Dr. Robert Jury joins MedSurgPI

Dr. Robert Jury is a board-certified general surgeon and specialist in complex gastrointestinal, hepatobiliary and pancreatic surgery. With nearly forty years of experience in healthcare, he offers expertise in strategic program development, surgical education, and emerging technology.

He is a graduate of the Honors College at Michigan State University and received his medical degree from The Wayne State University School of Medicine. Following general surgery residency at Beaumont Hospital in Royal Oak, Michigan, he received unique fellowship training in therapeutic surgical endoscopy, including ERCP at Fukuoka University in Japan. He formed a highly respected private surgical practice, emerging as a leader in pancreatic surgery. His work included translational research through the Erb Biobank leading to multiple publications and presentations.

During his career, Dr. Jury has served in key administrative positions as Associate Director of the General Surgery Residency, Chief of General Surgery and Vice Chief of Surgical Services for Strategic Planning and Program Development. As a member of the Executive Committee he played an important role in Beaumont’s growth from a large academic community hospital to that of a nine-hospital health care system. In 2011, the Oakland University/William Beaumont School of Medicine was established where Dr. Jury was appointed to the inaugural clinical faculty.

In 2010, Dr. Jury designed and established the Digestive Health Center of Excellence at Beaumont where he served as Physician Leader until 2018. The Center of Excellence established several physician-led multidisciplinary clinics for weight management, gastroesophageal reflux, colon cancer, pancreatic and liver disease. Dr. Jury has been a front-line participant in the evolution from open surgery to advanced minimally invasive and robotic surgical approaches. His experience provides valuable insight for product development, assessment, and clinical integration.

Currently, Dr. Jury serves as the Director of Abdominal Simulation for KindHeart, Inc. in Chapel Hill, NC. where porcine tissue models create high fidelity simulation to advance safety in surgical education and the safe adaptation of new surgical technology including robotics. He lives with his wife in Durham, NC. He is a strong advocate for patients and families affected by pancreatic cancer and an active supporter of The Pancreatic Cancer Action Network.

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MedSurgPI Welcomes Alethea Wieland, Advisor

Alethea Wieland serves as a seasoned clinical affairs, regulatory, and corporate strategy advisor. With more than 25 years in drug, medical device, biotechnology, and IT/healthcare analytics companies, her focus today is supporting the life science industry as a functional service provider. Alethea is a subject matter expert in clinical trial operations, regulatory strategy and face to face negotiations with the FDA, corporate compliance, and FDA inspection-readiness.

In 2017, Alethea received recognition for her mentorship and contribution in life sciences by receiving awards from Women in Bio. Alethea volunteers her time judging university pitch competitions and hackathons. She is a proponent of doing the right thing, even when it’s not popular or convenient, and teaches business ethics and integrity to countless mentees, students, and peers. As an avid reader, Alethea continues to refine her knowledge on leadership, blockchain, artificial intelligence, technology, and healthcare regulatory reform and policy. She is invited to speak on podcasts and write as a guest author for industry-leading online journals.

She shares a beautiful home, woods, and conifer garden with David and a handful of furry pets located in Wexford, Pennsylvania. Spare hobbies include taking care of wild animal residents, gardening, exercising in North Park, and building one-of-a-kind outdoor heated pet abodes for fun.

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MedSurgPI Partnership Announcement

 
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MEDSURGPI PARTNERSHIP ANNOUNCEMENT WITH DEVICIA FOR EU DEVICE EXPERTISE

MedSurgPI is expanding our services through our unique partnerships with experienced, dedicated, entrepreneurial consulting companies. In light of the current significant regulatory changes in the EU, increasing our regulatory and clinical expertise in Europe is essential. For that reason, we are proud to announce our new relationship with Sweden-based Devicia, a full-service medical device exclusive CRO. As members of Technical Committees and nominated as experts in international working groups writing medical device standards (such as ISO 14155), we will be able to provide our clients with an industry perspective and first-hand expert advice.

