clinical trials | FOCM Networking

June Networking Event Summary

June 12 FOCM | GLSA Online Networking Event Recap

2024 Mid-year Highlights: A Successful Gathering

On June 12, FOCM and Global Life Sciences Alliance (GLSA) hosted an engaging online networking event focusing on the 2024 mid-year highlights. The event saw a robust turnout with 35 participants, blending familiar faces with new members, fostering a vibrant and dynamic discussion.

Opening Remarks and Industry Updates

Chris Matheus kicked off the event with a warm welcome, introducing new members and setting the stage with industry updates, news, and conference reviews. Participants shared their travel plans, locations, and upcoming trips, adding a personal touch to the professional gathering.

Networking and Collaborative Initiatives

The meeting adopted an open house format, encouraging participants to share their LinkedIn profiles for seamless networking. Chris also promoted the Women of Life Sciences virtual event and called for volunteers to judge the best giveaways at the upcoming DIA, led by Sheila Mahoney-Jewels (smj@lifescihub.com).

GLSA’s Mission and Conference Insights

The GLSA reiterated its mission to provide solutions for clinical trial issues. Michael Young, Brian Langin, Cameron Robinson, and Denise McNerney shared insights from the BIO conference, which boasted over 19,000 attendees. Michael also reviewed the heavily attended ASCO conference, noting a significant presence of first-time exhibitors and attendees.

Business Update and Market Analysis

Chris Matheus presented a detailed analysis of the business performance in the first half of the year. He discussed the initial surge in activity, followed by a slowdown in decision-making and funding optimism. Chris also covered the recent Federal Open Market Committee meeting, touching on global uncertainties and their potential impact on market trends, including the upcoming US presidential election and geopolitical tensions.

Advances in Drug Approvals and Precision Medicine

Recent advancements in drug approvals for NASH/fatty liver and Alzheimer’s were highlighted, with Michael Young discussing precision medicine’s role in oncology drug development. Notable Labs’ blood test and Keliomics’ ex vivo tumor models, presented at ASCO, were showcased as revolutionary innovations that could transform early-stage development.

AI and ML Applications in Clinical Trials

Chris Matheus explored the applications of AI and machine learning in clinical trials. He highlighted the potential for large-scale simulations and AI tools to predict patient enrollment and rank doctors. Despite enthusiasm, participants expressed skepticism regarding the current state of these technologies, particularly in patient enrollment and regulatory validation.

Challenges in Patient Enrollment and Hiring Trends

The discussion also addressed the challenges in patient enrollment post-COVID and hiring trends. Michael Young and Chris Matheus were optimistic about the resurgence of in-person conferences, citing high attendance at recent events. Lisamarie O’Brien highlighted the difficulties in hiring, emphasizing the need for smarter recruitment strategies and the role of AI in applicant tracking systems.

AI in Language Translation and Clinical Studies

Duncan Shaw highlighted the challenges of using AI for language translation and clinical studies, stressing the need for exactness and precision. The group echoed these sentiments, agreeing on the importance of patience and caution in evaluating AI’s potential in these areas.

AI and Budget Building Challenges

Mike O’Gorman shared concerns about AI’s capabilities in budget building, while Ira Snyder emphasized the limitations in obtaining precise budgetary details due to data quality issues.

Site Negotiations and Challenges

The slow progress in securing site contracts was discussed by Michael Young and Jane Myles, with Viljena Trask highlighting the competitive nature of oncology site selection. Eliana R. Burke shared an encounter with a highly experienced clinical trial site, and Ira Snyder emphasized the need for balanced negotiations for successful collaboration.

If you would like a copy of the slide set, email me at chris@focmnetworking.com

or if I did this correctly you can get it here: https://globallifesciencesalliance.com/wp-content/uploads/2024/06/2024-Mid-year.pdf

Looking Ahead

The next GLSA event is scheduled for July 17, with the subject yet to be determined. To stay updated on GLSA | FOCM events, sign up here. Stay tuned for more updates and we look forward to seeing you at our next event!

