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.
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
General, Plastic and Reconstructive, Biomaterials, Trauma, Orthopedics, Wound Healing, Neurosurgery, Urology, Otolaryngology, Cardiothoracic.
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
Heart Failure, Hypertension, Thrombosis, Coronary Artery Disease
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
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.
Tissue Engineering, Biomaterials, Next Generation Sequencing, Personalized Medicine
MedSurgPI, LLC Team / The Associates
Roger E. Morgan, MD, FACS, Vice President of Medical Affairs
Dr. Morgan 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.
Dr. Morgan's areas of expertise include:
· Medical Monitoring
· Safety and Pharmacovigilance
· Protocol design
· Clinical development programs
· Interfacing with FDA
· Phase I through IV trial experience
· Therapeutic areas involve cardiovascular indications including device, drugs and biologics, metabolic indications including diabetes and lipid disorders, and critical care/trauma/surgery.
Roger D. Nolan, Ph.D., Physician Associate
Dr. Nolan 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.
Lynne E. Porter, MD, FACP, Physician Associate
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 interests are in liver regeneration and in the development of an artificial liver.
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.
Lynne also has significant experience in the non-profit sector both in fiscal management and grant writing. She has been a board member 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 her spare time, Lynne does animal rescue, reads non-fiction, particularly biographies, loves art, particularly glass and watercolors.
James D. Hundley, MD, FAOA, FAAOS, Physician Associate
Dr. Hundley 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.
Dr. Hundley's areas of expertise include:
- Orthopaedic surgery
- 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
- Articles and stories
- Operating a commercial website
- Boards and organizations:
- Understanding of the different roles of directors and management
- Meeting management: extensive experience in chairing boards, etc.
Paul Korner, MD, MBA, Physician Associate
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.
Peter S. Liebert, MD, MBA, Physician Associate
Dr. Peter Liebert 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.
Lee P. Schacter, Ph.D., M.D.
Dr. Schacter 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.
Wound Healing Consultant
Amelia Beatty, NP, CWCN-AP
Amelia Beatty, NP 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.
MedSurgPI LLC, Affiliates
Shabnam Vaezzadeh, MD, MPA, Physician Affiliate
Dr. Vaezzadeh offers more than 17 years of experience in the life sciences industry in areas of Medical Affairs strategy and execution, Product Safety and Pharmacovigilance, Clinical Affairs, and Business Development.
As the VP of Global Medical Affairs for KCI and then Acelity, Dr. Vaezzadeh led global matrixed teams through complex organizational changes, and delivered on strategic medical affairs initiatives in Americas, EMEA, and Asia Pacific. In addition, she instituted compliant strategic global Medical Affairs processes and delivered scientific educational presentations. She provided subject matter expertise during due diligence process of business development endeavors.
In collaboration with global Key Opinion Leaders (KOLs), Shabnam implemented initiatives to facilitate impactful marketplace introduction of medical products. She convened global advisory boards who provided advice on educational, marketing, and clinical strategies of products, and published consensus documents and practical algorithms for use. She executed national and international peer to peer educational programs to convey clinical & economic outcomes of therapeutic products, shape the standard of care, and encourage safe and effective use of innovative therapies. Shabnam collaborated with leaders of prominent medical institutions to implement academic Centers of Excellence.
She led KOL management, KOL database implementation, research, and educational grants, global publications, medical information, clinical operations, product safety and Medical Science Liaisons. She led Medical Education strategy and team, speaker development, and a portfolio of symposia, bioskills labs, preceptorships, CMEs, local medical education programs.
Utilizing her Johnson and Johnson (J&J) experience, in the role of Director of Global Safety for KCI, Dr. Vaezzadeh provided medical safety input throughout product lifecycle, including into risk management, clinical research, and product development initiatives. She instituted compliant safety processes and databases, and oversaw a 24/7 clinical hotline to address questions on safe and effective use of products.
During her tenure at LifeScan, J&J, Shabnam contributed to successful FDA audits, participated in product development teams and post market surveillance, was responsible for global pharmacovigilance and health hazard evaluations.
Shabnam’s experience includes therapeutic areas of acute and post-acute care, diabetes, wound healing, open abdomen, breast & abdominal wall reconstruction, surgical incisions, and technologies like Negative Pressure Wound Therapy, regenerative tissue matrices, fat grafting, epidermal harvesting, and glucose monitoring. She has built a professional network with thought leaders in orthopedics, plastic, vascular and general surgery, podiatry, wound care, WOCN, and CAET.
Dr. Vaezzadeh is an out of the box thinker with diverse cultural and international experiences. She holds an MD from Tehran University of Medical Sciences, Iran, and a Master’s in Public Administration with focus on HealthCare Administration from University of San Francisco, CA. Her professional development includes areas of leadership, medical affairs, and medical device development. Combining her experience in the biomedical industry and training in fashion design, Dr Vaezzadeh has an affinity towards wearable medical devices.
Robert L. Wolfert, PhD, Scientific Affiliate
Robert L. Wolfert, PhD, is an accomplished hands-on R&D and management executive with over 25 years of industry experience, with responsibilities encompassing strategic planning, discovery research, late-stage product development, clinical research and external partner and collaborations management. His background includes extensive ground-level startup and early-stage company management experience in the In vitro Diagnostics industry and has developed assays with applications in multiple therapeutic areas, including cancer, cardiology, neurology and bone disease. Dr. Wolfert received his BA in Chemistry from Cornell University and a PhD in Biochemistry from the Tufts University School of Medicine. He continued his training with a post-doctoral fellowship at the Scripps Research Institute in La Jolla, CA. He served as Director of Research at Hybritech/Beckman-Coulter, where he led the R&D efforts for the development of the first assay for prostate-specific antigen (PSA) approved by the FDA for the early detection of prostate cancer, and additional second-generation assays for the detection of prostate and other cancers. As the Chief Scientific Officer of diaDexus, he led the development of an assay for a novel marker of vascular inflammation and vulnerable rupture-prone plaque, which became the first blood test cleared by the FDA for determining the risk of ischemic stroke. He has served as Vice President R&D for Metabolon, Inc., where he helped establish a CLIA laboratory facility and led development of novel lab-developed tests for prostate cancer and diabetes. As VP of Commercial Test Development for MesoScale Diagnostics, he led the R&D efforts for product development and commercial test services. Dr. Wolfert has co-authored over 75 peer-reviewed journal articles and holds 10 issued U.S. patents.