 Through this collaboration, MedSurgPI will provide:

·       MDR & IVDR transit and compliance  

Devicia has extensive knowledge of regulatory changes currently taking place in the EU with the implementation of medical device regulation (MDR) and in-vitro diagnostic device regulation (IVDR). Through the collaboration, MedSurgPI and Devicia can assist with regulatory strategy & gap analysis, technical files and design dossiers, classifications, regulatory submissions etc.

·       Clinical Evaluations

A key component in getting or maintaining a CE mark is the Clinical Evaluation Report. All medical devices on the EU market must perform a Clinical Evaluation according to MEDDEV 2.7/1 Rev 4. Devicia’s experienced medical writing team performs clinical evaluations according to the current guidelines and fulfils the requirements of the role of a clinical evaluator.

·       EU Device Clinical Investigation

Devicia provides full-service support for all kinds of clinical investigations (single center, multicenter multinational RCT’s, registries etc.) both before and after CE mark. Devicia also supports clients with the new MDR requirements for Post Market Clinical Follow up (PMCF).  Devicia is nominated as a Swedish expert in the ISO/Technical Committee 194 Working Group 4 governing clinical investigations of medical devices in humans.

 ·       Licenses for ISO 14155 Clinical QMS

 ISO 14155:2011 is specifically tailored to the requirements for medical device clinical investigations. Through the collaboration, MedSurgPI can offer access through licenses to SOP’s, templates and forms to be able to conduct a clinical investigation according to ISO 14155:2011.

 gklein@medsurgpi.com                         pjohnson@medsurgpi.com

919-930-9180                                                   919-807-9132

 

MedSurgPI Welcomes Dr. Ken Carlson

Dr. Ken Carlson brings over 18 years of expertise in medical monitoring, drug development and drug safety. As medical monitor, his experience encompasses a wide range of indications to include early phase oncology studies consisting of small molecule and immune-oncology drugs, solid tumors and hematologic cancers; cardiology, specifically hypertension, congestive heart failure, and anti-arrhythmic drugs; neurology such as Alzheimer’s disease and psychiatric disorders.

 Dr. Carlson was also involved with the development of therapies for infectious diseases, male and female sexual dysfunction, and diabetes. In pulmonology he served as medical monitor for two pivotal phase III, multinational studies in asthma and COPD.   He previously worked with several CRO’s including INC Research and Premier Research. Most recently he has served as a consultant for several Biotech companies: Astellas Pharma, Aveo Oncology, Karyopharma, Prescient Therapeutics, Takeda Millenium Oncology and Kowa Research Institute.

He completed undergraduate studies at the State University of New York with a BA in Biology and Lipid Chemistry. His undergraduate thesis work in familial amyotrophic chorea was published in the Annals of Neurology. He then attended medical school at the Albert Einstein College of Medicine in New York City and trained in general medicine at Montefiore Medical Center in the Bronx, New York. He practiced emergency medicine in a busy New York hospital for almost seven years before becoming the supervising physician.

Dr. Scott Sykes joins MedSurgPI

Dr. R. Scott Sykes, MD has more than 30 years of experience in clinical research and pharmacovigilance experience. This unique experience includes clinical research in the areas of respiratory (inhaled beta-agonists, corticosteroids), GI, and oncology (serotonin antagonist). Pharmacovigilance experience includes pre and post marketing experience in almost all therapeutic areas, including all aspects of individual and aggregate safety data review, safety-related signal detection, risk-management, product labeling, periodic reporting (PADER, PSUR, DSUR, etc.), training, staff development, FDA presentations and negotiations, and management of teams ranging from 5 to 80 staff members. Management experience includes VP North American Product Surveillance (Glaxo Wellcome), Chief Medical Officer/VP (Salix), VP Corporate Drug Safety (Schwarz Biosciences), and Head Medical-Safety Evaluation (Merz North America).

As a consultant Dr. Sykes has served in a number of capacities for pharmaceutical companies and CROs throughout the industry, including audits, gap analyses, safety data review for the purpose of labeling updates/additions, developing internal pharmacovigilance departments with necessary adverse event database installation, standard operating procedures, working practices, audit/legal protection strategies, safety-related data review procedures and documentation, and strategic overview of existing departments.

