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<h1>Individual career planning, skill building, and connecting with professionals within and beyond academia</h1>
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<h1 class="page-heading"><span style="color: #000000;"><strong>Harald Clinical Trial/ Translation Module</strong></span></h1>
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<h1 class="page-heading"><span style="color: #000000;"><strong>Gautam Ghatnekar, DVM, PhD - </strong><strong>An entrepreneur’s story:  Case study of translation of a drug through clinical trials</strong></span></h1>
Dr. Ghatnekar is the President &amp; CEO of FirstString Research, Inc., a clinical-stage biotechnology company located in Charleston, South Carolina.  Dr. Ghatnekar studied veterinary medicine and developed his own veterinary practice specializing in small animal medicine and surgery. In 2000, he enrolled in a graduate program at North Carolina State University and in 2004 graduated with a PhD in Comparative Biomedical Science . During his doctoral studies, he was President of the Graduate Student Association and won various awards, including the Teratology Society Marie W. Taubeneck award for excellence in research and leadership and an American Heart Association Pre-Doctoral Fellowship. Following his PhD, Dr Ghatnekar did a post-doc with Dr Gourdie at the Medical University of South Carolina (MUSC). During these studies, Dr. Ghatnekar established ACT1 as a technology platform, with applications in regenerative medicine and he and Gourdie formed FirstString Research, Inc. in 2005. Under his leadership, FirstString Research has advanced the clinical development of its lead product Granexin Gel – a topical formulation containing the ACT1 peptide – through human clinical trials. The gel was tested on 48 subjects in a Phase 1 study and has been evaluated in three Phase 2 human clinical trials for acute surgical wounds and chronic wounds, such as diabetic foot ulcers and venous leg ulcers. The results from clinical trials were published in 2015 in the Journal of Investigative Dermatology (Nature) and Wound Repair and Regeneration. Phase III clinical trials on diabetic foot ulcers are now underway. Dr. Ghatnekar’s experience and expertise in preparing regulatory documentation, developing both GLP preclinical studies and clinical trial protocols; and working knowledge of both the device (CDRH) and drug (CDER) regulatory routes and requirements, has led FirstString Research to successfully navigate the FDA and obtain IND approvals. Dr. Ghatnekar is a member of various prestigious national and international scientific societies including the Wound Healing Society and the Association for Advancement of Wound Care. He has been awarded multiple Phase I and Phase SBIR/STTR small business grants by the NIH, is PI on a prestigious NIH BRiDG award and serves on NIH study sections as a reviewer. In 2006, he accepted the ‘Innovators 2006’ award, sponsored by the Charleston Regional Business Journal.  Dr. Ghatnekar was also recognized recently by the Charleston Regional Business Journal as one of Charleston’s ‘Forty Under 40’.

<span style="color: #000000;"><strong>Harald Sontheimer, PhD - </strong><strong>A scientist's story:  Case study of translating a glioblastoma drug.</strong></span>

Dr. Harald Sontheimer researches the biology of glial cells, the brain's most abundant cell type. He is credited with making foundational discoveries on the functional properties of glial cells in the brain, including the localization and mechanisms of a range of receptors and ion channels that were previously thought to exist only on nerve cells.

Currently, Dr. Sontheimer studies the molecular structure and activity of glial cells in health, cancer, and other diseases. He and his research team work to understand the mechanisms underpinning the functions of glial cells, and how these functions may fault.

Dr. Sontheimer also currently serves on several councils and committees, including the Scientific Advisory Board "Cure Epilepsy", the Scientific Advisory Board for the MIT Press, the Society for Neurochemistry Program Committee, the American Brain Tumor Association Scientific Advisory Council, and the College of CSR Reviewers. He previously served on the Scientific Advisory Board for The Max Plank Society. He also served as an editorial board member, in various capacities, for the <em>Journal of Neuroscience Letters</em>, <em>Glial</em>,<em>Jounal of Neuroscience Research</em>, <em>Glial-Neuronal Biology</em>, <em>NeuroReport</em>.

<span style="color: #000000;"><strong>Kurtis Moyer, MD - </strong><strong>A clinician’s story: Surgical breast reconstruction for breast cancer survivors.</strong></span>
<h2>Associate Professor, Surgery, Virginia Tech Carilion School of Medicine</h2>
<h2>Associate Residency Program Director, Plastic Surgery, Milton S. Hershey Medical Center</h2>
<h2>Medical Director, Hershey Cosmetic Surgery Center, Milton S. Hershey Medical Center</h2>
<h2>Medical Director, Doctor in the House Program, The Spa at the Hotel Hershey</h2>
<h2>Assistant Professor of Surgery, Penn State Milton S. Hershey Medical Center</h2>
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<span style="color: #000000;"><strong>Brian Giles, PhD, JD -</strong><strong> A lawyers story: Intellectual property and commercialization</strong></span>

Dr Gile’s practice focuses primarily on patent prosecution, due diligence, and portfolio management in the areas of biotechnology, pharmaceuticals and medical devices. He did his PhD degree at the Medical University of South Carolina on vasculogenesis He has spent the last decade working with dozens of universities, and numerous early and growth stage biotechnology and medical device companies, to develop patent portfolios individualized for his client's unique needs and intended markets. Prior to this, Dr Giles spent another decade conducting research in the areas of immunogenetics, endocrinology, infectious disease, cardiology, developmental biology, cell biology, and molecular biology. He has used his extensive technical and legal experience to protect a wide variety of technologies, including stem cells, recombinant proteins, synthetic peptides, oligonucleotides, viral vectors, antibodies, biomarkers, biomaterials, nanoparticles and microparticles, tissue engineering techniques and reagents, diagnostics, medical devices, and therapeutic methods. His experience includes drafting patent applications; preparing invalidity, freedom to operate, and non-infringement opinions; prosecuting U.S. and foreign patent applications; and advising companies and investors during I.P. due diligence. Dr Gile's is an active member of Georgia Bio, and currently serves as an Advisor for its Emerging Leader's Network (ELN). Brian is also involved in the Southeastern Medical Device Association (SEMDA), the Association of University Technology Managers (AUTM) and is Associate Editor of the Georgia State Law Review.

