Clinical Trial Supply West Coast 2023

Developing best practices and incorporating novel technologies to meet the demands of a more complex, international clinical trial supply chain

9 - 10

May

2023
  • Burlingame, CA, United States
  • Complimentary
close

Why attend?

WHAT TO EXPECT FOR 2023?

CTS West Coast is the meeting place for pharmaceutical and biotech experts to discuss key themes and opportunities to take control and optimize clinical supply chains.

120+

Attendees

25+

Exhibitors

20+

Speakers

120+

Attendees

25+

Exhibitors

20+

Speakers

See What It's All About

2022 Agenda

  • 13 Apr 2022
  • 14 Apr 2022
Expand All

7:45 AM

Registration and refreshments

8:25 AM

Chair’s opening remarks

8:30 AM

Leaders’ Panel Discussion: 2020 & 2021 – How did we do? Exploring the Impact of a Disrupted 2 Years on the Global Clinical Supply Chain

After the disruption of 2020 and 2021 (and early 2022!), we are offering this opportunity for the industry to come back together to share ideas and reflect on the past 2 years. Our panel will share their experiences and thoughts on the challenges and successes since we were last together in 2019 and we also welcome audience participation.

Discussion points include:

  • 2020 & 2021: how did we do? How badly impacted were your supply chains?
  • How did you find remote working? What were the positives and negatives of the 'new normal'?
  • How has COVID impacted our patients, partners and businesses
  • A glimpse into recovery: what strategies and mitigation factors helped you to overcome the challenges of the past year?

9:15 AM

From Protocol Draft to LPO, How to Keep Your Clinical Supply Planning Under Control

  • Challenges and limitations of clinical demand planning
  • Connecting the dots to get global visibility on your supply need – Understanding how robust and reliable forecasts avoid unnecessary wastage
  • Collaborating with ClinOps, CMOs & IRT vendors to build a resilient supply chain strategy from protocol draft
  • Learning how to leverage patient actuals and realign your forecasts and the associated supply strategy

9:45 AM

ASK THE EXPERTS: How to Ensure your Clinical Supplies Pass US Border Control from the CBP Perspective

  • Breaking down all that you need to know about CBP and other agency importation requirements to facilitate clinical supply shipments
  • Receive detailed information on how to correctly declare biological products at the US border (Ports of Entry)
  • Discover which biological products may have transportation restrictions that must be factored into your clinical supply chain strategy
  • Covering the importance of permit requirements, including looking at whether a biological material may be hand-carried in the air environment, and what the proper labelling and packaging criteria are

10:15 AM

Preparing for your Upcoming Clinical Trial: Avoid the Pitfalls that can Delay Study Timelines

  • Top tips in successful study start up
  • Common pitfalls and how to avoid them
  • Lessons learnt and advice in maintaining study timelines

10:45 AM

Morning refreshments and networking

11:15 AM

Building a Clinical Supply Chain From Scratch

  • Evaluation of current supply chain makeup
  • Deep dive on projected future demand
  • Finding the right people and developing the process to get you there
  • Laying it all out: Regulatory, Finance, Clinical, and Operations
  • The key to successful execution

11:15 AM

AI & Disruptive Technology: Harnessing the Future of Artificial Intelligence to Transform Supply Chains

Delving into the world of AI and Big Data to identify how it can support decentralized trials; site selection; advanced data analytics; robotics and process automation in supply chains; blockchain and voice-enabled technologies. Case study examples given for time and cost savings when implementing AI and machine learning tools.

Our expert speaker will give a 20min presentation followed by 10mins audience Q&A.

11:45 AM

One Size Does Not Fit All…..Global Diversity Requires Supply Strategy and Vendor Diversity

  • Global Diversity – Understanding how different countries, cultures, healthcare systems and distribution processes have an impact on supply strategy selection
  • Supply Strategy Diversity – Understand the value of a supply partner who can provide supply strategy diversity
  • Vendor Diversity – Understand the value of a supply partner who can provide services beyond supplies

11:45 AM

Case Study Proofs: How the Implementation of Drug Supply Automation Tools Reduce Waste and Cost

  • Identifying study designs where cost and waste can be reduced through automation
  • Applying case study success to your trial
  • New ways to optimize IP and drug supply operations

12:15 PM

FDA response to COVID-19 related challenges – lessons learned during the first year of the pandemic

  • FDA Organizational leadership changes
  • OEIO's involvement in the supply chain for Covid-19 vaccines, PPE and test kits
  • Lessons learned from the Covid-19 pandemic from the FDA ORA perspective

12:45 PM

Lunch and networking

12:45 PM

Lunch and networking

2 PM

Movement Towards Decentralized Trials

We welcome Scotty Chung-Siu to present his research into the current trends towards decentralized trials.

