Time Manufacturing
  • Direct to Patient solutions
  • QP release process
  • Patient centricity
  • Future of the clinical research arena
4.50 – 5.00 Workshop close and thank you
5.00 – 7.00 Networking reception

 

Global expert speakers

Jonathan Calderwood

Director Commercial Development
Jonathan Calderwood has a BSc (Hons) in Biochemistry and a Post-Graduate Diploma (PGDip) in Computer Science from Queen’s University Belfast. Jonny has over 25 years’ experience in the pharmaceutical industry, joining CTS as a Production Supervisor, then holding several key roles in Project Management and Business Development. During this time, he also achieved CIM Post Graduate Diploma in global marketing. Currently Jonny holds the Commercial Director position, responsible for leading the global marketing function.

Aidan Gribbon

Qualified Person
Aidan Gribbon is a Qualified Person with over 10 years’ experience in the pharmaceutical industry covering several dosage forms, including ATMPs, Biologics and small molecules.
 
Aidan joined Almac in 2014 where he has held multiple quality roles before qualifying as a Qualified Person in 2020. He is involved in the day-to-day activities of a QP, responsible for the assessment of supply chains to support the issuance of QP Declarations and the review of batch documentation against regulatory submissions as part of the certification process.  His role involves educating sponsors on the regulatory requirements, providing consultancy in all aspects of QP Certification. 
 
Aidan is passionate about working with sponsors to support their clinical trials, focusing on quality to ensure patient safety and regulatory compliance.  Aidan has an honours degree in Biological Sciences from Queen’s University Belfast.

Nathan Kohner

Supply Chain Solutions Group Manager
Nathan has been with Almac since 2005 and has over 18 years’ experience in Clinical Trial Supply Chain Operations including Clinical Supply Chain Management, Temperature Controlled Distribution and Project Management. This wealth of experience has given him a passion in delivering excellence in customer service to help reduce timelines and clinical trial complexity for sponsors. In his current position as Supply Chain Solutions Group Manager, he is responsible for providing innovative solutions across the Almac Clinical Services offering to help drug development companies meet todays and tomorrows challenges. Nathan graduated with a Degree in Mathematics from Edinburgh University and has a Diploma in Management and Leadership.

Kate Park

Head of Business Development, APAC
Joining Almac in 2015, Kate has over 18 years of extensive commercial experience in the healthcare industry, having held various regional leadership roles across Medical Devices, Pharmaceuticals and Contract Manufacturing firms in the Asia Pacific region.
 
As the Head of Business Development in APAC, Kate is responsible for leading a team of business development professionals in identifying and developing new business opportunities with companies that are seeking to outsource their clinical trials. Kate is also responsible for building and maintaining strong relationships with key stakeholders in the industry and driving growth and success for both Almac and its clients in the dynamic and rapidly evolving market.
 
Kate holds an Executive MBA from the IE Business School (Madrid, Spain) and dual bachelor’s degree of Bioengineering and Business Administration. Kate also holds a certificate in Medical Device Regulatory Affairs.