Dear Colleagues,

I trust this message finds you well as we enter the autumn season. The pandemic continues to present challenges in all facets of life, and ACT continues to monitor related activity as we plan for activities through the rest of 2021, with a special focus on our 42nd Annual Meeting.

Despite our best hopes and efforts to meet at National Harbor in November, ACT Council made the difficult decision to switch the Annual Meeting from an in-person event to a fully virtual event. This decision was made after evaluating all the variables at play, including the availability of speakers and session Chairs to present at the meeting site, input from members and past attendees regarding their ability to travel to the meeting, uncertainty regarding the current Delta variant surge, and the overall health and safety of meeting attendees and their loved ones. In the end, it was decided that a virtual meeting was the best option available to present a high-quality meeting in the planned November time frame. While I once again will miss seeing everyone in three dimensions, I look forward to what is sure to be a highly interesting discussion of science and regulation related to the field of toxicology!

Now that we have a firm direction, it is time to focus on making our Annual Meeting as successful as possible. Please support the College by first registering for the meeting and then promoting it to your colleagues, especially those who may not have attended in the past. This is a great opportunity for those new to ACT to dip their toes into the water and find out about the great Scientific Sessions and networking that are hallmarks of our meeting. Registration information and all the meeting details are available on the ACT website.

Here are a few of the key details:

• Registration fees will be held at the early-bird rates right up to the start of the meeting.
• The Annual Meeting will begin with Continuing Education courses on November 10 and 12, and Symposia will occur from November 15 to November 19. Session times have all been extended to allow for additional time for live question-and-answer sessions with the speakers.
• On-demand access to recorded sessions will be available to all registrants until mid-February 2022, so you will be able to view all the great Symposia and Workshops.
• Talking Tox Webinars (aka Exhibitor-Hosted Programs) will begin on November 8 and will continue through January.
• ACT will be hosting a variety of networking events throughout the meeting, including our Welcome and Closing Socials, our Awards Ceremony, a Member Mixer, and a Social and Speed Networking event for early career professionals. All these special events are included with your registration fee.

Special thanks go to our Program and Education Committees, all our Chairs and speakers, and our Contingency Planning Working Group, which drafted plans for various anticipated scenarios that helped in Council’s decision-making.

So, join us in November for enlightening discussions of toxicology and enjoyable interactions with your fellow attendees. I look forward to seeing you there!

Some other important information for your consideration:

• The new and improved ACT website launched on September 13. Be sure to check it out—we hope it enhances your ability to interACT with ACT!
• ACT eLearning Seminars—Basic Topics in Toxicology launched in September. It includes nine modules featuring experts in various fields of toxicology.
• Consider making a contribution to the ACT Endowment before the end of 2021. We reached a first milestone of $1 million this year and will begin using the Endowment to support the awards program this year for the first time. ACT will match contributions 2 to 1 through the end of the year.
• The Leadership Development Working Group (LDWG) released a podcast on September 7. The working group has been identifying potential gaps and opportunities for leadership development. Give it a listen and find out what they’ve been up to!
• There will be two Program Planning Meetings this year; October 7 at noon (ET) and October 22 at 3:00 pm (ET), be sure to sign up and share your ideas for next year's scientific program.
• The Members' Meeting will be held on November 3 from 3:00 to 4:00 pm (ET). I encourage all members to sign up and come to the meeting to hear the accomplishments and ongoing efforts of the College. 
• In line with the LDWG activities, as next year’s Chair of the Nominating Committee, I want to encourage you to consider nominating yourself or someone else for the various elected positions on the 2022 ballot. The nomination period opens soon, so keep an eye out for further details. We are looking to put together a highly diverse set of candidates to take on future leadership positions.
• The session proposal portal for our 2022 Annual Meeting in Denver is now open—see the ACT website for details. A number of brainstorming sessions are planned for October as well, so start thinking about submitting a proposal for consideration. The deadline is December 31, 2021.

Stay well and stay engaged with ACT! “See” you in November for the 42nd Annual Meeting!