Dr. Sykes received his BA in Chemistry at the University of North Carolina-Charlotte, his Medical degree from the University of North Carolina – Chapel Hill and completed internship at Shands Hospital – University of Florida in Gainesville, Florida. 

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Dr. Mark Monane Joins MedSurgPI

MedSurgPI is delighted to welcome Dr. Mark Monane as an Associate at MedSurgPI’s Consulting Group.  Mark is an expert in Public Health and Geriatrics as well as Equity Research in emerging Biotechnologies in the Cardiovascular and Oncologic spaces.  He has previously served as Chief Medical Officer at CardioDx, Managing Director of Equity Research at Needham & Company, Senior Director of Medical Policy and Practices at Medco Health, as well as being an Assistant Professor at Harvard Medical School and the Harvard School of Public Health.  Mark obtained an AB and MBA at Columbia, MD from NYU University, and a MS from Harvard in Health Policy and Management.   

Mark is available to consult for companies who are developing their Medical Affairs systems and as a guide to fundraising.  Please contact Mark at mmonane@medsurgpi.com.

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MedSurgPI Welcomes Dr. Michael Cynamon

MedSurgPI is pleased to welcome Michael Cynamon, M.D. an infectious disease specialist, as an affiliate member of its organization.  Michael graduated magna cum laude from Brooklyn College and attended Yale University School of Medicine.  He trained in internal medicine at Barnes Hospital and completed a Fellowship in Infectious Diseases at Washington University School of Medicine, Saint Louis.  Michael is a Professor of Medicine at at SUNY.  

 His research focuses on antimicrobial chemotherapy, particularly new agents and regimens for the treatment of mycobacterial infections. His laboratory has extensive experience in the in vitro and in vivo evaluation of anti-infective agents.  Michael has worked with academic researchers and small pharma to develop new chemotherapeutic agents.

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The Coming of Age of the Antimicrobial Post-Op Dressing?

Authors:  Gerald L. Klein, MD & Peter C. Johnson, MD

Post-operative home care has become more important than ever.  The use of an antimicrobial dressing in this setting is often essential to an uncomplicated recovery.  Previously, tape and gauze may have sufficed for most incisions and antimicrobial dressings were reserved for those incisions at the highest risk of infection.  However, the earlier discharge of surgical patients puts them at increased risk of acquiring a post-op surgical infection, which is most likely to occur 24-48 hours after surgery.  Increasingly, proper home management of wounds is critical to prevent infections.

As patients become more responsible for their wound care and adherence to follow up instructions becomes more critical, the following questions pertain: “What best post-operative practices reduce the risk of an infection?”  Furthermore, what options exist that empower the patient to be a good partner in their post-op care and recovery?

Dressing Features That Enable the Patient: Non-Invasive, Observational Wound Management

Educated patients with the resources to follow their discharge instructions are more likely to experience a positive outcome than those without.  Once home, the onus is on them to manage the care of their own surgery site.  So, what should the dressing provide to help them be a good partner in their care?

·       The dressing should contain an appropriate concentration of a broad-spectrum antimicrobial to prevent microbial growth at the patient-dressing interface.

·       The dressing should be thin and be attached with an adhesive that can withstand at least a week of wear time without being irritating. 

  • This obviates the need for dressing changes, saves time, cost, decreases skin irritation and reduces the potential for the new introduction of microbes.

·       The filmic portion of the dressing should allow for gas transfer without allowing microbial or fluid entry.

·       The dressing adhesive and film should be sufficiently pliant to conform to irregular wound shapes to form a seal with the skin.

·       The dressing should be transparent to enable both patient and physician to observe the incision for signs of inflammation and/or drainage.

If these criteria are met, the patient is provided with convenient and comfortable post-operative wound care.  Moreover, the ability to readily observe the status of the wound makes the patient a better partner to the physician in the early post-operative period when the potential for Surgical Site Infection is at its highest.

Commonly used antimicrobial dressings typically include one of the following:

·       PHMB (Polyhexanide)

·       Silver

·       CHG (Chlorhexidine gluconate)

·       Silver + CHG

 Lack of Guidelines to Prevent Surgical Site Infections (SSIs)

It is unfortunate that the current guidelines do not yet recommend antibiotic dressings but state that the issue is unresolved.  The earlier surgical hospital discharge should help necessitate this change. 

