MedSurgPI was founded by two highly experienced clinician-executives whose combined backgrounds encompass medicine, surgery, technology, product and clinical development.  We believe in product optimization, and preventing problems before you have to solve them.


The Principals

 
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Gerald L. Klein, MD is a board certified Allergist and Immunologist, and a board certified Pediatrician.  He is an expert in Medical Affairs and Clinical Development and has published numerous scientific papers.  He was a professor of Medicine and Pediatrics (Division of Basic and Applied Immunology) at University California, Irvine. Dr. Klein was a founder and CEO of Entera Health Inc., a biotherapeutics company.  There, he created and managed both the clinical development and medical affairs programs. He was the Chief Medical Officer of Talecris/Grifols and he was also its VP of Medical and Clinical Affairs. During his tenure at Talecris, Dr. Klein was instrumental in creating a comprehensive safety and pharmacovigilance plan and helping the company gain a new neurological indication. Dr. Klein has also been CMO/VP Medical and Clinical Affairs at several specialty biopharmaceutical companies including:  Dey/MerckKgAa: respiratory and allergy Clingenix:  Pharmacogenomic (diabetes)/CRO; Specialty Labs/Pathway Diagnosis:  Central and Specialty diagnostic laboratories; Oxygen Biotherapeutic/Tanex:  Acute Brain Injury/Heart Failure.  Dr. Klein began his career in industry by founding a CRO, San Diego Clinical Research Association, (SDCRA) where he served as CEO and CMO.  SDCRA conducted studies in Dermatology, Infectious Disease, Neurology, Cardiology, Psychiatry, Nephrology, Pulmonology, Women’s Health, Surgery, and Allergy.  SDCRA was sold to Quintiles, where Dr. Klein, was an SVP and worked in both Global Medical Affairs and Drug Development.  Additionally, Dr. Klein has been on the Board of Directors of Nano Corp and Oxygen Biotherapeutics.


 
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Peter C. Johnson, MD is a University of Notre Dame and SUNY Upstate Medical University graduate. After General and Plastic Surgery training, Dr. Johnson practiced reconstructive surgery for ten years at U. Pittsburgh where he founded and was the first President of the Pittsburgh Tissue Engineering Initiative.  Subsequent roles were co-founder/CEO of Tissue Informatics, EVP of Life Sciences, CMO and CBO of Icoria, EVP, Entegrion, Inc. and VP, Research and Development and Medical and Scientific Affairs of Vancive Medical Technologies, an Avery Dennison business.  He presently also serves as President and CEO of Scintellix, LLC.  He has chaired the Plastic Surgery Research Council, was President of the Pennsylvania Biotechnology Association and the Tissue Engineering Society, International (now TERMIS). He serves on the board of the Transverse Myelitis Association, of MEDIC as well as the Industrial Technology Advisory Board, Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center, the North Carolina Tissue Engineering and Regenerative Medicine Society and is on the Industry Advisory Board of the UNC/NC State Joint Program in Bioengineering.  He is an Adjunct Professor of Biomedical Engineering at the University of North Carolina at Chapel Hill, of Biomedical Engineering at NC State and Duke Universities and of Regenerative Medicine at Wake Forest University School of Medicine.  He is an avid cook; fly fisherman, artist, novelist and is the proprietor of Lark Farm

Our Therapeutic Experience:

Surgery:  General, Plastic and Reconstructive, Biomaterials, Trauma, Orthopedics, Wound Healing, Neurosurgery, Urology, Otolaryngology, Cardiothoracic.

Dermatology:  Acne, Pediculosis, Atopic Dermatitis, Psoriasis, Urticaria, Pruritus, Contact Dermatitis, Impetigo, Skin and Soft tissue infection, Abscess, Keloids, Scaring, Alopecia, Wound Healing, Burns, Skin Cancer, Seborrhea, Oncomycosis, and Dermatophystosis

Cardiovascular Disease:  Heart Failure, Hypertension, Thrombosis, Coronary Artery Disease

Allergy:  Allergic Rhinitis, Bronchial Asthma, Pediatric Asthma, Hymenoptera Allergy, Food Allergy, Gastrointestinal Allergy, Allergy Contact Dermatitis, Chronic and Recurrent Sinusitis, Drug Allergy, Allergic Bronchpulmonary Aspergillosis, and Angioedema

Other Medical:  Rare Diseases, Critical Care Medicine, Hematology/Oncology, Allergy, Autoimmune Disease, Rheumatology, Pulmonary, Infectious Disease, Neurology, Psychiatry, Nephrology, Women’s Health, Immunology, Pediatrics, Stem Cell/Regenerative Medicine Therapies, Medical Foods.