In late 2019, a working group was formed under the ACT Communications Committee with a goal to utilize LinkedIn to provide a social media presence for ACT and engage with both members and the toxicology community. The small team of Krishna Allamneni, Raluca Kubaszky, Ilona Bebenek, Logeswari Ponnusamy, and Jessica Pellman set forth with the mission and goal in mind to develop guidelines and best practices for posting on behalf of ACT. Much consideration was given surrounding the frequency of posting to continually engage with the community. Of particular importance was reaching and engaging current and future members, so all content needed to be available without membership credentials. The team developed a posting calendar to provide structure and strategy and worked closely to ensure relevance and variety to guide posting.

Two short and exciting years later, the working group has transitioned into a subcommittee, grown to eight members, and amassed more than 1,700 followers on LinkedIn, and it is now working toward an increased Twitter presence, currently with over 700 followers. Appointees to the Social Media Subcommittee continue to participate in sourcing content and posting to social media to support the College’s mission to educate, lead, and serve. Hundreds to thousands of LinkedIn users see each post (counted as impressions, meaning they are present on an individual’s screen).

Interested in the latest news and updates from ACT? Connect with ACT on LinkedIn and Twitter @ACToxicology! Would this Subcommittee be a good fit for you? Sign up on the Volunteer page of interACT.

Johnson & Johnson, in partnership with an international public-private consortium, recently announced results from the Imbokodo study, a Phase 2b clinical trial to assess the preventive vaccine efficacy, safety, and tolerability of an investigational vaccine regimen in women at high risk for contracting HIV in sub-Saharan Africa. Imbokodo enrolled approximately 2,600 women across five countries in sub-Saharan Africa (Malawi, Mozambique, South Africa, Zambia, and Zimbabwe). Subjects were administered an adenovirus vector containing four mosaic immunogens (Ad26.Mos4.HIV) four times over the course of a year and a soluble protein component (Clade C gp140 adjuvanted with aluminum phosphate) in combination with the third and fourth adenovirus vaccination. Subjects were followed for 24 months after administration of the first vaccination.

Imbokodo failed to meet its primary endpoint of vaccine efficacy in this population. After 24 months, 63 of 1,109 placebo-treated subjects and 51 of 1,079 vaccine-treated subjects contracted HIV, resulting in a vaccine efficacy of 25.2%. No serious adverse events were noted, and the vaccine regimen was generally well tolerated.

Although Imbokodo failed to prevent new HIV infections in adult women in sub-Saharan Africa, a Phase 3 study utilizing an improved version of the vaccine regimen is continuing. Mosaico is a Phase 3 clinical trial to assess the preventative vaccine efficacy of an investigational vaccine regimen in men who have sex with men and transgender individuals in the Americas and Europe. Subjects are being administered an adenovirus vector containing four mosaic immunogens (Ad26.Mos4.HIV) four times over the course of a year and a combination of two soluble proteins (Mosaic and Clade C trimeric gp140 adjuvanted with aluminum phosphate) in combination with the third and fourth adenovirus vaccination. Mosaico is anticipated to read out in 2023.

Read the full press release on the Johnson & Johnson website.

PDUFA was first enacted in 1992 in response to a bottleneck of new medicine approvals that left patients waiting for years for an under-staffed and under-funded FDA to review new drug applications. Before PDUFA, it often took the FDA more than two years to review new medicines, and more than 70% of medicines were first approved outside the United States. The PDUFA program helps provide efficiency and predictability of regulatory review while supporting continued independent rigor. PDUFA is reauthorized every five years and has been reauthorized five times since 1992, in 1997, 2002, 2007, 2012, and 2017. The next reauthorization, also known as PDUFA VII, will be in September 2022.

