Understanding GxP Regulations for Healthcare

OCTOBER 10, 2019
District
470 James Street, Suite 1
New Haven, CT 06513

EVENT SPONSORS

Understanding GxP Regulations for Healthcare

Thursday, October 10
5:00 to 7:00 p.m.

Understanding GxP regulations and implementing a quality system is often minimized by smaller companies in favor of activities that are perceived as added values, such as patents, licenses, and technological partnerships. But neglecting such a system until the development is completed and the product is launched can be risky. Having a quality system in place sooner rather than later could be a game-changer when it comes time to look for potential partners.

In this program, we will:

Learn the GxP compliance requirements and expectations of major healthcare regulators
Discuss how smaller companies that may not have deep expertise in QA and GMP/GCP compliance can build a quality system
Discuss best practices for managing a regulatory inspection

AGENDA

[5:00 – 5:30 PM]
Registration and networking
[5:30 – 7:00 PM]
Program

LOCATION

District
470 James Street, Suite 1
New Haven, CT 06513
+ Google Map

REGISTRATION HAS CLOSED

Check out the photos from the event!

PANELISTS

John Hanly
QA Validation Manager
Pfizer

John Hanley John has spent over 30 years at Pfizer in various areas of manufacturing bulk active pharmaceutical ingredients and Quality Assurance organization for clinical manufacturing activities in Groton, CT. In his current role at Pfizer John is primarily involved with qualifying solid dose manufacturing equipment and validating related computer systems. This also entails quality investigations, change management and regulatory compliance. In 2016, John was part of a team that built Pfizer’s first continuous tablet manufacturing facility which won an ISPE (International Society of Pharmaceutical Engineers) Facility of the Year Award. In 2018, John helped launch Pfizer’s first commercial product (Daurismo) using the new continuous manufacturing technology. John holds a BS in chemical engineering from Worcester Polytechnic Institute, an MBA in Operations Management from Rensselaer Polytechnic Institute, and is a Registered Professional Engineer in the State of Connecticut.

David King
Manager – R&D Innovation Team
Bayer

Dave King David leads a small team of technologists exploring innovative technologies to support Life Sciences R&D at Bayer. Over the last 20 years at Bayer, David has focused on leading organizational change, digital transformation, innovation methodologies, project management and GxP validation. Most recently, David was the IT lead for the Wearable POC for Bayer’s Digital Device platform, which provided a platform and business processes to enable digital monitoring and interactions with patients using biosensors, wearables, and mobile applications. David earned an MBA from Northeastern University and has worked in IT as a Developer, Project Manager and Manager across industries including Financial Services, IT Consulting and Life Sciences R&D.

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Matt Rizner

Matt Rizner is a Vice President with J.P. Morgan Private Bank who helps families and non-profits establish and meet their goals. This starts with building a deep relationship to understand not only the financial goals, but also the impact and legacy his clients want to leave. The advice covers investment and cash management, customized borrowing, complex trust and estate structuring, and charitable giving.

Outside of his day job, Matt spends his time with Inspirica, a Stamford-based non-profit to help fight homelessness, as well as at Temple Sinai with family and friends. Matt is also an active member of BioCT and CEF to support and expand entrepreneurship industry across Connecticut and Westchester.

Matt holds a bachelor's degree from the University of Vermont and an M.B.A. from Tulane University. Born and raised in Vermont, he resides in Stamford with his wife, two children, and their mini-labradoodle.

Matt Rizner

Vice President, J.P. Morgan Private Bank

Matthew Panicali

Matt Panicali is an Investment Associate at Connecticut Innovations, Inc. (CI), the State’s strategic venture capital arm and the leading source of financing and ongoing support for innovative, growing companies. At CI, Matt is responsible for sourcing new investment opportunities, serving on the boards of portfolio companies, and supporting their growth and success.

