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History of the Biotechnology Specialty Section

(As described by a few of the first members)

How was the BTSS born?

In early 2009, following an exchange of ideas with Matt Bogdanffy, Barbara Mounho-Zamora approached me with the need for SOT to have a Specialty Section within focused on biotechnology. I recall getting excited instantly, telling her that I was in agreement and I was certain there would be others who would agree.  The need was driven from different fronts. First, it was difficult at that time to get the more applied scientific sessions on issues regarding biotechnology accepted for presentation at the SOT annual meeting.  I was on the Scientific Program Committee at the time and was able to not only provide some insights to our members in the field regarding what things the SPC was looking for in highly rated proposals, but was also able to help the SPC understand the importance of some of the submitted proposals.  Second, as sessions on toxicological challenges regarding biotechnology began to increase at the Annual Meeting, the assigned rooms would be overflowing with attendees! They were completely full (standing room only).  Third, there was a lack of a group within SOT that focused on providing a discussion and education forum on biotechnology for graduate students and post-doctoral fellows.  Clearly there was a substantial interest in this area.

Who were the folks driving the development of the BTSS? 

As more discussion occurred among SOT members on the need for a biotechnology specialty section, the more people got excited and wanted to get involved in making it happen. A core group of individuals volunteered to work together to develop and submit a proposal to the SOT Council on the need for a specialty section focused on biotechnology.  We called ourselves the Biotechnology Specialty Section (BTSS) Core Team and included (with affiliations from that time):  Barbara Mounho – Amgen; Leigh Ann Burns Naas – Pfizer; Janet Clarke – Biogen Idec; Hanan Ghantous – FDA; Tim MacLachlan – Genzyme; Theresa Reynolds – Genentech; and Andrea Weir – CRL.

BTSS in Salt Lake City

We started with brainstorming and exchanging ideas to determine the goals of a BTSS but more importantly, what this Specialty Section would provide to the members of SOT.  We agreed this Specialty Section should facilitate education and broad discussion of key issues in biotechnology such as translational pharmacology and toxicology, biomarkers, mechanisms of toxicity, and overall risk evaluation of these entities.  In addition, while biotechnology has been used abundantly in the context of biotechnology-derived macromolecules developed to treat disease, the BTSS Core Team agreed that due to the diverse nature of applications of biotechnology products and the challenges they pose in toxicology, the scope of this Specialty Section would also include other modalities such as genetically modified organics, biodegradable plastics, and biofuels. We submitted the proposal to SOT Council in 2009 as well as developed the BTSS mission, by-laws, and a 3-year plan.

The BTSS Core Team then became the first set of officers for the new Specialty Section: 

President – Barbara Mounho

Vice President – Janet Clarke

Vice President-Elect – Hanan Ghantous

Secretary/Treasurer – Theresa Reynolds

Councilors – Leigh Ann Burns Naas (1 year), and Tim MacLachlan and Andrea Weir (both 2 years)

Barbara Mounho

Barbara Mounho presiding over the inaugural BTSS Reception in 2010

What were the hopes for the group when it was formed? What gaps were you hoping the BTSS would fill? Did the group feel that the creation of BTSS fulfilled the gaps and hopes?

At that time, some discussion, presentation and debates on issues related to biotechnology were sponsored by existing SOT specialty sections (i.e., Regulatory and Safety Evaluation, Immunotoxicology, Drug Discovery); however, we felt there was a need for a dedicated focus on such topics as:

1)   education on novel and evolving biotechnological agents of various modalities;

2)   risk assessment and regulatory approaches that are unique to biotechnology products;

3)   identification and development of relevant models for use in studying risks and mechanisms while maintaining the need to reduce the usage of animals;

4)   communication of different approaches used in addressing toxicological assessment of biotechnology products. 

While there had been opportunity to hold forums on these topics at recent (mid-2000’s) Annual Meetings of the SOT, we believed a community singularly focused on the particulars of biotechnology would lend itself best to a more organized and efficient progress towards the best toxicological science in the field.  Notably, while planning for the new Specialty Section and working on the proposal for SOT Council, leaders in some of the related specialty sections mentioned above voiced support for the BTSS, indicating that the biotechnology field has grown to the point of requiring its own forum as to not overcrowd other interests in other specialty sections.