Technology:  Tissue Engineering, Biomaterials, Next Generation Sequencing, Personalized Medicine


 Vice-President of Medical Affairs

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Dr. Roger E. Morgan, MD, FACS has extensive experience in global medical affairs with both pharmaceutical companies and CROs. While trained as a surgeon/critical care intensivist, he spent much of his industry career focused on metabolic and cardiovascular research.  Prior to MedSurgPI, Dr. Morgan served as the Executive Vice President Global Medical Affairs at Clinipace Worldwide, a contract research organization. Prior to that he was the Chief Medical Officer at Kowa Research Institute, where he worked on multiple cardiovascular, endocrine, ophthalmologic, and other therapeutic programs, and evaluated multiple preclinical molecules and potential in-licensing candidates in these areas. He also served as Director of Medical Affairs/Assistant Research Professor for the Department of Surgery at Duke University in the American College of Surgeons Oncology Group, and as the Senior Director of Medical/Scientific Services in the Internal Medicine Therapeutics Division at Quintiles.  Dr. Morgan received his M.D. from the University of Illinois College of Medicine and his A.B. in Biochemistry from Duke University. He received General Surgery and Critical Care training at Michigan State University and University of Pittsburgh, respectively. He is certified by the American Board of Surgery for Surgical Critical Care and General Surgery, and is a Fellow of the American College of Surgeons.


Physician Associate

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Dr. Roger D. Nolan, PhD is experienced in the management of preclinical and clinical drug development programs, regulatory strategy and interactions, financing, and outsourcing to specialist service providers.  He holds management positions with biotech companies BioKier and Plakous Therapeutics and consults with entrepreneurs in start-up and early-stage biotech companies to advance their products. His specific areas of expertise are in diabetes, oncology, anti-infectives, and cardiovascular indications.  Previous positions held are Senior Director, Science and Technology Evaluation for Calvert Research, Senior Scientist in Clinical Development at Cato Research, and Director Pharmacology at Insmed Pharmaceuticals.  At Calvert he directed a drug development program in diabetes that was in-licensed by Sanofi-Aventis. 

Dr. Nolan started his career at Eastern Virginia Medical School where he had a joint appointment in Biochemistry and Internal Medicine and conducted basic and clinical research at the Strelitz Diabetes Research Center.  Dr. Nolan received a PhD in Pharmacology and Biochemistry from Melbourne University; and completed postdoctoral fellowships at the National Institute of Environmental Health Sciences and at Burroughs Wellcome.  

Roger is an avid golfer and enjoys woodworking, reading, and exercising.


Physician Associate

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Lynne E. Porter MD, FACP is a cum laude graduate of Ohio Wesleyan University and a graduate of Jefferson Medical College of Thomas Jefferson University in Philadelphia. She did her medical training at Brown University. She is board certified in Internal Medicine and Gastroenterology. Her particular clinical interests are in liver regeneration and in the development of an artificial liver. Currently, she is very focused on the entrepreneurial space as an Executive-in-Residence at Carnegie Mellon University in Pittsburgh, PA.

Lynne is a former Associate Professor of Medicine at the University of Pittsburgh School of Medicine. Her publications are in the area of liver disease. Clinically, she was very involved in fellow training and developed and ran their outpatient medical experience. She also did internal medicine and gastroenterology teaching rounds.

Lynne also has significant experience in the non-profit sector both in fiscal management and successful grant writing. She has been a board member and board president of various non-profits involved in bettering the lives of children.