ATTENDEES:

(First time attendees in bold)

Judy Woods

Jane Myles

Viljena Trask

Bill Dirkes

Tom Lo

Lauren Sherwood

Ira Snyder

Cameron Robinson

Eliana Rivera Burke

Jared Byer

Joan Chambers

Lori Leathers

Jon Carlson

Christine Martin

Hiro Matsushima

Duncan Shaw

Lauren Merante

Lisa Marie O’Brien

Michael Young

Marlyn Brookins

Dr. Syed Rooh ul Arifeen Naqvi

Irene Rivera

Julia Oxley

Yuko Terasawa

GLSA

Denise McNerney

Jim Sarene

Kelvin Izevbekhai

Rocio Rayna Reyes

Timmina Williams

Chris Matheus

FOCM Networking a cold night

So on March 12, 2018 having given much more notice than usual, the plan was to have a FOCM networking event the night before the Outsourcing in Clinical Trials Southeast event. As fate would have it – the original location – Serenas on Highway 55 and Page Road in Durham was closed due to projected inclement weather (snow!). So last minute announcement went out to move it to Mez. These brave souls weathered (pun intended) the conditions and showed up. Their standing in FOCM was cemented with that effort.

FOCM Event at Mez (Drew Harrison, Derrick Ferrar, (name needed), Steve Caravaglio, me, Chad Pollio, Carol Miller, Pippa Wilson, Bernie Linner, (name needed)

Observations of DIA 2023

The first Drug Information Association (DIA) Annual Conference that I attended was the one in 1997 in Montreal. If one could look back at each of them through time lapse photographs quite a story it would tell. In bullet format:

The growth of the CRO industry through mergers and acquisitions
Scirex was the late night party sponsor
Fax and OMR/OCR data collection was a high-tech blip on the screen until –
EDC appeared with much noise but took longer than necessary to be adopted due to the inherent risk-aversion in the industry
Global trials for phase III studies
Patient recruitment via advertising had great stories to tell of saving trials
Transperfect is the late night party sponsor
Randomization and Drug Management system advances led to the ability to do increasingly complex trials and save millions of dollars in reducing drug waste
ePRO proved that paper diary data wasn’t reliable
Patient recruitment adjusted to pay for results (randomized patients)
eTMF vendors increase
Risk-based monitoring software appears
Integration of multiple sources of data
CluePoints is the late night party sponsor
Forced by Covid-19 we learned how to conduct decentralized trials, remote monitoring visits, mobile sites, tele-visits
Figuring out how to get EHR/EMR data into clinical trial databases
Insurance claims data allowing for Real World Evidence trials
The importance of patient diversity in clinical trials
AI gives a peek at our new future incredibly shortening study start-up: scan of protocol creates informed consent, eCRFs & edit checks, site instructions in 30 minutes not 8 – 12 weeks

These advances promise a brighter future for the population with illnesses seeking to be healthy and maximize quality of life.

I make a point of walking the entire exhibit hall every year. It allows me to sense the change in the needs of the industry, the new products, new services. I can also run into people who may have changed companies since our previous interactions. When I talk at the first time attendee orientation on Monday morning, I recommend everyone visit the exhibit hall and to be inquisitive – look at what the exhibitors are doing, ask questions, find opportunities to be helpful and/or build relationships and connections.

The content presented at DIA is prepared, submitted and presented by industry members who voluntarily do so. I encourage fellow industry members to submit an abstract. Abstract submissions are due September 14. The topics of interest and the instructions for submitting an abstract can be found here: https://www.diaglobal.org/abstract/meeting-details?productID=13251490&productcode=24001CFA

As a speaker, you receive a significant discount on the conference registration. It’s also a good addition to your career experience and can help you in networking and being seen as a key industry expert.

We hope to see you at DIA 2024 in San Diego.

May 2023 Networking Event Summary

May 17, 2023

As our passion is to connect people and companies we know and respect to other people and companies we know and respect, we open the meeting asking everyone to put the link to their LinkedIn profile in the chat. This facilitates future communication and connections.

Before we had our featured presenter begin, we shared industry info and upcoming events. A newish conference called: Clinical Research as a Care Option took place in Raleigh in mid-May. We mentioned that we’d be holding a networking event the night prior. It was stated that Joan Chambers would be attending. Joan recently joined Greater Gift as the CEO. Greater Gift’s mission is to increase awareness of clinical trials, especially among unrepresented communities, like women, ethnic minorities, individuals from diverse socio-economic and educational backgrounds. ds.

