Medical/Scientific Writer Scientist

INDUMATHI SRIDHARAN

E: *********.*********@*****.*** ● M: 312-***-**** ● Schaumburg, IL 60193

SCIENTIFIC WRITER/MEDICAL WRITER

Doctoral-level scientific writer with over 6 years of experience in writing a variety of compelling scientific

documents; Familiar with pharmaceutical, biomedical and biotechnology industry; Highly meticulous and

proactive with strong organizational skills.

Core Competencies include:

Graduate training in biological and biomedical sciences ● Scientific writing ● Project Management

●

● Collaboration ● Communication ● Data Analysis ● Problem Solving ● Detail Oriented

PROFESSIONAL EXPERIENCE

ASBMB ● Rockville, MD ● AJE ● Durham, NC ● June 2012 - Present

Prominent scientific societies(ASBMB and ACS) producing a portfolio of interdisciplinary scientific and educational

journals aimed to deliver scientific advancements to the readers; Manuscript services company (AJE) serving

international authors by providing pre-submission evaluation, editing and reviewing of scientific manuscripts.

Technical Writer & Editor

Plan, organize and develop content through literature research; write, edit and proof-read articles for digital and

online publications. Interview scientists, assimilate scientific content quickly and write articles to explain complex

subjects in simple terms for lay audience. Review and edit scientific manuscripts written by non-native English

speaking authors for quality, grammar and format.

Produced six articles with focus on biomedical 3-D printing, cancer biochemistry, molecular therapeutics

and silent diseases such as thyroid diseases, endometriosis, coronary heart disease for ASBMB.

Contributed to increasing the web traffic with the launch of explanatory series on the biochemistry of

relatively unknown diseases, writing featured articles on scientists with interesting hobbies.

Edited and reviewed manuscripts in the areas of stem cell engineering, biomaterials and biochemistry

with short turn-around time of 48 hours with minimal supervision while adhering to company's editorial

guidelines (AJE).

INFINITESIMAL LLC ● SKOKIE, IL ● Jan 2012 – Sept 2012

Start-up company focused on developing nanotechnology products & software algorithms for applications in drug

delivery and other biomedical applications.

Technical Lead & Business Process Consultant

Principal Investigator of the National Science Foundation-Small Business Innovation Research (NSF-SBIR) grant

in charge of developing a commercialization plan for the novel nanofountain probe technology. Technical point-

of-contact and acted as a liaison between the business development team and technical experts.

Drafted, reviewed and revised NIH and NSF grant applications, technology summary, business flyers,

technical reports and presentations on the company's technology.

Represented the company in conference meetings.

Developed approaches for product commercialization, business strategies, product definitions and market

segmentations for optimal competitive placement.

Performed primary and secondary market research and SWOT analysis.

Developed a commercialization plan that identifies point of differentiation, appropriate business model,

market segments and market potential, assessed competitor products, defined current product qualities

and outlined future capabilities for the company.

Established contacts with academic and industry researchers in the Chicago area Abbott, Takeda and

Astellas to promote iNfinitesimal's visibility and technological capabilities.

Drafted and edited reports summarizing the complex concepts behind the technology in easily

comprehensible terms for scientists, physicians and non-scientific team members (i.e. business

development personnel).

NORTHWESTERN UNIVERSITY● EVANSTON, IL ● Jan 2012 – Sep 2012

Large research university with programs in science, engineering, medicine, arts, literature, business and psychology

Postdoctoral Research Scholar

Plan and execute the development and implementation of the Nanofountain probe (NFP) technology for

applications in drug delivery.

Performed analysis and interpretation of biochemical and biophysical data.

Organized tables, graphs and drafted manuscripts, posters, grant proposals, slides and abstracts.

Organized an efficient communication channel for drafting multi-author manuscripts.

Reviewed manuscripts for Lab-on-a-Chip Journal focusing on micro-and nano-fluidics.