 Current Guidelines

Guideline & Conclusion

1.     CDC Guideline for Prevention of SSI, 2017 No recommendation/unresolved issue

2.     WHO Global Guidelines on the Prevention of SSI, 2016 Conditional recommendation

3.     American College of Surgeons and Surgical Infection Society Guidelines for Prevention and Treatment of SSI, 2016 No recommendations regarding choice of post-operative dressings.

4.     Society for Healthcare Epidemiology of America/Infectious Disease Society of America: Strategies to Prevent Surgical Site Infection in Acute Care Hospitals: 2014 Update Post-operative wound dressings not addressed

 References:

1.     CDC Guideline for Prevention of SSI, 2017. https://jamanetwork.com/journals/jamasurgery/fullarticle/2623725 

2.     WHO Global Guidelines on the Prevention of SSI, 2016. http://apps.who.int/iris/bitstream/handle/10665/250680/9789241549882-eng.pdf;jsessionid=9AAB8F406232C1294A363043D58CAF6F?sequence=1

3.     American College of Surgeons and Surgical Infection Society Guidelines for Prevention and Treatment of SSI, 2016 https://www.journalacs.org/article/S1072-7515(16)31563-0/fulltext

4.     Society for Healthcare Epidemiology of America/Infectious Disease Society of America: Strategies to Prevent Surgical Site Infections in Acute Care Hospitals: 2014 Update

https://www.jstor.org/stable/10.1086/676022

 One such post-operative wound dressing that fulfills these requirements is Eloquest’s ReliaTect™.  A description can be found here: http://www2.eloquesthealthcare.com/blog

Van Vactor Administrative Consulting joins MedSurgPI

MedSurgPI, LLC is pleased to announce that Van Vactor Administrative Consulting will be joining our group. Van Vactor Administrative Consulting provides cost effective, virtual administrative functions for Biotechnology, Contract Research, Consulting, Pharmaceuticals, Medical Device, and Diagnostic companies. Among other things, Van Vactor Consulting can provide the following: schedule meetings, teleconferences and travel; assist with technical writing and document review; web site management; marketing and business development follow up; conference partnering and more. These services are provided in a confidential, professional and efficient manner. Susan Van Vactor, CEO, a veteran, has been a Dean's Executive Administrative Assistant at Penn State University as well as the Head of Administration for Enter Health and has been providing virtual administrative support for over five years. Please join us in welcoming Sue to MedSurgPI.com. For more information, please contact Sue at svanvactor@medsurgpi.com or visit Van Vactor Consulting online.

A phase 1 clinical trial of the sigma-2 receptor complex allosteric antagonist CT1812, a novel therapeutic candidate for Alzheimer’s disease

Alzheimer’s & Dementia: Translational Research & Clinical Interventions 5 (2019) 20-26


Michael Grundmana, Roger Morgan, Jason D. Lickliter, Lon S. Schneider, Steven DeKosky, Nicholas J. Izzo, Robert Guttendorf, Michelle Higgin, Julie Pribyl, Kelsie Mozzoni, Hank Safferstein, Susan M. Catalanog


We would like to congratulate Roger Morgan, MD; for being a co-author on this new publication

Roger is the VP of Medical Affairs at MedSurgPI LLC.  MedSurgPI is a medical consulting group specializing in strategy for product development, medical affairs, medical monitoring, and fractional medical officer services.  For additional information about MedSurgPI services contact gklein@medsurgpi.com

Read the full article

Abstract:

Background: Elayta (CT1812) is a novel allosteric antagonist of the sigma-2 receptor complex that prevents and displaces binding of Ab oligomers to neurons. By stopping a key initiating event in Alzheimer’s disease, this first-in–class drug candidate mitigates downstream synaptotoxicity and restores cognitive function in aged transgenic mouse models of Alzheimer’s disease.