This session will cover:

  • A review of how big pharma have reacted to the trend: who is going virtual with their trials?
  • supply chain concerns due to COVID-19
  • Predictions for the future

2 PM

Blockchain use in the Clinical Supply Chain Management

2:30 PM

Using Modern Technology to Mitigate Supply Chain Risk from Unpredictable Demand

There will always be unpredictable demand within a clinical trial, which introduces risk and complexity into the supply chain. This is why it's critical for supply managers to not only have awareness of these complexities but also to have a clear understanding of how best to mitigate them within their trials. In this session, we will highlight prominent areas of risk and how modern trial technologies can help supply managers overcome them through more-informed supply decisions at every stage of the study lifecycle, from early-stage feasibility planning, all the way to trial completion.

2:30 PM

Behind the Scenes of Clinical Supplies and Comparators: The Latest Regulatory Perspective

  • Insights on Regulatory & Compliance Directives around the globe: what's happening
  • Difference between local frameworks and global harmonized procedures, what to look for and how to prevent surprises
  • Understanding single market characteristics to disseminate innovation in sourcing and distribution.
  • Considerations on how to promote Decentralized Clinical Trials (DCT) while following current guidelines

3 PM

Afternoon Refreshments, Networking & Prize Draw

3:30 PM

Q&A Session: Demand Forecasting for Clinical Sites and IRT Inventory Management

  • A chance to join this discussion forecasting site demand, including for prospective subject visits versus existing subject visits
  • Explore how to manage important dates in the IRT system, including Do Not Count, Do Not Ship and Do Not Dispense dates
  • Learn together more about key site IRT resupply strategies using the Pre-Allocation, Basic Min/Max, and Predictive tools
  • Receive tips on how to effectively manage resupply operations and inventory and offer your own tips on this subject

4 PM

KEYNOTE PANEL – Digital Transformation and Expanding on Innovation Lessons Learned through COVID-19

  • What trends addressing the current supply chain challenges will remain a part of the clinical landscape moving forward?
  • How will trial designs shift and how will supply chain strategies change as a result?
  • Direct-to-patient shipment - where does it work, how to navigate its associated challenges?
  • Speaker TBC, N-SIDE

4:45 PM

Chair’s Summary and Close of Day 1

5 PM

Drinks Reception

8:15 AM

Registration and Refreshments

8:50 AM

Chair’s Opening Remarks

8:55 AM

Utilizing IRT Reporting and Functionality for Demand and Supply Planning

  • Considering ways that IRT systems improve clinical trials supply management
  • Looking at strategies to ensure that demand-planning and forecasting solutions integrates with IRT, including adopting user-friendly web-tools
  • Thinking about ways to streamline system validation
  • Understand regulatory compliance requirements for using IRT processes in your supply chain
  • Make the most of your IRT system to track your product during shipment and patient distribution to maintain control over your clinical study

9 AM

Q&A Session: Preparing for a clinical trial: choosing the right CMO to manufacture your product

  • Balancing cost with quality when selecting a CMO
  • Understanding increasing complexity in clinical setup with different CMOs and shared sponsoring
  • Ensuring the best setup to work constructively with your CMO

9:30 AM

What’s Been Keeping Clinical Supplies Professionals Awake at Night?