ILLINOIS INSTITUTE OF TECHNOLOGY ● Chicago, IL ● Aug 2006 – May 2012

Private Ph.D.-granting Research University with programs in engineering, science, psychology, architecture, business,

communications, industrial technology, information technology, design and law.

Graduate Research Assistant

Responsible for the overall delivery of several projects in the field of stem cells, bio/nanomaterials and

nanotechnology. Conceptualize, define the scope, design, plan and execute projects to achieve targeted goals.

Compile, analyze and synthesize large volumes of data using SPSS and other statistical tools. Critically evaluate

and summarize primary literature.

Collected, analyzed and summarized large volumes of data into reports, presentations, posters and

manuscripts

Published 6 articles in peer-reviewed journals with high impact factor, one more in preparation, seven

conference presentations, assisted in the preparation of two NIH and NSF R01 grants.

Reviewed and edited presentations, proposals, theses and manuscripts written by junior lab members.

Organized content and data in manuscripts and created poster templates for future use.

Participated in the peer-review of manuscripts in material science, nanomaterials and stem cell biology.

BHABHA ATOMIC RESEARCH CENTRE, GOVT OF INDIA ● Mumbai, India ● Dec 2005 – May 2006

India's premier nuclear research facility offering a multi-disciplinary research centre with extensive infrastructure for

advanced research and development covering the entire spectrum of nuclear science, engineering and related areas.

Informatics Intern

Performed analysis and interpretation of biochemical and large-scale atomic structure data.

Compiled presentations on project updates for weekly meetings and prepared thesis on the research

project.

EDUCATION

Doctor of Philosophy, Molecular Biochemistry and Biophysics (GPA 3.76/4.00)

Illinois Institute of Technology ● Chicago, IL ● 2012

Bachelor of Technology, Bioinformatics (GPA 9.41/10.00)

Vellore Institute of Technology ● Vellore, India ● 2006

PUBLICATIONS

“Adapting collagen/CNT matrix for in directing HESC differentiation”, Sridharan I, Kim T, Wang R,

1.

Biochem.Biophy Res. Comm. Feb 2009(381) 508 -512. Cited by 38.

Structural and mechanical profiles of native collagen fibers in vaginal wall connective tissues” Sridharan I, Ma Y,

2.

Kim T, Kobak W, Rotmensch J, Wang R, Biomaterials 2012,33(5 ) 1520-7.

3. "Matrix-specified differentiation of human decidua parietalis placental stem cells" Sridharan I, Kim T, Strakova Z

and Wang R, 2013. Biochem.Biophy Res. Comm. 2013 Aug 2;437(3):489 -95.

4. "Effect of CNT on collagen fiber structure, stiffness assembl y kinetics and stem cell differentiation", Kim T,

Sridharan I, Zhu B, Orgel J, Wang R, Journal of Materials Science and Engineering: C 2015, 49 (1), 281 –289.

5. "Spatially resolved quantification of E -cadherin on target hES cells", by Li Z, Qiu D, Sridharan I, Qian X, Zhang

H, Zhang C, Wang R,Journal of Physical Chemistry, B., 2010, 114 (8), pp 2894–2900. Cited by 14.

“Analysis of affinity maps of membrane proteins on individual human embryonic stem cells" Li Z, Qui D, Xu K,

6.

Sridharan I, Qian X, Wang W, Langmuir 2011, 27 (13), pp 8294–8301. Cited by 3.

7. High resolution characterization of collagen in Pelvic organ prolapse tissue, manuscript in preparation.

ABSTRACTS

1. "A carbon nanotube based scaffold for rapid stem cell differentiation” by Indumathi Sridharan, Taeyoung Kim,

Zuzana Strakova, Rong Wang, AVS Prairie Chapter symposium, Northwestern university, Evanston,IL, September

1st 2011.

2. "A carbon nanotube based scaffold for rapid stem cell differentiation” by Indumathi Sridharan, Taeyoung Kim,

Zuzana Strakova, Rong Wang, Kilpatrick Lecture series, Illinois Institute of Technology, Chicago, IL, September

2011.