Methods: A phase 1, two-part single and multiple ascending dose study was conducted in 7 and 4 cohorts of healthy human subjects, respectively. In part A, healthy, young subjects (,65 years old) received CT1812 doses ranging from 10 to 1120 mg (6:2 active to placebo [A:P] per cohort). In part B, subjects were administered 280, 560, and 840 mg once daily for 14 days (8:2 A:P per cohort). An elderly cohort, aged 65-75 years, was dosed at 560 mg once daily for 14 days (7:2 A:P). Serum concentrations of CT1812 in part B were measured on day 3 and 14 and cerebrospinal fluid concentrations on day 7 or 9. Cognitive testing was performed in the healthy elderly cohort at baseline and at day 14 of treatment.

Results: Treatment with CT1812 was well tolerated in all cohorts. Adverse events were mild to moderate in severity and included headache and GI tract symptoms. Plasma concentrations of drug were dose proportional across two orders of magnitude with minimal accumulation over 14 days. Cognitive scores in the healthy elderly cohort were similar before and after treatment.

Conclusions: CT1812 was well tolerated with single dose administration up to 1120 mg and with multiple dose administration up to 840 mg and 560 mg in healthy young and healthy elderly subjects, respectively. CT1812 is currently being studied in early phase 2 trials in patients with Alzheimer’s disease.  2018 The Authors. Published by Elsevier Inc. on behalf of the Alzheimer’s Association. This is an open access article under the CC BY-NC-ND license: http://creativecommons.org/licenses/by-nc-nd/ 4.0/



Neglecting Regulations and Quality System Requirements is Detrimental to your Business

Mark E. Ramser, VP Quality Management, MedSurgPI, LLC; Peter C. Johnson, MD, Principal, MedSurgPI, LLC; Gerald L. Klein, MD, Principal, MedSurgPI, LLC

It’s never too early to start designing and implementing a company’s quality management system (QMS). Initiating the R&D process is not a problem for companies that have a well-defined QMS and a mature understanding of how it should operate. However, without a well-defined, compliant and effective system, this could be the start of potential future quality and regulatory nightmares. Even with a well-defined system in place, significant problems can occur if the organization is lacking the maturity and experience to utilize it properly. Typically, the R&D function is where most people think a product starts. The founders may not have any understanding of regulatory or quality system requirements. They can simply be focused on developing and launching a product, choosing to worry about the regulatory and quality system requirements once they have a product to sell. Unfortunately, by waiting until the product is ready for market, it will be too late. The ISO 13485 standard, 21 CFR Part 820 (FDA Regulations) and MDR (European Medical Device Regulations) require and expect the product development and launch to be performed under controlled processes and systems. Refer to the following links for the above referenced standards and regulations:

  • ISO 13485 (Quality Management System for Medical Devices)

  • 21 CFR Part 820 (FDA Medical Device Regulations)

  • MDR (European Medical Device Regulation)

The notified bodies and regulators expect the following areas to be controlled and managed per their documented standards and regulations:

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The most critical in early stage product development are:

  • Documented Quality Management System

  • Design Controls (Design History File sub-bullets to prove all these areas are addressed)

    • Design and Development Planning

    • Design Inputs

    • Design Outputs

    • Design Reviews

    • Design Verification and Validation

  • Change Management (design, system, process, supplier, raw material, etc.)

  • Process and Production Control

    • Process

    • Equipment

    • Supplier Selection and Control

Many of these activities need to be initiated from the start of the R&D process and the establishment of a Quality Policy and Quality Process at the proper time falls squarely upon the CEO. Companies cannot generally recreate documentation history at later dates in preparation for an FDA or regulatory body audit. The company is then open to all the risks related to not having required systems during product development. The risks can vary based on the severity of the issue and can range from:

  • A Form 483 may be issued to the firm. Form 483 is the communications method used by the FDA to inform the company’s management of objectionable conditions. This should be followed up with a thorough investigation, root cause analysis and corrective action within 15 days. These are available to the public, but only when specifically requested.

  • Severe issues on Form 483 or a significant number of issues on Form 483 could result in the issuance of a Warning Letter. A Warning Letter is one of the FDA’s principal means of achieving prompt voluntary compliance with the Act. The warning letters are much more significant than a Form 483 and are publicly posted on the FDA website and are easily searchable. This must be followed up with a thorough investigation, root cause analysis and corrective action within 15 days.

