EBP Master Class

EBP Master Class

Webinar Series

Accelerated knowledge and practical learnings specific to your emerging biopharma (EBP) and early stage medical device journey.

Tap into Consultant knowledge specific to emerging biopharma, early phase trials and early stage medical devices. For the first time, leading industry consultants are sharing advice and intelligence to your most pressing questions.

Join Medidata EBP Master Class for a eight-part webinar series with industry veterans responsible for bringing hundreds of drugs and devices to market.

Focus: Biopharma

The Importance
of Picking the Right CRO

Wednesday, October 30, 2019
1PM ET / 10AM PT

Sharon AydFEATURED CONSULTANT
Sharon W. Ayd, Ph.D.
Chief Executive Officer
Ayd BioPharma Consulting Group, LLC

RESERVE MY SEAT

All clinical trials come with their own set of unique complexities. You need a CRO partner that can help guide you through these challenges, especially during the critical early study phases.

If you are in the process of evaluating CROs, or are about to embark on your phase 1 trial, this webinar will be catered specifically for emerging biopharma companies and will highlight the importance of selecting the right CRO and the 5 main criteria you need to look for, while making the best use of your financial investment.

We will go over:

  • How to evaluate their nimbleness and responsiveness to a small companies needs.
  • One stop shop vs outsourcing
  • Pricing guarantees

Focus: Biopharma

Data Management Evolutions (part 1):
CRO Management

Tuesday, November 19, 2019
1PM ET / 10AM PT

Hajime ArnoldFEATURED CONSULTANT
Hajime Arnold
Co-Founder and Executive Director, Data Management
Emanate Life Sciences

RESERVE MY SEAT

The old paradigm of EDC as the primary source of data has shifted. With biomarker, genomics, imaging, bioanalytical labs, central labs, safety labs, and wearable data all proliferating, the approach to data management needs to shift.

Many CROs are ensconced in old processes and fail to respond to changes in the way clinical data is being collected. It is often missed that over 50% of the clinical data being collected are in external data sources. It is imperative a sponsor understands how a CRO will manage clinical data that is not EDC.

The first part of this series, we will be addressing the following items:

  • Contracting for data management what should be included.
  • Maintaining CRO Oversight

Focus: Medical Device

The 5 Top Pitfalls for Early Stage Medical Device Companies and How to Avoid Them

Wednesday, December 4, 2019
1PM ET / 10AM PT

Alethea WielandFEATURED CONSULTANT
Alethea Wieland
President and Founder
Clinical Research Strategies, LLC

RESERVE MY SEAT

Understand the costs and best locations to bring your product to market.

Many entrepreneurs and life science executives believe the EU CE Marking system is the cheapest and quickest option to market as opposed to working on the FDA regulatory pathway and accessing one of the largest device markets in the US. 

In today’s era of vast regulatory reform, there are a number of advantages to looking at the US first. Challenges remain with the EU changes to the Medical Device Regulations (MDR) and the backlash surrounding so few Notified Bodies approved to certify new and existing devices. 

We will go over:

  • How to avoid the most common pitfalls that lead to wasted time and resources
  • How to lay the critical foundations for your future advanced trial phases, including the use of real-world data.
  • Review key regulatory innovations to clinical research strategies

Focus: Biopharma

Top 5 Ways
to Reduce Study Times

Wednesday, December 11, 2019
1PM ET / 10AM PT

Inessa VulfovaFEATURED CONSULTANT
Inessa Vulfova
Principal
Beyond Pinnacle

RESERVE MY SEAT

Did you know that the median time for Emerging Biopharma to launch new drugs is 16.6 years, 30% longer than other segments*. This webinar will offer proven ideas on how to trim that timeline down from industry expert Inessa Vulfova.

In this webinar you will learn valuable tips on how to:

  • Reduce patient enrollment times
  • Speed up site activation
  • Negotiate CRO contracts to avoid renegotiations later
  • Conduct effective vendor management
  • Perform efficient study closeout

*IQVIA Institute, Emerging Biopharma’s Contribution to Innovation, June 2019

Focus: Medical Device

Engaging with Regulators: What you Need to Know and Share and When

Wednesday, January 22, 2020
1PM ET / 10AM PT

Alethea WielandFEATURED CONSULTANT
Alethea Wieland
President and Founder
Clinical Research Strategies, LLC

RESERVE MY SEAT

The FDA and other competent authorities are our collaborators.

However, we have a natural tendency to view regulators as adversaries, but with today’s research initiatives in software as a medical device (SaMD), AI, and in silico techniques, meeting with the FDA early is always a good idea to set a successful course for your product roadmap and clinical evidence program.

In this webinar we will go over the various types of meetings and how they can help you with.

  • Preparing for and conducting investor pitches
  • Raising capital
  • Building the right foundational strategies for success

Focus: Biopharma

Data Management Evolutions (part 2): The New Data Manager – What Skills Do They Need?

Thursday, January 30, 2020
1PM ET / 10AM PT

Hajime ArnoldFEATURED CONSULTANT
Hajime Arnold
Co-Founder and Executive Director, Data Management
Emanate Life Sciences

RESERVE MY SEAT

The old paradigm of EDC as the primary source of data has shifted. With biomarker, genomics, imaging, bioanalytical labs, central labs, safety labs, and wearable data all proliferating, the approach to data management needs to shift.

Many CROs are ensconced in old processes and fail to respond to changes in the way clinical data is being collected. It is often missed that over 50% of the clinical data being collected are in external data sources. It is imperative a sponsor understands how a CRO will manage clinical data that is not EDC.

