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Blog News - A Dose of Drug Development is a web publication produced by Integrium. The blog post content included conveys subjects of discussion and practice in the drug development process along with real-time Integrium activity. Readers interested in following are welcome to comment and interact on the Integrium website blog space.


Integrium, LLC to Attend the 2018 Biotechnology Innovation Organization (BIO) International Convention located in Boston, CA

By: Kevin Cho

Tustin, CA - Integrium, LLC announced they will be attending the 2018 Biotechnology Innovation Organization (BIO) International Convention located in Boston, CA on June 4-6. Integrium is looking forward to joining other industry thought leaders and pharmaceutical companies to fulfill networking goals and potential partnerships.

The key benefits of attending the BIO International Convention is to gain exposure to biotechnology and pharmaceutical leaders and opportunities to network with 16,000+ attendees from 74 countries. For more information, or to register, please see BIO’s website (http://convention.bio.org/)

Integrium Executives will be taking meetings throughout BIO and encourage guests to schedule meeting requests with Mike Loftus, Executive Director of Business Development and other companies attending BIO. Please contact kevin.cho@integrium.com to schedule time with Integrium during BIO.

About Integrium

Integrium helps Micro Cap, Small Cap, and Privately held Biotechs within the Innovator and Generic space attain clinical data so they can raise the next round of capital. Integrium’s areas of therapeutic focus include Cardiovascular, Metabolic, Renal, Inflammatory, Dermatology, Wound Healing, Gene Therapy, and Orphan Diseases. Secondary specialties include Schedule 2 drugs and Oncology.

Check out our new website!

www.integrium.com

To learn more about Integrium, contact:

Kevin Cho
Business Development Analyst
kevin.cho@integrium.com
714-591-0267


Staying on track for 2017 year end enrollment goals?

By: Emily MacHale

Sponsor s come to Or ange County Resea r ch Center (OCRC) because:

  • They are struggling to meet enrollment projection and goals.
  • They are frustrated by the lack of urgency of current clinical sites.
  • They are upset that their study is not a priority at the site level.
  • They are excited by the large database of patients in a vast population center, such as Irvine, CA.

Upcoming New Year

With the end of 2017 in clear view, many biotechs are struggling with their studies and their ability to enroll patients on time. Often times, biotechs are in need of a little push to meet or exceed their enrollment goals to prepare for a successful and innovative new year. What are the strategies your biotech takes to ensure enrollment goals and timelines are achieved? What are the current enrollment struggles and what have you done to ensure patients are enrolled on time?

Sponsors typically go to Orange County Research Center (OCRC), Integrium’s Phase I-IV clinical unit, as a rescue site when they are needing one-on-one, relationship oriented guidance and are under pressure to meet their timelines.

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About OCRC

Orange County Research Center, located in Tustin, CA, is a private medical facility which treats patients in clinical trials for Sponsors. OCRC recruits, manages, and executes cutting edge clinical research protocols for pharmaceutical and biotechnology companies. Some areas of focus are Cardiovascular Disease, Diabetes, Renal, Hypertension, Pain, Dermatology, and Wound Healing. OCRC, founded in 1985, has participated in over 450 clinical trials that have advanced the development of many new treatments.

Dr. Joel Neutel, OCRC’s Medical Director, has served as a Principal Investigator on several hundred-multinational cardiovascular, metabolic, dermatology and wound healing trials. He also carries with him extensive experience serving the biopharmaceutical industry in the areas of clinical and academic research, as well as marketing strategic planning.

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Are you a Sponsor in need of an OCRC-type relationship? For more information regarding OCRC’s vision and initiatives, contact Mike Loftus, Executive Director of Business Development at Mike.Loftus@integrium.com.


Join Integrium, LLC in San Francisco at the Microbiome Breakfast Round-Table: J.P. Morgan

During J.P. Morgan 36th Annual Healthcare Conference
Hosted by Integrium, LLC and EisnerAmper

The Microbiome breakfast will allow networking between Microbiome Companies
and Venture Capitalists who are active in the Microbiome space:

The following presentations and topics will be discussed:

  • Clinical lessons learned with respect to gut, dermatology, and metabolic microbiome studies.
  • Unique exit strategies with respect to Microbiome companies and how they differ from therapeutic companies.
  • A Venture Capitalist perspective on how they view Microbiome therapeutics from 510(k).
  • View or perspective from Microbiome sponsors on the unique challenges they see in the industry.

