Moonshot for Pediatric Pharmacology

August 30, 2016

By: Peter T. Kissinger

*Published in August 2016 issue of Drug Discovery News and Op/Ed section of the Indianapolis Business Journal Aug. 29 edition     

Fire up the rocket. This month I hope to stimulate debate in favor of an underrepresented group in clinical pharmacology research.  Two decades ago women were underrepresented, including even female rats.   We’ve made real progress. The same is true for the elderly and racial minorities, although that challenge continues, as reflected in the FDA declaring 2016 the Year of Diversity in Clinical Trials.


Children remain a group neglected by the pharmaceutical industry.  They are a vulnerable and inconvenient population for medical research, especially outside the developed economies.  This is a demographic which demands an individualized approach to therapy that is even more compelling than for adults.  Many children die of infectious diseases and malnutrition while others are permanently damaged.  Others have inborn metabolic errors which respond well when caught early. Children, of course, contract cancer.  Physicians often must guess on drug choice and dose, because there is limited supporting data and often no suitable formulation.  Mixing portions of drugs with compatible (or not) “baby food” is common for parents and not well controlled.  Adult formulations are often unsuitable for children in physical size, dose, and excipients. Special pediatric formulations, such as liquids, require extensive regulatory review, including oral syringes for parents to use, which are then medical devices.

Self-administered protein-based drugs become more popular for adults, for example, using pumps.  In children this presents costly regulatory issues with labeling, instructions and compatibility with little hands and physical play.

There is opportunity, step-by-step to now reduce the art and increase the science.  Pharmacophenomic progress can be made today, without any speculative drug discovery.  Most approved drugs compatible with pediatric disease are generic, but few have been thoroughly studied in children as N=1 individuals.   The goal of individualized, data-based dosing for children also has implications for adults. The current government precision medicine initiative is largely genetics focused and does not explicitly deal with the phenotypic reality of individuals. The likelihood of genomics solving many diagnostics challenges is very small.  It is only one dimension of a multifactorial problem for which we have many new tools.


Why are children not the focus of clinical pharmacology?


  1. Children are not small adults.  Their phenotype changes very rapidly from birth to their early 20s. This is inconvenient for scientists and statisticians alike.
  2. Children are generally healthy and thus represent a small market for new drugs. This is inconvenient for CFOs.
  3. The ethical challenges of clinical trials with children are daunting to some. Informed consent is for parents/guardians. We do not do drug trials on healthy children as we typically do for adults (Phase I).  On the other hand, adult trials will have been done first. Recruiting sufficient numbers of patients for statistical power is tough, but with better measurements you need fewer subjects.
  4. The rate of change in children confounds clinical trials of any length. For example, newborns vary biochemically month to month.  Age is NOT a good metric for measured phenotype. The equivalent of a three year trial for patients in their 40s is impossible in patients who will double in age over 3 years.
  5. While Congress and the FDA have provided incentives (extended market exclusivity) to pharmaceutical companies who add a pediatric component to trials for new drugs, the incentive is not often sufficiently compelling. There are many generic drugs that are useful in children, but most have not yet been studied in children using modern protocols before patents have expired.
  6. Young children are small. Neonates are tiny.  This makes both physical and chemical measurements more difficult than for adults. Small blood volumes is one challenge. Children also do not have the mobility to get to a clinic on their own and most can’t describe their feelings with any precision to a caregiver as researcher.
  7. Because of the “tyranny of averages” from clinical trials and the significant variations in the rate of ontogeny person-to-person, children are especially subject to medical errors of drug choice and dose. Dosing in units of mg/kg of body weight is done because it is better than nothing, not because it optimizes a satisfactory result.  It does not!



There are good things to say about pediatric research.


  1. The return on investment in children’s health promises to be much higher than the return on investment in the health of elderly professors like me. Preventive medicine means a lot.
  2. Children as a rule have avoided some of the bad habits that make studies in adults inconvenient (smoking, alcoholism, drug addiction, French fries,…) and have not experienced the degenerative diseases of aging.
  3. Children are less subject to polypharmacy and thus have fewer drug-drug interactions or drug induced enzymes.