The BTSS also wanted to a forum not only for experienced individuals but to facilitate for students and postdoctoral fellows a better understanding of the diverse applications of biotechnology products and how the various modalities of biotechnology have made a significant effect in the different fields of toxicology. In addition, to promote student/post-doctoral participation in the BTSS, we had a student and postdoctoral representative elected for a 1-year term, as well as provided awards for best presentation/poster/paper focusing on biotechnology product(s).  

We drafted a letter to SOT Council in June 2009, and submitted our request to form the BTSS (see below).

Letter to Council (June 2009):

“Biotechnology has been defined as “any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.”  In the field of toxicology, this term has been used most abundantly in the context of biotechnology-derived macromolecules being developed to treat disease; however, the term may also be applied to several other modalities as well as the impact of manufacturing processes on biopharmaceuticals.  This area of research and development has clearly been growing in importance and impact. As of December 31, 2006, there were 1,452 biotechnology companies in the United States ( This rapidly growing field has already had an effect on toxicology through a robust focus on the scientific rationale driving safety assessment program design and data interpretation, as well as the development of new or refined models for safety assessment. Due to the evolving molecular complexity of biotechnology products and the increasingly diverse nature of applications, we can expect that biotechnology-derived products will impact toxicology increasingly for many years to come.

The interest in biotechnology sessions at the SOT Annual Meeting in recent years (continuing education courses, workshops, symposia, roundtables) has been substantial.  At many times, these sessions have been standing room only.  While programs related to biotechnology have been sponsored by existing SOT Specialty Sections, a community within the SOT that is singularly focused on the particulars of biotechnology would lend itself best to making organized and efficient progress towards advancing the best toxicological science in the field.  The BTSS Core Team has informally solicited some members of the SOT to gauge interest in developing a Biotechnology Specialty Section and the response has been extremely positive.  A list of SOT members who have expressed support and interest in participating in such a specialty section has been provided in this proposal.

Central to the BTSS goals is the need to recognize the novel challenges that biotechnological agents pose, and to encourage discussion of how to best address these challenges.  This group would also facilitate education and broad discussion of key issues in the rapidly evolving biotechnology landscape such as translational pharmacology and toxicology, biomarkers, mechanisms of toxicity and target validation, study design and endpoint validation, manufacturing processes and other quality attributes, safety strategies, and overall risk evaluation of these entities.  The formation of this section would also be expected to stimulate recruitment of new SOT members such as those who have traditionally viewed the SOT as a more ‘classical toxicology’ organization without a focus or serious interest on this new and quickly developing area.

We recognize that there has been a proliferation of Specialty Sections within the SOT in recent years.  Similarly, we recognize the need for any Specialty Section to actively contribute to the overall mission of the SOT.  Along those lines, we refer Council to the Objectives outlined in our proposed by-laws. 

In summary, we are submitting to Council a proposal for the formation of a Biotechnology Specialty Section within the SOT.  We believe there is more than sufficient interest within the SOT membership for a group with a more focused approach to biotechnology, and that the formation will not have significant impact on the missions or membership of existing Specialty Sections.  Additionally, the BTSS would clearly be an active specialty section not only in terms of developing programs for the Annual Meeting but also in developing other programs such as a CCT, articles for the SOT website, and white papers/reviews on key topics.

Thank you for your consideration of our proposal, and we look forward to a positive opinion.”

When the BTSS first started out, how did it define its mission?

The mission we defined is still the one we use today:  to create a forum for all SOT members interested in biotechnology. This included those working in academia, government and regulatory organizations such as US FDA and US EPA, and industrial areas such as agriculture, environmental health, chemicals and biopharmaceuticals, and students and postdocs pursuing a specific area of biotechnology and aiming for a better understanding of biotechnology.  We further defined objectives for the BTSS which again, are still in existence today: 

  • To foster the evolution of scientifically relevant approaches to and interpretation of toxicological aspects that are unique to biotechnology-derived products
  • To develop, propose, and conduct a variety of cutting-edge programs and educational activities that emphasize the latest developments and issues in biotechnology
  • To relate the developments in biotechnology to the activities of the SOT and to the toxicology/environmental health sciences community-at-large
  • To facilitate education and discussion of, and the generation of position papers and review articles on, key issues in the rapidly evolving biotechnology landscape such as translational pharmacology and toxicology (in vitroto in vivo; animal to human), biomarkers, mechanisms of toxicity, and target validation, study design, and endpoint validation, manufacturing processes, and other quality attributes, safety strategies, and overall risk evaluation of these entities
  • To act as a resource not only to the SOT but broadly at the national and international level in the area of biotechnology

What were the biggest challenges getting the BTSS up and off the ground?

