Capabilities Overview

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About usGates Healthcare Associates is a consulting firm that provides extensive clinical, regulatory, real estate, contract evaluation and business development services and expertise to pharmacies, medical practices, hospitals, and health care organizations.

We help our clients confront challenges and overcome obstacles, positioning them for growth and long-term business success.

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Our Services and Expertise

Pharmaceutical Compounding

Quality & Safety

Business Development

Risk Management

Natural Medicine

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Pharmaceutical Compounding

Complete lab development, from design through construction

Comprehensive clean room design and construction

Compliance monitoring for sterile and non-sterile compounding (with USP 795 and 797, and cGMP)

Development and delivery of training programs

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Quality & Safety Development of compliance procedures and training for staff

Guidance through accreditation, regulatory affairs, license acquisition

Compliance with FDA and cGMP requirements for drug manufacturing

Quality assurance remediation

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Business Development Strategic planning; maximizing

growth opportunities

Repositioning or reorganization

Preparation for acquisition

Due diligence

Managed care contract evaluation

Real estate transactions

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Risk Management

Continuous quality improvement programs

Avoidance of drug errors

Controlled substance compliance monitoring

Implementation of new technologies

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Natural Medicine

Development of sales strategies for natural and homeopathic products

Integration of naturopathy into compounding and retail pharmacy practice

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Experience & Entrepreneurship

Gates Healthcare Associates brings CEO-level experience and an entrepreneur’s approach to all of its engagements.

Members of our firm have been in the corner office and have made the difficult decisions that running a business requires.

We can help build sales volume, increase referrals, and resolve logistical and procedural challenges.

Our versatile team has a depth of understanding of business and health care.

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Ernest P. Gates Jr., R.Ph., FACA, FASCP, FIACPPresident Entrepreneur and pioneer in the field of specialty

pharmacy

Founded and sold Gates Apothecary, one of the largest compounding pharmacies in U.S.

B.S. Pharmacy, Trustee Emeritus – Massachusetts College of Pharmacy and Health Sciences

Considered one of the nation’s leading authorities on pharmacy compounding and a frequent contributor on the subject to Drug Topics

Recipient of numerous awards, including 2009 Honorary Fellowship Award from International Academy of Compounding Pharmacists

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Jeremy CyrierSenior Associate for Real Estate Services

Certified Commercial Investment Member, CCIM Institute board member and senior instructor, past president of New England CCIM chapter

Expertise in scouting locations, site review, market analysis, financing, valuation, lease and purchase negotiation

Founder and president of CreInvestEd, a provider of commercial real estate investing training to investors

B.A., University of Vermont, master’s from University of London, doctoral studies at University of Virginia

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Kenneth Latta, R.Ph.Senior Associate

35+ years experience at Duke University Medical Center, including compounding facility manager

Nationally recognized expert in compounding pharmacy management and development

Served on several national committees for American Pain Society; developed programs for Accreditation Council for Pharmacy Education

Pharmacy Compounding Accreditation Board surveyor

B.S. Pharmacy, University of North Carolina School of Pharmacy

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William Mixon, R.Ph, M.S., FIACPSenior Associate

35 years of experience in hospital and community pharmacy, sterile compounding, long-term care

Owner of The Compounding Pharmacy, Hickory, NC; adjunct instructor at UNC’s Eshelman School of Pharmacy

Member, North Carolina Board of Pharmacy, National Association of Boards of Pharmacy

Elected to 2010-15 U.S. Pharmacopeia Council of Experts for compounding

B.S. from Medical University of South Carolina, M.S. from UNC

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Thomas Morrison, R.Ph.Senior Associate

35+ years of experience at CVS Caremark where he was member of senior management team

Former senior vice president of payer relations and business development at CVS Caremark

Served in roles overseeing retail store operations, pharmacy marketing, pharmacy purchasing, and managed care activities

Influential in developing CVS Health Connection, which was a provider of clinical and cognitive services in multiple practice settings

B.S. Pharmacy, Massachusetts College of Pharmacy and Health Sciences

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Ken Speidel, R.Ph., Pharm.D., FACASenior Associate

25+ years of experience across pharmacy sector; recipient of numerous industry awards

Professor of Pharmacy Practice, University of Findlay

Assisted in researching, developing, writing, and presenting many highly recognized educational programs domestically and internationally

Author of non-sterile and sterile chapters for North American Pharmacist Licensure Examination (NAPLEX)

Senior surveyor and standard committee member of Pharmacy Compounding Accreditation Board

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Charles Young , R.Ph., CFESenior Associate, Regulatory Affairs and Compliance

Specialty in controlled substance loss prevention, medication and patient safety/quality improvement

Retired CEO and compliance investigator at Mass. Board of Registration in Pharmacy

Foundation Board of Directors, Mass. Pharmacists Association

Past board member, Mass. Coalition for Prevention of Medical Errors; Executive Committee of National Association of Boards of Pharmacy

Former Pharmacy Manager at UMass Medical School, MassHealth division

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Success Story – Pharmacy

CHALLENGE A local pharmacy known for its fertility business wants to expand beyond its three locations and go national.

EXECUTION Gates facilitates plan to sell two smaller locations and use revenue to build merged facility with greater fulfillment capacity.

RESULT In less than a year, the pharmacy boosts its multimillion-dollar run rate by 50% and becomes fastest growing fertility pharmacy in U.S.

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Success Story – Health Center

CHALLENGE Two acute care hospitals and a health center want to merge to gain efficiencies and improve care, but avoid regulatory pitfalls.

EXECUTION Gates Healthcare Associates evaluates policies and procedures for controlled substances and confirms integrity of narcotics inventory process.

RESULT Merger avoids potential regulatory issues and combined organization becomes dominant provider of health care in its region.

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Our ClientsAetna

Compounding Pharmacy

Apothecare Bay State Medical Center

Beth Israel Hospital

Blue Cross Blue Shield Boston IVF Boston Medical

Imaging

Boulevard Pharmaceutical Compounding

Center

Brigham & Women’s Hospital

Boston Children’s Hospital

Cape Cod Healthcare

Cardone Reproductive

Choate Hall & Stewart LLP

Drug Enforcement

Administration

Express Scripts Fertility Centers of New England

Governor’s Oxycontin

Commission

Harvard Anesthesia Foundation

Helix Medical Hospice of the North Shore Hospice Inc.

International Center for

Reproductive Health

Johnson Compounding and Wellness

Center

New England Baptist Hospital

New England Surgicare PharmaHealth Pine Pharmacy Prescription

Dynamics

Ropes & Gray SkinCare Physicians

St. Jude’s Research Hospital TAG Pharmacy

Town & Country Compounding

Pharmacy

UMass Memorial Medical Center

Village Fertility Pharmacy

Wellington Manor Nursing Home

Whittier Nursing Homes

Whittier Rehabilitation

Hospital

Winchester Hospital

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“My business has gone from being in the red to being in the black, and is now experiencing unprecedented growth, and I would give a lot of the credit for that to Ernie Gates. He brings a wealth of experience and knowledge to bear on his work.”

– Stephen Bernardi, R.Ph., Co-OwnerJohnson Compounding and Wellness Center

One Meeting House SquareMiddleton, MA 01949www.gateshealthcareassociates.com

Phone: 978-646-0091Fax: 978-646-0092

Email: info@gateshealthcareassociates.com