  • Summary of Annual Surveys of Clinical Trials Supplies Professionals
  • What has been keeping us awake at night?
  • What solutions have been tried out?
  • Some key insights and take-home messages
  • Your chance to shape future surveys

9:30 AM

Moving Beyond the Status Quo: Tools to Manage Your Supply Chain with Flexibility, Visibility and Control

  • Explore why and how a responsive IRT approach can improve supply chain efficiency. In this presentation, we will discuss:
  • Challenges to optimizing clinical supply chains
  • Leveraging technology to create real-time visibility and streamline drug supply management
  • Deep dive in how trials are using flexible IRT to gain control over their supply chains

10 AM

Q&A Session: Empowering Excellence in Supply Through Digital Quality Management Systems

Join this informal discussion session where we will be covering such questions as:

  • Exploring how to introduce a new digital quality compliance management system
  • What is critical to get right to make a digital QM System work
  • How do you arrange with and clean the large amounts of data generated?
  • Examining how, even as a small company with limited resources you can successfully introduce time and cost saving QMS measures
  • Can you share some of your workflow procedures?

10 AM

Cloud Migration: From Server Room to Cloud

Since its inception in 2016, the Parker Institute for Cancer Immunotherapy (PICI) has heavily leveraged Cloud-based architecture, but with the onset of COVID and the remote work model, PICI launched a yearlong initiative to be a fully cloud-based organization. Toby Odenheim will cover the benefits and challenges of migrating to the cloud.

  • Business Drivers
  • Cloud Architecture
  • SSO & Security
  • System Validation & Compliance
  • Recommendations & Lessons Learned

10:30 AM

Morning refreshments and networking

11 AM

Q&A Session: Overcoming Pain Points in Supply Chain

Join this informal Q&A, where we will be discussing such questions as:

  • What are the main pain points in supply chain that companies face?
  • How to improve the sponsor/CRO relationship
  • What are the main impacts of the pandemic that are still disrupting supply chains and discussing advice for ensuring supply chain stability in disrupted times
  • Reviewing and debating new technologies to help overcome challenges in supply chain

11:30 AM

A Practical Look at Direct-to-Patient Shipment

  • Reflect on how it was applied as a response to the pandemic
  • Highlight the risks of DtP and how they can be mitigated
  • Discuss how to approach a direct-to-patient strategy
  • Consider how the process can be improved in the future

12 PM

Audience Discussion Roundtable Session: Ensuring Your Clinical Supplies Pass US Border Control

Join this interactive roundtable session which offers a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

12:30 PM

Lunch and Networking

1:30 PM

QUICK FIRE ROUNDS: The Patient Perspective

Our 2 expert speakers will each give a 10minute quick fire presentation on creating patient-centric trials, patient advocates and boosting patient engagement. The session will end with an audience Q&A.

  • Working with patient advocacy groups from pre-study start-up to facilitate engagement
  • Overcoming the barriers and challenges in patient engagement
  • Understanding where patient engagement gives you an edge over your competitors
  • Getting patient more involved in the trial design decision-making process
  • Seeing patients as passionate advocates for your trial utilizing their voice to engage others

2 PM

Key Randomization & Trial Supply Considerations: Starting your study on the right foot!

  • Strategic planning for your randomization and trial supply needs
  • Walk through a Study Start-Up Cheat Sheet to support critical initial discussions
  • How a flexible/feature rich IRT/RTSM platform can simplify the process and ensure IRT Success

2:30 PM

Leveraging Mobile Health Technologies to Engage Patients and Reduce Timelines

  • Acknowledging the challenges of implementing mobile health within clinical trials and potential solutions
  • Highlighting the benefits of mobile health for patients and sponsors alike
  • Showcasing industry efforts to enable patient technologies to become a reality
  • Appreciating regulatory buy-in and the opportunity this presents sponsors and suppliers alike

3 PM

Afternoon Refreshments, Networking & Prize Draw

4:30 PM

Chair’s Summary and Close of Conference

2022 Speakers

Select a speaker to learn more

Back
HEATHER DIFRUSCIA
VP, Randomization & Trial Supply Management, Axiom Real-Time Metrics
Next speaker
Back
CRAIG MOONEY
VP, Scientific ETech Enabled Services, Calyx

Craig joined Calyx in 2021 as Vice President Scientific eTech Enabled Services, Craig has nearly 30 years of experience in the clinical trial arena including clinical operations, IMP packaging, labeling & logistics, with a primary focus in Interactive Response Technology (IRT). In his current role Craig’s remit is to: Leverage experience as an IRT business owner & sponsor to drive excellence in product, project management, and commercialization; Consult with clients on IRT best practices and emerging trends in the regulatory landscape; Serve as an advocate for sponsors within Calyx through expanded partnership engagements; And contribute to the industry as an evangelist for IRT and its proper role in clinical trials.