The PDUFA VII goals letter expands upon the most recent iteration of the user fee agreements with a renewed focus on strengthening review fundamentals, enhancing accountability and transparency, and advancing innovation for patients, thereby ensuring that the agency remains the global “gold standard” of medicine review. The PDUFA VII agreement achieves the following objectives: (1) strengthens scientific dialogue between FDA and industry to promote innovation; (2) enhances patient-centric drug review and supports rare disease and gene therapies; (3) modernizes regulatory and drug development tools, including advancing the use of real-world evidence for regulatory decision-making; (4) advances digital technology tools and modernizes FDA’s information technology infrastructure, including the adoption of cloud-based systems and capabilities; (5) improves innovation in manufacturing and quality, including lessons learned from COVID-19; and (6) enhances FDA hiring, retention, and financial management systems.

Read more information on the PhRMA website.

Pompe disease is a rare disorder, affecting one in every 40,000 births, or 3,500 individuals in the US. It is caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha glucosidase (GAA), which results in buildup of complex sugars (glycogen) in muscle cells throughout the body. It can present as infantile-onset Pompe disease, the most severe form of the disease. Alternatively, it can present as late-onset Pompe disease (LOPD), which progressively damages muscles over time. Those with LOPD may require mechanical ventilation to help with breathing or a wheelchair to assist with mobility. First approved by the FDA in 2006, alglucosidase alfa, an enzyme replacement therapy (ERT), had been the only therapy for the treatment of Pompe disease.

FDA-approved in August (2021), NEXVIAZYME (avalglucosidase alfa-ngpt) is indicated for the treatment of patients 1 year of age and older with LOPD. The key pathway to transport the GAA enzyme into lysosomes in the cell is through the mannose-6-phosphate (M6P) receptor. NEXVIAZYME, an ERT, targets the M6P receptor to effectively clear glycogen buildup in muscle cells. Treatment with NEXVIAZYME improved lung function, similar to the improvement noted with the other therapy. In this pivotal study, 100 patients were randomized to take NEXVIAZYME or another FDA-approved ERT for Pompe disease.

NEXVIAZYME had received fast track, priority review, breakthrough therapy, and orphan drug designations.

What company do you currently work with, what is your profession, and how long have you been a member of ACT?
At AbbVie, I’m a senior principal scientist (Toxicology) supporting discovery and development programs (primarily oncology) and based at the North Chicago headquarters. I’ve been an ACT member since 2015.

When you were growing up, what did you want to be? 
I wanted to be an electrician, like my dad. However, I found out in elementary school that I am red-green color blind; my dad thoughtfully suggested I consider something else. My high school basketball coach really inspired me, so going into undergrad I was planning to be a teacher/coach.

What was the path that brought you to where you are now in your career?
I grew up in Washington state, across the water from Seattle, and attended undergrad at Western Washington University in beautiful Bellingham, Washington. I moved to Bloomington, Indiana, for grad school at Indiana University, which led to a postdoc opportunity in Dr. Klaassen’s lab at the University of Kansas Medical Center (great science, BBQ, and Jayhawks basketball!). I then joined Abbott Labs, from which AbbVie was formed in 2013. There have been several key people instrumental in mentoring me and helping to shape my career path—THANK YOU SO MUCH!

What has been your most rewarding career-related or personal project or experience to date? 
Among the most fun personal experiences: As a cyclist, I’ve been fortunate to ride in Maui several times, and completing the West Maui Loop is incredible. The climbs, views, and shaved iced at the mid-point . . . nothing beats it!

What’s the last book you read, and would you recommend it?
The last two books that have really captured my attention were Pappyland and Creativity, Inc. Pappyland is about life, family, and of course, world-class bourbon. Creativity, Inc. is a behind-the-scenes look at Pixar, with several learnings and practices applicable to fields beyond film/entertainment, including drug discovery/development.

Tell us three skills that have helped you grow in your career.
(1) Be engaged (fully present). (2) Be your authentic self (candid, transparent, let your personality show). (3) Never lose the drive (and courage) to ask “Why?” 

If you could switch places with anyone for one day, who would it be and why?
My son Landon. He just turned 11 and has developmental challenges due to a rare genetic condition. He is nonverbal, and I would love to know what his world looks and sounds like. The beauty that he sees, what is funny, what makes him scared or sad . . . all the things I’d love to ask him.

The Membership Committee didn't take any breaks during the summer and remained busy.