He earned his BS in Business Administration from Keene State College, and his MBA with a focus in Finance from the University of New Haven. Matt is an avid golfer and snowboarder and lives in North Haven with his fiancé and two dogs.

Matthew Panicali

Investment Associate at Connecticut Innovations

Sherwin Yoder

Sherwin is a partner at Carmody Torrance Sandak & Hennessey LLP, where he leads the firm’s Data Privacy and Security practice. He focuses on helping organizations mitigate data privacy and security risks and manage incident response, including related litigation and regulatory compliance. As a member of the start@Carmody team, he also counsels start-ups and emerging companies on their privacy and security obligations in designing and launching e-commerce sites, mobile applications, IoT devices, and other technologies or transactions involving the flow of sensitive data.

Sherwin Yoder

Partner, Carmody Torrance Sandak & Hennessey LLP

Ira Yellen, APR, Fellow PRSA

He has worked with Fortune 500 companies to 2 person start-ups by providing marketing communications, public relations, social media, public policy and advocacy for business-to-business, non-profit, and educational institutions. He has developed strategic initiatives for companies in high technology, precision manufacturing, insurance, healthcare, transportation, and financial services.

With a background in public relations, marketing, and design for over 35 years, Ira Yellen has overseen through his firm, First Experience Communications (FEC), a wide range of public relations and marketing communications projects and provide strategic counsel for clients ranging from Fortune 500 companies to non-profit organizations. Clients include: Deloitte & Touche, LLP; Connecticut Association of Nonprofits, Connecticut Primary Care Association, Statue of Liberty/Ellis Island Centennial Commission: Harold Leveer Cancer Center, Laidlaw Transit, Inc.; ADVO, Inc.; CIGNA; Connecticut Community College System; University of Connecticut; Charter Oak College; Hartford Hospital; United Healthcare; and Hartford Foundation for Public Giving.

During the past 15 years, he has concentrated in providing professional services to health care organizations (hospitals, cancer centers, community health centers, and state agencies) on integrated marketing strategies, online marketing, and branding, and has advised home care agencies on Internet strategies that help them find new clients and recruit staff.

He has counseled and provided professional services to health care organizations (hospitals, cancer centers, community health centers, and state agencies) on integrated marketing strategies, online marketing, and branding, and has advised home care agencies on Internet strategies that help them find new clients and recruit staff. A baby boomer who was a family caregiver for his mother and became frustrated in finding home care options for his mother and realizing many other families are experiencing the same thing, he decided to create an online family caregiver toolkit that would help others become discerning consumers of home care services. Ira created The Aging in Place Essential Toolkit™ to help family caregivers who search online to seek out information to assist them in taking care of a loved one.

Ira Yellen, APR, Fellow PRSA

President and CEO, First Experience Communications

David Wilson

Dr. David Wilson is a principal with DRWilson and Associates, providing product and business development services for small and mid-size companies. David has 30 years of experience in the development and manufacture of high technology products for instrumentation in the gas detection and photonics industries.

His prior experience includes Director of Engineering for Honeywell Life Safety, Engineering Manager of the Precision Positioning Solutions Department at Zygo Corporation, and Vice President of Operations at three startup companies, two of which were acquired.

He has been on the Board of the MIT Enterprise Forum of CT since 1992 and has also served on the national board. David has served two terms on the MIT Corporation, MIT’s board of trustees. He received a Bachelor’s degree from MIT in electrical engineering and Master’s and Ph.D. degrees from MIT in Mechanical Engineering.

David Wilson

Principal, DRWilson and Associates

Adam Silverman

Adam is an Associate in Wiggin and Dana's Corporate Department where he advises mature and emerging growth companies on commercial agreements, venture capital and debt financings, mergers and acquisitions, governance, and general corporate matters.

Adam works with a range of clients across several industries, including technology, life sciences, manufacturing, media and entertainment, food and beverage, and cannabis, with a focus on advising early-stage companies. Adam also counsels clients on federal regulatory clearance of mergers and acquisitions through compliance with the Hart-Scott-Rodino (HSR) Act.