Next speaker
Back
MARC LISI
Co-Founder And Director, Customer Solutions, Suvoda

Marc has spent his entire career in the eClinical technologies space, with most of that time focused in the area of IRT. Having spent years on the client services side, Marc has worked with 7 of the top 10 pharmaceutical companies and 6 of the top 7 CROs to design, implement, and maintain IRT solutions across a variety of therapeutic areas. As a Co-founder and Director of Business Development at Suvoda, Marc uses his IRT subject matter expertise to provide creative solutions to customers’ problems, all while growing Suvoda’s business globally. Marc enjoys creating long-lasting relationships with customers and colleagues and loves brokering introductions within his network. Marc is a graduate of Lafayette College with a degree in biochemistry and minor in music.

Next speaker
Back
Ian Hoban
Business Development Director , Abacus Medicine Pharma Services

Ian has over 30 years of pharmaceutical industry experience, predominantly within global organisations such as Pfizer and Eli Lilly.  He built his reputation in the commercialisation of numerous brands in a variety of disease areas, and at every stage of the product lifecycle.

During his career, Ian has worked closely with supply chain, ensuring accurate forecasting, and getting medicines to patients through the implementation of novel approaches.

Before joining Abacus Medicine Pharma Services Ian worked in senior roles at two leading global clinical solutions companies.  He provided many leading pharmaceutical and biotechnology companies with successful comparator sourcing solutions which helped successfully deliver their pivotal late phase clinical trials.

Next speaker
Back
ISAAC BLUM
Senior Manager Of Clinical Supply, ALX Oncology

Isaac Blum is currently the Senior Manager of Clinical Supply at ALX Oncology in South San Francisco, California. Previously, Isaac oversaw clinical supply chain operations at Puma Biotechnology and Sangamo Therapeutics. Isaac is excited about optimizing drug supply operations to help advance innovative, life-saving treatments. He has used his expertise to launch multiple global oncology clinical trials, and enjoys collaborating with others in the field through speaking at conferences and workshops. In his free time, Isaac enjoys hiking, running and spending time with his family.

Next speaker
Back
Edo Madussi
Managing Director, Euromed Pharma

Edo Madussi is the Managing Director, of Euromed Pharma US and Business Unit head of the Clinical Trial Division at the Petrone Group.

His business experience combined with his academic background and four spoken languages - English, German, French, and Italian - brought him to develop an extensive network within the global clinical supply chain space.  He is currently developing one of the latest ventures of the Petrone Group: a US-based integrated platform to support Clinical Trial Sponsors and other industry players around the world with a wide range of services in the R&D space.

Next speaker
Back
Tom Gottschalk
Director Business Development, Trialcard

Tom has worked in the life sciences industry for over 20 years, initially as a pharmaceutical representative and then as a pharmaceutical product manager. Over the past 10 years Tom has become an expert in providing sponsors and CRO’s with an innovative clinical supply process that is patient centric, saves clinical operations and supply management teams time and saves sponsors money.

Next speaker
Back
PHIL CHOU
Director, Clinical Supply Chain, Assembly Biosciences, Inc.

Phil is a supply chain professional working exclusively in the clinical space for over 15 years. He has managed all aspects of clinical supply, packaging and labeling and distribution, IXRS setup and management. He has worked with the following companies: Rainier Therapeutics Aimmune Therapeutics Myovant Sciences Onyx Pharmaceuticals Elan Pharmaceuticals

Next speaker
Back
TOM SCHIAVON
Sr. Analyst, UAT And Validation, Clinical IRT, Bristol Myers Squibb

Tom is currently serving as a Senior UAT Analyst for Bristol Myers Squibb. Most recently, he worked in clinical systems role for Ultragenyx Pharmaceutical, overseeing IRT, CTMS, eCOA, eConsent, CGM, and wearables systems and processes. Previously, he worked as an IRT senior project manager at Amgen, built and managed international technical support and data management teams, and worked as an IRT project manager, both at endpoint clinical. He has managed projects in the therapeutic areas of hematology & oncology, pain, bone, cardiovascular, and dermatology, from early-phase oncology through post-marketing studies. He graduated summa cum laude with a B.A in Philosophy and History from Florida Gulf Coast University, where he also earned an M.A. in English. He has published several articles on process improvement, change management, and making IRT concepts more accessible to sponsor study management personnel.