3. "Coaxing stem cell differentiation on a colla gen-CNT composite material” by Indumathi Sridharan, Taeyoung Kim,

Zuzana Strakova, Rong Wang, ACS 239th National meeting, San Francisco, CA, March 21-25 2010.

4. "Coaxing stem cell differentiation on a collagen-CNT composite material” by Indumathi Sridharan, Taeyoung

Kim, Zuzana Strakova, Rong Wang, Department of Biological and Chemical sciences, Illinois Institute of

Technology, April 2010.

5. "An AFM approach for studying human embryonic stem cell differentiation", Dengli Qiu, Jialing Xiang, Zhaoxia Li,

Indumathi Sridharan, Aparna Krishnamoorthy, and Rong Wang, International Meeting on Stem Cell Engineering,

Corona Island, January 23, 2008.

6. "Investigation of cadherin-E in hES cells", Zhaoxia Li, Dengli Qiu, Indumathi Sridharan, and Rong Wang, 235th

ACS National Meeting, New Orleans, April 7, 2008.

7. "An AFM Study of Human Embryonic Stem Cells at the Single Cell Level", by Dengli Qiu, Indumathi Sridharan,

Zhaoxia Li, Aparna Krishnamoorthy, Jialing Xiang, Rong Wang, 234th ACS National Meeting, Boston, August 21,

2007.

LINKS TO ASBMB TODAY ARTICLES:

http://www.asbmb.org/ASBMBToday/templates/asbmbtoday_search.aspx?q=indumathi%20sridharan

WRITING SAMPLE 1: Summary of a physician's presentation

Lessons on Herceptin® from metastatic breast cancer trials: Efficacy, Safety,

Alternative combination regimes and Extended use

By Indumathi Sridharan

Herceptin® is a monoclonal antibody that targets HER2 (human epidermal growth factor receptor- 2) in

breast cancer cells. It is a particularly effective treatment for breast cancer patients with adverse

prognosis, such as those characterized by over-expression of HER2. Herceptin® is currently

administered as a monotherapy or in combination with chemotherapeutic agents like paclitaxel.

In his talk, Dr. Brian Smith presented data from latest clinical trials that demonstrate the efficacy and

safety of Herceptin®, promising alternative regimens of Herceptin® and the merit of prescribing

Herceptin® beyond disease progression. The common underlying theme in all such clinical trials was

that Herceptin® was administered atleast until disease progression and the clinical benefits of

Herceptin® depended on the accurate assessment of HER2 status via immunohistochemistry (IHC) or

fluorescent in situ hybridization (FISH).

Dr. Smith first focused on the IHC 3+ subset of patients in two large clinical trials: H0648g, (first -line

Herceptin® combination with the chemotherapy drug, paclitaxel) and H0649g (Herceptin® alone as

second/third-line treatment) (Table 1). It is evident that combining Herceptin® with the

chemotherapeutic drug, paclitaxel was highly effective: the Herceptin® and paclitaxel combination

engendered a better response rate (49%) and doubled the time to progression to 7.1 months.

Additionally, the survival duration, which was 18 months in the paclitaxel-only group, increased to 25

months with the addition of Herceptin®. Herceptin® was also more effective if administered in the early

stages of treatment. Specifically, Herceptin® second/third-line treatment and Herceptin® in salvage

settings had poorer response rates and time-to-progression than the first-line Herceptin® combination

therapy.

"In human terms, 18 months versus 25

months- that might be one more

Christmas, one more birthday, a child

graduating from the university."

Table 1: Cross-trial comparison of two trials: first-line Herceptin® combination with chemotherapy and

Herceptin® monotherapy second/third line.

Dr. Smith referenced Professor Charles Vogel's data to bring home the point that Herceptin® as a single

agent is an effective first-line treatment (Figure 1), but emphasized that the response rates and clinical

benefit rates were dependent on how the patients were assessed: IHC 3+ and FISH-positive patients

achieved greater benefit than others did.

