The Life Science Effect

I've heard it said that culture beats strategy. I believe that. I also believe culture beats tactics and process and procedure and technique. In this episode (another solo episode), I will relate a recent story in which I had the chance to stand up and reinforce the safety culture of my client. It may not be for everybody. It may not be "life science" specific. That's okay. Not to worry. Life Science talk returns next time and guests return late summer or early fall this year. Thanks for your support! Thanks to our sponsor BPM Associates - www.bpm-associates.com

What Does It Take To Succeed As A Bioentrepreneur? Source: Life Science Leader By Karl Schmieder Steve continues the discussion of how to transition into the startup world. The context is an article from a while back that still has relevant lessons for today. Also referenced in this episode: EP. 455 — RICH KARLGAARD Maybe You're a Late Bloomer. It's More Possible Than Ever Now to Flourish Later in Life Good to Great: Why Some Companies Make the Leap...And Others Don't Kindle Edition by Jim Collins

Steve is solo this week. He decided to give his thoughts about an article in Life Science Leader - From Academia To Pharma CEO: Challenges and Lessons Learned by Graham Kelly Be sure and visit our presenting sponsor: BPM Associates

What if a cutting edge technology saved your life? And then what if you got to be part of a startup company that is working on similar technology to save others' lives? Karen Momper, of Theratome Bio is living that story. This week, Micheal Coleman, PhD, and Karen tell the story of Theratorm Bio and the exciting platform they are working on. Learn about how Theratome Bio is developing a portfolio of products derived from adult stem cell secretions. The future includes exciting potential therapies like stroke treatment and organ preservation during transport. Learn Michael's and Karen's inspiring stories. Resources in this episode: Indiana Center for Biomedical Innovation TheratomeBio.com Theratome Bio on LinkedIn Theratome Bio on Facebook About Michael Coleman, PhD: Michael brings a wealth of research and new drug development experience to Theratome Bio.  He directed multidisciplinary teams at GeneMedicine and Valentis in Houston, Texas, prior to accepting a role with Centelion (a subsidiary of Sanofi-Aventis) as Vice President of R&D.   He there led a team of scientists in discovery, process & clinical development, and regulatory affairs.  Most recently, Michael was President and CEO of InGeneron, a medical device firm committed to driving personal regenerative medicine therapies.  During his tenure InGeneron attained several regulatory approvals in Europe and initiated clinical trials in the US under FDA approval. Michael has dedicated his career to developing new therapies, ushering these innovations through regulatory paths, and ultimately seeing new therapies transitioned into the clinic.  He has also continued to publish research in peer-reviewed journals and maintain a close relationship with leading researchers and clinicians in academia. He earned his BS and MS degrees from Texas A&M, his PhD from Penn State, and completed post-doctoral work at the Baylor College of Medicine. Michael has a passion for the regenerative medicine space.  He's long thought that a cell-free option is where the future of regenerative therapy is headed, and believes that TheratomeTM technology provides the key attributes of product consistency and ease of handling and administration necessary to achieve widespread clinical application.  In his own words, “TheratomeTM technology solves the key issues limiting clinical application of stem cell based therapies.   I am excited for the opportunity to be part of developing this technology that will provide life changing benefits patients and disrupt the field of regenerative medicine.”   Karen earned a B.A. in Chemistry with a minor in Marketing from the University of Dayton.  She completed an Undergraduate Thesis while there, worked for the Office of Admission leading campus tours, and was hired as a new grad to work as a Traveling Student Recruiter. Karen began her career with the Bristol-Myers Squibb Company shortly thereafter.  During her ten years of employment, she served Primary Care and Hospital Sales roles, sold in multiple outpatient and inpatient therapeutic areas, negotiated formulary contracts, earned district, region, and national recognition for sales, and was selected to serve in leadership roles within her district. Since then, Karen has taken on several non-profit initiatives whereby she has initiated a group, raised funding, and marketed and maintained a leadership role in organizations. She has also used her public speaking abilities to fund-raise.  In one such effort, she contributed to the establishment of an in-house Therapeutic Massage Therapy Program to treat Oncology Patients at Oregon Health and Science University (OHSU) Hospital in Portland, Oregon, a cause that was previously only filled by intermittent volunteers. Karen is happily married, and proud mother to two sons. In addition to multiple volunteer roles at her Parish and children's schools, Karen reads live broadcasts for IRIS Radio, a free service that provides audio news and literature for the visually impaired.  Karen is also the survivor of a stem cell transplant (2009), and an autologous stem cell procedure to her hip to reduce the likelihood for need of replacement. These experiences fuel her unique passion for furthering regenerative medicine innovation.