Next speaker
Back
LOUIE BURKS
Associate Director Clinical Supply, Allakos

Experienced Project Manager in Product Development, Supply Chain, Business Operations and Logistics, and Change Management

Next speaker
Back
YUYI SHEN
Sr. Dir, PD, MFG & Supply Chain, Abcuro
Next speaker
Back
Ravi Kiron
Head, BioPharma External Innovation, EMD Serono,

Dr. Ravi Kiron based in California, USA is an experienced pharma/biotech executive with decades of experience in discovery R&D through late-stage clinical development, intellectual property and regulatory, technology & business development, M&A, strategy and product commercialization, negotiating and executing partnerships by leveraging his extensive global business development networks in CVMD, Oncology, CNS, Wound Healing, Microbiome and Diagnostics.

He was a tenure-track faculty member at Cornell University Medical College and adjunct faculty at University of Rhode Island. Dr. Kiron served in various operational & management roles at Pfizer Inc., and J&J/ALZA, in Cardiovascular R&D, Oncology clinical development (Tarceva), strategic business development and M&A (acquisition of WLA, PHA & other biotech).  Dr. Kiron has consulted for several dozen global biotech & pharma companies, founded and led multiple companies/new ventures, served as an Entrepreneur In Residence (EIR) at SRI Ventures, ShangPharma Innovation and advises company and non-profit boards. ​

Currently, Dr. Kiron is Head, BioPharma External Innovation at the Merck KGaA/EMD Serono’s Silicon Valley Innovation Hub in Menlo Park, California and is exploring cutting edge game changing technologies (Artificial Intelligence & Machine Learning, Microbiome, Electroceuticals etc.) to have an impact on pharma/biotech research, product development and launches.

Next speaker
Back
Dan Solis
Division Director, Division Of West Coast Imports, FDA

Experienced Import Director with a demonstrated history of working in the government administration industry. Skilled in U.S. Food and Drug Administration (FDA), Good Laboratory Practice (GLP), Import, Government, and Life Sciences. Strong operations professional with a MHA focused in Health/Health Care Administration/Management from University of La Verne.

Next speaker
Back
GINA RENEAU
Biological Threat Exclusion Coordinator, US Customs And Border Protection
Next speaker
Back
GINA FRANKLIN
Vice President Of Clinical Operations, NAPO Pharmaceuticals
Next speaker
Back
IRENE SZETO
Executive Director, Global Digital Quality Management Systems And Business Intelligence, BeiGene
Next speaker
Back
KEITH STOKKE
Client Director, 4G Clinical
Next speaker
Back
NICOLE MARXER
Business Development Manager, World Courier
Next speaker
Back
Toby Odenheim
Senior Vice President, R&D Technology, ProPharma Group & Technology Consultant, Parker Institute For Cancer Immunotherapy

Toby Odenheim is the former Director of Technology and Governance at the Parker Institute for Cancer Immunotherapy (PICI). He is now Senior Vice President, Research & Development Technology at ProPharma Group.

Committed to accelerating the development of new medical treatments through effective technology adoption and continual process improvement.

Next speaker
Back
Maxime Derep
Life Sciences Senior Consultant, N-SIDE
Next speaker
Back
Antoine Remiot
Clinical Supply Optimization - Director Solutions Engineering, N-SIDE

Antoine Remiot has been sharing his enthusiasm and technical advice to various pharma partners, helping them tackle clinical trial supply challenges and solve drug shortage. He truly enjoys complex situations where he can use his skills to solve tricky problems. Antoine has a Master’s Degree in Mechanical Engineering with a focus on optimization. After working for various optimization software companies in the aeronautical market, he joined N-SIDE to focus on new pharma companies

Next speaker
Back
CHRIS DRIVER
Director, IT Architecture, IQVIA

Chris Driver is currently Director, IT Architecture at IQVIA, with over 20 years of experience in the IRT and Biotechnology space, and across a number of R&D and Information Technology functions. Chris’s experience and background in infrastructure architecture, global health platforms and more recently, decentralized trial adoption through real-time integrations, drives his enthusiasm for the future state of patient-centered health care. In his “downtime”, Chris enjoys spending time with his growing family, advocating for adoption, especially for those blessed with an extra chromosome!