Most recently, Lynne has been the Principal of her own consulting firm, Porter Consulting LLC, which is in the entrepreneurial space. It is involved in identifying great science and developing the company, both scientifically and fiscally, to insure a significant return on investment (ROI) for investors. Additionally, she evaluates the science of a company, its team and its impact on the market for angel and venture capital investors. She has also judged/mentored several student/faculty start-ups at both PITT and Carnegie Mellon University in Pittsburgh, PA. Currently, she is very focused on continuing that work as an Executive-in-Residence at Carnegie Mellon University.

In her spare time, Lynne does animal rescue, reads non-fiction, particularly biographies, loves art, particularly glass and watercolors.

 


Physician Associate

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Dr. James D. Hundley, MD, FAOA, FAAOS is a board certified orthopaedic surgeon licensed by the State of North Carolina and is a member of several organizations including the American Orthopaedic Association and the American Academy of Orthopaedic Surgeons.  He is an English-major graduate of UNC Chapel Hill and received his medical-doctor degree from the UNC School of Medicine.  He completed his residency in orthopaedic surgery, which included a year of basic science research on the effects of calcitonin on calcium homeostasis, at UNC Hospitals.

After serving in the U.S. Air Force as an orthopaedic surgeon at a regional referral hospital, Hundley joined an orthopaedic surgery group in Wilmington, N.C. where he practiced general orthopaedic surgery with emphases on sports medicine (team physician for a university) and adult reconstructive surgery.  The treatment of patients with trauma was a routine part of his practice as were problems of the shoulders, elbows, hands, hips, knees and feet.

He has authored and co-authored numerous papers and made numerous presentations mostly relating to clinical disorders including being one of the first two surgeons to recognize abductor tendon tears of the hip and the discovery of a new way to reduce dislocated hips.  He devised a way to control version of cemented total hip femoral components to avoid inconsistent alignment between the trial and final insertion stages.

In 2003 he imagined and founded OrthopaedicLIST.com, a resource directory of orthopaedic products for orthopaedic surgeons and related professionals.  Now with nearly 14,000 products and over 3,000 companies listed, OrthopaedicLIST is the largest such resource.  Surgeons, operating room nurses, materials managers and others use the list daily to find needed products.  In addition there is an Implant Identification section where surgeons and others around the world submit images of identified implants to assist other surgeons in identify implants unknown to them.  This section is also used for teaching purposes in multiple venues.

Hundley’s entrepreneurial efforts include the development and clinical research on the CV2, a mechanical, inertia-assisted device that exploits the ability of the calf pump to increase venous and arterial circulation in the lower extremities.

Outside the delivery of medical care, Hundley has extensive experience in leadership in a variety of medical, civic and non-profit organizations and boards including a commercial bank and two multimillion-dollar foundations that fund medical and non-profit organizations.

Hundley is the principal author of the OrthopaedicLIST.com blog (www.orthopaediclist.com/blog) and one of three medical-doctor authors of a self-help blog:  Living Long and Well (www.agingdocs.com).  He has written extensively for local magazines.

He has received numerous awards for his work in orthopaedic surgery as well as public service.  His bad habits include but are not limited to golf, fishing, boating and reading useless novels.

Areas of expertise include:

  • Orthopaedic surgery

    • Diagnosis

    • Patient communication including demystifying medical terminology for non-medical people and helping people make difficult decisions about their choices of medical treatment

    • Joint replacement

    • Sports medicine

    • Fracture healing

  • Innovation: ability to consider a variety of and imagine new and different ways to solve problems

  • Writing

    • Articles and stories

    • Blogs

  • Operating a commercial website

  • Boards and organizations:

    • Understanding of the different roles of directors and management

    • Meeting management: extensive experience in chairing boards, etc.