If you have not already done so, check out Beyond the Stethoscope - Angela Demaree's wonderful podcast for veterinarians, healthcare providers and busy professionals who want actionable, implementable solutions surrounding work-life balance, accomplishing your goals and living your dreams. Angela does a great job of interviewing Steve Vinson in this cross-cast episode of The Life Science Effect. Resources mentioned in this episode: Indiana Health Industry Forum, https://ihif.org/ Indiana Biosciences Research Institute, https://www.indianabiosciences.org/ Inside Indiana Business, Life Science Newsletter http://www.insideindianabusiness.com/category/301752/life-sciences The Life Science Leader https://www.lifescienceleader.com/ Connect with Steve on Linked In https://www.linkedin.com/in/stevenvinson/ and Twitter  https://twitter.com/steve_vinson  Steven.vinson@bpm-associates.com

This is Part 2 of a two part conversation with Kyle Keeney, Entrepreneur-In-Residence, Elevate Ventures. In Part 1, Kyle told the story of bringing his experience on the coasts, in Europe, and around the world back home to boost the economy in Southern Indiana/Northern Kentucky. In part 2, Kyle describes how important it is for communities to take a long view when it comes to securing the future of innovation and sciences. Then, Kyle and Steve discuss some of their favorite books. Kyle tells Steve how he fosters a love of reading and learning in his children. An experienced Chief Executive Officer with a demonstrated record of success in supporting innovation in life science and think tanks, Kyle offers the skills to build meaningful partnerships and relationships that cross boundaries to move science-based discoveries forward. With his business development skills and a focus on entrepreneurship, Kyle establishes novel collaborations, and fosters the commercialization of new technologies and ideas. A proactive leader, Kyle encourages collaboration and communication, which serves as the foundation for bringing new ideas to fruition. He always seeks the opportunity to build new bridges as the means to fostering paths that lead to the emergence of capabilities in the sciences. Resources mentioned in this episode: https://www.ynharari.com/book/sapiens/ https://www.ynharari.com/book/21-lessons/ http://www.jareddiamond.org/Jared_Diamond/Guns,_Germs,_and_Steel.html http://www.jareddiamond.org/Jared_Diamond/Collapse.html https://www.goodreads.com/book/show/146153.What_Are_People_For_ https://www.simonandschuster.com/books/The-Tangled-Tree/David-Quammen/9781476776620 https://www.elevateventures.com/ http://communities.techstars.com/usa/indianapolis-in-usa/about

This is Part 1 of a two part conversation with Kyle Keeney, Entrepreneur-In-Residence, Elevate Ventures. In Part 1, Kyle tells the story of bringing his experience on the coasts, in Europe, and around the world back home to boost the economy in Southern Indiana/Northern Kentucky. How can entrepreneurs tap into the capital resources available for startups? Where can they get objective advice on how to attract and use the right resources? And, importantly, what's it all for? Kyle is a devoted family man and an active member of his community. An experienced Chief Executive Officer with a demonstrated record of success in supporting innovation in life science and think tanks, I offer the skills to build meaningful partnerships and relationships that cross boundaries to move science-based discoveries forward. With my business development skills and a focus on entrepreneurship, I establish novel collaborations, and foster the commercialization of new technologies and ideas. A proactive leader, I encourage collaboration and communication, which serves as the foundation for bringing new ideas to fruition. I always seek the opportunity to build new bridges as the means to fostering paths that lead to the emergence of capabilities in the sciences. Part 2 will be a more personal discussion about books and the importance of inspiring kids to read. Resources mentioned in this episode: https://www.elevateventures.com/ http://communities.techstars.com/usa/indianapolis-in-usa/about