Next speaker
Back
Frank Leu
CEO, Novapeutics,

Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman, speaker, moderator, and facilitator for many life-sciences and drug development events.

Next speaker
Back
Scotty Chung-Siu
Senior Analyst, GlobalData Healthcare
Next speaker
Back
Prasun Mishra
Founding Partner, World Investors and Entrepreneurs Society

Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American
Association for Precision Medicine ( and chair of ACT AAPM’s Coronavirus Taskforce He
is leading research efforts focused on preventing curing chronic diseases not only treating
the sick but also providing knowledge/tools to individuals to live longer, healthier lives

He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company
committed to revolutionizing drug discovery development through technology, big data,
robotics, and artificial intelligence He is a serial entrepreneur who founded his first company
after graduating high school, and his second company during his Ph D Since then, he has
accumulated a wealth of experience by building, investing, and advising numerous other
companies He is an investor, co founder/ board member of a few corporations, focused on
accelerating drug discovery/ development, data analytics, robotics, mental health, and digital
health He is also the founder of AAPM Angels and Investors AAi an investment group focused
on investing in drug discovery, diagnostics, precision medicine, technology healthcare
companies He is also the founding investor and advisor to Barcelona Ventures and serves as an
advisor to a 100 M private equity fund

Widely recognized as a thought leader in the field of ‘technology and healthcare’, Dr Mishra has
keynoted, chaired, curated, and organized numerous successful international conferences He
served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where
he participated in several drug discovery project teams Moreover, his passion for drug
development and precision medicine has led to the identification of new drug targets,
biomarkers, companion diagnostics, and several drugs/ combinations in the clinic

His research work has been recognized globally by over 40 prestigious awards and honors Due
to his unique perspective selfless service, he is a highly respected sought after mentor to
many The companies that he has advised have raised multimillion dollars Notably, he serves
as a mentor and advisor to several VC funds and startup accelerators, including IndieBio
HIMSS/Health 2 0 ’s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture,
UCSF Invent Fund, and California Life Sciences’s FAST program, to help grow California’s life
sciences innovation ecosystem

Next speaker
Back
RYAN MILLS
Director, Supply Chain, Denali Therapeutics
Next speaker
Back
BRITTNEY ELKO
Director, Supply Chain, Tricida

Brittney is Director, Head of Supply Chain at Tricida where she is responsible for the clinical supply group managing investigational drug and ancillary supplies for Tricida's global 1600 patient confirmatory post marketing trial for TRC 101 as well as the commercial supply chain group preparing for the launch of TRC 101 / Veverimer in the later part of 2020. Brittney has more than 12 years of experience working in both technical development and supply chain organizations. Prior to Tricida, she was at Intarcia and Genentech where she managed all aspects of supplying clinical trials. From developing forecasts from protocols, translating these forecasts to manufacturing plans and appropriate inventory levels, assessing the supply status of clinical sites and putting in place delivery plans that take into account production, release and distribution timing to ensure no stock-out situations at clinics, Brittney has extensive experience in forecasting creation and hopes to share those tools with you today. She also managed the commercial supply chain for the Clorox Disinfecting Wipes business, dealing with un-precedented demand changes through the H1N1 flu outbreak.

Next speaker
Back
David Larwood
CEO, Valley Fever Solutions

David Larwood is a founder, the CEO, and chief chemist for Valley Fever Solutions, running the manufacturing process for a novel antifungal headed for Phase 2a trials in 2022. In his role as BD lead, he is responsible for many aspects of the company’s planning and operations.

Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis), for which NikZ will transform the standard of care. NikZ shows promise against other important fungal diseases.

Mr. Larwood co-invented his first two commercial molecules before age 30. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today. At UCSF he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. Earlier as a bench chemist, he was the first to make Iotrolan, a CT X-ray contrast agent, generic for decades, replaced in about 2005 by newer agents.

