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WITI San Diego Regional Network
Moving Research Products Into Clinical Diagnostics: "What You Need to Know"

Thursday, April 7, 2005
8:30 AM - 3:00 PM

WITI San Diego presents a Biosciences seminar:

Welcome / Opening Remarks

Module I. Clinical Diagnostics Marketplace

Speaker: Paul Epner, Director, Global Business Research, Abbott Diagnostics Division

- Description of what it is and how it differs from research market
- Market Segmentation
- Competitive Overview
- Customer Buying Behavior
- Key Drivers of Market Acceptance
- New Product Adoption Challenges

Moving into the clinical diagnostics market from the research market requires a new mindset within your company—for sales, marketing, finance, and regulatory departments. Products are not only measured on their quality and use, but must demonstrate value to patient care and cost effectiveness. All facets of business operations need to adjust, particularly in what needs to be done to get customers to buy and pay for the products. In addition, selling in the clinical diagnostics market is often a “complex series of events”. The person who benefits from the product information is often not the decision maker in buying the product. Attendees will walk away with a better understanding of the customer and what it will take to get them to buy. Get a focused “tutorial” from Paul Epner, an industry expert, who will provide valuable insights into this market segment.

Module II. Customer Targets

Speaker: Paul Epner, Director, Global Business Research, Abbott Diagnostics Division

- Types defined and decision maker for product purchases
- What motivates them to buy and process of selling to each group
- Receptivity to new technology and product types

Selling in the clinical diagnostics market is often a “complex series of events”. The person who benefits from the product information is often not the decision maker in buying the product. Attendees will walk away with a better understanding of the customer and what it will take to get them to buy.

Module III. Regulatory Issues

Speaker: Nancy Hornbaker, Senior Consultant, The Biologics Consulting Group

- Manufacturing requirements
- Laboratory operations requirements
- Product requirements
- FDA requirements

Unlike the research market, the clinical diagnostics market is regulated by industry and government agencies to insure products are safe, reliable, and provide the results promised by the company. This session is designed to provide overviews of the regulatory requirements for manufacturing, laboratory operations, and government product approval processes. Hear from industry experts on the best regulatory path forward for your product –what needs to be in place when—for a successful product launch.

Module IV. Legal Issues

Speaker: Bruce Mackler, Co-Founder, Life Sciences Management Group

- Regulatory requirements for Homebrew, ASR, 510K, PMA
- Stark Law and its effects on the selling process
- Federal verses State legal requirements for products

Products sold in the clinical diagnostics market face regulatory requirements that are more stringent than products sold to research customers. Not only are there FDA requirements, often times individual states have regulatory hurdles to pass in order for a company to operate. Selling directly to physicians brings another legal dimension that requires specific marketing and selling tactics to stay within the guidelines. Gain legal insight from Bruce Mackler, who has helped clients throughout the country to navigate through these issues so that they conduct business within Federal and State guidelines.

Module V. Reimbursement

Speaker: Yola Gawlik, Principal, Covance Health & Outcome Services

- Coding and re-imbursement overview for tests by test type
- Payer types and requirements for re-imbursement
- Contracting process with a couple of examples outlined
- Patient issues to consider—when and how to bill directly

All new products in the clinical diagnostic market are ultimately re-imbursed by a government or private health care agency. Companies selling instruments. kits, services, devices—must all know how these agencies code and re-imburse their products—because it will effect what the customer is willing to pay. Get first hand information on reimbursement from a speaker who has spent many years understanding the issues and helping companies to navigate through the process.

Module VI. Marketing Tactics

Speaker: Diane Kuehn, President/CEO, VisionPoint Media

- Identifying your target audience segments and categorizing each as influencers or decision markers
- Messaging – Creating messaging that educates and motivates your target audience
- Using qualitative and quantitative research to develop your marketing strategy and plan
- Executing an integrated marketing plan across tradeshows, your website, email marketing, search marketing, direct mail and PR
- Programs that bring best success – Case Studies

Successful marketing programs are created on a crystal clear understanding of your target audience including who they are, where they are, how to best reach them, and what messaging will motivate them to take the action that you want. Attendees of this session will get first hand knowledge of marketing case studies including the identification of the target audience, refining the messaging, marketing programs and the results they delivered for other life science organizations.

