Amado B. Carino 310-***-****

***** **** ****, ********, ** 92595 wellv1@r.postjobfree.com

Professional Experience

Associate Medical Director, Medical Affairs, Bioness Inc.

Valencia, CA July 2008 – March 2009

• Serve as primary contact with clinical investigators/sites and customers (including private insurers, CMS, and other relevant healthcare professionals) on Managed Care issues, representing the company on coverage issues with both private insurers and CMS.

• Provide medical input on content of instructions for use, package inserts, brochures, advertisements, payer packets.

• Provide guidance to Medical Affairs and Clinical Research as well as R&D, Regulatory, Manufacturing, QA, Business Development and other departments on matters requiring medical opinion on technologies and applications under review related to the company’s product pipelines, mainly Pain, CNS and Functional Electrical Neurostimulation

• Serve as consultant to R&D on Musculo-skeletal Anatomy, surgical exposures and design of medical device and surgical instrumentation

• Assist in the clinical study protocol design to optimize scientific and strategic company goals. Follow up review of clinical study results and write up reports for regulatory submission and/or publication

• Identify opportunities for clinical research through evaluation and recommendation of potential clinical study investigators and study sites

• Represents the company in medical meetings, scientific symposia, specialty workshops

• Support Marketing in the development of lifecycle management brand strategies

• Reviews all competitive clinical claims and responds to editors and/or authors with counter evidence as appropriate; defends against flawed competitive studies and claims presented by competitors

• Develop and oversee internal and external training(Cadaver and Animal studies) on Musculo-skeletal Anatomy and the Nervous System pertaining to surgical approach

• As needed, establishes external panel of experts (Rehab Medicine, Pain Anesthesiologists, Neurosurgeons, Urosurgeons) for ongoing consultation and speaker selection for scientific meetings

Manager, Medical Information, Global Medical Affairs, Baxter BioScience

Westlake Village, CA February 2008 – May 2008

• Provide accurate, timely, and appropriate verbal or written responses to inquiries from internal and external customers.

• Develop and update standard letters used for responding to inquiries.

• Manage the medical information database (IRMS) that is used for storing standard letters; capturing, fulfilling and tracking inquiries.

• Compile and analyze medical information reports. Communicate inquiry trends and unmet medical needs to stake holders and strategically use inquiry trends to guide Medical Information activities.

• Staff the Medical Affairs booth at scientific meetings.

• Maintains appropriate files and documentation as necessary for regulatory compliance.

• Keep abreast of scientific information in assigned therapeutic areas (Hematology, Oncology, Immunology, Nephrology). Build relationships with other groups (e.g., Marketing, Sales) in order to stay informed about strategic direction for assigned products.

Medical Science Liaison, Baxter BioSurgery, Global Medical Affairs

Deerfield, IL February 2007 – December 2007

• Identify, develop and maintain professional relationships with key opinion leaders, thought leaders, professional societies and major academic centers in line with the company’s therapeutic areas of commercial and research interests.

• Serves as a member of the advertising/promotional review committee representing Global Medical Affairs (GMA) and provides editorial input related to product line/therapeutic area

• Provide medical education to healthcare and allied health professionals through lectures and presentations at appropriate venues to augment awareness of company products to current and future opinion and academic leaders and key decision makers in their respective therapeutic areas of expertise

• Act as primary point of contact for trial investigators and sites on investigator-initiated research; facilitate and monitor studies ensuring timely review of study results as well as identifying opportunities for clinical research consistent with company objectives

• Maintain clinical, scientific and technical expertise in therapeutic areas (Orthopedic Surgery, Orthobiologics, Musculo-skeletal Anatomy, Cardiovascular, Nephrology, Renal, OG/Gyn) through education, review of scientific journals and attending key scientific/technical meetings, CME events, workshops and preceptorships

• Serve as scientific resource to sales, marketing and medical affairs providing scientific and health economics information on areas that need to be addressed in line with the company’s objectives. Assist with CME content development, medical content review and professional communication materials

• Develop strategies and initiatives that improve and streamline current processes within Global Medical Affairs. Provide strategic assessment, planning, execution of scientific, clinical, and educational initiatives and communications

• Provide support for answering unsolicited medical questions, adverse event follow through, drug safety issues and other clinically related medical information issues

• Assigned to Orthobiologics therapeutic area mainly for the bone void filler product, maintaining expertise on all existing similar orthobiologics in the market

• Act as in-house point person for inquiries on Orthopedic Surgery, surgical anatomy and orthobiologic products

Research Associate/Coordinator, The Spine Institute at Saint Johns Health Center

Santa Monica, CA June 2004 – February 2007

• Worked closely with spine and orthopedic surgeons on both basic science and clinical research mainly on orthobiologics and disc replacement procedures

• Managed clinical trials dealing with recombinant Osteogenic Proteins, growth factors, orthobiologic disc arthroplasty systems, synthetic bone void fillers, synthetic polymers for non-fusion technology and other bone substitutes

• Coordinate Contract Research Organizations, Contract CRAs and Central Laboratories

• Review and negotiate pre-clinical and clinical trial agreements/contracts, budgets, material transfer agreements, collaboration agreements and confidentiality agreements.