One of the challenges was “how exactly do we go about doing this?”  SOT had some general guidance and requirements, but it’s never that simple, right?  We decided that if we wanted to act quickly, we didn’t want to reinvent the wheel, so Leigh Ann reached out to Drew Badger, who had recently helped start the Drug Discovery Toxicology Specialty Section, and with his suggestions from their experience as well as many reviews of other component group bylaws, we were able to get off to a fast start. 

We don’t recall specific challenges along the way in getting BTSS up and off the ground.  This is probably because everyone was so excited and committed to making it happen.  But the BTSS did face some of the same challenges as other Specialty Sections, and probably the same ones still faced today:  which reception to attend (since several often overlap) and finances, especially when it came to the Annual Meeting Reception costs.  That’s just one that all the component groups at SOT have to work through every year.  We were very lucky in our first couple years that we had Sponsors who were willing to make donations specifically for BTSS so we could host our receptions.

Inaugural BTSS Reception

 Scenes from the 2010 Inaugural BTSS Reception (from the May 2010 Newsletter)

What were some of the early defining moments and successes for the BTSS?

SOT requires that there be at least 50 individuals agreeing to become members of a newly proposed specialty section.  BTSS started with 104!  And we were dispersed across multiple employment sections including biopharmaceuticals, academia, government, consultants, and CROs.  One thing we also remember was how engaged everyone wanted to be.  We had a committee to work on the awards we wanted to give (including funding and criteria), a program committee for the 2011 Annual Meeting proposals, and a student/postdoc committee that was geared toward engaging them and not specifically comprised of them. We also had great support from Sponsors:  Aclairo Pharmaceutical Development Group, Brock Scientific Consulting, CRL, Genentech, and Pfizer provided donations to help support us the first year.


Janet Clarke and Leigh Ann

2011 Annual Meeting Reception

President Janet Clarke giving Leigh Ann her Councilor Service Award

Immediately after forming and approving our bylaws, Hanan Ghantous led the new Awards Committee to define the types of awards we would like to give and what our mechanisms might be to establish funding for this.  We wanted to be able to provide a Career Achievement Award, a Young Investigator Award, Best Paper of the Year, and a Student Achievement Award.  Thanks to an annual commitment from Aclairo Pharmaceutical Development Group, Inc., we knew at the 2010 reception that we were going to be able to provide the Student Achievement Award beginning the following year!  And in fact, the following year we did present not only two Student Achievement Awards, we also presented the first Best Paper Award (sponsored by Burleson Research Technologies; to Vahle et al, Tox Path 38:522, 2010), and the Career Achievement in Biotechnology Award (to Joy Cavagnaro).  We had also grown our membership to 176 by the 2011 Annual Meeting while maintaining our employment diversity.  We even made a very thoughtful contribution to the SOT 50th Anniversary Time Capsule. 

Today, we are impressed with the fact that BTSS has an Endowment Fund upon which to draw to help fund the various awards we give.

What are your hopes for the BTSS in the future?

Certainly, we want to continue to grow the membership in BTSS, and to continue to provide opportunities for students and postdocs.  When we were proposing the formation of the BTSS, we noted that the scientific approach to studying these biotechnology products and processes was evolving at a rapid pace as the community gathered information and acquired experience.  Biotechnology was no longer a niche area. Central to our goals was the need to recognize the novel challenges that biotechnological agents pose and to encourage discussion of how to address these challenges in the most relevant fashion possible.  We desired to be a forum within the SOT for those discussions.  While we believe that BTSS has achieved those specific goals, we also still see them as goals to be achieved in a time when novel biotechnology continues to rapidly expand!  Within the pharmaceutical industry, where we have spent our careers, the types of biopharmaceuticals and vaccines has rapidly evolved and the possibilities seem to limited only by where your imagination – and a little science and ingenuity – can take you.  There are also significant advances still coming in the areas of waste management, biofuels, and genetically-modified organics for food and other applications. So, there is still so much the BTSS and its members can contribute.