Applications to join ACT were consistent and strong in the summer. The committee recommended membership to 35 applicants in various membership categories. We would like to extend a very warm welcome to the new members! With these new members, the membership numbers are remaining fairly consistent, with 1,023 members as of the writing of this article. This number includes 673 Full members, 189 Associate members, 54 Emeritus members, and 21 corporate members.

New ACT Members:

In addition, the committee has made an update to the membership SOP, clarifying the experience and training needed for a “Full” membership and an “Associate” membership. The primary change was clarifying that postdoctoral training is not considered part of the five years of experience needed to qualify as a Full member of the College. 

The committee has also been continuing its work on certain parts of the Strategic Plan as well as engagement with the Education Committee. The committee is actively discussing ways to increase member engagement and/or the value proposition, including mentorship and networking opportunities.  

As a friendly reminder, the Mentorship Program is fully active! Please go to the ACT website and sign up today to be a mentor and/or mentee!

Hello fellow members of the American College of Toxicology,

Thank you for your support of the College and for entrusting me as your Treasurer. I am pleased to report that an audit of the ACT finances (for fiscal years ending 31 December 2019 and 31 December 2020) was completed in July, with no significant findings. The Finance Committee reviewed and approved the College’s federal and State of Virginia tax returns for fiscal year 2020 in August, which were promptly filed electronically. During the remaining months of 2021, both the Finance Committee and I will be reviewing the proposed annual budget for 2022.

As your Treasurer, my ongoing priorities are to closely monitor our operating budget and the impact on programming and budgets due to the pandemic and to minimize any potential operating deficits as components of sound fiduciary practice. Because of the College’s strong financial position, I anticipate that ACT will be able to manage any unanticipated impacts of the pandemic on our finances.

Hello, fellow ACT members,

Thank you for your support of the College and for entrusting me as your Treasurer. I am pleased to report that as of August 31, 2021, the ACT Endowment had a balance of $1,190,190. Thanks to the generosity of the ACT membership, an initial distribution of up to $35,000 from the Endowment will be made in 2021 to help fund ACT scholarships and educational awards.

For 2021, we are pleased to announce that ACT Council has recently approved a 2:1 match for gifts made to the Endowment by individual donors in 2021, with a cap of $150,000. Please consider this an opportunity to build upon the outstanding legacy the ACT community has created to support scholarships and educational awards for future generations.

Sincerely,
Alan P. Brown, PhD, DABT

ACT sponsored and organized a Continuing Education (CE) course entitled “Vaccine Development in the 21st Century: General Outline” at the 11th Congress of Toxicology in Developing Countries (CTDC11), held virtually between June 13 and 16, 2021, in Kuala Lumpur. An ad hoc working group (WG) was created, with participation from the Outreach and Education Committees’ members (Raluca Kubaszky, Arianne Motter, Maralee McVean, and Caitlin Murphy). The O/E WG was charged with identifying potential speakers, setting a budget, and, once the proposal was approved by the ACT leadership, proceeding with the actual planning and execution.

The session presenters were Deborah Novicki (“Introduction and History of Vaccines”), David Pepperl (“Nonclinical Regulatory and Testing Considerations for Vaccine Development in 2021”), Alex Rodriguez (“Case Studies on Regulatory Toxicology for Prophylactic Vaccines for the Developing and Developed World”), and Alan Hoberman (“Vaccines (COVID-19) and Pregnancy (Special Groups)”).

The prerecorded course, which was one of two at the meeting, provided an overview of achievements in vaccinology to date and introduced the audience to some of the complex challenges that vaccine developers, regulatory authorities, health agencies, and vaccine end users currently face. Key nonclinical regulatory expectations for novel vaccines were discussed and case studies of different novel vaccines were presented, showcasing specific regulatory toxicology approaches taken to support licensure of these vaccines for use in the developing and developed world. The administration of vaccines to women of childbearing age and/or during pregnancy and considerations of their effect on the developing conceptus (embryo/fetus) were also covered. A live, three-hour Q&A session with the speakers was held following the CE course.