To facilitate research, we are moving step-by-step from accumulated “art” to evidence-based medicine (decisions by averages from randomized trials) and on now to individualized medicine based on N=1 data.  While physics plays a role, chemistry is more specific in health care research.  My own team has developed means of automatically sampling exquisitely small blood volumes in a preprogrammed painless way that eliminates labor and reduces infection risk.  This is especially important with respect to recruiting children for trials where parental approval is crucial.  Colleagues have further developed measurement technologies that are compatible with much smaller sample volumes than even a decade ago. These include several ambient ionization mass spectrometry schemes, among others.   Today the required sample volumes and concentrations for quality measurements are both reduced by up to a million-fold compared to 1980.   Expertise in modelling and predicting, much of it developed from industrial engineering, is now coming into play.  Health care is a process that is largely “out of control” because of inadequate process monitoring along the way.  Proper decisions by health care providers are thus inhibited.  Imagine operating a chemical, electronics or auto plant with such haphazard in-process monitoring.


Nutrition matters because food-effects matter and the microbiome also impacts circulating drug concentrations.  Today these are not adequately measured in children.  Some data will improve decision making.  Better, faster, cheaper data will improve decision making more.  A malnourished child in Africa will not react to a drug the way a plump over-nourished child in Indiana will.


Collaborative Opportunities:


There are several networks of Children’s Hospitals, many of which have a research component. The NIH (NICHD) has organized a pediatric trials network (PTN) and a neonatal research network (NRN) among children’s hospitals that share experiences and data. [Taken from the NICHD website: “Formed in 1986, the NICHD Neonatal Research Network (NRN) is a collaborative network of neonatal intensive care units across the United States. The NRN comprises 18 clinical centers.”  “The main objective of the PTN is to provide an environment and an appropriate infrastructure for conducting safe and effective pediatric clinical trials for the Best Pharmaceuticals for Children Act (BPCA) drug development program and for performing ancillary activities in support of these trials. The network will conduct pediatric clinical drug trials in a variety of therapeutic areas, including but not limited to cardiovascular diseases, cancer, infectious diseases, gastroenterology, respiratory diseases, neonatology, and medical devices.”]  I encourage those working in drug discovery to consider pediatric applications early and often. Please also recall that many drugs used in this population were approved before the new tools became available.  When you consider estate planning, consider pediatric pharmacology. After all, government contribution to R/D is far below traditions in % of the federal budget and as a % of GDP.  The kids will be unaware of this until they are 30.  Let’s lend them a hand now to reduce the cost of the downstream consequences of inadequate care.


[Note:  On July 14, The Research to Accelerate Cures and Equity (RACE) for Children Act was introduced to Congress requiring compliance with the Pediatric Research Equity Act (PREA) of 2003.  This no doubt will be debated for quite some time. Alert readers will note that the word compliance almost always implies longer R/D cycles, higher drug prices and less venture investing in research.  Of course, RACE would not stimulate the optimization of generic drug use in children as described above.]



IHIF is a Proud Partner in National Health IT Week

August 21, 2016

This September, IHIF — as a partner in the advancement of health information technology to help improve healthcare —is a Proud Partner in National Health IT Week.  National Health IT Week is the premier event offering all healthcare stakeholders an opportunity to unite under one banner, expressing the benefits that health information technology (IT) brings to U.S. healthcare. “The Value of Health IT.”

Comprehensive health care reform is not possible without system-wide adoption of health information technology, which improves the quality of healthcare delivery, increases patient safety, decreases medical errors, and strengthens the interaction between patients and healthcare providers.

With Meaningful Use now providing the way forward, eligible providers across the country increasingly understand the benefits for themselves and their patients, and are adopting Meaningful Use compliant electronic health records.

Initiated in 2006 by the Healthcare Information and Management Systems Society (HIMSS), National Health IT Week has emerged as a landmark occasion for using health IT as part of the overall solution to improve America’s healthcare as a bipartisan, federally led, market driven initiative.

The Week consists of events across the country, including National Health IT Weekparticipants —vendors, provider organizations, payers, pharmaceutical/biotech companies, government agencies, industry/professional associations, research foundations, and consumer protection groups— all working together to elevate national attention to the advantages of advancing health IT.