At this point, we had 21 attendees and we turned over the meeting to Steve Galen, PhD with Validcare. The focus of the presentation was to talk about how not to run out of funding before you get a read on the success of your product. Validcare has the tools and technology to forward plan a trial, find potential bottlenecks and prepare for them. With so many eclinical tools available, the predictability of the cost of a trial is greatly improved. This disruptive change shakes up the traditional and archaic approach of CRO’s low-bidding a project only to begin issuing change orders shortly after the study starts. Such an approach prevents the biotech from managing their financial spend. Steve is an experienced clinical research professional having worked at Merck, Covance, PRA, Syneos and Navitas.

Reminder of these meetings’ guidelines:

Think of this as an open house event – drop in when you can and leave when you need to;
When we have a presenter we have them start when we have assembled a strong amount of respondents – usually 10-15 minutes after the start.
Presenters’ topics are not sales pitches – the focus is on an aspect of clinical trials; where in the process their services are used and aspects of that step.
The link to get the GLSA newsletter and notifications about future live and virtual events: http://bit.ly/3UTb8hL
We ask everyone to put their LinkedIn link into the chat to facilitate connecting and future follow up.
To read the April summary https://focmnetworking.com/networking/april-2023-networking-event-summary/

Attendees:
Steve Galen, PhD, Validcare & the evening presenter
Ira Snyder, Consultant
Holly Jochims, Adaptive Clinical Systems
Joan Chambers, Greater Gift
Brian Langin, Diligent Pharma
Mike O’Gorman; Life Science Marketplace
Kevin Boos; Aixial Group
Amy Lee, PharmD
Michael Young, biomedwoRx
Ali Hussein, Science 37
Viljena Trask, Syneos Health
Sumitra Sheeri, S-Clinical

GLSA Attendees:

Katie Barrett
Joe Buser
Chris Matheus
Denise McNerney
Hannah Lloyd
Timmina Williams
Charity Dube
Jordan Brown
Sally Haller
Ori Geshury
Liz Mirra

March Networking Event Summary

The March FOCM | GLSA Networking event started out with welcoming everyone and reminding attendees of the meetings guidelines:

Think of this as an open house event – drop in when you can and leave when you need to;
When we have a presenter we have them start when we have assembled a strong amount of respondents – usually 10-15 minutes after the start.
Presenters’ topics are not sales pitches – the focus is on an aspect of clinical trials; where in the process their services are used and aspects of that step.
The link to get the GLSA newsletter and notifications about future live and virtual events: http://bit.ly/3UTb8hL
We ask everyone to put their LinkedIn link into the chat to facilitate connecting and future follow up.

In GLSA news: it was announced that co-founder, Denise McNerney had moved from Virginia to Florida. She is enjoying pointing out the weather to those north of where she now lives. I gotta say, she’s enjoying it a bit too much.

Cass Hui – founder of Heal Mary was then introduced to the attendees. She shared her story of how she came from the tech industry into the clinical research industry. Her mom first and then two sisters all had breast cancer. Cass encountered frustrations in finding clinical trials for them to consider and decided to apply her experience and skills to making this easier for others. Rather than becoming a patient recruitment company, she provides her service in the software as a service (Saas) model. Multiple patient advocacy and disease foundations are using her platform to inform people about clinical trials. https://healmaryapp.com/search

Cass utilized the kahoot.it platform to poll/question the attendees about clinical trial recruitment information. This was a fun way to get people thinking about the topic and led to a lively question and answer session.

After the Q&A, we broke into separate breakout rooms for people to introduce themselves, their companies and their needs to the others in the room.

The April event will feature Joseph Cheng with PiVOT CRO on the demographics, clinical research experience and capabilities of the Philippines.

Attendees:
Cassandra Hui; Heal Mary and evening presenter
Stacey Richardson; Parexel
Mike O’Gorman; Life Science Marketplace
Dave Gibboni, Beigene
Amy Lee; Kaiser Permanente
Loretta Cipkus Dupray; Global Clinical Connections
Peter Payne; Consultant
Matthew Plaud, Consultant
Nancy Zeleniak; Advocate Health
Joseph Cheng; PiVOT
Jean-Pascal Rugiero; SVM Pharma
Rodan Zadeh; Consultant
Kim New, ClinChoice
Duncan Shaw; DTS Language Services
Maria Frane; Corlexia
Gabrielle DeBoer; Consultant
Arti Bhosale, Sieve Health

GLSA Attendees:
Holly Cliffe
Sally Haller
Hannah Lloyd
Jordan Brown
Joe Buser
Timmina Williams
Megan Hoffman
Charity Dube
Chris Matheus
Denise McNerney
Ori Geshury
Liz Mirra
Alex Hoppe
Shiquita Hinton
Whitney Davis

A couple snapshots from the event are below:

December Networking Event Summary

The December FOCM | GLSA Networking event started out with welcoming everyone and a review of these meetings’ agendas summarized in the paragraph below.