Figure 1: Herceptin® has demonstrable clinical activity with greater clinical efficacy in IHC or FISH -

positive patients.

Currently, the choice between Herceptin® monotherapy and Herceptin® with paclitaxel as a first-line

treatment is driven by patient characteristics, not substantive clinical data. With the proviso that cross -

trial comparison could be misleading, Dr. Smith suggested that similar survival duration (~25 months) in

the two treatments might indicate that neither strategy has adverse impact on patient survival (Table 1).

However, conclusive evidence on the best initial strategy can only be derived from clinical trials that

directly compare the two treatments.

Alternative regimens, such as combination of Herceptin® with other chemotherapy drugs like

Vinorelbine, Docletaxel or Herceptin® with weekly paclitaxel schedule, show high response rates

(between 44% and 83%) and promising safety profile in IHC- and FISH-positive patients. Dr. Smith

cautioned that such high response rates in preclinical studies, although promising, do not always

translate into clinical success, particularly because of the heterogeneity of tumor characteristics in

HER2-positive patients.

Other than minor infusion-related events (Figure 2), Herceptin® therapies are not directly associated

with severe cytotoxic effects or adverse cardiac events that are commonly reported with chemotherapy.

Therefore, Herceptin® is generally tolerated well and is associated with better quality of life. Given the

favorable safety and tolerability profile, there may be a justification to use Herceptin® beyond disease

progression.

A retrospective analysis of a small study offers some evidential support in this regard. Of the 40% that

were administered Herceptin® beyond disease progression, a 11% of patients reported 22% higher

clinical benefit and a reasonable duration of response (6.7 months) (Figure 3).

Figure 2: Incidence of minor infusion-related events that are reported with Herceptin® monotherapy or

combination therapy

"In every case, Herceptin® with chemotherapy is better than

chemotherapy alone."

In summarizing his talk, Dr. Smith revisited the two recurring themes:

Herceptin® offers clear clinical benefits when used atleast until disease progression.

The benefits of Herceptin® treatments depend on the accurate assessment of HER2 status based

on IHC or FISH.

Additionally, he concluded that more concrete evidence of Herceptin® efficacy should come from

comprehensive clinical trials that evaluate the optimal initial strategy in administering Herceptin®, the

appropriate type of combination regimes and the duration of its use for metastatic breast cancer

treatments.

WRITING SAMPLE 2: Summary of two clinical trials

Mechanism of action, Clinical efficacy and Tolerability of Tapentadol in the Management of

Chronic Pain

By Indumathi Sridharan

Introduction

Opioids such as morphine, tramadol and oxycodone are currently the most effective analgesics available

for managing non-cancer related chronic pain. However, despite the promising analgesic efficacy,

adverse side effects such as constipation, nausea and somnolence are highly common with long-term use

of opioids. Opioid therapy is known to cause atleast one adverse event in over 80% of patients and 23%

of patients discontinued therapy because of such adverse events. Gastrointestinal problems, such as

gastric reflux, abdominal cramping, bloating and constipation is prevalent in over 80% of patients taking

opioids (1). Moreover, concerns of developing dependence, tolerance and addiction with long-term use

have deterred the widespread use of opioid therapy. There is a need for developing opioids with better

tolerability along with significant analgesic efficacy. Clinical studies have demonstrated that tapentadol,

a centrally acting µ opioid receptor agonist and norepinephrine uptake inhibitor, may be an effective

alternative to oxycodone in managing chronic pain.

Mechanism of Action

The analgesic effects of opioids emerge from their agonistic interactions with the µ opioid receptor of

neurons in the pain pathway. The interactions result in a series of complementary reactions that reduce

neurotransmitter release and thus, alleviate pain (1). µ opioid receptors are also found in the

gastrointestinal tract. The adverse gastrointestinal issues of opioid therapy are the result of non-specific

activity of opioids with the gastrointestinal µ opioid receptors.