View our full list of partners and updates on the Week’s events. Working together with our growing coalition of stakeholders, IHIF is helping to transform healthcare for all.

Deadlines to Apply for NCATS Funding Opportunities are Coming Up September 6!

August 21, 2016

This is a reminder that the National Center for Advancing Translational Sciences (NCATS) has several open Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) program funding opportunities designed to help advance and commercialize translational research technologies. NCATS encourages applications in these four research areas of interest: drug discovery and development, diagnostics and devices, bioinformatics and information technology, and clinical research.


All opportunities below have an application deadline of Sept. 6, 2016, 5 p.m. local time.


2016 Omnibus Solicitation

Small businesses, research and technology transfer organizations are eligible to apply for the 2016 Omnibus Solicitation. Applications may address any stage of translation, from target validation through pre-clinical and clinical evaluation to intervention, implementation and dissemination. Review NCATS’ research priorities to determine its areas of interest.

Other Funding Opportunities

SBIR Direct Phase II

Small businesses that have accomplished the objectives of a Phase I SBIR grant through non-SBIR funds are able to apply for SBIR direct-to-Phase II funding. Applicants must demonstrate the scientific and technical merit and feasibility of the prototype stage of developing a biomedical technology that has commercial potential.

  • PAR-15-288: Direct Phase II SBIR Grants to Support Extended Development, Hardening, and Dissemination of Technologies in Biomedical Computing, Informatics, and Big Data Science
  • PAR-14-088: Direct Phase II SBIR Grants to Support Biomedical Technology Development


SBIR Technology Transfer

This funding opportunity encourages SBIR grant applications from small business concerns for projects to transfer technology out of the NIH intramural research labs into the private sector.

  • PA-15-354: SBIR Technology Transfer (R43/R44)


Platform Delivery Technologies for Nucleic Acid Therapeutics

This funding opportunity is designed to incentivize small businesses to generate new technologies and products for delivering nucleic acids into cells and tissues for the purpose of treatment or prevention of human disease.

  • PA-14-307: Platform Delivery Technologies for Nucleic Acid Therapeutics (R43/R44)
  • PA-14-308: Platform Delivery Technologies for Nucleic Acid Therapeutics (R41/R42)


Development of Appropriate Pediatric Formulations and Drug Delivery Systems

Applications must address different and complementary research needs for the development of appropriate pediatric drug formulations in different age groups.

  • PAR-13-345: Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R43)
  • PAR-13-346: Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R41)


Learn more about current funding opportunities for small business at NCATS Small Business, including eligibility requirements and research priorities. Need help? Contact NCATS SBIR and STTR to discuss your project idea.


Connect with NCATS! Like us on Facebook and follow us on Twitter. Use #NCATSsbir and join the online conversation.



NCATS’ SBIR and STTR programs are engines of innovation for developing and commercializing tools, technologies and intervention platforms to support the creation of new therapeutics and diagnostics. SBIR and STTR are government set-aside programs for domestic small businesses to engage in research and development that has the potential for commercialization and public benefit.

Ivy Tech Bloomington led development of national educational skill standard for medical device careers

August 9, 2016



August 9, 2016


Contact:  Amanda Billings

Executive Director, Marketing/Communications

Ivy Tech Community College – Bloomington

(812) 330-6222   |


BLOOMINGTON – Ivy Tech Community College’s Bloomington campus led a consortium of 12 other community colleges and 72 medical device industry partners nationwide to develop the nation’s first skill set standards for entry-level medical device jobs in the U.S. The Community College Consortium for Bioscience Credentials (c3bc) published “Medical Device Skill Standards,” a manual of educational guidelines to ensure educators and trainers develop and teach the skills needed in entry level medical device jobs in the U.S. The project was funded by a $15 million dollar grant from the U.S. Department of Labor.


Sengyong Lee, Ph.D., professor and Ivy Tech Bloomington biotechnology program chair, is c3bc’s medical device hub leader. Dr. Lee and his team at Ivy Tech Bloomington led the nationwide collaboration. “The advancement of medical technology and growing health care needs for elderly populations around the globe have accelerated the growth of companies like Cook Medical in recent decades,” Dr. Lee said. “The medical device industry is in need of a continuous pipeline of skilled workers to meet their growth demands. Our partners and educators who developed the skill standards manual hope for a long-term return on investment in the form of graduates from community colleges who will fill those jobs.”


