CONTENTS

04 Breaking Barriers - Harriette F. Witmer Becomes DCAT’s First Female President in 1981

06 Women in DCAT - An Interview with Two of DCAT’s Female Leaders

08 DCAT Highlights - First DCAT Pocket Guide - First Strategic Plan - Mission Statement adopted - DCAT gets “tech-savvy”

11 1980-1990: Biotechnology Transforms the Pharmaceutical Industry - Biotech start-ups Amgen, Genzyme, Gilead Sciences, IDEC Pharmaceuticals are formed - Biogen founders win Nobel Prize in Chemistry - US FDA approves first biotech drug - Hatch-Waxman Act signed into law

15 DCAT’s Past Presidents 1980-1990

16 DCAT’s Executive Staff

ISSUE 07

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Those who knew Harriette Witmer describe her as poised, charming, and self-assured. She possessed all of the qualities of a leader, though she did not set out to be one. For years, Harriette attended DCAT Annual Meetings as a guest of her husband, Jim Witmer, who owned a small chemical company in Southern California called Deepwater Chemical Company. In 1970, Jim died in a plane crash, and Harriette found herself with two teenage boys and a company she didn’t know much about. But she knew the contacts her husband had made through DCAT were critical to the survival of her company.

Harriette F. Witmer Becomes DCAT’s First Female President in 1981

Breaking Barriers

DCAT Executive Officers at the 1982 Annual Dinner. Standing L to R: J.R. Lee, Treasurer; Robert Gutheil, Vice President; Dave Seligman, Legal Counsel; Joe Madden, Executive DirectorSitting L to R: David B. Swoap, Annual Dinner Speaker; Harriette Witmer, President

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When Harriette asked DCAT leaders to attend events on her own, their first reaction was “sorry, men only.” But a strong-willed Harriette would not take no for an answer. Her position, according to Mike Gorman, President of Vitaminerals Inc. and an active DCAT member at that time, was that “Deepwater was a member company. She owned Deepwater. Get used to it.” And they did. Harriette soon found ways to get involved with the association and worked her way up into leadership positions. “Once her foot was in the door, it was over,” says Mike. She earned a spot on the board and moved through the officer chairs, becoming the first female president in 1981. During her time with DCAT, Harriette helped shape the association for success in an evolving world. She encouraged talented women in the industry to become active members, as well as recruited more high-level executives. “She was a groundbreaker in many ways,” says Mike. “Looking back it’s hard to believe that a no-women membership policy existed, but that was right when so much was changing in the world. It was the watershed. She must be credited with a sea change in DCAT. As society and the workplace were evolving, change was inevitable, but someone had to be the catalyst.” Harriette Witmer has definitely earned her place in DCAT history, and will not only be remembered as the first female president, but for her strength of will and character. The DCAT staff would like to thank Mike Gorman, President of Vitaminerals Inc. and Kathy Gianetti, global consultant, for their contributions to this article.

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When Harriette F. Witmer broke the barrier for women to participate in the association, she opened doors for other women in the pharmachem industry. One of those women was Kathleen “Kathy” Gianetti.

In 1977, Kathy was encouraged by Harriette to join the DCAT association and become a volunteer. At that time, Kathy says DCAT was “a boys club that saw the world was changing and was ready to change.” Kathy recalls that DCAT realized this need for change years before other industry associations.

At Kathy’s first DCAT event, the 1977 Annual Meeting, she received a standing ovation. She laughs, “In those days women were introduced at events just because there were so few of us. It wasn’t just at DCAT; it was in the business world, too.”

She appreciated the warm welcome, and hit the ground running with the association, earning a position on DCAT’s Membership Committee. Over the years she climbed the DCAT leadership ladder – from regional representative to East Coast vice president, and then through the officer chair positions, becoming only the second female DCAT president in 1996.

During her 25+ years with the association, Kathy says she became the “Poster Girl” for DCAT, serving as an example for other industry women to get involved. She is grateful for all of the opportunities her involvement with DCAT has given her, especially in the early years of her career. “When I became active in the association, we were at a time in history when women really started to enter the industry. Belonging to DCAT made my career in sales,” says Kathy.