  • Additional actions can result in a consent decree, product seizure and up to and including criminal prosecution against the firm and individuals, with a special focus on the CEO.  A consent decree may be viewed as the equivalent to a court order under which the manufacturing and distribution of products can only resume, with conditions closely monitored by FDA.

The regulations defined in 21 CFR Part 820 are legal requirements and carry the stiff penalties noted above. This carries much more significance than merely an ISO standard that defines the requirements without having any legal recourse. One must keep this in mind from the earliest possible point of the inception of the company and not just during the product launch. Not following QMS at product inception and all along the development cycle can have dire consequences for the company.

The timing of onset and the complexity of any company’s QMS is dependent upon the risk that a product may represent when used with humans. Therefore, judgment and expertise are required to properly craft and institute such systems. MedSurgPI can assist your company at the earliest stages to institute a QMS, perform Gap Assessment and Corrective Actions for an existing QMS and assist with the ongoing management of a QMS. Please contact MRamser@medsurgpi.com for additional information.

MedSurgPI welcomes Mark Ramser

MedSurgPI welcomes Mark Ramser as Vice President of Quality Management for Devices.  Mark brings over 25 years of Quality Management experience.  His unique skill set focuses primarily on Quality Assurance, (QA) however, he also has spent considerable time in operations and supply chain.  Mark has extensive experience in medical device quality systems being a former Global Director of QA.

Mark has a BS,  in Mechanical Engineering  from Kettering University (formerly GMI),  and MBA,  in Finance from Case Western Reserve University.  He has also earned a six-sigma black belt as a quality engineer.  Mark has been recognized for strategic planning and program implementation impacting bottom line results through cost reduction, productivity improvements, effective compliance.  So that in addition to QA management Mark is noted for business acumen related to financial, supply chain and operations.

If you wish to consult with Mark, please contact: info@medsurgpi.com or call 919-807-9132

Todd Rowland, MD joins MedSurgPI

MedSurgPI welcomes Dr. Todd Rowland to the MedSurgPI team.  Dr. Rowland has more than 25 years of healthcare industry experience. He brings unique executive experience as a practicing physician, CEO of health information exchange, chief medical information officer, enterprise senior vice president CIO, and principal investigator for several federal grants.

For more information on Dr. Rowland and other associates, visit 'Our Team' portion of the website.

 

$78 million invested as Innovation Works celebrates 20 years

Aethon turned a couple hundred thousand dollars into an international robotics company with delivery robots in hospitals and hotels.

TissueInformatics used a six-figure grant to build a ground-breaking tissue engineering company that raised more than $25 million before a top biotech company bought it.

Both Pittsburgh-area companies were among the first to receive funding from Innovation Works decades ago. And both said that the initial investment led to millions more.

“Without Innovation Works, we probably would not have gotten started as a company,” said Aldo Zini, CEO of Aethon. “It wasn’t just the money, but they also opened some doors for us in order to raise more.”

Innovation Works has been providing early-stage investment to young Pittsburgh startup companies for 20 years. The organization celebrated its anniversary last week by recognizing the achievements of the companies it has helped start and fund.

In its 20 years, Innovation Works, now based in the North Side’s Nova Place, has worked with more than 1,000 companies. Nearly 300 were formed with direct assistance from the organization, and 376 companies received investments totaling $78 million. The companies went on to raise an additional $2.1 billion.

Innovation Works claimed it has created or retained nearly 12,000 jobs, nearly two-thirds of which don’t require an advanced degree. More than half of the companies have a woman founder; 72 percent of the founders came from local universities, and 86 percent of the companies work source from vendors in Pittsburgh, according to information complied by Innovation Works.

“I’m proud of the companies and the entrepreneurs. We have a saying here that we succeed when they succeed. At the end of the day, it’s not about us,” said Rich Lunak, president and CEO of Innovation Works, where he has worked since 2005. “We all take a lot of pride in that.”

The organization calculated that $3.60 was returned to the state economy for every $1 of state money invested. The company receives $3.5 million a year in state money.