Before joining the firm, Adam was an associate at Greenberg Traurig, where he advised clients on regulatory, transactional, and litigation matters related to environmental law. Prior to that, he worked in the music industry as a manager and record label executive.

Adam received his J.D. cum laude from Benjamin N. Cardozo School of Law where he was an Associate Editor of The Cardozo Arts & Entertainment Law Journal. He received his B.A. in English from the University of Connecticut.

Adam Silverman

Associate, Wiggin and Dana

Cheryl Rice

Cheryl is a communication strategist, media executive, and entrepreneur with three decades of experience expanding brands, creating alliances, and leading projects and teams to success. She began her career in the television industry as a writer and producer of commercials, station promotions, and award-winning children's programming. She then transitioned to corporate marketing communications, working in product strategy, brand management, and public relations for two of Connecticut's largest and most respected corporations, Kaman and Loctite. In 2020, she founded Outreach Strategies, a B2B-focused marketing communications and public relations consultancy. Cheryl is particularly passionate about working with tech-focused startups and early stage companies, as their success plays a key role in Connecticut's overall economic development and growth.

Cheryl Rice

Principal, Outreach Strategies LLC

Alan Mendelson

Alan Mendelson is the Founder and Managing General Partner of Axiom Venture Partners, which invests in both information technology and life sciences. As Head of Life Sciences, Alan has invested in a number of successful biotechnology companies.

Prior to founding Axiom, he spent 25 years at Aetna Life and Casualty, where he was a Vice President. He ran Aetna’s venture program, generating significant profits, helped create MBIA, the country’s largest municipal bond insurance company, and helped Aetna develop strategy and policy for their commercial mortgage loan portfolio.

Alan has been involved in technology policy and development in Connecticut for over 20 years. He was the Finance Committee Vice Chairman of the state’s first High Technology Task Force in 1984, where he created the Connecticut Seed Ventures and two Centers of Excellence. He has also been on the Advisory Board of Connecticut Innovations since 1989 and is currently on the Board of the Connecticut Technology Council and the MIT Enterprise Forum.

In his industry roles for the State, he has received the Distinguished Service Award from the Connecticut Venture Group of which he was a past president. Alan has a Bachelor’s of Science degree in Economics from Trinity College and a Doctor of Law (LLD) from the University of Connecticut.

Alan Mendelson

General Partner, Axiom Venture Partners

Angel Li

As a tax and accounting service partner, Angel has over 15 years of experience with tax planning, research and consulting for clients in a variety of industries, including technology, pharmaceutical, biotech, service, as well as real estate for both the public and private sectors. She specializes in accounting services and tax compliances for privately held corporations and partnerships. In addition, Angel is responsible for tax consulting services, including structuring of new business ventures and assistance in IRS examinations. Angel works closely with her client to design services to their needs and expectations. Her team's cooperation can include comprehensive general ledger accounting or selective accounting processes.

Angel Li

Partner, Fiondella, Milone & LaSaracina LLP

John Ireland

John Ireland has held positions as CEO, CFO, COO and Director of Business Development in both private and public corporations in several verticals. This experience makes him uniquely qualified to advise companies on all aspects of their business.

Mr. Ireland has worked in many industries helping companies prosper. He has been engaged by various companies including a solar thermal company, a privately held software company, an electronics company, an electronic component manufacturer, an upstream energy transaction exchange, a healthcare leasing company, a medical imaging enhancement company, a transaction based marketing company, and a tree seed oil company.

More specifically, Mr. Ireland recently worked as CFO and COO for Sightlines, a facility benchmarking firm that grew from less than $1 million in revenue to over $7.5 million while he was employed by them.

Mr. Ireland was the Founder and CEO of Downstream Energy Corporation focusing on providing an Internet-based solution that would be an innovative alternative to the existing manual business processes and proprietary technologies available to support communication between suppliers and marketers of petroleum refined products.