Microbiome-1

Meet the Experts and Learn Industry Secrets

Join Integrium, LLC and EisnerAmper Executives at our breakfast round-table during the week of the 2018 J.P. Morgan 36th Annual Healthcare Conference.

Integrium will be sharing their expertise within microbiome clinical trials, fecal sample collection lessons learned, tips to shorten the path to commercialization, exit strategies for microbiome companies, and alternative financing solutions. Integrium has worked on a solid number of Microbiome-related trials and has an extensive database of 2,500+ pre-screened patients whom are interested in microbiome skin and stool-based studies.

EisnerAmper, who has partnered with Integrium in the past on a number of events, will be covering a broad range of topics such as impact of tax reform on life sciences companies, the current life sciences financing environment, and beyond.

A Time To Collaborate and Connect

Come ready to discuss, enjoy a light breakfast with coffee, and develop relationships with like-minded industry folks in the microbiome, biotech, medical device, diagnostic, and financial sectors.

Who: Microbiome Companies, Microbiome Venture Capital and Private Equity
When: January 10th, 2018
Where: EisnerAmper: 1 Market St # 620, San Francisco, CA 94105
Time: 8:00 - 10:00 AM PST

Microbiome

Please RSVP by December 22, 20 17

Please RSVP to:
Emily MacHale
Associate Director, Marketing & Research
Emily.MacHale@Integrium.com
Main Phone: (908)-375-2009
Mobile Phone: (201)-704-2066

About Integrium

Founded in 1998 by visionary clinical research thought leaders, Integrium is a full-service Phase I-IV clinical CRO that specializes in a wide range of therapeutic areas. Integrium plays a key role in furthering new medical advancements by helping pharmaceutical companies design and execute clinical studies, ensuring they achieve their objectives on time, on budget, and with expected quality.

Integrium helps Micro Cap, Small Cap, and Privately held Biotechs within the New Chemical Entity, 505(b)(2) and Generic space attain clinical data so they can raise the next round of capital. Integrium’s areas of therapeutic focus include Cardiovascular, Metabolic, Renal, Inflammatory, Dermatology, Wound Healing, Gene Therapy, and Orphan Diseases. Secondary specialties include Schedule II drugs and Oncology.

Check out our new website!
www.integrium.com


Integrium, LLC Executives to Attend American Association of Pharmaceutical Scientists

By: Emily MacHale

Tustin, CA – Integrium, LLC Executives will be attending the American Association of Pharmaceutical Scientists (AAPS) in San Diego on November 12-15, 2017. Taking place at the San Diego Convention Center, Integrium is looking forward to connecting with industry folks and learning more about patient-centric innovations and opportunities.

The chance to be able to hear from top speakers, keynote presentations, and more is valuable to Integrium and their current initiatives in the biotechnology ecosystem. This conference provides the opportunity to connect with CEOs, scientists and clinical partners that are advancing Generic, 505b2 and other healthcare initiatives while finding solutions to improve patient-centric goals. Integrium welcomes CEOs, scientists and clinical partners to join them in finding potential ways to collaborate and develop partnerships for current and future opportunities.

Integrium will be available for meetings throughout the event and encourages guests reach out to Emily MacHale, Associate Director of Marketing & Research at Emily.MacHale@integrium.com for any meeting requests.

About Integrium

Founded in 1998 by visionary clinical research thought leaders, Integrium is a full-service Phase I-IV clinical CRO that specializes in a wide range of therapeutic areas. Integrium plays a key role in furthering new medical advancements by helping pharmaceutical companies design and execute clinical studies, ensuring they achieve their objectives on time, on budget, and with expected quality.

Integrium helps Micro Cap, Small Cap, and Privately held Biotechs within the New Chemical Entity, 505(b)(2) and Generic space attain clinical data so they can raise the next round of capital. Integrium’s areas of therapeutic focus include Cardiovascular, Metabolic, Renal, Inflammatory, Dermatology, Wound Healing, Gene Therapy, and Orphan Diseases. Secondary specialties include Schedule II drugs and Oncology.

Check out our new website!
www.integrium.com

To learn more about Integrium, contact:
Emily MacHale
Associate Director of Marketing & Research
Emily.MacHale@Integrium.com
908-375-2009


Integrium, LLC to Discuss Alternative Financing Solutions for Biotech during J.P. Morgan 36th Annual Healthcare Conference Week

By: Emily MacHale

Tustin, CA – Integrium, LLC Executives will be in San Francisco during the J.P. Morgan 36th Annual Healthcare Conference on January 8-11, 2018. Being in San Francisco during the conference over the past 7 years, Integrium is able to continue connecting with biotech, medical device, and diagnostic companies, while building new relationships and cross-pollinating a wide span of industry sectors.