Physician Associate

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Paul Korner, MD, MBA is  a board certified obstetrician & gynecologist with private practice and 19 years of biopharmaceutical industry experience. He is an expert in Clinical Development and Medical Affairs, having served in senior leadership roles within small biotech, midsized and Big Pharma companies. Dr. Korner supported the development and approvals of several well-known women’s health products such as YAZ®, ANGELIQ®, and CLIMARAPRO®, and medically managed YASMIN®, YAZ® , MIRENA®, ANGELIQ®, CLIMARA®, CLIMARAPRO®, and MENOSTAR®. He has published numerous scientific papers across various therapeutic areas. Dr. Korner is founder and CEO of Korner BioPharma Advisors, LLC  and is Vice President, Medical Strategy for Sarepta Therapeutics, a biopharmaceutical company focused on RNA targeted therapeutics for Duchenne muscular dystrophy.  Prior to consulting and joining Sarepta, he was the Executive Vice President and Chief Medical Officer of Ardelyx, a clinical-stage biotech focused on the development of differentiated, minimally systemic medicines for patients with end-stage renal disease and gastroenterology disorders.  Dr. Korner also served as President of Ferring International PharmaScience Center U.S., where he built and led Ferring Pharmaceutical’s U.S. clinical development subsidiary responsible for gastroenterology, reproductive health, orthopedics and urology therapeutic areas and was a member of senior global R & D management. During his tenure at Ferring, Dr. Korner oversaw multiple phase 1 to 3 programs resulting in multiple NDA/sNDA/PMA approvals. Dr. Korner has also been VP Medical Affairs – Female Healthcare for Bayer Healthcare Pharmaceuticals, Senior Director, Clinical R&D - Women’s Health and Bone for Wyeth Research, and Director, Medical Affairs – Women’s Health & Gastroenterology for Solvay Pharmaceuticals.   He received his MD from Loyola University, Stritch School of Medicine in Illinois. He also holds an MBA from the Michael J. ColesCollege of Business at Kennesaw State University in Georgia.


Physician Associate

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Dr. Peter Liebert, MD, MBA is an experienced pediatric surgical specialist with extensive clinical, administrative and organizational responsibilities as chief of his specialty division at two hospitals.  He currently serves as a pediatric surgeon in Westchester County, NY and Fairfield County, CT.  Past positions include Chief, Division of Pediatric Surgery, White Plains Hospital and Chief, Division of Pediatric Surgery, Stamford Hospital. He is currently Chief of Pediatric Surgery at Columbia-Presbyterian/Lawrence  Hospital in Bronxville, NY.  Dr. Liebert is the sole author of the textbook: Color Atlas of Pediatric Surgery and  on the Editorial  Board. of the Journal of Pediatric Surgery.

With a BA in Biology (cum laude) from Princeton University, Dr. Liebert received his MD from Harvard Medical School, in addition to an MBA (with Honors) in Finance and Healthcare Management from the Hagan School of Iona College where he continues as an Adjunct Professor of Management.

He has served in numerous leadership positions over the years to include: President of the Westchester County Medical Society; Board Member of the Legislative Physician Advocacy Committee of the Medical Society of the State of New York; Chairman of the Finance Committee, Westchester County Medical Society and is an active member of the Westchester County and New York State Medical Societies.  

Dr. Liebert has Public Health experience as a physician member of the Westchester County Board of Health and corporate experience as a Director of the publicly traded Cadus Corporation, and ImClone Corporation.  He has served as Chairman of the Board of RxVitamins, Inc., a privately held supplement company with world-wide distribution.  In addition, he is a Director and Health Consultant for Mary Ann Liebert, Inc., Publishers.

His memberships include: Fellow, American College of Surgeons; Fellow, American Academy of Pediatrics; Charter Member, American Pediatric Surgical Association; Association for Academic Surgery; Juror, Scientific Awards Jury, Lasker Foundation for Medical Research; and Westchester County Board of Health where he has served as Chair, Nominating Committee.

Dr. Liebert’s interests include collector cars, vintage auto racing, sailing, tennis, his children and two young grandsons.