Zini said there was a lot of skepticism over robotics companies in the early 2000s, when Aethon was just getting its start. The dot-com bubble had just burst and some investments in robotics in the 1990s didn’t pan out, leaving investors shy.

“Innovation Works, they stepped up,” Zini said.

The organization invested a few hundred thousand in Aethon over a two rounds of investing starting in 2002. Since, Aethon raised more than $50 million. ST Engineering bought Aethon in 2017. The Singapore firm kept the company in the Pittsburgh-area and allowed it to grow.

Aethon has added 18 people to its team over the last 10 months and plans to add another 10, Zini said. The company is moving into a larger building. It has robots in China, Turkey, Singapore, Australia and all over Europe.

But Zini hasn’t forgotten who helped the company at the beginning. He’ll talk to the staff at Innovation Works whenever he is looking for new hires or advice.

“And they’re still helpful,” Zini said.

When four doctors and scientists at University of Pittsburgh spun TissueInformatics in 1997, the startup scene in Pittsburgh was shaky. The city, and its reputation, was still recovering from the collapse of the steel industry, said Dr. Peter Johnson, who came to Pitt in 1987 to train as a plastic surgeon and was one of the three founders of TissueInformatics, which used machine vision to identify pathology slides.

Johnson said building a biotech company in Pittsburgh was rare at that time.

“They took a leap as one of the first to say this was a sector that we really need to invest in,” Johnson said.

TissueInformatics went on to raise $25 million over five years. In 2004, Paradigm Genetics, a North Carolina company, bought the startup. Johnson moved to the Raleigh area where he still lives. He recently bought a 40-acre farm, grows barley and plans to open a distillery.

Innovation Works invited Johnson back to Pittsburgh two years ago to speak. He was impressed the growth of the tech scene. And he expects Innovation Works to keep it growing by finding undiscovered technologies and taking chances, just like it did years ago.

“They’re going to figure out where the fringe is,” Johnson said.

Aaron Aupperlee is a Tribune-Review staff writer. You can contact Aaron at 412-336-8448, aaupperlee@tribweb.com or via Twitter @tinynotebook

UMASS Lowell M2D2 / Advancing Med Device & Biotech Innovations

Thursday, September 13, 2018

DESCRIPTION

Created especially for healthcare startups and medtech innovators: A half-day workshop packed with authoritative insights on leading-edge technologies, new best practices, business intelligence, and networking opportunities (with continental breakfast and light lunch included).

WORKSHOP AGENDA

7:30-8:00 Coffee w/continental breakfast

8:00-8:15 Welcome & Introductions

8:15-9:15 Blockchain & Artificial Intelligence – Real World Healthcare Applications

  • Speakers: Kris Srinivasan, CEO, Life Sciences, Alpha MD & Edward Bukstel, CEO, Clinical Blockchain

9:15-9:45 Blockchain: What Startups need to succeed; What larger corporations like J&J can do to support their growth

  • Speaker: Kate Merton, Head of JLABS NYC & Boston — J&J Innovation

9:45-10:15 Healthcare Industry Update

  • Speaker: Ibraheem Badejo, Senior Director, New Ventures, J&J Innovation

10:15-10:30 Break

10:30-11:00 Continuum of Medical Affairs in a Startup Company

  • Speakers: Dr. Peter Johnson & Dr. Gerald Klein, Co-Principals, MedSurgPl, LLC

11:00-11:30 Friction Points in Health Communications at Point of Care

  • Speaker: Richard Nordstrom, CEO, Liberate Ideas, Inc.

11:30-12:00 Lunch Break

12:00-12:45 Mock interview with Investors: One or more investors with successfully financed entrepreneur and startup pitch. How to deal with Investors.

  • Speakers: Steven Schwartz, Robert Bausmith

12:45-1:00 Ice Cream Hour: One-on-one interactive meetings with the speakers and the management of JLabs while you enjoy ice-cream during Q&A.

  • You are welcome to send in your questions in advance via email to Kris@AlphaMD.com or ask during Ice Cream Hour.  You will also be able to talk in person with Kate Merton, Head of JLABS NYC & Boston, and Dr. Ibraheem Badejo, Senior Director, New Ventures, J&J Innovation.