• Responsible for budgetary management of sponsor-initiated trials

• Preparation and review of regulatory documents for IRB submission

• Responsible for updating and maintaining databases

• Conduct pre-study, initiation and study close-out visits

• Perform device/drug accountability

• Edit and review clinical data on spine surgery device/drug trials

• Resolve discrepancies via Data Clarification Forms

• Track and code Adverse Events and Concomitant Medications

• Management of sponsor-initiated trials

Executive Vice-President Alaminos Doctors’ Hospital Inc (Philippines)

January 2000 – December 2001

• Provide strategic leadership for the development of the service line so that a full continuum of services is created and structured in response to patient needs

• Guide the development of the overall leadership structure and strategic plan and create goals and plans for quality and financial management of the service line

• Develop and implement a strategic and operational plan for the service line that addresses: mission, medical staff development issues, charity care, access, quality improvement, financial performance, market assessment and analysis, human resources and information management

• Assure compliance with all external regulatory agencies and organizations for all areas of responsibility

• Utilize continuous quality improvement philosophies, techniques and tools in all aspects of the position

• Assist in the development of a structure or framework integrating physicians and staff into decision making involving strategic planning and budgeting

Staff Surgeon (Orthopedic Surgery) Alaminos Doctors’ Hospital (Philippines)

January 1998 – December 2003

• Performs surgery to correct deformities, repair injuries, prevent diseases, and improve function in patients with orthopedic and rheumatologic entities

• Examines patient to verify necessity of operation, estimate possible risk to patient, and determine best operational procedure

• Reviews reports of patient's general physical condition, reactions to medications, and medical history

• Performs operations, using variety of surgical instruments and employing established surgical techniques appropriate for specific procedures (Total/Partial Hip Replacement, Knee Replacement, Open Reduction Internal Fixation)

Education/Training

• Residency Orthopedic Surgery Philippine Orthopedic Center June 1993-May 1997

Quezon City, Philippines

• Research Fellow Philippine Orthopedic Center June 1993-May 1997

Quezon City, Philippines

• Doctor of Medicine Lyceum-Northwestern University April 1988

• Bachelor of Science Letran College April 1983

Clinical Psychology Manila, Philippines

Qualifications:

• Subspecialty training in Orthopaedic Surgery at an accredited institution

• More than ten years of clinical practice in Orthopedic Surgery treating chronic conditions like Osteoarthritis of hip and knee, performing surgical procedures like total and partial hip replacements, total knee replacements

• Extensive knowledge of the Musculo-skeletal System and Surgical Anatomy gained from surgical practice

• Orthopedic infection, spine and orthobiologics research background

• Comprehensive knowledge of ICH and GCP guidelines and FDA regulations, SOP development, maintenance and practical management of clinical trials

• Proficient in Microsoft Office software: Outlook, Access, Word, PowerPoint and Excel

Publications:

• Carino AB: The Predictive Value of C-reactive Protein in Post-operative Septic Complications in Orthopedic Surgery. Philippine Journal of Orthopaedics, Dec. 1995

• Carino AB, Navarro C, Claudio RF: Fifteen Cases of Tuberculous Osteomyelitis Seen at the Philippine Orthopedic Center, Philippine Journal of Orthopedics, June 1996

Awards

• Philippine Orthopedic Association – ROCHE Philippines Clinical Research Award 1995

Studies Managed:

• A Prospective, Randomized, Controlled, Multicenter Pivotal Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions (S01-01US)

Stryker Biotech, Hopkinton, MA

• A Phase-1 Study to Evaluate OP-1 (SB0405) Injected Into One Lumbar Intervertebral Disc in patients with Symptomatic Degenerative Disc Disease

Stryker Biotech, Hopkinton, MA

• A Multicenter, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of the Mobi-C Prosthesis to Conventional Anterior Cervical Discectomy and Fusion in the Treatment of Degenerative Disc Disease in the Cervical Spine

LDR Spine, Austin, TX

• Clinical Investigation of the NuCore Injectable Disc Nucleus for

Treatment of Degenerative Disc Disease

Spine Wave, Inc., Shelton, CT

• A Prospective, Randomized, Controlled, Multicenter Pivotal Clinical Trial of the Artificial Cervical Disc – LP at Two Levels for Symptomatic Cervical Disc Disease

Medtronic Sofamor Danek, Memphis, TN

• A Multi-center, Prospective, Randomized, Controlled Study to Compare Balloon Kyphoplasty to Non-Surgical Fracture Management in the Treatment of Painful, Acute Vertebral Body Compression Fractures in Cancer Patients

Kyphon, Inc., Sunnyvale, CA

• A Prospective, Multicenter Study of the Disc Dynamics DASCOR™ Disc Arthroplasty System in the Treatment of Degenerative Disc Disease

Disc Dynamics, Inc., Eden Prairie, MN

• An Open-Label, Randomized, Parallel-Group Study to Confirm the Safety and Efficacy of PROCRIT (Epoetin Alfa) Administered Peri-Operatively vs. the Standard of Care in Blood Conservation in Subjects Undergoing Major, Elective, Spinal Surgery

OrthoBiotech, Bridgewater, NJ

• Clinical Efficacy of Quantitative Measurements of Intervertebral Motion

Baylor College of Medicine, Houston, TX

• A Pilot Study to Obtain Initial Information on the Feasibility of Using CORTOSS, A Synthetic Cortical Bone Void Filler in Vertebral Augmentation Using an Inflatable Bone Tamp

Orthovita Inc., Malvern, PA

• A Pilot Study to Obtain Initial Information on the Feasibility of Using CORTOSS, A Synthetic Cortical Bone Void Filler in Vertebroplasty

Orthovita, Inc., Malvern, PA

• A Randomized, Controlled Clinical Study to Evaluate the Safety and Effectiveness of CORTOSS Synthetic Cortical Bone Void Filler in Vertebral Augmentation

Orthovita, Inc., Malvern, PA

• Pivotal IDE Study of the Wallis Mechanical Normalization System

Abbott Spine, Austin, TX

• A Pivotal Study to Evaluate OP-1 Implant + Stryker TCP Putty in

Patients Requiring Instrumented Posterolateral Fusions of the Lumbar

Spine

Stryker Biotech, Hopkinton, MA

References:

References are available upon request

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