Local employers, including Chapman Lake Instrument Corp., Cook Medical, Cook Polymer Technology, and Boston Scientific Corporation, participated as industry partners. Employers outlined skills needed in entry-level medical device positions, which educators used to create skill standards for teaching and testing students.


Educators nationwide have already begun to use the skill standards manual to create new and revise educational courses, certificates, and degrees to align with industry needs. For example, Ivy Tech Bloomington developed a new medical device quality certificate that counts toward the biotechnology associate degree and leads to a career in the industry. Ivy Tech Bloomington also has a plastics program and regulatory affairs certificate to meet local employer needs.


In addition to publishing the manual, c3bc also developed ‘Courses in a Box’ which educators nationwide can use to develop curriculum. The downloadable, digital materials outline exactly what should be taught, and includes everything a credentialed instructor would need to teach the course online or in person.


“The courses in a box project will be especially valuable to educators and trainers who are new in the field. Of course, the main beneficiaries of the project are the students and trainees who will receive valuable education,” Dr. Lee said.


The c3bc’s Medical Device Skill Standards manual and Courses in a Box are now published and are free and available to download. The standards manual can be found online at and the Courses in a Box can be found at


For information about Bloomington programs in medical device manufacturing, plastics, and biotechnology, visit and click Bloomington. Fall classes begin August 22 but students should enroll by August 12 in order to be prepared on the first day of classes. To enroll, visit, stop into Ivy Tech Bloomington located at 200 Daniels Way, or call (812) 330-6013.


About Ivy Tech Community College
Ivy Tech Community College ( is the state’s largest public postsecondary institution and the nation’s largest singly accredited statewide community college system.  Ivy Tech has campuses throughout Indiana. It serves as the state’s engine of workforce development, offering affordable degree programs and training that are aligned with the needs of its community along with courses and programs that transfer to other colleges and universities in Indiana. It is accredited by the Higher Learning Commission and a member of the North Central Association.




Interview contacts:


Dr. Sengyong Lee


Chris Kilander

Global Product Manager/Team Leader – Peripheral Intervention

Cook Incorporated

750 Daniels Way

Bloomington, IN 47404

1-800-468-1379 ext. 10-1978

Mobile: 812-322-8097


Kathy Heuer,

Executive Director, Indiana Medical Device Manufacturing Council, Inc.

Kathy Heuer

Executive Director, IMDMC, Inc.

PO Box 441385

Indianapolis, IN 46244

(260) 609-2802


NCI FY2017 Contract Topics Now Available

August 3, 2016

FY2017 Contract Topics Now Available!

The National Cancer Institute Small Business Innovation Research (NCI SBIR) Development Center funding opportunities come in two large categories: grants and contracts. Contracts are legally binding agreement for the direct use or benefit of the Government, and involve deliverables at the end. This year, there are 15 contract topics in high priority research areas ranging from therapeutics to digital health. See below or visit our website to find out more about this year’s topics. Proposals are due by October 21, 2016, 5:00 PM EDT.  Please direct all questions regarding contracts to the NCI Office of Acquisitions (




August 24, 2016, 2:00 PM EDT


The session will cover:
PHS2017-1 Solicitation
Contract Topics per IC
Electronic Contract Proposal Submission (eCPS) Website

For more information about the NCI SBIR & STTR Programs, please visit the website.

The SBIR & STTR Programs are NCI’s engine of innovation for developing and commercializing novel technologies and products to prevent, diagnose, and treat cancer. The SBIR & STTR Programs are government set-aside programs for domestic small businesses to engage in research and development that has the potential for commercialization and public benefit.