16 Tech is the future of collaboration in downtown Indianapolis. It will bring together the talent, capital, and technology to make innovation happen. Robert Coy is President and CEO of 16 Tech Community Corporation Inc., the entity overseeing the development of the 16 Tech innovation community. As President, Coy leads the development of 16 Tech into a major hub for scientific research, technology innovation, entrepreneurial activity and talent development, retention and attraction.Prior to 16 Tech, Coy was President and CEO of CincyTech, a venture development organization that accelerated the growth of start-up bioscience, healthcare, technology and advanced manufacturing companies in Southwest Ohio. Under Coy's leadership for more than 11 years, CincyTech invested in 70 startups that raised more than $680 million in seed, early and late stage capital and that today employ nearly 1,000 people.Coy has held entrepreneurial and economic development leadership positions with public and private institutions over the past 32 years in Ohio, Missouri, Delaware and Pennsylvania.Prior to joining CincyTech, Coy was senior vice president for entrepreneurial development and of economic development at the St. Louis Regional Chamber and Growth Association, where he co-founded the St. Louis Arch Angels, a group of individuals who invest in early-stage companies in the St. Louis region.In Delaware, Coy served as the principal economic adviser to the governor, established a seed fund to invest in technology start-up companies and developed initiatives to promote technology partnerships between universities and businesses. In Pennsylvania, he served as executive director of the Ben Franklin Partnership Program, the state's premier technology development program that invests in start-up companies.Coy earned a master's degree from University of Notre Dame and a bachelor of arts degree from Pennsylvania State University.

Angela is a Doctor of Veterinary Medicine (DVM) passionate about improving patient compliance and clinical outcomes, at least partly because her cat Chester has quietly spat out its medicine behind the couch. She has worked at the national level of the American Veterinary Medical Association (AVMA), and has regulatory experience at both state and federal levels. She can also be found with her horse Tommy, her husky Dakota, or her parrot Drexler. Visit https://pinpointpharma.co/ to learn more.

This is one of the most inspirational and informative episodes yet. Jason Bork is a man on a mission. A mission to serve others. He is working to accelerate the search for an Alzheimer's cure through the Global Alzheimer's Platform Foundation. He is mentoring young professionals through the EDGE mentoring program. And he is applying his many years of executive leadership experience at Pintail Solutions, where a team of passionate leaders are moving the needle for innovative pharma organizations. I hope you learn as much from this conversation with Jason as I did... Resources mentioned in this episode: https://www.pintailsolutions.net/ https://globalalzplatform.org/ https://www.edgementoring.org/ Good to Great by Jim Collins What Got You Here Won't Get You There by Marshall Goldsmith How Will You Measure Your Life? by Clayton M. Christensen  

What if you have an idea for a medical product but you have no experience with the complex regulations or the healthcare industry? There are experts who know how to help you and Nathan Glass is one of those experts. Nathan and Genesis Plastics Welding started MedTech Launch to fill this need. Nathan Glass serves at the helm of MedTech Launch by Genesis Plastics Welding as VP of Product Development. With medical devices at the center of his life work and passion, Nathan focuses on the human factor of innovative products, along with speed to market and minimal regulatory burden. An Indiana University-Purdue University at Indianapolis graduate, he has nearly ten years of project management and engineering experience. Throughout his career, Nathan has closely worked with sales and marketing teams, as well as quality personnel to smoothly launch numerous innovative medical device products. His areas of expertise includes design definition, material selection, technical documentation, proof of concept, quality management, validation, design for manufacturability, project management and Go-To-Market strategies. As a proven design and development professional, he and his skilled team have the ability to drive a designed and validated product through all regulatory and manufacturing roadblocks for launch success. Resources: medtechlaunch.com genesisplasticswelding.com Bad Blood: Secrets and Lies in a Silicon Valley Startup by John Carreyrou

Arun Giridhar is not your typical startup entrepreneur. One of the latest success stories coming out of Purdue Foundry, Arun earned a PhD in Chemical Engineering in the mid-2000s and saw an opportunity to optimize how pharmaceuticals are made. Arun has over ten years' experience in pharmaceutical production. In his professional life, he applies his chemical engineering background towards improving health care. At other times, he can be found at his Toastmasters club, or catching up with feline and canine friends. Resources mentioned in this episode: Starting March 4: www.petsgetit.com Enlightenment Now: The Case for Reason, Science, Humanism, and Progress by Steven Pinker