Module VII. Sales Strategy & Execution

Speaker: Beverly Cormier, President & CEO, BioScience Business Solutions

- Direct, partners, distribution—definition of each and how to decide
- Sales structure and operations overview
- Sales skill sets & training necessary for each customer types
- Relationship of sales to other company departments
- Tactics for ROI

Products in clinical diagnostics only get sold if the customer is constantly reminded of their availability and use. If it is new technology that will change the “standard of patient care” or “current laboratory practices”, it is important to provide first- hand customer education and customer service. What type of sales organization, how many people, what type of skill set is needed, how much it will cost, and what internal support is necessary for success must all be considered. Get inside information on the right sales strategy and tactics from Beverly Cormier, a business executive with more than 18 years of experience in both the research and clinical diagnostics markets.

Close/Wrap Up

About Our Speaker(s)


Beverly A. Cormier
BioScience Business Solutions
San Diego, California

Paul Epner
Director, Global Business Research
Abbott Diagnostics Division
Abbott Park, Illinois

Yola Gawlik
Covance Health Economics and Outcome Services
Gaithersburg, Maryland

Nancy Hornbaker
Senior Consultant
The Biologics Consulting Group

Diane Kuehn
President / CEO
VisionPoint Media
Raleigh, North Carolina

Bruce Mackler
Life Sciences Management Group
Washington, D.C.

Bio of Paul Epner, Director, Global Business Research, Abbott Diagnostics Division:

Paul L. Epner, BS, M.Ed., M.B.A. Paul is currently Director of Global Business Research for the Diagnostics Division of Abbott Laboratories, a global diversified healthcare company with more than $3B in diagnostic sales. He has spent more than 27 years with Abbott serving the laboratory community while living in the U.S., in Japan and in China. Since 1985, his positions have been in various facets of commercial operations, both in the US and internationally. Paul has held several positions emphasizing operational excellence, strategic planning, and leadership, including managing several hundred employees in technical support call centers, establishing a clinical diagnostics manufacturing facility in China and driving visibility for the “voice of the customer” through market research. His varied responsibilities have given Paul the opportunity to interact with all components of diagnostic testing from physician ordering to physician-received result including point-of-care diagnostics, LIS and informatic tools, and pre/post analytics spanning small, rural hospitals to large, central hospitals and reference labs worldwide. His current position keeps him in direct contact with global laboratory professionals through industry initiatives as well as overseeing advisory boards and surveys. Paul is currently serving as a member of the Quality Advisory Council for CLMA and as an active member of the Network Workgroup of the Institute for Quality in Laboratory Medicine (IQLM). Previously he has served as a panelist at a CLMA annual conference as well as at an AACC conference on Laboratory Workforce Shortages. Recently, he served as a faculty member at the Clinical Laboratory Educator’s Conference (ASCLS) in February and is an invited speaker at the 2005 IQLM Conference in April. Outside of Abbott, he also serves on the board of two not-for-profit organizations.

Bio of Bruce F. Mackler, Ph.D., J.D.

Dr. Mackler’s 27 years of FDA legal/regulatory experience in biomedical products includes biologics, drugs, medical and in vitro diagnostic devices, food and cosmetics manufactured by traditional and biotechnology processes (recombinant proteins, genomics, cell and gene therapy). Dr. Mackler has counseled clients on agreements relative contract manufacturing (outsourcing), contract animal studies and contract monitoring of clinical studies. He has also taught workshops on outsourcing agreement development, clinical development, FDA inspections, negotiating with FDA for 510(k)/PMA approvals, preparing investigational (IND/IDE) and marketing permits (NDAs/ANDAs) and many other important regulatory issues.

Dr Mackler has a Ph.D. and M.S. in the area of Immunology/Microbiology and has authored more than 100 published scientific papers and abstracts in immunology, immunopathology, and dental/mucosal diseases as well as numerous additional articles and briefing papers on FDA and FDA-related legal and regulatory issues. Dr. Mackler has counseled clients and venture capital groups on FDA regulatory approval strategies, problems regarding inspection of manufacturing facilities and how to effectively interact with FDA. He has assisted clients in developing regulatory approval strategies and pre-clinical and clinical study strategies to facilitate market entry, and preparing applications for marketing registrations for drugs, biologics, in vitro diagnostics and devices.