Sign up to receive updates about SBIR & STTR funding opportunities at


IHIF Welcomes New Members

August 3, 2016

Quality Connection

Quality Connection is a labor management partnership comprised of 100 union electrical contractors and nearly 3,000 International Brotherhood of Electrical Workers (IBEW) #481 electrical workers. Together labor and management provide the needed expertise, highly trained workforce, safety and dedication to help build many of Central Indiana’s premiere education, health care, utility sites and logistics projects. The unique business relationship spans more than 50 years and represents a strong tradition of quality electrical construction, progressive labor negotiations and community service. With an unprecedented commitment to workforce training, job safety and worker standards. Quality Connection . . .Quality Work, Customer Connected. Learn more at

NeRX Biosciences

One of the most effective chemotherapeutics used in the treatment of cancer continues to be the DNA damaging agent cisplatin. Pioneered by our Medical Advisor, Dr. Larry Einhorn at the Indiana University School of Medicine for the treatment of testicular cancer, cure rates now exceed 90% for this cancer. This represents one of the few shining stories since the “War on Cancer” was initiated in the early 1970’s. Unfortunately, cisplatin is considerably less effective in treating other cancers but remain first-line treatment for lung and ovarian cancer. NERx Biosciences co-founder and CSO, Dr. John Turchi has been studying the biology and biochemistry of cisplatin for 25 years and in 2005 was recruited to the Indiana University Cancer Center where advances in his laboratory have paved the way for recapitulating the successes of platinum treatment for testicular cancer in lung and ovarian cancer.

NĒRx Biosciences was established in 2009 to capitalize on these advances and discoveries to develop novel therapeutics to enable the effective treatment of highly prevalent and difficult to treat cancers including lung and ovarian. Learn more at


Azenix/Futago Corporation

 Researching and developing advanced process technology and design manufacturing plan cooperated with Futago LLC.


KinaSense is developing cell-based assays used in preclinical drug discovery to identify and characeterize new compounds for oncology. Our assays are faster, less expensive, and have more physiological relevance than traditional methods used in target validation and potency studies, allowing earlier decision making fro progressing compounds into animal studies.Learn more at


MorNuCo, Inc. is a biotech company focused on age related diseases with an emphasis on cancer detection. Learn more at

Phytoption LLC

Phytoption LLC is an innovation company developing propriatory ingredients to improve drug bioavailability, food quality, and cosmetics functionality. It offers patented technology and ingredients to pharmaceutical, food, or cosmetic industrial partners.

Safekeeping (2)

Safekeeping is a moblie application that delivers health and lifestyle information to family members of patients in care facilities.Learn more at

July 2016 Lunch Program: Women in Life Science Leadership

July 21, 2016

Tuesday, July 19

Every so often we like to highlight and recognize the success and influence of women in the life science industry.  This year, we focus on how women make the move out of the lab (or its sector equivalent) and into company leadership.  Reflecting a national conversation backed by some rather dismal (but improving!) statistics, we will here from 3-4 entrepreneurs and more seasoned leaders about how women acquire the experience, tools, networks, and investor confidence to take charge of their innovations and lead their companies forward.


Deborah Pollack-Milgate, Partner

Barnes & Thornburg LLP


Kristin Eilenberg, CEO
Lodestone Logic/Lodestone Insights

Terri Pascarelli, CEO
AIT BioScience

Sherry Harbin, Ph.D., CEO
GeniPhys LLC

Margo Enright

The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in life science. Each month, at lunch, a policymaker or a panel in the field of life science will be available to answer questions concerning the major challenges and opportunities in the life science industry. We hope you will join us.

For more information on upcoming programs, please visit

Follow us on Twitter @IHIF1 #LifeScienceLunch @BTLawNews

NCI SBIR/STTR Webinar & Great Funding Opportunity by JLABS!

July 8, 2016

The National Cancer Institute Small Business Innovation Research (NCI SBIR) Development Center will be participating in the Women in Biotech webinar on Tuesday, July 14, 2016. NCI SBIR Program Staff Kory Hallett, Ph.D. will be speaking at the webinar about NCI SBIR/STTR funding opportunities and application tips. Register today for this free webinar and get in-depth information about SBIR and STTR programs.

In addition to the webinar, we would like to share with you a great funding opportunity that could help fuel your cancer research. The JLABS QuickFire Challenge will award up to $500,000 in a research grant and entrance to JLABS. We hope you find the contest useful for advancing your cancer research. Detailed information about the webinar and the QuickFire Challenge can be found below.