Lynn Tyler is a partner and registered patent lawyer in Barnes & Thornburg's Intellectual Property Department. He also chair's the firm's Food, Drug and Device Law Practice Group. He earned a degree in philosophy from Notre Dame. And a law degree from the University of Michigan. And a masters in Biology from IUPUI. This conversation ranges from how someone goes from philosophy to law to biology and patent law to how to get good seats at a Bruce Springsteen concert. Finally (after the break)... how do you know if your product is a medical device? Resources mentioned in this episode: https://www.btlaw.com/insights/alerts/2019/fda-issues-final-guidance-on-medical-device-safety-and-performance-based-pathway https://www.fda.gov/MedicalDevices/default.htm https://www.fdli.org/  https://www.amazon.com/Love-Does-Discover-Secretly-Incredible/dp/1400203759 https://www.amazon.com/Darkness-Edge-Town-Bruce-Springsteen/dp/B0000025D0 Contact Lynn at lynn.tyler@btlaw.com   

We are used to hearing about athletes coming off the field and heading to the locker room to go into "the concussion protocol". What if the medical professionals could whip out their iPhone, open an app, and determine in minutes whether the player is experiencing a problem? Kurtis Sluss is the kind of entrepreneur that will make you see the future. And with the launch of their latest product, Kurtis and brightlamp are creating that future. This was one of my favorite conversations in the course of this show. Kurtis is wise beyond his years - heck, he's wise beyond my years. And, he is applying that wisdom to cutting edge healthcare products using AI, machine learning, and computer vision. I hope you are as inspired by Kurtis as I was. Kurtis is an American engineer, inventor, and entrepreneur. His focus is redefining medicine and disrupting current diagnostic technologies. He leads brightlamp as Founder and CEO with experience in innovative detection and diagnostic methods and an intuition for startup success. Go to https://www.brightlamp.org/ to learn more.

WARNING! Focusing on compliance is not the answer. It is the problem. That is the message that Greenlight Guru is preaching these days. And it's why Jon Speer started the company in the first place. After years of making a huge difference with major companies by managing medical device development projects, Jon decided it was time to encode his expertise into a system. A system that would embed quality into the process of designing, developing, and manufacturing medical devices. If you don't know Jon, it's time you got to know him. In one of our best episodes yet, Jon shares why he started Greenlight Guru (you may be surprised how personal this was for him). Jon goes on to share why data and true electronic quality systems are critical today. Jon is on a mission to improve healthcare and the safety of medical devices in this world. Check out this important episode. To connect with Jon and Greenlight Guru, go to greenlight.guru

EU MDR and FDA's Case for Quality are just two of the initiatives impacting medical devices in 2019. According to the new EU MDR (European Union Medical Device Regulation), combination products must meet medical device standards. This is new. Listen to Steve's advice on where to get more information. Also: How do you go from managing projects in dirty chemical plants to Healthcare IT projects to Medical Devices and back to Pharma? What is the difference between medical devices and pharmaceuticals? What are FDA and European Union medical device regulators doing in 2019 that Medical Device and Pharma professionals need to know about? Mentioned in this episode: www.mgmt-ctrl.com www.greenlight.guru email Steve for more info at steven.vinson@bpm-associates.com

How do you create something that is greater than the sum of its parts? For decades, the foundries and steel mills of northwest Indiana, have melted and cast and forged metal into shape, creating something completely new from a few basic elements. At Purdue Foundry they bring together the basic elements of technology and talent and capital to bring innovations to life. John Hanak and his colleagues created Purdue Foundry when Purdue's innovative President Mitch Daniels saw an opportunity for Indiana to capitalize the university's rich ecosystem of innovators. John is now the Managing Director of Purdue Ventures, a key component of Purdue Foundry. The product of generations of steel workers, John was the first salaried steel worker in his family. He worked his way to the C-Suite at a major steel mill and then went on to lead high-tech startups before bringing his leadership to Purdue University. Steve Vinson had the opportunity to hear John's story and to pick his brain to find out how Purdue Foundry, Purdue Ventures, and Now the Discovery Park District is launching technology into the marketplace. Learn more about Discovery Park District at http://discoveryparkdistrict.com/ Connect with Purdue Foundry and Purdue Ventures at https://purduefoundry.com/ Thank for listening. Do not forget to subscribe and tell your colleagues about our show.