He has assisted companies in the integration of new technologies into FDA product development strategies and achieved the approval of a number of biologics, drugs and medical/diagnostic devices. These activities have included actually serving as agent and holding INDs and IDEs for clients and assistance in organizing clinical studies and troubleshooting regulatory problems. During his regulatory activities, he meets regularly with FDA staff and maintains a dialogue with them in the biologic, drug and devices areas and has a hands-on approach to solving regulatory problems ranging from pre-clinical, clinical and marketing submissions, as well as pre- and post-marketing promotion and advertising.

Dr. Mackler has represented and counseled a number of traditional and biopharmaceutical companies developing drug products to treat diseases including multiple sclerosis, ALS, stroke, spinal cord injuries as well as endocrine hormones, opthalmics, anti-infectives, pulmonary delivery, to name a few of the therapeutic areas, using traditional organic (new chemical entities & generic) compounds, and biotech-derived therapeutics (monoclonal antibodies, cytokines, fusion proteins), classic and new technology-driven vaccines, and cellular and gene therapy. He has been involved in a number of in vitro diagnostic and medical device product developments and has a working relationship and dialogue with CDRH/FDA staff in this area on evolving regulatory/legal issues. His experience in medical devices includes bandages and surgical medical devices, wound healing, in vitro diagnostics, instrumentation, implants, etc.

Dr. Mackler has experience drafting and evaluating numerous FDA regulatory documents (e.g., IDEs/PMAs, INDs/NDAs, DMFs, and BLAs, 510(k)s), Accelerated and Fast Track Approvals, Orphan Drug Designation applications, and USDA submissions. He has, as a U.S. agent, held IDEs/INDs and secured Treatment-INDs with substantial reimbursement, and has written Orphan Drug Development/SBIR grants and Designation applications. He lectures regularly at industry conferences and workshops, and internally for companies to update or train personnel on FDA legal and regulatory matters.

Dr. Mackler is an Advisor with Techno Venture Management (TVM) in Boston & Munich, Paul Capital Royalty Fund (Advisor) in New York City, Apax Partners (London & Israel), Index Ventures (Geneva), ABN AMRO Capital/Life Sciences (Amsterdam), UNUS Ventures (Birmingham, AL) and other venture capital groups, performing in depth FDA due diligence evaluations prior to investing, and assisting portfolio companies with FDA strategy. He is a member of the Scientific Advisory Boards (SABs) of several biopharmaceutical companies. Dr. Mackler has lectured extensively on performing FDA due diligences.

Dr. Mackler received his J.D. from the South Texas College of Law (magna cum laude, 1979), his Ph.D. (Immunology/Microbiology) from the University of Oregon Medical School (1970), his M.S. (Immunology/Microbiology) from the Pennsylvania State University (1965), and his B.A.(Biology) from Temple University (1964). He is a member of the District of Columbia Bar, and admitted to practice before the Federal District and Appeals Court and before the U.S. Supreme Court. Dr. Mackler founded the Association of Biotechnology Companies (ABC) and grew it to over 250 members before it merged to form the current Biotechnology Industry Organization (BIO).

Bio of Yola Gawlik, Principal, Covance Health Economics and Outcome Services:

Yola Gawlik is experienced in coding, reimbursement, and strategic planning for novel and early stage pharmaceutical, biotech, device, and diagnostic products. Her experience with economic market analyses encompasses a number of clinical and therapeutic areas, including rheumatology, cardiology, oncology, and nephrology.

Prior to joining Covance, Ms. Gawlik negotiated managed care contracts for the Carolinas Healthcare System, a large integrated delivery system in Charlotte, NC. Ms. Gawlik also worked at NYLCare Health Plans, Inc., providing strategic services for the divestiture of subsidiary physician practices and for NYLCare’s merger with Aetna.

Ms. Gawlik received an M.H.A. degree from the Medical College of Virginia at Virginia Commonwealth University and a B.S. in Health Services Administration from James Madison University.

Bio of Nancy Hornbaker, Senior Consultant, The Biologics Consulting Group:

Ms. Hornbaker joined BCG's West Coast operations in July of 2002. She brings to the firm over 20 years of experience in regulatory affairs and quality assurance. Ms. Hornbaker most recently served as the Director of Regulatory and Clinical Affairs at Bayer Diagnostics and also held regulatory positions at Chiron Corporation, Baxter Diagnostics, Abbott Diagnostics Division of Abbott Laboratories, and Searle Pharmaceuticals, Inc.