If you have any questions about the webinar or the NCI SBIR/STTR programs, please send us an email at

Securing SBIR and STTR Funding: Support for Women
Entrepreneurs and Researchers in Biotech

Thursday, July 14, 2016, 1:00 – 2:00 p.m. ET | 10:00 – 11:00 a.m. PT

Register Today


  • Kory Hallett, Ph.D., Program Staff, AAAS Science & Technology Policy Fellow, NCI, NIH
  • Cartier Esham, Ph.D., Executive Vice President, Emerging Companies, Biotechnology Innovation Organization (BIO)
  • Lili M. Portilla, M.P.A., Director, Strategic Alliances, NCATS, NIH
  • Stephanie Fertig, M.B.A. Director, NINDS Small Business Programs, NIH

The webinar will feature:

  • An overview of SBIR and STTR programs and funding opportunities
  • Examples and case studies of women founders of bio- and healthcare-technology early-stage businesses

Tips and tools for applying for funding, and resources available for women entrepreneurs and researchers from socially and economically disadvantaged backgrounds


JLABS QuickFire Challenge


Johnson & Johnson Innovation and Janssen Pharmaceuticals, Inc. aim to improve the health and wellness of people around the world. To that end, there is a passionate and engaged workforce across the consumer, medical device and pharmaceutical units who are interested in finding and deploying comprehensive, end to end, integrated solutions which take into account the world in which we live today. Johnson & Johnson Innovation and Janssen Pharmaceuticals, Inc. are bringing together the consumer, medical device and pharmaceutical sectors to award a prize or a series of prizes to the person or team(s) who submits the best idea, technology, or solution that will address a critical health need for the world’s population. Please check out the areas of interest, with an emphasis on lung cancer and metabolism.

Solutions will be evaluated based on their ability to meet the following criteria:

  • Address a particular cohort with a critical unmet medical need in strategic areas of interest, such as lung cancer and metabolic diseases.
  • Integrate a novel approach that combines pharmaceutical, devices and/or consumer health solutions.
  • Address part or all of the spectrum of prevention, interception and cure.
  • Outline how the award would help them reach a critical milestone within the time frame of a single year and provide a full “time-to-market” plan for their solution.

The deadline to apply is August 31, 2016, and winners will be announced by the end of the year.

Pearl Pathways’ CEO completes Goldman Sachs 10,000 Small Businesses entrepreneurship program

July 6, 2016


July 6, 2016




Contact: Michele Taylor

Pearl Pathways

Business: (317) 899-9341 (ext. 112)



Indiana Life Science Executive completes Goldman Sachs 10,000 Small Businesses entrepreneurship program


Pearl Pathways’ Diana Caldwell welcomed into elite alumni group of the Babson College Cohort of Goldman Sachs’ 10,000 Small Business program



INDIANAPOLIS, INDIANA – July 6, 2016 — Pearl Pathways is pleased to announce that its President and CEO, Diana Caldwell recently completed an elite entrepreneurship training program in the Babson College Cohort of Goldman Sachs’ 10,000 Small Business program.  She is among 137 entrepreneurs who graduated in May 2016 representing 34 states, Washington D.C, and Puerto Rico.  Goldman Sachs 10,000 Small Businesses is a national program created to help entrepreneurs create jobs and economic opportunity by providing greater access to education, capital, and business support services. The graduates of the program this spring completed the blended online and face-to-face program that delivers intensive practical entrepreneurship training from Babson’s business experts and peers, alongside educational teams who teach the 10,000 Small Businesses program at community colleges across the country.

“We’re proud of our graduates of the Goldman Sachs 10,000 Small Businesses Initiative. These entrepreneurs put forth incredible effort to complete this program and we are confident their efforts will continue in growing their businesses. We are excited to watch their many successes,” said Kerry Healey, President of Babson College.

Pearl’s President and CEO, Diana Caldwell shares “The 10,000 Small Business program offered training for entrepreneurs that I was able to immediately implement in the business, and allowed me to network and learn from impressive CEOs across the country. I would recommend this program to fellow CEO’s who want to take their company to the next stage.”