What is going on in the medical device industry right now that is driving companies and the FDA to address quality systems differently? What is the Quality Systems Management (QSM) Strategic Plan? How will it help organizations? How will it help patients? Larry Mager is an experienced medical device quality executive with success in taking quality management systems to the next level at major global medical device companies. He now is leveraging his decades of leadership and making his system available for any organization that wants or needs to improve. Quality System(s) Management (QSM) = Measure | Manage | Improve 1. A Quality System(s) Management (QSM) plan is utilized to measure, manage, and improve the ‘quality' of an organization's Quality Management System (QMS) 2. QSM measures what matters in regard to product and process quality, and does so in a manner that is actionable for Management 3. QSM enables the strategic understanding of product & process ‘quality', as is expected of Management by the stakeholders 4. QSM targets issues of constraint, enabling the responsible and targeted improvement of the organization's constraints 5. Supports EU MDR and Case for Quality initiatives (see below) EU MDR defines significant responsibilities associated with the verification of product & process ‘quality' through the PMS & QMS surveillance activities utilized within a medical device company. The accountability for doing so resides within the designated role of Person Responsible for Regulatory Compliance (PRRC). The capability to satisfy the obligations of that role must be ‘built' into the Quality Management System (QMS). The Case for Quality is an FDA-driven initiative, coordinated in partnership with the Medical Device Innovation Consortium (MDIC) and in collaboration with the Medical Device Industry, focused on creating “sustained predictive practices that advance medical device quality and safety.” To connect with Larry: info@mgmt-ctrl.com  

What is the latest in Biopharma? What is in store for this $300 billion industry in 2019? What if I told you the market is growing at more than 12% annually but that there is a global shortage of manufacturing capacity? What will it take to close the gap? Join me this week for a 1:1 conversation with you about the future of our industry. Who else should be on the show? Drop me a line at steven.vinson@bpm-associates.com

Google and J&J have joined forces to create powerful, innovative surgical solutions. Rick Ditto and Matt Dressler have joined forces to create an exciting, inspirational episode this week. Open source seems to be winning in tech. Can it win in Life Science? What macro trends are shaping medical device careers and how can you be prepared? What will surgery look like in 30 years? Nobody knows the specific answers to these questions, but Rick and Matt are the right people to ask and folks are listening.

From TRS80 to artificial intelligence and big data, Dan Robertson has lived through some of the most amazing transformations in technology and life sciences. And he is at the center of the biggest disruptions yet to come. What does Apple's ResearchKit for iOS mean for healthcare innovation? How is IBRI leading the way in the next big disruption in healthcare? Can Life Science innovate like tech? Or maybe Amazon, Google, and Uber should pay close attention to what's happening in the medical innovation space to avoid some potential land mines as they dive into healthcare. On a personal note, Dan relates his journey from university to research-based pharma to non-profit institute and how his passion is always the same: medical innovation to make a difference for patients. Thanks to IBRI and BPM Associates for sponsoring this week's episode: www.indianabiosciences.orgwww.bpm-associates.com Daniel Robertson, PhD Research Fellow, VP of Digital Technology, and Director of the Applied Data Sciences Center Daniel H. Robertson, a proven and experienced technical leader in information technology (IT), computational science and research, is focused on defining and developing the Institute's computational analytics, digital, and data science capabilities. Dr. Robertson originally joined the IBRI in mid-2015 as part of a loaned executive program at Eli Lilly and Company, but in mid-2017 he accepted a permanent position at the IBRI due to the opportunity at the IBRI to drive innovative research among multiple life sciences companies, academic institutions, and technology companies to advance solutions to critical problems. His most recent role at Eli Lilly and Company was Senior Director of Research IT where he led the IT team supporting discovery systems and processes across six global research sites and nine functional/therapeutic areas. During leadership role in IT at Lilly, Dr. Robertson restructured Research IT to become a leaner, more efficient organization, reset the Research IT strategy supporting the discovery functions, delivered emerging new technology and analyses through informatics, enhanced support for HPC, cloud, and internal big data storage and analysis. He also transformed the IT support for Open Innovation Drug Discovery program to be the first high-performing DevOps team, which was recognized with an InformationWeek 500 award. Throughout his 10 years in leadership roles at Lilly, Dr. Robertson developed several individuals within his organization to advance to higher level roles in other organizations within Lilly. He joined Lilly as a research scientist in Lilly Research Laboratories and performed numerous independent contributor and scientific leadership roles before transitioning to the IT organization in 2010. Dr. Robertson earned his PhD in physical chemistry from Florida State University and his Bachelor of Science degree in chemistry, graduating Summa Cum Laude, from Florida Southern College. After earning his PhD., Dr. Robertson served as an NRC/NRL Postdoctoral Research Associate at the Naval Research Laboratory in Washington, D.C., and then held several positions at Indiana University-Purdue University Indianapolis (IUPUI) from 1993 through 2000. He last served as Associate Scientist and Director of Technical and Administrative Services and Manager of the Facility for Computational Molecular Science at IUPUI before joining Eli Lilly and Company in 2000. Dr. Robertson has published 67 papers in refereed journals, authored three invited book chapters, and conducted more than 65 professional/technical presentations. He has been honored with multiple awards from Eli Lilly and Company and IUPUI, and is a member of the American Chemical Society, American Physical Society and physics and mathematics honoraries.