Bio of Diane Kuehn, President & CEO, VisionPoint Media:

Eighteen years of experience in direct marketing from the media, agency, and marketer perspectives provides Diane with expert foundation of the pros and cons of each type of medium and how to best integrate direct marketing principles throughout your sales and marketing initiatives. With the explosion of the Internet population and the potential for interactive communications, Diane founded VisionPoint Media to help life science marketers leverage the benefits of true one to one marketing with a variety of proprietary technologies and integrated services including permission email marketing, website design, search engine optimization, custom web applications, and streaming video email.

Prior to founding VisionPoint Media, Diane held numerous executive sales and marketing positions including EVP of Sales and Marketing of SourceLink; VP of Channel Development of High Speed Net Solutions; VP of Direct Results Group, an interactive agency in Boston; Director of New Business Development for ADVO, the country's largest direct marketing firm, and General Manager for a Cox Communications direct marketing firm in Baltimore, Maryland, The Clipper.

Bio of Beverly Cormier, President & CEO, BioScience Business Solutions:

Ms. Cormier has more than eighteen years of business strategy and marketing experience in the bioscience and medical product industries. Throughout her career she has provided senior level strategic and tactical expertise to a number of companies with products or services sold in both the research and clinical markets.

In 1990, after a successful five-year sales career with Dianon Systems, she was appointed national sales manager for Specialty Laboratories, a full service clinical reference laboratory in southern California . In 1992 Ms. Cormier joined UroCor, a urology diagnostics and disease management company based in Oklahoma where she held a number of senior management positions. In 1997, she was recruited to Prometheus, a San Diego-based gastrointestinal diagnostic and therapeutic company as director of sales, marketing, and business development. In 1999, Ms. Cormier joined PPGx, a pharmacogenomic solutions start-up, as VP, Strategic Development.

In July 2000, after PPGx was acquired by DNA Sciences, she successfully launched BioScience Business Solutions with marquee life science clients. Relationships have ranged from individual projects to full time contract positions with companies in drug discovery, clinical genomics and clinical diagnostics.

Ms. Cormier graduated cum laude from the University of Cincinnati with additional graduate work at Miami University . She has written " A Guide to Raising Capital from the Private Sector " for Drug and Market Research Publications, served as a national speaker for IBC, and is an active member of Women in Technology International, as well as other key industry organizations.


Event Date and Venue

This event will be held from 8:30 AM - 3:00 PM on Thursday, April 7, 2005 at:

    Avanir Pharceuticals Conference Center
    11404 Sorrento Valley Road
    San Diego, California 92121

Driving Directions:

From the south (I-5):

Going north on Interstate 5,
Take the Sorrento Valley Road exit
Turn left onto Roselle Street
Turn right onto Sorrento Valley Blvd.
Turn left onto Sorrento Valley Road

From the south (I-805):

Going north on the 805 freeway,
Take the Sorrento Valley Road exit
Turn right onto Vista Sorrento Parkway
Turn right onto Sorrento Valley Road

From the north (I-5):

Going south on the Interstate 5,
Take the Carmel Valley Road exit
Turn left onto Carmel Valley Road
Turn right onto El Camino Real
Turn right onto Carmel Mountain Road
Turn left onto Sorrento Valley Road


8:30 AM - 9:00 AM: Registration/networking
9:00 AM - 10:30 AM: Program
10:30 AM - 10:45 AM: Coffee break/refreshments
10:45 AM - 12:15 PM: Program
12:15 PM - 1:00 PM: Lunch/Networking/Break
1:00 PM - 3:00 PM: Program/Close


Pre-registration for this event is closed and on-site registrations will not be accepted.

About Our Sponsor(s)

Meeting Sponsors:

Abbott Laboratories

The Biologics Consulting Group, LLC

Bioscience Business Solutions

Covance Health & Outcome Services

Life Sciences Management Group


Contact Us

For more info regarding registration or event details, please contact Jennifer Beckey/(858-344-3825) ([email protected]).

For more details about pre-registration, contact Tech Support.