The CTDC11 meeting was fully virtual and well organized and employed an interactive platform that allowed easy access for attendees. The meeting had 260 registrants from over 50 countries and 6,281 views during the virtual meeting. O/E WG Chairs Raluca Kubaszky and Caitlin Murphy attended the meeting and represented ACT. 

ACT Council also authorized funds of $10,000 to support this international meeting, hosted by the Malaysian SOT.

Thank you to the Outreach and Education Committees, session presenters, ACT Council, and all involved for the support of this outreach/educational effort and for making this ACT initiative a great success, in line with our mission to educate, lead, and serve! Plans for ACT participation at the 16th International Congress of Toxicology in Maastricht, the Netherlands, September 18–22, 2022, have been proposed to ACT Council.

The Education Committee has been very busy over the summer making sure the Continuing Education (CE) courses are ready for the Annual Meeting. It’s always an exciting and busy time for the committee, making sure we are delivering valuable, scientifically exciting sessions for CE. This year is no exception, with six excellent courses being presented in November. Registration for the CE courses is open now on the Annual Meeting website. Information on the courses can be found there as well.

While CE is a big component of what the Education Committee has been working on, it’s not the only thing. The Education Committee works with the Webinar, eLearning, and Podcast Subcommittees, as well as all in-person courses, to support and influence their activities. These subcommittees have been very active and have produced successful courses shared throughout the year.

In addition to these activities, new ideas are emerging to deliver more content to members over the year. We need to hear from you about what you want to see, hear, and learn and how you want material delivered. The Education Committee is also interested in hearing your thoughts on focusing Annual Meeting CE on active, hands-on learning, while delivering more passive content virtually throughout the year. We need your feedback, so we intend to set up surveys and suggestion boxes. If you have an idea of a way to solicit feedback broadly, please reach out to any of the Education Committee members directly.

As another part of our summer initiative work and as part of the strategic plan for the Education Committee, we have been categorizing our courses, virtual and in person, old and new, in order to share the breadth and diversity of our courses in a consistent manner. All course offerings will now be identified as basic or advanced and then identified as whether they are an emerging area of science or a technical/practical presentation. This will allow the Education Committee to deliver a diverse learning program. Look for more soon, as we will need volunteers to help us go through the archives and listen to courses!

We look forward to bringing you exciting educational offerings at the Annual Meeting, as well as year-round, and would really appreciate your feedback and input.

ACT has a longstanding history of presenting an award for the best paper published in International Journal of Toxicology. Criteria include papers that address a contemporary issue in toxicology; show immediate positive impact as measured by citations, downloads, and Altmetric score; and have potential to have a broad and long-lasting impact on the field or practice of toxicology. I am delighted to announce that the winning paper from those published in Int J Toxicol in 2020, selected by a subset of the Editorial Board, is entitled “Cadmium-Induced Renal Cell Toxicity Is Associated with MicroRNA Deregulation.” The corresponding author, from the University of Lille, in Lille, France, is Dr. Christelle Cauffiez. If you would like to read this paper, the citation is Int J Toxicol 2020 39(2):103-114. Thank you to everyone who nominated papers for this award, and please be thinking about papers published in 2021 that you would like to see recognized with next year’s award.

I would also like to remind our Annual Meeting session Chairs and Continuing Education course directors to consider preparing a paper based on these efforts for publication in IJT. A number of early career professionals are very interested in helping develop these articles, so if you and your presenters need assistance, just ask!

In terms of the journal itself, we have received nearly 350 articles to date, so we are on track to exceed our usual ~400 submissions annually. Special thanks are extended to ACT members who have submitted papers to the journal or have recommended that their colleagues publish in IJT. Your collective support of the journal is appreciated. Also, thank you to the members of the Editorial Board, whose tireless work helps us get great content for the journal.

Check out the newly updated ACT website! The site has been updated to give users a fresh perspective on the informative content that is already available to members and nonmembers alike. In addition to updating the materials and resources that you have come to know, the new site contains several new pages, including committee organizational charts, information on the ACT Endowment, and details on global outreach.