Mr. Ireland gained a great deal of experience by spending eight years at Tosco Corporation in Business Development and Strategic Planning. Mr. Ireland was instrumental in the growth of Tosco Corporation through mergers and acquisitions from a single refinery to the largest independent oil refiner and marketer in the United States whose assets included 7 refiners and over 5000 retail assets before its sale to Phillips Petroleum in 2001.

Upon graduation from Brown University with a bachelor's degree in chemical engineering and a master's degree in biochemical engineering. He also holds an MBA from MIT's Sloan School of Management.

John Ireland

President, Upfront Analysis

Richard Harris

Richard (“Rick”) Harris is a Partner in Day Pitney LLP’s New Haven office where he leads the firm’s Technology, Telecommunications, and Outsourcing practice group. Rick’s practice includes structuring, negotiating, and documenting the acquisition, disposition, and recapitalization of technology-related business enterprises.

In addition, Rick advises leading technology companies in connection with computer and other technology licenses; technology transfer and joint venture agreements; system development agreements; and copyright, trademark, and trade secret matters. Much of Rick’s technology licensing practice is devoted to the transfer and commercialization to private industry of technology from research universities around the United States.

He has been on the board of the MIT Enterprise Forum of Connecticut since 1992, is a former Chair of the Board and also serves as a Director and Secretary of the Connecticut Technology Council.

Rick received a Bachelor’s of Science in Economics from the Wharton School at the University of Pennsylvania and a Juris Doctor from the University of Connecticut’s School of Law. Rick currently serves as Vice- Chair of the MIT Enterprise Forum of Connecticut.

Richard Harris

Partner, Day Pitney LLP

Marina Cunningham

Marina F. Cunningham is a Managing Partner with McCormick, Paulding & Huber, an Intellectual Property firm with offices in Hartford, Connecticut and Springfield, Massachusetts.

Marina worked as a design supervisor for AT & T Bell Laboratories and, subsequent to obtaining her law degree, as an intellectual property attorney for United Technologies Corporation. She is admitted to practice before the State and Federal Courts of Connecticut and before the U.S. Patent & Trademark Office.

Marina is also Co-Chair of Technology and Intellectual Property Committee of the Hartford County Bar Association; Advisory Board Member for UCONN School of Law Intellectual Property Clinic; Committee member for INTA; and member of CPLA; AIPPI; and AIPLA.

Marina has experience in domestic and foreign patent prosecution, trademark and copyright matters, e-commerce related issues, negotiation of licenses and other types of agreements relating to intellectual property, and litigation. She is fluent in Russian and Ukrainian.

Marina holds a Bachelor’s degree in Mechanical Engineering from Columbia University and a Master’s degree in Mechanical Engineering from MIT. She received a Juris Doctor from the University of Connecticut’s School of Law. Marina has served as Chair of the MIT Enterprise Forum of Connecticut 2000 – 2013 and now serves as Director.

Marina Cunningham

Managing Partner, McCormick, Paulding & Huber

Benjamin Jensen

Benjamin Jensen is a partner at Robinson + Cole, where he represents clients in litigation and regulatory compliance matters involving technology, data privacy and cybersecurity. He is a member of the firm’s Intellectual Property + Technology and Business Litigation Groups, as well as the Data Privacy + Cybersecurity Team.

Benjamin’s litigation practice involves representing business clients in technology-based disputes, including intellectual property litigation in federal courts throughout the country. His experience includes patent infringement litigation in the Eastern District of Texas and the Southern District of New York. He has also managed major litigations in federal courts involving theft of trade secrets, trademark infringement, including proceedings before the Trademark Trial and Appeal Board, software license disputes and copyright infringement, including claims under the Digital Millennium Copyright Act.