For the newcomers, think of this as an open house event – drop in when you can and leave when you need to; when we have a topic and presenter we have them start when we have assembled a good number of people and that’s usually 10-15 minutes after the start.

There were several (ahem) great looking holiday sweaters and several pets were seen on camera as well. Candy Dupree won best outfit hands down. The link to get notifications about our future live and virtual events>> http://bit.ly/3UTb8hL

As our passion is to connect people and companies we know and like to other people and companies we know and like, we asked everyone to put into the chat the link to their LinkedIn profile. This allows for quick and simple connecting and facilitates future follow up.

We opened the event sharing industry updates, news, and/or gossip that anyone wanted to bring up. Chris shared that GLSA has contracted with two new clients: Validcare and Cool Chain to help the in their promotional and sales efforts. Validcare is disrupting clinical research with an all digital approach and fixed price study management. Cool Chain has shipping containers that can maintain a specified internal container temperature for 120 hours, be that sub zero frozen, frozen, refrigerated or room temperature. One of our clients Heal Mary, a SaaS AI enhanced patient recruiting platform has been awarded a project from a company we introduced them to and that will begin in February.

The group chose not to go into smaller breakout sessions, so we stayed in one room and talked about the holidays and what people’s plans were. We acknowledged the industry begins to get quite busy by the third week of January and we’re bracing for it.

Attendees:

Mike Burrows	Burrows Life Sciences Associates, PLC
Arti Bhosale	Sieve Health
Duncan Shaw	DTS Language Services
Nancy Zeleniak	Atrium Health
Debbie McCoy	Business Development Consultant
Michael Young	biomedwoRx; Life Sciences Consulting
Eric Nier	Block Clinical
Erica Hill	Marketing Consultant
Judy Carmody	Carmody Quality Solutions
Charles Speno	TrialX
Holly Jochims	Adaptive Clinical Systems
Kim Lupo	Portrett Pharmaceuticals
Nadia Bracken	Clinical Operations Director
Shruti Vashisht	Software Development
Chris Clancy	Medidata
Jon Matheus	A.T. Pancrazi Real Estate
Ori Geshury	Mirraponte
Liz Mirra	Mirraponte
Loretta Dubray	Global Clinical Connections
Mike O’Gorman	Life Science Marketplace
Candy Dupree	Adam’s Bridge Global

GLSA Attendees:

Denise McNerney
Chris Matheus
Joe Buser
Megan Hoffman
Charity Dube
Hannah LLoyd
Sally Haller
Timmina Williams
Holly Cliffe

A few screenshots from the event are below:

Networking Pictures from SCDM 2017

I recall a much simpler time. I know this confession will highlight my years of experience (nicer way to say “old age”). In my working life time there was a 2 decade period where people could get in touch with you 1 of 3 ways: call you at your home phone number, contact you via a pager to call them or an answering service or mail you a letter/memo through internal company mail or US Postal service if you were remote.

So this realization hit me when I was going back through text messages to find pictures from past FOCM networking events for posting here. These are from 2017 at the Society for Clinical Data Management conference in Orlando. Nowadays (you don’t hear this word often enough – add another digression, as my friend Kevin Boos says, another phrase that we don’t use much any more is: “all the live long day”), you can be reached or reached out to via:

email (and you probably have more than 1 email address – I have 5)
Instagram message
Facebook messenger
Cellphone call
Text to cellphone
LinkedIn Message
WhatsApp
Instagram
Twitter
GoogleChat
Venmo
Paypal
and the above are just the ones I know of – which means you can also be reached out/called out on MeWe, Telegram, Rumble, NextDoor and many others I am sure. Oh how could I forget the one I have to tend to the most: my OnlyFans account!! So many requests for pictures of my feet – barefoot, in sandals, huaraches, etc. But with each follower paying the monthly subscription fee, I’m netting around $10/month. I don’t have to tell you that over twelve months that’s around $120 straight to the bottom line.