Dr. Fischer is back! On his second trip to the show, Dr. Fischer reveals the inspiration behind “Discovery with Purpose”. How can life science innovate like tech? How is IBRI helping to combat midwestern “brain drain”? Why is it so important to focus on curing disease in addition to just finding the next treatment? Does the band U2 really hang out in Joshua Tree National Park? Rainer Fischer, PhD Chief Executive Officer, Chief Scientific and Innovation Officer Rainer Fischer, PhD, joined the IBRI in April of 2017 as the Chief Scientific and Innovation Officer. In October that same year, he also was named Chief Executive Officer. Fischer spent 19 years building and leading the Fraunhofer Institute for Molecular Biology and Applied Ecology (IME) in Aachen, Schmallenberg, Muenster, Giessen, Frankfurt and Hamburg in Germany, and its subsidiaries in Newark, Delaware, USA and Santiago, Chile. The Fraunhofer-Gesellschaft is the largest applied science research organization in Europe, with applied research aimed at addressing issues of health, security, production technology, energy, materials, and the environment. During his time at the Fraunhofer-Gesellschaft, Fischer grew the IME Institute from 40 to 680 employees, raised with his team almost one billion euro in extramural research funding, and established international collaborations with academia and industry in more than 25 countries. Those collaborations include many of the leading global companies in the biotechnology, pharmaceuticals, agriculture, food and chemical industries. Fischer also served as Department Head of the Institute for Molecular Biotechnology at RWTH Aachen University where he was awarded a Distinguished Professorship in 2015. He created the department, co-establishing both undergraduate and graduate programs that have matriculated more than 500 students including 115 graduated PhD students. Fischer is a prolific presenter and has published more than 340 peer reviewed scientific papers that have been cited over 16,000 times.  In addition to his academic and leadership experience, he co-founded five biotechnology startups, holds over 60 issued patents and has more than 120 patent applications pending. Fischer also holds a second Professorship at Maastricht University, Netherlands where he co-founded the Aachen-Maastricht-Institute-of-Biobased-Materials (AMIBM) in 2015.

Scott is the CEO of the Scottish Lifesciences Association. With a background in Pharma tech transfer and R&D, Scott has gone on to start and lead many life sciences companies. He is currently a Director of Benenox Ltd and Marine Biotech Ltd., in addition to giving back as the CEO of SLA. From https://www.scottishlifesciencesassociation.org.uk With over 130 member life sciences companies and organisations of all types and sizes, the Scottish Lifesciences Association is the voice of Scotland's vibrant life sciences industries to investors, NHSScotland, the Scottish and UK Governments, and the wider community.  We are member driven through 14 Special Interest Groups and 4 sub-groups.  We deliver on every aspect of members' businesses, helping each other to attract investment and increase business activity, and engaging with the NHS and Government to grow the life sciences sector in Scotland.

How do you start from scratch and build a multimillion dollar company? Stop. How do you do that two or three times? Check out my chat with Matt Wyatt. He is not just a successful startup leader. He is a dad and a great boss. Check out this episode to see what I mean...