               Physician Associate

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Dr. Lee P. Schacter, PhD, MD initially trained as a bench scientist and maintains an active basic research program.  After medical training in medical oncology, in which he is board certified, he was on the faculty of Case Western Reserve.  He transitioned to the drug industry at Bristol-Myers (Squibb) where he helped evaluate more than 15 potential cancer drugs, designed and conducted clinical trials, and served on the licensing committee that evaluated several hundred opportunities.  After 12 years, an NDA and a sNDA he returned to academia at Yale as Associate Director of the Cancer Center for Clinical Research.  While there he chaired the Scientific Review Board, served on the Human Investigations Committee (IRB), was responsible for the operations of the data management office and continued to serve as a consultant for a number of biotech companies including Vion and CarboMed.  He then took a position with Astra-Zeneca in order to work with targeted therapies which were then unproven.  After Astra-Zeneca he was Senior VP for clinical development and CMO for Protarga, a startup biotech.  When its lead compound failed, he was Global Head of Oncology for MDS Pharma Services leaving to work as an independent consultant/contractor for a variety of companies including Incyte, Sopherion, Saphire, Boston Life Sciences, Hybridon and JnJ.  After buying an apartment in Manhattan he took a position with Pfizer as Senior Director of Medical Affairs where, amongst other functions he again served on the licensing committee.  After Pfizer he was a Senior Director for Clinipace and then Novella Clinical where he continues to work as a contractor.

From 1986 to 1996 and again from 2000 to 2015 he saw patients weekly at the West Haven and Philadelphia VA medical centers without compensation.

Dr. Schacter has extensive experience in all phases of cancer drug development and trial conduct.  He has worked with cytotoxics, targeted therapies, immune therapies, antibody drug conjugates and other treatment modalities.  He is currently directing and funding a research program to discover the compound(s) that cause asymptomatic weight loss in some cancer patients.

When not engaged in medical research Dr. Schacter is an avid sailor and restores mid-century Lionel trains.


Physician Associate

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J. Blake Long, MD, MBA is focused on driving innovation in clinical science and health care delivery through both entrepreneurial ecosystem development and capital deployment based on experience in health care delivery, payment, and investing.  Blake provides clinical expertise, strategy analysis for both provider and payer markets, and capital acquisition support to early stage health care companies, as well as, innovation groups and investment firms.

Blake previously served as Chief Clinical Officer of Echo Health Ventures, the venture capital/private equity investment group of BlueCross BlueShield of NC and Cambia Health Solutions, providing clinical and strategy expertise to the evaluation of investment opportunities and working with portfolio companies on collaboration with providers and insurers.  Prior to the formation of  Echo in 2016, he served a similar role as Chief Clinical Officer of Mosaic Health Solutions.  He has served on the Boards of Axis Point Health, FastMed, and Citizen's RX, and currently serves on the advisory board for Prepped Health.

Before Joining Mosaic in 2015, Blake served as a practicing pediatric cardiologist at Savannah Children's Heart Center and as a clinical professor at Mercer University School of Medicine.  He also served as director of life sciences for Ariel Southeast Angel Partners, managing the evaluation and implementation of investments in healthcare and life sciences.  Previous roles have included chief medical officer and chairman of pediatrics in healthcare system in Georgia.

Dr. Long earned his BA and MD from Duke University.  He completed his residency in pediatrics at Walter Reed Army Medical Center, fellowship at Duke Medical Center, and served in Desert Shield/Storm.  He received his MBA from Duke's Fuqua School of Business in December of 2015 and now serves as a guest lectcurer and student mentor at Fuqua.


Physician Associate

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Todd Rowland, MD 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.

He provides expert advisory services to optimize enterprise and community-oriented solutions. Successful solutions align with existing services, process improvement, support complex health care, and incorporate data interoperability. Dr. Rowland is a seasoned leader and his portfolio of work includes engagement with physician, healthcare, and community leaders in the production of large-scale health IT solutions in both rural and metropolitan environments.

Todd led the development of a regional health information exchange in Indiana with startup capital from local hospitals and physician practices aligned with pre-existing HRSA grant funding. HealthLINC continues to provide profitable services which support participation in value-based payment such as TCM, CCM, ACO, and CIN activities.

He participated as the lead physician consultant to I.U. Health (Director of Medical Informatics) during the conversion of McKesson E.H.R. to Cerner E.H.R. for 4 hospitals in the southern region. This conversion built upon established physician IT governance structure and processes which were established during the successful launch of physician computer order entry.  This work as a consultant to I.U. Health was concurrent with his role as CEO HealthLINC.