The committee organizational chart allows for greater visibility of members and provide insight into the structure of the nine ACT committees and six subcommittees that work together to advance the mission of the College. The site also provides a link to easily request more information for those interested in becoming involved.

The Endowment pages provide information regarding the history and importance of the ACT Endowment and allow access to contribute.

The Global Outreach page serves to highlight the geographical areas and ways in which ACT is actively promoting toxicology advancement through educational opportunities around the world.

Stay tuned for future updates on this exciting refresh!

ACT and the Japanese Society of Toxicology (JSOT) sponsored the Joint Session “Nonvaccine Therapeutic Alternatives for COVID-19” at the 48th Annual Meeting of JSOT, held both virtually and in person on July 9 at the Kobe International Conference Center in Japan. An ad hoc ACT working group (WG) was created, chaired by Chris Sheth, with participation from Program and Outreach Committee members (Lorrene Buckley, Alan Hoberman, Tim McGovern, LaRonda Morford, Mary Ellen Cosenza, and Logeswari Ponnusamy). The WG was charged with selecting a theme for the joint session, identifying potential speakers, setting a budget, and, once the proposal was approved by the ACT leadership, proceeding with the actual planning and execution.

The Joint Session presenters were Roy Bannister (“Remdesivir: A Direct Acting Antiviral for the Treatment of COVID-19”) and Daniel Urban (“Preclinical Considerations for Cell and Gene Therapies for COVID-19”). The session Chairs were Kazushige Maki (PMDA) and Hideo Fukui (Axcelead DDP). The discussion organizer, Chris Sheth (Aclairo), attended the meeting and represented ACT.

The collaboration represented the first Joint Session between ACT and JSOT. The theme was selected by representatives of both ACT and JSOT as being highly relevant to current events and of great interest to attendees of both meetings, warranting similarly themed sessions to be presented at this year’s annual meetings of both JSOT (July 2021) and ACT (to be held in November 2021). SARS-CoV-2 infectious disease (COVID-19) emerged as a highly transmissible agent, resulting in the need for a rapid assessment of existing antiviral interventions and new product development to combat the infection and prevent the spread of disease. The session covered how various sponsors across a gambit of product areas and modalities have been leveraging their abilities to bring some promising treatments to bear, in addition to regulatory expectations for the preclinical toxicology data needed to support these endeavors. The audience heard about modern safety testing of advanced cell and gene therapies and about the development and success of the small molecule antiviral drug Remdesivir.

Acknowledgment also goes out to four speakers from the ACT 41st Annual Meeting who shared their presentations as Educational Lectures that were viewed on July 8 and 9 at this year’s JSOT Annual Meeting. Thank you to Judith Prescott (Merck & Co.) for “Streamlined Development Approach to Evaluating Severely Debilitating or Life-Threatening Indications (SDLTs) Therapeutics and Vaccines,” to Robert W. Amler (New York Medical College) for “The Coming Conquest of COVID,” and to Stephanie Leuenroth-Quinn (US FDA) for “The US FDA’s Coronavirus Treatment Acceleration Program (CTAP) and Considerations for Pre-IND Meeting Requests” and for “Integrated Review Process within the Office of New Drugs.”

The WG would also like to acknowledge other ACT members who presented at the 48th Annual Meeting of JSOT, including Ken Hasting (Hastings Toxicology Consulting LLC) for the Special Lecture given on July 7, “Risks and Benefits of Vaccine or Nonvaccine Therapeutic Interventions for COVID-19.”

Feedback from the session Chairs indicated the ACT/JSOT collaboration at the 48th Annual Meeting of JSOT was quite successful, with a combined (in person and online) audience of around 200 viewers. We’re all looking forward to presenting a similarly successful Joint Session at the upcoming ACT 42nd Annual Meeting at the Gaylord National Harbor in Washington, DC.

A very special thanks goes out to the ACT Program and Outreach Committees, session presenters, ACT Council, JSOT, AIM (especially to Nancy Rollman), and all involved for the support of this Joint Session and for making this ACT/JSOT initiative a great success, in line with our mission to educate, lead, and serve!