After recording a dozen takes of me reading from a script, my audio editor and I decided to just have a conversation about what this show is supposed to be about. He is shy so he edited out all of the pieces where he is talking. So, I hope you like the sound of my voice as much as I do. Because here is where I make my case for why you should tune in every week. TheLifeScienceEffect.com

Hugh Devine, Dir. Bus. Dev., Promedim and co-Founder Caledonian Informatics As Director of Business Development for Promedim, Hugh oversees the company's sales and growth strategy. He is trained in US & EU IT Regulatory requirements and has led pilot projects for key IT systems within the regulated space. He has significant experience in Product/IT Design Control Validation, Data Centre qualification, Product/IT Quality Strategies, System Implementation and Support for the Life Science and Health IT Industry. Hugh has led high growth startups in both the US and EU and has extensive experience in strategic planning and partnerships to help develop and resource customer solutions. Hugh holds a Bachelor of Science Honours degree in Technology and Business from the University of Strathclyde in Glasgow. Caledonian Informatics - https://www.caledonianinformatics.com/ Caledonian Informatics was founded in Scotland in 2017 by Life Science professionals in the US & UK. Our goal is to provide the Life and Health Science sector with a partner who understands the regulatory rigor necessary to develop and maintain health and patient impacting software. Caledonian Informatics supports a host of international companies, we specialize in SaaS and Cloud enabled platforms while ensuring regulatory standards such as IEC62304 are followed and adhered to. Our team can deliver a full application or augment an existing team all the while ensuring that when your software is ready your compliance burden is met. Our significant experience in the FDA & MHRA regulated markets, and the NHS, has enabled us to bring a wealth of knowledge and pragmatism to the UK and EU IT/Software development space. Promedim – https://www.promedim.com Promedim's medical specialists provide comprehensive oversight for clinical trials using advanced cloud-based technology. Our service combines industry-leading physician management technology with 24/7 real-time access to medical expertise.

Don't let his unassuming character fool you. Euan Cameron is a force to be reckoned with. After years making other peoples' projects happen, he had an idea. To transform how healthcare providers think about using digital health to add value - for the patient and for the bottom line. Euan and Steve have a great conversation about motivation and drive; risk management; and loving what you do more than the reward that come with it. It's not what you are, it's who you do it for... Cohesion Medical was founded by Euan in 2012 to realise the potential of turning the medical software projects he developed with his other business NewEngineering.Net into full specialist clinical software products and support services. Euan has over 20 years of business experience running his own internet services business providing application design, hosting and digital media services to a variety of clients, from small businesses through to national organisations. Euan is a graduate of the University of Strathclyde holding a Masters of Engineering in Manufacturing Sciences & Engineering and a Masters of Science in BioEngineering. With Cohesion Medical, he operates as General Manager responsible for all daily operations of the business as well as devising the longer-term business strategy. Reach out to Euan at euan.cameron@cohesionmedical.com or visit cohesionmedical.com to learn more. Resources mentioned in this episode: Black Box Thinking by Matthew Syed www.cohesionmedical.com  

Diana Caldwell co-founded Pearl Pathways to help get medical innovations to patients sooner. After a successful corporate career at a large pharma company, she knew there had to be a way to get drugs and devices to market more nimbly. Because, as is often heard around Diana's office - the Patient is Waiting! Putting the patient first comes naturally to Diana. She caught the life science bug early on while working for her mentor Woody Myers as an intern at the Indiana State Board of Health. She never stopped wanting to make a difference for patients. In this episode, hear how she went from serving patients in the public sector to becoming a successful corporate leader to being one of the leading entrepreneurs in Indiana. In addition, find out how Diana services the community through her volunteer service and how she is leading the way to inspire and assist the next generation of woman leaders.