An Interview with Two of DCAT’s Female Leaders

Women in DCAT

Kathleen Gianetti, President 1996-97 (Left)Lyra Myers, President 2013-14 (Right)

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Harriette and Kathy’s leadership in the association paved the way for more industry women, including DCAT presidents Lynda Doyle (2005-2006), Joan Connolly (2011-2012) and Lyra Myers (2013-2014).

When Lyra Myers attended her first DCAT event in 2003, more women were making their mark in the industry. She had recently joined a small-molecule pharma company to manage the Procurement function. “APIs and excipients were part of the scope and they were new to me. I didn’t know who the players were in the space, and was looking for a resource in the industry to help build my knowledge,” recalled Lyra. Luckily, she found DCAT just in time for DCAT Week.

“Since I was just figuring out what we bought, and from whom, I was only able to schedule a couple of meetings and spent a lot of time trying to find people around the Waldorf clock. But I immediately saw the value in DCAT,” says Lyra and by the following DCAT Week, her meeting schedule was packed.

Lyra says the decision to become a volunteer was easy. “I knew it would be an opportunity to learn more about the industry, make great contacts, and help create even more value for members.”

Lyra has held many leadership positions in the association including the Supply Management Committee and pharmaceutical sector vice president, then making her way through the officer chairs becoming president in 2013.

Both Lyra and Kathy expressed their gratitude for DCAT, noting their involvement has given them the opportunity to work alongside some incredible volunteers with so much industry knowledge. “I’ve found them to be valuable resources for me personally and professionally,” adds Lyra.

Reflecting, Kathy says, “It has been a joy to watch DCAT grow over the years. I am so proud of what DCAT has become, and the amount of women now involved in the association. It’s amazing to think I was just one of a few women at my first DCAT event, and now we have enough women involved to fill an entire room at the Women’s Networking Breakfast!”

As women continue to break barriers in the industry, Kathy and Lyra are confident DCAT will continue to serve as a valuable resource for all industry representatives.

In DCAT’s 125 year history, there have only been five female presidents.

L-R: Harriette F. Witmer, Kathleen Gianetti, Lynda Doyle, Joan Connolly, and Lyra Myers

DCAT Highlights

1981 DCAT’s First Female President

Harriette F. Witmer of Deepwater Chemical Company was elected president on October 14, 1981 at the Annual Meeting in The Breakers Resort in Palm Beach, Florida.

1986 Establishes Seminar & Education Committee

In DCAT President Proctor Houghton’s address to members at the 60th Annual Dinner, he explained how the association is creating more ways to service its members. One member benefit was the formation of a Seminar & Education Committee. As you know, education programs are still an important asset of the DCAT organization today. Click here to read the address.

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• 1987 The First DCAT Pocket Guide (Pictured Left)

The first DCAT Pocket Guide was orchestrated by longtime DCAT member Benjamin W. Jones of Centcom, Ltd., that managed advertising for Chemical & Engineering News. Fourteen companies advertised in the first Pocket Guide. DCAT’s share of net proceeds from the Pocket Guide was donated to the 1987 Scholarship Program. Benjamin W. Jones (right), Senior VP, Centcom, Ltd.,

advertising management for Chemical & Engineering News, presents a check for $3,038.80 to DCAT’s Executive Director Joseph Madden.

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1987 Commemorates 10th Anniversary of the DCAT Scholarship Program

For the 10-year anniversary of the DCAT Scholarship Program, DCAT awarded eight students scholarship grants of $3,000 each toward their college education. A special, commemorative ninth “runner-up” scholarship in the amount of $1,500 was also granted. Scholarships were awarded to sons or daughters of employees of member companies. Click here to read the article that appeared in the September 1, 1987 edition of DCAT Digest.

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1987 Executive Director Joseph Madden Retires

After 19 years with the DCAT association, Joseph Madden retired from his role of Executive Director. During his tenure, the annual budget grew from $100,000 to $500,000 and membership from 250 member companies to 525. Click here to read an article about Mr. Madden that appeared in a 1987 edition of DCAT Digest.

1988 First Strategic Plan

In the minutes from June 16, 1988, the Executive Committee outlined the organization’s strengths and weaknesses and presented a strategic plan with four main objectives. Click here to find out what these objectives were.