This will be the second of a two part series where we discuss how the role of data management is changing. In this conversation, we will be going over:

  • An overview on how the data manager role is evolving
  • What this means for existing data managers and hiring strategies
  • CRO oversight

Focus: Biopharma

The FDA is Your Friend:
How to engage the FDA the right way

Wednesday, February 12, 2020
1PM ET / 10AM PT

Sharon AydFEATURED CONSULTANT
Sharon W. Ayd, Ph.D.
Chief Executive Officer
Ayd BioPharma Consulting Group, LLC

RESERVE MY SEAT

Having a strategic roadmap to navigate and meet the requirements of the FDA for approvals is critical as well as knowing how to engage with them to get the results you need especially with IND requests.

Industry expert Sharon Ayd has brought hundreds of drugs to market and will provide practical takeaways in:

  • IND guidance and requests
  • Navigating and submitting correct forms
  • Picking strategic endpoints and patient population to meet FDA requirements

Focus: Medical Device

In-house or Outsource, Consultant or CRO? How to get the best bang for your limited bucks?

Wednesday, February 26, 2020
1PM ET / 10AM PT

Alethea WielandFEATURED CONSULTANT
Alethea Wieland
President and Founder
Clinical Research Strategies, LLC

RESERVE MY SEAT

The strength of the evaluation process of your CRO, vendors, and various partners can make or break a small life science business. Don’t be another statistic of a trial rescue and having to fire your CRO or partners because your due diligence or oversight was lacking.

In this webinar we will review

  • Basic RFP techniques to perform the necessary evaluations on your CROs and partners
  • How to maximize the chance of completing your trials on time and on budget
  • Opportunities to provide investor groups with more realistic predictions that do not endanger the shareholder relationship or confidence.

Alethea Wieland

ALETHEA WIELAND

President and Founder
Clinical Research Strategies, LLC

Alethea Wieland is founder and president of Clinical Research Strategies, LLC, an executive-level management consulting firm and boutique, functional service provider for the life sciences industry.

Her firm’s solutions include analyzing the intersection of healthcare innovation and policy; providing flexible clinical trial resourcing; developing sustainable corporate affairs programs and policies; training and managing resilient, high-performing clinical operations teams; mitigating risks of clinical trials; rescuing clinical trials and TMFs; and facilitating transparent, accountable sponsor-CRO partnerships.

Learn more by connecting with her on LinkedIn, and by visiting the Clinical Research Strategies website, www.clinicalresearchstrategies.com.

Hajime Arnold

HAJIME ARNOLD

Co-Founder and Executive Director, Data Management
Emanate Life Sciences

Hajime founded Emanate Life Sciences to help increase the likelihood of clinical trial success for small and mid-sized biotech, pharma, and medical device companies. He enjoys sharing his knowledge and experience to support other life science organizations.

Prior to Emanate, he founded Chrysalis Insight, an analytics platform supporting protocol development and site selection activities based on electronic health records. Hajime has worked for various industry leaders such as Guidant, Abbott Vascular, Onyx Pharmaceuticals, and Amgen. He has held various positions including clinical operations, data management, safety, and medical affairs. Under his leadership, his teams successfully implemented clinical trial management systems, electronic trial master files, electronic data capture, and safety systems.

Hajime currently serves on the PAMF (Palo Alto Medical Foundation) Community Board and is a former Court Appointed Special Advocate (CASA). Hajime holds a bachelor’s degree in Organizational Behavior and Leadership from the University of San Francisco.

Learn more by connecting with him on LinkedIn, and by visiting the Emanate Life Sciences website, emanatelifesciences.com.

Sharon Ayd

SHARON W. AYD, Ph.D.

Chief Executive Officer
Ayd BioPharma Consulting Group, LLC

Dr. Sharon W. Ayd is a biopharmaceutical industry veteran with more than 30-years of experience in commercializing Branded/Novel, Specialty, Rare/Orphan, and Complex Generic drugs. During her career, Dr. Ayd has worked in several multinational companies including, Baxter International, Apotex Inc., Hospira (now Pfizer), and Fresenius-Kabi. She has also been a founding/C-level executive in start-ups; Transcend Therapeutics, Advanced Life Sciences, and Pinnacle Biologics. Under her leadership, ~100 drug application approvals (NDA, 505(b)(2), ANDA and biosimilar and supplements) have been obtained. She has also been a key player in many M&A transactions up to $1b.

In 2015, Dr. Ayd formed Ayd BioPharma Consulting Group LLC, a consultancy that serves start up to big Pharma clients in Life Sciences, Pharmaceuticals, Biologics, and Combination Products. She received a Ph.D. in Biopharmaceutical sciences from the University of Illinois at Chicago. She is also an Adjunct Professor at Northwestern University, Pritzker School of Law and is on the Board of Reglagene Inc.

Learn more by connecting with her on LinkedIn, and by visiting the Ayd BioPharma Consulting Group website, aydbiopharmaconsultinggroup.com.

Inessa Vulfova

INESSA VULFOVA

Principal
Beyond Pinnacle

Highly knowledgeable Global Clinical Trial Manager with 15 years of pharmaceutical industry experience, with a proven track record of leading clinical trial coordination strategies, overseeing project management initiatives, and contributing toward organizational success. Possess advanced communication, excellent working understanding of clinical study and drug development processes, deep knowledge of monitoring procedures, detailed understanding of GCP and ICH guidelines, and regulatory requirements supporting the research goals of industry leaders.