Moving to law, in leading law firms he advised major companies on patent matters. After 3 years as a patent lawyer at Apple Computer, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through successful acquisition in 2005.

Mr. Larwood is the third of his family to be involved in Valley Fever.  His father was a physician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever.

Next speaker
Back
Sean Smith
Biological Threat Exclusion Coordinator, US Customs And Border Protection

Sean Smith is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Agro/Bio-Terrorism Countermeasures. As a BTEC, Mr. Smith is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S.

Mr. Smith joined CBP in 2005 as an Agriculture Specialist (CBPAS) and was promoted to Supervisory CBPAS in 2008. He has served CBP in the following ports of entry: San Diego, San Ysidro, Otay Mesa and Boston Logan Airport. From 2011- 2018, Mr. Smith served as the primary Public Affairs Liaison and Border Community Liaison, respectively, for CBP in New England. He has also volunteered to assist in past domestic and international CBP disaster recovery operations, including: Hurricane Ike (2008), 'Operation Safe Return' (Haitian Relief Effort- 2010), and Hurricane Harvey, DHS Surge Capacity Force (2017).

Prior to CBP, Mr. Smith contributed to wildlife conservation for nearly a decade, completing field work on rare endemic Hawaiian birds on the Big Island of Hawaii, and raising rare and endangered birds (in some cases, extinct in the wild) at the San Diego Zoo's Avian Propagation Center. Also, Mr. Smith is a former reserve firefighter and EMT for the City of Borrego Springs in California. He holds a Bachelor of Science degree in Ecology and Systematic Biology from Cal Poly San Luis Obispo, California.

Mr. Smith, his wife, two children, one dog, and one chicken live in an old farmhouse in Massachusetts.

Next speaker
Back
CHRISTINE VON RAESFELD
Independent Patient Advocate

Few people with a cause walk the talk as boldly and graciously as Christine Von Raesfeld, founder and CEO of People with Empathy. Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. Through the lens of her lived experiences in healthcare, she has become a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. Christine has brought her unique perspective and honed expertise to countless roles as a featured speaker for numerous conferences dedicated to the rare disease community and disease awareness initiatives. Wherever possible, Christine generates momentum toward progress along her patient advocacy interests and stimulates dialog on a range of topics relevant to patients, clinicians, and industry. As a patient advisor, Christine has assisted several initiatives including the Stanford "Humanwide" Precision Medicine Program, All of Us Research, and the 23andMe Lupus initiative. For her many contributions to her field, she has been named one of the top 100 Women of Influence by Silicon Valley Business Journal, a member of the 2021 HIMSS Future 50, and one of Medika Life's medikal life 50 most influential voices in healthcare 2022 among other distinctions. With her guidance and support, we will continue to optimize the patient journey for people worldwide.

Next speaker
Back
Estela Mata-Carcamo
President, Healthcare Advocate Looms for Lupus
Next speaker

Sponsors

Select a sponsor to learn more

Featured Sponsor

Session Sponsors

Associate Sponsor

Exhibitors

Media Centre

Become A Media Partner

A FANTASTIC NETWORK OF YOUR PEERS AND COLLEAGUES

Simply register, login on the day and get ready to connect and learn.

The CTS West Coast is the meeting place for pharmaceutical and biotech experts to discuss key themes and opportunities to take control and optimize clinical supply chains.

See What It's All About

Enquiry

Contact Us

SPONSORSHIP ENQUIRIES

Jaz Sidhu

Senior Sponsorship Manager

+44 (0) 207 9472755

SPEAKING OPPORTUNITIES

Ruth Atterbury

Portfolio Manager

+44 (0) 20 4540 7796

MARKETING ENQUIRIES

Moona Popal

Marketing Manager

+44 (0)20 7661 8812

Sponsorship Enquiries

To enquire about sponsorship opportunities for the conference, please contact:

 

Jaz Sidhu

Senior Sponsorship Manager


+44 (0) 20 7947 2755

Speaker Enquiries

To enquire about speaking opportunities for the conference, please contact:

 

Ruth Atterbury

Portfolio Manager


+44 (0) 20 4540 7796