As a member of the firm’s Data Privacy + Cybersecurity Team, Benjamin assists clients in developing policies and procedures to comply with state, federal and international data privacy laws and regulations. He works with companies to investigate potential data breaches and to comply with notification requirements under applicable law. He is a regular contributor to the firm’s Data Privacy + Security Insider blog, with a focus on applications of blockchain technology.

Benjamin Jensen

Partner, Robinson + Cole

Guergana Rangatcheva, CPA

Guergana Rangatcheva is the Chief Financial Officer of Bradley, Foster & Sargent, Inc., an independently owned investment advisory firm focused on serving individuals, families, and institutions and providing comprehensive investment portfolio management services. As CFO, Guergana provides financial oversight and strategic leadership for Bradley, Foster & Sargent and its affiliates. Prior to Bradley, Foster & Sargent, Guergana spent 16 years in public accounting, providing audit services to both public and private companies in a broad range of industries including technology, manufacturing, healthcare, financial services, educational institutions, and employee benefit plans. She spent the last 10 years of her career in public accounting at CohnReznick LLP, rising to a Senior Manager in the Assurance Group.

In 2014, Guergana joined the Board of MIT Enterprise Forum of Connecticut, the predecessor to Connecticut Entrepreneurs Forum. In 2017, she was elected President. She is driven to build and sustain a high-performing, successful not-for-profit organization.

Guergana Rangatcheva, CPA

President, Connecticut Entrepreneurs Forum

Chief Financial Officer
Bradley, Foster & Sargent, Inc.

Craig Colson

Craig Colson is an Investment Analyst at Connecticut Innovations. Craig helps to identify and support investments in the digital health, InsurTech, and enterprise SaaS areas. As an analyst, Craig works closely with founders and managers in conducting due diligence and writing investment memos for prospective seed and series A venture investments.

Prior to joining CI in 2019, Craig worked as a Corporate Strategy Analyst at Taco Comfort Solutions, where he was responsible for managing the company’s M&A funnel, conducting market and industry research, competitor intelligence, and supporting the development of annual and multiyear strategic plans.

Craig received a bachelor’s degree in International Business from Bryant University, with Summa Cum Laude honors and a dual concentration in Finance and Economics.

Craig Colson

Investment Analyst, Connecticut Innovations

Understanding GxP Regulations for Healthcare

OCTOBER 10, 2019District470 James Street, Suite 1New Haven, CT 06513

EVENT SPONSORS

Understanding GxP Regulations for Healthcare

Thursday, October 105:00 to 7:00 p.m.

AGENDA

LOCATION

REGISTRATION HAS CLOSED

PANELISTS

John HanlyQA Validation ManagerPfizer

David KingManager – R&D Innovation TeamBayer

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FOLLOW US ON

Connecticut Entrepreneurs Forum, Inc.

Legal | Site Credits

Matt Rizner

Matt Rizner

Matthew Panicali

Matthew Panicali

Sherwin Yoder

Sherwin Yoder

Ira Yellen, APR, Fellow PRSA

Ira Yellen, APR, Fellow PRSA

David Wilson

David Wilson

Adam Silverman

Adam Silverman

Cheryl Rice

Cheryl Rice

Alan Mendelson

Alan Mendelson

Angel Li

Angel Li

John Ireland

John Ireland

Richard Harris

Richard Harris

Marina Cunningham

Marina Cunningham

Benjamin Jensen

Benjamin Jensen

Guergana Rangatcheva, CPA

Guergana Rangatcheva, CPA

Chief Financial OfficerBradley, Foster & Sargent, Inc.

Craig Colson

Craig Colson

OCTOBER 10, 2019
District
470 James Street, Suite 1
New Haven, CT 06513

Thursday, October 10
5:00 to 7:00 p.m.

John Hanly
QA Validation Manager
Pfizer

David King
Manager – R&D Innovation Team
Bayer

Chief Financial Officer
Bradley, Foster & Sargent, Inc.