Babson has been partnering with Goldman Sachs and others on the 10,000 Small Businesses program since 2010, and has helped train over 200 faculty and staff who deliver the program. The small businesses in this group represent a total of $240M in revenues and over 3,000 jobs from a broad range of industries.

Starting in March 2016, for 11 weeks, these small business owners connected with peers and worked together through practical business education delivered through a blend of online and in-person sessions.

“The program is designed to be highly participative, focusing on peer and experiential types of learning – just Babson’s style,” said Babson Professor Patricia Greene, National Academic Director of Goldman Sachs 10,000 Small Businesses and 10,000 Women. “Babson is proud to see these business owners applying what they have learned to take their next steps in growing their revenues, creating jobs, and supporting our economy.”

About Pearl Pathways


Pearl Pathways is a comprehensive life science product development services company. Our experienced team is obsessed with expediting life science product development regulatory pathways. We have three business units to serve you:

Pearl IRB is a full service commercial Independent Review Board that provides human research IRB reviews, IRB exemptions and waivers, and also offers support for research protocol/ICF medical writing, site assessments, and monitoring services.

Pearl ReGXP is a regulatory and quality compliance consulting practice that provides regulatory filing guidance, conducts global health authority negotiations, develops/improves quality systems, and delivers GMP/GLP/GCP auditing services.

Pearl IDEAS provides strategic product development assistance, third party vendor selection and management strategies, due diligence services, and sales and marketing services for drug, biologic and device companies.

To learn more, please visit us at, call us at (317) 899 – 9341, or email Pearl Pathways is located in Indianapolis, Indiana, and is AAHRPP accredited and a WBENC certified woman owned business. For media inquiries, contact


About Goldman Sachs 10,000 Small Businesses

Goldman Sachs 10,000 Small Businesses is based on the broadly held view of leading experts that greater access to this combination of education, capital and support services best addresses barriers to growth for small businesses. 10,000 Small Businesses is guided by an Advisory Council on which Babson President Kerry Healey serves and is co-chaired by Goldman Sachs chairman and CEO Lloyd C. Blankfein, Bloomberg L.P. founder, president and CEO, and 108th Mayor of the City of New York Michael R. Bloomberg, Berkshire Hathaway chairman and CEO Warren Buffett, and the Initiative for a Competitive Inner City’s Dr. Michael Porter.  The National Urban League and the U.S. Hispanic Chamber of Commerce are also represented on the Advisory Council, among other groups.

10,000 Small Businesses offers qualified business owners:

  • Guidance in creating a customized growth plan that includes opportunity identification and feasibility analysis, financial management, leadership, negotiations, and marketing.
  • One-on-one business counseling and a network of peer support from other small business owners, as well as leaders in the business world.

To apply for the 10,000 Small Businesses business and management education program, please visit

About Babson College

Babson College is the educator, convener, and thought leader for Entrepreneurship of All Kinds®. The top-ranked college for entrepreneurship education, Babson is a dynamic living and learning laboratory where students, faculty, and staff work together to address the real-world problems of business and society. We prepare the entrepreneurial leaders our world needs most: those with strong functional knowledge and the skills and vision to navigate change, accommodate ambiguity, surmount complexity, and motivate teams in a common purpose to make a difference in the world, and have an impact on organizations of all sizes and types. As we have for nearly a half-century, Babson continues to advance Entrepreneurial Thought & Action® as the most positive force on the planet for generating sustainable economic and social value.


June Life Sciences Lunch: FDA Guidance: An Abundance of Information in 2016

July 4, 2016

The U.S. Food and Drug Administration has released a number of guidance documents this year, with more on the way. Please join us as we discuss some of the biggest changes, how companies should incorporate this information into their regulatory strategies, and how to reconsider your recall strategy in order to keep up.

Deborah Pollack-Milgate, Partner
Barnes & Thornburg LLP

M. Benhur Benjamin M.S. RAC
Safis Solutions

Lynn Tyler, Partner
Barnes & Thornburg LLP

The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in life science. Each month, at lunch, a policymaker or a panel in the field of life science will be available to answer questions concerning the major challenges and opportunities in the life science industry. We hope you will join us.

There is no charge to attend, but please register so we know how many lunches to order. Please see registration page for details. Some of the discussion questions will be submitted to the speakers in advance.