The JPM Conference is expecting to host over 400 public and private companies, in addition to more than 8,000 guests. Being the largest healthcare investment conference in the industry, Integrium values the opportunity to connect with investors and like-minded folks looking to collaborate and develop strategic partnerships.

Integrium will be available for meetings January 8-11, 2018 and encourages guests to reach out to Emily MacHale, Associate Director of Marketing & Research at Emily.MacHale@integrium.com for any meeting requests.

About Integrium

Founded in 1998 by visionary clinical research thought leaders, Integrium is a full-service Phase I-IV clinical CRO that specializes in a wide range of therapeutic areas. Integrium plays a key role in furthering new medical advancements by helping pharmaceutical companies design and execute clinical studies, ensuring they achieve their objectives on time, on budget, and with expected quality.

Integrium helps Micro Cap, Small Cap, and Privately held Biotechs within the New Chemical Entity, 505(b)(2) and Generic space attain clinical data so they can raise the next round of capital. Integrium’s areas of therapeutic focus include Cardiovascular, Metabolic, Renal, Inflammatory, Dermatology, Wound Healing, Gene Therapy, and Orphan Diseases. Secondary specialties include Schedule II drugs and Oncology.

Check out our new website!
www.integrium.com

To learn more about Integrium, contact:
Emily MacHale
Associate Director of Marketing & Research
Emily.MacHale@Integrium.com
908-375-2009


Integrium, LLC Executives to Attend 5th Microbiome R&D and Business Collaboration Forum: USA

By: Emily MacHale

Tustin, CA – Integrium Executives are attending the 5th Microbiome R&D and Business Collaboration Forum in San Diego on November 2-3, 2017; with the collaboration of the 2nd Probiotics Congress: USA. Integrium Executives are excited to network and share ideas with the projected over 400 attendees and 70 speakers that will be involved in roundtables, panel discussions, networking events, and more. More specifically, Integrium is looking forward to learning more about the innovative opportunities involving the human microbiome: the gut, skin, oral, genetic disease states and beyond.

Integrium is heavily invested in the microbiome space, currently conducting various dermatology and gut microbiome studies. In addition, Integrium’s clinical Phase I - IV unit (Orange County Research Center) has thousands of pre-screened healthy volunteers that participate (or want to participate) in upcoming fecal sampling studies. Having better knowledge of the microbiome is important to understanding numerous existing genetic diseases. Many genetic diseases require their own unique approach, and grasping the ins and outs of the microbiome can impact the way we tackle these innovative drug development goals.

Actively participating in the 5th Microbiome R&D and Business Collaboration Forum allows Integrium to broaden goals and initiatives for microbiome-based disease cures, provides opportunity to dip into recent findings, and to stay in touch with industry trends. With that, investors are able to join and find potential partnerships with early-stage biotechs and start-ups.

Integrium is available for meetings all day on November 2, 2017 and encourages guests reach out to Emily MacHale, Associate Director of Marketing & Research at Emily.MacHale@integrium.com for any meeting requests.

About Integrium

Founded in 1998 by visionary clinical research thought leaders, Integrium is a fullservice Phase I-IV clinical CRO that specializes in a wide range of therapeutic areas. Integrium plays a key role in furthering new medical advancements by helping pharmaceutical companies design and execute clinical studies, ensuring they achieve their objectives on time, on budget, and with expected quality.

Integrium helps Micro Cap, Small Cap, and Privately held Biotechs within the New Chemical Entity, 5o5b2 and Generic space attain clinical data so they can raise the next round of capital. Integrium’s areas of therapeutic focus include: Cardiovascular, Metabolic, Microbiome, Regenerative Medicine, Renal, Inflammatory, Dermatology, Wound Healing, Gene Therapy, and Orphan Diseases. Secondary specialties include Schedule 2 drugs and Oncology.

For more information on Integrium’s microbiome clinical studies and initiatives, please visit us online at: http://www.integrium.com/our-expertise/microbiome/

Check out our new website!
www.integrium.com

To learn more about Integrium, contact:
Emily MacHale
Associate Director of Marketing & Research
Emily.MacHale@Integrium.com
908-375-2009