1988 Mission Statement Adopted

Along with the strategic plan, the Executive Committee adopted a new mission statement for the association. Click here to read DCAT’s Mission Statement in 1988. >>

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1987 First Female DCAT Annual Dinner Speaker(Pictured Left)

U.S. Secretary of Transportation Elizabeth Dole addressed the 61st DCAT Annual Dinner on Thursday, March 19, 1987 at the Waldorf Astoria. Click here to see the Annual Dinner Announcement and a photo collage from the 1987 Dinner.

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1988 DCAT Headquarters Relocates

In November 1988, the DCAT headquarters moved from Long Island, NY to Roosevelt Avenue in Syosset, NY. The move allowed DCAT to save a substantial amount per square foot and improve working conditions for the staff.

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1988 DCAT Gets “Tech-Savvy”

Once in their new office, the DCAT staff installed their own computer and copier system. Executive Director Richard Lerman had urged for this installation in order to provide a cost effective data management and word processing system with graphics and typesetting capabilities to offset the cost of printing the DCAT Digest and other documents submitted to the board, Executive Committee and all other standing committees.

1989 Standing Committee System in Place

In accordance with the association’s strategic plan, qualified leaders were chosen for each of the new committee chair positions. Click here to learn more about the newly established positions.

1989 Institutes Hospitality Suite Reservation Process

DCAT’s Board of Directors approved a new policy to take effect for the 64th Annual Dinner on March 8, 1990, which allowed DCAT members to register their hospitality suites directly through the DCAT office. The policy also encouraged member companies to hold special events around the Annual Dinner as long as they did not directly conflict with the hours of the Annual Dinner. This policy is still in effect today. Click here to learn more.

1989 DCAT Establishes Antitrust Policy Statement

The DCAT Antitrust Policy first appeared in the 1989 DCAT Pocket Guide. In the Executive Committee minutes from March 8, 1989 a motion was passed to recommend the policy for addition to the by-laws to the Board of Directors for adoption. Click here to read the original antitrust policy.

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1980 - 1990

INDUSTRY TIMELINE

Amgen is established in Thousand Oaks, California. Three years later in 1983, Amgen becomes the company’s official name, concurrent with its initial public offering. The name is derived from the company’s original name, Applied Molecular Genetics. Also in 1980, the newly founded biotechnology company, Genentech, goes public.

Biogen scientists announce two groundbreaking discoveries: the expression of biologically active human leukocyte (alpha) interferon and biologically active human fibroblast (beta) interferon. Many years later, this pioneering work will ultimately lead to the development of Avonex (interferon beta-1a) used to treat multiple sclerosis. In the same year, Walter Gilbert, of Harvard University and a Biogen founder, and Frederick Sanger of the MRC Laboratory of Molecular Biology in Cambridge, UK, and Paul Berg of Stanford University are awarded the Nobel Prize in Chemistry for their work in understanding the sequencing of DNA.

Feldene (piroxicam) becomes one of the largest-selling prescription anti-inflammatory medications in the world and, ultimately, Pfizer’s first product to reach a total of $1 billion in

Sanofi acquires Clin Midy, itself created via the merger of Clin Comar Byla, which was founded at the end of the 19th century, and Laboratoires Midy, founded in 1718 by a family of pharmacists. >>

The pharmaceutical majors advance biotechnology. At the Roche Institute of Molecular Biology, a pure interferon alfa is isolated. Roche Nutley and Genentech start to work on a joint project to produce a genetically engineered version of the substance. It later leads to the development of Roche’s first biotechnologically produced cancer drug, Roferon-A, in 1986. Also in 1980, Ciba-Geigy creates a biotechnology unit.

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In the 1980s, the scientific and commercial potential of biotechnology is more fully realized. New start-up companies, Amgen, Genzyme, and Gilead Sciences, are founded. The pharmaceutical majors advance biologic-based drugs with key discoveries in research, development, and biomanufacturing. The first biotech drug, biosynthetic human insulin, is approved by the US Food and Drug Administration in 1982. Later in the decade, approval of other key recombinant pharmaceuticals and vaccines, mark the entry of biologics into the pharmaceutical marketplace. And the industry continues to expand led by several key mergers and acquisitions.

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Biotechnology Transforms the Pharmaceutical Industry

The Orphan Drug Act is passed, enabling the US Food and Drug Administration to promote research and marketing of drugs needed for treating rare diseases.