During his time as senior vice president and chief information officer from 2014-2017, Todd established an evidence-based emergency care alerting system. (Peer-reviewed publication on request).  This model built on several enterprise activities including revision of Tidelands Health IT governance, Duke Endowment funded LEAN transformation and partnership with eClinicalWorks E.H.R. vendor.

Dr. Rowland continues his consultative work by establishing Bridge2Medical.com in the Research Triangle region of North Carolina.  


Physician Associate

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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.

Outside of work, his interests include travel and reading.


Physician Associate

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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.

 Mark grew up in NYC and has lived on the Amtrak corridor all his life.  He currently resides in New Jersey with his wife Susan; two grown children have left the nest.  Mark’s hobbies include collecting animation art and sports memorabilia.


Wound Healing Consultant

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VP of Quality Management for Devices

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Amelia Beatty, NP, CWCN-AP has worked in Wound Care at Duke University Hospital Clinics, Durham, NC since 2012.  She certified as a Wound Care Nurse – Advance Practiced having obtained her certification from the University of Washington in 2013.  Amelia has surgical wound healing knowledge gained from former positions in Trauma and Acute Pain Management as well as Plastic Surgery. She integrated the wound management theory and concepts for the medical and surgical wound care population she serves.

In her spare time Amelia enjoys spending time with her husband and two young boys.  An avid outdoor enthusiast she enjoys hiking and gardening as well as reading and crafts.

Mark Ramser is a Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), and Six Sigma Black Belt with over 25 years of quality management experience across multiple industries.  He received his Bachelor of Science in Mechanical Engineering (BSME) from Kettering University and completed his Master’s in Business Administration (MBA) from Case Western Reserve University.   

Mark was previously the Senior Global Director of Quality Assurance for the Industrial and Healthcare Materials Group at Avery Dennison.  He primarily focused on the Vancive Medical Technologies division.  While there, he also focused on harmonizing quality management systems globally to be compliant with:  ISO 13485, Title 21 CFR Part 820, ANVISA (Brazil), KGMP (Korea), Medical Device Single Audit Program (MDSAP) and the Medical Device Regulations (MDR).   

During Mark’s time at Vancive Medical Technologies, he successfully led the due diligence and integration of the acquisition of Finesse Medical in Longford Ireland.  Mark developed the transition plan to move finished medical device manufacturing between sites to optimize the manufacturing footprint. 

Additionally, while at Avery Dennison, Mark led the upgrade of regional new product development processes into a more robust, globally harmonized system that reduced development times 25%, reduced initial product complaints by 50% and improved margins by 25%.  He drove the cultural and systems changes for the organization to move from a medical components manufacturer to a class II and III medical device manufacturer. 

Prior to Avery Dennison, Mark was a Partner at Advanced Quality Sourcing Solutions, a global sourcing and consulting firm.  In this capacity, he developed global sourcing strategies for small businesses by identifying current supplier performance issues and transitioned to higher performing suppliers.  Mark was also the Director of Quality and Global Supplier Development for a mobility and respiratory medical device manufacturer.  

Between 2010 and 2018 Mark participated in 10 FDA site inspections, including one in China, two in Belgium and seven in the U.S.  In addition, he participated in the following international regulatory agency audits: ANVISA, KGMP and MDSAP.   

Earlier in his career Mark had various assignments in Quality, Supply Chain and Operations in Industrial, Aerospace and Automotive companies.    

Mark is married to Connie and lives in Strongsville, OH.  During his spare time he enjoys working out and spending time with his family.


Physician Associate

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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. 

When he is not working, Scott is an avid golfer. He also enjoys gardening and dog rescue.


Physician Associate

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.

 Ken has also served as volunteer and member of the board of directors for Cape Fear Clinic, a free clinic serving the underprivileged in the greater Wilmington, North Carolina area.  He spends the majority of his time now in Southeastern North Carolina and enjoys boating along the Intracoastal Waterway and fishing.


Advisor

 
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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.


Physician Associate

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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.