Okay, back to the topic at hand, no more chasing shiny objects;

SCDM 2017 was held in Orlando. FOCM card carrying member Brian Langin with card # 00000001 encourages me to have a FOCM Networking event at Bob Marley – A tribute to Freedom in Universal CityWalk Orlando. And therefore, I do.

Entering into evidence the following two pictures:

Vicky Martin, Jennifer Price, Hugh Levaux, Karen McPoyle, Joby John, Tina Pietropaolo, Susan Howard and Karen Hicks.

The Brain Trust; Photo assumed to be taken by Brian Langin

Apologies for the darkness of the picture of Brian – at the time he was keeping a low profile due to some criminal or civil investigation of one type or another.

Meeting Summary July Virtual Networking

The GLSA | FOCM Networking Event on Wednesday, July 20th, 2022 at 5:00 PM EST was a lively affair boasting a diverse crowd of life science professionals. Many who attended were the previous colleagues and / or the current friends of Chris Matheus (FOCM, President; GLSA Chief Commercial and Networking Officer).

The topic of the day was “Summer Fun” due to the prevalence of the industry to go semi-dormant in July and August to accommodate the well-deserved vacations of its workers. The introduction, led by Chris, briefly spoke of former events which usually involved the related capabilities or education topic of a guest speaker to spur industry-related discussions and aid in collaboration among the group. He expressed the intention of this event to be focused more on the personal activities and vacations of attendees in order to keep our minds on the relaxation of these summer months.

To nobody’s surprise, we couldn’t stay away from discussing work including the most recently held conferences; BIO International Convention in San Diego, CA and DIA Annual Meeting in Chicago, IL with a specific mention about the limited presence of sponsors. An outbreak of Coronavirus at these events and the apparently foul-tasting Paxlovid medicine used to treat moderate cases of COVID sparked conversation about who among us has contracted the virus and the varying degrees by which each individual was affected.

Andrew Mulchinski stated that Symbio hasn’t fully adapted to DCT yet, sparking the post-quarantine observations of many regarding the transition to decentralized and hybrid studies. Chris noted a number of CRO’s that have changed leadership or have been acquired by other companies.

By far the most celebratory moment of the event was the announcement of the recent success of the Memorial Sloan Kettering Cancer Center in a small clinical trial using immunotherapy. They achieved 100% remission of rectal cancer without the use of surgery, chemotherapy or radiation that can leave patients with life-long effects including infertility and colostomy bags.

Let’s continue to reinforce our collective goal to improve patients’ lives across the globe. If you would like to present briefly on an educational life sciences topic and spur our event discussions, please contact me.

Attendees: (first time attendees in bold)

Kimberly Lupo, MS, MBA, RAC	Founder & CEO at Portrett Pharmaceuticals LLC
Sara Tylosky	CEO, Farmacon
Nadia M. Bracken	Operational Advisor, Medidata
Brian Horan	CEO & Co-founder, SupplyRx
Tina Tran	Director, Business Development, Unlearn.ai
Heather Hollick	Rizers LLC; Author of “Helpful, A guide to life, careers and the art of networking”
Amy Zastawney	Seeking a new executive business development role
Jon Matheus	Commercial Real Estate, A.T. Pancrazi Real Estate Services
Unnat Patel	Founder & President, AnalysisMate
Peter Payne	Life Sciences Executive – Available for Consulting
Griffin Robertson	Partner Account Manager, Mednet
Nancy Zeleniak	Enterprise Strategic Partnerships & Participant Engagement; Atrium Health
Dhruv Wadhwa	Director of Business Development, HUMA
Michael Young	Founder & Principal, BIOMedworx
Scott Robertson	Vice President of Sales, Global Partnerships; Mednet
Ravipal Luthra, MS, BDS	Clinical Research Coordinator, University of Miami, Miller Medical Center
Andrew Mulchinski, MPA, MT, ASCP, CCRC	Business Development; Symbio, LLC
Lani Hashimoto	Associate Director Patient Engagement Management; Novartis
Amanda Putnam	Team Lead Manager; Data Recognition Corporation
Michael O’ Gorman	CEO and Founder at Life Science Marketplace
Eliana Burke	Global Head of Client Engagement & Marketing; Greenlight Clinical
Michael Minor	EVP, Clinical Research; IMA Clinical Research
Vaibhav Sawant	Pharma Marketing Executive
GLSA ATTENDEES
Denise McNerney	Chief Operations Officer
Hannah Lloyd	Account Manager
Zulma Varela	Director of Public Communications
Sally Haller	Operations Manager
Todd Neilson	Account Manager
Joe Buser	Chief Revenue Officer
Chris Matheus	Chief Commercial and Networking Officer
Yutong Liang	Intern, Data Management and Technology