A research team led by Larry M. Souza at Amgen clones the gene for human granulocyte colony-stimulating factor (G-CSF) and produces recombinant G-CSF, later patented and named Neupogen (filgrastim). It later would be approved by the US Food and Drug Administration in 1991 to reduce infection caused by chemotherapy.

An Amgen research team, led by Fu-Kuen Lin, clones the human erythropoietin gene and subsequently produces the first human erythropoietin product. Five years later in 1989, recombinant human erythropoietin, epoetin alfa, is approved by the US Food and Drug Administration. The drug stimulates red blood cell production in the same way as naturally occurring erythropoietin produced by the kidneys, a major advancement; before recombinant human erythropoietin, blood transfusions and testosterone-based therapies had to be used.

Rocephin, an antibiotic of the cephalosporin class, is launched 1982 in Switzerland only four years after its discovery by Roche; by 1987, Rocephin will be outselling all other Roche products worldwide.

The Drug Price Competition and Patent Term Restoration Act (known as the Hatch-Waxman Act) becomes law and provides a regulatory framework for the generic drug industry. The new law expedites the availability of generic drugs by permitting the FDA to approve applications to market generic versions of brand-name drugs without repeating the research done to prove them safe and effective. At the same time, the brand-name companies were allowed to apply for additional patent protection for up to five years for the new medicines they developed to make up for time lost while their products were going through the FDA’s approval process.

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The biotechnology company Genzyme is founded in Boston, Massachusetts. Starting with only 21 employees and $2.2 million in revenues in its first year, it would grow to 490 employees with revenues of $34 million by the end of the decade. The company goes public with an initial public offering in 1986. In 1989, Genzyme acquires Integrated Genetics (a biotech start-up established in 1981) with a focus on producing therapeutic proteins in mammalian cell culture and on using DNA probes for diagnostic and genetic testing.

Biogen holds an initial public offering. The company also officially opens its expanded US facilities in Cambridge, Massachusetts.

The first biotech drug – biosynthetic human insulin that is produced in genetically modified bacteria – is approved by the US Food and Drug Administration (FDA), making it the first human healthcare product made using recombinant DNA technology to be approved by the FDA. The new insulin is manufactured by Eli Lilly under license from Genentech. Lilly would later apply this technology to the introduction of Humatrope (somatropin [rDNA origin] for injection), a new therapy for treating growth hormone deficiency in children. The drug would receive FDA approval in 1987.

Niels Kaj Jerne, the first director of the Roche-supported Basel Institute for Immunology, is awarded the Nobel Prize in Physiology or Medicine, along with Georges Köhler, also of the Basel Institute for Immunology, and César Milstein of the MRC Laboratory of Molecular Biology in Cambridge, UK, for their discoveries in immunology and the production of monoclonal antibodies.

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Interferon becomes the first anticancer drug produced through biotech. With approval from the FDA, Schering-Plough begins commercial sales of Intron A (interferon alfa-2b), which marks the first product developed by Biogen to be brought to market. Licensed by Biogen a few years earlier, the product addresses an unmet need for patients affected by a rare form of leukemia. At the same time, Genentech’s interferon alfa-2a, licensed to Roche as Roferon-A, received approval from the US Food and Drug Administration for the treatment of hairy cell leukemia.

The biotechnology company Gilead Sciences is founded.

Boehringer Ingelheim’s biotechnological center in Biberach, Germany starts production, making it one of Europe’s largest plants for the production of biopharmaceuticals from cell cultures.

The US Food and Drug Administration approves the first recombinant vaccine for humans – a vaccine for hepatitis B – that was developed by researchers at Chiron Corporation. Chiron had been founded in 1981 by three researchers from the University of California (UC): William J. Rutter (UC, San Francisco), Edward Penhoet (UC, Berkeley), and Pablo DT Valenzuela (UC, San Francisco). Merck & Co. collaborated with the researchers for developing a recombinant vaccine for hepatitis B as an improvement to Merck’s plasma-based hepatitis B vaccine that had been earlier approved.

Novo starts production of human insulin with the help of genetically engineered yeast cells.

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Genentech receives approval from the US Food and Drug Administration to market its first product, Protropin (somatrem for injection) growth hormone for children with growth hormone deficiency. It is the first recombinant pharmaceutical product to be manufactured and marketed by a biotechnology company.