Biotech, pharma, digital health inventors, researchers, entrepreneurs: Your inventions - your intellectual property (IP) - is at risk if you do not have a strategy for how you will protect it. IP protection is more than just patents. A comprehensive strategy - or even a relatively brief conversation with an IP expert attorney - is critical to ensuring you create value for yourself, your investors, and the marketplace. In this episode, Deborah Pollack-Milgate is both informative and inspirational. She and Steve discuss everything from how to protect IP to how to become a successful lawyer or other professional to how to inspire and promote women and minorities in the workplace. You don't want to miss this value-packed episode. Deborah Pollack-Milgate is a partner in the Barnes & Thornburg Indianapolis office. She concentrates her practice in patent litigation, trade secrets litigation, trademark litigation, and complex commercial litigation, including antitrust litigation, contract litigation and appellate matters. Ms. Pollack-Milgate has assisted and advised clients in a number of complex patent suits across multiple areas including: chemical products, digital radio, adhesives, healthcare, pest control, and insulation products. She has represented clients in appellate matters in the Indiana appellate courts and in federal courts of appeal, including the U.S. Court of Appeals for the Federal Circuit. Ms. Pollack-Milgate acts as outside in-house IP counsel for both national and international clients, assisting with virtually all aspects of Intellectual Property Portfolio management. She assists clients with putting systems in place, from the stage of invention to patent protection and enforcement, which will allow them to fully maximize the value of their intellectual property. During her time at Barnes & Thornburg, Ms. Pollack-Milgate spent an extended stay in Mannheim, Germany, where she worked for and advised an international client of the firm in U.S. litigation and patent matters. She routinely presents in the German language on patent matters, and is the author of BLIPs, a quarterly German-language IP newsletter. Ms. Pollack-Milgate has been selected for inclusion in The Best Lawyers in America and Indiana Super Lawyers for several years and was recognized by The Best Lawyers in America as a 2018 Indianapolis “Lawyer of the Year” in patent litigation. She is a member of the American Bar Association, the Indiana State Bar Association, and the Indianapolis Bar Association. She is also a member of the German-American Lawyers' Association (DAJV), the German American Chamber of Commerce, and the German Association for the Protection of Intellectual Property. She is a member of the Board of the Indiana Health Industry Forum (IHIF), and a founding member of the Indianapolis ChIPs Chapter, an international organization devoted to promoting women at the confluence of technology, law, and policy. She served on the board of Women & Hi-Tech for seven years and as president in 2013-2014. Over the years, Deborah has moderated panels for various organizations, and is currently a frequent moderator for the IHIF's monthly Life Sciences Luncheon series. (bio from http://www.btlaw.com/deborah-pollack-milgate/) Resources mentioned in this episode: Book: Nevermoor: The Trials of Morrigan Crow by Jessica Townsend Author: Trenton Stewart For laughs: www.theonion.com IP news resources: www.btlaw.com www.patentlyo.com/  www.ipwatchdog.com/

Brad Moss started Patients Choice Laboratories with a team of entrepreneurs and Pharma veterans because he and his team saw an opportunity to partner with care providers. In this episode, Steve and Brad discuss the challenges of leading a laboratory in the age of managed care. A veteran of the healthcare industry, Brad chief Business Officer for SeKayi Management, a $10M healthcare management organization. While at SeKayi, Moss oversaw three subsidiaries that managed over 500,000 patients in four states. Before SeKayi, Moss served as National Director of Sales for DailyMed Pharmacy, a subsidiary Arcadia Resources, Inc., (NYSE Amex: KAD), a ~$100M healthcare provider. While at Arcadia, Moss led corporate sales for DailyMed, a comprehensive Medication Therapy Management and medication adherence program.

With Cambridge Analytica and the Facebook data breach in the news, my conversation with Valita Fredland could not be more timely. Is it possible to keep our health information safe? It is if Valita has anything to say about it. And as you will see, she has plenty to say about data privacy. Valita Fredland - VP, General Counsel, and Privacy Officer for the Indiana Health Information Exchange (IHIE). Mother, wife, athlete, and passionate advocate for ethical data privacy. Today we talk about how Valita ended up as a leading influencer in the ethical responsibility of Big Data. She describes how she adapted the well-known medical ethical framework to an ethical framework for managing health data - or any personal data. As parents of daughters, we have a great chat about the importance of raising girls to be strong leaders. And how to even the playing field so their hard work is as effective and as recognized as anyone else's. This is a good one, folks. Please subscribe, leave a review, and share with your friends and colleagues.

Kristin Jones is the President and CEO of the Indiana Health Industry Forum (IHIF). Kristin knows what is going on in Life Sciences in Indiana. If you need a job, Kirstin can tell you who you should talk to. If you need seed money or venture capital, Kristin will tell you who just got funding for a similar project. In this first episode, we could not have asked for a more delightful guest. Kristin is engaging and energetic. Her passion for Life Sciences in Indiana is infections. Go to www.ihif.org to learn more about IHIF and Kristin Jones. Go to www.bpm-associates.com to learn more about our presenting sponsor, BPM Associates, and your host, Steve Vinson.