In contrast to other opioids, tapentadol's has two different mechanism of action: the µ opioid receptor

activity and norepinephrine reuptake inhibition. The analgesic effects of tapentadol are not mediated via

active metabolites or enantiomers, unlike tramadol, or codeine (1). Tapentadol has 50-fold lower

affinity to µ opioid receptor compared to morphine and yet its analgesic effect is only two to three times

lower (2).

The inhibitory activity of tapentadol on norepinephrine reuptake has an opioid-sparing effect, i.e. it

supplements the analgesic effects of µ opioid receptor activation and reduces the incidence of adverse

gastrointestinal distress events by limiting the non-specific interactions of the molecule with µ opioid

receptors in the gastrointestinal tract.

Efficacy and tolerability of tapentadol in managing chronic pain

The efficacy, tolerability and safety of tapentadol in managing moderate-to-severe osteoarthritis-related

knee pain and low back pain have been demonstrated in two randomized, active and placebo-controlled,

phase III clinical studies with controlled dose adjustment. In both studies, treatment with tapentadol ER

100-250 mg caused a significant reduction in pain intensity in a higher percentage of patients (~30%)

compared to those treated with oxycodone HCL 20-50 mg controlled release formulation or placebo

(Figure 1).

Figure 1: Distribution of the percentage improvement in pain intensity from the baseline (intent -to-treat

population). Tapentadol ER vs. placebo, p = 0.004; oxycodone CR vs. placebo, p = 0.090. CR=

controlled release, ER= extended release. Image courtesy: Buynak R et al, Expert Opin Pharmacother.

2010.

Tapentadol ER also lowered incidence of adverse events, including gastrointestinal distress, compared to

oxycodone CR. For example, in the study on osteoarthritis-related knee pain, only 18.9% of patients in

the tapentadol ER group reported constipation, nausea and vomiting while 36.8 % of patients in the

oxycodone CR group reported such side effects (2). Additionally, the time to onset of adverse events

was longer (figure 2) and fewer patients discontinued treatments due to adverse side effects in the

tapentadol ER group than in the oxycodone CR group (Figure 3). Thus, tapentadol has a better

tolerability profile than oxycodone CR, in addition to its significant analgesic efficacy. Incidence of

opioid withdrawal symptoms was also lesser in the tapentadol ER group in both studies.

Figure 2: Distribution of time to onset of adverse events leading to treatment discontinuation. CR=

controlled release, ER= extended release, DB= double blind. Image courtesy: Buynak R et al, Expert

Opin Pharmacother. 2010.

Figure 3: Percentage of patients who discontinued from the study because of adverse events. Incidence

is based on number of patients with atleast one adverse events, not the number of adverse events;

patients could experience more than one adverse event. CR= controlled release, ER= extended release.

Image courtesy: Afilalo M et al, Clin Drug Investig. 2010.

Conclusion

The reduction in the adverse events is attributed to the dual action of tapentadol. The significant

improvement in analgesic effects combined with a desirable reduction in adverse events with the

administration of tapentadol makes it a favorable candidate for long-term opioid therapy for chronic pain

management.

References

1. Candiotti KA, Gitlin MC. Review of the effect of opioid-related side effects on the undertreatment of

moderate to severe chronic non-cancer pain: tapentadol, a step toward a solution? Curr Med Res Opin.

2010 Jul;26(7):1677-84.

2. Buynak R, Shapiro DY, Okamoto A, Van Hove I, Rauschkolb C, Steup A, Lange B, Lange C,

Etropolski M . Efficacy and safety of tapentadol extended release for the mana gement of chronic low

back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III

study. Expert Opin Pharmacother. 2010 Aug;11(11):1787-804.

3. Afilalo M, Etropolski MS, Kuperwasser B, Kelly K, Okamoto A, Van Hove I, Steup A, Lange B,

Rauschkolb C, Haeussler J. Efficacy and safety of Tapentadol extended release compared with

oxycodone controlled release for the management of moderate to severe chronic pain related to

osteoarthritis of the knee: a randomized, double-blind, placebo- and active-controlled phase III study.

Clin Drug Investig. 2010;30(8):489-505.

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