<span style="color: #000000;"><strong>Mark Van Dyke, PhD</strong><strong> - A bioengineer's story: Case study of translating a device - Regulatory considerations</strong></span>

Biomaterials are an essential tool that provides the basis for bioengineered devices, growing and delivering cells, developing functional tissues, and engineering whole organs. Natural biopolymers that self-assemble on the nano scale have the potential to provide native cellular environments that facilitate the directed behavior of cells. Research conducted in the Nanostructured Biopolymer Engineering Lab makes use of naturally derived keratin nanomaterials for biomaterials development. Dr. Van Dyke’s research group studies the fundamental characteristics of keratin nanomaterials such as their solution behavior, self-assembly into network structures, and structure-function relationships. Keratin nanomaterials can be purified from natural fibers and when properly isolated, demonstrate several remarkable characteristics. First, keratin nanomaterials are highly biocompatible and can be used for tissue regeneration, drug delivery, and as carriers for cells; purified keratin nanomaterials contain no cellular elements so they do not elicit an immune response. Second, keratin nanomaterials have a unique capacity for molecular self-assembly that results in the spontaneous formation of network structures. Self-assembly occurs on the nanometer scale and builds to the micron scale, resulting in homogenous, porous architectures that are conducive to cell attachment and growth. Third, keratin nanomaterials contain cellular binding motifs that mimic the sites of cell attachment found in native extracellular matrix. By leveraging these unique characteristics, we are creating inexpensive biomaterials with the potential for use in a host of biomedical applications. Commercializing the results of our research is also a focus of the lab. Our current research programs are directed toward developing greater understanding of the molecular self-assembly process and keratin’s ligand-like function. We have projects that are aimed toward clinical applications such as heart regeneration, inflammation, and bone repair.

<span style="color: #000000;"><strong>Cole Dudley BS, MBA -</strong><strong> An investors Story: Venture Capital and Investment in Biomedical Innovations</strong></span>

Mr Dudley has extensive experience in technology commercialization, venture capital, and leading startup and small companies. His 10 years as a venture capitalist included 2 years as founding CEO of a biotech startup thatwas later listed on the NASDAQ. He was Managing Director of a consulting firm and personally provided due diligence services to private equity firms. Most recently, he led a successful corporate turnaround as an owner and COO for 9 years and then was Managing Director of a private investment group.

[gravityform id="16" name="April 2016 TBMH Lectures Registration"]

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<h1 class="page-heading"><span class="double-line"> </span></h1>
<h1 class="page-heading">Professional Development Course (TBMH 5106, 2 credits)</h1>
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This course will be offered each Spring semester, starting Spring 2015. Class time will include guest lectures from various biomedical professionals, who will present case studies and exercises designed to provide an understanding of various biomedical career paths, and how these professionals interact to promote biomedical research and the implementation of important discoveries.  Additional focus on career development planning (IDPs) and building scientific communication skills.

<span style="text-decoration: underline;">Location</span><em>:</em> Course instruction will take place at Virginia Tech facilities in Roanoke, and possibly Blacksburg.<a href="http://info.vtc.vt.edu/best/wp-content/uploads/2014/03/Career-Bridge.jpg"><img class="alignright size-medium wp-image-99" src="http://info.vtc.vt.edu/best/wp-content/uploads/2014/03/Career-Bridge-300x203.jpg" alt="Career Bridge" width="300" height="203" /></a>

<span style="text-decoration: underline;">Student Commitment</span>: Trainees will attend class for 2 hours per week for one semester at Virginia Tech. Trainees must commit to attending all classes, and completing all reading and written assignments, including completion of an Individual Development Plan. At the end of the course, trainees will complete a course assessment questionnaire that should take 10 minutes to complete. Trainees must also complete a consent form that will allow the BEST program to issue them the annual BEST Survey, which should take less than 30 minutes to complete. This BEST survey will be issued annually for 10 years.

<span style="text-decoration: underline;">Eligibility</span>:   This course is required for all students in the PhD program in Translational Biology, Medicine, and Health (TBMH), and open to students in other biomedical graduate programs at Virginia Tech as part of the BEST program. Space is limited, and we encourage non-TBMH students to apply as early as possible to secure space in the course.

Postdoctoral trainees who are <span style="text-decoration: underline;">within three years</span> of earning their doctorate are eligible to audit this course as part of the BEST program (0 credits), but <strong>must attend all classes</strong>.

Registration for the Spring 2016 class is now closed.

<em>Trainees who are not TBMH students will need to sign up here to receive instructor permission to register for the course for Spring 2016. Space is limited and trainees will be selected in the order in which they sign up. Trainees must sign an informed consent form and return it on the first day of class</em>.

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<em> Be sure to <a title="CONTACT" href="http://info.vtc.vt.edu/best/contact/">subscribe</a> to our e-alerts to be notified of future BEST activities!  Additional opportunities for professional development at VT can be found on our <a title="RESOURCES" href="http://info.vtc.vt.edu/best/resources/">Resources</a> page.</em>

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