Merck & Co. introduces Mevacor (lovastatin), the first statin in that class of medicines to treat high cholesterol, to be approved by the US Food and Drug Administration. It emerges from 35 years of study by scientists in the US and abroad at universities, independent laboratories, and at Merck & Co.

Silicon Valley venture capitalists join forces with a group of research scientists to establish IDEC Pharmaceuticals (which would later merge with Biogen to form Biogen Idec) with the goal of developing and commercializing monoclonal antibodies. This new first target is a patient-specific, customized approach to treating non-Hodgkin’s lymphoma.

Susumu Tonegawa, a researcher at the Roche-supported Basel Institute for Immunology, is awarded the Nobel Prize in Physiology or Medicine in 1987 for his discovery of the genetic mechanisms underlying the diversity of antibodies produced by the immune system. His fundamental discoveries were instrumental in advancing the field of recombinant antibody technology, which would later make it possible to produce humanized antibodies.

The Food and Drug Administration Act of 1988 officially establishes the US Food and Drug Administration as an agency of the Department of Health and Human Services with a Commissioner of Food and Drugs appointed by the president with the advice and consent of the Senate, and broadly spells out the responsibilities of the secretary and the commissioner for research, enforcement, education, and information. >>

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Biogen announces US Food and Drug Administration approval of its recombinant hepatitis B vaccine, which is licensed to SmithKline Beecham, which would later become GlaxoSmithKline.

1989

Industry growth continues through mergers and acquisitions with two mega-mergers in 1989. Bristol-Myers merges with Squibb to form the Bristol-Myers Squibb Company. SmithKline Beckman and the Beecham Group merge to form SmithKline Beecham plc, laying the foundation of today’s GlaxoSmithKline. And in another move in 1989, Dow Chemical acquires a controlling interest in Marion Laboratories, which was renamed Marion Merrell Dow, which through a succession of other acquisitions in the 1990s, would become a piece of what is today’s Sanofi.

Nordisk Insulinlaboratorium, the Nordisk Insulin Foundation, and the Novo Foundation merge to become the Novo Nordisk Foundation. Novo Industri A/S and Nordisk Gentofte A/S merge to become Novo Nordisk A/S, a major producer of insulin, and Novo’s product NovoLet, the world’s first prefilled insulin syringe, is marketed.

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DCAT’s Past Presidents1980 - 1990

1984-1985C.N. Keriazakos, Essex Industrial Chemicals

1989-1990James W. Witmer, Deepwater, Inc.

1983-1984John R. Lee, Dow Chemical USA

1988-1989William D. Benfer, Pfizer Inc.

1980-1981Dr. James E. Cochran, Stauffer Chemical Company

1985-1986Proctor W. Houghton, Houghton Chemical Corporation

1981-1982Harriette F. Witmer, Deepwater Chemical Company

1986-1987Alan Novak, Burroughs Wellcome Company

1982-1983Robert Gutheil, Borden Chemical

1987-1988Douglas W. Nabholz, Mallinckrodt, Inc.

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NOPHOTO

AVAILABLE

DCAT’s ExecutiveStaff

Joseph Madden, Executive Director(1970-1987)Joseph D. Madden joined the DCAT staff in 1969 and assumed the role of Executive Director when Helen L. Booth retired in 1970. Mr. Madden retired from Executive Director in 1987, but remained on the DCAT staff as a consultant until 1988 – accumulating 19 years of service to the association, and becoming yet another longtime, beloved member of the DCAT Executive Staff.

Click here to read an article that appeared in a 1988 edition of DCAT Digest honoring Mr. Madden on his retirement.

Mary F. McManus, Secretary(1973-1992)Mary F. McManus joined the DCAT staff as secretary in 1973, when the DCAT office was in the New York Empire State Building. She remained in this role for 19 years until retiring in 1992 at the age of 80. Longtime DCAT members say “DCAT was her family” and that “she was loved and absolutely adored by everyone”.

Richard J. Lerman, Executive Director(1987-1996)Richard J. Lerman was hired as Executive Director in 1987. He hit the ground running as the association developed a strategic plan, mission statement and antitrust policy in his first two years of service.

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