Screen shots of the event follow:

Screen shot at 5:06 Start of the event Screen shot at 5:18 Screen shot at 5:21

Meeting Summary of May Networking Event

On May 18, the GLSA and FOCM held their monthly online networking event. We always start the meeting with some time for people to give an update on any news they’re heard or a significant event that has happened in the past month. Then we move to a featured presenter for 10 – 15 minutes presenting information about themselves, their company or a clinical research topic of relevance to them or to the industry.

This event featured Alison Macpherson, CEO and Founder of Bright Pharmaceutical Services, a full service CRO headquartered in Los Angeles. Bright is celebrating their 20th year in business.
http://www.brightps.com/

Alison talked about her experiences starting out in the clinical trials industry and how that led to her forming Bright with a boutique sponsor-centric approach and a focus on subject recruitment and retention. The company has worked in a variety of therapeutic areas and all phases of research. Its differentiators from other similar sized CRO’s is the very low turnover (less than 5%) over the 20 years in business, which means clients’ projects are supported by only very experienced and engaged staff. Additionally, while much of their experience is in phase I and II North America trials, they have worked in 30+ countries globally. Questions were handled as they came up leading to discussions about Bright’s experience with risk-based monitoring; the new normal of hybrid and decentralized trials; reducing the frequency of subject visits to the sites; and Bright’s experience with trials that require collecting data from wireless, connected devices, e-source data, etc.

After the presentation we had first time participants share their company names and experience. Josh Lang, Mike O’Gorman and Denise McNerney will be attending BIO in San Diego June 13 – 16. Carlos mentioned the networking event they are having on June 12 in San Diego for people interested in Farmacon Global’s August 25 conference focused on conducting clinical trials in Rare Diseases in Emerging Markets.In posing this question to the group – what are you working on and what do you need help with, Heather Hollick (who taught me this approach for successful networking) mentioned she is starting the Institute for Vibrant Leadership and could use connections to leaders, coaches with whom to collaborate as well as writers and virtual assistants. Subsequently, a few potential connection candidates have been sent to her. https://heatherhollick.com/

Attendees (bolded names indicate first time attendees):

Alison Macpherson, Bright Pharma Services
Heather Hollick, Rizers LLC; Author of “Helpful, A guide to life, careers and the art of networking”
Nicole O’Brien, Pain Care Labs
Josh Lang, Asymchem Group
Barbara Hilewsky, BRCR Global
Shane Krauss, Strados Labs
Carlos Martinez, Farmacon Global
David Holland, Cmed Research
Michael O’Gorman, Life Science Marketplace
Keisha Felix, IQVIA
Ludmilla Scodeler
Jim Choi, CRScube
Cesar Serapiao
Chris Matheus, Global Life Sciences Alliance
Sally Haller, Global Life Sciences Alliance
Denise McNerney, Global Life Sciences Alliance
Hannah Lloyd, Global Life Sciences Alliance
Todd Neilson, Global Life Sciences Alliance
Zulma Varela, Global Life Sciences Alliance

Several screen shots follow:

Networking from 2017

I am most definitely playing catch up with posts – but I’ve always been a strong believer or follower of the “better late than never” philosophy.

Here’s a picture of Bryan Clayton and Tope Keyes at a January 2017 Healthtech event. I’ve seen them both recently as we’re returning to in -person conferences and networking events.

and this next photo may have been taken at the same event – at least I do know it was also taken in January of 2017. Brian Langin, Nithiya Ananthakrishnan, Deb Jendrasek and Rob Nichols. Please note neither Brian nor Rob have registration badges – it’s possible their attendance involved using the time honored Business Development technique known as “the Strand” or “the Langin”.

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